Biological and Preclinical Evaluations of Designed Optically Guided Medical Devices with Light Scattering Modules for Carpal Tunnel Syndrome Treatment and Surgical Procedure

*Ching-Cheng Huang and Ming-Che Chiang*

### **Abstract**

A novel technique and product applied to carpal tunnel microscopic surgical procedures through the designed medical devices were prepared and studied. The novel design of the medical device could be developed and applied for new carpal tunnel microscopic surgical procedures instead of the traditional carpal tunnel surgical procedures. Also, a new medical device with optical LLLT module was designed for wound healing in carpal tunnel syndrome treatments. Furthermore, assistive surgical healing dressings for carpal tunnel syndrome treatments via minimally invasive surgery (MIS) such as air-foam soft cleaning sponges and hydrogel surgical dressings with polymeric films were designed for more comfortable treatments. Biological and clinical evaluations of carpal tunnel surgical procedure using the new designed medical devices are studied. For commercialized reasons, guidance such as ISO 10993-1:2009(E) for biological evaluation of medical devices must be considered. Furthermore, the clinical evaluation of modified medical devices would be carried out.

**Keywords:** clinical evaluation, carpal tunnel syndrome, surgical procedure, minimally invasive surgery, scalpel

#### **1. Introduction**

Novel optically guided medical devices were designed for the clinical needs of carpal tunnel surgical procedure. The word "carpus" means "wrist." The wrist is the joint between your hand and the lower part of your arm and is surrounded by a band of fibrous tissue as a support for the joint. The tight space between the wrist bone and the fibrous band is called the carpal tunnel. The median nerve could pass through the carpal tunnel to receive any kind of sensations from the thumb, index, and middle fingers of the hand. Hence, any condition that causes swelling or a change in position of the tissue within the carpal tunnel would

repress and damage the median nerve. Repression and irritation of the median nerve would cause numbness and tingling of the thumb, index, and the middle fingers of the hand which is a clinical condition known as "carpal tunnel syndrome." Although it is a gradual process, for most people carpal tunnel syndrome will worsen over time without some form of treatment. For this reason, it is important to be evaluated and diagnosed by doctor early on. In the early stages, it may be possible to slow or stop the progression of carpal tunnel syndrome. Two kinds of treatments could be employed in the stages such as nonsurgical treatments and surgical treatments. If diagnosed and treated early, the symptoms can often be relieved without surgery. If diagnosis is uncertain or if symptoms are mild, nonsurgical treatment would be recommend first. The nonsurgical treatments may include wearing a brace or splint at night; keeping the wrist in a straight or neutral position reduces pressure on the nerve in the carpal tunnel. It may also be useful to wear a splint during the day when doing activities that aggravate symptoms. In addition, nonsurgical treatments may include using the medical devices with light, electrode, etc. Also, nonsteroidal anti-inflammatory drugs (NSAIDs) could be a chosen way for nonsurgical treatments. Some medical devices such as photo- and electrotherapies could help relieve pain and inflammation for carpal tunnel syndrome. Furthermore, nerve gliding exercises, activity changes, and steroid injections would also be recommended as kinds of nonsurgical treatments for carpal tunnel syndrome. About nerve gliding exercises, some patients would benefit from exercises of nonsurgical treatments that help the median nerve move more freely within the confines of the carpal tunnel. About activity changes, symptoms often occur when the hand and wrist are in the same position for too long—particularly when the wrist is extended or flexed. About steroid injections, corticosteroid or cortisone is a powerful anti-inflammatory agent that could be injected into the carpal tunnel. If nonsurgical treatment could not relieve or stop the progression of carpal tunnel syndrome after a period of time, surgical treatments of carpal tunnel syndrome such as "carpal tunnel release" would be recommended and employed. Open carpal tunnel release could be employed as a kind of surgical treatment*.* In open surgery, a small incision must be made in the palm of target hand and views the inside of your hand and wrist through this incision [1]. During the procedure, the transverse carpal ligament will be divided in the roof of the carpal tunnel. This increases the size of the tunnel and decreases pressure on the median nerve. When the ligament heals after surgery, there is more room for the nerve and tendons. The other way, **e**ndoscopic carpal tunnel release was employed. In endoscopic surgery, one or two smaller skin incisions must be obtained and called portals for using an endoscope to observe inside target hand and wrist. A special knife is used to divide the transverse carpal ligament, similar to the open carpal tunnel release procedure [1].

In this report, we propose a series of novel techniques and medical devices of treatments for carpal tunnel syndrome. The novel design of the medical device could be developed and applied for new carpal tunnel microscopic surgical procedures instead of the traditional carpal tunnel surgical procedures. For the design of new medical devices, selections of materials or suitable materials for biomedical applications such as polymethacrylate, polyester, polyamide, polyimide, polyester, polynorbornene, polytetrafluoroethylene, polydiphenylacetylenes, and polymeric resins could be substantially considered and employed [1–19]. Also, the surface modification technology could be considered to change the surface microenvironment of materials for specific need [20–24]. Furthermore, the biological and clinical evaluations of materials and medical devices must be considered for the application and design.

**51**

**Figure 1.**

*Biological and Preclinical Evaluations of Designed Optically Guided Medical Devices with Light…*

**2.1 A new design of optical guided medical device with an electrical scalpel**

**2.2 A new design of laser optical guided medical device with a scalpel**

New designed optical guided medical device with an electrical scalpel and a light scattering module was studied. The optical guided medical device with an electrical scalpel and a light scattering module contains a scalpel with a blade, an optical guided system with a scattering propagation, a power controller, and a connectable

New designed optical guided medical device with a scalpel was studied. Laser light sources could be employed as optical guided modules, and a series of laser optical guided medical devices with a scalpel are designed on the demands of clinical applications. The laser optical guided medical device with a scalpel contains a scalpel with a blade, an optical guided laser source with a designed strengthen arm, a power controller, and a connectable power supplier (King-Yard Tech. Co., TW). The different colors of laser light could be chosen depending on the clinical

**2.3 Assistive surgical healing dressings for carpal tunnel syndrome treatments via minimally invasive surgery(MIS): air-foam soft cleaning sponges** 

An air-foam soft cleaning sponge was designed for deeply soft cleaning the surgical skins before and after carpal tunnel syndrome treatments (Parsd Pharm. Tech. Co., TW) (**Figure 3**). The high medical grade Cenefom PVA raw sheet is a synthetic sponge essentially composed of cross-linked polyvinyl alcohol (PVA) through an air-foaming process, which could provide characteristics of lint-free and fiber-free, high hydrophilic, low chemical residues, and high cleanness of air-foam soft cleaning sponges. The sponges would be employed as assistive anti-adhesion dressings and satisfied for carpal tunnel syndrome treatments via minimally invasive surgery. The designed soft cleaning sponges must be a kind of open-celled microstructure, highly absorbent porous medical material that wicks aqueous solutions quickly. Their high-water content allows vapor and oxygen transmission to the wounds such as pressure sores, leg ulcers, surgical and necrotic wounds, lacerations, and burns. They seem to play an important role as emergency burns treatment alone or in combination with other products, thanks to their cooling and hydrating effects.

**and hydrogel surgical dressings with polymeric films**

*New design of optical guided medical device with scalpel and its key functional components [1].*

*DOI: http://dx.doi.org/10.5772/intechopen.82523*

**2. Materials and methods**

power supplier (**Figure 1**) [1].

demands (**Figure 2**) [2, 3].

*Biological and Preclinical Evaluations of Designed Optically Guided Medical Devices with Light… DOI: http://dx.doi.org/10.5772/intechopen.82523*

