Bipolar endoscopic device with parallel electrodes for endoluminal and transluminal haemostasis

[0001] The present application relates to medical devices and systems and, more particularly, to medical devices and systems for coagulating tissue with electrical energy.

[0002] Bleeding in the gastrointestinal (“GI”) tract may be associated with various ulcers, lesions, cancers and the like. For example, peptic ulcers in the upper GI tract have been identified as a common cause of GI bleeding. If left untreated, GI bleeding may lead to anemia-like symptoms (e.g., fatigue, dizziness and chest pain), hepatic encephalopathy, hepatorenal syndrome, shock and death.

[0003] Successful treatment of GI bleeding typically includes addressing the cause of the bleeding and/or haemostasis. For example, peptic ulcers may be associated with an infection of Helicobacter pylori and, therefore, may require treatment of the infection to reduce the risk of re-bleeding coupled with tissue coagulation to achieve haemostasis.

[0004] Haemostasis may be achieved by invasive surgery or by various less invasive endoscopic techniques, such as laser treatment, bipolar electrocautery, heat probing, injections with sclerosing agents (e.g., epinephrine) or application of mechanical clips. While prior art endoscopic haemostasis techniques have presented some success, physicians continue to seek improved techniques for achieving haemostasis, while reducing damage to tissue adjacent to the treated tissue.

[0005] Accordingly, there is a need for an improved apparatus and system for achieving haemostasis in the GI tract.

[0006] One aspect of the disclosed surgical device includes a shaft defining an axis and having a distal end and a proximal end, a first elongated electrode pivotally connected to the distal end of the shaft and deployable from a first configuration, wherein the first electrode is generally coaxially aligned with the axis, to a second configuration, wherein the first electrode is generally perpendicular relative to the axis, and a second elongated electrode pivotally connected to the distal end of the shaft and deployable from the first configuration, wherein the second electrode is generally coaxially aligned with the axis, to the second configuration, wherein the second electrode is generally perpendicular relative to the axis, wherein the first elongated electrode is adapted to extend radially relative to the second elongated electrode.

[0007] In another aspect, the disclosed surgical system includes a shaft defining an axis and including a first wire and a second wire extending therethrough, a source of electrical energy including a first electrical connection and a second electrical connection, the first wire being electrically connected to the first electrical connection and the second wire being electrically connected to the second electrical connection, a first elongated electrode pivotally connected to the shaft and deployable from a first configuration, wherein the first electrode is generally coaxially aligned with the axis, to a second configuration, wherein the first electrode is generally perpendicular relative to the axis, the first elongated electrode being electrically connected to the first wire, and a second elongated electrode pivotally connected to the shaft and deployable from the first configuration to the second configuration, the second elongated electrode being electrically connected to the second wire, wherein the first elongated electrode is moveable relative to the second elongated electrode to grasp tissue positioned therebetween.

[0008] Other aspects of the disclosed apparatus and system will become apparent from the following description, the accompanying drawings and the appended claims.

[0015] Referring to FIG. 1, one aspect of the disclosed bipolar device, generally designated 100, may include an elongated shaft 102 having a distal end 104 and a proximal end 106, a coagulation assembly 108 disposed at the distal end 104 of the shaft 102 and a handle assembly 110 disposed at the proximal end 106 of the shaft 102. The shaft 102 may be flexible and may mechanically connect the coagulation assembly 108 to the handle assembly 110. The shaft 102 and the coagulation assembly 108 may be sized and shaped to pass through a working channel 112 of an endoscope 114 (FIG. 6).

[0016] As shown in FIG. 2, one aspect of the handle assembly 110 may include a base portion 116 and an actuator 118. The actuator 118 may include an opening 130 sized to receiving a finger (not shown), such as a thumb, of a user and may be connected (e.g., mechanically) to the coagulation assembly 108 to actuate the coagulation assembly 108 in response to movement of the actuator 118. The base portion 116 may include a finger gripping portion 120 and an electrical connection portion 122 including a first electrode wire 124 and a second electrode wire 126. The electrode wires 126 may extend through the shaft 102 and, as shown in FIG. 6, may connect the device 100 to a source of electrical energy (e.g., a generator) 128, such as bipolar electrical energy. The finger gripping portion 120 may allow a user to securely grasp the base portion 116 of the device 100 with, for example, a middle finger and a forefinger, while a user manipulates the actuator 118 with a thumb.

[0017] Referring to FIGS. 3-5, the coagulation assembly 108 may include a first arm 132, a second arm 134, a first elongated electrode 136, a second elongated electrode 138, a pivot member 140 and an actuation cable 142. The first and second elongated electrodes 136, 138 may be positioned generally parallel with respect to each other and may be formed from an electrically conductive material, such as surgical grade stainless steel, copper, gold, silver of the like.

