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Kyoungchul Kong

Mem. ASME Assistant Professor Department of Mechanical Engineering, Sogang University, Seoul, Korea 121-742 e-mail: kckong@sogang.ac.kr

A Robotic Biopsy Device for Capsule Endoscopy


This paper introduces a robotic biopsy device for capsule endoscopes. The proposed device consists of three modules for the complete process of biopsy, which includes monitoring the intestinal wall by a tissue monitoring module (TMM), aligning onto a polyp by an anchor module (AM), and sampling of the polyp tissue by a biopsy module (BM). The TMM utilizes a trigonal mirror as well as an on-board camera; since the TMM continuously takes images through lateral apertures, an operator such as a medical doctor is able to anchor the capsule endoscope onto the polyp and biopsy it with the visual feedback in real-time. When the operator nds a polyp using the TMM and the frontal camera of a capsule endoscope, then the AM is used to approach the polyp for biopsy. When the AM is in use, outriggers are extruded by shape-memory-alloy (SMA) springs, which results in the swelling of capsule endoscope body. In addition, an alignment module, which is a part of the AM, rotates the body of the capsule endoscope such that the biopsy razor can be aligned onto the polyp. Then, the BM excises a part of the polyp and seals the aperture, and the capsule endoscope continues exploring the intestine. The concept and working principles of the proposed device are introduced in this paper and are veried by a prototype that successfully integrates the three modules. [DOI: 10.1115/1.4007100]

Sehyuk Yim
Graduate Student Department of Mechanical Engineering, Carnegie Mellon University, Pittsburgh, PA 15289 e-mail: sehyuky@andrew.cmu.edu

Sunhee Choi
Engineer Samsung Engineering Co. Ltd. Seoul, Korea 134-090 e-mail: sh0120.choi@samsung.com

Doyoung Jeon1
Professor Mem. ASME Department of Mechanical Engineering, Sogang University, Seoul, Korea 121-742 e-mail: dyjeon@sogang.ac.kr

Introduction

Capsule endoscopy has enabled reliable diagnosis of gastrointestinal (GI) tract diseases in a minimally invasive way for many years [1,2]. By the pill-sized medical device, many patients suffering from obscure bleeding and inammatory disease could experience a comfortable diagnosis, and doctors could get clinically reliable data. Currently, many research projects are in progress to improve the functionalities of the capsule endoscopes. A capsule endoscope with advanced functions is often called an active capsule endoscope (ACE) [3,4]. One of the most important functions of ACEs is self-locomotion for shortening the diagnosis time and providing medical professionals with controllability of the device. Various self-locomotive capsule endoscopes have been developed in recent years. Their working principles and mechanisms are different according to the target organs. For example, ACEs for a stomach diagnosis may employ an external magnetic eld for three-dimensional positioning and orientation [57], and ones for an intestine diagnosis may use legs or ination mechanism to grab the intestinal wall and to move along the lumen of the intestine [810]. Another important function for ACEs is a diagnostic and treatment capability. For example, when a medical professional nds a polyp, an ACE may take a sample of the tissue for more precise diagnosis. Also, it is necessary for an ACE to perform a basic treatment, such as sterilization and medication, during the endoscopy. In our previous research, two different types of biopsy modules for capsule endoscopes were developed. For the biopsy of a tissue on the intestinal wall, a rotational razor mechanism was devised to take a sample of the tissue by scratching the intestinal wall [11]. In Ref. [12], a microspike manufactured using a MEMS technology was proposed. The proposed methods showed feasibility as a biopsy module for active capsule endoscopy. In spite of
1 Corresponding author. Manuscript received February 22, 2012; nal manuscript received May 14, 2012; published online July 30, 2012. Assoc. Editor: Hamid M. Lankarani.

