Bipolar probe with an injection needle

A surgical system including a bipolar generator having a first electrical connection and a second electrical connection, a needle, the needle being formed from a first electrically conductive material and electrically connected to the first electrical connection, and a conductor coaxially disposed over the needle, the conductor being formed from a second electrically conductive material and electrically connected to the second electrical connection, wherein the needle is electrically isolated from the conductor.

FIELD OF THE INVENTION

The present application relates to medical devices and methods and, more particularly, to medical devices and methods for treating tissue with electrical energy and/or an injectable agent.

BACKGROUND OF THE INVENTION

Non-variceal upper gastrointestinal (“GI”) bleeding typically refers blood loss originating at or proximal to the ligament of Treitz. Peptic ulcers have been identified as being a common cause of non-variceal upper GI bleeding. If left untreated, non-variceal upper GI bleeding may lead to anemia-like symptoms (e.g., fatigue, dizziness and chest pain), hepatic encephalopathy, hepatorenal syndrome, shock and death.

Successful treatment of non-variceal upper GI bleeding typically includes addressing the cause of the bleeding and ultimately haemostasis. For example, peptic ulcers may be associated with an infection ofHelicobacter pyloriand, therefore, may require treatment with antibiotics or the like to eradicate the infection and prevent re-bleeding. Haemostasis may be achieved by invasive surgery or by various less invasive endoscopic techniques, such as laser treatment, multipolar electrocautery, heat probing or injections with epinephrine.

While prior art endoscopic haemostasis techniques have presented some success, the re-bleed rate associated with such techniques remains relatively high. For example, the use of electrocautery to stop upper GI bleed often creates a relatively large treated zone on and around the bleeding site, thereby increasing the risk of re-bleeding.

Accordingly, there is a need for an improved apparatus and method for stopping the bleeding and reducing the re-bleeding associated with non-variceal upper GI bleeding.

SUMMARY OF THE INVENTION

In one aspect, a surgical system includes a bipolar generator having a first electrical connection and a second electrical connection, a needle, the needle being formed from a first electrically conductive material and electrically connected to the first electrical connection, and a conductor coaxially disposed over the needle, the conductor being formed from a second electrically conductive material and electrically connected to the second electrical connection, wherein the needle is electrically isolated from the conductor.

In another aspect, a surgical system includes a source of bipolar electrical energy, the source including a first electrical connection and a second electrical connection, a needle defining an internal passageway therein, the needle being formed from a first electrically conductive material and electrically connected to the first electrical connection, a conductor coaxially disposed over the needle, the conductor being formed from a second electrically conductive material and electrically connected to the second electrical connection, and an injectable agent disposed within the internal passageway, wherein the needle is electrically isolated from the conductor.

In another aspect, a method for treating a target tissue with a bipolar device includes positioning a conductor coaxially around a needle such that the needle is electrically isolated from the conductor, wherein a penetrating tip portion of the needle extends distally beyond the conductor, inserting the penetrating tip portion into the target tissue and electrically connecting the needle and the conductor to a source of bipolar electrical energy such that electrical energy flows through the needle and the conductor.

Other aspects of the disclosed bipolar apparatus and methods will become apparent from the following description, the accompanying drawings and the appended claims.

DETAILED DESCRIPTION OF THE INVENTION

Referring toFIG. 1, one aspect of the disclosed bipolar device, generally designated100, may include a working end102, an elongated shaft104, a handle assembly106, which may include a base portion108and an actuator110, such as a plunger or trigger, and two electrode wires112,114extending from the base portion108for connecting the device100to a bipolar generator or other source of bipolar electrical energy116(FIG. 5). The shaft104may be flexible and may mechanically connect the working end102to the handle assembly106. The entire device100may be sized and shaped to pass through a working channel117of an endoscope118(FIG. 5).

Referring toFIGS. 2-4, the working end102of the device100may include an injection needle120and a coaxial conductor122. The coaxial conductor122may be electrically isolated from and coaxially disposed over the needle120. In one aspect, the needle120may extend distally a predetermined distance D beyond the distal most end123of the conductor122. Optionally, an insulator124may be disposed in the annular region between the needle120and the conductor122to facilitate electrical isolation of the needle120from the conductor122.

In one aspect, the needle120may be a syringe-type needle and may include a penetrating tip126(FIG. 3) and an internal passageway127(FIG. 4). For example, the needle120may be a 25 gauge syringe needle having a 0.5 mm outer diameter. In one aspect, the needle120may be formed from an electrically conductive material, such as surgical grade stainless steel, and may be electrically connected to the bipolar generator116by way of the electrode wire112such that the needle120may function as a first electrode of the bipolar device100.

In one aspect, the needle120may be coupled to the plunger portion110of the handle106such that, when the plunger portion110is urged in the direction shown by arrow A, an injectable agent128disposed within the internal passageway127of the needle120may be ejected from the needle120through the tip126. Therefore, in one aspect, the needle120may function as a syringe.

The injectable agent128may be a sclerosing agent, such as alcohol, epinephrin or the like. However, those skilled in the art will appreciate that the needle120may be used to inject various substances and materials, such as analgesics, antibiotics, tissue markers or the like.

As shown inFIGS. 2 and 3, in one aspect, the coaxial conductor122may be shaped as a coil spring to allow the working end102of the device to flex as is passes through the working channel117of an endoscope118. In another aspect, the coil spring shape of the conductor122may facilitate articulation of the working end102of the device100in response to user commands and/or inputs. Alternatively, the conductor122may be a continuous structure, such as a continuous cylindrical structure, disposed axially around the needle120.

The conductor122may be formed from an electrically conductive material, such as surgical grade stainless steel, and may be electrically connected to the bipolar generator116(FIG. 5) by way of the electrode wire114such that the conductor122may function as a second electrode of the bipolar device100.

The insulator124may be formed from any electrically insulating material, such as a biocompatible polymer material, a surgical rubber or the like. In one aspect, the insulator124may extend approximately the entire length of the needle120and/or the conductor122. In another aspect, the insulator124may be disposed adjacent to the tip126of the needle120.

Reference will now be made toFIG. 6, which is a finite element model of one aspect of the bipolar device100described herein applying bipolar electrical energy to tissue130. As shown inFIG. 6, the bipolar electrical energy may be directed below the surface of the tissue130and the heating that occurs as a result of the bipolar electrical energy may be confined to within the coaxial conductor122.

Thus, the device100may be applied to tissue130(FIG. 6) such that the tip126of the needle120may penetrate the tissue130(e.g., the penetration may correspond to distance D of the tip126) and the conductor122may abut the surface of the tissue130. Therefore, when the bipolar energy is applied (e.g., about 20 to about 40 Watts for about 1 second), the energy may be confined to within the coaxial conductor122and may be applied below the surface of the tissue130(e.g., directly into a vessel), thereby limiting the amount of unnecessary tissue coagulation that occurs. Additionally, either simultaneously with or separately from the application of the electrical energy, the injectable agent128(e.g., a sclerosing agent) may be injected into the tissue130.

Accordingly, the apparatus, systems and methods described herein allow a physician to apply electrical energy and an injectable agent to a target tissue area, while limiting the amount of damage that occurs to adjacent tissue, thereby reducing the risk of re-bleeding and shortening the required healing time.

Although various aspects of the disclosed bipolar apparatus, system and method have been shown and described, modifications may occur to those skilled in the art upon reading the specification. The present application includes such modifications and is limited only by the scope of the claims.