Docket #: S21-127
An Organ Transplantation Facilitation Apparatus with an Incorporated Method of Temperature Regulation
Researchers at Stanford University have invented an applied temperature regulating medical device to maintain target preoperative and/or intraoperative organ temperatures for transplant procedures. Kidney transplant patients who develop delayed graft function (DGF) have shorter graft survival by an estimated 3–5-year half-life. During the second warm ischemia time period, kidney allograft warming to temperatures above threshold necrosis (15-18oC) is a key contributor to DGF. This warming can happen as early as 10 minutes into surgical anastomosis. Reducing the second warm ischemia time to less than 30 minutes reduces the risk of DGF by 3.5-fold. Researchers have invented a single piece medical apparatus, designed with the input of nearly 200 transplant surgeons and organ preservation specialists, that maximizes surface area coverage over which temperature regulation will be applied to the kidney or organ of interest. This apparatus reduces the rate of allograft kidney warming and maintains the temperature of the allograft at 4oC +/- 2oC for over 60 minutes. In addition, this device is easily removed following anastomosis, has a maximum thickness of 5mm, does not contain any tubing, tracks temperature, and records anastomosis time.
It is currently undergoing approval for FDA breakthrough designation.
Applications
- Medical cooling apparatus to be used by the transplant surgeon in preparation for implantation into the recipient
- Apparatus can be:
- used for open and minimally invasive or robotic-assisted transplantation surgeries
- applied to organ procurement and transportation to maintain at specific temperature range
- used for a range of solid organs or appendages: kidney, liver lung, heart, pancreas, hand, foot etc..
Advantages
- Eliminates the second warm ischemia time by using a unique combination of insulation to maintain the temperature of the allograft at 4oC +/- 2oC for at least 60 minutes with or without static cooling
- Easily removed after anastomosis
- Apparatus has grasping area, so surgeon does not have to physically hold the allograft throughout the duration of anastomosis
- There are no commercial products for this specific application during transplantation currently on the market
- Expands the donor pool by allowing for use of higher KDPI kidneys and DCD kidneys with a prolong first warm ischemia period
- The device may be used in conjunction with other cooling techniques or as an adjunct to existing organ preservation techniques during procurement and transport
Publications
- Related/Cited Publications:
- Kim, DW, Tsapepas, D, King, KL, et al. Financial impact of delayed graft function in kidney transplantation. Clin Transplant. 2020; 34:e14022.
- Kami?ska, D., Ko?cielska-Kasprzak, K., Chudoba, P. et al. The influence of warm ischemia elimination on kidney injury during transplantation – clinical and molecular study. Sci Rep 6, 36118 (2016).
- Heylen, L, Pirenne, J, Samuel, U, Tieken, I, Naesens, M, Sprangers, B & Jochmans, I. The Impact of Anastomosis Time During Kidney Transplantation on Graft Loss: A Eurotransplant Cohort Study. Am J Transplant 2017; 17: 724– 732
- Tennankore KK, Kim SJ, Alwayn IPJ, Kiberd BA. Prolonged warm ischemia time is associated with graft failure and mortality after kidney transplantation Clinical Investigation Vol. 89, Issue 3, P648-658 (2016).
Marketing
Three Abstracts about the device development and its health economic value have been accepted to the January 2022 American Society of Transplant Surgeons Winter meeting in Miami. Three other abstracts have been submitted to the American Transplant Congress:
- Addressing the Impact of Warming During Anastomosis: Using the Biodesign Process to Develop a Kidney Cooling Device
- Addressing the Organ Shortage and Reducing Delayed Graft Function: An Intra-operative Allograft Kidney Anastomosis Facilitation and Cooling Device
- Cost-Effectiveness and Clinical Effectiveness of an Intra-operative Renal Allograft Cooling Device
Also selected as a finalist in the Transplant Visionaries Challenge at the Cutting Edge of Transplantation Conference in February 2022.
Related Links
Patents
- Published Application: WO2022198090
- Published Application: 20240000067
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