their successful experimental results in a laboratory setting, several challenging issues have not been solved. For example, it is impossible to monitor the targeting and sampling procedures because the frontal camera is not aligned with the workspace of the biopsy tool. Moreover, they lack mobility to approach the target tissue. Due to these limitations, the complete biopsy process was not possible with the previously proposed devices. In this paper, a complete biopsy device for capsule endoscopes is introduced. The proposed device successfully integrates three critical mechanisms: (i) a tissue monitoring module (TMM) using a trigonal reector and a camera, (ii) an anchor module (AM) using shape-memory-alloy (SMA) springs, and (iii) a biopsy module (BM) using two cylindrical razors. Each of the three modules provides a critical function for the complete process of biopsy as follows. First, the TMM allows a medical professional to directly monitor the whole biopsy process, as well as to observe the intestinal wall. Then the AM enables the capsule endoscope to properly align onto a polyp. Finally the BM takes a sample of the polyp and seals the lateral apertures to continue observation of the intestine. These modules are integrated in a prototype shown in Fig. 1 and are veried by experiments in this paper. The remainder of this paper is organized as follows. Section 2 introduces the overall working principle, and Sec. 3 discusses on the details of the TMM. Section 4 shows the design of the AM, which consists of outriggers and a rotation shaft. In Sec. 5, the BM, including razors and a trigger mechanism, is introduced. Finally, in Sec. 6 experimental results are shown to verify the functionality of a system that integrates the TMM, the AM, and the BM. Summary is given in Sec. 7.

Overall Configuration

Figure 2 shows a schematic of the proposed biopsy device, which consists of three modules: a tissue monitoring module (TMM), an anchor module (AM), and a biopsy module (BM). The SEPTEMBER 2012, Vol. 6 / 031004-1

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Fig. 3 Biopsy procedure with the proposed device

Fig. 1 A prototype of robotic biopsy device for capsule endoscopy

alignment mechanism, which is a part of the AM, is not shown in Fig. 2. A frontal camera may also be necessary for full functionality of the active capsule endoscope, but it is omitted in the prototype and schematic shown in Figs. 1 and 2 since the main focus of this paper is on the three modules that enable biopsy by the capsule endoscope. The diameter of the proposed system is 15 mm in an idle state. The integrated module, which excludes the frontal camera, is 40 mm long, where the BM takes about 13 mm. The effective diameter of each aperture on the BM is 8 mm. The biopsy procedure by the proposed device is depicted in Fig. 3; an active capsule endoscope with the proposed biopsy device obtains a tissue sample by the following steps. (1) Observation: The intestinal wall is observed by a camera in the TMM, as well as the frontal camera of the capsule endoscope. If a medical professional nds an abnormal tissue from real-time images taken by the cameras, he/she may activate the AM in order to closely observe the tissue and to obtain a tissue sample. The TMM provides images of the intestinal wall observed through lateral apertures. (2) Anchoring: The outriggers of the AM are extruded as shown in Fig. 3(b), and the capsule endoscope is xed on the abnormal tissue. (3) Alignment: Even if the capsule endoscope is anchored at the right place, the BM may not be properly aligned onto the target tissue. Therefore, the AM rotates the BM, as shown in Fig. 3(c), such that it is aligned properly. (4) Biopsy: Once the medical professional makes a decision, the trigger of the BM is released and a part of the tissue is cut by rapid rotation of razors.

Fig. 4

Tissue monitoring module

(5) Finish: The sampled tissue is contained in the BM. When the razor of the BM is fully rotated, the aperture is sealed automatically, and the capsule endoscope continues exploring the lumen of the intestine.

Tissue Monitoring Module

Fig. 2

Schematic of the proposed robotic biopsy device

In order for a medical professional to align the BM onto a target tissue successfully, he/she should be aware of the location of the tissue throughout the biopsy process. For this purpose, the TMM provides the visual information obtained through lateral apertures, as shown in Fig. 4. In addition to the frontal camera, the TMM also includes a camera for monitoring the biopsy process through lateral apertures. Due to the size of the camera, however, it cannot be mounted such that the camera directly takes images through the lateral apertures. Moreover, since the housing that has the apertures plays the role of a razor of the BM and is connected to a trigger module, there is no space for the camera around the aperture. Therefore, in order to avoid interference between the camera and the other parts of the capsule endoscope, a reector is utilized, as shown in Fig. 4. As in the gure, the camera is located at the head of the capsule facing the reector and takes an image reected in the mirror. By this conguration, the TMM is able to observe the intestinal wall through the lateral apertures while the camera does not interfere the other parts of the biopsy device. For the TMM to observe a large area, the mirror is fabricated to the shape of a triangular pyramid. Each face of the trigonal reector is aligned to an aperture, and thus, the TMM can observe about 40% of the intestinal wall at each sampling instance. Figure 4(b) shows an image taken by the TMM. Notice that the intestinal wall, including a polyp, is reected in the trigonal reector. A medical professional would watch this image transferred from the capsule endoscope and decide if there exists a polyp on the intestinal wall and/or if the biopsy device is properly aligned onto a polyp. Figure 5 shows the camera module used in the TMM, which is originally designed for the frontal camera of capsule endoscopes [13]. It consists of a CMOS camera, six light-emitting diode (LED) light sources, and an image processing circuit. The electrical devices are mounted on two circular circuit boards, the diameter of each circuit board is 10 mm. The two boards are connected by a exible bus cable, and thus, the circuit boards can be stacked in parallel. When the two boards are stacked, its total height is Transactions of the ASME

