Patent Application
20150045787
The human body includes a number of internal body lumens, passageways, and cavities, many of which have an inner lining or layer. These inner layers can be susceptible to disease and damage. In some cases, this leads to bleeding that requires surgical intervention of targeted areas.
Surgeons make use of elongated medical devices such as catheters to navigate narrow passageways to a desired location to perform diagnostic and therapeutic procedures. Elongated medical devices can extend into a body from outside via an access point through various connected passageways to a target location. The elongated medical devices must meet a variety of requirements such as a desired length, a sufficiently small outer diameter to permit navigation of narrow body passageways, and sufficiently large inner diameter to permit delivery of the required functionality at the remote location. It is sometimes desired to perform electrosurgical procedures at the remote target location. In some cases, the target location is treated by balloon catheter dilation followed or accompanied by the application of electrical energy to perform the electrosurgical procedure. Heat cauterization is a commonly used hemostatic technique for bleeding wounds and can be accomplished through electrodes. Tissue is heated and coagulation is effected, which plugs the bleeding points and stops the bleeding.
Electrosurgical devices are configured for use with electrical energy, most commonly radio frequency (RF) energy, to cut tissue or to cauterize blood vessels by delivering electrosurgical energy to the tissue through the electrodes. With sufficiently high levels of electrical energy, the heat generated is sufficient to stop the bleeding from severed blood vessels. Current electrosurgical devices can cause the temperature of the tissue being treated to rise significantly higher than 100° Celsius, resulting is tissue desiccation, tissue sticking to the electrodes, tissue perforation, char formation and smoke generation. Peak tissue temperatures as a result of RF treatment of target tissue can be as high as 320° Celsius, and such high temperatures can be transmitted to adjacent tissue via thermal diffusion. Undesirable results of such transmission to adjacent tissue include unintended thermal damage to the tissue. Using saline coupled with RF electrical energy can help inhibit such undesirable effects. However, tissue desiccation and other undesirable results still occur when treatment of tissue occurs at temperatures exceeding 100° Celsius. Additionally, access and treatment of internal target locations can require multiple tools to support the cavity walls and perform electrosurgery and are not able to conform to a shape of a body cavity and contact the tissue to effectuate selective application of thermal energy to the tissue.
Aspects of the present disclosure relate to an electrosurgical device useful in internal surgery. The electrosurgical device includes an inner catheter, an outer catheter, a balloon, and a plurality of tubular electrodes. The inner catheter extends along a longitudinal axis. The outer catheter includes a first section and a second section each disposed around the inner catheter. The balloon is disposed around the inner catheter and extends between the first and second sections of the outer catheter. The balloon is a tubular member having an outside surface and the plurality of tubular electrodes extend along the longitudinal axis adjacent to the outside surface of the balloon.
Other aspects in accordance with principles of the present disclosure relate to an electrosurgical device useful in internal surgery. The device includes an inner catheter, a balloon, an outer catheter, and a plurality of electrodes. The inner catheter extends along a longitudinal axis. The balloon has opposing first and second ends and an inflatable portion extending between the opposing first and second ends. The balloon is disposed around the inner catheter. The outer catheter is disposed around the inner catheter and has a first section and a second section extending in opposite directions from the balloon. Each of the plurality of electrodes extends from the first section, across the inflatable portion of the balloon, and through the second section.
Other aspects in accordance with principles of the present disclosure relate to a method of performing electrosurgery on a patient. The method includes receiving an electrosurgical device configured for accessing an internal target site of the patient. The electrosurgical device includes an inner catheter, an outer catheter, a balloon, and a plurality of electrodes. The inner catheter extends along a longitudinal axis and includes a leading end. The outer catheter includes a first section and a second section each disposed around the inner catheter. The balloon is disposed around the inner catheter and extends between the first and second sections of the outer catheter. The plurality of electrodes extends parallel to the longitudinal axis and includes fluid ports positioned alongside the balloon. The method includes inserting the leading end into the patient's passageway and maneuvering the electrosurgical device along an internal passageway to position the balloon at a target site and inflating the balloon. Saline is injected into the electrodes to be dispensed from the fluid ports of the plurality of electrodes. At least a subset of the plurality electrodes is electrically energized.
One embodiment of a surgical system 10 in accordance with principles of the present disclosure is illustrated in
With the above in mind, perspective views of a tip portion of the electrosurgical device 100, in accordance with principles of the present disclosure, are shown in
In general terms, the device 100 includes an inner catheter 102, an outer catheter 104, a plurality of electrodes 106, and a balloon 108. The outer catheter 104 includes a first section 110 and a second section 112. In one embodiment, a conical or dome shaped introducer 118 is attached at a distal end 120 of the first section 110. The introducer 118 provides for smooth insertion of the device 100 into the patient's body cavity or passageway.
