Pulsed field electroporation systems and methods
An improved system described herein can include an expandable member (e.g., to temporarily dilate a targeted tissue) equipped with one or more Pulsed Field Electroporation (PFE) electrodes configured to cause localized and targeted PFE output at the targeted tissue.
1 . A method comprising:
inserting an elongated shaft of a Pulsed Field Electroporation (PFE) delivery instrument into a nose site having targeted nasal tissue such that an adjustable PFE electrode of a treatment tip at a distal end of the PFE delivery instrument is adjacent to the targeted nasal tissue, wherein the elongated shaft defines an inflation lumen that extends through the elongated shaft across an entire axial length of the PFE electrode such that one or more distal sidewall fluid ports of the inflation lumen are located distally of a distal-most end of the PFE electrode;
adjusting the PFE electrode relative to the elongated shaft by delivering an inflation fluid through the inflation lumen that extends across the entire axial length of the PFE electrode so as to compress the PFE electrode against the targeted nasal tissue, the inflation fluid being delivered through said one or more distal sidewall fluid ports of the inflation lumen located distally of the distal-most end of the PFE electrode, through one or more proximal sidewall fluid ports of the inflation lumen located proximally of a proximal-most end of the PFE electrode, and through one or more intermediate sidewall fluid ports of the inflation lumen located between of the distal-most end of the PFE electrode and the proximal-most end of the PFE electrode, wherein the inflation lumen extends distally beyond said one or more distal sidewall fluid ports;
activating a PFE generator of a control console connected to the PFE delivery instrument to output, via a conductor connected to the PFE electrode, an electric field in a predefined pattern from the PFE electrode to induce at least one of irreversible electroporation (IRE) at the targeted nasal tissue and reversible electroporation (RE) at the targeted nasal tissue, wherein the conductor is located within a conductor lumen that extends through the elongated shaft to a conductor sidewall opening that is proximal to the PFE electrode, and wherein the conductor passes through the conductor sidewall opening and extends distally from the conductor sidewall opening and along a surface of the treatment tip to connect to the PFE electrode at a connection point, the conductor extending distally along the surface of the treatment tip between the conductor sidewall opening and the connection point, an entire length of the conductor between the sidewall opening and the connection point located radially outward of the surface of the treatment tip.
2 . The method of claim 1 , further comprising, in response to receiving a communication at the control console indicating that the PFE delivery instrument is authorized for use, adjusting the PFE generator from a disabled state to an enabled state.
3 . The method of claim 1 , wherein the PFE delivery instrument includes a handle, the elongated shaft extending distally from the handle, and the treatment tip at a distal end portion of the elongated shaft with a dilation balloon and the adjustable PFE electrode.
4 . The method of claim 3 , further comprising contemporaneously dilating the targeted nasal tissue while outputting PFE treatment from the PFE electrode compressed against the targeted nasal tissue.
5 . The method of claim 3 , wherein the PFE delivery instrument includes a unique identifier affixed to an exterior surface that is readable by the control console.
6 . The method of claim 5 , further comprising capturing the unique identifier using a user interface of the control console.
7 . The method of claim 6 , further comprising modifying characteristics of a PFE output from the PFE electrode in response to the control console detecting a type of the PFE delivery instrument from the captured unique identifier.
8 . The method of claim 3 , wherein the handle of the PFE delivery instrument includes a PFE activation button to selectively activate the PFE electrode to output PFE treatment.
9 . The method of claim 1 , further comprising delivering a fluid drug through at least one fluid drug delivery lumen of the elongated shaft in communication with at least one drug delivery port at the treatment tip of the PFE delivery instrument such that the treatment tip is contemporaneously delivers PFE treatment from the PFE electrode at the targeted nasal tissue and a fluid drug at the targeted nasal tissue, each fluid drug delivery lumen of the at least one fluid drug delivery lumen extending through the elongated shaft across an entire axial length of the PFE electrode, wherein each fluid drug delivery lumen of the at least one fluid drug delivery lumen comprises a fluid drug delivery sidewall opening located proximal to the one or more proximal sidewall fluid ports of the inflation lumen, the fluid drug delivery sidewall opening being in fluid communication with the at least one drug delivery port at the treatment tip of the PFE delivery instrument for said delivering the fluid drug.
