Systems and methods for endoluminal device treatment
Various concepts relate to treatment systems for medical devices delivered into patients in medical procedures. The treatment system may include a proximal valve configured to receive the endoluminal device, an optional distal valve configured to receive the endoluminal device, and a treatment chamber configured to receive a portion of the endoluminal device.
1 . A treatment system comprising:
an endoluminal device having a sleeve extending about a body of the endoluminal device;
a proximal valve configured to receive the endoluminal device, the proximal valve including a proximal seal mechanism actuatable between a sealed state and an unsealed state to seal around the endoluminal device;
a distal valve configured to receive the endoluminal device, the distal valve including a distal seal mechanism actuatable between a sealed state and an unsealed state around the endoluminal device;
a sheath extending distally of the distal valve; and
a treatment chamber configured to receive a treatment portion of the endoluminal device that extends between the proximal valve and the distal valve such that a sleeve maintaining the treatment portion in a compacted, delivery state extends through a portion of the proximal valve and into the treatment chamber, the treatment chamber being fluidly coupled between the proximal valve and the distal valve to define a treatment space between the proximal valve and the distal valve,
wherein the treatment system defines a length including the proximal valve, the distal valve, the sheath and the treatment chamber, the treatment system further having an inner lumen extending along the length of the treatment system, and
wherein the proximal valve is sealable about the endoluminal device such that a treatment medium exits the treatment chamber through one or more gaps between the sleeve and the body of the endoluminal device and through the proximal valve when the proximal valve is closed about the endoluminal device.
2 . The system of claim 1 , wherein one or both of the proximal seal mechanism and the distal seal mechanism includes an outer tube, an inner tube, and a pressurizable space formed between an inner surface of the outer tube and an outer surface of the inner tube, and the pressurizable space being pressurizable to cause the inner tube to conform around the endoluminal device to form a seal around the endoluminal device.
3 . The system of claim 2 , wherein the inner tube is formed of a conformable material.
4 . The system of claim 3 , wherein the conformable material includes one or more of ePTFE (expanded polytetrafluoroethylene), silk, and Poly-paraphenylene terephthalamide.
5 . The system of claim 2 , wherein the outer tube is formed of an elastomeric material.
6 . The system of claim 5 , wherein the elastomeric material includes silicone.
7 . The system of claim 1 , wherein the treatment chamber has a proximal portion adjacent to the proximal valve, a distal portion adjacent to the distal valve, the system further comprising a proximal treatment port in fluid communication with the proximal portion of the treatment chamber and a distal treatment port in fluid communication with the distal portion of the treatment chamber.
8 . The system of claim 7 , wherein each of the proximal and distal treatment ports includes a valve for fluidly sealing and unsealing the proximal and distal treatment portions, respectively.
9 . The system of claim 1 , wherein the endoluminal device is a transcatheter delivery system including a catheter and an implantable device maintained at a compacted, delivery diameter or state, and further wherein the treatment chamber is configured to receive the implantable device at the compacted, delivery diameter or state.
10 . The system of claim 1 , wherein the endoluminal device is a transcatheter delivery system including a catheter and an implantable device maintained at a compacted, delivery diameter or state by the delivery catheter, and further wherein the treatment chamber is configured to receive the implantable device at an intermediate, partially expanded diameter that is greater than the compacted, delivery diameter.
11 . A method of treating an endoluminal device for introduction into a body of a patient, the method comprising:
positioning the endoluminal device into a treatment system, the treatment system including a proximal valve, a distal valve, and a treatment chamber defining a treatment space between the proximal valve and the distal valve, the endoluminal device including a first portion extending through the proximal valve, a second portion extending through the distal valve, and a treatment portion extending through the treatment space of the treatment chamber, wherein at least a portion of the first portion is maintained in a compacted delivery state by a sleeve, and the sleeve extends through at least a portion of the proximal valve and the proximal valve is closed over the sleeve;
closing the proximal and distal valves to seal the proximal valve against the first portion of the endoluminal device and the distal valve against the second portion of the endoluminal device; and
delivering a treatment medium into the treatment space to expose the treatment portion of the endoluminal device to the treatment medium, wherein the treatment medium exits the treatment chamber through one or more gaps between the sleeve and a body of the endoluminal device and through the proximal valve when the proximal valve is closed.