#### **2. Materials and methods**

*Peripheral Nerve Disorders and Treatment*

repress and damage the median nerve. Repression and irritation of the median nerve would cause numbness and tingling of the thumb, index, and the middle fingers of the hand which is a clinical condition known as "carpal tunnel syndrome." Although it is a gradual process, for most people carpal tunnel syndrome will worsen over time without some form of treatment. For this reason, it is important to be evaluated and diagnosed by doctor early on. In the early stages, it may be possible to slow or stop the progression of carpal tunnel syndrome. Two kinds of treatments could be employed in the stages such as nonsurgical treatments and surgical treatments. If diagnosed and treated early, the symptoms can often be relieved without surgery. If diagnosis is uncertain or if symptoms are mild, nonsurgical treatment would be recommend first. The nonsurgical treatments may include wearing a brace or splint at night; keeping the wrist in a straight or neutral position reduces pressure on the nerve in the carpal tunnel. It may also be useful to wear a splint during the day when doing activities that aggravate symptoms. In addition, nonsurgical treatments may include using the medical devices with light, electrode, etc. Also, nonsteroidal anti-inflammatory drugs (NSAIDs) could be a chosen way for nonsurgical treatments. Some medical devices such as photo- and electrotherapies could help relieve pain and inflammation for carpal tunnel syndrome. Furthermore, nerve gliding exercises, activity changes, and steroid injections would also be recommended as kinds of nonsurgical treatments for carpal tunnel syndrome. About nerve gliding exercises, some patients would benefit from exercises of nonsurgical treatments that help the median nerve move more freely within the confines of the carpal tunnel. About activity changes, symptoms often occur when the hand and wrist are in the same position for too long—particularly when the wrist is extended or flexed. About steroid injections, corticosteroid or cortisone is a powerful anti-inflammatory agent that could be injected into the carpal tunnel. If nonsurgical treatment could not relieve or stop the progression of carpal tunnel syndrome after a period of time, surgical treatments of carpal tunnel syndrome such as "carpal tunnel release" would be recommended and employed. Open carpal tunnel release could be employed as a kind of surgical treatment*.* In open surgery, a small incision must be made in the palm of target hand and views the inside of your hand and wrist through this incision [1]. During the procedure, the transverse carpal ligament will be divided in the roof of the carpal tunnel. This increases the size of the tunnel and decreases pressure on the median nerve. When the ligament heals after surgery, there is more room for the nerve and tendons. The other way, **e**ndoscopic carpal tunnel release was employed. In endoscopic surgery, one or two smaller skin incisions must be obtained and called portals for using an endoscope to observe inside target hand and wrist. A special knife is used to divide the transverse carpal ligament, similar to the open carpal tunnel release procedure [1]. In this report, we propose a series of novel techniques and medical devices of treatments for carpal tunnel syndrome. The novel design of the medical device could be developed and applied for new carpal tunnel microscopic surgical procedures instead of the traditional carpal tunnel surgical procedures. For the design of new medical devices, selections of materials or suitable materials for biomedical applications such as polymethacrylate, polyester, polyamide, polyimide, polyester, polynorbornene, polytetrafluoroethylene, polydiphenylacetylenes, and polymeric resins could be substantially considered and employed [1–19]. Also, the surface modification technology could be considered to change the surface microenvironment of materials for specific need [20–24]. Furthermore, the biological and clinical evaluations of materials and medical devices must be considered for the

**50**

application and design.

#### **2.1 A new design of optical guided medical device with an electrical scalpel**

New designed optical guided medical device with an electrical scalpel and a light scattering module was studied. The optical guided medical device with an electrical scalpel and a light scattering module contains a scalpel with a blade, an optical guided system with a scattering propagation, a power controller, and a connectable power supplier (**Figure 1**) [1].

#### **2.2 A new design of laser optical guided medical device with a scalpel**

New designed optical guided medical device with a scalpel was studied. Laser light sources could be employed as optical guided modules, and a series of laser optical guided medical devices with a scalpel are designed on the demands of clinical applications. The laser optical guided medical device with a scalpel contains a scalpel with a blade, an optical guided laser source with a designed strengthen arm, a power controller, and a connectable power supplier (King-Yard Tech. Co., TW). The different colors of laser light could be chosen depending on the clinical demands (**Figure 2**) [2, 3].

#### **2.3 Assistive surgical healing dressings for carpal tunnel syndrome treatments via minimally invasive surgery(MIS): air-foam soft cleaning sponges and hydrogel surgical dressings with polymeric films**

An air-foam soft cleaning sponge was designed for deeply soft cleaning the surgical skins before and after carpal tunnel syndrome treatments (Parsd Pharm. Tech. Co., TW) (**Figure 3**). The high medical grade Cenefom PVA raw sheet is a synthetic sponge essentially composed of cross-linked polyvinyl alcohol (PVA) through an air-foaming process, which could provide characteristics of lint-free and fiber-free, high hydrophilic, low chemical residues, and high cleanness of air-foam soft cleaning sponges. The sponges would be employed as assistive anti-adhesion dressings and satisfied for carpal tunnel syndrome treatments via minimally invasive surgery. The designed soft cleaning sponges must be a kind of open-celled microstructure, highly absorbent porous medical material that wicks aqueous solutions quickly. Their high-water content allows vapor and oxygen transmission to the wounds such as pressure sores, leg ulcers, surgical and necrotic wounds, lacerations, and burns. They seem to play an important role as emergency burns treatment alone or in combination with other products, thanks to their cooling and hydrating effects.

#### **Figure 1.** *New design of optical guided medical device with scalpel and its key functional components [1].*

#### **Figure 2.**

*(A) A series of new designed laser guided medical devices with a scalpel and different colors of laser light sources for various clinical demands (King-Yard Tech./Chuang Sheng Medicine Equipment Co., TW). (B) The white light focus on a hand, (C) the red light focus on a hand, (D) the orange light focus on a hand, (E) the green light focus on a hand, and (F) the blue light focus on a hand.*

#### **Figure 3.**

*Assistive surgical healing dressings for carpal tunnel syndrome treatments via minimally invasive surgery: airfoam soft cleaning sponges and hydrogel surgical dressings with polymeric films such as PU films.*

In sual, the cross-linked or non-cross-linked polyvinyl alcohol (PVA) was employed to prepare hydrogel surgical dressings. The polyurethane film was used to be a protecting material, practically, for surgical dressings. The new surgical dressings were designed with well-protecting and surgical wound healing functions, which could provide good surgical wound managements after carpal tunnel syndrome treatments via minimally invasive surgery. That is, the hydrogel surgical dressing with a polymeric film was designed for the outside surgical wound healing after carpal tunnel syndrome treatments via minimally invasive surgery (Chuang Sheng Medicine Equipment Co., TW) (**Figure 3**). The polymeric film was used with the hydrogel surgical dressing for protecting the outer surgical wound from environments.

#### **3. Results and discussion**

#### **3.1 New design of fabrication optical guided medical device with scalpel for carpal tunnel syndrome**

In this study, traditional and conventional medical methods for carpal tunnel surgical procedure were modified, and novel optical guided medical device with

**53**

**Figure 4.**

*employed in carpal tunnel surgical procedure.*

*Biological and Preclinical Evaluations of Designed Optically Guided Medical Devices with Light…*

scalpel was designed for carpal tunnel syndrome. For clinical demand, new design and fabrication of optical guided medical device with scalpel were necessary. Some essential components could be considered for the clinical need for carpal tunnel surgical procedure. Therefore, a new medical device was designed and had optically guided components with scalpel including a scalpel with a blade, an optically guided system with scattering propagation, a power controller, and a connectable power supplier (**Figure 1**). An individual head containing a surgical scalpel and an optically guided system could be considered in this study. Practically, the scattering propagation could be achieved by using the design of multiple stages in the optical guided cutting component [1]. Furthermore, the electrical supply, which could provide the function of optical guidance and electric cutting, was also considered as one part of the medical device as shown in **Figure 1**. The relative large operating area would be observed by traditional carpal tunnel surgical procedures as shown, respectively, in **Figure 4A**. Furthermore, the fabrication optical guided medical device with scalpel for carpal tunnel syndrome was carried out, and the new medical device could be used for carpal tunnel syndrome as shown in **Figure 4B**–**E**. The new designed light laser guided medical devices with a scalpel were employed in

**3.2 Characterization of the designed optical guided medical device with scalpel**

The modified medical devices containing a head as a surgical scalpel under optical guidance were designed, and the newly designed head as a surgical scalpel was shown in **Figure 1**. The multiple stages for light scattering propagations were designed. The light scattering propagation occur because of the light transfer delay among different light waves, which satisfy the clinical demand during carpal tunnel surgical procedure to show the light pass route under the skin [1]. The polyacrylate was designed as a material for optical guidance instead of glass. The thermal deformation temperature was obtained as 93.9°C under 0.455 MPa (ASTM D648-07B). The new designed laser guided medical devices with a scalpel and a green light source was employed in carpal tunnel surgical procedure as shown in **Figure 4F**. The designed strengthen arm of medical devices increases the safety of carpal tunnel syndrome treatments via minimally invasive surgery. The surgery treatments would produce internal and external surgical damages. **Figure 5A** showed the surgical wounds of internal and external surgical damage after traditional carpal tunnel syndrome treatments. Comparably, **Figure 5B** showed the surgical wounds of internal and external surgical damage after the carpal tunnel syndrome

*Photos of (A) traditional design of medical devices for carpal tunnel surgical procedure (http://www. medicinenet.com/carpal\_tunnel\_syndrome/article.htm), (B) new design of optical guided medical device with scalpel in this study, and (C)–(E) new design of optical guided medical device with scalpel was employed in carpal tunnel surgical procedure. (F) The new designed light laser guided medical devices with a scalpel were* 

*DOI: http://dx.doi.org/10.5772/intechopen.82523*

carpal tunnel surgical procedure (**Figure 4F**).

#### *Biological and Preclinical Evaluations of Designed Optically Guided Medical Devices with Light… DOI: http://dx.doi.org/10.5772/intechopen.82523*

scalpel was designed for carpal tunnel syndrome. For clinical demand, new design and fabrication of optical guided medical device with scalpel were necessary. Some essential components could be considered for the clinical need for carpal tunnel surgical procedure. Therefore, a new medical device was designed and had optically guided components with scalpel including a scalpel with a blade, an optically guided system with scattering propagation, a power controller, and a connectable power supplier (**Figure 1**). An individual head containing a surgical scalpel and an optically guided system could be considered in this study. Practically, the scattering propagation could be achieved by using the design of multiple stages in the optical guided cutting component [1]. Furthermore, the electrical supply, which could provide the function of optical guidance and electric cutting, was also considered as one part of the medical device as shown in **Figure 1**. The relative large operating area would be observed by traditional carpal tunnel surgical procedures as shown, respectively, in **Figure 4A**. Furthermore, the fabrication optical guided medical device with scalpel for carpal tunnel syndrome was carried out, and the new medical device could be used for carpal tunnel syndrome as shown in **Figure 4B**–**E**. The new designed light laser guided medical devices with a scalpel were employed in carpal tunnel surgical procedure (**Figure 4F**).

