\r\n\t• Role of technological innovation and corporate risk management
\r\n\t• Challenges for corporate governance while launching corporate environmental management among emerging economies
\r\n\t• Demonstrating the relationship between environmental risk management and sustainable management
\r\n\t• Contemplating strategic corporate environmental responsibility under the influence of cultural barriers
\r\n\t• Risk management in different countries – the international management dimension
\r\n\t• Global Standardization vs local adaptation of corporate environmental risk management in multinational corporations.
\r\n\t• Is there a transnational approach to environmental risk management?
\r\n\t• Approaches towards Risk management strategies in the short-term and long-term.
Current therapies for cancerous tumors suffer from both toxic secondary effects and the development by the tumor of drug resistance. These effects usually block therapy for metastatic cancers, the cause of 90% of cancer deaths [1, 2, 3, 4, 5]. For solving these problems, our first thesis is that the best strategy is to increase tumor specificity of anticancer drug delivery in several, independent stages. If, for example, three stages are used and each stage is 80% efficient (20% nonefficient) in increasing specificity, then overall efficiency is 99% [100 × (1.0 − 0.23)]. In this case, (1) drug dosages to tumors can be raised 100× without changing toxicity and, therefore, (2) tumor cell evolution of drug resistance is minimized.
The primary alternative is to continue testing chemotherapies [6, 7, 8], immunotherapies [9, 10, 11] and radiotherapies [12, 13, 14] that have tumor-specificity determined at one independent stage. This one stage is often cellular DNA replication, which is more rapid and, therefore, more drug- and radiation-sensitive, in cancerous cells than it is in healthy cells. One-stage strategies are >100 years old for immunotherapy and radiotherapy. Chemotherapeutic agents typically used are over 50 years old [8]. Even major effort has not produced systematic therapies for metastatic cancer. Apparently, new, possibly more biology-based, strategy is needed to counter risk that the above one-stage-based strategies, in general, are not realistic for reaching objectives (reviewed in [1, 15, 16, 17]).
In theory, one implementation of multi-stage strategy starts with drug delivery in a drug delivery vehicle (DDV) that is gated. The gate is opened to load drug, closed in circulation to deliver drug and opened again in tumors to administer drug. Stages of DDV-derived toxicity reduction are the following tumor-specific events: (1) DDV delivery, (2) DDV opening and, (3) drug activation, for masked drugs. We address stages (1) and (2) here.
In this implementation, tumor-specific delivery is achieved via the EPR effect. The EPR effect is the spontaneous accumulation of nanoparticles in tumors, observed for an uncharacterized phage in 1940 [18] (reviewed in [19]). The causes of the EPR effect are (1) porosity of tumor blood vessels and relative tightness of healthy blood vessels, so that nanoparticles enter tumors, but usually not healthy tissue and (2) poor tumor lymphatic drainage, so that nanoparticles remain [20, 21, 22, 23, 24, 25]. The EPR effect is the basis for the use of several FDA-approved, drug-loaded, liposomal DDVs [23, 24, 26].
However, circulating, drug-loaded, liposomal DDVs undergo drug leakage that causes significant toxicity [22, 23, 25, 27]. Also, liposomes are removed from circulation by the macrophage-phagocyte innate immune system. That is to say, liposomes are not very persistent. Chemical solutions to the leakage problem do not exist to our knowledge. Chemical solutions to the persistence problem (e.g., polyethylene glycol derivatization [28, 29]) introduce quality control problems and are not adaptable to future improvements, for example, achieving of tumor-specific unloading. The second thesis is that the optimal solution is linked to finding an appropriate, biologically produced, microbial DDV. Unlike some biology-based anticancer strategies [1, 15, 16, 19], use of a DDV is implementable with nononcolytic viruses and, therefore, avoids the dangers [19] of using oncolytic viruses.
In practice, we have discovered a phage T3 capsid that appears to have DDV-favorable characteristics needed for implementation of our strategy. First, phage T3 (and presumably its capsid) has recently been found to have exceptionally high persistence in mouse blood (3–4 h), unlike the T3 relative, T7 [30]. Second, one empty, but otherwise phage-like T3 capsid, is impermeable (for over 20 years) to the compound, Nycodenz (821 Da molecular weight) (reviewed in [31]). But, when the temperature is raised to 45°C, Nycodenz enters this capsid [32], presumably through a gate that opened. The concept is that, if we adapt this capsid to use as gated DDV, some of the needed engineering has already been done by natural selection.
Phages T3 and T7 are illustrated at the left in Figure 1. The gated capsid is illustrated at the right in Figure 1. This capsid is generated during DNA packaging that had been initiated by a DNA-free procapsid called capsid I (not shown). During packaging, capsid I expands and becomes the more angular and stable capsid (capsid II) illustrated in Figure 1. In nature, the capsid-gate is a ring of 12 gp8 molecules (Figure 1) that acts as entry portal for DNA during DNA packaging [31, 32, 33]. Most T3 and T7 capsid II particles are purified after having detached from DNA during infected cell lysis. The amount is 5–10 mg capsid II per liter of culture. The last purification step is buoyant density centrifugation in a Nycodenz or Metrizamide density gradient. Nycodenz low density (NLD) capsid II has the gp8 “gate” and is impermeable to Nycodenz and Metrizamide. The low density (1.08 g/ml) is caused by high internal hydration, which is caused by Nycodenz impermeability. Nycodenz high density (NHD) capsid II is Nycodenz-permeable (1.28 g/ml) and is completely separated from NLD capsid II during buoyant density centrifugation in a Nycodenz or Metrizamide density gradient [31, 33, 34, 35]. We use NHD capsid II as a control during loading experiments.
Phages T3 and T7 (left); and T3 and T7 NLD capsid II (right). The graphic legend at the top indicates the various capsid components. A protein is labeled by gp, followed by the number of the encoding gene. Analogous T3 and T7 genes have the same numbers. If NLD capsid II is used as DDV, the perimeter of the DDV is defined by the gp10 shell; the gate is the gp8 portal. All structures are the same for phage T3 as they are for phage T7 (reviewed in [31, 32]).
In the case of T3 NLD capsid II, gated entry of Nycodenz has been observed via raising of temperature. The likely entry channel was the axial hole of the gp8 ring. This conclusion was drawn, in the case of T7 NLD capsid II, from (1) entry kinetics of the fluorescent dye, bis-ANS [1,1′-bi(4-anilino)naphthalene-5,5′-di-sulfonic acid; 673 Da], and (2) covalent cross-linking of bis-ANS to channel proteins [33]. Asymmetric reconstruction-cryo-EM [36] revealed that obstruction of the T7 gp8 channel (and presumably the T3 channel) varies.
In support of working to implement the above gating-based strategy, the following quote from 2005 presents an expert opinion of what is needed for the next generation of anticancer DDVs [27]. “An ideal liposomal anticancer drug would exhibit little or no drug release while in the plasma compartment, thus ensuring limited exposure of the drug to healthy tissue. This feature would also maximize drug delivery to disease sites, as mediated by the movement of the drug-loaded liposomes from the plasma compartment to the extravascular space at disease sites, such as a region of tumor growth. Following localization, however, the drug-loaded liposome must transform itself from a stable carrier to an unstable carrier. This would ensure that the drug, which has localized in the diseased site, is bioavailable.” To our knowledge, no details for such “controlled release” via a liposomal DDV have been published. The system described here is designed to accomplish what is described in the above quote. However, implementation uses gating of a DDV, not programmed instability of a DDV.
To proceed further, we need a procedure for rapidly determining whether a drug is loaded in a capsid. In the current study, we have developed native agarose gel electrophoresis (AGE) for this purpose. The detection is performed via capsid band fluorescence produced by the compound loaded.
We tested the loading of two fluorescent compounds. The first was GelStar, a fluorescent nucleic acid stain typically used after AGE. In contrast, we incubated GelStar with our capsid and then performed AGE without further use of GelStar. The second compound was bleomycin, an anticancer drug [37, 38] that is also fluorescent [38]. Neither the manufacturer nor the vendor provided either the structure of GelStar or the concentration of commercial GelStar solutions. GelStar is sold in solution only.
