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Master in Biomedical Engineering Delft University of Technology Email: M.Branco@student.tudelft.nl
Master in Biomedical Engineering Delft University of Technology Email: S.Agrawal@student.tudelft.nl
I. I NTRODUCTION Simple mastectomy, or "total mastectomy", is a procedure where there is a surgical removal of one or both breasts. In this procedure the adjacent lymph nodes and chest muscles are left intact. The principles of surgery were ﬁrst deﬁned in ancient Egyptian literature, but later in 1882, they were systematically detailed by Halsted, who described this radical extensive procedure as an excision not only of the breast but also of the underlying pectoral muscles and axillary lymph nodes. Another usual procedure is modiﬁed radical mastectomy. A modiﬁed radical mastectomy is a procedure in which the entire breast is removed, including the skin, areola, nipple, and the most axillary lymph nodes, but the pectoralis major muscle is spared. Historically, a modiﬁed radical mastectomy was the primary method of treatment of breast cancer. Despite other recent procedures, mastectomy still remains a viable option for women with breast cancer  . Unfortunately, this surgical operation does not have properly designed medical instruments, but instead it uses the ones designed for surgical interventions of other body parts. In this project we intend to identify, describe and design a required medical instrument for this type of surgery, namely a pair of forceps or tweezers which hold off the skin, namely breast skin ﬂap, during mastectomy. II. D ESCRIPTION OF THE PROCEDURE AND INSTRUMENT A. Description of the procedure The purpose of modiﬁed radical mastectomy is the removal of breast cancer (abnormal cells in the breast that grow rapidly and replace normal healthy tissue). This procedure leaves a superﬁcial chest muscle called the Pectoralis Major intact. Leaving this muscle in place will provide a soft tissue covering over the chest wall and a normal-appearing junction of the shoulder with the anterior (front) chest wall. This sparing of the pectoralis major muscle will avoid a disﬁguring hollow defect below the clavicle. Additionally, the purpose of modiﬁed radical mastectomy is to allow the option of breast reconstruction, a procedure that is possible, if desired, due to the presence of intact muscles around the shoulder of the affected side. Hence, the modiﬁed radical mastectomy procedure is a local controlling surgery which spares the breast muscles while removes all axillary lymphatic metastases .
In the operation, the skin is cut in a ﬁsh-mouth way around the nipple producing two ﬂaps of skin with a thin layer of fat tissue lifted up. This dissection between breast and skin ﬂap is carried out until the pectoralis major muscle and its aponeuroses are reached. The lifted skin ﬂap is clamped with two forceps and held upright for about an hour until the muscle is exposed. According to the procedure described in , in general both, the upper skin ﬂap and lower skin ﬂap are held in this way. In these cases, as illustrated by ﬁgures 1 and 2, the skin ﬂap is pushed in a speciﬁc direction and kept upright during the procedure. One possible tool to support is a retractor (Figure 2) and another one is forceps or tweezers (Figure 1). Normally the surgeon opts for retractor to hold the skin. In order to execute the mastectomy it is supports and keeps the skin ﬂap in a position orthogonal to the patient’s body, ideally suspended in a perpendicular direction. Retractor cannot be used to this extent, only clench tweezers or forceps. B. Description of the instruments During this kind of operation several surgical instruments are available   . By inspection of ﬁgure 3 it is possible to see:
• • •
Disinfection material - like a vat and Collin forceps; Cutting material - like scalpel and tissue dissection scissors; Clench and retractor material - like Pozzi, Babcock, Allis, Lahey forceps and fork and Sen-Miller, Mathyeu, Meyerding, Volkmann retractors; Dissection tweezers - with or without teeth; Hemostatic forceps like Adson, Kocher, Crile, Kelly, Halsted, amongst others.
