Biocompatibility Studies of a New Biosynthetic Dermal Substitute Based on Collagen/Hyaluronan Conjugate

The use of glycosaminoglycans (GAGs) as the second macromolecular component with collagen for the membrane preparation is based on the idea to create a biodegradable scaffold for new tissue. A hybrid collagen/hyaluronan membrane with specific bubble macrostructure was designed to serve as a synthetic dermal substitute. The objectives were to explain the two questions: what is the local biological response to the implanted membrane, and what is its reconstruction rate in tissue. The histological study proved low irritability, good compatibility, ingrowth of autologous tissue starting on day 7 post implantation, and resorption within four weeks. The major part of the implant was replaced by autologous tissue at the end of three weeks post implantation. The overall local biological response to implant was very good.     

A novel injectable collagen matrix: in vitro characterization and in vivo evaluation

We present here a unique engineered collagen formulation that is injectable and compacts into a porous viscoelastic solid after implantation, achieving completely focal application without cross-linking. This implant provides a cohesive continuously porous matrix, as demonstrated by permeability and compression experiments. Those experiments also provide initial mechanical characterization of the material and establish the ability to modify these essential properties by design. Further, the short-term compaction and long-term stability of the implant in vivo in terms of both physical and histological responses are assessed in an animal model to demonstrate the mechanism of action and long-term persistence of this novel material.     

Implantation of Temperature Loggers in 100 Danish Dairy Calves: Surgical Procedure and Follow-up

One hundred Danish dairy calves had temperature loggers implanted subcutaneously on the neck. Post-operatively, the calves were given a single antibiotic treatment, and tissue reactions were assessed on 6 post-operative visits. After approximately 5 months, the loggers were removed and material submitted for histologic examination. This paper presents 1) the surgical procedure, 2) the prevalence of tissue reaction at the post-operative visits, 3) the degree of implant recovery, 4) the results of histopathologic examinations, 5) an evaluation of age at implantation or veterinary practitioner as risk factors for tissue reaction and missing implant recovery 5 months after implantation, and 6) evaluation of tissue reaction as a risk factor for lack of recovery 5 months after implantation. The implant was rejected on 7 calves (7%). Additionally, 5 calves (5%) had the temperature logger removed because of presence of an abcess. No migration of the temperature loggers were observed. The results of a repeated measures analysis and the histopathological findings indicate that contamination during the surgery resulted in inflammation and abcess formation. It is recommended that in the presence of an abcess, the temperature logger should be removed.     

KOM—段式种植体即刻种植的动物实验研究

目的:观察KOM一段式种植体即刻种植骨愈合过程,探索即刻种植的可行性。材料与方法:将6只狗分3组分别作实验。每组2只动物行KOM一段式种植体即刻种植愈合过程观察;动物分别于术后1、2、3个月各处死2只行大体标本观察、X线片、光镜、扫描电镜观察;结果:KOM一段式种植体即刻种植可以达到骨性愈合。结论:1、KOM一段式种植体的即刻种植是一种临床可行的种植方式。2、即刻中植时种植体与骨组织之间的骨间隙是否充填生物替代材料,除了考虑种植体周围骨间隙的大小,还要考虑种植体的初期稳定性。     

氧化钛纳米管对即刻种植骨结合影响的实验研究

目的:评价氧化钛纳米管对犬即刻种植骨结合效果的影响。方法:犬拔牙后即刻将光滑表面(对照组)和氧化钛纳米管表面(实验组)种植体植入拔牙窝内,于12周后处死取材,进行显微CT扫描、组织学染色分析以及生物力学检测。结果:扫描电镜显示经过阳极氧化后,钛表面形成了直径为30-80纳米的纳米管状结构;12周后,显微CT扫描结果提示实验组骨体积分数(BV/TV)、骨小梁数目(Tb.N)、骨小梁厚度(Tb.Th)均显著高于对照组,骨小梁间隙(Tb.Sp)显著低于对照组,差异具有统计学意义(P0.05)。术后12周,实验组与对照组骨结合率分别为49.35±11.76%、31.79±13.07%,最大拔出力分别为105.28±27.87N、79.23±20.46N,实验组均显著高于对照组,差异均具有统计学意义(P0.05)。结论:氧化钛纳米管表面有利于促进即刻种植后骨结合的效果。     