The dominant fluorescence emission of nucleic acid-bound GelStar is in the green range. Apparently not previously documented is that the dominant fluorescence emission of free GelStar is in the orange range, at least when the GelStar is in an agarose gel. Ultraviolet light stimulated GelStar fluorescence emission vs. GelStar dilution is shown in Figure 2. Free GelStar, at several dilutions, had been pipetted in 5 μl amounts onto an agarose gel before ultraviolet light illumination and photography through an orange filter (spots labeled G in Figure 2). The effective volume in μl (dilution, multiplied by 5) of the stock GelStar solution is also indicated. In Figure 2, the color of GelStar spots is orange for all dilutions, as it also is found to be (not shown) with yellow and green emission filters. The orange color is real and is not produced by the emission filter because green Alexa 488 dye fluorescence retains its green color (spots labeled A in Figure 2). The number next to the Alexa 488 spots is the total amount (μg) of Alexa 488, also applied in 5 μl amounts.
Fluorescence of free GelStar. GelStar and Alexa Fluor 488 were diluted and, then, pipetted onto the surface of an agarose gel. The fluorescence was photographed through the orange filter. The GelStar samples are indicated by G, followed by the effective volume (μl) of the original, undiluted GelStar solution. The Alexa Fluor 488 samples are indicated by A, followed by the amount (μg) of Alexa Fluor 488.
DNA-bound GelStar had the expected green emission at all dilutions, when viewed through the same orange emission filter used for Figure 2 (right side of the right panel of Figure 3). Green emission was also dominant when yellow and green emission filters were used for DNA-bound GelStar (not shown).
Association of GelStar with T3 NLD capsid II. A commercial GelStar solution was diluted to the extent indicated above a lane and incubated with T3 NLD capsid II. Association of GelStar with the capsid was determined by AGE, followed by, first, photography of fluorescence (right panel, lanes labeled NLD CII) and, then, staining of protein with Coomassie blue (left panel). Also analyzed was purified T3 DNA (right panel, lanes labeled DNA), which does not stain with Coomassie blue. The arrow indicates the direction of electrophoresis; the arrowheads indicate the origins.
Without fluorescent compound, the background of an agarose gel was blue when emission was photographed without an emission filter (not shown). Thus, not surprising was that optimal detection of bleomycin was not obtained with a blue filter, even though the blue range was where peak emission was previously found for bleomycin [38]. Among the blue, green, yellow and orange filters, optimal detection was obtained with the green filter.
With the green emission filter, the minimal detected bleomycin amount was 0.2–0.4 ng when a bleomycin dilution series like the GelStar dilution series in Figure 2 was photographed (not shown). Contrast enhancement of images was used at these lower amounts.
We succeeded in loading GelStar into NLD capsid II. To achieve loading, 10 μg of NLD capsid II was incubated with GelStar at 45°C. Loading was then assayed by AGE at 10°C. Then, the gel was illuminated with ultraviolet light. The result was a fluorescent band of intensity that monotonically increased with decreasing GelStar dilution (left section of the right panel of Figure 3). The capsid amount was invariant, as judged by Coomassie staining of the same gel (left panel of Figure 3). At GelStar dilutions lower than those in Figure 3, down to 1/10, the band intensity reached a plateau (not shown). The dominant fluorescence, at all dilutions, was green, implying that the GelStar was bound to something capsid associated. GelStar did not detectably associate with NHD capsid II (not shown).
The following data indicated that the GelStar-binding capsid site was not on a DNA molecule associated with the capsid. As the dilution of GelStar decreased, the DNA-bound GelStar fluorescence underwent, first, an increase and then a decrease (Figure 3, right segment of right panel). However, the decrease was not observed for the binding to NLD capsid II. Second, although a minor NLD capsid II fraction has DNA [31], the DNA-containing NLD capsid II had been excluded during purification by selecting the low-density side of the NLD capsid II band after buoyant density centrifugation in a Nycodenz density gradient. Thus, the GelStar was apparently either self-bound or bound to capsid protein.
Association of bleomycin with T3 NLD capsid II was also achieved. However, the fluorescence signal was relatively weak (Figure 4). The bleomycin fluorescence signal of a NLD capsid II band did not change when the concentration of bleomycin was changed from 2 to 16 mg/ml. A bleomycin-associated NLD capsid II band is shown in Figure 4. Most of the free bleomycin migrated toward the cathode (not shown), i.e., in a direction opposite to the direction of capsid migration.
Association of bleomycin with T3 NLD capsid II. The experiment of Figure 3 was repeated with bleomycin (8 mg/ml), instead of GelStar. The capsid region of the post-AGE gel is shown. The right (protein) panel has a single band of capsid stained with Coomassie blue. This band marks the position of the capsid-associated bleomycin fluorescence in the left panel. The arrow indicates direction of electrophoresis.
The strength of the signal in Figure 4 was weakened by the blue background and use of a green filter. In addition, a contaminant in the bleomycin preparation migrated close to the capsids, and is seen above the capsid band at the top of the left panel of Figure 4.
Calibration data for bleomycin, like the data for GelStar in Figure 2, were obtained. These data revealed that the amount of bleomycin loaded was 150–300 molecules per capsid.
In the Introduction, we outlined a strategy that is expected to work, if we can achieve the following objectives: (1) high (~4 h) persistence of NLD capsid II in blood so that the EPR effect has time to work, (2) adequate loading and sealing of NLD capsid II and (3) tumor-specific, controlled release (de-sealing or unloading). Objective #1 is likely already achieved, given the high persistence of T3 phage. That is to say, if one considers this strategy to be engineering based, some of the engineering might already be been done by natural selection.
Concerning adequate loading, the volume of the internal cavity of NLD capsid II = 6.95 × 10−17 ml. For volume occupancy (FV) of 0.5 (equal to the FV of DNA packaged in mature phage [34]), the number of bleomycin molecules (1416 Da; density estimated at 1.6 g/ml as sulfate) per NLD capsid II particle is 2.4 × 104. The recommended dose of DDV-free bleomycin depends on the tumor, but is typically [39, 40] 10–20 units/m2, corresponding roughly to 10–20 mg/m2; 15 mg/m2 is 1.76 × 1018 bleomycin molecules/m2.
To calculate the number (ND) of NLD capsid II particles needed for this dose at FV = 0.5, we initially assume a 25 g mouse, which on average, has 78.6 cm2 surface area [41]. Then, ND is 3.6 × 1011. A 6-liter culture yields 150–300 mouse doses of this size (cost ~ $1500), assuming (1) laboratory-scale production technique, (2) no development of procedures to increase the amount produced per bacterial cell, and (3) no drug-dose reduction caused by improved targeting. That is to say, if we can half-fill the volume of NLD capsid II, we have a viable beginning. However, thus far, we have filled no more than 2% of FV = 0.5, NLD capsid II volume. So, increasing the loading is a major objective for the future.
An apparent obstacle to achieving this goal is the nonincrease in loading as bleomycin concentration increases above 2 mg/ml. At least two possible explanations exist. (1) After passing through an open gate, the bleomycin eventually causes the gate to close. We were hoping to close the gate by lowering temperature. (2) After diffusing through an open gate, the bleomycin is prevented from diffusing in reverse by binding to internal proteins; the internal proteins become saturated as the concentration of bleomycin increases. In either case, increasing the loading is a problem of engineering.
An advantage of using a phage DDV is that the human-design engineering potential is relatively high. First of all, the capsids in a T7 NLD capsid II preparation are structurally uniform enough so that symmetric cryo-EM reconstruction is obtained at 3.5 Å [34] and asymmetric reconstruction, at ~8 Å [36]. Assuming T3 capsids to be comparably homogeneous, use of chemistry to improve gating should produce relatively uniform results.
Second, phages, in general, and phage T3 in particular, can be genetically manipulated, which is not possible with liposomes. Information for determining which nucleotides to change can be obtained from high-resolution cryo-EM structure. Structure of this type is not obtainable with liposomes.
Finally, we note that, as far as we know, the only phages tested for production of an NLD capsid II-like capsid are the related coliphages, T7, T3 and ϕII. All three of these phages produce a NLD capsid II-like capsid [42]. Other phages are potential sources of gated capsids, perhaps with properties even more DDV-favorable.
