539046
research-article2014
SRIXXX10.1177/1553350614539046Surgical InnovationSurgical InnovationCho et al
Innovative Technologies
Development of Biopsy Gun for Aspiration and Drug Injection
Surgical Innovation 2015, Vol. 22(2) 163–170 © The Author(s) 2014 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1553350614539046 sri.sagepub.com
Hyun Guy Kang, PhD, MD2, Sung Ho Cho1, Chang Nho Cho1, and Kwang Gi Kim, PhD1
Abstract Tumor samples are required for pathological examinations, and different instruments are generally used to obtain samples of different types of tumors. Among the many methods available for obtaining tumor tissues, gun biopsy is widely used because it is much simpler than incisional biopsy and can collect many more samples than aspiration biopsy. However, conventional biopsy guns cannot simultaneously perform biopsy aspiration, bleeding prevention, and marker injection. In this study, we developed a biopsy gun that can simultaneously perform biopsy aspiration and sample collection, in addition to injecting a styptic agent and marker to prevent bleeding and contamination in the biopsy track. We then used a prototype to evaluate the feasibility of the developed device. The collectable sample size was also assessed. Performance of the biopsy aspiration feature was also evaluated, including the maximum aspiration viscosity. Finally, we tested the maximum amount of drug that can be injected. We found that the biopsy gun developed here is an alternative tool for biopsy collection with improved procedure safety and diagnostic accuracy. Keywords gun biopsy, aspiration, hemostasis, track marking, drug injectable
Introduction Current methods of obtaining tumor tissues for pathological examinations include incisional biopsy, aspiration biopsy using fine-needle aspiration, scopic biopsy using endoscopic forceps, and gun biopsy using gun biopsy devices.1-3 Incisional biopsy allows the collection of sufficient amounts of tissue with high diagnostic accuracy, but it is invasive and costly because of the requirement for anesthesia during the incision. Therefore, in the absence of a precise and meticulous surgical technique, there is a high risk of tumor cell contamination around the incision.4 Aspiration biopsy involves less discomfort and pain but can be used to collect only small tissue samples, which limits its diagnostic accuracy. Gun biopsy is less invasive than incisional biopsy. Because a tissue-cutting needle can be used to collect more tissues than aspiration biopsy, its diagnostic accuracy is also relatively high, and this method has been widely used in the diagnosis of several types of cancers.5-8 Percutaneous tissue biopsy using an automated biopsy gun is a relatively simple and rapid procedure, with a low risk of complications and a high detection rate. These superior features have resulted in its extensive use as a diagnostic technique and in the histological examination of various organs in the body.9-11 Musculoskeletal tumors vary in size
and their internal organization is observed in liquid, solid, or mixed forms. Solid tumor tissues can be collected using existing gun biopsy products, but it is difficult to collect liquid or mixed-phase tissue specimens, in which case the neoplastic liquid flows out after the biopsy, increasing the risk of needle track tumor contamination.1,2,5 To compare the diagnostic results of aspiration biopsy and incision or incisional biopsy, preoperative aspiration biopsy was performed on 25 patients, 13 of whom also underwent additional aspiration and incisional biopsies. Our results showed that 8 of these patients had identical findings from both the aspiration and incisional biopsies, whereas 5 showed completely different diagnostic findings.12 Because of the nature of tumor tissues, its characteristics cannot be accurately determined based on aspiration biopsy alone when they 1
Biomedical Engineering Branch, National Cancer Center, Goyang-si, Gyeonggi-do, Republic of Korea 2 Orthopaedic Oncology Clinic, National Cancer Center, Goyang-si, Gyeonggi-do, Republic of Korea Corresponding Authors: Hyun Guy Kang, Orthopaedic Oncology Clinic, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do 410-769, Republic of Korea. Email: [email protected]
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are in the liquid or mixed form. Therefore, a method that allows tumor tissue to be collected along with aspiration is needed. Even for aspiration biopsy, which almost never has any complications, contamination by malignant tumor cells has occurred around the needle track area. The tracks produced by blunt needles or needles >20G increase the risk of contamination.13,14 However, Lee et al15 reported that the complication rate is significantly more affected by the practitioner’s skills and experience than by the needle size. Therefore, to specifically reduce the rate of contamination, it is necessary to remove biopsy tracks during wide excisions of malignant tumors. If anticancer drug therapy (preoperative chemotherapy or neoadjuvant chemotherapy) is administered preoperatively immediately after the biopsy, the biopsy tracks may disappear over time, making it difficult to identify and remove the biopsy area. In such cases, a method to mark the biopsy track area is needed. In this study, a biopsy gun was developed that (a) allows biopsy aspiration and sampling to be performed simultaneously using a single needle and (b) injects a styptic agent or marker at the needle entrance after the biopsy to prevent contamination and bleeding within the biopsy track. This technique was compared with existing commercial products using an in vitro test.