#### **3.2 Characterization of the designed optical guided medical device with scalpel**

The modified medical devices containing a head as a surgical scalpel under optical guidance were designed, and the newly designed head as a surgical scalpel was shown in **Figure 1**. The multiple stages for light scattering propagations were designed. The light scattering propagation occur because of the light transfer delay among different light waves, which satisfy the clinical demand during carpal tunnel surgical procedure to show the light pass route under the skin [1]. The polyacrylate was designed as a material for optical guidance instead of glass. The thermal deformation temperature was obtained as 93.9°C under 0.455 MPa (ASTM D648-07B). The new designed laser guided medical devices with a scalpel and a green light source was employed in carpal tunnel surgical procedure as shown in **Figure 4F**. The designed strengthen arm of medical devices increases the safety of carpal tunnel syndrome treatments via minimally invasive surgery. The surgery treatments would produce internal and external surgical damages. **Figure 5A** showed the surgical wounds of internal and external surgical damage after traditional carpal tunnel syndrome treatments. Comparably, **Figure 5B** showed the surgical wounds of internal and external surgical damage after the carpal tunnel syndrome

#### **Figure 4.**

*Peripheral Nerve Disorders and Treatment*

In sual, the cross-linked or non-cross-linked polyvinyl alcohol (PVA) was employed to prepare hydrogel surgical dressings. The polyurethane film was used to be a protecting material, practically, for surgical dressings. The new surgical dressings were designed with well-protecting and surgical wound healing functions, which could provide good surgical wound managements after carpal tunnel syndrome treatments via minimally invasive surgery. That is, the hydrogel surgical dressing with a polymeric film was designed for the outside surgical wound healing after carpal tunnel syndrome treatments via minimally invasive surgery (Chuang Sheng Medicine Equipment Co., TW) (**Figure 3**). The polymeric film was used with the hydrogel surgical dressing for protecting the outer surgical wound from environments.

*Assistive surgical healing dressings for carpal tunnel syndrome treatments via minimally invasive surgery: air-*

*(A) A series of new designed laser guided medical devices with a scalpel and different colors of laser light sources for various clinical demands (King-Yard Tech./Chuang Sheng Medicine Equipment Co., TW). (B) The white light focus on a hand, (C) the red light focus on a hand, (D) the orange light focus on a hand, (E) the* 

*green light focus on a hand, and (F) the blue light focus on a hand.*

*foam soft cleaning sponges and hydrogel surgical dressings with polymeric films such as PU films.*

**3.1 New design of fabrication optical guided medical device with scalpel** 

In this study, traditional and conventional medical methods for carpal tunnel surgical procedure were modified, and novel optical guided medical device with

**52**

**Figure 3.**

**Figure 2.**

**3. Results and discussion**

**for carpal tunnel syndrome**

*Photos of (A) traditional design of medical devices for carpal tunnel surgical procedure (http://www. medicinenet.com/carpal\_tunnel\_syndrome/article.htm), (B) new design of optical guided medical device with scalpel in this study, and (C)–(E) new design of optical guided medical device with scalpel was employed in carpal tunnel surgical procedure. (F) The new designed light laser guided medical devices with a scalpel were employed in carpal tunnel surgical procedure.*

**Figure 5.**

*(A) The surgical wounds of internal and external surgical damage after traditional carpal tunnel syndrome treatments and (B) the surgical wounds of internal and external surgical damage after the carpal tunnel syndrome treatments via minimally invasive surgery.*

treatments via minimally invasive surgery with new designed laser guided medical devices. Remarkably, the relative small surgical wounds could be obtained by using new designed laser guided medical devices.

#### **3.3 Characterization of the designed assistive dressings of air-foaming soft cleaning surgical sponge before carpal tunnel syndrome treatments via minimally invasive surgery**

The surgical wounds of internal and external surgical damage would be observed after the carpal tunnel syndrome treatments whether the new designed laser guided medical devices via minimally invasive surgery or not (**Figure 5A** and **B**). For the specific clinical demands, designed assistive dressings of air-foaming soft cleaning surgical sponge must be designed before carpal tunnel syndrome treatments via minimally invasive surgery. The air-foaming soft cleaning PVA surgical sponge was prepared. The air-foaming soft cleaning PVA surgical sponge is a kind of synthetic sponge essentially composed of cross-linked polyvinyl alcohol, which was employed as assistive anti-adhesion dressings for carpal tunnel syndrome treatments via minimally invasive surgery. It is a kind of open-celled microstructure, highly absorbent porous material that wicks aqueous solutions quickly. It is compressible when dry and expandable when wet and has high tensile strength, good elongation, and excellent resistance to most chemicals. PVA sponge is hydrophilic and can hold up to 12 times its dry weight in water. Cell size can be varied depending on the required use; the finer the cell, the better the capillary action. The wet sponge can withstand temperatures approaching 70°C and the dry about 100°C. PVA sponge is effectively inert and will not, in itself, support microbial growth. Extremely soft when wet, air-foaming soft cleaning PVA surgical sponges are hypoallergenic, which are suitable and ideal for soft and sensitive skin, specific in the use of surgical treatments such as carpal tunnel syndrome treatments via minimally invasive surgery.

Air-foaming soft cleaning PVA sponge with interlinked cell structure is perfect for any application where absorbency, durability, and versatility are key points. Air-foaming soft cleaning PVA requires different handling and processing than other more widely used foams. Strong chemical and abrasion resistance of airfoaming soft cleaning PVA sponges go through stringent quality control and super cleaning medical grade Cenefom PVA raw materials prepared in medical and clean room environments. Because of biocompatible properties, air-foaming soft cleaning

**55**

**Figure 6.**

*Biological and Preclinical Evaluations of Designed Optically Guided Medical Devices with Light…*

PVA sponges were documented as being used for medical purposes. Available in a wide range of pore sizes and water-holding capacity could be selected for different clinical purposes (**Figure 6**). Furthermore, air-foaming soft cleaning PVA sponge and thin membrane provide strong chemical and abrasion resistance, non-linting, non-abrasive, latex Free, non-phthalate, biocompatible, UV resistant, withstanding temperatures of up to 70°C when wet and 100°C dry without deformation,

*The designed assistive dressings of air-foaming soft cleaning surgical sponge for carpal tunnel syndrome treatments via minimally invasive surgery (Medical grade Cenefom PVA foam in PARSD Pharmaceutical Technology Co.). (A) The SEM photo of the surgical sponge with an open-cell microstructure, (B) the photo of the surgical swab, (C) the photo of the dried surgical sponge, and (D) the photo of the wet surgical sponge.*

**3.4 Characterization of the assistive hydrogel surgical dressing with polymeric films designed for using after carpal tunnel syndrome treatments** 

Advanced dressings are designed to maintain a moist environment at the site of application, allowing the fluids to remain close to the wound but not spread to unaffected, healthy skin areas [25]. Several biomedical polymers are employed to be materials of hydrogel dressings such as polyvinyl alcohol, polymethacrylate, collagen, alginate, polyelectrolyte, water-soluble polymers, etc. [8–10, 14–16]. The relevance of the moist wound environment as a factor accelerating the healing process was first observed by Winter in 1962 but only recently has received more serious attention [26]. Dressings designed for moist wound healing are represented by hydrogel and hydrocolloid products. Both induce autolytic debridement, which facilitates the elimination of the dead tissue [27]. Hydrogel-based wound dressings are one of the most promising materials in wound care, fulfilling important dressing requirements, including keeping the wound moist while absorbing extensive exudate, adhesion-free coverage of sensitive underlying tissue, pain reduction of pain managements through cooling ability of hydrogel, and a potential for active intervention in the wound healing procedures [28, 29]. Because of the moisture provided to the wound from the moist hydrogel dressing with a moist swollen layer, common healing phases such as granulation, epidermis repair, and the removal of excess dead tissue become simplified. In addition to aiding the wound treatment stages, the cool sensation provided by the assistive hydrogel surgical dressing to the wound offers relief from pain for at least 6 hours. When hydration is provided

extremely durable, available in a wide range of pore sizes.

**via minimally invasive surgery**

*DOI: http://dx.doi.org/10.5772/intechopen.82523*

*Biological and Preclinical Evaluations of Designed Optically Guided Medical Devices with Light… DOI: http://dx.doi.org/10.5772/intechopen.82523*

#### **Figure 6.**

*Peripheral Nerve Disorders and Treatment*

new designed laser guided medical devices.