We obtained bacteriophage T3 and T3 capsid II from 30°C-lysates of host, Escherichia coli BB/1, that had been infected by phage T3 in aerated liquid culture [43]. The growth medium was 2× LB medium: 2.0% Bacto tryptone, 1.0% Bacto yeast in 0.1 M NaCl. We initially purified both phage and capsids by centrifugation through a cesium chloride step gradient, followed by buoyant density centrifugation in a cesium chloride density gradient [43]. The latter fractionation separates capsid I from capsid II.
To separate NLD capsid II from NHD capsid II, we performed buoyant density centrifugation of capsid II in a Nycodenz density gradient, as previously described [32]. The purified NLD and NHD capsid II were dialyzed against 0.1 M NaCl, 0.01 M Tris-Cl, pH 7.4, 0.001 M MgCl2. NLD capsid II, which formed a band near the top of the Nycodenz density gradient, had no detected contamination with NHD capsid II and vice versa, as previously seen by analytical ultracentrifugation [31]. Phage, NLD capsid II and NHD capsid II were dialyzed against the following buffer before use in the experiments described below: 0.2 M NaCl, 0.01 M Tris-Cl, pH 7.4, 0.001 MgCl2.
T3 DNA was obtained from purified T3 phage by phenol extraction. The DNA was dialyzed against and stored in 0.1 M NaCl, 0.01 M Tris-Cl, pH 7.4, 0.001 M EDTA. DNA concentration was obtained from optical density at 260 nm.
GelStar was obtained from Lonza (Basel, Switzerland) in solution. The company recommends dilution by a factor of 1:10,000 for use as a nucleic acid stain after gel electrophoresis. Alexa Fluor 488 succinimidyl ester was obtained from Molecular Probes (Eugene, OR, USA) as a powder.
Bleomycin was obtained from Cayman Chemical Company (Ann Arbor, MI, USA) as a powder. The bleomycin was dissolved in the aqueous buffer indicated and diluted to the concentrations indicated before incubation with capsids and DNA.
Tests of fluorescence emission vs. fluorescent molecule concentration were made by pipetting 5 μl of diluted fluorescent molecule onto the surface of a 0.7% agarose gel (LE agarose, Lonza) that had been cast in a plastic Petri dish in the electrophoresis buffer of Section 4.3. The gel was then photographed by use of the procedures described in Section 4.3.
To test for fluorescent compound/nanoparticle association, fluorescent compounds were mixed with one of the following T3 nanoparticles: NLD capsid II, NHD capsid II, phage, DNA. First, a 12.5 μl amount of fluorescent compound in 0.1 M NaCl, 0.01 M sodium citrate, pH 4.0, 0.001 M MgCl2 (citrate buffer) was added to 4.5 μl of additional citrate buffer. Then, 8.0 μl of a nanoparticle sample was added and mixed (final pH, 4.1). This mixture was incubated at 45.0°C for 2.0 h.
To perform AGE, we added to this mixture 2.5 μl of the following solution: 60% sucrose (to increase the density for layering in sample wells) in the electrophoresis buffer below. This final mixture was layered in a well of a horizontal, submerged, 0.7% agarose gel (LE agarose, Lonza), cast in and submerged under the following electrophoresis buffer: 0.05 M Tris-acetate, pH 8.4, 0.001 M MgCl2. The temperature of the gel and buffer had been pre-adjusted to 10°C in an effort to seal NLD capsid II and, therefore, prevent leakage of fluorescent compounds.
AGE was performed at 1.0 V/cm for 18.0 h with the gel and buffer maintained at 10°C by circulation through a controlled-temperature water bath. After AGE, the gel was soaked in 25% methanol in electrophoresis buffer for 1.5 h at room temperature, to cause leakage of fluorescent compounds from NLD capsid II and, therefore, to prevent auto-quenching.
Finally, the gel was photographed during illumination with a Model TM-36 ultraviolet transilluminator (Ultra Violet Products, Inc.). The camera used was a Canon Power Shot G2, 4.0 Megapixels. The following Tiffin emission filters were used as described in Section 2: Blue, 80A #290513; Green, 11Green 1—#287305; Yellow, Yellow 12—#282224; Orange, Orange 16—#289750. To detect capsid protein, the gel was subsequently stained with Coomassie blue and photographed during illumination with visible light [43].
Obtaining an increase in the current tumor-specificity of anticancer drugs should be possible via use of a DDV that implements multiple, independent stages of specificity increase. T3 NLD capsid II is an example of a bio-nanoparticle that has undergone some of the needed DDV-bioengineering via mutation/selection in the environment. Other examples, not yet found, are assumed to exist and potentially have even more favorable characteristics.
The authors acknowledge support from the San Antonio Area Foundation and the Morrison Trust.
The authors declare no conflict of interest.
The anterior cruciate ligament (ACL) is a critical knee joint, bone-to-bone connected, stability ligament that is attached from an anterior location of the proximal tibia to a posterior location of the distal femur. The ACL is highly susceptible to failure during athletic activities and slip-fall events. The goal of ACL reconstruction surgery is to rebuild the ligament attachments as closely as possible to the native anatomy in order to restore pre-injury knee function and normal proprioception in the affected knee [1]. Personalized medicine in surgery allows the customization of insertion sites, graft size, tunnel placement, and graft tension for each individual patient [2]. A critical pre-operative decision concerns the placement of a tibial-femoral tunnel mimicking the native orientation of the ACL attachment [2]. Surgeons need to consider particular aspects of the local anatomy and, by extension, the biomechanical artifacts introduced during surgery. Here, we report an alternative approach based on the understanding of knee affordances to guide surgeons in the design of knee reconstruction strategies.
As aforementioned, an important predictor of clinical outcome during ACL reconstruction is tunnel placement [3, 4]. Roof impingement occurs when an ACL graft prematurely contacts the intercondylar roof before the knee reaches terminal extension. A tibial tunnel anterior to the tibial intersection of the intercondylar roof’s slope allows the distal half of the roof to impinge on the anterior surface of the graft (arrow I in Figure 1(a)). Impingement syndrome occurs when the relationship between two articular components are incongruous, with resulting friction, inflammation, and degeneration [6]. Failure of grafts placed anteriorly is likely due to the impact of the bony roof on the graft’s anterior surface during knee extension (Figure 1(b)) [5].
(a) Schematic representation for the surgical placement of the tibial-femoral tunnel, presenting the possibility for uniform motion transmission within the knee. The (positive) affordance based approach encourages surgical designers to customize the position of the tibial-femoral tunnel to intersect with the instantaneous knee screw (IKS or $). The point of contact (c) is determined from femoral and tibial velocity vectors during joint movement (VF and VT, respectively). (b) Radiographic and magnetic resonance images (MRI) of an exemplar of tibia tunnel placement leading to roof impingement during ACL reconstruction. Negative affordances (severe and moderate impingement) inform about the tunnel locations to avoid, in order to prevent roof impingement of the ACL. Severe roof impingement occurs when the surgeon places the tibial tunnel in a local totally anterior to the slope of the intercondylar roof (top). Moderate roof impingement occurs when the surgeon places the tibial tunnel in a local partially anterior to the slope of the intercondylar roof (middle). A graft may also become impinged when the surgeon places the tibial tunnel in a local entirely posterior and parallel to the slope of the intercondylar roof (bottom). An impinged graft has a low, uniform signal intensity on the MRIs. The original schematic and images were published previously [5] and are used by the permission of Dr. Stephen Howell.
To our knowledge, this is the first study to use psychological theory to address this surgical design concept [7]. Traditional rating systems to assess clinical outcome after joint arthroplasty are often based on the surgeon’s objective ratings, such as range of motion and strength, or clinical ratings of function and pain. However, the patient’s perceptions after arthroplasty may differ significantly from those of their clinician. Moreover, surgeons often underappreciate the needs and views of their patients [8]. There is, therefore, increasing awareness of the need to include patient-reported outcome (PRO) instruments in the evaluation of surgical procedures. Indeed, these patient-centered assessments of treatment outcomes are becoming today’s standard [9]. Patient-reported outcome metrics (PROMs) can be simply described as a patient’s health status self-report. A ‘forgotten joint score’, corresponding to when a patient forgets the artifact in their everyday life, was introduced in PROM as the ultimate goal in joint reconstruction [10]. ‘Forgotten joint scores’ are often observed in patients after surgery [11]. Nevertheless, these ratings do not replace the need to understand the general role of artifacts and affordances in reconstruction surgery. This study aims to identify measurable invariants using a (positive) affordance-based design strategy for structural tunnel placement during ACL reconstruction.