Materials and Methods The present study was conducted to develop a biopsy gun that leaves a mark or injects drugs into the target area to secure various forms of tissues using a single surgical tool. The developed gun’s performance was analyzed through a comparative test with a commercial biopsy gun on pork and injection and aspiration tests on widely excised soft-tissue sarcoma from a female cadaver. Considering the user’s grip, the biopsy gun was modeled after existing products, whereas the firing power of the cannula needle was increased according to the needle resistance. A needle was mounted for the injection and aspiration functions, and the flexible tube was connected to a syringe to facilitate fluid flow.
Development of a Device That Performs FineNeedle Aspiration and Gun Biopsy In this study, a biopsy-sampling device that can overcome the limitations of existing devices was developed. To reduce discomfort in actual users, the appearance and size of existing biopsy guns (TSK Laboratory, Tochigi, Japan) were used as models. The developed National Cancer Center aspiration injection (NCC AI) biopsy gun consists of an aspiration hole that collects liquid tissues, an aspiration syringe, a sample-collecting slot that stores the tissue collected
Figure 1. Comparison of biopsy gun shapes: (A) ACECUT (TSK Laboratory) and (B) National Cancer Center aspiration injection.
through an incision, and a drug injection needle and syringe (Figure 1). The developed product is divided into the body, a needle-fire button, two 3 cm3 syringes for aspiration and injection, and a slide-type lever. The aspiration lever was designed with a locking groove that prevents any backlash that may occur due to suction pressure. There is also room to maneuver the biopsy gun approximately 30° vertical to the body to facilitate the removal and attachment of the syringes, and a cover for the fixed syringe. The fixed syringe is connected to the ends of the aspiration hole and the drug injection hole through a flexible tube. Each connecting part is sealed to prevent leakage due to syringe pressure. The needle section consists of a biopsy needle equipped with a sample-collecting slot, aspiration hole, and cutting cannula with a drug injection pipe. The needle part inserted into the body was prepared using a 15G needle, including the cutting cannula part, which controls the tissue, and a biopsy needle. The samplecollecting slot was designed to contain a maximum volume of 13.6 mm3. To enable aspiration biopsy, the hole of the 24G needle was pointed toward the sample-collecting slot. The drug could be injected by welding a 23G needle to the bottom of the needle holder using a laser (Figure 2C). For the user’s convenience, the NCC AI gun is designed for 1-handed use and fires 2 shots. The first shot is fired to place the collecting slot of the needle inside the sampling area of the target tumor. Once the needle is placed in the desired position, the piston of the aspiration syringe is pulled backward to aspirate a liquid tumor or fix the position of a solid tumor. The second shot is fired to enable the cutting cannula to excise the target tumor and capture it inside the sample-collecting slot. The piston of the injection syringe is then pushed forward to inject the drug into the sampled tumor and the biopsy track. The fire button and the piston can be controlled using the thumb of the dominant hand (Figures 2B-D). The TSK biopsy gun features a force of approximately 25 N during the second shot. The force of the second shot of the NCC AI gun was set at approximately
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Figure 2. Detailed view of the National Cancer Center aspiration injection biopsy gun: (A) front view, (B) bottom view, and (C) needle view.
28 N considering the resistance that occurs due to the additional needle required for drug injection. For aspiration and injection using the needle, two 3 cm3 syringes were attached to the NCC AI gun, but its limited body structure only allows a 2 cm3 capacity during actual use. A thin and flexible tube was used to connect the 2 syringes and the needle and was fixed in a streamlined manner to minimize the resistance of the fluid within the tube.
Performance Evaluation of the NCC AI Gun Comparative Test Using a Commercial Biopsy Gun. The size, weight, and sample-collecting performance of the developed biopsy gun were compared with those of the ACECUT (TSK Laboratory), one of the most widely used biopsy guns worldwide. An 18G × 75 mm × 11 mm needle was installed on the ACECUT. Samples of pork loin and Boston butt were collected 12 times with each device, and the weights of the collected samples were recorded for comparison. Samples were collected under the same conditions for both devices. Also, a Vernier caliper (CD-20C; Mitutoyo, Kawasaki, Japan), push-pull gauge (DS2-200N; IMADA, Toyohashi, Japan), and precision weight (92SM-202A; PRECISA, Dietikon Switzerland) were used for the measurement. The experimental setup is shown in Figure 3. In addition, for the NCC AI gun, an additional sample-collecting test was conducted on pork liver with the application of aspiration pressure. In Vivo and Human Cadaver Tests. Unlike conventional biopsy guns, the NCC AI gun can be used to perform aspiration and injection. To evaluate the aspiration and
Figure 3. Electronic precision scales and pork samples for the tissue weight measurement experiment.
injection performances of the NCC AI gun, additional in vivo and cadaver tests were conducted.