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Fig. 5 A camera module used in the TMM

less than 3.5 mm. The overall camera module is operated with the supply voltage of 3 V, and it takes 10 images every second. The output of the module is in the format of binary synchronous communication (BSYNC).

Anchor Module

4.1 Outrigger Mechanism. Once the operator makes a decision to take a tissue sample, an anchor module (AM) may be utilized. The AM is for the capsule endoscope to anchor itself on the place where the abnormal tissue exists. Since the BM generates a large reaction torque while rotating razors to cut the tissue, it is difcult for the BM to perform successful biopsy process unless it is rmly xed on the intestinal wall using the AM. Figure 6 shows the schematic and principle of the AM. It consists of four outriggers with independently connected SMA springs, as shown in Fig. 6(a). Each outrigger can be controlled (i.e., extruded) by current signals applied to the SMA springs. The SMA springs show two useful properties; rstly, they have a large

power density so that a large actuation force can be generated in a limited space, and secondly they can be fabricated in any shape. When a proper current signal ows through an SMA spring, it is heated and generates a contractile force. By the contractile force of the SMA spring, the associated outrigger extrudes along a linear guide, as shown in Fig. 6(c). When the outriggers are fully extruded such that the capsule endoscope lls the cross-sectional area of the intestine, friction between the outriggers and the intestinal wall is increased and the capsule endoscope is xed. In addition, the outriggers can be selectively controlled such that the BM closely contacts the intestinal wall, as shown in Fig. 6(b), which makes it possible for the BM to take a tissue sample. The outriggers are also wrapped in a silicone rubber band, as shown in Fig. 6(c), which is to prevent the undesired extrusion of the outriggers in an idle state and to return to the original state after the biopsy process. The silicone rubber band also seals the gaps between the outriggers such that the electronic devices in the capsule endoscope are protected from the intestinal juice. Figure 7 shows the AM of a prototype. Notice in the gure that the outriggers can be selectively extruded. Figure 6(d) shows the equivalent mechanical model of an outrigger connected to an SMA spring and a silicone rubber band. In the gure, the silicone rubber band and the SMA spring are labeled as A and B respectively. For the sake of simplicity, it is assumed that A has a constant stiffness and that the spring constant of B is a function of T, the temperature of the SMA spring [9]. Let the spring constants of A and B be kA and kB T, respectively. kA should be higher than kB T0 , where T0 is the body temperature, in order for the outriggers to be rmly closed in an idle state. According to the equivalent mechanical model, the length change of the SMA spring (i.e., the extrusion height of an outrigger) can be calculated by a force-balance equation. Note that the elastic force by A is FA kA lC x l0A , where x is the extrusion height of the outrigger, lC is the diameter of the capsule

Fig. 6 Anchor module: (a) the anchor module with extruded outriggers, (b) the principle of anchoring, (c) the use of a silicone rubber band, and (d) an equivalent mechanical model

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Fig. 7 Experimental results of the AM: (a) an idle state, (b) one outrigger extruded, (c) two outriggers extruded, and (d) three outriggers extruded

endoscope, and l0A is the initial length of A. Due to the initial deformation (i.e., lC l0A ), the silicone rubber band applies a force to the outrigger, even if x 0. This initial tension prevents the undesired extrusion of the outriggers in an idle state. On the other hand, the SMA spring generates a contractile force, FB kB TlC x l0B , where l0B is the initial length of the SMA spring. Since FA FB for the balance of the forces, the extrusion height of the outrigger x can be calculated as   kB TlC l0B kA lC l0A ;0 (1) x max kA kB T Notice that x is a function of the temperature of the SMA spring T. Since the outrigger can only be extruded, max function is used in Eq. (1). Namely, the outriggers would not be extruded until B is heated such that its spring constant satises the following condition: kB T > kA lC l0A lC l0B (2)