With further reference to
The balloon 108, or inflation member, is disposed around the inner catheter 102. In one embodiment, the balloon 108 is a tubular member. The balloon 108 is generally characterized as being more readily expandable than the inner catheter 102 or the outer catheter 104. The balloon 108 is can be formed of a variety of semi-compliant materials such as nylon, nylon derivatives, Pebax, polyurethane, or PET, for example. The balloon 108 is attached to the inner catheter 102 at a desired location or locations. In one embodiment, the balloon 108 is positioned proximal to the introducer 118. Alternatively, the balloon 108 can be positioned anywhere along the length of the inner catheter 102 or even in multiple locations along the inner catheter 102. The balloon 108 is mechanically or thermally attached and sealed to an outer surface 128 of the inner catheter 102 as indicated by a seal 134 at each of the opposing ends 130, 132 of the balloon 108. In one embodiment, the opposing ends 130, 132 are sealably attached to the inner catheter 102 with adhesive. The seal 134 is selected to be compatible with the materials of the inner catheter 102 and the balloon 108.
The balloon 108 is positioned along the inner catheter 102 such that an inflatable portion 136, extending between the opposing ends 130, 132, is free to inflate and deflate. When fully assembled, the inflatable portion 136 extends over the port 126 of the inner catheter 102. The balloon 108 has an outer surface 138. With additional reference to
Returning to
The inner and outer catheters 102, 104 are typically made of an electrically non-conductive material such as plastic or rubber. The inner catheter 102 and the plurality of electrodes 106 extend fully through the second section 112 and at least partially through first section 110 of the outer catheter 104. In some embodiments, the first section 110 terminates at the introducer 118 and the inner catheter 102 terminates at the leading end 122 within the introducer 118. Each of the plurality of electrodes 106 extends along the longitudinal axis 142 within a wall thickness formed between the inner and outer diameters of the outer catheter 104. The outer catheter 104 has a wall thickness between the inner diameter and an outer diameter that is sufficient to allow the electrodes 106 to pass within the wall and be electrically separated from each other. In one embodiment, the electrodes 106 are fixedly coupled to the first and second sections 110, 112 of the outer catheter 104. The electrodes 106 can be fixedly coupled to the outer catheter 104 with adhesive or other suitable means. Alternatively, the electrodes 106 are slidably disposed within lumens of the outer catheter 104 positioned around the main lumen to allow for longitudinal extension of the plurality of electrodes 106 disposed within the outer catheter 104, as discussed more below. The electrodes 106 can be slidably disposed within the first section 110, the second section 112, or both the first and second sections 110, 112.
The electrodes 106 are formed of elastic or shape memory material and have the ability to “remember” the shape given during original thermo-mechanical processing allowing the material to revert to the original shape when not extended beyond their elastic limit. The electrodes 106 are hypodermic tubing (i.e., hypotubes) made of spring tempered stainless steel, nickel-cobalt based alloy such as MP35 N or MP35 NLT, or nickel-titanium (nitinol) super elastic or shape memory, for example. Each electrode 106 is an elongated tubular member and includes a lumen 144 extending through the length of the electrode 106. The lumen 144 is fluidly coupled to the fluid source 50 (
The electrodes 106 are “weeping” electrodes in that the electrodes 106 include fluid ports 140 to dispense electrically charged fluid (e.g., saline). The fluid ports 140 can be either drilled or laser cut into the electrodes 106. The fluid ports 140 are formed along a length of the electrodes 106. When assembled, the fluid ports 140 are located alongside the balloon 108 between the first and second sections 110, 112 of the outer catheter 104. In one embodiment, the fluid ports 140 are facing radially outward relative to the balloon 108.
Each of the plurality of electrodes 106 extends from the first section 110, along the outer surface 138 of the balloon 108, and through the second section 112 of the outer catheter 104. The electrodes 106 extend along a longitudinal length of the inner catheter 102 and are arranged in a pattern about the circumference of the inner catheter 102. The electrodes 106 are spaced apart by a selected spacing and aligned along the longitudinal axis 142 of the inner catheter 102. With reference to the embodiments of
The balloon 108 can be non-compliant (i.e., a certain shape) or compliant (i.e., conforms to the shape of the shaped area exposed to).
The diameter of the electrodes 106, as well as the spacing between the electrodes 106, is suitable for providing hemostasis to the desired target area in which the device 100 is intended to be used. The spacing between the electrodes 106 determines the conveyance or non-conveyance of energy between electrodes 106. The spacing between the electrodes 106 is sufficiently close to allow conveyance of a given level of energy sufficient to cause hemostasis. The number of electrodes 106 is based, as least in part, on the size of the balloon 108 in the expanded state in order to have the desired spacing, and associated energy output, in the expanded state. The amount of energy to be delivered can also be a factor in the number and size of the electrodes 106. The energy transmitted to the electrodes 106 can be controlled to deliver a specific level of power to individual, a subset, or all of the electrodes 106.
