BACKGROUND
Technical Field
The present disclosure relates to tissue dissectors and, more particularly, to percutaneously deployable tissue dissectors including an inflatable balloon at a distal end thereof configured to protect critical tissue structures.
Background of Related Art
During an electrosurgical procedure, e.g., a thermal ablation procedure, target tissue is heated to high temperatures, e.g., temperatures high enough to ablate tissue. Under certain surgical environments, it is sometimes necessary to protect critical tissue structures, e.g., organ, bone matter, etc. adjacent the target tissue from the heat associated with the thermal ablation procedure. To protect adjacent tissue, the adjacent tissue is typically dissected, covered, shielded or otherwise treated.
For example, one technique that is commonly utilized for protecting adjacent tissue structure during a thermal ablation procedure includes dissecting adjacent tissue by injecting a fluid, e.g., saline, CO2, D5W, etc., into a space between target tissue and the adjacent tissue. While this technique works well under certain surgical environments, this technique is limited, however, due to the difficulties in controlling the location of the fluid and difficulty in removing all the fluid from the body. In addition, and in the instance where the fluid is a gas, e.g., CO2, the CO2 often dissolves into the tissue, which requires the CO2 to be replenished (sometimes quite frequently) during a surgical procedure. As can be appreciated, having to replenish the CO2 during a surgical procedure may increase the length of time needed to effectively perform the surgical procedure.
SUMMARY
The present disclosure provides a tissue dissector configured for use during an electrosurgical procedure. The tissue dissector includes a cannula having a longitudinal channel with a longitudinal axis defined therethrough. The cannula has a notch defined along a length thereof. An introducer is coaxially coupleable to the cannula and movable therein from a retracted position to an extended position. The introducer including a generally annular lumen disposed in fluid communication with an inflation port operably disposed on the introducer and in fluid communication with an inflatable balloon that couples to the introducer. The inflatable balloon is movable from a deflated condition for positioning the introducer adjacent target tissue, to an inflated condition for separating the target tissue from nearby tissue and for providing a barrier therebetween such that the nearby tissue is not critically affected during the electrosurgical procedure.
The present disclosure provides a system for performing an electrosurgical procedure. The system includes a source of electrosurgical energy, an electrosurgical instrument that is adapted to operably couple to the source of electrosurgical energy and configured to electrosurgically treat tissue of interest and a tissue dissector. The tissue dissector includes a cannula having a longitudinal channel with a longitudinal axis defined therethrough. The cannula has a notch defined along a length thereof. An introducer is coaxially coupleable to the cannula and movable therein from a retracted position to an extended position. The introducer including a generally annular lumen disposed in fluid communication with an inflation port operably disposed on the introducer and in fluid communication with an inflatable balloon that couples to the introducer. The inflatable balloon is movable from a deflated condition for positioning the introducer adjacent target tissue, to an inflated condition for separating the target tissue from nearby tissue and for providing a barrier therebetween such that the nearby tissue is not critically affected during the electrosurgical procedure.
The present disclosure also provides a method for electrosurgically treating tissue. A step of the method includes positioning an introducer of a tissue dissector adjacent target tissue. Deploying a shaft from the introducer between the target tissue and nearby tissue is a step of the method. The method includes inflating an expandable balloon operably coupled to the introducer such that the nearby tissue separates from the target tissue. The expandable balloon may be segmented into two or more chambers that are sealed from one another by a divider membrane extending along the elongated shaft of the introducer. And, electrosurgically treating the target tissue is a step of the method.
