MINIMALLY INVASIVE SYSTEMS WITH EXPANDABLE SUPPORT AND PROXIMAL OPENING FOR HEMOSTASIS IN A BLEEDING CLOSED TISSUE VOLUME
Disclosed herein are improved methods and apparatuses for providing hemostasis within a cavity defined by an internal surface of a bleeding tissue space. A catheter comprising a proximal end and a distal end may be advanced into the cavity through a proximal opening of the tissue space into the cavity. A distal balloon coupled to the catheter may be positioned adjacent a distal opening of the tissue space, and expanded to seal the distal opening. A hemostatic agent may be applied from the catheter to the internal surface of the tissue space to inhibit bleeding of the tissue space. The hemostatic agent may be applied without occluding the proximal opening, the distal opening, and a path extending therebetween with the hemostatic agent.
1 . An apparatus for providing hemostasis within a cavity defined by an internal surface of a bleeding tissue space, the apparatus comprising:
a catheter having a distal end and a proximal end, the catheter comprising a distal balloon inflation port near the distal end and a sealant infusion port at the proximal end;
a balloon adjacent the distal end of the catheter, the balloon fluidly coupled to the distal balloon inflation port; and
a sealant delivery port of the catheter proximally adjacent to the balloon, the sealant delivery port fluidly coupled to the sealant infusion port,
wherein the catheter is configured to be advanced into the cavity through a proximal opening of the tissue space,
wherein the tissue space comprises a prostatic capsule of a prostate, the proximal opening comprises an opening to a urethra, and the distal opening comprises a bladder neck between the prostate and a bladder, and wherein the balloon is sized and shaped to be advanced into the bladder and engage the bladder neck when expanded,
wherein the balloon is configured to be expanded near a distal opening of the tissue space to reversibly seal the distal opening, and
wherein the sealant delivery port is configured to deliver a sealant introduced into the catheter through the sealant infusion port to the cavity to inhibit bleeding of the tissue space.
2 . An apparatus as in claim 1 , wherein the apparatus is configured to prevent the sealant from occluding the distal opening, the proximal opening, and a path extending therebetween.
3 . An apparatus as in claim 1 , wherein the balloon comprises a distal balloon, wherein the catheter further comprises a proximal balloon inflation port at the proximal end, and wherein the apparatus further comprises a proximal balloon positioned proximally with respect to the distal balloon.
4 . An apparatus as in claim 3 , wherein the proximal balloon is configured to be expanded within the cavity to compress the sealant delivered to the cavity against the internal surface of the tissue space.
5 . An apparatus as in claim 3 , wherein the proximal balloon comprises a plurality of pores, wherein the sealant infusion port and the proximal balloon inflation port are the same port, and wherein the sealant introduced into the catheter is delivered to the proximal balloon to expand the proximal balloon and to subsequently enter the cavity through the plurality of pores of the proximal balloon.
6 . An apparatus as in claim 3 , wherein the proximal balloon is configured to be expanded near a proximal opening of the tissue space to seal the proximal opening, and wherein the sealant delivery port is positioned distally with respect to the proximal balloon to deliver the sealant in the cavity between the sealed distal opening and the sealed proximal opening.
7 . An apparatus as in claim 3 , further comprising an actuation mechanism coupled to the proximal balloon, the actuation mechanism configured to move the proximal balloon, in an expanded configuration, along a longitudinal axis of the catheter between the proximal opening and the distal opening to spread the sealant over the internal surface of the tissue space.
8 . An apparatus as in claim 3 , further comprising a sealant scaffold disposed over at least a portion of an external surface of the proximal balloon, wherein the proximal balloon is configured to be expanded with the cavity thereby expanding and compressing the sealant scaffold against the internal surface of the tissue space.
9 . An apparatus as in claim 1 , wherein the catheter further comprises a sealant overflow port distally adjacent the sealant delivery port, the sealant overflow port configured to remove excess sealant from the cavity.
10 . An apparatus as in claim 1 , wherein the catheter further comprises an aspiration port near the distal end, the aspiration port configured to remove resected tissue and fluids from the cavity.
11 . An apparatus as in claim 1 , wherein the catheter further comprises an insufflation port near the distal end, the insufflation port configured to insufflate the cavity to a predetermined profile.
12 . An apparatus as in claim 11 , wherein the catheter comprises a delivery probe configured to deliver energy to the predetermined profile of the tissue space, and wherein the sealant delivery port is configured to deliver the sealant introduced into the catheter through the sealant infusion port to the predetermined profile of the tissue space.
13 . An apparatus as in claim 11 , wherein the delivery probe is configured to deliver the energy to the tissue space at a first flow rate to resect the tissue space and thereby create the cavity having the predetermined profile, and wherein the sealant delivery port is configured to deliver the sealant at a second flow rate lower than the first flow rate.
14 . An apparatus as in claim 13 , wherein the sealant scaffold is further disposed over at least a portion of an external surface of the distal balloon, wherein expansion of the distal balloon expands the sealant scaffold to compress the sealant scaffold against the internal surface of the tissue space near the distal opening.
15 . An apparatus as in claim 1 , wherein the distal balloon is in fluid communication with the proximal balloon, and wherein inflating the proximal balloon also inflates the distal balloon.
16 . An apparatus as in claim 1 , wherein the balloon is coated with a hemostatic agent.