With the above construction in mind, the plurality of electrodes 106 are configured to dispense saline, or other appropriate electrically conductive fluid, and deliver bipolar RF energy. In one embodiment, each of the electrodes 106 delivers an opposite energy to that of the immediately adjacent electrode. In other words, the plurality of electrodes 106 is bipolar with alternating electrodes 106 conducting either positive or negative current. For example, a positive current is delivered to the first and third electrodes 106a and 106c of
The delivery of energy along with saline by the electrodes 106 provides therapeutic treatment, such as hemostasis, to the tissue within a target area. Coagulation, shrinkage of tissue, or sealing may also occur. The target area could be, for example, a portion of the sinuses, cardiovascular system, or gastrointestinal tract. The method includes controlling the delivery of radiofrequency energy into tissue by controlling energy delivery across the surface area of tissue within the target area and controlling delivery into the depth of tissue within the target area such that some volume of vessels of the tissue ceases to bleed.
In some embodiments of the method, controlling the number of the electrodes 106 delivering radiofrequency energy and saline disbursement limits the portion of the target area that receives hemostasis. In other words, only a subset of the plurality of electrodes 106 may be employed in order to target a desired area. In this manner, only the electrodes 106 receiving energy and saline, and adjacent to a portion of the tissue target area, cause hemostasis. Thus, if only a subset of the plurality of electrodes 106 are employed, only the portion of tissue in the area of the subset of the electrodes 106, and not another portion of the tissue within the target area, is treated.
Electrosurgery methods in accordance with some embodiments of the present disclosure can entail the surgeon receiving a single electrosurgical device 100 or a set of electrosurgical devices. The set, or kit, includes two or more devices each sized, shaped, and configured for insertion, accessing, and treating a different internal region of a patient. The surgeon determines the appropriate site or sites for treatment. Identifying the site(s) can be by endoscopic or other visualization and diagnostic methods known in the industry. The surgeon evaluates the area to be treated, considering the amount of energy to be delivered, the energy density, the duration of time over which energy is to be delivered, and the surface area to be treated and then selects the appropriate electrosurgical device 100. In one aspect, evaluation includes identifying the locale of the treatment site, including its dimensions, the multiplicity of sites if there is more than one site, and further identifying their locale and respective dimensions.
With continued reference to
With the above construction in mind, use of the electrosurgical device 100 in treating internal bleeding of the patient entails coupling the device 100 electronically and fluidly to the instrument 20 which is electronically and fluidly coupled to the inflation device 30, the energy source 40, and the fluid source 50 of
Once connected, the device 100 can be inserted into the patient's body cavity or internal passageway and maneuvered to position the balloon 108 of the device 100 at the target site. With reference back to
With the configuration discussed above, the device 100 can be extended into the patient's respiratory or other bodily tract in which a catheter is passable. The surgeon inserts the device 100 by initially inserting the leading end 122 and corresponding distal end 120 of the device 100 into the body cavity or passageway with the balloon 108 in the deflated state and the plurality of electrodes 106 in a first position with the electrodes 106 extending generally parallel to the longitudinal axis 142 of the inner catheter 102. The device 100 is pushed through the passageway and maneuvered to position the balloon 108 at the target site for electrosurgically treating the target site. Operation of the electrosurgical device 100 with respect to use in the frontal sinus of a patient is described in greater detail below. It is to be understood, however, that principles of the present disclosure are similarly provided in electrosurgical devices configured to access other sinuses, the cardiovascular system, and the gastrointestinal tract, for example.
For example,
Upon placement of the device 100 at the target site and activation of the inflation device 30, the balloon 108 is inflated, as shown in
Once inflated, the energy source 40 and fluid source 50 illustrated in
The surgeon can evaluate the treatment site(s) to determine if further treatment is needed. If appropriate, the above steps are repeated for further treatment. When multiple target areas are to be treated, the method may include the positioning, moving, inflating, and transmitting energy and saline steps to another target area without removing the electrosurgical device 100 from the patient.
In some embodiments, the device 100 of the present disclosure is a relatively inexpensive and disposable surgical tool (e.g., suitable for one-time use). Alternatively, in other constructions, the device can incorporate various structural features (e.g., materials, seals, etc.) that facilitate surgically-safe cleaning and sterilization (e.g., autoclave sterilization) and are re-usable. The device 100 and the instrument 20 are releasably mounted to one another. With these constructions, following the electrosurgical procedure, the device 100 is disengaged from the instrument 20, the instrument 20 is sterilized, and a new device 100 is assembled to the instrument 20 and the electronic and fluid connections carried by and through the instrument 20.
As described above, the device 100 reduces the time and cost associated with patient recovery. The device provides both dilation and therapeutic electro-therapy in a single device and procedure. Placing and maintaining the device 100 in the desired position and providing positive contact with the selected tissue enhances treatment. The ability to provide therapeutic therapy at 100° C. reduces the opportunity to damage the balloon 108 and undesired results to the target tissue and surrounding tissue.
Although the present disclosure has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes can be made in form and detail without departing from the spirit and scope of the present disclosure.