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Surgical Innovation 22(2) Table 1. Comparison of the Performance of the ACECUT (TKU Laboratory) and the Newly Developed National Cancer Center Aspiration Injection (NCC AI) Gun. Product Name Performance Needle gauge Body weight Incisional biopsy Aspiration Drug injection Tissue control force (F) Average amount of collected sample
Figure 4. Aspiration test setup with glycerin.
First, an in vivo experiment was conducted to evaluate the injection performance of the NCC AI gun. The injection syringe was filled with 2 mL of radio-opaque contrast (Ultravist; Bayer Korea, Seoul, Republic of Korea) and inserted into the sliding lever of the NCC AI gun. A solid soft-tissue sarcoma immediately obtained from the operation room was used, and the injection test was performed under fluoroscopic guidance after samples of the sarcoma were collected using the NCC AI gun. An additional injection test was performed on the calf muscle and kidney of a female cadaver. Gentian violet (GV; DLC Laboratory, Paramount, CA) was used to visualize the drug injection area, and an incision was made to confirm dye injection. Finally, glycerin was used to verify the aspiration performance of the NCC AI gun under the assumption that a cyst has a viscosity similar to that of blood. A disposable 3 cm3 syringe (Jung Rim Medical Device Industry, Seoul, Republic of Korea) that uses the same needle as the NCC AI gun was used for a comparative test. The test was performed at 20°C using 100% glycerin diluted to 50% to 65%. Note that the resulting viscosity of glycerin was higher than that of blood (2.8-4.0 cp). The experimental setup for the aspiration test is shown in Figure 4.
Results Table 1 compares the NCC AI gun and the ACECUT. As can be seen from the results, the size and weight of the NCC AI gun is similar to those of the ACECUT, but the
Biopsy Gun From NCC AI Gun, National Company A Cancer Center 18 G 80.8 g × × 25 N
15 G 117.6 g 2 cm3 28 N
16 mg
22 mg
NCC AI gun can collect larger samples as well as perform aspiration and injection. Figure 5 shows the weights of the samples collected using the NCC AI gun and ACECUT from pork loin and Boston butt. The mean sample weight collected by the NCC AI gun was 2.2 mg, which is heavier than the 1.6 mg collected by the ACECUT (P < .001). It is important to note that the needle of the NCC AI gun is larger than that of the ACECUT because of its injection and aspiration functions. For tissue sampling, the NCC AI gun and the ACECUT both use an 18G needle. When aspiration pressure was applied, the mean weight of the collected liver sample was 2.6 mg (Figure 6). The NCC AI gun collects larger samples when the aspiration pressure is applied because the aspiration pressure prevents the tissue from sliding during the sample collection process. The tissue samples of soft tissue sarcoma are shown in Figure 7. Figure 8 is a fluoroscopic image of the NCC AI gun injecting the contrast media into the soft tissue sarcoma. As the figure shows, the media was successfully injected into the tissue, although it was the solid part of the tumor. An additional test was performed using distilled water in which approximately 1.8 ± 0.2 cm3 of the drug could be injected using the NCC AI gun. Note that only 1.8 ± 0.2 cm3 of the drug could be injected despite the NCC AI gun being equipped with a 3 cm3 syringe. This is because the tube between the end of the syringe and the injection pipe is approximately 220 mm long with a 1.2 cm3 volume. Figure 9 shows the result of the cadaver study in which the injected dye is clearly visible in the cross-section of the calf and the kidney. A comparative aspiration test between the NCC AI gun and a 3 cm3 syringe was performed using 100% glycerin diluted in triple distilled water. The experiment was carried out at 20°C, and we found that both the syringe
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Figure 5. Tissue sampling amount experimental results: (A) weight of collected pork loin sample and (B) weight of collected pork neck sample.
Figure 6. Results of the collected pork liver sample test with and without aspiration pressure.
and the NCC AI gun were capable of aspirating glycerin at a 65% concentration. However, we noted that, with glycerin at concentrations >60%, the piston of the syringe tended to move backward because of the internal pressure caused by the viscosity. The viscosity of 65% glycerin at 20°C is approximately 15 cp. Assuming that the temperature of blood inside the human body is >30°C, the viscosity of the blood would be 2.8 to 4.0 cp. Thus, it can be concluded that the NCC AI gun is capable of aspirating cysts (liquid tumors).16
Discussion The present study was conducted to develop a biopsy gun that can leave a mark or inject a drug while simultaneously
securing various types of tissues. Aspiration biopsy was attempted for all experimental subjects using the NCC AI gun, but liquid tissues were not aspirated and the sampling amount could not be measured. Therefore, only solid tissues were collected. In the cadaver experiment, in which solid tissues were among the sampling targets, the sampled amount varied and could not be included in the analysis. To verify product integrity, additional experiments were performed on pork and the sampling amounts were examined. The amount of pork samples obtained by the NCC AI gun was consistent. We believe that the varying sampling amount of the cadaver experiments was because of the characteristics of the cadaveric tissue. Despite the use of identical tissues and sampling slots, the NCC AI gun collected larger samples than the ACECUT. This may be attributable to the adjustment of the NCC AI spring force to 28 N. This may also have been caused by the fact that the tissue was not pushed away since the attractive force that was generated by the negative pressure on the aspiration syringe and exerted through the aspiration hole before the second shot held the tumor tissue in place at the sampling slot. These results suggest that exerting aspiration pressure can increase the sampling amount but lead to aspiration of soft tissues into the collecting syringe. Thus, instead of increasing aspiration pressure, it is more desirable to directly address this problem by increasing the spring force that operates the cutting cannula. However, increasing the spring force would also increase needle elasticity and cause the needle to move away from the desired location at the second shot because of the repulsive force.