BRIEF DESCRIPTION OF THE DRAWINGS
Embodiments of the presently disclosed tissue dissectors are described hereinbelow with reference to the drawings wherein:
FIG. 1 is a schematic view of a system for performing an electrosurgical procedure according to an embodiment of the present disclosure;
FIG. 2 is a cross-sectional view of a tissue dissector configured for use with the system depicted in FIG. 1;
FIG. 3 is a cross-sectional view of the tissue dissector depicted in FIG. 2 with an introducer in a deployed state;
FIG. 4 is an enlarged view of the area of detail depicted in FIG. 3;
FIGS. 5 is a cross-sectional view of a tissue dissector configured for use with the system depicted in FIG. 1 according to another embodiment of the present disclosure;
FIG. 6 is a cross-sectional view taken along the line segment 6-6 in FIG. 5; and
FIG. 7 is a cross-sectional view taken along the line segment 7-7 in FIG. 5.
DETAILED DESCRIPTION OF THE EMBODIMENTS
Detailed embodiments of the present disclosure are disclosed herein; however, the disclosed embodiments are merely examples of the disclosure, which may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.
In the drawings and in the descriptions that follow, the term “proximal,” as is traditional, will refer to an end of a surgical instrument that is closer to the user, while the term “distal” will refer to an end of a surgical instrument that is farther from the user.
Referring to FIG. 1, a system 100 for electrosurgically treating tissue is illustrated including a source of electrosurgical energy, e.g., an electrosurgical generator 2, an electrosurgical instrument, e.g., a microwave antenna assembly 4, a fluid source 3 and a tissue dissector 6. The system 100 may be configured to perform one or more electrosurgical procedures for treating tissue including, but not limited to, ablating, coagulating, and fulgurating tissue. For purposes herein, the system 100 is described in terms of tissue ablation.
With continued reference to FIG. 1, electrosurgical generator 2 is configured to generate electrosurgical energy suitable for ablating tissue. Microwave antenna assembly 4 is adapted to operably couple to the electrosurgical generator 2 and is configured to electrosurgically treat tissue of interest (hereinafter referred to as target tissue “T”). Examples of an electrosurgical generator 2 and microwave antenna assembly 4 are detailed in commonly-owned U.S. patent application Ser. No. 12/606,767 to Brannan, filed on Oct. 27, 2009.
Continuing with reference to FIG. 1, and with reference to FIGS. 2 and 3, an embodiment of the tissue dissector 6 is shown including a cannula 8 and an introducer 10. Cannula 8 (and operative components associated therewith) may be made from any suitable material including but not limited to plastic, surgical steel, etc. In the illustrated embodiment, cannula 8 is made from stainless steel.
Cannula 8 includes open proximal and distal ends 9 and 11, respectively (FIGS. 2 and 3). Open proximal end 9 is of suitable configuration to facilitate translation of the introducer 10 within the cannula 8 (FIG. 2). A flange 13 is disposed adjacent the proximal end 9 of the cannula 8 and functions as a handle for sliding the cannula 8 with respect to the introducer 10 (FIGS. 2 and 3). In certain embodiments, the flange 13 may include one or more components, e.g., hose clamp or the like (not shown), that serve to lock or otherwise maintain the cannula 8 and introducer 10 in a relatively fixed position with respect to one another.
Distal end 11 is configured to releasably couple to the introducer 10 to facilitate inserting the introducer 10 into tissue. More particularly, distal end 11 “overlaps” (FIG. 2) a distal tip 15 of the introducer 10 such that the distal tip 15 is maintained in a relatively fixed orientation with respect to the cannula 8 and is releasable therefrom when a predetermined pressure is applied to the cannula 8, e.g., flange 13, and/or introducer 10. In the illustrated embodiment, the distal end 11 and distal tip 15 of the introducer 10 releasably couple to one another via a friction-fit or press-fit. Other coupling methods are contemplated.
Cannula 8 includes a longitudinal channel 12 (FIGS. 2-4) having a longitudinal axis “A-A” defined therethrough. The channel 12 is configured to receive the introducer 10 therein (FIG. 2) such that the introducer 10 is movable, e.g., translatable and/or rotatable, therein from a retracted position (FIG. 2) to an extended position (FIG. 3).