Figure 8 shows the simulated extrusion height of an outrigger with respect to the spring constant of B. Since the spring constant of an SMA spring (i.e., kB T) exponentially increases by a constant electric current, the graph in the gure is shown in a log scale. The spring constant of an SMA spring, which is in the shape of a compression spring, is calculated by kB T GTd4 8nD3 (3)

where GT is the modulus of rigidity of SMA with respect to the temperature T, d is the wire diameter, n is the number of coils, and D is the mean coil diameter. According to Ref. [9], GT is measured to 43 kPa at the body temperature and 7464 MPa when fully heated. The remaining dimensions are d 0:0005 m, D 0:003 m, and n 10; thus, kB T varies from 1:24 103 N=m to 2:16 102 N=m by Eq. (3). On the other hand, the spring constant of the silicone rubber band (i.e., the spring A)

Fig. 8

Simulated extrusion height of an outrigger

is approximately kA 5:79 101 N=m, which is experimentally obtained in this paper. Notice in Fig. 8 that the idle state is remained until the spring constant of B reaches 0:4N=m, which prevents undesired extrusion of outriggers. Therefore, the SMA spring should be fully heated to overcome the initial tension by the silicone rubber band. According to this simulation study, the outrigger can be extruded up to 7 mm. In practice, however, the extrusion height would be limited by the diameter of intestine; when the intestine is fully stretched, the outriggers cannot be extruded further and the capsule endoscope may be anchored rmly. When an SMA spring connected to an outrigger is heated, the outrigger applies a compressive force to the intestinal wall. The compressive force results in the increase of friction between the capsule endoscope and the intestinal wall such that it is rmly xed for further processes of biopsy. In order to measure and verify the compressive force generated by an outrigger, an experiment was carried out, as shown in Fig. 9; a set of an outrigger, an SMA spring, and a silicone rubber band were installed on the substrate. An additional (referential) spring was utilized to measure the compressive force by the AM. Figures 9(b) and 9(c) show the experimental results. As an electric voltage was supplied to the SMA spring, the outrigger was extruded successfully, but its extrusion height was limited by the referential spring. Since the spring constant of the referential spring is known (762 N=m), the compressive force generated by the AM can be calculated from the maximum extrusion height. In the experiment, the AM generated a force of 1:9 N when fully heated, which is large enough to rmly x the capsule endoscope in the intestine. It should also be noted in Fig. 9(b) that the outrigger started extrusion after 2:8 J was provided to the AM, which was for the SMA spring to overcome the initial tension by the silicone rubber band. It required about 20 seconds to overcome the initial tension; this time can be reduced by adjusting the stiffness of the silicone rubber band. The response time of the outrigger is shown in Fig. 9(c). In general, when SMA wires are used for bidirectional actuation, their response time is very slow because of the cooling. The SMA spring used in the AM, however, is used for one-directional actuation, and thus the response time of the outrigger is not as slow as the bidirectional settings. Notice in the gure that the outrigger was fully extruded in about 10 seconds. The response time can be shortened, if the heat transfer ratio is considered in the design. Figure 9(b) also provides important information on the energy consumption of the proposed device. The SMA spring of the outrigger mechanism may be the major part that consumes the energy of a capsule endoscope. From the gure, notice that about 10 J is necessary for an outrigger to be fully extruded. Since the system has four outriggers and other energy-consuming devices such as a camera and trigger, it is expected that the proposed system requires at least 300 J for one trial of biopsy. Since a Li-Po battery for microdevices has the energy capacity of 30 mAh at 5V (i.e., the total energy of 540 J), the proposed system would consume most of the energy of a capsule endoscope. Therefore, for proper operation of the proposed device, the capsule endoscope should be wired to an external power supply. We expect to solve this problem in the near future by improving our design and using a battery with higher energy capacity. Transactions of the ASME

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Fig. 10 Working principle of alignment mechanism

