Tissue Anchor Research Articles

Soft Tissue Anchor System

Biomedical Safety & Standards 42(1):p 4, January 15, 2012. | DOI: 10.1097/01.BMSAS.0000410606.97324.dd

Complications associated with tissue anchor migration after vaginal surgery using the tissue fixation system – a case series

This case series describes eleven women with serious complications related to migration of tissue anchors after vaginal surgery for uterovaginal prolapse and/or urinary incontinence using the tissue fixation system.

Multicenter study of a novel adjustable tongue-advancement device for obstructive sleep apnea

Objective The safety and clinical effect of a new surgical device for tongue suspension for obstructive sleep apnea (OSA) was assessed. Study Design Multicenter phase 2 prospective case series. Setting Multicenter academic and private. Subjects and Methods Surgically naïve patients with moderate-to-severe OSA and tongue base obstruction (body mass index < 32, apnea/hypopnea index [AHI] 15-60) underwent surgical insertion of a midline tissue anchor into the posterior tongue and connected to an adjustable mandibular bone anchor with a flexible tether. Outcomes included changes in AHI, sleepiness (Epworth Sleepiness Scale), sleep-related quality-of-life (Functional Outcomes of Sleep Questionnaire), snoring, swallowing, speech, and pain (0-10 visual analog scale). Results After the implant, 42 patients (mean age 50 years, body mass index 28) noted improvement at six months for AHI (mean [SD]: 35.5 [20.4] to 27.3 [18.8]), Epworth Sleepiness Scale (11.5 [3.9] to 7.8 [4.7]), and Functional Outcomes of Sleep Questionnaire (15.5 [2.6] to 17.5 [2.6], all P < 0.01). Snoring VAS scores improved (7.3 [2.1] to 4.7 [2.9], P < 0.01). Postimplant pain scores were mild to moderate (4.4) at day one and resolved by day five. Post-titration pain scores were mild (< 2). Device-related adverse events included wound infection (7%) and edema or seroma (5%), which resolved. However, in 31 percent of patients, asymptomatic tissue anchor barb fractures were observed radiographically. Conclusion The tissue anchor failure rate of the tested device precludes its clinical use; however, the study results support that a titratable, tongue-suspension device with low direct surgical morbidity in patients with moderate-to-severe sleep apnea significantly improves multiple measures of sleep apnea. Further investigation is warranted.

Endoscopic full-thickness resection and defect closure in the colon

Endoscopic full-thickness resection (eFTR) is a minimally invasive method for en bloc resection of GI lesions. The aim of this pilot study was to evaluate the feasibility of a grasp-and-snare technique for eFTR combined with an over-the-scope clip (OTSC) for defect closure. Nonsurvival animal study. Animal laboratory. Fourteen female domestic pigs. The eFTR was performed in porcine colons using a novel tissue anchor in combination with a standard monofilament snare and 14 mm OTSC. In the first group (n = 20), closure of the colonic defects with OTSC was attempted after the resection. In the second group (n = 8), an endoloop was used to secure the resection base before eFTR was performed. In the first group (n = 20), eFTR specimens ranged from 2.4 to 5.5 cm in diameter. Successful closure was achieved in 9 out of 20 cases. Mean burst pressure for OTSC closure was 29.2 mm Hg (range, 2-90; SD, 29.92). Injury to adjacent organs occurred in 3 cases. Lumen obstruction due to the OTSC closure occurred in 3 cases. In the second group (n = 8), the diameter of specimens ranged from 1.2 to 2.2 cm. Complete closure was achieved in all cases, with a mean burst pressure of 76.6 mm Hg (range, 35-120; SD, 31). Lumen obstruction due to the endoloop closure occurred in one case. No other complications or injuries were observed in the second group. Nonsurvival setting. Colonic eFTR using the grasp-and-snare technique is feasible in an animal model. Ligation of the resection base with an endoloop before eFTR seems to reduce complication rates and improve closure success and leak test results despite yielding smaller specimens.

Endoscopic mucosal resection using a grasp-and-snare technique

Endoscopic mucosal resection (EMR) is a minimally invasive method for en bloc removal of superficial gastrointestinal lesions. The aim of this study was to evaluate the feasibility of a novel grasp-and-snare EMR technique. In 10 domestic pigs, gastric lesions of approximately 3 cm were marked using electrocautery. EMR was performed using a double-channel endoscope. A novel tissue anchor was used through one channel, and a monofilament snare through the other. After submucosal injection, a circumferential mucosal incision was created. The tissue-anchoring device was then advanced through the open snare and anchored into the submucosal layer. The tissue-anchoring device was partly retracted into the endoscope and the snare was positioned into the circular incision. The snare was subsequently closed and the specimen resected by applying high-frequency electrocautery. Mean time to perform EMR was 32.4 minutes (range 22-41 minutes, SD 6.3). EMR yielded specimens that ranged in area from 2.7 cm (minor axis) by 2.8 cm (major axis) to 4.0 cm by 4.2 cm (mean area 9.36 cm(2); range 5.94-13.19 cm(2); SD +/- 2.50). Complete en bloc resection including all electrocautery markings was achieved in 9/10 cases. In one case, resection was achieved in two steps. One gastric wall perforation occurred. No other adverse events were observed. Grasp-and-snare EMR is feasible in an animal model. The technique can be performed efficiently compared with standard methods. To avoid perforation, caution is needed to ensure that tissue anchor needles are placed within and not deeper than the submucosal layer prior to tissue retraction.