A notch 14 (FIGS. 2 and 3) of suitable proportion is operably disposed on the cannula 8. The notch 14 is configured to movably house an inflation port 24 (FIGS. 2 and 3) of the introducer 10 therein, as described in more detail below. That is, the notch 14 allows translation of the inflation port 24 along the longitudinal axis “A-A” such that a distal end 19 including an inflatable balloon 22 of the introducer 10 may be deployed from the cannula 8.
With continued reference to FIGS. 2 and 3, the introducer 10 is illustrated. Introducer 10 (and operative components associated therewith) may be made from any suitable material, including those previously mentioned above. In the illustrated embodiments, a portion of the introducer 10 may be made from stainless steel and a portion of the introducer 10 may be made from plastic, as described in more detail below.
Introducer 10 includes a proximal end 16 that functions as a handle that is maneuverable by a user, e.g., a clinician, such that a user may position the introducer 10 within the lumen 12 of the cannula 8 (FIGS. 2 and 3). The proximal end 16 also serves as a “stop member.” That is, the proximal end 16 is configured to limit movement of the introducer 10 past a predetermined distance with respect to the cannula 8. To this end, the proximal end 16 is configured to contact the flange 13 of the cannula 8 (FIG. 3).
The introducer 10 includes a generally elongated configuration. In particular, introducer 10 includes a shaft 18 that extends from the proximal end 16 to the distal end 19, see FIGS. 2 and 3. The introducer 10 includes a generally cylindrical outer member 17 that couples to the shaft 18 adjacent the proximal end 16, see FIGS. 2 and 3. Outer member 17 is disposed around and partially along an elongated shaft 18. Outer member 17 and elongated shaft 18 are positioned about one another to form at least one generally annular lumen 20 therebetween, as best seen in FIG. 4. Outer member 17 may be an integral part of the introducer 10 or, in certain embodiments, outer member 17 may be a separate component coupled to the introducer 10 via one or more suitable coupling devices and/or methods, such as, for example, ultrasonic welding, brazing or the like. Outer member 17 may be made from any suitable material, including those previously mentioned above. In the illustrated embodiment, the outer member 17 is made from plastic, ceramic or metal (FIGS. 2-4).
The annular lumen 20 extends along the length of the outer member 17 to the inflatable balloon 22 (FIGS. 2-4). The annular lumen 20 is configured to receive one or more suitable fluids including gases, e.g., CO2, saline, water, etc. therein. The annular lumen 20 is in fluid communication with the inflation port 24 (FIGS. 2 and 3) and in fluid communication with the inflatable balloon 22, as best seen in FIG. 4.
A generally annular projection in the form of a ring 26 (FIGS. 2-4) is disposed on the elongated shaft 18 and is configured to engage the distal end 11 of the cannula 8 to maintain the introducer 10 in a relatively fixed position as the introducer 10 is positioned adjacent target tissue “T.” The ring 26 also serves as a point of fixation for the inflatable balloon 22, as described in more detail below.
Sharpened distal tip 15 is disposed at the distal end 19 adjacent the ring 26 and is configured to pierce tissue to facilitate positioning the tissue dissector 6 adjacent target tissue “T” (FIGS. 2-4). The distal tip 15 may include one or more beveled edges (not shown) that form a relatively sharpened peripheral outer edge. Under certain surgical scenarios, the sharpened distal tip 15 may be configured to temporarily secure to tissue, e.g., bone matter, for maintaining the introducer 10 in a substantially fixed orientation with respect to the cannula 8, such as, for example, when the cannula 8 is being “drawn back” or pulled to deploy the inflatable balloon 22. Alternatively, distal tip 15 may be rounded or dull to prevent unintentional tissue damage as the tissue dissector 6 is being positioned adjacent target tissue.
With reference again to FIGS. 2-4, inflatable balloon 22 is illustrated. Inflatable balloon 22 is configured to protect tissue adjacent or neighboring target tissue, e.g., tissue that is to be electrosurgically treated. More particularly, the inflatable balloon 22 is configured to limit or diminish electrosurgical energy, e.g., microwave field propagation, in addition to thermal conductivity such that neighboring tissue is not critically affected during an electrosurgical procedure. As can be appreciated, this enables aggressive thermal treatment of lesions near a surface of solid organs, e.g., kidney, liver, lungs, etc., with reduced risk of neighboring tissue damage, e.g., bowel, chest wall, abdominal wall, diaphragm, etc.