Forceps is a hand-held, hinged instrument used for grasping and holding objects. It is used as a surgical instrument when objects are needed to be held. The term ’forceps’ is used almost exclusively within the medical ﬁeld. It can also be usually referred to as tweezers, tongs, pliers, clips or clamps. During this procedure the breast skin has to be held with forceps in order to permit the surgeon to access the inner tissues. According to the Portuguese medical expert Dr. Luis Branco, a general surgeon from Senology Center of Setúbal Hospital Center (associated to breastcentresnetwork.org), this
task is not optimized and it may also have some inﬂuence on the effectiveness of the procedure. We organized a video-conference with the surgeon where we asked him for the most crucial problems in his area of expertise and a way of approaching the problem. He supplied us with pictures, catalogues, diagrams and literature about mastectomy and surgical instruments that he uses. In the present method, the breast skin is held with clench forceps such as Collin (Figure 4), Babcock (Figure 5), Pozzi (Figure 6), Duval (Figure 7), Green-Armytage (Figure 8) and Millin (Figure 9), however the most popular one is Pozzi or retractors1 . However these instruments are not specially designed for this kind of surgery, therefore, they tend to pop out of there position (poor tension) or hurt the skin (excess of tension). For example, Pozzi cannot hold the skin ﬂap perfectly, rather it pops out unexpectedly. Popping out of the retractor implies it leaves its position of clinging the skin because of insufﬁcient hold with the skin. Since it looks as if the retractor jumps out we will use the verb ’to jump’ to describe this problem further in this report. Babcock forceps scratches the skin from the outside and slips from the inside of the skin. All the forceps are symmetric, so holding the inner skin tightly hurts the outer skin, and holding the outer skin gently makes it slip. Nevertheless, senology surgeons tend to adapt to the available instruments which are retractors, tweezers, forceps and hand grasping at the same time.
Figure 1: First part of the procedure.
Figure 3: Surgical instruments used in mastectomy procedure.
Figure 2: Second part of the procedure. Figure 4: Collin forceps.
Figure 5: Babcock forceps. Figure 9: Millin forceps.
Figure 6: Pozzi forceps.
2) There is a constant need of an assistant (two hands necessary) to hold the tool to keep the skin tight in a position; it is uncomfortable and difﬁcult for a human being to remain still for long duration. Also, slight disturbance caused in the position could be a problem to the operating surgeon producing an irregular thickness of the ﬂap with aesthetic or adequacy problems; 3) There are forceps which lay less pressure on the skin, however, their limitation is that they tend to loosen the grip and jump. B. Problem Deﬁnition The major target of improvement in this project would be the clamping instrument. The improved design should distribute the pressure over the skin reducing the damage; and it will require none or less manual power to keep it in a still position. Ideally, the designed forceps should be atraumatic for the outside skin and sharp for the inside skin. Please note that sharp in this context is relative to outer surface. Furthermore, it should be wider, like a skirt-pants hanger. Currently, only Pratt forceps has a structure similar to that , but it does not meet all the other requirements. Another aspect that could be considered in this project is the possible use of a steel arc placed on the top or bottom of the operation bed, which may or may not be rigid, and would be useful to ﬁx the designed clamping instruments in a precise position, angle and stress. IV. R EQUIREMENTS L IST
Figure 7: Duval forceps.
Figure 8: Green-Armytage forceps.
III. P ROBLEM I DENTIFICATION AND D EFINITION A. Problem Identiﬁcation The forceps mentioned above are not the most optimum tools for holding the tender breast skin for long. They are rather meant to handle other organs. This leads to following problems: 1) It damages (scratches) the skin by laying excessive pressure on few small points of contact, see ﬁgures in previous section;
images were provided by free online surgical instruments catalogues, avaliable in any browser.
For this project there are following requirements for designing the forceps: 1) Skin mechanical properties - i.e. Young’s Modulus, friction coefﬁcient; 2) Stiff and tough material for the scaffold - i.e. steel; 3) Biomaterial with elastic properties - i.e. rubber or plastic; 4) Knowledge of different surface textures for the sharp and atraumatic working ends; 5) Study of loads submitted to the skin during this particular procedure. V. BACKGROUND K NOWLEDGE In order to design a pair of forceps that only handles skin, ﬁrstly, it is necessary to study and understand skin’s anatomy and physiology, as well as skin mechanical properties and
representational models. The following paragraphs introduce several concepts and deﬁnitions. A. Functional anatomy of the skin Considering the cross section of skin in Figure 10, it is composed of two principal layers, the epidermis and the dermis, joined by a distinct structure called dermal-epidermal junction. The epidermis is the outer layer, serving as the physical and chemical barrier between the interior body and exterior environment, whereas the dermis is the deeper layer providing the structural support of the skin, below which is a loose connective tissue layer, the subcutis or hypodermis which is a deposit of fat. The breast tissue is held in place by ligamentous tissue of Cooper to the dermis. In the mastectomy procedure the surgeon removes the entire breast beneath the skin and from the deep muscular fascia (a dense ﬁbrous connective tissue that surrounds the muscles) or even the muscle, leaving only all other skin layers .