Fig. 11

Operation of alignment mechanism

Fig. 9 AM

Experimental setup and results for characterization of

4.2 Alignment Mechanism. The proposed device has three apertures on its housing, as shown in Fig. 4, for the TMM and BM to observe and perform the biopsy process. Therefore, even if the capsule endoscope is successfully anchored on the place where a target tissue exists, the device should be further controlled such that an aperture is aligned onto the target tissue. For this purpose, the AM has an alignment mechanism that rotates the biopsy module with respect to the AM, as shown in Figs. 3(c) and 3(d). Figure 10 shows a schematic of the alignment mechanism. Recall Journal of Medical Devices

that the AM achieved extrusion of outriggers by a combination of SMA springs and a silicone rubber band. Similarly, the alignment mechanism makes rotation of the BM using an SMA wire and a spiral spring. The SMA wire is to be deformed by the spiral spring in an idle state. Once an electric voltage is provided to the SMA spring, however, it overcomes the tension of the spiral spring and returns to its original shape. Since the contraction force of the SMA wire depends on the heat supplied to it, the rotation angle of the alignment mechanism can be controlled by an electric current owing through the SMA wire. Figure 11 shows that the biopsy module rotates with respect to the outriggers by the alignment mechanism. The alignment mechanism is designed to have the maximum rotational angle of 90 deg in an ideal case. In a greasy and wet environment, such as the lumen of the intestines, about 50% performance degradation is observed empirically, i.e., in practice the maximum rotational angle ranges from 40 to 50 deg in experiments. This performance degradation is due to the energy loss of the SMA spring and the slipping of outriggers on the intestinal wall. Figure 10 depicts an interaction between the capsule endoscope and the intestinal wall. FSMA is the contractile force of an SMA spring, F1 A is the friction between the capsule and the intestinal wall, and F2 P is the friction between the outriggers and the intestinal wall. F1 A and F2 P are functions of the contact area (i.e., A) and the compressive force by outriggers (i.e., P), respectively. Eloss is the energy loss due to heat transfer, hr is the relative h rotational angle of the BM with respect to the outriggers, r is the rotation radius, and d1 and d2 are the displacements of the BM and the outriggers on the intestinal wall, respectively. Assuming that F1 A and F2 P are constant, the relationship between the energy provided to the SMA spring and the rotational angle of the BM is (4) F2 Pd2 FSMA rdhr ESMA Eloss F1 Ad1 h SEPTEMBER 2012, Vol. 6 / 031004-5

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Fig. 12 Biopsy procedure by the proposed BM: (a) aligned onto a target tissue, (b) adhered by AM, (c) trigger released, (d) tissue sample cut

4.3 mm and width of 3.3 mm, which implies that the maximum jaw opening length is 8.6 mm. From this specication, the effective diameter of the aperture of the proposed BM was selected to 8.0 mm. In order to excise the tissue, the razors should be able to apply a shear stress larger than the destructive stress (sdes ) of the tissue. In Ref. [15], sdes of the intestinal tissue was measured from transversal specimens; it was measured up to 20 MPa. Thus, the shear stress that razors of the BM can apply to the tissue should be larger than 20 MPa. The shear stress induced by the razors (sex ) can be approximately calculated as sex F0 ts (5)

Note from the right hand side of Eq. (4) that the performance degradation occurs due to the heat transfer from the SMA spring and the slipping of the outriggers. The heat transfer problem may be solved by precisely sealing gaps between parts. The slipping of the outriggers may be avoided by utilizing particular materials, such as gecko-structured silicone pad.

