US 12,213,673 B2
Systems and methods for introducing and monitoring a negative pressure device for protecting an intestinal anastomosis
Michael J. Augelli, Avon, CT (US); and Daniel Congdon, Somerville, MA (US)
Assigned to SafeHeal SAS, Paris (FR)
Filed by SafeHeal SAS, Paris (FR)
Filed on Mar. 15, 2024, as Appl. No. 18/607,051.
Claims priority of provisional application 63/589,965, filed on Oct. 12, 2023.
Claims priority of provisional application 63/589,973, filed on Oct. 12, 2023.
Claims priority of provisional application 63/490,847, filed on Mar. 17, 2023.
Claims priority of application No. 23305367 (EP), filed on Mar. 17, 2023.
Prior Publication US 2024/0307061 A1, Sep. 19, 2024
Int. Cl. A61B 17/11 (2006.01); A61B 5/06 (2006.01); A61B 5/145 (2006.01); A61B 17/00 (2006.01); A61F 2/04 (2013.01); A61M 1/00 (2006.01)
CPC A61B 17/1114 (2013.01) [A61M 1/98 (2021.05); A61B 2017/00022 (2013.01); A61B 2017/00119 (2013.01); A61B 2017/00544 (2013.01); A61B 2017/00566 (2013.01); A61B 2017/00818 (2013.01); A61B 2017/00955 (2013.01); A61M 2205/3351 (2013.01)] 30 Claims
OG exemplary drawing
 
1. A system for monitoring a bypass device for protecting an intestinal anastomosis, the bypass device comprising a negative pressure chamber and configured to be implanted at a target location upstream of the intestinal anastomosis, the system comprising:
a pump;
one or more fluid inlet tubes each having a downstream end coupled to the pump and an upstream end having one or more pores in fluid communication with the negative pressure chamber of the bypass device;
one or more sensors configured to measure data indicative of pressure within the negative pressure chamber; and
a controller operatively coupled to the pump and the one or more sensors, the controller programmed with instructions configured to:
actuate the pump at predetermined pump parameters to evacuate fluid from the negative pressure chamber via the one or more fluid inlet tubes to generate a vacuum within the negative pressure chamber having a pressure within a predetermined pressure range, the vacuum sufficient to pull intestinal tissue toward the bypass device to anchor the bypass device at the target location upstream of the intestinal anastomosis;
compare the data indicative of the pressure within the negative pressure chamber received from the one or more sensors over time with the predetermined pressure range; and
adjust, if the pressure within the negative pressure chamber falls outside the predetermined pressure range, the predetermined pump parameters of the pump, such that the pump applies and maintains the vacuum within the predetermined pressure range within the negative pressure chamber.