The influence of bone damage on press-fit mechanics

Press-fitting is used to anchor uncemented implants in bone. It relies in part on friction resistance to relative motion at the implant–bone interface to allow bone ingrowth and long-term stability. Frictional shear capacity is related to the interference fit of the implant and the roughness of its surface. It was hypothesised here that a rough implant could generate trabecular bone damage during implantation, which would reduce its stability. A device was constructed to simulate implantation by displacement of angled platens with varying surface finishes (polished, beaded and flaked) onto the surface of an embedded trabecular bone cube, to different nominal interferences. Push-in (implantation) and Pull-out forces were measured and micro-CT scans were made before and after testing to assess permanent bone deformation. Depth of permanent trabecular bone deformation (‘damage’), Pull-out force and Radial force all increased with implantation displacement and with implantation force, for all surface roughnesses. The proposed hypothesis was rejected, since primary stability did not decrease with trabecular bone damage. In fact, Pull-out force linearly increased with push-in force, independently of trabecular bone damage or implant surface. This similar behaviour for the different surfaces might be explained by the compaction of bone into the surfaces during push-in so that Pull-out resistance is governed by bone-on-bone, rather than implant surface-on-bone friction. The data suggest that maximum stability is achieved for the maximum implantation force possible (regardless of trabecular bone damage or surface roughness), but this must be limited to prevent periprosthetic cortical bone fracture, patient damage and component malpositioning.     

Cell cultivation on porous titanium implants with various structures

The paper presents data on the cultivation of human dermal fibroblasts and rabbit mesenchymal stromal cells on two types of porous titanium implants, i.e., those with irregular pores formed by pressed titanium particles and those with regular pores formed by the cohesion of one-size titanium particles inside the implant. The goal of this study was to determine what type of titanium implant porosity ensured its strongest interaction with cells. Cells were cultivated on implants for 7 days. During this period, they formed a confluent monolayer on the implant surface. Cells grown on titanium implants were monitored by scanning electron microscopy. Fibroblasts interaction with implants depended on the implant porosity structure. On implants with irregular pores cells were more spread. On implants with regular pores fibroblasts enveloped particles and were only occasionally bound with neighboring particles by small outgrowths. There was no tight interaction of particles inside the implant. In implants formed by pressed particles, cells grow not only on surface, but also in the depth of the implant. Thus, we suppose that a tighter interaction of cells with the titanium implant and, supposedly, tissues with the implant in the organism will take place in the variant when the implant structure is formed by pressed titanium particles, i.e., cellular interaction was observed inside the implant. In implants with irregular pores, cells grew both on the surface and in the depth. Thus, cells exhibited more adequate interactions with irregular pore titanium implants in vitro and hopefully the same interaction will be true in tissues after the implantation of the prosthesis into the organism.     

Radiation-resistance of the local tumor rejection response

Summary The effect of single -dose local treatment with 400 to 1600 rad of gamma irradiation on the growth of syngeneic mammary carcinoma (MC) and fibrosarcoma (FS) subcutaneous (SC) implants was investigated in female C3H/He hosts. The mice were prepared so as to present the tumor implant in various stages of growth at the time of irradiation and with the implantation site at various stages of development of the local immune rejection response. With the doses of radiation used, the growth of the tumors was, under all experimental conditions, reduced by irradiation, and the incidences of complete rejection were increased. On the basis of these observations, and supported by histological examinations, it appears that therapeutic doses of small field irradiation are unlikely to compromise a local tumor rejection response.     

Effect of temperature upon heart preservation for transplantation.

In this work we studied the effect of three different temperatures (7 °, 15 °, and 30 °C) on heart preservation. The best temperature for 24 hr pulsatile perfusion of canine hearts was 7 °C. Hearts perfused at this temperature showed no evidence of abnormal preservation changes nor of histological damage immediately upon transplantation. If the temperature was increased to 15 ° or 30 °C, moderate to severe preservation and histological damage were observed, and only three out of 10 dogs survived upon heart implantation.     