Biopsy Module

5.1 Working Principle. A biopsy module (BM) is to obtain a tissue sample. It consists of two cylindrical razors, a spiral spring, and a trigger. Figures 12 and 13 show the proposed biopsy procedure and the fabricated mechanical parts of the BM, respectively. An outer cylindrical razor (i.e., the housing of the capsule endoscope) has three apertures with sharp edges (see Fig. 13(c)), which are to cut the tissue as well as to observe the intestinal wall by the TMM. Once an aperture is properly aligned onto a target tissue using the AM (Fig. 12(a)), an outrigger on the opposite side of the BM is further extruded such that the target tissue is inserted into the aperture (Fig. 12(b)). According to a trigger signal, an inner cylindrical razor rotates rapidly and the two sharp edges of the inner and outer razors are crossed closing the aperture, as shown in Figs. 12(c) and 12(d). The proposed mechanism has three useful properties, and thus, it is appropriate for the biopsy module of a capsule endoscope. First, the reaction force (or moment) due to the rotation of razors is minimal because the housing is rmly xed by the AM. This helps the capsule endoscope maintain its position and orientation during the biopsy process. Second, the biopsy process is reliable. Since the two razors rotate closing the aperture of the housing, it is guaranteed that the tissue inserted into the aperture can be cut by the razors. Recall that the overall biopsy process is observed by the TMM. Therefore, an operator can make sure that the target tissue is properly inserted into an aperture. The remaining useful property is due to the use of a spiral spring shown in Fig. 13(b). The spiral spring has a high energy density, i.e., energy per volume. Namely, large energy can be stored in the spiral spring and be released in an instant, which results in a high torque. This high torque makes excision of the tissue easy. It is reasonable to design the aperture such that the size of a tissue sample obtained by the proposed device is similar to that by existing biopsy forceps. The Radial JawTM 3 Max Capacity Biopsy Forceps of Boston Scientic [14] has the jaw length of

where t is the thickness of the sharp edge of a razor, s is the effective diameter of the aperture, and F0 is a force that the razor applies to the tissue. In order to reduce the magnitude of a excision force (i.e., F0 ), the edge of the razor should be as sharp as possible; note that F0 ! 0 as t ! 0. In practice, however, the thickness of a fabricated razor is limited due to the engineering tolerance; t of the razor shown in Fig. 13(d) is 30 lm. The effective diameter of the aperture (i.e., s in Eq. (5)) is 8.0 mm. Therefore, F0 should be larger than 5:0 N in order for sex to be larger than sdes 20 MPa. Recall that sex should be larger than sdes for successful biopsy by the proposed BM. From the calculated cutting force (F0 5:0 N), a spiral spring can be designed. The moment that a spiral spring should apply is M0 F0 rinner , where M0 is the moment by the spring and rinner is the radius of the inner razor. In the fabricated prototype, rinner 7:5mm; by a simple calculation, the required moment is M0 37:5 mNm. Since the precise calculation of the spring constant of a spiral spring is not available, various spiral springs were fabricated and tested. Figure 14(a) shows an experimental setup to measure the moment by a selected spring. For precise tests, a position-controlled dc motor was used to rotate the inner razor connected to a spiral spring. The moment by the spring can be approximately calculated from the magnitude of an electric current supplied to the dc motor because the electric current is proportional to the load torque.

Fig. 13 Fabricated parts of the BM: (a) PCB with a chip resistor, (b) a spiral spring, (c) an outer razor with three apertures, (d) an inner razor

Fig. 14 Measurement of the spring constant of a spiral spring: (a) an experimental setup, (b) the elastic torque with respect to the rotation angle

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Table 1 Electrical properties of a trigger mechanism V (V) <4.00 4.45 4.85 5.35 >5.50 Power (W) Time delay (sec) 1 3.89 1.82 1.61 burnt immediately Energy (mWh)

0.99 1.18 1.43

1.07 0.60 0.64

Fig. 15 Principle of the proposed trigger mechanism: (a) an idle state, (b) the trigger released

Figure 14(b) shows the experimental result. The spiral spring used in the experiment has the height of 2 mm, the thickness of 1 mm, and the span length of 113 mm. The material was common stainless steel for surgical applications. It should be noted in Fig. 14(b) that the spring can generate more than 37:5 mNm at the rotational angle of 60 deg. Therefore, successful biopsy is guaranteed as long as the spiral spring is initially wound more than 60 deg. Since the spiral spring can be wound more than 180 deg, the proposed BM can generate a large torque that is enough to cut a tissue. 5.2 Trigger Mechanism. The inner razor of the BM is loaded by winding the spiral spring and is to be released for biopsy. For this purpose, a trigger, which is able to endure the initial tension by the spring force and is electrically controllable, is necessary. In this paper, a chip resistor mounted on a circuit board is used as a trigger. Figures 15 and 16 show the principle and schematic of the proposed trigger mechanism, respectively. Suppose that the inner razor has a hump and that the hump is mechanically blocked by the chip resistor, as shown in Fig. 15(a). Since the chip resistor is soldered on the circuit board rmly, the inner razor cannot rotate in the idle state. When an electric voltage is applied to the chip resistor, the supplied electric power is converted into the heat, which increases the temperature of the chip resistor rapidly. Once the temperature of the chip resistor reaches the melting temperature of the solder (i.e., 200 C), the solder loses its rigidity and the chip resistor cannot endure the spring force, as shown in Fig. 15(b), i.e., the trigger is released. The proposed trigger mechanism with a chip resistor is useful for capsule endoscopes. Since the mechanical strength of the solder is large enough when it is solid, it endures the large torque by the spiral spring in an idle state. Therefore, a strong spiral spring can be utilized, which makes the biopsy process more reliable and successful. In addition, since the chip resistor is rmly mounted in the idle state, the loading process is easy and convenient. The circuit board where the chip resistor is mounted on may also include other peripherals, such as a communication circuit or a controller, and thus the required space for the trigger mechanism is minimal. The resistor detached from the printed circuit board (PCB) after triggering is stored in a space between the PCB and the BM. When multiple chip resistors are utilized, triggering can be