Inflatable balloon 22 is movable from a deflated condition (FIG. 2) for positioning the introducer 10 adjacent target tissue “T,” to an inflated condition (FIGS. 3 and 4) for separating the target tissue “T” from nearby or neighboring tissue “NT” and for providing a barrier therebetween such that the neighboring tissue “NT” is not critically affected during the electrosurgical procedure. (FIGS. 3 and 4), as described in more detail below. In the inflated condition, the inflatable balloon may exhibit one or more suitable shapes, spherical, oval, rectangular, etc. For illustrative purposes, the inflatable balloon 22 is shown having a generally spherical configuration in the expanded configuration (FIGS. 3 and 4). As can be appreciated, the specific shape that the inflatable balloon 22 may exhibit in the inflated condition may vary for a different surgical procedure, the type of tissue that is to be electrosurgically treated, the location of the tissue that is to be treated, a manufacturer's preference, etc.
The inflatable balloon 22 operably couples to the outer member 17 and the ring 26 of the introducer 10 by one or more suitable coupling methods, e.g., ultrasonic welding, soldering, etc (FIGS. 2-4).
Inflatable balloon 22 may be made from any suitable material including but not limited to elastomers, metals or combination thereof. In the embodiment illustrated in FIGS. 1-4, the inflatable balloon 22 is made from a high temperature plastic, e.g., plastic that can withstand temperatures of up to 200° C. In certain embodiments, the inflatable balloon 22 may be made from plastic and have operably coupled thereto one or more conductive materials, described in more detail below.
Inflatable balloon 22 is in fluid communication with the annular lumen 20 and the inflation port 24 such that one or more suitable fluids or gases, e.g., CO2, saline, water, D5W, DI, etc., may be introduced to an interior of the inflatable balloon 22, as best seen in FIG. 4. In the embodiment illustrated in FIGS. 1-4, an interior wall 28 of suitable proportion defines a single reservoir or chamber 30 (FIG. 4) that is configured to be filled with one or more of the previously described fluids, e.g., CO2.
In certain embodiments, the interior wall 28 of the inflatable balloon 22 is configured to support (via one or more suitable coupling methods) one or more temperature sensors or probes 32 thereon (FIGS. 3 and 4). In the illustrated embodiment, the temperature sensor 32 is selected from the group consisting of thermocouples, thermistors and diodes. The temperature sensor 32 is configured to monitor a temperature of the interior wall 28 of the inflatable balloon 22, and therefore monitor temperature of tissue in indirect contact with the interior wall 28. As can be appreciated, this provides an additional level of safety such that an end user may monitor dissected or separated tissue, e.g., neighboring tissue “NT.” In the illustrated embodiment, the temperature sensor 32 is operably coupled to an optional audio or visual indicator 34. Moreover, the temperature sensor 32 may be in operative communication with the generator 2 and/or one or more modules, temperature control module (not shown), associated therewith.
Operation of the system 100 is described in terms of use of a method for electrosurgically treating tissue, e.g., a microwave ablation procedure for treating target tissue “T” on a lung “L.” The introducer 10 including the distal tip 15, initially, is utilized to pierce tissue such that the introducer 10 may be positioned adjacent target tissue “T,” FIG. 2. Subsequently, the inflatable balloon 22 is deployed from the cannula 8 such that the inflatable balloon 22 is between the target tissue “T” and nearby tissue “NT” (FIGS. 3 and 4). The inflatable balloon 22 is inflated with one or more of the aforementioned fluids, for example, CO2, such that the inflatable balloon 22 transitions from the non-inflated state (FIG. 2) to the inflated state (FIGS. 3 and 4). As the inflatable balloon 22 transitions from the non-inflated state to the inflated state, the inflatable balloon 22 separates the nearby tissue “NT” from the target tissue “T”. Thereafter, the target tissue “T” is electrosurgically treated via the microwave antenna assembly 4.