*syndrome treatments via minimally invasive surgery.*

**Figure 5.**

**via minimally invasive surgery**

treatments via minimally invasive surgery with new designed laser guided medical devices. Remarkably, the relative small surgical wounds could be obtained by using

*(A) The surgical wounds of internal and external surgical damage after traditional carpal tunnel syndrome treatments and (B) the surgical wounds of internal and external surgical damage after the carpal tunnel* 

**3.3 Characterization of the designed assistive dressings of air-foaming soft cleaning surgical sponge before carpal tunnel syndrome treatments** 

The surgical wounds of internal and external surgical damage would be observed after the carpal tunnel syndrome treatments whether the new designed laser guided medical devices via minimally invasive surgery or not (**Figure 5A** and **B**). For the specific clinical demands, designed assistive dressings of air-foaming soft cleaning surgical sponge must be designed before carpal tunnel syndrome treatments via minimally invasive surgery. The air-foaming soft cleaning PVA surgical sponge was prepared. The air-foaming soft cleaning PVA surgical sponge is a kind of synthetic sponge essentially composed of cross-linked polyvinyl alcohol, which was employed as assistive anti-adhesion dressings for carpal tunnel syndrome treatments via minimally invasive surgery. It is a kind of open-celled microstructure, highly absorbent porous material that wicks aqueous solutions quickly. It is compressible when dry and expandable when wet and has high tensile strength, good elongation, and excellent resistance to most chemicals. PVA sponge is hydrophilic and can hold up to 12 times its dry weight in water. Cell size can be varied depending on the required use; the finer the cell, the better the capillary action. The wet sponge can withstand temperatures approaching 70°C and the dry about 100°C. PVA sponge is effectively inert and will not, in itself, support microbial growth. Extremely soft when wet, air-foaming soft cleaning PVA surgical sponges are hypoallergenic, which are suitable and ideal for soft and sensitive skin, specific in the use of surgical treatments such as carpal tunnel syndrome treatments via

Air-foaming soft cleaning PVA sponge with interlinked cell structure is perfect for any application where absorbency, durability, and versatility are key points. Air-foaming soft cleaning PVA requires different handling and processing than other more widely used foams. Strong chemical and abrasion resistance of airfoaming soft cleaning PVA sponges go through stringent quality control and super cleaning medical grade Cenefom PVA raw materials prepared in medical and clean room environments. Because of biocompatible properties, air-foaming soft cleaning

**54**

minimally invasive surgery.

*The designed assistive dressings of air-foaming soft cleaning surgical sponge for carpal tunnel syndrome treatments via minimally invasive surgery (Medical grade Cenefom PVA foam in PARSD Pharmaceutical Technology Co.). (A) The SEM photo of the surgical sponge with an open-cell microstructure, (B) the photo of the surgical swab, (C) the photo of the dried surgical sponge, and (D) the photo of the wet surgical sponge.*

PVA sponges were documented as being used for medical purposes. Available in a wide range of pore sizes and water-holding capacity could be selected for different clinical purposes (**Figure 6**). Furthermore, air-foaming soft cleaning PVA sponge and thin membrane provide strong chemical and abrasion resistance, non-linting, non-abrasive, latex Free, non-phthalate, biocompatible, UV resistant, withstanding temperatures of up to 70°C when wet and 100°C dry without deformation, extremely durable, available in a wide range of pore sizes.

#### **3.4 Characterization of the assistive hydrogel surgical dressing with polymeric films designed for using after carpal tunnel syndrome treatments via minimally invasive surgery**

Advanced dressings are designed to maintain a moist environment at the site of application, allowing the fluids to remain close to the wound but not spread to unaffected, healthy skin areas [25]. Several biomedical polymers are employed to be materials of hydrogel dressings such as polyvinyl alcohol, polymethacrylate, collagen, alginate, polyelectrolyte, water-soluble polymers, etc. [8–10, 14–16]. The relevance of the moist wound environment as a factor accelerating the healing process was first observed by Winter in 1962 but only recently has received more serious attention [26]. Dressings designed for moist wound healing are represented by hydrogel and hydrocolloid products. Both induce autolytic debridement, which facilitates the elimination of the dead tissue [27]. Hydrogel-based wound dressings are one of the most promising materials in wound care, fulfilling important dressing requirements, including keeping the wound moist while absorbing extensive exudate, adhesion-free coverage of sensitive underlying tissue, pain reduction of pain managements through cooling ability of hydrogel, and a potential for active intervention in the wound healing procedures [28, 29]. Because of the moisture provided to the wound from the moist hydrogel dressing with a moist swollen layer, common healing phases such as granulation, epidermis repair, and the removal of excess dead tissue become simplified. In addition to aiding the wound treatment stages, the cool sensation provided by the assistive hydrogel surgical dressing to the wound offers relief from pain for at least 6 hours. When hydration is provided

for the wound bed, discomfort experienced from changing the dressing becomes reduced, and the risk of infection also becomes decreased. Hydrogels are widely used as debriding agents, moist dressings, and components of pastes for wound care because of the moist ability of amphiphilic materials and structures such as semiinterpenetrating polymeric networks and interpenetrating polymeric networks (IPN). The IPN structure could be prepared from multiple cross-linking reactions via thermal or photochemical procedures. However, they do not need further wound fluids to become gels and are suitable for dry wounds [28, 29]. The so-called "moisture donor" effect of hydrogel surgical dressing helps autolytic debridement, increasing collagenase production and the moisture content of necrotic wounds [25]. At the same time, a protective polymeric film was used. Assistive hydrogel surgical dressin*g* could absorb and retain contaminated exudate within the gel mass through expansion of cross-linked polymer chains resulting in isolation of bacteria and detritus molecules in the liquid. Their high-water content allows vapor and oxygen transmission to the wounds such as pressure sores, leg ulcers, surgical and necrotic wounds, lacerations, and burns. Assistive hydrogel surgical dressing seems to play an important role as emergency burns treatment alone or in combination with other products, thanks to their cooling and hydrating effects [26]. Hence, the hydrogel surgical dressing with a polymeric film was designed for using after carpal tunnel syndrome treatments via minimally invasive surgery as shown in **Figure 7**.

#### **3.5 LLLT for carpal tunnel syndrome treatments after minimally invasive surgery**

**Figure 7A** shows a new design of optical guided medical device with LLLT sources and its key functional components for wound healing. Furthermore, **Figure 7B** shows clinical applications of new designed medical devices for carpal tunnel syndrome treatments via minimally invasive surgery and the wound healing of internal and

#### **Figure 7.**

*(A) New design of optical guided medical device with LLLT sources for wound healing (Transverse Industries Co-design) and its key functional components. (B) Clinical applications of new designed medical devices for carpal tunnel syndrome treatments via MIS and the wound healing of internal and external surgical damages after elective surgery.*

**57**

**Table 1.**

PhotoMedex (Manchester, UK)

OPUSMED (Montreal, Canada)

Lightwave technologies (Phoenix, AZ)

Dynatronics (Salt Lake City,

Transverse (Taipei, TW)

UT)

Lightwave professional deluxe LED system

*Biological and Preclinical Evaluations of Designed Optically Guided Medical Devices with Light…*

external surgical damage after elective surgery. Practically, a series of new designed medical devices with LLLT sources were employed for healing in internal and external surgical damages. Most important, the designed medical devices with LLLT sources were used for internal surgical damage such as the target ligament healing and reducing inflammation under the skin. The medical device with LLLT sources showed no damage H-bonding or molecule interaction. LLLT sources are not enough to change and damage cell or tissue molecule structure, have no remarkable increasing temperature (<0.1–0.5°C), and observed biological response being due to photobiostimulation. Most important, the designed medical devices with LLLT sources provide a kind of invasive immediately continuous treatments with no heat, no pain, no medicine, and no needle for internal surgical damage healing after MIS to greatly reduce the potential harms to the body and enhance convenience of healing wounds. LLLT, phototherapy, or photobiomodulation refers to the use of photons at a nonthermal irradiance to alter biological activity. LLLT uses coherent light sources (lasers), noncoherent light sources consisting of filtered lamps or LED, or laser, and, on occasion, a combination of both. The main medical applications of LLLT are reducing inflammation and pain and promoting regeneration of different tissues and nerves [30, 31]. In the past, laser therapies have been used increasingly for the esthetic treatment of fine wrinkles, aged skin, and scars, a process known as photo-rejuvenation (**Table 1**) [32]. Recently, this approach has also been used for inflammatory acne (**Table 1**) [32]. LLLT involves exposing cells or tissue to low levels of light sources. This process is referred to as "low level" because the energy or power densities used are low compared with other forms of laser therapy such as cutting or thermally coagulating tissue. More recently, clinical treatments with LLLT have been found to stimulate or inhibit an assortment of cellular processes or cellular photobiostimulation [33]. The basic biological mechanism would be thought to be through absorption of specific light by mitochondrial chromophores, in particular cytochrome *c* oxidase (CCO), which is contained in the respiratory chain located within the mitochondria [34–36], and perhaps also by photoacceptors

**Supplier Device name Wavelength (nm) Clinical applications**

OMNILUX 415(±5)/633(±6)/830(±5) Acne, photodamage,

LumiPhase-R 660 Skin firmness, rhytid depth,

Synergie LT12 660/880 Antiaging, skin firmness,

TI-816 830/660 REHACARE, pain

*The designed medical devices with different LLLT sources for relative clinical applications [30].*