A nonlinear homogenized finite element analysis of the primary stability of the bone–implant interface

Stability of an implant is defined by its ability to undergo physiological loading–unloading cycles without showing excessive tissue damage and micromotions at the interface. Distinction is usually made between the immediate primary stability and the long-term, secondary stability resulting from the biological healing process. The aim of this research is to numerically investigate the effect of initial implantation press-fit, bone yielding, densification and friction at the interface on the primary stability of a simple bone–implant system subjected to loading–unloading cycles. In order to achieve this goal, human trabecular bone was modeled as a continuous, elasto-plastic tissue with damage and densification, which material constants depend on bone volume fraction and fabric. Implantation press-fit related damage in the bone was simulated by expanding the drilled hole to the outer contour of the implant. The bone–implant interface was then modeled with unilateral contact with friction. The implant was modeled as a rigid body and was subjected to increasing off-axis loading cycles. This modeling approach is able to capture the experimentally observed primary stability in terms of initial stiffness, ultimate force and progression of damage. In addition, it is able to quantify the micromotions around the implant relevant for bone healing and osseointegration. In conclusion, the computationally efficient modeling approach used in this study provides a realistic structural response of the bone–implant interface and represents a powerful tool to explore implant design, implantation press-fit and the resulting risk of implant failure under physiological loading.     

Identification of the critical level of implantation of an osseointegrated prosthesis for above-knee amputees

The aim of our study was to identify potential critical levels of implantation of an osseointegrated prosthesis for above-knee amputees. The implant used was the OPRA system. It was inserted in the femur at four different amputation heights, characterized by their residual limb ratios (0.299, 0.44, 0.58 and 0.73). The stress and strain distribution was evaluated in the bone-implant system during walking, considering a body mass of 100 kg. Considerably high stimulus (11,489 με) in the tissue near the tip was found at the highest implantation level. All models presented small non-physiologic stress values in the tissue around the implant. The results revealed that the implantation level has a decisive effect on bone-implant performance. Mainly, the analysis indicates adverse biomechanical conditions for implantations in very short residual limbs.     

Techniques for Processing Eyes Implanted with a Retinal Prosthesis for Localized Histopathological Analysis: Part 2 Epiretinal Implants with Retinal Tacks

Retinal prostheses for the treatment of certain forms of blindness are gaining traction in clinical trials around the world with commercial devices currently entering the market. In order to evaluate the safety of these devices, in preclinical studies, reliable techniques are needed. However, the hard metal components utilised in some retinal implants are not compatible with traditional histological processes, particularly in consideration for the delicate nature of the surrounding tissue. Here we describe techniques for assessing the health of the eye directly adjacent to a retinal implant secured epiretinally with a metal tack.Retinal prostheses feature electrode arrays in contact with eye tissue. The most commonly used location for implantation is the epiretinal location (posterior chamber of the eye), where the implant is secured to the retina with a metal tack that penetrates all the layers of the eye. Previous methods have not been able to assess the proximal ocular tissue with the tack in situ, due to the inability of traditional histological techniques to cut metal objects. Consequently, it has been difficult to assess localized damage, if present, caused by tack insertion.Therefore, we developed a technique for visualizing the tissue around a retinal tack and implant. We have modified an established technique, used for processing and visualizing hard bony tissue around a cochlear implant, for the soft delicate tissues of the eye. We orientated and embedded the fixed eye tissue, including the implant and retinal tack, in epoxy resin, to stabilise and protect the structure of the sample. Embedded samples were then ground, polished, stained, and imaged under various magnifications at incremental depths through the sample. This technique allowed the reliable assessment of eye tissue integrity and cytoarchitecture adjacent to the metal tack.     

Outcome following implantation of a peripheral nerve stimulator in patients with chronic nerve pain

This study evaluated the usefulness of the implanted peripheral nerve stimulator in patients with pain following injury to a peripheral nerve. The patient sample (n = 17) consisted of 7 men and 10 women with a mean age of 48 years (SD = 18 years). The mean follow-up time since implantation of the stimulator was 21 months (SD = 15 months). Workers' compensation and/or litigation were involved in 11 cases. Peripheral nerve stimulators were placed in the upper extremity in 12 patients and in the lower extremity in 5 patients. Pain relief following implantation was rated as excellent by five patients, good by six patients, fair by four patients, and poor by two patients. A statistically significant decrease in reported pain level was found postoperatively (p < 0.0003). There was no statistically significant difference in postoperative pain level between men and women (p = 0.30), between cases involving workers' compensation or litigation and those not involving these issues (p = 1.0), or between patients who received an upper-extremity implant and those who received a lower-extremity implant (p = 0.56). Of the 12 patients who were unable to work before the operation, 6 returned to work after the operation. In conclusion, peripheral nerve stimulators can be useful in decreasing pain in carefully selected patients with severe neurogenic pain.     

