Transluminal delivery devices and related kits and methods
Prosthesis deployment devices are disclosed herein. In some embodiments, the prosthesis deployment device comprises an elongate delivery catheter assembly configured for electrosurgery and also configured to retain and deploy a prosthesis. Kits comprising the prosthesis deployment devices with a prosthesis loaded into a prosthesis pod of the device are disclosed herein as well as methods of using the prosthesis deployment devices.
1 . A method of deploying a prosthesis in a patient, the method comprising:
introducing a delivery catheter assembly into a working channel of an echoendoscope, wherein the delivery catheter assembly comprises: an outer sheath; a prosthesis loaded into a prosthesis pod region of the outer sheath, wherein the prosthesis has a proximal end and a distal end; and at least one marker visible on the outer sheath to indicate a position of the delivery catheter for deployment of the prosthesis;
inserting with one-hand the prosthesis pod region at least partially into a target structure through an access port in the target structure;
ascertaining the position of the delivery catheter including the prosthesis relative to the target structure by visually observing the at least one marker before deployment of the prosthesis; and
after ascertaining the position of the delivery catheter relative to the target structure of the prosthesis by visually observing the at least one marker, actuating with the same one-hand an actuator of a housing assembly operably connected to the delivery catheter assembly to deploy the prosthesis with the distal end of the prosthesis within the target structure and the proximal end of the prosthesis outside the target structure, wherein actuating comprises depressing the actuator one or more times to deploy the prosthesis.
2 . The method of claim 1 , wherein inserting the prosthesis pod region comprises creating the access port in the target structure.
3 . The method of claim 2 , wherein the delivery catheter assembly further comprises a tip electrode, and creating the access port comprises:
energizing the tip electrode;
pushing with the same one-hand the tip electrode into the target structure; and
de-energizing the tip electrode after penetrating the target structure.
4 . The method of claim 1 , wherein ascertaining the position of the delivery catheter including the prosthesis comprises observing the at least one marker endoscopically or fluoroscopically.
5 . The method of claim 1 , further comprising engaging with the same one-hand a safety button on the housing assembly, prior to actuating with the same one-hand the actuator to deploy the prosthesis.
6 . The method of claim 1 , further comprising coupling the delivery catheter assembly with the working channel of the echoendoscope via a rotatable luer lock adapter.
7 . The method of claim 1 , wherein introducing the delivery catheter assembly comprises sliding the delivery catheter assembly over a guidewire inserted into the working channel of the echoendoscope.
8 . The method of claim 1 , wherein the proximal end and the distal end of the prosthesis each comprises a flare that is situated outside the access port when the prosthesis is deployed.
9 . The method of claim 1 , wherein the housing assembly comprises a slide assembly, and further comprising adjusting a position of the delivery catheter assembly relative to the echoendoscope while visually observing the at least one marker.
10 . The method of claim 1 , wherein a first marker of the at least one marker indicates a position of the proximal end of the prosthesis.
11 . A method for draining a first lumen of a patient into a second lumen of the patient, comprising:
inserting a delivery catheter assembly into a working channel of an echoendoscope, wherein the delivery catheter assembly comprises: an outer sheath; a prosthesis loaded into the outer sheath in a prosthesis pod region having a proximal end and a distal end; and at least one marker visible on the outer sheath to indicate a position of the delivery catheter for deployment of the prosthesis;
advancing a tip of the delivery catheter assembly into the first lumen within the patient, wherein the first lumen has a first lumen wall;
pushing with one-hand the tip of the delivery catheter assembly and at least the distal end of the prosthesis pod region through the first lumen wall and into the second lumen;
confirming the position of the delivery catheter including the prosthesis pod region relative to the first lumen wall by visually observing the at least one marker before deployment of the prosthesis;
adjusting with the same one-hand a position of the delivery catheter assembly so that the proximal end of the prosthesis pod region is in the first lumen and the distal end of the prosthesis pod region is in the second lumen; and
after visually observing the at least one marker, actuating with the same one-hand an actuator of a housing assembly operably connected to the delivery catheter assembly and thereby deploying the prosthesis, wherein actuating comprises depressing the actuator a plurality of times to deploy the prosthesis.
12 . The method of claim 11 , wherein the tip comprises an electrode and further comprising energizing the electrode prior to pushing the tip through the first lumen wall and then de-energizing the electrode after penetrating the second lumen.
13 . The method of claim 11 , wherein confirming the position of the delivery catheter including the prosthesis pod region comprises observing the at least one marker endoscopically or fluoroscopically.
14 . The method of claim 11 , further comprising engaging with the same one-hand a safety button on the housing assembly, prior to actuating with the same one-hand the actuator to deploy the prosthesis.
15 . The method of claim 11 , wherein the first lumen is a gastrointestinal tract of the patient.
16 . The method of claim 11 , wherein the second lumen is a gallbladder, a biliary tract, a pancreatic cyst, or a pancreatic pseudocyst in the patient.
17 . The method of claim 11 , further comprising coupling the delivery catheter assembly with the working channel of the echoendoscope prior to pushing the tip through the first lumen wall.
18 . The method of claim 11 , wherein the proximal end and the distal end of the prosthesis comprises a flared proximal end and a flared distal end that are situated within the first lumen and the second lumen, respectively, upon deployment of the prosthesis.
19 . The method of claim 11 , wherein a first marker of the at least one marker indicates a position of the proximal end of the prosthesis rod region.
20 . A prosthesis deployment device comprising:
an elongate delivery catheter assembly configured for electrosurgery and also configured to retain and deploy a prosthesis, and comprising: an outer sheath; a prosthesis pod region within the outer sheath configured to receive the prosthesis in elongated form; and at least one marker visible on the outer sheath and configured to provide visibility of the outer sheath including prosthesis pod region to a user before deployment of the prosthesis;
a housing assembly operably coupled to the delivery catheter assembly and configured to connect to an electrosurgical power generator, wherein the housing assembly comprises an actuator configured to displace a portion of the delivery catheter assembly to deploy the prosthesis, upon actuation, wherein the actuator is configured for one-handed operation, wherein the actuator is configured to be depressed and pivot upon actuation, and wherein the actuator returns to its unpivoted position when the actuator is no longer depressed.