630/880 Antiaging and skin

nonmelanoma skin cancers, skin rejuvenation, vitiligo, and wound healing after elective surgery

and wrinkles

rejuvenation

wrinkles, skin tone, and texture for face and neck

management, skin rejuvenation, wound healing after surgery, and nerve

regeneration

*DOI: http://dx.doi.org/10.5772/intechopen.82523*

#### *Biological and Preclinical Evaluations of Designed Optically Guided Medical Devices with Light… DOI: http://dx.doi.org/10.5772/intechopen.82523*

external surgical damage after elective surgery. Practically, a series of new designed medical devices with LLLT sources were employed for healing in internal and external surgical damages. Most important, the designed medical devices with LLLT sources were used for internal surgical damage such as the target ligament healing and reducing inflammation under the skin. The medical device with LLLT sources showed no damage H-bonding or molecule interaction. LLLT sources are not enough to change and damage cell or tissue molecule structure, have no remarkable increasing temperature (<0.1–0.5°C), and observed biological response being due to photobiostimulation. Most important, the designed medical devices with LLLT sources provide a kind of invasive immediately continuous treatments with no heat, no pain, no medicine, and no needle for internal surgical damage healing after MIS to greatly reduce the potential harms to the body and enhance convenience of healing wounds. LLLT, phototherapy, or photobiomodulation refers to the use of photons at a nonthermal irradiance to alter biological activity. LLLT uses coherent light sources (lasers), noncoherent light sources consisting of filtered lamps or LED, or laser, and, on occasion, a combination of both. The main medical applications of LLLT are reducing inflammation and pain and promoting regeneration of different tissues and nerves [30, 31]. In the past, laser therapies have been used increasingly for the esthetic treatment of fine wrinkles, aged skin, and scars, a process known as photo-rejuvenation (**Table 1**) [32]. Recently, this approach has also been used for inflammatory acne (**Table 1**) [32]. LLLT involves exposing cells or tissue to low levels of light sources. This process is referred to as "low level" because the energy or power densities used are low compared with other forms of laser therapy such as cutting or thermally coagulating tissue. More recently, clinical treatments with LLLT have been found to stimulate or inhibit an assortment of cellular processes or cellular photobiostimulation [33]. The basic biological mechanism would be thought to be through absorption of specific light by mitochondrial chromophores, in particular cytochrome *c* oxidase (CCO), which is contained in the respiratory chain located within the mitochondria [34–36], and perhaps also by photoacceptors


#### **Table 1.**

*The designed medical devices with different LLLT sources for relative clinical applications [30].*

*Peripheral Nerve Disorders and Treatment*

for the wound bed, discomfort experienced from changing the dressing becomes reduced, and the risk of infection also becomes decreased. Hydrogels are widely used as debriding agents, moist dressings, and components of pastes for wound care because of the moist ability of amphiphilic materials and structures such as semiinterpenetrating polymeric networks and interpenetrating polymeric networks (IPN). The IPN structure could be prepared from multiple cross-linking reactions via thermal or photochemical procedures. However, they do not need further wound fluids to become gels and are suitable for dry wounds [28, 29]. The so-called "moisture donor" effect of hydrogel surgical dressing helps autolytic debridement, increasing collagenase production and the moisture content of necrotic wounds [25]. At the same time, a protective polymeric film was used. Assistive hydrogel surgical dressin*g* could absorb and retain contaminated exudate within the gel mass through expansion of cross-linked polymer chains resulting in isolation of bacteria and detritus molecules in the liquid. Their high-water content allows vapor and oxygen transmission to the wounds such as pressure sores, leg ulcers, surgical and necrotic wounds, lacerations, and burns. Assistive hydrogel surgical dressing seems to play an important role as emergency burns treatment alone or in combination with other products, thanks to their cooling and hydrating effects [26]. Hence, the hydrogel surgical dressing with a polymeric film was designed for using after carpal tunnel syndrome treatments via minimally invasive surgery as shown in **Figure 7**.

**3.5 LLLT for carpal tunnel syndrome treatments after minimally invasive surgery**

*(A) New design of optical guided medical device with LLLT sources for wound healing (Transverse Industries Co-design) and its key functional components. (B) Clinical applications of new designed medical devices for carpal tunnel syndrome treatments via MIS and the wound healing of internal and external surgical damages* 

**Figure 7A** shows a new design of optical guided medical device with LLLT sources and its key functional components for wound healing. Furthermore, **Figure 7B** shows clinical applications of new designed medical devices for carpal tunnel syndrome treatments via minimally invasive surgery and the wound healing of internal and

**56**

**Figure 7.**

*after elective surgery.*

in the plasma membrane of cells. A cascade of events occurs consequently in the mitochondria, which leads to biostimulation of various systems in specific clinical applications (**Table 1**) [37]. Furthermore, absorption spectra obtained for cytochrome *c* oxidase in different oxidation states could be recorded and found to be similar to the action spectra for biological responses to the light [37]. The absorption of laser light energy could cause photodissociation of inhibitory nitric oxide (NO) from cytochrome *c* oxidase [38], leading to enhancement of enzyme activity [39], electron transport [40], mitochondrial respiration, and adenosine triphosphate production (**Table 1**) [41, 42]. LLLT is now used to treat a wide variety of ailments (**Table 1** and **Figure 7**) [30, 43–54]. In turn, LLLT alters the cellular redox state, which induces the activation of numerous intracellular signaling pathways, and alters the affinity of transcription factors concerned with cell proliferation, survival, tissue repair, and regeneration (**Table 1** and **Figure 7**) [34, 35, 44–54]. The medical devices with different LLLT sources are designed for relative clinical applications as listed in **Table 1**.

#### **3.6 Clinical evaluation of carpal tunnel surgical procedure with the new designed medical devices**

The clinical evaluation of carpal tunnel surgical procedures with the new light guided medical device was studied by a design of "clinical evaluation table of carpal tunnel surgical procedure." Also, three kinds of finger activities such as clenching, finger splaying, and touching from the index finger to thumb could be employed for clinical evaluation of carpal tunnel syndrome as shown in **Figure 8A–C**, respectively. Difficulty in the movement or coordination of the fingers in one or both hands hints possibility of carpal tunnel syndrome. It is because the median nerve would pass through the carpal tunnel to receive any kind of sensations from the thumb, index, and middle fingers of the hand. Numbness and tingling of the thumb, index, and the middle fingers in the hand are clinical evaluations for carpal tunnel syndrome by using three kinds of finger activities (**Figure 8**). The area of numbness and tingling of the thumb, index, and the middle fingers in the hand could be marked in the "clinical evaluation table of carpal tunnel surgical procedure" (**Table 2**). The red part involves the muscular dystrophy position of carpal tunnel syndrome as shown in **Table 2a**. The red marks of suture as shown in **Table 2b** indicate the cut position of carpal tunnel surgical procedure. Also, the "Suggesting Procedure before carpal tunnel surgical procedure" and "Suggesting Procedure after carpal tunnel surgical procedure" could be reported in the designed clinical evaluation table of "Carpal Tunnel Syndrome Treatments via minimally invasive surgery by using designed medical devices."

#### **Figure 8.**

*Photos of two kinds of finger activities such as (A) finger splaying and (B) touching from the index finger to thumb for clinical evaluation of carpal tunnel syndrome [1].*

**59**

**4. Summary**

*designed medical devices" [1].*

**Table 2.**

yyyy)

related clinical applications.

*Biological and Preclinical Evaluations of Designed Optically Guided Medical Devices with Light…*

• Suggesting procedure: (*Date:* mm, dd, yyyy)

cleaning external surgical damages

1.The wound healing of internal and external surgical damage after minimally invasive surgery 2.LLLT for internal surgical damages

3.The air-foaming soft cleaning surgical sponge for soft

4.The hydrogel surgical dressing for external surgical

**(a) Before carpal tunnel surgical procedure (b) After carpal tunnel surgical procedure**

This study provides a novel design and fabrication of optical guided medical devices with a light scattering module for carpal tunnel syndrome. The LED light or laser could be employed as optical guided modules. A new medical device with optical LLLT module and a series of assistive surgical healing dressings such as airfoam soft cleaning sponges and hydrogel surgical dressings were also designed for wound healing in carpal tunnel syndrome treatments. Last, the designed medical devices such as optical guided medical devices and assistive surgical dressings could be found as a powerful device not only for carpal tunnel syndrome but also for

*The clinical evaluation table of "Carpal tunnel syndrome treatments via minimally invasive surgery by using* 

damages

*DOI: http://dx.doi.org/10.5772/intechopen.82523*

• Suggesting procedure: (*Date:* mm, dd,

1. Carpal tunnel syndrome treatments via

minimally invasive surgery

*Biological and Preclinical Evaluations of Designed Optically Guided Medical Devices with Light… DOI: http://dx.doi.org/10.5772/intechopen.82523*

#### **Table 2.**

*Peripheral Nerve Disorders and Treatment*

applications as listed in **Table 1**.

