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Internal Polymeric Vessel Occluder for Temporary Vascular Occlusion of the Kidney

用于暂时肾血管闭塞的内部聚合物血管封堵器

基本信息

批准号：
7327336
负责人：
Peter Nathan Madras
金额：
$ 9.98万
依托单位：
PLUROMED, INC.
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-09-18 至 2008-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7327336
关键词：
Ablation Anastomosis - action Animal Experiments Animals Aorta Applications Grants Arteries Back Biochemical Biocompatible Blood Blood Circulation Blood Vessels Blood Volume Blood flow Body Temperature Bypass Calcified Caliber Cannulas Chairperson Chronic Clinic Clinical Coagulation Process Development Devices Dissection Dose Drug Formulations Evaluation Event Excision Family suidae Gel Generations Goals Government Hemodialysis Hemorrhage Hemostatic function Ice Injection of therapeutic agent Intention Invasive Ischemia Kidney Lasers Lead Left Liquid substance Measurement Medical center Microscopic Needles Nephrectomy Nephrons Numbers Operating Rooms Operative Surgical Procedures Organ Pathology Patients Persons Phase Plague Polymers Postoperative Period Property Pump Puncture procedure Purpose Radiofrequency Interstitial Ablation Rate Renal Blood Flow Renal Mass Research Robotics Saline Side Site Small Business Funding Mechanisms Small Business Innovation Research Grant Solid Solutions Standards of Weights and Measures Surface Surgeon Surgical sutures Sus scrofa Syringes System Techniques Temperature Testing Thumb structure Time Tissues Transition Temperature Ultrasonography United States National Institutes of Health Urologic Surgical Procedures Urology Venous Viscosity Warm Ischemia Water Work Wound Healing abstracting base clinical application cold temperature design experience in vivo kidney vascular structure microwave electromagnetic radiation non-invasive system pressure prevent renal artery repaired research study size trend

项目摘要

DESCRIPTION (provided by applicant): Pluromed, Inc. NIH SBIR Phase I Grant Application Internal Polymeric Vessel Occluder for Temporary Vascular Occlusion of the Kidney During Partial Nephrectomy Project Summary/Abstract Nephron-sparing surgery has become more common for the treatment of renal masses. With increasing experience, the need to control intraoperative renal bleeding is increasingly significant. This need is amplified by the trend in urologic surgery towards robotic and minimally invasive techniques where visibility can be severely limited by even small volumes of blood. As a result, many techniques have been developed to achieve hemostasis, including conventional suture repair, tissue sealants, radiofrequency ablation, laser ablation, water dissection, and microwave tissue coagulation. Pluromed has developed a biocompatible gel in which the blood vessel is filled with and occluded by the gel. The gel's working principle is based on the reverse thermosensitive properties of the polymer. At low temperatures, the polymeric solution is a liquid. As the temperature increases to body temperature, the viscosity of the solution rapidly increases several orders of magnitude to the consistency of a hard gel. Cooling the occlusion site, for example by applying ice, lowers the viscosity back to that of a liquid, dissolving the gel in blood and reestablishing blood flow. The gel has been developed for applications in anastomosis such as Off-Pump Bypass surgery (OPCAB), hemodialysis access, and tibial anastomosis. It has been shown to work very gently, neither compromising nor changing the biochemical make-up the arterial wall, as evidenced by measurements of the microvascular reactivity after filling and opening up the blood vessel. The proposal of this Phase I application is to apply the same principle to nephron-sparing surgery. In this approach, the renal artery leading to the diseased kidney is infused with the reverse thermosensitive gel. This has been shown to lead to cessation of blood flow within the renal parenchyma. It appears that, with the appropriate injection rate, the polymer flows downstream to occlude small, intra-renal vessels on both the arterial and venous sides of the circulation. This produces a completely bloodless surgical field, allowing speedy resection. After about 20 minutes the flow gradually resumes, with no apparent adverse consequences to the kidney. Return of blood flow may then be accelerated, if necessary, by cooling the kidney. Initial short-term in-vivo experiments indicate the feasibility of this approach. However, the polymer used in these preliminary experiments has a lower than optimal transition temperature for a solid organ. In a solid organ, such as the kidney, temperatures during the surgery may be higher than in exposed arteries where the company has greater experimental experience. A polymer solution with a higher transition temperature may be superior to the present formulation for solid organ applications. Furthermore, a more extensive animal study is needed to ascertain the relationship between rate/volume of injection and the expected downstream ischemic time. It is also necessary to develop an injection system that does not unduly increase the procedural time by requiring a long dissection of the artery or by requiring additional surgery to repair the artery at the injection site. Delineation of these parameters will allow for chronic animal experiments in Phase II and a clear path forward to subsequent clinical application with the declared involvement of Dr. John A. Libertino, Chairman of the Department of Urology at Lahey Clinic Medical Center. Pluromed, Inc. NIH SBIR Phase I Grant Application Internal Polymeric Vessel Occluder for Temporary Vascular Occlusion of the Kidney During Partial Nephrectomy