[0018] As shown in FIG. 5, the electrodes 136, 138 may have a length L that may be generally larger than the diameter or width W. If the electrodes 136, 138 are not circular in cross-section, then the width W may refer to the width of the electrodes 136, 138 as they lay on the tissue rather than the height of the electrodes 136, 138. In one aspect, the length L may be about 1 to about 20 times the width W. In another aspect, the length L may be about 4 to about 8 times the width W.

[0019] The first elongated electrode 136 may include a distal end 144 connected to the first electrode wire 124 and a proximal end 146 pivotally connected to the first arm 132 at a pivot point 148 (e.g., a swivel joint). The second elongated electrode 138 may include a distal end 150 connected to the second electrode wire 126 and a proximal end 152 pivotally connected to the second arm 134 at a pivot point 154 (e.g., a swivel joint).

[0020] Thus, the first and/or second elongated electrodes 136, 138 may be deployed from the first (i.e., un-deployed) configuration shown in FIG. 3, wherein the electrodes 136, 136 are generally axially aligned with an elongated axis E (FIG. 3) of the shaft 102, to the second (i.e., deployed) configuration shown in FIGS. 4 and 5, wherein the electrodes 136, 138 are generally perpendicular to the elongated axis E of the shaft 102. The elongated axis E may be generally straight or may be curvilinear in response to flexing of the shaft 102.

[0021] In one aspect, the electrodes 136, 138 may be deployed by retracting the associated electrode wires 124, 126 into the shaft 102 of the device (i.e., in the direction shown by arrow A in FIG. 5), such that the electrode wires 124, 126 function as actuation cables. In another aspect, actuation cables (other than electrode wires 124, 126) may be provided for deploying the electrodes. Furthermore, those skilled in the art will appreciate that various techniques and structural arrangements may be used to achieve deployment of the electrodes 136, 138 from the first configuration to the second configuration.

[0022] Referring to FIGS. 3-5 and, in particular, to FIG. 4, the second arm 134 may include a cam slot 162 and the pivot member 140 may include a first end portion 156, a second end portion 158 and a central portion 160. The first end portion 156 of the pivot member 140 may be pivotally connected to the first arm 132, the central portion 160 may be pivotally connected to the shaft 102 at a pivot point 164 and the second end portion 158 may include a pin (not shown) slidably engaged with the cam slot 162. The actuation cable 142 may be connected to the second end portion 158 of the pivot member 140.

[0023] Thus, when the actuation cable 142 is urged in the direction shown by arrow A (FIG. 5) by, for example, actuation of the actuator 118 on the handle portion 110 of the device 100, the pivot member 140 may pivot about the pivot point 164, thereby approximating the first arm 132 towards the second arm 134 in a grasping-type action. For example, FIG. 3 shows the arms 132, 134 in a closed (i.e., grasping) configuration and FIGS. 4 and 5 show the arms 132, 134 in an open configuration. Optionally, a spring or other biasing member (not shown) may be provided to bias the first arm 132 away from the second arm 134 (i.e., to the open configuration). The grasping-type action may be performed while the electrodes 136, 138 are in the deployed and/or the un-deployed configuration.

[0024] In one aspect, the size of each electrode 136, 138, including the length L and diameter or width W, and spacing between adjacent electrodes 136, 138 may be selected to provide an Ablation Index value of about 10 to about 30, as Ablation Index is defined in U.S. Pat. No. 6,918,906 to Long, the entire contents of which are incorporated herein by reference. In another aspect, the size and spacing of each electrode 136, 138 may be selected to provide an Ablation Index value of about 10 to about 15. In another aspect, the size and spacing of each electrode 136, 138 may be selected to provide an Ablation Index value of about 13.

[0025] At this point, those skilled in the art will appreciate that by controlling the Ablation Index value of the device 100, the area of bipolar coagulation achieved by the device 100 may be limited to the area between the two electrodes 136, 138 when the electrodes are in the deployed configuration, thereby limiting undesired tissue damage.

[0026] Accordingly, the device 100 may provide a user (e.g., a physician) with a surgical tool for applying mechanical tamponade (by way of the grasping-type action described herein) and bipolar electrical energy to target tissue using moveable, generally parallel electrodes. In one aspect, a user may apply bipolar electrical energy while simultaneously using the grasping-type action for mechanical tamponade, thereby providing improved haemostasis results. In another aspect, the user may adjust the size and area of tissue treatment as desired by adjusting the spacing between the electrodes 136, 138.

[0027] Although various aspects of the disclosed apparatus and system 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.