**designed medical devices**

in the plasma membrane of cells. A cascade of events occurs consequently in the mitochondria, which leads to biostimulation of various systems in specific clinical applications (**Table 1**) [37]. Furthermore, absorption spectra obtained for cytochrome *c* oxidase in different oxidation states could be recorded and found to be similar to the action spectra for biological responses to the light [37]. The absorption of laser light energy could cause photodissociation of inhibitory nitric oxide (NO) from cytochrome *c* oxidase [38], leading to enhancement of enzyme activity [39], electron transport [40], mitochondrial respiration, and adenosine triphosphate production (**Table 1**) [41, 42]. LLLT is now used to treat a wide variety of ailments (**Table 1** and **Figure 7**) [30, 43–54]. In turn, LLLT alters the cellular redox state, which induces the activation of numerous intracellular signaling pathways, and alters the affinity of transcription factors concerned with cell proliferation, survival, tissue repair, and regeneration (**Table 1** and **Figure 7**) [34, 35, 44–54]. The medical devices with different LLLT sources are designed for relative clinical

**3.6 Clinical evaluation of carpal tunnel surgical procedure with the new** 

The clinical evaluation of carpal tunnel surgical procedures with the new light guided medical device was studied by a design of "clinical evaluation table of carpal tunnel surgical procedure." Also, three kinds of finger activities such as clenching, finger splaying, and touching from the index finger to thumb could be employed for clinical evaluation of carpal tunnel syndrome as shown in **Figure 8A–C**, respectively. Difficulty in the movement or coordination of the fingers in one or both hands hints possibility of carpal tunnel syndrome. It is because the median nerve would pass through the carpal tunnel to receive any kind of sensations from the thumb, index, and middle fingers of the hand. Numbness and tingling of the thumb, index, and the middle fingers in the hand are clinical evaluations for carpal tunnel syndrome by using three kinds of finger activities (**Figure 8**). The area of numbness and tingling of the thumb, index, and the middle fingers in the hand could be marked in the "clinical evaluation table of carpal tunnel surgical procedure" (**Table 2**). The red part involves the muscular dystrophy position of carpal tunnel syndrome as shown in **Table 2a**. The red marks of suture as shown in **Table 2b** indicate the cut position of carpal tunnel surgical procedure. Also, the "Suggesting Procedure before carpal tunnel surgical procedure" and "Suggesting Procedure after carpal tunnel surgical procedure" could be reported in the designed clinical evaluation table of "Carpal Tunnel Syndrome Treatments via minimally invasive surgery by using designed medical devices."

*Photos of two kinds of finger activities such as (A) finger splaying and (B) touching from the index finger to* 

*thumb for clinical evaluation of carpal tunnel syndrome [1].*

**58**

**Figure 8.**

*The clinical evaluation table of "Carpal tunnel syndrome treatments via minimally invasive surgery by using designed medical devices" [1].*

#### **4. Summary**

This study provides a novel design and fabrication of optical guided medical devices with a light scattering module for carpal tunnel syndrome. The LED light or laser could be employed as optical guided modules. A new medical device with optical LLLT module and a series of assistive surgical healing dressings such as airfoam soft cleaning sponges and hydrogel surgical dressings were also designed for wound healing in carpal tunnel syndrome treatments. Last, the designed medical devices such as optical guided medical devices and assistive surgical dressings could be found as a powerful device not only for carpal tunnel syndrome but also for related clinical applications.

*Peripheral Nerve Disorders and Treatment*

#### **Author details**

Ching-Cheng Huang1 \* and Ming-Che Chiang2

1 Department of Biomedical Engineering, Ming-Chuan University, Taoyuan, Taiwan

2 Neurosurgery Department, Taichung Veterans General Hospital, Taichung, Taiwan

\*Address all correspondence to: junas.tw@yahoo.com.tw

© 2018 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/ by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

**61**

*Biological and Preclinical Evaluations of Designed Optically Guided Medical Devices with Light…*

[8] Zhai G, Toh SC, Tan WL, Kang ET, Neoh KG, Huang CC, et al. Poly(vinyliden e fluoride) with grafted Zwitterionic polymer side chains for electrolyte-responsive microfiltration membranes. Langmuir.

[9] Liaw DJ, Huang CC, Sang HC, Kang ET. Photophysical and solution properties of naphthalene-labeled styrene/N, N-dimethyl maleimido propylammonium propane sulfonate copolymer. Langmuir.

[10] Vlierberghe SV, Cnudde V, Dubruel P, Masschaele B, Cosijns A, Patric IDP, et al. Porous gelatin hydrogels: 1. Cryogenic formation and structure analysis. Biomacromolecules.

[11] Liaw DJ, Chen TP, Huang CC. Selfassembly aggregation of highly stable co-polynorbornenes with amphiphilic architecture via ring-opening metathesis polymerization. Macromolecules.

[12] Kumar M, Sanford KJ, Cuevas WA, Katharine MD, Collier D, Chow N. Designer protein-based performance materials. Biomacromolecules.

[13] Katsumata T, Maitani M, Huang CC, Shiotsuki M, Masuda T. Synthesis and proper ties of various poly(diphenylacetylenes) containing tert-amine moieties. Polymer. 2008;**49**:2808-2816

[14] Hrynyk M, Martins-Green M, Barron AE, Neufeld RJ. Alginate-PEG sponge architecture and role in the design of insulin release dressings. Biomacromolecules.

[15] Liaw DJ, Huang CC, Kang ET. Effect of architecture and environments on

2003;**19**:7030-7037

1999;**15**:5204-5211

2007;**8**(2):331-337

2005;**38**:3533-3538

2006;**7**(9):2543-2551

2012;**13**(5):1478-1485

*DOI: http://dx.doi.org/10.5772/intechopen.82523*

[1] Chiang MC, Huang CC. Biological and clinical evaluations of designed optically guided medical devices with scalpel and light scattering modules for carpal tunnel surgical procedure. Journal Bio-Medical Materials and Engineering (BMME).

[2] Fu KL, Huang CC, Fu YC, Chiang MC. King-yard tech.: A safety surgical devices with bio-inspired trunk strengthening structure for minimally invasive surgery. Taiwan Patent 2018;

[3] Fu KL, Huang CC, Fu YC, Chiang MC. King-Yard Tech.: A safety surgical devices with photo-guiding and positioning surgical modules for minimally invasive surgery. Taiwan

[4] Liaw DJ, Huang CC, Sang HC, Wu PL. Macromolecular microstructure, reactivity ratio and viscometric studies of water-soluble cationic and/ or Zwitterionic copolymers. Polymer.

[5] Liaw DJ, Huang CC, Liaw BY. Synthesis and properties of

polyurethanes based on bisphenol-S derivatives. Polymer. 1998;**39**:3529-3535

[6] Reddy TT, Kano A, Maruyama A,

Thermosensitive transparent semiinterpenetrating polymer networks for wound dressing and cell adhesion

[7] Liaw DJ, Chen WH, Huang CC. Synthesis and characterization of new organosoluble poly(ether-imide)s derived from various novel bis (ether anhydride)s. In: Mittal KL, editor. Polyimides and Other High Temperature

Polymers, Utrecht. Vol. 2. VSP Publisher; 2003. pp. 47-70

control. Biomacromolecules.

Hadano M, Takahara A.

2008;**9**(4):1313-1321

**References**

2015;**26**:S173-S179

Patent. 2017; M552335

2000;**41**:6123-6131

M553983

*Biological and Preclinical Evaluations of Designed Optically Guided Medical Devices with Light… DOI: http://dx.doi.org/10.5772/intechopen.82523*

#### **References**

*Peripheral Nerve Disorders and Treatment*

**60**

**Author details**

Taoyuan, Taiwan

Taichung, Taiwan

Ching-Cheng Huang1

provided the original work is properly cited.

© 2018 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/ by/3.0), which permits unrestricted use, distribution, and reproduction in any medium,

\* and Ming-Che Chiang2

1 Department of Biomedical Engineering, Ming-Chuan University,

2 Neurosurgery Department, Taichung Veterans General Hospital,

\*Address all correspondence to: junas.tw@yahoo.com.tw

[1] Chiang MC, Huang CC. Biological and clinical evaluations of designed optically guided medical devices with scalpel and light scattering modules for carpal tunnel surgical procedure. Journal Bio-Medical Materials and Engineering (BMME). 2015;**26**:S173-S179

[2] Fu KL, Huang CC, Fu YC, Chiang MC. King-yard tech.: A safety surgical devices with bio-inspired trunk strengthening structure for minimally invasive surgery. Taiwan Patent 2018; M553983

[3] Fu KL, Huang CC, Fu YC, Chiang MC. King-Yard Tech.: A safety surgical devices with photo-guiding and positioning surgical modules for minimally invasive surgery. Taiwan Patent. 2017; M552335

[4] Liaw DJ, Huang CC, Sang HC, Wu PL. Macromolecular microstructure, reactivity ratio and viscometric studies of water-soluble cationic and/ or Zwitterionic copolymers. Polymer. 2000;**41**:6123-6131

[5] Liaw DJ, Huang CC, Liaw BY. Synthesis and properties of polyurethanes based on bisphenol-S derivatives. Polymer. 1998;**39**:3529-3535

[6] Reddy TT, Kano A, Maruyama A, Hadano M, Takahara A. Thermosensitive transparent semiinterpenetrating polymer networks for wound dressing and cell adhesion control. Biomacromolecules. 2008;**9**(4):1313-1321