12 . The method of claim 11 , wherein the treatment portion of the endoluminal device includes an implantable device maintained by a delivery catheter.
13 . The method of claim 12 , wherein at least a portion of the second portion is maintained in the compacted delivery state by the sleeve and the distal valve is closed over the sleeve and the treatment medium exits the treatment chamber from the distal valve through one or more gaps between the sleeve and the implantable device.
14 . The method of claim 11 , wherein the treatment portion of the endoluminal device includes a proximal portion of an implantable device and a distal portion of the endoluminal device extends from the distal valve.
15 . The method of claim 11 , wherein the treatment medium is selected from one or more of saline, carbon dioxide, perfluorocarbon solution, methylene blue, and combinations thereof.
16 . The method of claim 11 , further comprising delivering the treatment medium into the treatment space through at least one of a proximal treatment portion in fluid communication with a proximal portion of the treatment chamber, and a distal treatment portion in fluid communication with a distal portion of the treatment chamber.
17 . The method of claim 11 , wherein the treatment medium exits the treatment chamber through a distal treatment port in fluid communication with a distal portion of the treatment chamber.
18 . The method of claim 11 , wherein the treatment system includes an introducer sheath, and the method further comprises inserting the introducer sheath into a body lumen of the patient.
19 . The method of claim 18 , wherein the treatment medium is delivered into the treatment space with the introducer sheath inserted into the body lumen of the patient.
20 . A method of treating an endoluminal device for introduction into a body of a patient, the method comprising:
positioning the endoluminal device into a treatment system, the endoluminal device having a distal end and the treatment system including a valve and a treatment chamber extending from the valve, the endoluminal device including a first portion extending through the valve and a treatment portion extending into the treatment space of the treatment chamber, the distal end of the endoluminal device being positioned within the treatment chamber such that a sleeve maintaining at least a portion of the endoluminal device in a compacted delivery state extends through a portion of the valve and into the treatment chamber;
closing the valve to seal the valve against the first portion of the endoluminal device including the sleeve;
sealing the treatment system when the distal end of the endoluminal device is within the treatment chamber; and
delivering a treatment medium into a treatment space within the treatment chamber to expose the treatment portion of the endoluminal device to the treatment medium, wherein the treatment medium exits the treatment chamber through one or more gaps between the sleeve and a body of the endoluminal device and through the valve when the valve is closed.
21 . The method of claim 20 , wherein the treatment system is sealed with a cap member.
22 . The method of claim 20 , further comprising adjusting a length of the treatment system.
23 . The method of claim 22 , wherein the treatment system is sealed digitally by a user.
24 . The method of claim 20 , wherein a portion of the treatment medium flows in a proximal direction out from the treatment system and past the valve when the valve is sealed.
25 . The method of claim 20 , wherein the treatment medium flows in a proximal direction out from the treatment system through at least one folds, creases, or gaps present in the endoluminal device.
26 . The method of claim 20 , wherein the endoluminal device includes an implantable device and a catheter coupled to the implantable device, wherein positioning the endoluminal device includes positioning the catheter such that a first portion of the catheter extends within the treatment chamber and a second portion of the catheter extends through the valve.
27 . A treatment system for an endoluminal device comprising:
a valve configured to receive at least a portion of the endoluminal device; and
a treatment chamber extending from the valve and including a treatment space containing a treatment medium, the treatment chamber configured to receive a treatment portion of the endoluminal device such that a sleeve maintaining the treatment portion in a compacted, delivery state extends through a portion of the valve and into the treatment chamber and is sealed to the valve,
wherein at least a portion of the treatment medium exits the lumen of the treatment chamber through one or more gaps between the sleeve and the endoluminal device and through the valve when the valve is closed.