Device for Surgical Adhesion Prevention

描述（由申请人提供）：术后粘连形成是手术的最大并发症。美国每年进行2700万例外科手术，患者面临手术粘连并发症的风险。手术后，腹膜、中枢神经系统、心包、胸膜和滑膜中形成纤维粘连。手术后发生的纤维粘连会导致并发症，由于再次手术、术后肠梗阻、不孕症和慢性疼痛的发生率增加，这些并发症会显著增加医疗费用。尽管需要抗粘连治疗，但目前还没有FDA批准的预防器械可有效预防脊柱和腹腔镜手术后的手术粘连。获得FDA批准用于预防粘连的治疗的一个障碍是缺乏良好的临床终点指标来评估治疗效果。NovelMed基于先前的合成阴离子碳水化合物ADCON开发了一种新型合成碳水化合物NM 2040，尽管ADCON成功地抑制了粘连，但报告了显著的副作用。NovelMed最近发现ADCON对血小板有毒。鉴于血小板在止血和伤口愈合中的关键作用，ADCON的副作用可能与血小板毒性有关。开发NM 2040是为了克服ADCON对血小板的毒性作用。初步研究结果表明，这种生物相容性缀合物可以通过防止与纤维化发展相关的细胞侵入和增殖到手术部位来有效抑制手术粘连，而没有血小板毒性。本申请的目的是：1）使用经验证的腰椎椎板切除术模型，测试使用NM 2040作为预防手术粘连治疗的可行性; 2）开发妇科粘连的手术粘连模型，该模型具有良好的临床终点指标;并确定NM 2040预防输卵管粘连的疗效。我们的最终目标是开发一种有效的FDA批准的防粘连装置，用于背部和腹部手术。 公共卫生相关性：术后粘连形成是手术的最大并发症。在美国，每年进行2700万例外科手术，患者面临并发症的风险，由于再次手术、术后肠梗阻、不孕症和慢性疼痛的发生率增加，这些并发症显著增加了医疗保健成本。本申请的目的是：1）使用经验证的腰椎椎板切除术模型，测试使用NM 2040作为预防手术粘连治疗的可行性; 2）开发妇科粘连的手术粘连模型，该模型具有良好的临床终点指标;并确定NM 2040预防输卵管粘连的疗效。我们的最终目标是开发一种有效的FDA批准的防粘连装置，用于背部和腹部手术。

DESCRIPTION (provided by applicant): Postoperative adhesion formation is the single greatest complication of surgery. Twenty seven million surgical procedures are performed annually in the U.S. where the patient is at risk for the complications from surgical adhesions. After surgery, fibrous adhesions form in the peritoneum, central nervous system, pericardium, pleura and synovium. Fibrous adhesion that develop after surgery cause complications that markedly increase healthcare costs due to increased rates of re-operation, postoperative bowel obstruction, infertility, and chronic pain. Despite the need for anti-adhesive treatments, there are currently no FDA approved prevention devices that effectively prevent surgical adhesions following spinal and laparoscopic surgery. One obstacle to gaining FDA approval for therapies targeting prevention of adhesions has been the lack of good clinical endpoint measures to assess treatment efficacy. NovelMed has developed a novel synthetic carbohydrate, NM2040, based on a previous synthetic anionic carbohydrate, ADCON, which despite successfully inhibiting adhesions, and had reports of significant side-effects. NovelMed recently discovered that ADCON is toxic to platelets. Given the critical role of platelets in hemostasis and wound healing, ADCON's side-effects could be linked to platelet toxicity. NM2040 was developed to overcome the toxic effects of ADCON on platelets. Preliminary findings indicate that this biocompatible conjugate can effectively inhibit surgical adhesions by preventing invasion and proliferation of cells associated with fibrosis development into the surgical site without platelet toxicity. The objectives of this application are 1) to test the feasibility of using NM2040 as a treatment to prevent surgical adhesions using a validated lumbar spine laminectomy model; 2) to develop a surgical adhesion model for gynecological adhesions for which good clinical endpoint measures are available; and to determine efficacy of NM2040 to prevent fallopian tube adhesions. Our ultimate goal is to develop an effective FDA approved anti-adhesion device for use in back and abdominal surgeries. PUBLIC HEALTH RELEVANCE: Postoperative adhesion formation is the single greatest complication of surgery. Twenty seven million surgical procedures are performed annually in the U.S. where the patient is at risk for complications that markedly increase healthcare costs due to increased rates of re-operation, postoperative bowel obstruction, infertility, and chronic pain. The objectives of this application are 1) to test the feasibility of using NM2040 as a treatment to prevent surgical adhesions using a validated lumbar spine laminectomy model; 2) to develop a surgical adhesion model for gynecological adhesions for which good clinical endpoint measures are available; and to determine efficacy of NM2040 to prevent fallopian tube adhesions. Our ultimate goal is to develop an effective FDA approved anti-adhesion device for use in back and abdominal surgeries.