[7] Liaw DJ, Chen WH, Huang CC. Synthesis and characterization of new organosoluble poly(ether-imide)s derived from various novel bis (ether anhydride)s. In: Mittal KL, editor. Polyimides and Other High Temperature Polymers, Utrecht. Vol. 2. VSP Publisher; 2003. pp. 47-70

[8] Zhai G, Toh SC, Tan WL, Kang ET, Neoh KG, Huang CC, et al. Poly(vinyliden e fluoride) with grafted Zwitterionic polymer side chains for electrolyte-responsive microfiltration membranes. Langmuir. 2003;**19**:7030-7037

[9] Liaw DJ, Huang CC, Sang HC, Kang ET. Photophysical and solution properties of naphthalene-labeled styrene/N, N-dimethyl maleimido propylammonium propane sulfonate copolymer. Langmuir. 1999;**15**:5204-5211

[10] Vlierberghe SV, Cnudde V, Dubruel P, Masschaele B, Cosijns A, Patric IDP, et al. Porous gelatin hydrogels: 1. Cryogenic formation and structure analysis. Biomacromolecules. 2007;**8**(2):331-337

[11] Liaw DJ, Chen TP, Huang CC. Selfassembly aggregation of highly stable co-polynorbornenes with amphiphilic architecture via ring-opening metathesis polymerization. Macromolecules. 2005;**38**:3533-3538

[12] Kumar M, Sanford KJ, Cuevas WA, Katharine MD, Collier D, Chow N. Designer protein-based performance materials. Biomacromolecules. 2006;**7**(9):2543-2551

[13] Katsumata T, Maitani M, Huang CC, Shiotsuki M, Masuda T. Synthesis and proper ties of various poly(diphenylacetylenes) containing tert-amine moieties. Polymer. 2008;**49**:2808-2816

[14] Hrynyk M, Martins-Green M, Barron AE, Neufeld RJ. Alginate-PEG sponge architecture and role in the design of insulin release dressings. Biomacromolecules. 2012;**13**(5):1478-1485

[15] Liaw DJ, Huang CC, Kang ET. Effect of architecture and environments on

polymeric molecular assemblies of novel amphiphilic diblock copolynorbornenes with narrow polydispersity via living ring-opening metathesis polymerization (ROMP). Journal of Polymer Science Part A: Polymer Chemistry. 2006;**44**:2901-2911

[16] Liaw DJ, Huang CC, Ju JY. Novel star-like multifunctional polymeric materials with predominant cis microstructures derived from α-norbornenyl macromonomer and stable macroinitiator via ring-opening metathesis polymerization and atom transfer radical polymerization. Journal of Polymer Science, Part A: Polymer Chemistry. 2006;**44**:3382-3392

[17] Karakasyan C, Legros M, Lack S, Brunel F, Maingault P, Ducouret G, et al. Cold gelation of alginates induced by monovalent cations. Biomacromolecules. 2010;**11**:2966-2975

[18] Liu HW, Chen CH, Tsai CL, Lin IH, Hsiue GH. Heterobifunctional poly (ethylene glycol)-tethered bone morphogenetic protein-2-stimulated bone marrow mesenchymal stromal cell differentiation and osteogenesis. Tissue Engineering. 2007;**13**(5):1113-1124

[19] Makino A, Kurosaki K, Ohmae M, Kobayashi S. Chitinasecatalyzed synthesis of alternatingly N-deacetylated chitin: A chitin− chitosan hybrid polysaccharide. Biomacromolecules. 2006;**7**:950-957

[20] Chaw JR, Liu HW, Shih YC, Huang CC. New designed nerve conduits with porous ionic cross-linked alginate/ chitosan structure for nervous regeneration. Journal Bio-Medical Materials and Engineering(BMME). 2015;**26**:S95-S102

[21] Zhai G, Toh SC, Tan WL, Kang ET, Neoh KG, Huang CC, et al. Poly(vinylidene fluoride) with grafted Zwitterionic polymer side chains for electrolyte-responsive

microfiltration membranes. Langmuir. 2003;**19**:7030-7037

[22] Zhai G, Yu WH, Kang, Neoh KG, Huang CC, Liaw DJ. Functionalization of hydrogen-terminated silicon with polybetaine brushes via surface-initiated reversible additionfragmentation chain-transfer (RAFT) polymerization. Industrial and Engineering Chemistry Research. 2004;**43**:1673-1680

[23] Kang ET, Neoh KG, Chen W, Tan KL, Liaw DJ, Huang CC. Surface structures and adhesion characteristics of poly(tetrafluoroethylene) films after modification by graft copolymerization. Journal of Adhesion Science and Technology. 1996;**10**:725-743

[24] Li ZF, Kang ET, Neoh KG, Tan KL, Huang CC, Liaw DJ. Surface structures and adhesive-free adhesion characteristics of polyaniline films after modification by graft copolymerization. Macromolecules. 1997;**30**:3354-3362

[25] Stashak TS, Farstvedt E, Othic A. Update on wound dressings: Indications and best use. Clinical Techniques in Equine Practice. 2004;**3**:148-163

[26] Osti E, Osti F. Treatment of cutaneous burns with burnshield (hydrogel) and a semi-permeable adhesive film. Annals of Burns and Fire Disasters. 2004;**7**:137-141

[27] Turner TD. Hospital usage of absorbent dressings. The Pharmaceutical Journal. 1979;**222**:421-424

[28] Murphy PS, Evans GRD. Advances in wound healing: A review of current wound healing products. Plastic Surgery International. 2012:**2012**;190436

[29] Koehler J, Brandl FP, Goepferich AM. Fast and excellent healing of hydroxypropyl guar gum/ poly(N,N-dimethyl acrylamide)

**63**

*Biological and Preclinical Evaluations of Designed Optically Guided Medical Devices with Light…*

[39] Wong-Riley MT, Liang HL, Eells JT. Photobiomodulation directly benefits primary neurons functionally inactivated by toxins: Role of cytochrome c oxidase. Journal of Biological Chemistry.

[40] Pastore D, Greco M, Petragallo VA. Increase in H+/e-ratio of the cytochrome c oxidase reaction in mitochondria irradiated with helium-neon laser. Biochemistry and Molecular Biology International. 1994;**34**:817-826

[41] Karu T, Pyatibrat L, Kalendo G. Irradiation with He-Ne laser increases ATP level in cells cultivated in vitro. Journal of Photochemistry and Photobiology. B. 1995;**27**:219-223

[42] Harris DM. Editorial comment biomolecular mechanisms of laser biostimulation. Journal of Clinical Laser Medicine & Surgery. 1991;**9**:277-280

[43] Liu H, Colavitti R, Rovira II. Redoxdependent transcriptional regulation. Circulation Research. 2005;**97**:967-974

[44] Peplow PV, Chung TY, Ryan B. Laser photobiomodulation of gene expression and release of growth factors and cytokines from cells in culture: A review of human and animal studies. Photomedicine and Laser Surgery.

[45] Wang CZ, Chen YJ, Wang YH, Yeh ML, Huang MH, Ho ML, et al. Low-level laser irradiation improves functional recovery and nerve regeneration in sciatic nerve crush rat injury model. PLoS One. 2014;**9**(8):e103348

[46] Wu JY, Wang YH, Wang GJ, Ho ML, Wang CZ, Yeh ML, et al. Low-power GaAlAs laser irradiation promotes the proliferation and osteogenic differentiation of stem cells via IGF1 and BMP2. PLoS One.

2011;**29**:285-304

2012;**7**(9):e044027

2005;**280**:4761-4771

*DOI: http://dx.doi.org/10.5772/intechopen.82523*

hydrogels. European Polymer Journal.

[30] Avci P, Gupta A, Sadasivam M, Vecchio D, Pam Z, Pam N, Hamblin MR. Low-level laser (light) therapy (LLLT) in skin: Stimulating, healing, restoring. Seminars in Cutaneous Medicine and

[31] Gupta A, Avci P, Sadasivam M. Shining light on nanotechnology to help repair and regeneration. Biotechnology

[32] Seaton ED, Mouser PE, Charakida A. Investigation of the mechanism of action of nonablative pulsed-dye laser therapy in photorejuvenation and inflammatory acne vulgaris. The British Journal of Dermatology.

[33] Barolet D. Light-emitting diodes (LEDs) in dermatology. Seminars in Cutaneous Medicine and Surgery.

[34] Karu TI, Kolyakov SF. Exact action spectra for cellular responses relevant to phototherapy. Photomedicine and Laser

2018;**100**:1-11

Surgery. 2003;**32**:41-52

Advances. 2013;**31**:607-631

2006;**155**:748-755

2008;**27**:227-238

Surgery. 2005;**23**:355-361

1989;**163**:1428-1434

Sciences. 2004;**3**:211-216

Nature. 2006;**443**:901-903

2011;**3**(6):627-629

[35] Greco M, Guida G, Perlino E. Increase in RNA and protein synthesis by mitochondria irradiated with helium-neon laser. Biochemical and Biophysical Research Communications.

[36] Karu TI, Pyatibrat LV, Kalendo GS. Photobiological modulation of cell attachment via cytochrome c oxidase. Photochemical & Photobiological

[37] Oron U. Light therapy and stem cells: A therapeutic intervention of the future? Interventional Cardiology.

