US-12622735-B2 - Systems and methods of an electrohemostatic renal sheath

US12622735B2US 12622735 B2US12622735 B2US 12622735B2US-12622735-B2

Abstract

Systems and methods directed to a renal sheath, one or more electrode pairs in the renal sheath, and a wiring system configured to connect the one or more electrode pairs to an electric current. The renal sheath can include a distal end portion, a proximal end portion, and a medial portion between the distal and proximal end portions. The medial portion can include the one or more electrode pairs. The one or more electrode pairs can be configured to produce heat sufficient to induce hemostasis in bleeding tissue surrounding the renal sheath. The wiring system can be configured to connect the one or more electrode pairs to the electric current to produce the heat sufficient to effect the hemostasis. In some embodiments, an electrosurgical generator can be configured to provide an alternating current to the one or more electrode pairs to produce the heat sufficient to effect the hemostasis.

Inventors

Abigail Wilms
Dahoney L. Swarns
Kevin Knollman
Morgan Rex

Assignees

C. R. BARD, INC.

Dates

Publication Date: 20260512
Application Date: 20180430

Claims (8)

1 . A system, comprising: a renal sheath including: a distal end portion, a proximal end portion, and a medial portion between the distal end portion and the proximal end portion, the renal sheath configured to provide a portal for kidney-stone fragmentation and retrieval during a percutaneous nephrolithotomy procedure; and one or more electrode pairs disposed in the medial portion of the renal sheath, the one or more electrode pairs designed to produce heat sufficient to induce hemostasis in bleeding tissue surrounding the renal sheath; a wiring system designed to connect the one or more electrode pairs to an electric current to produce the heat sufficient to induce the hemostasis; a needle configured to establish a needle tract from a back to a kidney of a patient; and a dilator configured to dilate the needle tract to establish a dilated tract, wherein a distal end of the renal sheath is beveled for atraumatic insertion of the renal sheath into the dilated tract over the dilator.
2 . The system according to claim 1 , further comprising an electrosurgical generator designed to provide an alternating electric current to the one or more electrode pairs to produce the heat sufficient to induce the hemostasis.
3 . The system according to claim 1 , wherein: the one or more electrode pairs are embedded in the renal sheath, each electrode pair of the one or more electrode pairs includes an active electrode and a return electrode, and the heat sufficient to induce the hemostasis is produced in circuit-completing bleeding tissue surrounding the renal sheath between the active electrode and the return electrode.
4 . The system according to claim 1 , wherein the wiring system includes a pair of wires at least partially disposed within a first wall of the renal sheath extending from a proximal end of the renal sheath to at least a first electrode pair of the one or more electrode pairs.
5 . The system according to claim 4 , further comprising a guidewire notch in the proximal end portion of the renal sheath, wherein the guidewire notch is in a second wall of the renal sheath opposite the first wall including the pair of wires.
6 . The system according to claim 1 , wherein the renal sheath includes poly(vinyl chloride) (“PVC”), polytetrafluoroethylene (“PTFE”), or a combination of PVC and PTFE.
7 . The system according to claim 1 , wherein the renal sheath includes transparent PVC and a non-transparent marker band for accurate insertion of the renal sheath into the dilated tract over the dilator.
8 . The system according to claim 1 , wherein the renal sheath is at least about 8 mm in diameter and 17 cm in length.

Description

CROSS-REFERENCE This application claims the benefit of priority of U.S. Provisional Application No. 62/500,382, filed May 2, 2017, which is hereby incorporated by reference in its entirety into this application. BACKGROUND Percutaneous nephrolithotomy (“PCNL”) is a minimally invasive surgical procedure primarily for removing kidney stones or other kidney obstructions from kidneys, wherein the stones or the other obstructions are either too large or too complex to be removed by other procedures. In a PCNL procedure, a puncture is made with a needle through a patient's back and into a kidney. Once a tract is established by the needle, the needle is replaced by a guidewire, a dilator is advanced over the guidewire to dilate the tract, and a renal sheath is advanced over the dilator. Removal of the dilator leaves the renal sheath, which provides a portal through which the PCNL procedure can be completed. However, the PCNL procedure is not without complications such as patient bleeding. As such, the PCNL procedure can benefit from mitigating or eliminating complications such as patient bleeding. Provided herein in some embodiments are systems and methods that address the foregoing, thereby reducing risk associated with the PCNL procedure. SUMMARY Provided herein, in some embodiments, is a system including a renal sheath, one or more electrode pairs in the renal sheath, and a wiring system configured to connect the one or more electrode pairs to an electric current. The renal sheath can include a distal end portion, a proximal end portion, and a medial portion between the distal and proximal end portions, the medial portion including the one or more electrode pairs disposed therein. The one or more electrode pairs can be configured to produce heat sufficient to induce hemostasis in bleeding tissue surrounding the renal sheath. The wiring system can be configured to connect the one or more electrode pairs to the electric current to produce the heat sufficient to effect the hemostasis. Also provided herein, in some embodiments, is a system including a renal sheath, one or more electrode pairs in the renal sheath, a wiring system configured to connect the one or more electrode pairs to an alternating electric current, and an electrosurgical generator configured to provide the alternating electric current. The renal sheath can include a distal end portion, a proximal end portion, and a medial portion between the distal and proximal end portions, the medial portion including the one or more electrode pairs disposed therein. The one or more electrode pairs can be configured to produce heat sufficient to induce hemostasis in bleeding tissue surrounding the renal sheath. The wiring system can be configured to connect the one or more electrode pairs to the electrosurgical generator-provided alternating electric current to produce the heat sufficient to effect the hemostasis. Also provided herein, in some embodiments, is a system including a renal sheath, at least two electrode pairs embedded in the renal sheath, and a wiring system configured to connect the at least two electrode pairs to an alternating electric current. The renal sheath can include a distal end portion, a proximal end portion, and a medial portion between the distal and proximal end portions, the medial portion including the at least two electrode pairs embedded therein. Each electrode pair of the at least two electrode pairs can include an active electrode and a return electrode. The at least two electrode pairs can be configured to produce heat sufficient to induce hemostasis in circuit-completing bleeding tissue surrounding the renal sheath between the active and return electrodes. The wiring system can be configured to connect the at least two electrode pairs to the alternating electric current to produce the heat sufficient to effect the hemostasis. The wiring system can include a pair of wires at least partially disposed within a wall of the renal sheath extending from a proximal end of the renal sheath to a first electrode pair of the at least two electrode pairs. The wiring system can further include an external cable including an external portion of the pair of wires extending from the proximal end of the renal sheath. The wiring system can further include a connector at a proximal end of the external cable opposite the renal sheath configured to connect the renal sheath to an electrosurgical generator. These and other features of the concepts provided herein may be better understood with reference to the drawings, description, and appended claims. DRAWINGS FIG. 1A provides a schematic illustrating a top view of a renal sheath with one or more electrode pairs in accordance with some embodiments. FIG. 1B provides a schematic illustrating a side view of a renal sheath with one or more electrode pairs in accordance with some embodiments. FIG. 2A provides a schematic illustrating a top view of a renal sheath with one or more electrode pairs in accor