change, and it is considered to be fully intact before the procedure. Beyond a certain limit of time or force, however, the tissue can break down . Additionally, skin undergoes adaptation under pressure displaying edemas and redness. Relative to shear pressure, tension occurs when skin is pulled along the plane of the surface. It can be relevant near a scar tissue or even when considering a retraction of the skin during procedure. The main loads that the breast ﬂap is submitted during mastectomy are essentially the ones represented in Figure 11.
Figure 11: Main loads applied during mastectomy procedure: σ - Normal stress; τ - Shear stress; T - Torsion. C. Problems solved As mentioned before, the aim of this study is to solve the problems posed to the breast skin of the patients undergoing mastectomy and some operational difﬁculties faced by the surgeons during mastectomy. The root cause of the problems to the patient and the jumping problem lies in the parameters and the surface properties of the clamping end of the forceps and excessive pressure laid by the retractor, while the mechanical functioning of the opening and closing mechanism needs to be altered in order to get rid of the discomfort of the retractor. Firstly, excessive pressure laid by the currently used forceps leaves bruises and wounds on the skin. Secondly, the forceps tend to open and slip if less pressure is applied in order to protect the skin. It can also be attributed to the surface friction of the forceps with respect to the outer and inner faces of the skin. The third and the last limitation is the discomfort caused to the person holding the re-tractor or the forceps still in the upright position. We have solved the ﬁrst two problems to a great extent while the third problem remains unsolved due to some limitations of resources. D. Material properties When studying a surgical instrument it is necessary to ﬁrst analyze the mechanical properties of all possible materials (or biomaterials) that can be used with the view of not infecting the skin and their ease of sterilization. In general, forceps are made of metallic materials, and most commonly stainless steel. Metals have many attributes, such as stress, strain, elastic and plastic behaviors, and toughness, ductility and hardness properties. Taking into account the latter deﬁnitions, it is
Figure 10: Cross-section of skin. B. Skin mechanical properties The skin consists of the dermal ﬁbrous proteins collagen and elastin embedded in an amorphous ground substance. It is also known that in relaxed skin, the collagen ﬁbres, which are arranged roughly parallel to the epidermis, are intertwined in a wavy appearance (Finlay,1969, Brown, 1973). Moreover, upon stretching the wavy form disappears and the ﬁbers tend to line up with the stress direction (Gibson and Kenedy, 1967; Finlay, 1969). The gradual straightening of the collagen ﬁbers results in an increasing skin stiffness, and after the loading the ﬁbres tend to return to their primary wavy form . There are three major types of stresses at different locations on the skin pressed with forceps as shown in Figure 11. 1) Tension at the joint between the two ﬂaps, and/or compression perpendicular to the surface of the skin. 2) Torsion because of turning the skin inside out. 3) Shear stress at the recently cut extremity of the skin ﬂap. The stresses are expressed as pressure, a uniformly distributed force applied perpendicular or parallel to the skin. Studies suggest that application of normal pressure for low or moderate duration is acceptable to keep the skin intact, which is a good assumption for this research. Only when the skin is stretched for about an hour, it undergoes any permanent
possible not only to characterize different material but also to compare them. Stainless steels are Iron based alloys containing Chromium, Nickle and other alloying elements, characterized by a high corrosion resistance. There are different types of stainless steels, from martensitics to ferritics and austenitics. Most surgical equipment is made out of martensitic steel which is much harder than austenitic steel and easier to keep sharp. In addition, this material is easy to disinfect and sterilise and to keep in asceptic conditions. The are other possible materials, such as titanium alloys, which offers more mechanical and corrosion resistance than steel, but are usually too expensive. It is also possible to consider Chromium Cobalt alloys which are very resistive to corrosion, but not as much resistive to mechanical loads. An option for designing the working ends of the forceps is considering