[38] Lane N. Cell biology: Power games.

*Biological and Preclinical Evaluations of Designed Optically Guided Medical Devices with Light… DOI: http://dx.doi.org/10.5772/intechopen.82523*

hydrogels. European Polymer Journal. 2018;**100**:1-11

*Peripheral Nerve Disorders and Treatment*

(ROMP). Journal of Polymer Science Part A: Polymer Chemistry.

[16] Liaw DJ, Huang CC, Ju JY. Novel star-like multifunctional polymeric materials with predominant cis microstructures derived from α-norbornenyl macromonomer and stable macroinitiator via ring-opening metathesis polymerization and atom transfer radical polymerization. Journal of Polymer Science, Part A: Polymer Chemistry. 2006;**44**:3382-3392

[17] Karakasyan C, Legros M, Lack S, Brunel F, Maingault P, Ducouret G, et al. Cold gelation of alginates induced by monovalent cations. Biomacromolecules. 2010;**11**:2966-2975

[18] Liu HW, Chen CH, Tsai CL, Lin IH, Hsiue GH. Heterobifunctional poly (ethylene glycol)-tethered bone morphogenetic protein-2-stimulated bone marrow mesenchymal stromal

osteogenesis. Tissue Engineering.

[19] Makino A, Kurosaki K, Ohmae

catalyzed synthesis of alternatingly N-deacetylated chitin: A chitin− chitosan hybrid polysaccharide. Biomacromolecules. 2006;**7**:950-957

[20] Chaw JR, Liu HW, Shih YC, Huang CC. New designed nerve conduits with porous ionic cross-linked alginate/ chitosan structure for nervous regeneration. Journal Bio-Medical Materials and Engineering(BMME).

[21] Zhai G, Toh SC, Tan WL, Kang ET, Neoh KG, Huang CC, et al. Poly(vinylidene fluoride) with grafted Zwitterionic polymer side chains for electrolyte-responsive

cell differentiation and

M, Kobayashi S. Chitinase-

2007;**13**(5):1113-1124

2015;**26**:S95-S102

2006;**44**:2901-2911

polymeric molecular assemblies of novel amphiphilic diblock copolynorbornenes with narrow polydispersity via living ring-opening metathesis polymerization

microfiltration membranes. Langmuir.

[22] Zhai G, Yu WH, Kang, Neoh KG, Huang CC, Liaw DJ. Functionalization of hydrogen-terminated silicon with polybetaine brushes via

surface-initiated reversible additionfragmentation chain-transfer (RAFT) polymerization. Industrial and Engineering Chemistry Research.

[23] Kang ET, Neoh KG, Chen W, Tan KL, Liaw DJ, Huang CC. Surface structures and adhesion characteristics

[24] Li ZF, Kang ET, Neoh KG, Tan KL, Huang CC, Liaw DJ. Surface structures and adhesive-free adhesion

[25] Stashak TS, Farstvedt E, Othic A. Update on wound dressings: Indications and best use. Clinical Techniques in Equine Practice. 2004;**3**:148-163

[26] Osti E, Osti F. Treatment of cutaneous burns with burnshield (hydrogel) and a semi-permeable adhesive film. Annals of Burns and Fire

[27] Turner TD. Hospital usage of

International. 2012:**2012**;190436

[29] Koehler J, Brandl FP, Goepferich AM. Fast and excellent healing of hydroxypropyl guar gum/ poly(N,N-dimethyl acrylamide)

absorbent dressings. The Pharmaceutical

[28] Murphy PS, Evans GRD. Advances in wound healing: A review of current wound healing products. Plastic Surgery

Disasters. 2004;**7**:137-141

Journal. 1979;**222**:421-424

characteristics of polyaniline films after modification by graft copolymerization. Macromolecules.

of poly(tetrafluoroethylene) films after modification by graft copolymerization. Journal of Adhesion Science and Technology.

2003;**19**:7030-7037

2004;**43**:1673-1680

1996;**10**:725-743

1997;**30**:3354-3362

**62**

[30] Avci P, Gupta A, Sadasivam M, Vecchio D, Pam Z, Pam N, Hamblin MR. Low-level laser (light) therapy (LLLT) in skin: Stimulating, healing, restoring. Seminars in Cutaneous Medicine and Surgery. 2003;**32**:41-52

[31] Gupta A, Avci P, Sadasivam M. Shining light on nanotechnology to help repair and regeneration. Biotechnology Advances. 2013;**31**:607-631

[32] Seaton ED, Mouser PE, Charakida A. Investigation of the mechanism of action of nonablative pulsed-dye laser therapy in photorejuvenation and inflammatory acne vulgaris. The British Journal of Dermatology. 2006;**155**:748-755

[33] Barolet D. Light-emitting diodes (LEDs) in dermatology. Seminars in Cutaneous Medicine and Surgery. 2008;**27**:227-238

[34] Karu TI, Kolyakov SF. Exact action spectra for cellular responses relevant to phototherapy. Photomedicine and Laser Surgery. 2005;**23**:355-361

[35] Greco M, Guida G, Perlino E. Increase in RNA and protein synthesis by mitochondria irradiated with helium-neon laser. Biochemical and Biophysical Research Communications. 1989;**163**:1428-1434

[36] Karu TI, Pyatibrat LV, Kalendo GS. Photobiological modulation of cell attachment via cytochrome c oxidase. Photochemical & Photobiological Sciences. 2004;**3**:211-216

[37] Oron U. Light therapy and stem cells: A therapeutic intervention of the future? Interventional Cardiology. 2011;**3**(6):627-629

[38] Lane N. Cell biology: Power games. Nature. 2006;**443**:901-903

[39] Wong-Riley MT, Liang HL, Eells JT. Photobiomodulation directly benefits primary neurons functionally inactivated by toxins: Role of cytochrome c oxidase. Journal of Biological Chemistry. 2005;**280**:4761-4771

[40] Pastore D, Greco M, Petragallo VA. Increase in H+/e-ratio of the cytochrome c oxidase reaction in mitochondria irradiated with helium-neon laser. Biochemistry and Molecular Biology International. 1994;**34**:817-826

[41] Karu T, Pyatibrat L, Kalendo G. Irradiation with He-Ne laser increases ATP level in cells cultivated in vitro. Journal of Photochemistry and Photobiology. B. 1995;**27**:219-223

[42] Harris DM. Editorial comment biomolecular mechanisms of laser biostimulation. Journal of Clinical Laser Medicine & Surgery. 1991;**9**:277-280

[43] Liu H, Colavitti R, Rovira II. Redoxdependent transcriptional regulation. Circulation Research. 2005;**97**:967-974

[44] Peplow PV, Chung TY, Ryan B. Laser photobiomodulation of gene expression and release of growth factors and cytokines from cells in culture: A review of human and animal studies. Photomedicine and Laser Surgery. 2011;**29**:285-304

[45] Wang CZ, Chen YJ, Wang YH, Yeh ML, Huang MH, Ho ML, et al. Low-level laser irradiation improves functional recovery and nerve regeneration in sciatic nerve crush rat injury model. PLoS One. 2014;**9**(8):e103348

[46] Wu JY, Wang YH, Wang GJ, Ho ML, Wang CZ, Yeh ML, et al. Low-power GaAlAs laser irradiation promotes the proliferation and osteogenic differentiation of stem cells via IGF1 and BMP2. PLoS One. 2012;**7**(9):e044027

[47] Sculean A, Schwarz F, Becker J. Anti-infective therapy with an Er:YAG laser: Influence on peri-implant healing. Expert Review of Medical Devices. 2005;**2**(3):267-276

[48] Stadler I. In vitro effects of low level laser irradiation at 660 nm on peripheral blood lymphocytes. Lasers in Surgery and Medicine. 2000;**27**(3):255-261

[49] Karu TI. Mechanisms of low-power laser light action on cellular level. In: Simunovic Z, editor. Lasers in Medicine and Dentistry. Rijeka: Vitgraph; 2000. pp. 97-125

[50] Whelan HT, Smits RL, Buchman EV. Effect of NASA light emitting diode irradiation on wound healing. Journal of Clinical Laser Medicine & Surgery. 2001;**19**(6):305-314

[51] Rochkind S, Shahar A, Nevo Z. An innovative approach to induce regeneration and the repair of spinal cord injury. Laser Therapy. 1997;**9**(4):151

[52] Macedo AB, Moraes LHR, Mizobuti DS, Fogaca AR, Moraes FSR, Hermes TA, et al. Low-level laser therapy (LLLT) in dystrophin-deficient muscle cells: Effects on regeneration capacity, inflammation response and oxidative stress. PLoS One. 2015;**10**(6):e0128567

[53] Almeida-Lopes L. Comparison of the low level laser therapy effects on cultured human gingival fibroblasts proliferation using different irradiance and same fluence. Lasers in Surgery and Medicine. 2001;**29**(2):179-184

[54] Shefer G. Low energy laser irradiation promotes the survival and cell cycle entry of skeletal muscle satellite cells. Journal of Cell Science. 2002;**115**:1461-1469

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Section 2

Peripheral Nerve Injury,

Diagnosis and Treatment

## Section 2