描述（由申请人提供）：Pluromed, Inc。美国国立卫生研究院SBIR第一期资助申请：用于部分肾切除术期间肾脏暂时性血管闭塞的内部聚合血管闭塞器项目摘要/摘要：保留肾脏的手术在治疗肾肿块中越来越常见。随着经验的增加，控制术中肾出血的必要性越来越重要。这种需求被泌尿外科向机器人和微创技术发展的趋势所放大，在这些技术中，即使是少量的血液也会严重限制能见度。因此，已经开发了许多技术来实现止血，包括传统的缝合修复、组织密封剂、射频消融、激光消融、水剥离和微波组织凝固。Pluromed开发了一种生物相容性凝胶，其中血管充满并被凝胶堵塞。凝胶的工作原理是基于聚合物的反向热敏特性。在低温下，聚合物溶液是液体。当温度升高到体温时，溶液的粘度迅速增加几个数量级，达到硬凝胶的稠度。冷却闭塞部位，例如用冰，降低粘度回到液体，溶解凝胶在血液中，重新建立血液流动。该凝胶已被开发用于吻合，如非泵旁路手术（OPCAB），血液透析通路和胫骨吻合。它的作用非常温和，既不会损害也不会改变动脉壁的生化组成，这一点可以通过填充和打开血管后微血管反应性的测量得到证明。这个I期应用的建议是将相同的原则应用于保留肾单元的手术。在这种方法中，通向病变肾脏的肾动脉被注入反向热敏凝胶。这已被证明会导致肾实质内血流停止。看起来，在适当的注射速率下，聚合物向下游流动，阻塞循环动脉和静脉两侧的肾内小血管。这产生了一个完全无血的手术区域，允许快速切除。大约20分钟后，血流逐渐恢复，对肾脏没有明显的不良后果。如果有必要，可以通过冷却肾脏来加速血液的回流。初步的短期体内实验表明了这种方法的可行性。然而，在这些初步实验中使用的聚合物具有低于固体器官的最佳转变温度。在固体器官中，如肾脏，手术过程中的温度可能高于暴露的动脉，而该公司有更多的实验经验。对于固体器官应用，具有更高转变温度的聚合物溶液可能优于本配方。此外，需要更广泛的动物研究来确定注射速率/体积与预期下游缺血时间之间的关系。开发一种注射系统也很有必要，这种注射系统不会因为需要长时间的动脉剥离或需要额外的手术来修复注射部位的动脉而过度增加手术时间。这些参数的描述将允许在II期进行慢性动物实验，并为随后的临床应用提供明确的路径，Lahey诊所医疗中心泌尿外科主任John a . Libertino博士宣布参与。Pluromed公司。美国国立卫生研究院SBIR一期拨款申请：用于部分肾切除术期间肾脏暂时性血管闭塞的内聚血管闭塞剂

项目成果

期刊论文数量（4）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Temporary segmental renal artery occlusion using reverse phase polymer for bloodless robotic partial nephrectomy.

使用反相聚合物进行临时肾动脉节段闭塞，用于机器人无血肾部分切除术。

DOI：
10.1016/j.juro.2009.06.009
发表时间：
2009
期刊：
The Journal of urology
影响因子：
0
作者：
Moinzadeh,Alireza;Flacke,Sebastian;Libertino,JohnA;Merhige,John;Vogel,Jean-Marie;Lyall,Katy;Bakal,CurtisW;Madras,PeterN
通讯作者：
Madras,PeterN

Temporary targeted hemostasis to facilitate bloodless partial nephrectomy.

临时定向止血以促进无血肾部分切除术。

DOI：
10.1016/j.urology.2011.07.1417
发表时间：
2011
期刊：
Urology
影响因子：
2.1
作者：
Harty,NiallJ;Moinzadeh,Alireza;Flacke,Sebastian;Pettit,Jeffrey;Benn,JamesA;Libertino,JohnA;Madras,PeterN
通讯作者：
Madras,PeterN

Temporary targeted renal blood flow interruption using a reverse thermosensitive polymer to facilitate bloodless partial nephrectomy: a swine survival study.

使用反向热敏聚合物临时靶向肾血流中断以促进无血部分肾切除术：一项猪生存研究。

DOI：
10.1111/j.1464-410x.2012.10967.x
发表时间：
2012
期刊：
BJU international
影响因子：
4.5
作者：
Harty,NiallJ;Laskey,DanielH;Moinzadeh,Alireza;Flacke,Sebastian;Benn,JamesA;Villani,Rosanna;Kalra,Aarti;Libertino,JohnA;Madras,PeterN
通讯作者：
Madras,PeterN