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Figure 7. Widely excised soft-tissue sarcoma of human tissue: (A) first needle firing, (B) the aspiration syringe is moved back, (C) biopsy cutting needle firing, and (D) the injection syringe is moved back.
Figure 8. Injection experiments using a fluoroscope: (A) fluoroscopic view of the NCC AI gun with contrast media loaded in its injection syringe and (B) fluoroscopic view of the NCC AI gun injecting contrast media into the collected tissue.
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Figure 9. National Cancer Center aspiration injection gun injection of Gentian violet (GV) into a female cadaver: (A) injection of GV into the kidney, (B) viewing of the injected GV after the kidney incision, (C) injection of GV into the lower leg muscle, and (D) viewing of the injected GV after the calf muscle incision.
As previously described, soft tissues may be aspirated into the syringe during excision. However, if not used on particular areas, this may not be a major issue because the surgeon performs the biopsy based on his or her personal judgment of soft tissues. The NCC AI biopsy gun developed here can greatly improve diagnostic accuracy because it can obtain both solid and liquid tissues. In addition, the ability to inject a drug would help patient recovery and mark the corresponding area. Thus, the NCC AI gun is expected to greatly reduce injection-related risks, even if a large needle is used or an unskilled surgeon performs the procedure, since it can disinfect the biopsy track. However, it can cause problems during the aspiration procedure because approximately 1.2 cm3 of the syringe remains empty, which commonly occurs when one uses an 80-mm needle and a 140-mm tube to aspirate liquid tissues. To resolve such problems, the empty volume can
be compensated by up to approximately 0.4 cm3 by design modification of the aspirating syringe. The drug injection function of the NCC AI gun offers many advantages during a biopsy procedure, as it can prevent the spread of tumor cells by disinfecting the biopsy track and shorten the hospital stay of patients by enabling direct drug injection into the lesion. During the injection test, we found that the NCC AI gun could inject Greenplast (Green Cross Corp, Yongin-si, Republic of Korea), which contains calcium chloride, thrombin, aprotinin, and fibrinogen; however, it was not able to inject Floseal (Baxter, Hayward, CA), which contains calcium chloride, thrombin, and gelatin, because of its gel-like structure. Thus, a study on an injectable styptic agent is required. Thus, the results of this study suggest that the NCC AI gun can potentially serve as an alternative tool for biopsy collection in certain surgical areas.
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Author Contributions Sung Ho Cho was in charge of hardware design and he also participated in experiments. He also wrote the manuscript. Chang Nho Cho participated in hardware design. Kwang Gi Kim participated in hardware design and experiments preparation. Hyun Guy Kang provided clinical insight and was in charge of exeperiments.
Authors’ Note Kwang Gi Kim and Hyun Guy Kang both contributed equally to this work.
Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was supported by grants from the National Cancer Center of Korea (NCC-1210260).
References 1. Parker SH, Hopper KD, Yakes WF, Gibson MD, Ownbey JL, Carter TE. Image-directed percutaneous biopsies with a biopsy gun. Radiology. 1989;171:663-669. 2. Elvin A, Andersson T, Scheibenpflug L, Lindgren PG. Biopsy of the pancreas with a biopsy gun. Radiology. 1990;176:677-679.