Current approaches in design science are characterized by a strong emphasis on methods as opposed to theory. Herbert Simon [12] was one of the early proponents studying design as a science. In the 1960s, Simon criticized the lack of a theoretical basis in design methods, describing such ad hoc methods as ‘cook-book approaches.’ Novel conceptual frameworks for design allow engineers to better describe and solve problems at the system level, such as those involving user interactions. We propose a conceptual approach for design based on affordances, a concept used in the study of perception in ecological psychology.
‘Architecture and design do not have a satisfactory theoretical basis,’ wrote psychologist James J. Gibson three decades ago. He also asked, ‘can an ecological approach to the psychology of perception and behavior provide it?’ [13]. Gibson’s affordances theory describes how animals perceive their environment [14]. We applied Gibson’s concept of affordance to the design of artifacts, in particular anatomic artifacts, which impacts on their biomechanics.
A decade after Gibson’s seminal work, another psychologist, Donald A. Norman, use Gibson’s theory of affordance to understand artifact design [15]. However, Norman’s approach stopped short of incorporating the concept of affordance as fundamental to the design of any artifact [16]. When Norman revised the 1988 edition of his book in 2013, he rejected the ecological theory. He noted that the term affordance was often misused by psychologists, and as a result, he introduced the term ‘signifier.’ Signifiers make explicit that affordances are inputs used during cognitive deliberation for creating internal mental representations, which contradicts Gibson’s claims that, if a designer successfully makes affordances possible, the artifact directly informs how it can be used—which is the hallmark of successful design. Intriguingly, in a recent study [17], Norman regrets that different psychology fields and design science have become separate silos unable to communicate with one another.
Ecological psychologist William Warren has applied the concept of affordances to the design of specific artifact-user relationships, such as the height of stairway steps [18]. His approach relied on the ratio of leg height to step height. Paola Cesari followed up on Warren’s stair climbing studies by showing that older people perceive stairs differently than young people. However, the ratio between step height and the distance between the stepping foot and the top edge of the step was similar in both groups [19].
Since the concept of ‘affordance’ was introduced almost 40 years ago, it has been used in a variety of fields, including child psychology [20], the design of graphical user interfaces [21], mobile robots [22], control room interfaces [23], and more recently, in engineering design [24, 25, 26]. The impetus for any design project can be understood in terms of creating and changing affordances. The design process is the construction of an artifact that offers specific affordances, but not certain undesired affordances. An artifact with more positive affordances is considered better, while an artifact with more negative affordances is considered worse. However, this approach does not follow ecological psychology, but instead, it addresses the difficulty of identifying affordances with engineering [27].
Maier and Fadel coined the term artifact-artifact affordance (AAA) [24, 25]; however, AAA has not been properly incorporated within the larger theory of affordances. Although AAA was developed as a new concept, the idea that inanimate objects offer action possibilities in an organism is a foundational concept known since Gibson’s work in ecological psychology. The ecological approach demonstrates how animal (including human) perception and action is continuous with interactions between inanimate physical systems, or the world in general. The entrainment of separate limbs during biological coordination, for example, follows the same physical laws as entrainment between two pendulum clocks or other purely mechanical (inanimate) systems [28]. The fact that interactions between inanimate and animate systems are continuous precludes the need to identify AAA as a distinct category.
In short, these concepts should be used with great care if knowledge is to be gathered. In the present study, we used a surgical technique as an example of how the theory of affordances may be utilized for affordance-based design.
Gibson demonstrated how animal perception and action is continuous, with interactions with inanimate objects or surfaces [14]. The affordances of a product are what it provides, offers, or furnishes to a user. Gibson’s ‘system theory’ of perception corresponds to an open system, which is rather different from the view of isolated artifacts [29]. For engineering design, an affordance can be defined as the relationship between person and artifact from which the behavior emerges. These affordances between artifacts and the people that use them are called artifact-user affordances (AUA).
For example, the gear pair (Figure 2(a)) is referred to as an artifact-artifact affordance (AAA) for uniform motion transmission between two parallel axes, and it is possible only if the line of action passes through a fixed point, known as the pitch point. Moreover, assuming that gear 1 rotates with constant angular velocity
(a) The artifact-artifact conjugate action, in the form of two interacting gears, demonstrating the uniform motion transmission between two parallel axes as can be found in a knee joint. (b) the knee joint synergy as represented by six constraints $i′,i=1,..,6, which are conjointly reciprocal to the instantaneous knee screw ($) as indicated by their intersections (at the ⊗‘s). A balance of forces happens when the virtual coefficient vanishes, being it the necessary and sufficient condition for knee equilibrium.
Gibson claims that some affordances are beneficial while others are injurious, such as maintaining a line of action versus veering off course [14]. These benefits and disadvantages, safeties and dangers, positive and negative affordances are properties of events taken with reference to an observer, and not properties of the observer’s experiences; they are not personal values or feelings of pleasure or pain added to neutral perceptions [14]. For example, physical properties of the tibial tunnel and the intercondylar notch roof are not affordances in and of themselves, but they do determine what affordances are offered to a surgeon depending on a patient’s anatomic features. Thus, the characteristics that affect positive AUA are the same as those affecting negative AUAs. The artifact only has one set of characteristics, which is a customization of the tunnel placement, and this is all that the designers or surgeons can act upon. As a consequence of such mutuality, affordances do not exist in the patient’s tunnel or intercondylar roof, but in what they offer to the surgeon. Importantly, AUAs may conflict with one another when the graft becomes slack or loose (i.e., loss of extension in the graft at full extension, or the graft being trapped in the notch), indicating a negative affordance or an increase in the potential for injury. Thus, when a surgical designer identifies a functional range in which a joint is not allowed to fail, they need to constrain the target bounds for that same joint to enhance positive affordances and avoid negative affordances. This approach is addressed in the section below.
A joint ‘gear’ cannot perceive itself or its joint gear since gears are inanimate. Gears simply conjugate uniform motion transmission by virtue of their tensegrity structure, manifesting that structure influences behavior [31]. However, the knee is an active set of bone structures that come to equilibrium via a joint function. The function of a joint is not only to permit mobility of the articulated bones but also to maintain a stable bone position and movement. Knee structures include muscles/tendons, anterior cruciate ligaments (ACL), posterior cruciate ligament (PCL), medial collateral ligament (MCL), lateral collateral ligament (LCL), and articular cartilage contact in the medial (P1) and lateral (P2) compartments (Figure 2(b)). From a biomechanical point of view, several studies have shown that these intra-articular knee structures work in synergy with the ACL [32, 33, 34]. The knee synergy engages afferent/efferent motor control loops that establish functional equilibrium gait patterns [35].
Neurophysiologist Nikolai Bernstein defined coordination as mastering the many degrees of freedom (DOF) of a particular movement by reducing the number of variables to be controlled [36]. Recently, a contemporary perspective on Bernstein’s concept of synergies has been proposed [37]. The muscle synergy is equivalent to the complexity of lines, a manifold approximated by individual fibers (Figure 3(a)). Muscles are not functional units, even though this is a common misconception. Instead, most muscular movements are generated by many individual motor units distributed over some portions of one muscle, plus portions of other muscles. The tensional forces of these motor units are then transmitted to a complex network of fascia sheets, bags, and strings, which convert them into the final joint/body movement [38].
(a) Fiber tractography image of a portion of the lateral gastrocnemius muscle as demonstrated in an exemplar healthy subject. The overlying images were generated at one region of interest, corresponding to the muscle boundaries where the anatomical cross-section area was maximal (whole-body MRI scanner, Signa HDxT 1.5 T, GE Healthcare, USA). The patients were placed in the supine position, feet first, and the position of each participant was considered in relation to the long axis of the leg, which was placed in parallel to the magnetic field. (b) a manifold of muscle fibers in tension forms to the linear complex identified as an instantaneous screw ISp and its perpendicular pole (q) within the synergy of gait.