a material that has a high friction coefﬁcient with skin, such as rubber and plastic. Rubber is not used for medical instruments, but plastics have had an increasing importance in medicinal instruments. Nowadays, surgical plastic instruments are constructed with heavy-duty plastic that are prone to toughest conditions. These kind of surgical instruments are perfect in situations when a secure, non-piercing hold or a pair of lightweight and disposable forceps are needed. Some examples of plastics are hypoallergic latex, a stable dispersion (emulsion) of polymer microparticles in an aqueous medium; Polytetraﬂuoroethylene (PTFE), a synthetic ﬂuoropolymer of tetraﬂuoroethylene; Bakelite, thermosetting phenol formaldehyde resin, formed from an elimination reaction of phenol with formaldehyde; Thermosetting polymers, is polymer material that irreversibly cures; A Thermoplastic, also known as a thermosoftening plastic polymer that becomes pliable or mouldable above a speciﬁc temperature, and returns to a solid state upon cooling (i.e. POM-C); Carbon-ﬁber-reinforced polymer (CFRP) is an extremely strong and light ﬁber-reinforced polymer which contains carbon ﬁbers amongst others. In general, the friction coefﬁcient of skin is approximately 0.2  and so in case of choosing a plastic material, it should have a higher coefﬁcient. For the reasons stated above, the ideal material to develop the basic structure of the forceps would be stainless steel and some kind of disposable and hypoallergic plastic. However, the critical choice of this material should be performed by a material science engineer specialized in biomaterials, once it is crucial to design it as a functional instrument. VI. C ONCEPTUAL SOLUTION Our proposed solution of the forceps employs the functioning of a lever but has a modiﬁed working end specialized to provide an improved grip with its skin and distributes the pressure more uniformly without forcing the skin much farther than its natural shape and form. The pair of forceps has three parts: the working end, the shaft and the handle. All the parts of forceps are made of stainless steel which gives them a structural strength, but there are also detachable plastic components on the working ends.
To gain a clear insight of the conceptual instrument, it is represented as a three-dimensional digital model in Creo Parametric 2.0 R and KeyShot R from Figure 14 to 20. The ﬁnal version of the instrument is represented in Figure 20. A. Working ends We aim at solving the ﬁrst two problems stated above by providing it large and curved rather than small and ﬂat working ends, unlike Millin or Green-Armytage forceps; and grooves on the surface would form a better grip with the inner skin. The detailed description of the features of the working ends of the new device is given below:
Anatomy of the working ends: Each of the working ends is composed of the two layers (Figure 12) - stainless steel layer and plastic layer. Steel layer is drawn directly from the shaft while the plastic layer is in form of detachable pads over the stainless steel layers. It is only this plastic that is in contact with either side of the skin while steel just forms the scaffold. The plastic pads are disposable and must be replaced after a surgery.
Figure 12: Detailed view of the working ends. Shape of the working ends: The two working ends are curved along the longitudinal direction and the curvature for both is in the same direction which is perpendicular to their surface (Figure 13). The end with the sharp contact surface (inner surface) is convex to the inner side of the skin while the end with the atraumatic contact side (outer surface) is concave to the outer side of the skin. Thus, when the skin ﬂap is lifted and held by these clamps, the working ends have the same curvature as the lifted skin. The two ﬂaps of the working ends would form cups sandwiching the skin ﬂap between them. Surface area of the working ends: Our skin is very elastic, so it needs a large force to hold the skin ﬂap. The breast skin ﬂap under work is of quite a large area. The surface area of the working ends of the proposed design is larger than the conventional forceps to distribute the force over a larger area of skin, and thus reducing the pressure at all the points. The size of the working areas is approximately 4.5cm. Interface with the skin: We have conceptualized four types of plastic layers that can be ﬁtted on the clamps depending on the amount of grip needed. They vary from each other in terms of their surface architecture. The surgeon is free to
Figure 13: Front view of the forceps.