Studies of implantation traces in rats. III. Histological examination

We carried out a histological examination of the implantation traces in delivered rats. The implantation traces could be identified more than 500 days after delivery on the mesometrial side as black and brown spots. The implantation traces were recognizable as a cicatrix remaining in the parametrium, mesometrial triangle, which was formed by repair of injury caused by placental desquamation. In this area, metrial gland cells which were laid down through pregnancy were recognized for about two months after delivery. The implantation traces consisted of cicatrix tissue associated with collagen production and hemosiderin. It was possible to distinguish old and new traces by the size of the siderophile cells and by the degree of hemosiderin present. It was also possible to discriminate new traces as yellowish-brown areas, covered with a yellowish-white mass of degenerated metrial gland, in cleared uteri stained with 2% NaOH solution. Siderophile cells on the implantation traces were derived from giant cells which persisted around the peripheral region of the placental desquamation site, and these giant cells were considered to be identifiable with metrial gland cells. It was considered that formation of the cicatrix is essentially the same in abortion, stillbirth and normal delivery. However, it was found that the implantation traces had different histological appearances depending on the degree of injury to the endometrium and myometrium and time of placental desquamation. The iron content of the implantation traces corresponded quantitatively with the hemosiderin observed in the histological investigations. The iron content decreased rapidly up to 21 days after delivery, decreasing gradually thereafter. The iron in the implantation traces could, however, be analyzed quantitatively by atomic absorption spectroscopy until day 365 after delivery.     

Scanning electron microscopy of plasma etched implant specimens

Following surface etching of previously processed plastic embedded specimens containing hard and soft tissues and implanted biomaterials with oxygen plasma, the fine structure of the tissues can be examined by scanning electron microscopy. One micrometer plastic orientation sections (with the implant removed in processing) and 110 microns histological sections (with the implant in situ) were examined. Direct comparison can be made between the scanning and histological observations. An examination in situ of oral tissues next to the biomaterial was also made, care being taken to minimize damage to the specimen. The fine structure of intracellular organelles was examined in detail. The method allows consecutive gathering of histological and ultrastructural data from the same plastic embedded specimen.     

Shear stability of an elastomeric disk spacer within an intervertebral joint: a parametric study.

A parametric study was conducted to compare the resistance to shear force provided by three surgical implantation techniques and three endplate designs for use with a polymeric lumbar intervertebral disk spacer. While under an axial load, the implant was pushed out laterally through the surgical window created for implantation. Force at 0.3 mm displacement, slope of the initial portion of the force-displacement graph, and maximum force were measured. The results indicate that implants with pegs, inclined planes, or domes on the surfaces of the disk will add significantly to the shear stability of the implant while maintaining the simplicity of a single part device.     

Long-term functional outcomes after 10 years of bilateral cochlear implantat use

The aims were to determine the benefit of bilateral cochlear implantation in a 20 years old patient implanted in Croatia on hearing and speech development. The male patient, after 10 years of deafness, got cochlear implants Med-EL Combi 40+ on both sides in one-stage surgery. The etiology of his deafness was posttraumatic meningitis. Auditory capacity and speech recognition tests were performed for both ears separately and together Average hearing level on the right ear with right cochlear implant switched on started at 62 dB 1 month after the cochlear implantation and was on 55 dB after 10 years. Average hearing level on the left ear with left cochlear implant switched on started at 55 dB 1 month after the cochlear implantation and was on 32 dB after 10 years. Average hearing level on the both ears with 2 cochlear implants switched on started at 35 dB 1 month after the cochlear implantation and was on 27 dB after 10 years. Long-term functional outcomes with bilateral cochlear implantation provides advantages over unilateral implantation including improved hearing level, speech perception in noise and improved sound localization.     

Effect of neonatal spleen and thymus implants on H-Y incompatible skin grafts

The transplantation reactivity of adult splenectomized C57BL females to H-Y incompatible skin grafts was significantly reduced by the implantation of spleen and thymus from foetal or 0-1-day-old syngeneic female donors. The thymus implant served as a possible source of natural suppressor cell precursors and the spleen implant as a microenvironment for their maturation.