Female urology: What method will you select?

When I was a resident, my leader taught me that the gold standard forpatients with stress incontinence is the Marshall–Marchetti–Krantz(MMK) procedure. But a few years later, urologists who could performadvanced techniques showed me needle suspension as the best methodat a urological meeting. Fortunately my boss gave me a chance for ahand-to-hand lesson of the stamay procedure by the specialist. Sincethen, I have been selecting this procedure for a few years. Withoutdoubt, this needle suspension was the gold standard at that time.But now most urologists do not select this technique because of badresults. After I had mastered the technique of tension-free vaginal tape(TVT), I could see the smiling faces of patients after the operation. Atthat time I believed that TVT would be the gold standard for thiscondition. But the present status is what you know.Recently most specialists, including myself, believe that using‘mesh’ is the best operation for patients with pelvic organ prolapse. Isthis tendency good for the patients in the long run? No one can predictthe results of this procedure more than ten years from now.God knows what procedure will be the gold standard in the future.Assistant Professor Yasuyuki Suzuki

Adjustable Tongue Advancement for Obstructive Sleep Apnea: A Pilot Study

Surgical treatment of obstructive sleep apnea (OSA) caused by hypopharyngeal collapse of the upper airway can be considered in patients who are intolerant to continuous positive airway pressure (CPAP). The present procedures addressing the hypopharynx are invasive and have substantial morbidity and limited efficacy. Ten patients (mean age, 44 years) with moderate to severe OSA, ie, an apnea-hypopnea index (AHI) between 15 and 50, with CPAP intolerance were included in a prospective, nonrandomized, multicenter study to evaluate the feasibility, safety, and efficacy of a novel tongue advancement procedure. The procedure consists of the implantation of a tissue anchor in the tongue base and an adjustment spool at the mandible. Titration of this tissue anchor results in advancement of the tongue and a patent upper airway. The mean AHI decreased from 22.8 at baseline to 11.8 at the 6-month follow-up (p = 0.007). The Epworth Sleepiness Scale score decreased from 11.4 at baseline to 7.7 at the 6-month follow-up (p = 0.094), and the snoring score decreased from 7.5 at baseline to 3.9 at the 6-month follow-up (p = 0.005). Four technical adverse events were noted, and 1 clinical adverse event occurred. Adjustable tongue advancement is a feasible and relatively safe way to reduce the AHI and snoring in selected patients with moderate to severe OSA and CPAP intolerance. Technical improvements and refinements to the procedure are ongoing.

Multicenter Study of Adjustable Tongue Advancement Device

Objective Surgical tongue advancement and stabilization is limited by morbidity and lack of adjustability. This study was designed to assess the feasibility and effectiveness of a novel titratable minimally invasive tongue advancement system. The objectives of the multicenter prospective study were to assess: 1) clinical effect on AHI, sleepiness and snoring, and 2) procedure morbidity. Methods Previously untreated patients (N=42) with evidence of tongue obstruction (BMI&lt;32, AHI &lt;60) underwent placement of a bone anchor attached to the mandible, tethered to a tissue anchor in the tongue base. Tissue anchor advancement was performed several weeks later under local or sedation anesthesia. Outcome measures included baseline and follow-up PSG, home sleep testing, and questionnaire data. Results Titration advanced the anchor up to 1.5 cm. There were no acute or long-term significant effects in speech, swallowing or taste. In 13 patients, tissue anchor barb fractures were observed on x-ray. AHI significantly decreased in the total group (29.1 to 23.1, p&lt;0.01). The barb-intact group improved (29.6 to 22.1, p&lt;0.01) but no change was observed in the barb fracture group (28.1 to 25.3, p = 0.17). Improvements were observed in snoring (7.3 to 3.6, p &lt; 0.01), ESS (11.5 to 7.5, p &lt; 0.01). Postoperative average pain scores decreased from 4.4 to 1.5 on day 5 (10 point scale). Conclusions Soft tissue anchor failure occurred and was associated with less effect and warrants correction prior to widespread application. Titrable tongue suspension is feasible, well tolerated, and significantly improves multiple measures of sleep apnea.

