Device for Surgical Adhesion Prevention

描述（由申请人提供）：术后粘连形成是手术中最大的并发症。在美国，每年有2700万例外科手术，患者面临手术粘连并发症的风险。手术后，在腹膜、中枢神经系统、心包、胸膜和滑膜形成纤维粘连。术后纤维粘连引起并发症，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，显著增加了医疗费用。尽管需要抗粘连治疗，但目前还没有FDA批准的预防设备可以有效防止脊柱和腹腔镜手术后的手术粘连。获得FDA批准以预防粘连为目标的治疗的一个障碍是缺乏良好的临床终点措施来评估治疗效果。NovelMed在之前的阴离子碳水化合物ADCON的基础上开发了一种新的合成碳水化合物NM2040，尽管ADCON成功地抑制了粘连，但有报道称其有明显的副作用。NovelMed最近发现ADCON对血小板有毒性。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NM2040是为了克服ADCON对血小板的毒性作用。初步研究结果表明，这种生物相容性偶联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而有效地抑制手术粘连，而不会产生血小板毒性。本应用的目的是：1)通过验证腰椎椎板切除术模型，测试使用NM2040作为预防手术粘连的治疗方法的可行性；2)建立具有良好临床终点指标的妇科粘连的外科粘连模型；并确定NM2040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批准的抗粘连设备，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.