10 . The method of claim 1 , wherein said inserting comprises inserting the elongated shaft of the PFE delivery instrument into the nose site, and the PFE delivery instrument comprises a nasal dilation instrument having a handle, the elongated shaft extending distally from the handle, and the treatment tip at a distal end portion of the elongated shaft with a dilation balloon and the adjustable PFE electrode.
11 . The method of claim 10 , wherein said adjusting the PFE electrode comprises inflating, by delivering the inflation fluid through the inflation lumen, the dilation balloon of the nasal dilation instrument so that the nasal tissue is dilated by the dilation balloon and the PFE electrode is compressed against the nasal tissue, the inflation lumen in fluid communication with the dilation balloon via the one or more distal sidewall fluid ports, the one or more intermediate sidewall fluid ports, and the one or more proximal sidewall fluid ports located inside of the dilation balloon, wherein at least a portion of the entire length of the conductor extending between the conductor sidewall opening and the connection point extends along a surface of the dilation balloon at a location radially outward of the dilation balloon, and wherein the conductor sidewall opening is proximal to the dilation balloon.
12 . The method of claim 11 , wherein said activating the PFE generator provides delivery of PFE from the treatment tip at the nasal tissue dilated by the dilation balloon.
13 . The method of claim 10 , wherein the control console is configured to receive a connector of the nasal dilation instrument, the PFE control console including a user interface display and the PFE generator configured to output the electric field in the predefined pattern from the PFE electrode via the conductor extending through the connector.
14 . The method of claim 13 , wherein the nasal dilation instrument includes a unique identifier affixed to the connector that is readable by the control console.
15 . The method of claim 14 , wherein the PFE generator is maintained in a disabled state and, in response to the control console capturing the unique identifier of the nasal dilation instrument to confirm the nasal dilation instrument is an authorized instrument, the control console adjusts the PFE generator into an enabled state.
16 . The method of claim 10 , wherein the handle of the nasal dilation instrument includes a PFE activation button to selectively activate the PFE electrode at the treatment tip of the nasal dilation instrument.
17 . The method of claim 10 , wherein the inflation lumen is in fluid communication with an interior of the dilation balloon via the one or more distal sidewall fluid ports, the one or more proximal sidewall fluid ports, and the one or more intermediate sidewall fluid ports, and wherein the method further comprises delivering, via a drug delivery sidewall opening of a fluid drug delivery lumen extending through the elongated shaft across an entire axial length of the PFE electrode, a fluid drug or agent to the nasal tissue from one or more pores in an outer balloon disposed outward from the dilation balloon, the drug delivery sidewall opening located proximal to the one or more proximal sidewall fluid ports of the inflation lumen, and the fluid drug delivery lumen in fluid communication with a space between the outer balloon and the dilation balloon via the drug delivery sidewall opening for said delivering the fluid drug or agent.
18 . The method of claim 17 , wherein the drug delivery sidewall opening is located proximal to the dilation balloon and distal to a location where a proximal end of the outer balloon attaches to the elongated shaft.
19 . The method of claim 10 , further comprising contemporaneously delivering a fluid drug or agent to the nasal tissue from at least one drug delivery port at the treatment tip of the dilation balloon while the electric field is output from the PFE electrode at the treatment tip of the dilation balloon.
20 . The method of claim 19 , wherein the elongated shaft includes at least one fluid drug delivery lumen in communication with the at least one drug delivery port at the treatment tip of the nasal dilation instrument such that the treatment tip is configured to contemporaneously dilate the nasal tissue, deliver PFE treatment from the PFE electrode at the nasal tissue, and deliver a fluid drug or agent to the nasal tissue, each fluid drug delivery lumen of the at least one fluid drug delivery lumen extending through the elongated shaft across an entire axial length of the PFE electrode.
21 . The method of claim 1 , wherein at every point along the entire length of the conductor between the sidewall opening and the connection point, the conductor represents the outward-most extent of the treatment tip at the distal end of the PFE delivery instrument.
22 . The method of claim 1 , wherein the inflation lumen comprises a greater number of intermediate sidewall fluid ports than proximal sidewall fluid ports, and wherein the inflation lumen comprises a greater number of intermediate sidewall fluid ports than distal sidewall fluid ports.
23 . The method of claim 1 , wherein the conductor sidewall opening is proximal to a most proximal one of the one or more proximal sidewall fluid ports.