repeated as the number of the resistors; i.e., the biopsy module can take multiple tissue samples. The magnitude of the electric voltage supplied to the chip resistor is an important factor in the trigger mechanism. Since the resistance of the chip resistor is xed (20X), the heat is proportional 2 to the square of the voltage; notice that P V , where V is the R supply voltage, P is the electric power, and R is the resistance of the chip resistor. Thus if the voltage is low, the temperature of the chip resistor does not reach the melting temperature of solder. In this case, the supplied electric power may be dissipated by heating the overall capsule endoscope. When excessively high voltage is supplied, the chip resistor may be burnt abruptly even before the solder is melted. Moreover, the high current induced by the high voltage is dangerous to electronic peripherals of the capsule endoscope. In this paper, the supply voltage for triggering was selected by repeated experiments. The time delay for triggering and the electric current were measured using a data acquisition board. The experimental results are shown in Table 1. For the supply voltage lower than 4:00 V, the solder was not melted, i.e., the trigger was not released. On the other hand, the supply voltage higher than 5:50 V resulted in an immediate burning of the resistor, and the trigger was not released also. The experiments suggested that the supply voltage in the range of 4:45 V and 5:35 V is appropriate for the proposed trigger mechanism.

Experiments

Three individual modules (i.e., the TMM, the AM, and the BM) necessary for the complete process of biopsy by a capsule endoscope were introduced in Sections 3, 4, and 5. They are integrated in a prototype shown in Fig. 1. In this section, various experiments carried out with the prototype are discussed. 6.1 Tissue Observation and Alignment by TMM and AM. Figure 17 shows an experimental setup for verication of the proposed methods integrated in a prototype. Due to the animal-rights issues, an articial test-bed was established with a piece of the large intestine of a pig, which has an abnormal swelling that was suspected to be a polyp. The large intestine was cleaned due to the hygienic policy of the university and coated with silicone oil to prevent dehydronation. The silicone oil also substituted for the intestinal juice. The treated intestine was then xed on two parallel holders with the distance of about 100 mm. The inner diameter of the intestine was about 20 mm; it could be stretched up to about

Fig. 16 Schematic of the trigger mechanism; a chip resistor is used as a trigger

Fig. 17 Experimental setup of in vitro experiment

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Fig. 18 Alignment experiment Fig. 20 Rotation speed of the inner razor during biopsy process