3. Chezmar JL, Keith LL, Nelson RC, Plaire JC, Hertzler GL, Bernardino ME. Liver transplant biopsies with a biopsy gun. Radiology. 1991;179:447-448. 4. Bernardino ME. Automated biopsy devices: significance and safety. Radiology. 1990;176:615-616. 5. Stevens GM, Jackman RJ. Outpatient needle biopsy of the lung: its safety and utility. Radiology. 1984;151:301-304. 6. Nordenström B. New instruments of biopsy. Radiology. 1975;117:474-475. 7. Dutra FR, Geraci CL. Needle biopsy of the lung. JAMA. 1954;155:21-24. 8. Andriole JG, Haaga JR, Adams RB, Nunez C. Biopsy needle characteristics assessed in the laboratory. Radiology. 1983;148:659-662. 9. Smith EH. Complications of percutaneous abdominal fineneedle biopsy. Review. Radiology. 1991;178:253-258. 10. Hopper KD, Baird DE, Reddy VV, et al. Efficacy of automated biopsy guns versus conventional biopsy needles in the pygmy pig. Radiology. 1990;176:671-676. 11. Charboneau JW, Reading CC, Welch TJ. CT and sonographically guided needle biopsy: current techniques and new innovations. AJR Am J Roentgenol. 1990;154:1-10. 12. Ji JH. Diagnostic value of fine needle aspiration biopsy. J Korean Assoc Oral Maxillofac Surg. 1996;22:710. 13. Wolinsky H, Lischner MW. Needle track implantation of tumor after percutaneous lung biopsy. Ann Intern Med. 1969;71:359-362. 14. Ferrucci JT, Wittenberg J, Margolies MN, Carey RW. Malignant seeding of the tract after thin-needle aspiration biopsy. Radiology. 1979;130:345-346. 15. Lee SM, Lee JH, Kim H. Efficacy and safety of percutaneous biopsies using biopsy gun. Keimyung Med J. 1993;12:510-519. 16. Dorsey NE. Properties of Ordinary Water-Substance in All Its Phases: Water-Vapor, Water, and All the Ices. New York, NY: Reinhold; 1940.
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research-article2014
SRIXXX10.1177/1553350614539046Surgical InnovationSurgical InnovationCho et al
Innovative Technologies
Development of Biopsy Gun for Aspiration and Drug Injection
Surgical Innovation 2015, Vol. 22(2) 163–170 © The Author(s) 2014 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1553350614539046 sri.sagepub.com
Hyun Guy Kang, PhD, MD2, Sung Ho Cho1, Chang Nho Cho1, and Kwang Gi Kim, PhD1
Abstract Tumor samples are required for pathological examinations, and different instruments are generally used to obtain samples of different types of tumors. Among the many methods available for obtaining tumor tissues, gun biopsy is widely used because it is much simpler than incisional biopsy and can collect many more samples than aspiration biopsy. However, conventional biopsy guns cannot simultaneously perform biopsy aspiration, bleeding prevention, and marker injection. In this study, we developed a biopsy gun that can simultaneously perform biopsy aspiration and sample collection, in addition to injecting a styptic agent and marker to prevent bleeding and contamination in the biopsy track. We then used a prototype to evaluate the feasibility of the developed device. The collectable sample size was also assessed. Performance of the biopsy aspiration feature was also evaluated, including the maximum aspiration viscosity. Finally, we tested the maximum amount of drug that can be injected. We found that the biopsy gun developed here is an alternative tool for biopsy collection with improved procedure safety and diagnostic accuracy. Keywords gun biopsy, aspiration, hemostasis, track marking, drug injectable
Introduction Current methods of obtaining tumor tissues for pathological examinations include incisional biopsy, aspiration biopsy using fine-needle aspiration, scopic biopsy using endoscopic forceps, and gun biopsy using gun biopsy devices.1-3 Incisional biopsy allows the collection of sufficient amounts of tissue with high diagnostic accuracy, but it is invasive and costly because of the requirement for anesthesia during the incision. Therefore, in the absence of a precise and meticulous surgical technique, there is a high risk of tumor cell contamination around the incision.4 Aspiration biopsy involves less discomfort and pain but can be used to collect only small tissue samples, which limits its diagnostic accuracy. Gun biopsy is less invasive than incisional biopsy. Because a tissue-cutting needle can be used to collect more tissues than aspiration biopsy, its diagnostic accuracy is also relatively high, and this method has been widely used in the diagnosis of several types of cancers.5-8 Percutaneous tissue biopsy using an automated biopsy gun is a relatively simple and rapid procedure, with a low risk of complications and a high detection rate. These superior features have resulted in its extensive use as a diagnostic technique and in the histological examination of various organs in the body.9-11 Musculoskeletal tumors vary in size
and their internal organization is observed in liquid, solid, or mixed forms. Solid tumor tissues can be collected using existing gun biopsy products, but it is difficult to collect liquid or mixed-phase tissue specimens, in which case the neoplastic liquid flows out after the biopsy, increasing the risk of needle track tumor contamination.1,2,5 To compare the diagnostic results of aspiration biopsy and incision or incisional biopsy, preoperative aspiration biopsy was performed on 25 patients, 13 of whom also underwent additional aspiration and incisional biopsies. Our results showed that 8 of these patients had identical findings from both the aspiration and incisional biopsies, whereas 5 showed completely different diagnostic findings.12 Because of the nature of tumor tissues, its characteristics cannot be accurately determined based on aspiration biopsy alone when they 1
Biomedical Engineering Branch, National Cancer Center, Goyang-si, Gyeonggi-do, Republic of Korea 2 Orthopaedic Oncology Clinic, National Cancer Center, Goyang-si, Gyeonggi-do, Republic of Korea Corresponding Authors: Hyun Guy Kang, Orthopaedic Oncology Clinic, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do 410-769, Republic of Korea. Email: [email protected]
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are in the liquid or mixed form. Therefore, a method that allows tumor tissue to be collected along with aspiration is needed. Even for aspiration biopsy, which almost never has any complications, contamination by malignant tumor cells has occurred around the needle track area. The tracks produced by blunt needles or needles >20G increase the risk of contamination.13,14 However, Lee et al15 reported that the complication rate is significantly more affected by the practitioner’s skills and experience than by the needle size. Therefore, to specifically reduce the rate of contamination, it is necessary to remove biopsy tracks during wide excisions of malignant tumors. If anticancer drug therapy (preoperative chemotherapy or neoadjuvant chemotherapy) is administered preoperatively immediately after the biopsy, the biopsy tracks may disappear over time, making it difficult to identify and remove the biopsy area. In such cases, a method to mark the biopsy track area is needed. In this study, a biopsy gun was developed that (a) allows biopsy aspiration and sampling to be performed simultaneously using a single needle and (b) injects a styptic agent or marker at the needle entrance after the biopsy to prevent contamination and bleeding within the biopsy track. This technique was compared with existing commercial products using an in vitro test.