Line manifold contraction is a linear line complex [39] defined by screws (
In our previous research [42, 43], we introduced the concept of measurable invariant of the knee perceptual organ. In such invariant, six constraints ($) are collectively reciprocal to the instantaneous knee screw (IKS or $) indicated by ⊗ (Figure 2(b)). These metrics predicted the knee synergy model based on synergies [44]. Moreover, this perspective defines torque-free pure forces based on the tensegrity structure [45, 46, 47, 48]. It is important to note that this configuration is a tensegrity configuration, as the system is pre-stressable in the absence of external forces, such as ground reaction forces during actual locomotion [49]. It was shown the knee tensegrity structure (KTS) has six constraints, and that it can balance the forces between tension and compression in the joint such that no work results [50]. The KTS can be pre-stressed to obtain the same configuration as if external loads were applied. The selected pre-stress may yield the same configuration in the swing phase (external forces are absent) as in the stance phase (external forces are present) [49]. Notably, preparedness is not only a reactive aspect of the movement apparatus, but it also relates to anticipatory adjustments that predispose a system to behave in a particular way [37].
If a knee joint is only free to twist about a screw IKS while in equilibrium, despite being acted upon by the fiber reaction, the mechanical work during a small displacement against the reaction forces
Uniform motion transmission between two axes (defining the thigh and shank, respectively) is affordable only if their lines of action pass through the IKS, as expressed in the Eq. (1). Thus, the affordances of the knee synergy must be positive, and the joint ligaments should remain in an isometric/isokinetic condition or continuous length/tension. If not, the ligaments become slack or loose, resulting in roof impingement, post-reconstruction [5]. Moreover, Eq. (1) also implies that the moving self ($) and the invariant structure of the KTS reaction are reciprocal aspects of the same perception. Gibson called this information gathering approach propriospecific, as opposed to exterospecific, to specify the observer (here the self) as distinguished from the environment.
The knee synergy approach proposed herein was recently validated experimentally [51]. The authors calculated if all the lines of action intersect at the IKS ($) following natural knee motion to describe the knee surgery invariant. The results show the mean distances between each constraint line of action, and the IKS stayed below 3.4 mm and 4.5 mm for ex vivo and in vivo assessments, respectively (Figure 4(b)).
(a) An exemplar Ball-Disteli diagram [52] with two generally disposed screws (T and S or p1 and p2), conveniently placed on the z-axis along their common perpendicular (with b). The origin of coordinate O is halfway between the screws, and the x-axis is inclined by half the included angle σ between the two screws (S, T). An instantaneous knee screw (IKS) after normalization is linearly dependent on the screws during any point of knee movement. The Ball-Disteli diagram aligns itself using the principle of three axes. (b) Representation of the IKS (green line); see Online Supplementary Video 1 (video is available via the following link: https://drive.google.com/file/d/18_YtszzT3_IvNIken5uxObj4jmSd0Zs_/view?usp=sharing). The lines of action of the ligaments (blue lines) and cartilage contact (red areas and red lines) for wrenches identified every 30° within the range of knee motion for a given patient. The white or colored dots represent the closest point to the IKS for each wrench. The colors range from white (di > 5 mm) to the color of the corresponding intersecting line (di = 0 mm). Cartilage contact colors on the tibia are proportional to the tibial-femoral relative separation (red: Distance ≤0 mm; blue: Distance >7 mm). The original anatomic schematics and lines of action were published previously [51] and are used by permission of professor Michele Conconi.
It has been hypothesized that a tensegrity system serves the medium of haptic perception, from the individual cells to the whole body, maintaining continuous tension and discontinuous compression [53], which clearly exhibit the determinate character of the entire body system perception [38, 40]. In this study, we present the positive affordance-based design on graft placement while in continuous tension, rather than designing against the negative affordance by preventing impingement. As described, we use the invariant structure of the KTS [54] as an appropriate ecological frame of reference to locate the tibial tunnel placement. For the ACL-patient to engage the IKS directly, clinicians have to measure the tunnel placement relative to the posture and behavior of the person being considered, making continuous graft tension possible. First, an invariant should not be applied to the patient directly, for it is not a stimulus. Second, invariants can be considered qualitative rather than quantitative so that other clinical assessments can make it available to their surgeons/observers in an exact mathematical description [14].
The IKS is defined in terms of the second-order invariant by a linear combination of the two screws of the first-order invariant, S and T, instantaneous screw axes of the shank and thigh (Figure 4(a)) [55]. Then the IKS must be a screw that has been picked up from the many candidate screws on the cylindroids [40], which is reciprocal to KTS (via Eq. 1). Hence, the ratio of the amplitudes about S and Tmay be determined (Figure 4(a)), which manifests the fact that the sensitivity of the knee joint to its disposition is of crucial importance in picking up information.
Two lines were projected respectively to the sagittal plane so that the path of the graft could be aligned to any transversal axis intersecting the IKS ($), the central line of KTS that is the second-order invariant line, also called the IKS (Figure 1(a)). The lines were generated at full knee joint extension. Notice that if the graft line is not precisely aligned with the member line within the KTS, due to position errors, for example, the velocity difference on the graft line would not be zero, but would still be small. If the path of an ACL graft is so selected that it cuts the IKS of the KTS, then the line becomes a member of the KTS, which ensures the isokinetic graft placement related to trans-tibial-femoral tunneling. Consider now the necessary kinematic relations in that contact point c as the common point belonging to both the tibial and femoral tunnels (Figure 1(a)).
The velocity of the point c residing on the femoral tunnel (
As described, we identified the measurable second-order invariant of knee synergy and proposed it as a new view of the basis of tunnel placement by using Eq. (1). The knee synergy approach identifies the information as a means to perceive the affordance of uniform motion transmission. To apply the described approach and identify the invariant, we characterized the shank to the thigh (the tibia to the femur) relative motion, i.e., the second-order invariance of the knee synergy. These results were then compared with experimental data for validation as provided by the “Grand Challenge Competition to Predict In Vivo Knee Loads” as part of the Symbiosis project funded by the National Institutes of Health [56].
Contrasting the established idea of senses, Gibson considered separate anatomical units as perceptual systems [29]. In the present case, a joint yields spatial information, skin-nerve conveys contact information, and in certain dynamic combinations, joint and skin-nerve yield synchronization, or entrainment specifying information about the layout of external surfaces during locomotion.
Behavioral dynamics in a consistent approach has proposed to account for the dynamics of perception and action [57]. This approach followed Gibson’s idea that rather than being localized in an internal (or external) structure, control is distributed over the agent-environment system, in the present case, the user-artifact-surface system. Therefore, Warren’s behavioral dynamics argues for a one-to-one correspondence between the internal structure IKS, constituted by the internal forces formed by the distal end of the femur and the proximal end of the tibia, and the external structure, represented by the ground reaction forces (GRFs) on foot [58].
Behavioral dynamics control laws indicate that the entrainment or coordination of shank and thigh (S, T) follows the same physical laws as the entrainment between the knee and ground (IKS, GRF). Therefore, the cross-ratio [59] of the ordered pair (IKS, GRF) with respect to the ordered pair (S, T) is
For a given IKS (when an observer perceives the affordance of the surface) and the location of the center of pressure (COP) on the axis of the GRF is known, then the GRF vector is limited to a plane in the screw system of the first order [47, 48] (Figure 5(a)). The muscle synergy η and GRF φ are then compounded into an invariant, limited to the plane of the COP in reciprocity with the IKS. This theorem was originally proposed by Möbius, who showed that forces from six lines could be equilibrated, and also, if five of the lines are given along with a point on the sixth line, then the sixth line is limited to a polar plane [40].
(a) The framework for estimating responses to constraints on the knee joint (ligament forces and contact forces) is influenced by the inclusion of muscle synergy (η) and GRF (φ) relative to the center of pressure (COP). The judicious generation of the IKS for the one DOF in knee equilibrium simplifies the estimation. This figure was adapted from the original figure published previously [47, 48]. (b) Perception and action during the stance phase of gait entrain the knee joint rotation with the touch pattern (GRF) of the foot. The invariant knee-manifolds demonstrates that an affordance for postural stability is measured relative to the posture of the patient, as represented by the entrainment of the GRF with the IKS at any point in the gait pathway.