Figure 15: How the working end ﬁts the plastic heads.
use different types of pads on the two ends at the same time. Following are the types of surfaces: Type 1: Smooth surface as shown in Figure 14 which provides grip only due to its high coefﬁcient of friction. Type 2: Fish-brush like surface. It has needle-like protrusions which are not perpendicular to the surface. Such a layer is useful for gripping with the inner side of the skin. Type 3: Threaded surface with transverse threads stretching from one end to the other. Type 4: Surface with discrete small round balls scattered all over it. These balls not only would ﬁx into the grooves of the inner side of the skin along with reducing friction with the outer skin but also increase blood circulation on the outer surface. The balls may also have different degrees of thickness, high and pointed shapes. The working areas (now referred as heads) were then designed to be disposable and made of plastic or latex kind of material, and with different textures and degrees. In other words, considering the type of surgery and skin, the surgeon can choose between a sharper and more atraumatic shape of the heads. The ﬁtting method between the heads and the working areas of the forceps is a common T-shape slip ﬁtting (Figure 15).
the optimum dimensions of these forceps which minimizes the stress on the skin and also eases the method of holding the forceps. The conventional size of the total forceps should be between 17cm and 25cm, and so we opted 20cm. Moreover, since the working ends are asymmetric, it was necessary to colour a shaft differently so it would be easy to recognize which shaft (yellow shaft) would handle the outer part of the skin.
Figure 16: Technical drawing showing the shape of the instrument. VII. D ESCRIPTION OF THE PROCESS TOWARDS THE
Figure 14: Shape of the heads. B. Shaft and Handle The shaft of the forceps is straight, similar to those of the Millin and other usual forceps. The handle is similar to those of conventional scissors. Figure 16 and Figure 17 show the technical drawings of the designed forceps and the surface architectures. Deeper insight of the mechanical properties of our skin and a detailed force diagram of the skin ﬂap under tension are needed to design
The process of developing the new design involved a thorough understanding of the anatomy and compressive and tensile strengths of the skin in various directions. First, an elaborate plan was made containing the main steps towards the goal, including: 1) fundamental research about forceps, 2) properties of the skin, 3) materials and biomaterials, 4) design and ergonomics and 5) future work and prospects. In each step, the medical surgeon’s feedback was taken into account, in order to achieve an optimal solution. Namely, during the material choice and design process, it was crucial to understand the surgeon’s opinion and idea about the usage of the instruments. The ﬁrst idea of the design was a one-piece instrument, but then it was modiﬁed into an instrument with disposal heads, as mentioned previously. In order to fully design this instrument it would be necessary to acquire more information about every possible material and perform some tests and simulations with real skin, in order to project the correct dimensions and mechanical properties.
Figure 19: Final model with two coloured shafts and coloured heads.
it is possible to have disposable plastic pads with different surface abrasions. Hence, the ﬁnal design reduces the pressure perpendicular to the skin by increasing the surface area. The torsion is reduced by having curvature in transverse direction rather than having ﬂat faces. Moreover, it provides a better grip with the inner and the outer skin keeping the blood circulation intact. Figure 17: Technical drawing showing the T-ﬁtting and surface architectures. IX. F INAL RESULTS AND DISCUSSION The problem suggested was to design a pair of forceps that could hold skin pieces apart during the procedure without scratching the skin and also not slip out. In order to develop such instruments it was necessary to consider asymmetric heads where the inner parts would be different but with complementary shapes. In the ﬁnal design, the end in contact with the outer skin are atraumatic, whereas the one for inner skin which contacts the connective tissue are sharp. Also, the material should have enough friction to make a ﬁrm grip without much pressure and also not infect the skin. Therefore, plastic material is chosen which constitutes the disposable clamping heads with different textures and degrees of atraumaticity in surface and sharpness in surface. Some examples of possible textures are presented here. Figures 21, 22 and 23 correspond to atraumatic heads and Figures 24, 25 and 26 to sharp heads. The same texture as Figure 23 could also be applied in the sharp head only with slight bigger and thinner blunt nails. Additionally, in order to ease the operation for the surgeon, the shaft can also be bent towards the clamping ends which keeps the shaft away from the view of the work.
Figure 18: Lateral view of the forceps.