Materials and Methods The present study was conducted to develop a biopsy gun that leaves a mark or injects drugs into the target area to secure various forms of tissues using a single surgical tool. The developed gun’s performance was analyzed through a comparative test with a commercial biopsy gun on pork and injection and aspiration tests on widely excised soft-tissue sarcoma from a female cadaver. Considering the user’s grip, the biopsy gun was modeled after existing products, whereas the firing power of the cannula needle was increased according to the needle resistance. A needle was mounted for the injection and aspiration functions, and the flexible tube was connected to a syringe to facilitate fluid flow.
Development of a Device That Performs FineNeedle Aspiration and Gun Biopsy In this study, a biopsy-sampling device that can overcome the limitations of existing devices was developed. To reduce discomfort in actual users, the appearance and size of existing biopsy guns (TSK Laboratory, Tochigi, Japan) were used as models. The developed National Cancer Center aspiration injection (NCC AI) biopsy gun consists of an aspiration hole that collects liquid tissues, an aspiration syringe, a sample-collecting slot that stores the tissue collected
Figure 1. Comparison of biopsy gun shapes: (A) ACECUT (TSK Laboratory) and (B) National Cancer Center aspiration injection.
through an incision, and a drug injection needle and syringe (Figure 1). The developed product is divided into the body, a needle-fire button, two 3 cm3 syringes for aspiration and injection, and a slide-type lever. The aspiration lever was designed with a locking groove that prevents any backlash that may occur due to suction pressure. There is also room to maneuver the biopsy gun approximately 30° vertical to the body to facilitate the removal and attachment of the syringes, and a cover for the fixed syringe. The fixed syringe is connected to the ends of the aspiration hole and the drug injection hole through a flexible tube. Each connecting part is sealed to prevent leakage due to syringe pressure. The needle section consists of a biopsy needle equipped with a sample-collecting slot, aspiration hole, and cutting cannula with a drug injection pipe. The needle part inserted into the body was prepared using a 15G needle, including the cutting cannula part, which controls the tissue, and a biopsy needle. The samplecollecting slot was designed to contain a maximum volume of 13.6 mm3. To enable aspiration biopsy, the hole of the 24G needle was pointed toward the sample-collecting slot. The drug could be injected by welding a 23G needle to the bottom of the needle holder using a laser (Figure 2C). For the user’s convenience, the NCC AI gun is designed for 1-handed use and fires 2 shots. The first shot is fired to place the collecting slot of the needle inside the sampling area of the target tumor. Once the needle is placed in the desired position, the piston of the aspiration syringe is pulled backward to aspirate a liquid tumor or fix the position of a solid tumor. The second shot is fired to enable the cutting cannula to excise the target tumor and capture it inside the sample-collecting slot. The piston of the injection syringe is then pushed forward to inject the drug into the sampled tumor and the biopsy track. The fire button and the piston can be controlled using the thumb of the dominant hand (Figures 2B-D). The TSK biopsy gun features a force of approximately 25 N during the second shot. The force of the second shot of the NCC AI gun was set at approximately
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Figure 2. Detailed view of the National Cancer Center aspiration injection biopsy gun: (A) front view, (B) bottom view, and (C) needle view.
28 N considering the resistance that occurs due to the additional needle required for drug injection. For aspiration and injection using the needle, two 3 cm3 syringes were attached to the NCC AI gun, but its limited body structure only allows a 2 cm3 capacity during actual use. A thin and flexible tube was used to connect the 2 syringes and the needle and was fixed in a streamlined manner to minimize the resistance of the fluid within the tube.