To test such ecological approach to perception and action during the stance phase of a gait, we compared previously published experimental data sets [56] with our predicted datasets [47, 48] in terms of medial and lateral contact forces. Available data included limb motion capture, fluoroscopy images, GRFs, electromyographical readings determining muscle forces, as well as medial and lateral knee contact forces derived from GRFs. Data were collected from an adult male with a right knee reconstruction (65 kg mass and 1.7 m height). When the variations in the ground contact (magnitudes and direction) were shown along with the variations of knee movement in terms of IKS, an invariant was determined uniquely by the two corresponding pairs, see Eq. (2) (Figure 5(b)).
In this study, the IKS was determined by a linear combination of two instantaneous screw axes of the shank and thigh (Figure 4(a)). The IKS nearly coincides with a reciprocal screw of the GRF, as indicated in a magnified inset image in Figure 5(b). A perceptual system of the knee can come to equilibrium since twists of amplitudes S and T neutralize. We thus see that the evanescence of one function must afford all that is necessary for subordinate organs (S, T) belong to an IKS of the superordinate organ for information pickup over paths of locomotion. This reciprocity is captured by the concept of a mutual relationship between the constraints and the DOF [60, 61]. Information about the person accompanies information about the environment. Here it is shown that proprioception accompanies exteroception; information is available to specify both poles [14].
A lateral radiograph of the knee in extension was the traditional approach to diagnose any roof impingement, and a portion of the tibial tunnel was traditionally placed anterior to the intercondylar roof [5] (Figure 1(b)). However, the available information on the experimental images can not be applied to another patient because they do not provide environmental information. Thus, AUA has the potential to diagnose pathologies. The last decade has seen a paradigm shift in the measurement of clinical outcomes, with an increasing focus on the user’s perspective, PROMs. Many clinicians, though, are less confident in self-reported PROMs, than in ‘objective measurements’ [11]. Recent studies identified several sensations, activities, and psychological factors such as feelings of instability and knee-related fears that make the patients aware of their artificial knee joint [62]. They concluded that joint awareness might work as an overarching parameter. This is aligned with Gibson’s statement that an affordance cuts across the dichotomy of subjective-objective and helps us to understand its inadequacy [14]. Affordances have to be designed in relation to the uniqueness of each patient, and thus posture and movement need to be measured in terms of a specific patient-environment system, not in patient-centered terms.
This study presented an affordance based design supporting knee reconstruction surgery, with applications to the user/surgeon/therapist. It brings ecological theory to robustly explain knee biomechanics and clarifying the general role of physical artifacts and affordances in surgery. The mutuality of user and artifact that we defended here is not traditionally guiding individualized ACL reconstruction. Instead, the anatomic ACL reconstruction seems to lead to the idea that a deficient ACL is not understandable within knee joint biomechanics [32]. As we argued, the ACL is a highly organized synergy with intra- and extra-articular components [34] and yet still an identifiable system within the anatomic environment. The knee complexes in Eq. (2) reinforce how perception and action are coupled. A unique combination of invariants, a compound invariant, is just another invariant [14]. In particular, this study identified the knee complexes as the measurable invariable structures that specify the persisting placement of the tunnel during ACL reconstruction.
Author WK extends thanks to Ms. Flávia Yázigi for her hard work with the radiography and a long recruitment process. WK also thanks to his mother-in-law, Ms. Sun Lee, for her continuous encouragement for this research. The experimental data used for validation were provided by the “Grand Challenge Competition to Predict In Vivo Knee Loads” as part of the Symbiosis project funded by the US National Institutes of Health via the NIH Roadmap for Medical Research (Grant # U54 GM072970). WK also thanks Dr. Michele Conconi of University of Bologna, for making the videos “The Geometrical Arrangement of Knee Constraints That Makes Natural Motion Possible” available to us.
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El-Hemaly\nProfessor OB/GYN & Urogynecology\nFaculty of medicine, Al-Azhar University \nPersonal Information: \nMarried with two children\nWife: Professor Laila A. Moussa MD.\nSons: Mohamad A. M. El-Hemaly Jr. MD. Died March 25-2007\nMostafa A. M. El-Hemaly, Computer Scientist working at Microsoft Seatle, USA. \nQualifications: \n1.\tM.B.-Bch Cairo Univ. June 1963. \n2.\tDiploma Ob./Gyn. Cairo Univ. April 1966. \n3.\tDiploma Surgery Cairo Univ. Oct. 1966. \n4.\tMRCOG London Feb. 1975. \n5.\tF.R.C.S. Glasgow June 1976. \n6.\tPopulation Study Johns Hopkins 1981. \n7.\tGyn. Oncology Johns Hopkins 1983. \n8.\tAdvanced Laparoscopic Surgery, with Prof. Paulson, Alexandria, Virginia USA 1993. \nSocieties & Associations: \n1.\t Member of the Royal College of Ob./Gyn. London. \n2.\tFellow of the Royal College of Surgeons Glasgow UK. \n3.\tMember of the advisory board on urogyn. FIGO. \n4.\tMember of the New York Academy of Sciences. \n5.\tMember of the American Association for the Advancement of Science. \n6.\tFeatured in �Who is Who in the World� from the 16th edition to the 20th edition. \n7.\tFeatured in �Who is Who in Science and Engineering� in the 7th edition. \n8.\tMember of the Egyptian Fertility & Sterility Society. \n9.\tMember of the Egyptian Society of Ob./Gyn. \n10.\tMember of the Egyptian Society of Urogyn. \n\nScientific Publications & Communications:\n1- Abdel Karim M. El Hemaly*, Ibrahim M. Kandil, Asim Kurjak, Ahmad G. Serour, Laila A. S. Mousa, Amr M. Zaied, Khalid Z. El Sheikha. \nImaging the Internal Urethral Sphincter and the Vagina in Normal Women and Women Suffering from Stress Urinary Incontinence and Vaginal Prolapse. Gynaecologia Et Perinatologia, Vol18, No 4; 169-286 October-December 2009.\n2- Abdel Karim M. El Hemaly*, Laila A. S. Mousa Ibrahim M. Kandil, Fatma S. El Sokkary, Ahmad G. Serour, Hossam Hussein.\nFecal Incontinence, A Novel Concept: The Role of the internal Anal sphincter (IAS) in defecation and fecal incontinence. Gynaecologia Et Perinatologia, Vol19, No 2; 79-85 April -June 2010.\n3- Abdel Karim M. El Hemaly*, Laila A. S. Mousa Ibrahim M. Kandil, Fatma S. El Sokkary, Ahmad G. Serour, Hossam Hussein.\nSurgical Treatment of Stress Urinary Incontinence, Fecal Incontinence and Vaginal Prolapse By A Novel Operation \n"Urethro-Ano-Vaginoplasty"\n Gynaecologia Et Perinatologia, Vol19, No 3; 129-188 July-September 2010.\n4- Abdel Karim M. El Hemaly*, Ibrahim M. Kandil, Laila A. S. Mousa and Mohamad A.K.M.El Hemaly.