Finally, this instrument, as it was developed and prototyped, can be proposed to many surgical instruments companies. The main companies in the market of surgical instruments are Citel, Codman, Johnson & Johnson, Ethicon, Lister Surgical, amongst many. VIII. O UTCOME OF BOTH THE SESSIONS WITH THE
MEDICAL EXPERT AND EVALUATION
The meetings with Dr. Luis Branco were organized over a video conference. There we showed him the technical drawings of our design, explained its working and discussed about the materials for making ﬂexible pads. He, with his experience, evaluated the idea and appreciated it as a huge improvement. Nonetheless, he suggested us to restrict the curvature only on the transverse direction and to leave it ﬂat in the second direction. He also approved the use of plastic pads from the point of view of disinfection and sterilization. However, the discussion with him led us to a conclusion that
Figure 20: Atraumatic surface with grooves or threads. We consider the result of this project a feasible and possible solution for a forceps prototype design to handle skin breast during procedures such as simple and modiﬁed radical
Figure 21: Atraumatic bubble like surface.
Figure 22: Atraumatic surface with discrete small round balls.
Figure 23: Sharp surface with concentric blunt nails of different size.
Figure 24: Sharp surface with blunt nails islands.
Figure 25: Sharp surface with uniform blunt nails, that can be perpendicular to surface or tilted.
mastectomy. Considering this project to be under the master course, it is not possible to explore in depth all the mechanical and material details necessary to fully develop this surgical instrument. However, it gave us an opportunity to work with a medical expert and to understand the needs and the role of a biomedical engineer. X. F UTURE WORK AND C ONCLUSION Surgical instruments are very integral part of the surgery which demand a lot of attention in their design. There
is always a scope of improvement in the design of such instruments. Since mastectomy is a recurrent surgery of the 21st century, not much development have taken in the instruments used till now. We proposed a very viable solution to some of the many limitations posed by current designs of forceps. However, still this design is mechanically static. So, the pressure at each point remains the same throughout the process. An alternating amount of pressure could also be applied on all the points keeping the total force over the skin ﬂap constant. A cost effective way to achieve this is utilizing the pressure of ﬂuid ﬂow in a pipe. Each plastic pad could be replaced by a pair of plastic pipes (total four pipes per forceps) could be introduced through which ﬂuid could be ﬂown via a controlled pump. According to Bernouille’s incompressible ﬂuid ﬂow equation, the ﬂowing ﬂuid applies a pressure perpendicular to the pipe walls which is proportional to the square of the velocity of the ﬂuid at that point. Because of continuity and constant volume, the velocity in a pipe in turn is a function of the cross sectional area. Fluid ﬂows faster in a thinner part than in a wider part. So, a combination of two pipes of complementary shapes ﬁxed next to each other would serve the purpose. Fluid could be ﬂown through each of them during different time intervals alternatively. Such a time dependent pressure would normalize the average pressure at a point over the complete duration of surgery. Alternatively, memory shaped alloys could also be deployed to redistribute the pressure dynamically. However, feasibility and cost considerations are important while choosing one of them. It was also in our interest to ﬁnd a way of handling the forceps without human support. However this problem brings other implications, such as operation room design and surgical conditions in the hospital. The conceptual idea is to have a kind of support that would not be an interference in the surgeon’s working area and working sight, and yet be have a strong locking force to handle the skin resistance. A rigid or ﬂexible arc above the operation bed could be considered as a support to hang the forceps, but it could only handle the upper skin ﬂaps of the breast. For the lower ﬂaps, a rigid steel shaft needs to be suspended over the bed and it should have as many degrees of freedom as possible. For example, an arm connected to the under part operation bed that could be shifted freely along one side of the bed. We hope to have proposed an optimal solution for the presented problem, and to continue developing this prototype in order to be implemented in the surgical instruments industry later. ACKNOWLEDGMENT We would like to thank Dr. Luis Branco for sharing the problems he faces during surgery, for providing us with the required information and feedback and also for considering us capable to solve them. We would also like to thank Dr. Jie Zhou and Dr. E. L. Fratila-Apachitei for sharing information on surgical materials and, at last but not the least, to thank
Stephen Perry for creating the 3D CAD model of the design instrument in Creo Parametric 2.0 R and KeyShot R . R EFERENCES
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