Performance Evaluation of the NCC AI Gun Comparative Test Using a Commercial Biopsy Gun. The size, weight, and sample-collecting performance of the developed biopsy gun were compared with those of the ACECUT (TSK Laboratory), one of the most widely used biopsy guns worldwide. An 18G × 75 mm × 11 mm needle was installed on the ACECUT. Samples of pork loin and Boston butt were collected 12 times with each device, and the weights of the collected samples were recorded for comparison. Samples were collected under the same conditions for both devices. Also, a Vernier caliper (CD-20C; Mitutoyo, Kawasaki, Japan), push-pull gauge (DS2-200N; IMADA, Toyohashi, Japan), and precision weight (92SM-202A; PRECISA, Dietikon Switzerland) were used for the measurement. The experimental setup is shown in Figure 3. In addition, for the NCC AI gun, an additional sample-collecting test was conducted on pork liver with the application of aspiration pressure. In Vivo and Human Cadaver Tests. Unlike conventional biopsy guns, the NCC AI gun can be used to perform aspiration and injection. To evaluate the aspiration and
Figure 3. Electronic precision scales and pork samples for the tissue weight measurement experiment.
injection performances of the NCC AI gun, additional in vivo and cadaver tests were conducted.
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Surgical Innovation 22(2) Table 1. Comparison of the Performance of the ACECUT (TKU Laboratory) and the Newly Developed National Cancer Center Aspiration Injection (NCC AI) Gun. Product Name Performance Needle gauge Body weight Incisional biopsy Aspiration Drug injection Tissue control force (F) Average amount of collected sample
Figure 4. Aspiration test setup with glycerin.
First, an in vivo experiment was conducted to evaluate the injection performance of the NCC AI gun. The injection syringe was filled with 2 mL of radio-opaque contrast (Ultravist; Bayer Korea, Seoul, Republic of Korea) and inserted into the sliding lever of the NCC AI gun. A solid soft-tissue sarcoma immediately obtained from the operation room was used, and the injection test was performed under fluoroscopic guidance after samples of the sarcoma were collected using the NCC AI gun. An additional injection test was performed on the calf muscle and kidney of a female cadaver. Gentian violet (GV; DLC Laboratory, Paramount, CA) was used to visualize the drug injection area, and an incision was made to confirm dye injection. Finally, glycerin was used to verify the aspiration performance of the NCC AI gun under the assumption that a cyst has a viscosity similar to that of blood. A disposable 3 cm3 syringe (Jung Rim Medical Device Industry, Seoul, Republic of Korea) that uses the same needle as the NCC AI gun was used for a comparative test. The test was performed at 20°C using 100% glycerin diluted to 50% to 65%. Note that the resulting viscosity of glycerin was higher than that of blood (2.8-4.0 cp). The experimental setup for the aspiration test is shown in Figure 4.
Results Table 1 compares the NCC AI gun and the ACECUT. As can be seen from the results, the size and weight of the NCC AI gun is similar to those of the ACECUT, but the
Biopsy Gun From NCC AI Gun, National Company A Cancer Center 18 G 80.8 g × × 25 N
15 G 117.6 g 2 cm3 28 N
16 mg
22 mg
NCC AI gun can collect larger samples as well as perform aspiration and injection. Figure 5 shows the weights of the samples collected using the NCC AI gun and ACECUT from pork loin and Boston butt. The mean sample weight collected by the NCC AI gun was 2.2 mg, which is heavier than the 1.6 mg collected by the ACECUT (P < .001). It is important to note that the needle of the NCC AI gun is larger than that of the ACECUT because of its injection and aspiration functions. For tissue sampling, the NCC AI gun and the ACECUT both use an 18G needle. When aspiration pressure was applied, the mean weight of the collected liver sample was 2.6 mg (Figure 6). The NCC AI gun collects larger samples when the aspiration pressure is applied because the aspiration pressure prevents the tissue from sliding during the sample collection process. The tissue samples of soft tissue sarcoma are shown in Figure 7. Figure 8 is a fluoroscopic image of the NCC AI gun injecting the contrast media into the soft tissue sarcoma. As the figure shows, the media was successfully injected into the tissue, although it was the solid part of the tumor. An additional test was performed using distilled water in which approximately 1.8 ± 0.2 cm3 of the drug could be injected using the NCC AI gun. Note that only 1.8 ± 0.2 cm3 of the drug could be injected despite the NCC AI gun being equipped with a 3 cm3 syringe. This is because the tube between the end of the syringe and the injection pipe is approximately 220 mm long with a 1.2 cm3 volume. Figure 9 shows the result of the cadaver study in which the injected dye is clearly visible in the cross-section of the calf and the kidney. A comparative aspiration test between the NCC AI gun and a 3 cm3 syringe was performed using 100% glycerin diluted in triple distilled water. The experiment was carried out at 20°C, and we found that both the syringe
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Figure 5. Tissue sampling amount experimental results: (A) weight of collected pork loin sample and (B) weight of collected pork neck sample.