Placement of a Lateral Nasal Suspension Suture Via an External Rhinoplasty Approach

Placement of a Lateral Nasal Suspension Suture Via an External Rhinoplasty Approach

Initial experience with a novel endoscopic device allowing intragastric manipulation and plication

Current developments in intraluminal and transluminal natural orifice surgery are limited by issues of access, tissue manipulation, and secure tissue approximation/closure. This report describes an initial laboratory experience with a novel tissue approximation and suturing device. The device is deployed via a previously described platform and is 6 mm in diameter. Desirable qualities of this tissue approximation/closure device include robust tissue grasping, minimal tissue trauma, fully visualized anchor placement via off-axis needle and anchor deployment, full reloadability without instrument withdrawal, single-operator operating capability, torque-stable manipulability, and operator-controlled tension setting of tissue anchor pairs. The device was trialed in performing several maneuvers in porcine or canine models. The features of the system allowed bimanual tissue manipulation, full-thickness tissue approximation and plication, and secure closure of an ex vivo gastrotomy hole similar to that used during transluminal surgical interventions. This device appears to offer promise in achieving more complex endoluminal and potentially transluminal tasks, including secure suture closure of tissue defects and access holes. As such, devices of this type may prove useful in addressing some of the identified barriers to further development of natural orifice surgical intervention. Further investigation of the qualities and capabilities of this device in these settings is warranted.

Endoscopic full-thickness closure of large gastric perforations by use of tissue anchors

A flexible needle-catheter tissue-anchoring device was developed to accomplish full-thickness tissue apposition of the GI wall. The aim of this study was to identify the performance of this device for repair of large iatrogenic gastric perforations in a porcine model. Six pigs. Short-term survival animal study. Pigs were studied while they were under general anesthesia. Device performance in differing gastric locations and wall thicknesses was assessed by 2 perforations more than 2 cm in size created for each pig along the greater curvature and the anterior wall. Each perforation was closed by parallel placement of tissue anchor sets sequentially along the length of the perforation. One week follow-up endoscopy and necropsy were performed. Twelve perforations were closed with the 48 tissue anchor sets. All animals survived for 1 week without clinical complications. Follow-up endoscopy and necropsy revealed that all tissue anchors remained with firmly held sutures and sealed perforations. Full-thickness closure with a new tissue-anchoring device simply and successfully repaired large iatrogenic gastric perforations.

Arthroscopic meniscal repair: a comparative study between three different surgical techniques

The purpose of this prospective study was to evaluate and compare the results of arthroscopic meniscal repair using three different techniques. Between January 2002 and March 2004, 57 patients who met the inclusion criteria underwent an arthroscopic meniscal repair. The outside-in technique was used in 17 patients (group A), the inside-out in 20 patients (group B), while the rest of the 20 patients (group C) were managed by the all-inside technique using the Mitek RapidLoc soft tissue anchor (Mitek Surgical Products, Westwood, MA, USA). Anterior cruciate ligament (ACL) reconstruction was performed in 29 patients (51%). The criteria for clinical success included absence of joint line tenderness, locking, swelling, and a negative McMurray test. The minimum follow-up was one year for all groups. The mean follow-up was 23 months for group A, 22 months for group B, and 22 months for group C. All meniscal repairs were considered healed according to our criteria in group A, while 19 out of 20 repairs (95%) healed in group B. Finally 7 of 20 repairs (35%) were considered failures in group C and this difference was statistically significant in comparison with other groups. The time required for meniscal repair averaged 38.5 min for group A, 18.1 min for group B, and 13.6 min for group C. Operation time for meniscal repair in group A was statistically longer in comparison with other groups. There were no significant differences among the three groups concerning complications. According to our results, arhtroscopic meniscal repair with the inside-out technique seems to be superior in comparison with the other methods because it offers a high rate of meniscus healing without prolonged operation time.

Traumatic hallux varus repair utilizing a soft-tissue anchor: A case report

Hallux varus is usually iatrogenic in nature; however, congenital and acquired etiologies have been described in the literature. The authors present a case of traumatic hallux varus secondary to rupture of the adductor tendon. Surgical correction was performed using a soft tissue anchor for maintenance of the soft tissues utilized for repair.

Soft tissue anchor systems.

The concept of soft tissue attachment and reattachment has been addressed over the years through a variety of surgical techniques. This includes tendons and ligaments that have been detached both surgically and traumatically from their osseous origins or insertions. This study is designed to provide the reader with a comprehensive overview of current commercially available devices. Detailed descriptions of the various devices are provided along with a discussion of the advantages and disadvantages of each. Their application and use in reconstructive foot and ankle surgery are also discussed.

Clinical Case Applications of Mitek® Tissue Anchors in Veterinary Orthopaedics

SummaryThe Mitek®a tissue anchor is a new device designed for reattaching avulsed tendons, ligaments and joint capsule to bone. This device has proven useful in human orthopaedics. Initially approved for use in Bankart repair (reattachment of glenohumeral ligament to anterior glenoid rim) procedures (1-3), the Mitek® anchor is now utilized in ligamentous repairs and tenodesis of the foot, ankle (4, 5) and wrist (6, 7). These devices have the advantages of biocompatibility, small size, impressive pullout strength, versatility and ease of application (8). In this study Mitek® anchors were used to repair avulsed or ruptured tarsal and phalangeal collateral ligaments, coxofemoral luxations and to provide stability to cruciate deficient stifles.This paper describes the use of Metek® tissue anchors to repair tendinous, ligamentous, and joint capsule ruptures and avulsions.