\nUrethro-vaginoplasty, an innovated operation for the treatment of: Stress Urinary Incontinence (SUI), Detursor Overactivity (DO), Mixed Urinary Incontinence and Anterior Vaginal Wall Descent. \nhttp://www.obgyn.net/urogyn/urogyn.asp?page=/urogyn/articles/ urethro-vaginoplasty_01\n\n5- Abdel Karim M. El Hemaly, Ibrahim M Kandil, Mohamed M. Radwan.\n Urethro-raphy a new technique for surgical management of Stress Urinary Incontinence.\nhttp://www.obgyn.net/urogyn/urogyn.asp?page=/urogyn/articles/\nnew-tech-urethro\n\n6- Abdel Karim M. El Hemaly, Ibrahim M Kandil, Mohamad A. Rizk, Nabil Abdel Maksoud H., Mohamad M. Radwan, Khalid Z. El Shieka, Mohamad A. K. M. El Hemaly, and Ahmad T. El Saban.\nUrethro-raphy The New Operation for the treatment of stress urinary incontinence, SUI, detrusor instability, DI, and mixed-type of urinary incontinence; short and long term results. \nhttp://www.obgyn.net/urogyn/urogyn.asp?page=urogyn/articles/\nurethroraphy-09280\n\n7-Abdel Karim M. El Hemaly, Ibrahim M Kandil, and Bahaa E. El Mohamady. Menopause, and Voiding troubles. \nhttp://www.obgyn.net/displayppt.asp?page=/English/pubs/features/presentations/El-Hemaly03/el-hemaly03-ss\n\n8-El Hemaly AKMA, Mousa L.A. Micturition and Urinary\tContinence. Int J Gynecol Obstet 1996; 42: 291-2. \n\n9-Abdel Karim M. El Hemaly.\n Urinary incontinence in gynecology, a review article.\nhttp://www.obgyn.net/urogyn/urogyn.asp?page=/urogyn/articles/abs-urinary_incotinence_gyn_ehemaly \n\n10-El Hemaly AKMA. Nocturnal Enuresis: Pathogenesis and Treatment. \nInt Urogynecol J Pelvic Floor Dysfunct 1998;9: 129-31.\n \n11-El Hemaly AKMA, Mousa L.A.E. Stress Urinary Incontinence, a New Concept. Eur J Obstet Gynecol Reprod Biol 1996; 68: 129-35. \n\n12- El Hemaly AKMA, Kandil I. M. Stress Urinary Incontinence SUI facts and fiction. Is SUI a puzzle?! http://www.obgyn.net/displayppt.asp?page=/English/pubs/features/presentations/El-Hemaly/el-hemaly-ss\n\n13-Abdel Karim El Hemaly, Nabil Abdel Maksoud, Laila A. Mousa, Ibrahim M. Kandil, Asem Anwar, M.A.K El Hemaly and Bahaa E. El Mohamady. \nEvidence based Facts on the Pathogenesis and Management of SUI. http://www.obgyn.net/displayppt.asp?page=/English/pubs/features/presentations/El-Hemaly02/el-hemaly02-ss\n\n14- Abdel Karim M. El Hemaly*, Ibrahim M. Kandil, Mohamad A. Rizk and Mohamad A.K.M.El Hemaly.\n Urethro-plasty, a Novel Operation based on a New Concept, for the Treatment of Stress Urinary Incontinence, S.U.I., Detrusor Instability, D.I., and Mixed-type of Urinary Incontinence.\nhttp://www.obgyn.net/urogyn/urogyn.asp?page=/urogyn/articles/urethro-plasty_01\n\n15-Ibrahim M. Kandil, Abdel Karim M. El Hemaly, Mohamad M. Radwan: Ultrasonic Assessment of the Internal Urethral Sphincter in Stress Urinary Incontinence. The Internet Journal of Gynecology and Obstetrics. 2003. Volume 2 Number 1. \n\n\n16-Abdel Karim M. El Hemaly. Nocturnal Enureses: A Novel Concept on its pathogenesis and Treatment.\nhttp://www.obgyn.net/urogynecolgy/?page=articles/nocturnal_enuresis\n\n17- Abdel Karim M. El Hemaly. Nocturnal Enureses: An Update on the pathogenesis and Treatment.\nhttp://www.obgyn.net/urogynecology/?page=/ENHLIDH/PUBD/FEATURES/\nPresentations/ Nocturnal_Enuresis/nocturnal_enuresis\n\n18-Maternal Mortality in Egypt, a cry for help and attention. The Second International Conference of the African Society of Organization & Gestosis, 1998, 3rd Annual International Conference of Ob/Gyn Department � Sohag Faculty of Medicine University. Feb. 11-13. Luxor, Egypt. \n19-Postmenopausal Osteprosis. The 2nd annual conference of Health Insurance Organization on Family Planning and its role in primary health care. Zagaziz, Egypt, February 26-27, 1997, Center of Complementary Services for Maternity and childhood care. \n20-Laparoscopic Assisted vaginal hysterectomy. 10th International Annual Congress Modern Trends in Reproductive Techniques 23-24 March 1995. Alexandria, Egypt. \n21-Immunological Studies in Pre-eclamptic Toxaemia. Proceedings of 10th Annual Ain Shams Medical Congress. Cairo, Egypt, March 6-10, 1987. \n22-Socio-demographic factorse affecting acceptability of the long-acting contraceptive injections in a rural Egyptian community. Journal of Biosocial Science 29:305, 1987. \n23-Plasma fibronectin levels hypertension during pregnancy. The Journal of the Egypt. Soc. of Ob./Gyn. 13:1, 17-21, Jan. 1987. \n24-Effect of smoking on pregnancy. Journal of Egypt. Soc. of Ob./Gyn. 12:3, 111-121, Sept 1986. \n25-Socio-demographic aspects of nausea and vomiting in early pregnancy. Journal of the Egypt. Soc. of Ob./Gyn. 12:3, 35-42, Sept. 1986. \n26-Effect of intrapartum oxygen inhalation on maternofetal blood gases and pH. Journal of the Egypt. Soc. of Ob./Gyn. 12:3, 57-64, Sept. 1986. \n27-The effect of severe pre-eclampsia on serum transaminases. The Egypt. J. Med. Sci. 7(2): 479-485, 1986. \n28-A study of placental immunoreceptors in pre-eclampsia. The Egypt. J. Med. Sci. 7(2): 211-216, 1986. \n29-Serum human placental lactogen (hpl) in normal, toxaemic and diabetic pregnant women, during pregnancy and its relation to the outcome of pregnancy. Journal of the Egypt. Soc. of Ob./Gyn. 12:2, 11-23, May 1986. \n30-Pregnancy specific B1 Glycoprotein and free estriol in the serum of normal, toxaemic and diabetic pregnant women during pregnancy and after delivery. Journal of the Egypt. Soc. of Ob./Gyn. 12:1, 63-70, Jan. 1986. Also was accepted and presented at Xith World Congress of Gynecology and Obstetrics, Berlin (West), September 15-20, 1985. \n31-Pregnancy and labor in women over the age of forty years. Accepted and presented at Al-Azhar International Medical Conference, Cairo 28-31 Dec. 1985. \n32-Effect of Copper T intra-uterine device on cervico-vaginal flora. Int. J. Gynaecol. Obstet. 23:2, 153-156, April 1985. \n33-Factors affecting the occurrence of post-Caesarean section febrile morbidity. Population Sciences, 6, 139-149, 1985. \n34-Pre-eclamptic toxaemia and its relation to H.L.A. system. Population Sciences, 6, 131-139, 1985. \n35-The menstrual pattern and occurrence of pregnancy one year after discontinuation of Depo-medroxy progesterone acetate as a postpartum contraceptive. Population Sciences, 6, 105-111, 1985. \n36-The menstrual pattern and side effects of Depo-medroxy progesterone acetate as postpartum contraceptive. Population Sciences, 6, 97-105, 1985. \n37-Actinomyces in the vaginas of women with and without intrauterine contraceptive devices. Population Sciences, 6, 77-85, 1985. \n38-Comparative efficacy of ibuprofen and etamsylate in the treatment of I.U.D. menorrhagia. Population Sciences, 6, 63-77, 1985. \n39-Changes in cervical mucus copper and zinc in women using I.U.D.�s. Population Sciences, 6, 35-41, 1985. \n40-Histochemical study of the endometrium of infertile women. Egypt. J. Histol. 