Figure 6. Results of the collected pork liver sample test with and without aspiration pressure.
and the NCC AI gun were capable of aspirating glycerin at a 65% concentration. However, we noted that, with glycerin at concentrations >60%, the piston of the syringe tended to move backward because of the internal pressure caused by the viscosity. The viscosity of 65% glycerin at 20°C is approximately 15 cp. Assuming that the temperature of blood inside the human body is >30°C, the viscosity of the blood would be 2.8 to 4.0 cp. Thus, it can be concluded that the NCC AI gun is capable of aspirating cysts (liquid tumors).16
Discussion The present study was conducted to develop a biopsy gun that can leave a mark or inject a drug while simultaneously
securing various types of tissues. Aspiration biopsy was attempted for all experimental subjects using the NCC AI gun, but liquid tissues were not aspirated and the sampling amount could not be measured. Therefore, only solid tissues were collected. In the cadaver experiment, in which solid tissues were among the sampling targets, the sampled amount varied and could not be included in the analysis. To verify product integrity, additional experiments were performed on pork and the sampling amounts were examined. The amount of pork samples obtained by the NCC AI gun was consistent. We believe that the varying sampling amount of the cadaver experiments was because of the characteristics of the cadaveric tissue. Despite the use of identical tissues and sampling slots, the NCC AI gun collected larger samples than the ACECUT. This may be attributable to the adjustment of the NCC AI spring force to 28 N. This may also have been caused by the fact that the tissue was not pushed away since the attractive force that was generated by the negative pressure on the aspiration syringe and exerted through the aspiration hole before the second shot held the tumor tissue in place at the sampling slot. These results suggest that exerting aspiration pressure can increase the sampling amount but lead to aspiration of soft tissues into the collecting syringe. Thus, instead of increasing aspiration pressure, it is more desirable to directly address this problem by increasing the spring force that operates the cutting cannula. However, increasing the spring force would also increase needle elasticity and cause the needle to move away from the desired location at the second shot because of the repulsive force.
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Figure 7. Widely excised soft-tissue sarcoma of human tissue: (A) first needle firing, (B) the aspiration syringe is moved back, (C) biopsy cutting needle firing, and (D) the injection syringe is moved back.
Figure 8. Injection experiments using a fluoroscope: (A) fluoroscopic view of the NCC AI gun with contrast media loaded in its injection syringe and (B) fluoroscopic view of the NCC AI gun injecting contrast media into the collected tissue.
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Figure 9. National Cancer Center aspiration injection gun injection of Gentian violet (GV) into a female cadaver: (A) injection of GV into the kidney, (B) viewing of the injected GV after the kidney incision, (C) injection of GV into the lower leg muscle, and (D) viewing of the injected GV after the calf muscle incision.
As previously described, soft tissues may be aspirated into the syringe during excision. However, if not used on particular areas, this may not be a major issue because the surgeon performs the biopsy based on his or her personal judgment of soft tissues. The NCC AI biopsy gun developed here can greatly improve diagnostic accuracy because it can obtain both solid and liquid tissues. In addition, the ability to inject a drug would help patient recovery and mark the corresponding area. Thus, the NCC AI gun is expected to greatly reduce injection-related risks, even if a large needle is used or an unskilled surgeon performs the procedure, since it can disinfect the biopsy track. However, it can cause problems during the aspiration procedure because approximately 1.2 cm3 of the syringe remains empty, which commonly occurs when one uses an 80-mm needle and a 140-mm tube to aspirate liquid tissues. To resolve such problems, the empty volume can
be compensated by up to approximately 0.4 cm3 by design modification of the aspirating syringe. The drug injection function of the NCC AI gun offers many advantages during a biopsy procedure, as it can prevent the spread of tumor cells by disinfecting the biopsy track and shorten the hospital stay of patients by enabling direct drug injection into the lesion. During the injection test, we found that the NCC AI gun could inject Greenplast (Green Cross Corp, Yongin-si, Republic of Korea), which contains calcium chloride, thrombin, aprotinin, and fibrinogen; however, it was not able to inject Floseal (Baxter, Hayward, CA), which contains calcium chloride, thrombin, and gelatin, because of its gel-like structure. Thus, a study on an injectable styptic agent is required. Thus, the results of this study suggest that the NCC AI gun can potentially serve as an alternative tool for biopsy collection in certain surgical areas.
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Author Contributions Sung Ho Cho was in charge of hardware design and he also participated in experiments. He also wrote the manuscript. Chang Nho Cho participated in hardware design. Kwang Gi Kim participated in hardware design and experiments preparation. Hyun Guy Kang provided clinical insight and was in charge of exeperiments.
Authors’ Note Kwang Gi Kim and Hyun Guy Kang both contributed equally to this work.
Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was supported by grants from the National Cancer Center of Korea (NCC-1210260).
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