Fig. 19

Inserted tissues by the AM

30 mm. Since the diameter of the prototype shown in Fig. 1 is 15 mm, it is not possible for the proposed BM to excise a tissue sample successfully without the anchor and alignment mechanisms. The prototype of the capsule endoscope was then inserted into the test-bed. It was connected by thin electrical wires to an external power-supply for supplying an electric power to release the trigger of BM. Since the trigger mechanism does not require much power as shown in Table 1, a battery for typical capsule endoscopes can be utilized for the same purpose. The capsule endoscope was manually inserted into the test-bed until the abnormal tissue was observed. In actual capsule endoscopy, it would explore the intestinal wall by peristaltic movement of the intestine or by a self-locomotive mechanism. After the capsule endoscope reached the target tissue, it was anchored by the AM; namely, the outriggers were extruded by heating the SMA springs. In order for the aperture of the BM to properly align onto the target tissue, it was then rotated by the alignment module. Figure 18 shows the images obtained by the TMM while the alignment mechanism rotates the BM with respect to the outriggers anchored on the intestinal wall. Notice that the white area that an arrow indicates is clearly observed in Fig. 18(d), which implies that an aperture of the BM is properly aligned onto the target tissue. After the alignment, an outrigger on the opposite side of the aperture was further extruded such that the target tissue was inserted into the aperture, as shown in Fig. 19. Note in the gure that the tissue was inated by the compression (see the dotted-circle in Fig. 19(c)). The experiments shown in Figs. 18 and 19 verify that: (1) The TMM can observe the intestinal wall through apertures on the lateral side of a capsule endoscope. (2) The AM is able to x the capsule endoscope in the lumen of intestine by extruding outriggers. (3) The AM successfully rotates the BM such that an aperture is properly aligned onto a target tissue. (4) The AM is able to apply a compressive force by selectively extruding outriggers such that the target tissue is inated into the body of a capsule endoscope. 6.2 Tissue Sampling by BM. In order for the proposed device to successfully obtain a tissue sample, the BM should be able to excise the tissue; i.e., the spiral spring should generate a moment large enough for excision of the tissue. In this section, the performance of BM is veried by an experimental result. Figure 20 shows the rotation speed of the inner razor during the biopsy process. A potentiometer was utilized to measure the angle of the inner razor, and the measured data was differentiated to calculate the rotation speed. A moving average method with the 031004-8 / Vol. 6, SEPTEMBER 2012

Fig. 21 Biopsy experiment: (a) an experimental setup with an additional camera, (b) images while the biopsy process

width of 100 samples was applied to smoothen the calculated rotation speed. Since the momentum of inertia of the inner razor was small, the rotation speed became high immediately (see the graph at t 0 in the gure). When the razor started excising the tissue, however, the rotation speed decreased due to the resistive force by the tissue (see Excision start in the gure). It should be noted that the rotation speed was not zero at all the time during the biopsy process, i.e., the razor continued the rotation excising the tissue. After the tissue was completely cut (see Excision complete in the gure), the rotation speed increased until the razor was blocked by the next latch. The result in Fig. 20 veries that the BM generates a moment that is large enough to overcome the destructive stress of the tissue. Figure 21 shows the experimental setup and images taken by a camera during the biopsy process. An additional camera was utilized in this particular experiment to clearly observe the biopsy process, as shown in Fig. 21(a). The complete process of biopsy by the proposed device is shown in Fig. 21(b). Notice in Figs. 21(b1)21(b4) that the AM was used such that an aperture shown in the gure was aligned onto the target tissue; the white scratched tissue shown in Fig. 21(b4). Then, the tissue started inating through the aperture, as shown in Figs. 21(b5)21(b6), which was achieved by extruding an outrigger on the opposite side of the capsule endoscope. The inner razor rotated as the trigger was released (see Figs. 21(b7)21(b8) and the tissue was successfully sampled as in Fig. 21(b9). Notice that the aperture was automatically closed in Fig. 21(b9).

Summary

In this paper, a biopsy device for capsule endoscopes was proposed. The proposed device consisted of three major modules; a tissue monitoring module (TMM) to observe the intestinal wall through apertures on the housing, an anchor module (AM) to x the capsule endoscope on the intestinal wall and to rotate it for better alignment, and a biopsy module (BM) to excise and sample the tissue. Due to the TMM and AM, an operator could observe the intestinal wall continuously and monitor the overall biopsy Transactions of the ASME

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process for successful tissue sampling. In order to realize the complicated functions in a limited space, the TMM employed a trigonal reector as well as a camera. The AM included two mechanisms to rmly x the capsule endoscope in the lumen of the intestine and to rotate the BM for better alignment. Once the capsule endoscope was properly anchored and aligned, the BM sampled the tissue with two cylindrical razors, a spiral spring, and a trigger. The outer razor, which was the housing of the capsule endoscope, had apertures for observation of the intestinal wall and for sampling a tissue. The spiral spring was selected such that it generates a large moment for excision of the tissue. The trigger utilized a chip resistor soldered on a circuit board. All of the proposed methods were integrated into a prototype and veried by experiments in this paper. By utilizing the three modules properly, the complete biopsy process from the diagnosis of intestinal wall to the sampling of the tissue was achieved.

References
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Journal of Medical Devices

SEPTEMBER 2012, Vol. 6 / 031004-9

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