Dialysis catheters with integrated fluid status sensing and related systems and methods
A dialysis catheter with an elongate body has a distal end defining blood removal and return ports communicating with internal blood removal and return lumens extending through the elongate body. A sensing pathway is disposed in or on the elongate body. A vascular dimension sensor is provided to dynamically measure changes in dimension of the SVC or IVC during dialysis. The sensor communicates with a control system and may be controlled or positioned via the communication pathway of the catheter body. Systems disclosed included integrated closed-loop treatment based on monitored vascular dimension input. Methods included patient optimized treatments incorporating treatment modulation based on dynamic vascular dimension monitoring.
1 . A dialysis catheter system, comprising:
an elongate body with a proximal end configured to be manipulated outside a patient's body and a distal end configured to extend into the patient's vasculature, the distal end defining blood removal and return ports communicating with internal blood removal and return lumens extending through the elongate body to the proximal end;
a sensing pathway disposed in or on the elongate body;
a sensor configured to dynamically measure changes in a diameter or area of the vessel, the sensor supported by the elongate body so as to be positioned in the SVC or IVC with the distal end blood removal and return ports positioned at a treatment location in the patient's vasculature, wherein the sensing pathway is configured to provide communication between the sensor and the proximal end of the elongate body;
a dialyzer communicating with the blood removal and return lumens;
at least one pressure gauge and at least one pump to control blood flow through the dialyzer; and
at least one processor and memory containing instructions for control of the dialyzer based on signals from the sensor received through the sensing pathway, and wherein the at least one processor communicates with the at least one pressure gauge and at least one pump to control a rate of dialysis treatment delivered by the dialyzer; and
one or more anchor means for anchoring at least one of the distal end of the elongate body or the sensor at a desired location in the SVC or IVC, the anchor means comprising a catheter hub at the proximal end of the elongate body configured to be positioned outside the patient's body and fixed relative to the patient's body, and a predetermined length and stiffness of the elongate body configured and dimensioned to position and maintain the distal end at the desired location in the SVC or IVC with the catheter hub.
2 . The dialysis catheter system of claim 1 , further comprising a retractable deployment sheath disposed around the elongate body.
3 . The dialysis catheter system of claim 1 , wherein the sensing pathway comprises a third lumen defined within the elongate body.
4 . The dialysis catheter system of claim 3 , further comprising an elongate control member wherein the sensor is disposed at a distal end of the elongate control member and the elongate control member is deployable through said third lumen.
5 . The dialysis catheter system of claim 1 , wherein the anchor means further comprises plural individual resilient members extending from an anchor support.
6 . The dialysis catheter system of claim 1 , wherein an anchor means further comprises at least one inflatable balloon member disposed on an anchor support, said at least one balloon defining passages for blood flow therethrough.
7 . The dialysis catheter system of claim 1 , wherein the elongate body comprises an anchor support for an anchor means and retraction of a retractable deployment sheath disposed around the elongate body at least in part deploys the anchor means.
8 . The dialysis catheter system of claim 1 , further comprising an elongate control member, and wherein
the sensing pathway comprises a third lumen defined within the elongate body;
the sensor is disposed at a distal end of the elongate control member and the elongate control member is deployable through said third lumen; and
the elongate control member comprises the anchor support and relative movement between the third lumen and the elongate control member at least in part deploy an anchor means.
9 . The dialysis catheter system of claim 8 , wherein the sensing pathway comprises at least one wire embedded in or disposed on a wall of the elongate body or a wall of the elongate control member.
10 . The dialysis catheter system of claim 1 , wherein at least one said sensor comprises one or more of an ultrasound sensor, an expandable and collapsible coil forming a resonant circuit, one or more strain gauges disposed between two extendable arms, an inflatable balloon, an impedance sensor comprising a series of electrodes disposed on a conductive framework configured to contact and expand and collapse with the vessel wall or a light sensor.
11 . The dialysis catheter system of claim 1 , wherein the elongate body comprises a peripheral outer wall divided by a central inner wall to form parallel blood return and removal lumens therein.
12 . A diagnostic and dialysis catheter system, comprising:
a dialysis catheter comprising:
an elongate body with a proximal end configured to be manipulated outside a patient's body and a distal end configured to extend into the patient's vasculature, the distal end defining blood removal and return ports communicating with internal blood removal and return lumens extending through the elongate body to the proximal end,
a sensing pathway disposed in or on the elongate body,
a sensor configured to dynamically measure changes in a diameter or area of the vessel, the sensor supported by the elongate body so as to be positioned in the SVC or IVC with the distal end blood removal and return ports positioned at a treatment location in the patient's vasculature, wherein the sensing pathway is configured to provide communication between the sensor and the proximal end of the elongate body,
a catheter hub disposed at the proximal end of the elongate body, the catheter hub configured to provide connection and communication for the blood removal and return lumens and the sensing pathway with a therapy system, and
a sheath hub disposed at the proximal end of the retractable deployment sheath, the sheath hub configured for actuation and manipulation of said sheath;
a system-side connector configured to mate with the catheter hub to form a hub assembly and provide fluid and electronic communication with the dialysis catheter;
a dialyzer communicating with the blood removal and return lumens through the hub assembly and at least one pressure gauge and pump to control blood flow through the dialyzer; and
at least one processor and memory containing instructions for control of the dialyzer based on signals from the sensor received through the sensing pathway and hub assembly indicative of patient fluid volume state, and wherein the at least one processor communicates with the at least one pressure gauge and pump to control a rate of dialysis treatment delivered by the system.