8(1) 63-66, 1985. \n41-Genital flora in pre- and post-menopausal women. Egypt. J. Med. Sci. 4(2), 165-172, 1983. \n42-Evaluation of the vaginal rugae and thickness in 8 different groups. Journal of the Egypt. Soc. of Ob./Gyn. 9:2, 101-114, May 1983. \n43-The effect of menopausal status and conjugated oestrogen therapy on serum cholesterol, triglycerides and electrophoretic lipoprotein patterns. Al-Azhar Medical Journal, 12:2, 113-119, April 1983. \n44-Laparoscopic ventrosuspension: A New Technique. Int. J. Gynaecol. Obstet., 20, 129-31, 1982. \n45-The laparoscope: A useful diagnostic tool in general surgery. Al-Azhar Medical Journal, 11:4, 397-401, Oct. 1982. \n46-The value of the laparoscope in the diagnosis of polycystic ovary. Al-Azhar Medical Journal, 11:2, 153-159, April 1982. \n47-An anaesthetic approach to the management of eclampsia. Ain Shams Medical Journal, accepted for publication 1981. \n48-Laparoscopy on patients with previous lower abdominal surgery. Fertility management edited by E. Osman and M. Wahba 1981. \n49-Heart diseases with pregnancy. Population Sciences, 11, 121-130, 1981. \n50-A study of the biosocial factors affecting perinatal mortality in an Egyptian maternity hospital. Population Sciences, 6, 71-90, 1981. \n51-Pregnancy Wastage. Journal of the Egypt. Soc. of Ob./Gyn. 11:3, 57-67, Sept. 1980. \n52-Analysis of maternal deaths in Egyptian maternity hospitals. Population Sciences, 1, 59-65, 1979. \nArticles published on OBGYN.net: \n1- Abdel Karim M. El Hemaly*, Ibrahim M. Kandil, Laila A. S. Mousa and Mohamad A.K.M.El Hemaly.\nUrethro-vaginoplasty, an innovated operation for the treatment of: Stress Urinary Incontinence (SUI), Detursor Overactivity (DO), Mixed Urinary Incontinence and Anterior Vaginal Wall Descent. \nhttp://www.obgyn.net/urogyn/urogyn.asp?page=/urogyn/articles/ urethro-vaginoplasty_01\n\n2- Abdel Karim M. El Hemaly, Ibrahim M Kandil, Mohamed M. Radwan.\n Urethro-raphy a new technique for surgical management of Stress Urinary Incontinence.\nhttp://www.obgyn.net/urogyn/urogyn.asp?page=/urogyn/articles/\nnew-tech-urethro\n\n3- Abdel Karim M. El Hemaly, Ibrahim M Kandil, Mohamad A. Rizk, Nabil Abdel Maksoud H., Mohamad M. Radwan, Khalid Z. El Shieka, Mohamad A. K. M. El Hemaly, and Ahmad T. El Saban.\nUrethro-raphy The New Operation for the treatment of stress urinary incontinence, SUI, detrusor instability, DI, and mixed-type of urinary incontinence; short and long term results. \nhttp://www.obgyn.net/urogyn/urogyn.asp?page=urogyn/articles/\nurethroraphy-09280\n\n4-Abdel Karim M. El Hemaly, Ibrahim M Kandil, and Bahaa E. El Mohamady. Menopause, and Voiding troubles. \nhttp://www.obgyn.net/displayppt.asp?page=/English/pubs/features/presentations/El-Hemaly03/el-hemaly03-ss\n\n5-El Hemaly AKMA, Mousa L.A. Micturition and Urinary\tContinence. Int J Gynecol Obstet 1996; 42: 291-2. \n\n6-Abdel Karim M. El Hemaly.\n Urinary incontinence in gynecology, a review article.\nhttp://www.obgyn.net/urogyn/urogyn.asp?page=/urogyn/articles/abs-urinary_incotinence_gyn_ehemaly \n\n7-El Hemaly AKMA. Nocturnal Enuresis: Pathogenesis and Treatment. \nInt Urogynecol J Pelvic Floor Dysfunct 1998;9: 129-31.\n \n8-El Hemaly AKMA, Mousa L.A.E. Stress Urinary Incontinence, a New Concept. Eur J Obstet Gynecol Reprod Biol 1996; 68: 129-35. \n\n9- El Hemaly AKMA, Kandil I. M. Stress Urinary Incontinence SUI facts and fiction. Is SUI a puzzle?! http://www.obgyn.net/displayppt.asp?page=/English/pubs/features/presentations/El-Hemaly/el-hemaly-ss\n\n10-Abdel Karim El Hemaly, Nabil Abdel Maksoud, Laila A. Mousa, Ibrahim M. Kandil, Asem Anwar, M.A.K El Hemaly and Bahaa E. El Mohamady. \nEvidence based Facts on the Pathogenesis and Management of SUI. http://www.obgyn.net/displayppt.asp?page=/English/pubs/features/presentations/El-Hemaly02/el-hemaly02-ss\n\n11- Abdel Karim M. El Hemaly*, Ibrahim M. Kandil, Mohamad A. Rizk and Mohamad A.K.M.El Hemaly.\n Urethro-plasty, a Novel Operation based on a New Concept, for the Treatment of Stress Urinary Incontinence, S.U.I., Detrusor Instability, D.I., and Mixed-type of Urinary Incontinence.\nhttp://www.obgyn.net/urogyn/urogyn.asp?page=/urogyn/articles/urethro-plasty_01\n\n12-Ibrahim M. Kandil, Abdel Karim M. El Hemaly, Mohamad M. Radwan: Ultrasonic Assessment of the Internal Urethral Sphincter in Stress Urinary Incontinence. The Internet Journal of Gynecology and Obstetrics. 2003. Volume 2 Number 1. \n\n13-Abdel Karim M. El Hemaly. Nocturnal Enureses: A Novel Concept on its pathogenesis and Treatment.\nhttp://www.obgyn.net/urogynecolgy/?page=articles/nocturnal_enuresis\n\n14- Abdel Karim M. El Hemaly. Nocturnal Enureses: An Update on the pathogenesis and Treatment.\nhttp://www.obgyn.net/urogynecology/?page=/ENHLIDH/PUBD/FEATURES/\nPresentations/ Nocturnal_Enuresis/nocturnal_enuresis",institutionString:null,institution:{name:"Al Azhar University",country:{name:"Egypt"}}},{id:"113313",title:"Dr.",name:"Abdel-Aal",middleName:null,surname:"Mantawy",slug:"abdel-aal-mantawy",fullName:"Abdel-Aal Mantawy",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"Ain Shams University",country:{name:"Egypt"}}}],filtersByRegion:[{group:"region",caption:"North America",value:1,count:5684},{group:"region",caption:"Middle and South America",value:2,count:5166},{group:"region",caption:"Africa",value:3,count:1682},{group:"region",caption:"Asia",value:4,count:10211},{group:"region",caption:"Australia and Oceania",value:5,count:887},{group:"region",caption:"Europe",value:6,count:15616}],offset:12,limit:12,total:1689},chapterEmbeded:{data:{}},editorApplication:{success:null,errors:{}},ofsBooks:{filterParams:{hasNoEditors:"0",sort:"dateEndThirdStepPublish'aqPGYX<'\">DfEsJx"},books:[],filtersByTopic:[{group:"topic",caption:"Agricultural and Biological Sciences",value:5,count:9},{group:"topic",caption:"Biochemistry, Genetics and Molecular Biology",value:6,count:18},{group:"topic",caption:"Business, Management and Economics",value:7,count:2},{group:"topic",caption:"Chemistry",value:8,count:7},{group:"topic",caption:"Computer and Information Science",value:9,count:10},{group:"topic",caption:"Earth and Planetary Sciences",value:10,count:5},{group:"topic",caption:"Engineering",value:11,count:15},{group:"topic",caption:"Environmental Sciences",value:12,count:2},{group:"topic",caption:"Immunology and Microbiology",value:13,count:5},{group:"topic",caption:"Materials Science",value:14,count:4},{group:"topic",caption:"Mathematics",value:15,count:1},{group:"topic",caption:"Medicine",value:16,count:61},{group:"topic",caption:"Nanotechnology and Nanomaterials",value:17,count:1},{group:"topic",caption:"Neuroscience",value:18,count:1},{group:"topic",caption:"Pharmacology, Toxicology and Pharmaceutical Science",value:19,count:6},{group:"topic",caption:"Physics",value:20,count:2},{group:"topic",caption:"Psychology",value:21,count:3},{group:"topic",caption:"Robotics",value:22,count:1},{group:"topic",caption:"Social Sciences",value:23,count:3},{group:"topic",caption:"Technology",value:24,count:1},{group:"topic",caption:"Veterinary Medicine and Science",value:25,count:2}],offset:0,limit:12,total:null},popularBooks:{featuredBooks:[{type:"book",id:"9208",title:"Welding",subtitle:"Modern Topics",isOpenForSubmission:!1,hash:"7d6be076ccf3a3f8bd2ca52d86d4506b",slug:"welding-modern-topics",bookSignature:"Sadek Crisóstomo Absi Alfaro, Wojciech Borek and Błażej Tomiczek",coverURL:"https://cdn.intechopen.com/books/images_new/9208.jpg",editors:[{id:"65292",title:"Prof.",name:"Sadek Crisostomo Absi",middleName:"C. 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