As can be appreciated, the tissue dissector 6 disclosed herein effectively separates and isolates the nearby tissue “NT” from the target tissue “T” and reduces and/or eliminates the likelihood of the nearby tissue “NT” being critically affected as the target tissue “T” is electrosurgically treated. This is accomplished without the need of having to introduce any extra fluid to the surgical environment, which, as noted above, may increase the length of time needed to effectively perform the surgical procedure.
With reference to FIGS. 5-7, a tissue dissector 106 is illustrated according to another embodiment of the present disclosure. Tissue dissector 106 is substantially similar to the tissue dissector 6. Accordingly, only those features that are unique to tissue dissector 106 are described in detail herein.
An annular lumen 120 defined between an outer member 117 and an elongated shaft 118 includes a split configuration defining two hemispherical lumens 120a and 120b (FIG. 6). Each of the hemispherical lumens 120a and 120b is in fluid communication with an inflation port (not explicitly shown) that is configured to supply each hemispherical lumen 120a and 120b with a corresponding fluid or gas. To this end, the inflation port includes a multivalve configuration having two or more valves that selectively supply fluid or gas to a corresponding one of the hemispherical lumens 120a and 120b. Alternatively, the inflation port may include a lumen pair, i.e., two independent lumens, that are in fluid communication with a respective hemispherical lumen 120a and 120b. In the embodiment illustrated in FIGS. 5-7, the inflation port is configured to supply CO2 to hemispherical lumen 120a and either saline or water to hemispherical lumen 120b (FIG. 6). As can be appreciated, the specific fluid or gas supplied to either of the hemispherical lumens 120a and 120b may vary for a different surgical procedure, the type of tissue that is to be electrosurgically treated, the location of the tissue that is to be treated, a manufacturer's preference, etc.
FIG. 7 illustrates a cross-sectional view of an inflatable balloon 122. Inflatable balloon 122 includes two segmented reservoirs or chambers 130a and 130b that are sealed from one another by a divider membrane 132 that extends along the elongated shaft 118 of the introducer 110. The divider membrane 132 may be made from any suitable material, e.g., an elastomeric material. The divider membrane 132 is configured to provide a fluid-tight seal between the two chambers 130a and 130b such that the respective fluids CO2 and saline do not mix during inflation and deflation of the inflatable balloon 122. The chamber 130a with the CO2 therein is configured to provide thermal insulation from the heated saline in the chamber 130b when the target tissue “T” is heated. Moreover, the chamber 130b with the saline therein provides a medium that allows the electrosurgical energy, e.g., microwave energy, to attenuate rapidly therein when the target tissue “T” is heated.
Unlike inflatable balloon 22, one or more suitable conductive materials, such as, for example, metal, is operably disposed on the inflatable balloon 122. More particularly, a portion or side, e.g., a hemisphere of the inflatable balloon that corresponds to a chamber that is configured to receive the CO2, is made from or configured to operably couple to one or more suitable conductive materials. For example, and in one particular embodiment, a coating of one or more suitable metals 134, e.g., a thin film 134 of copper or stainless steel, conductive polymer, titanium, gold, etc., is disposed on an exterior (or in some instances both an exterior and interior) surface along a side of the inflatable balloon 122 that corresponds to the chamber 130a (FIG. 7). In another embodiment, the conductive material may be disposed on the interior wall of the inflatable balloon 122 that corresponds to the chamber 130a. The conductive metal 134 is configured to reflect a majority of the microwave energy such that the microwave energy does not critically affect neighboring tissue “NT.”
In certain instances, it may prove advantageous to coat the divider membrane 132 with a thin metal film or conductive material to achieve the same or similar effect as coating the exterior and/or interior surface of the inflatable balloon 122. In this instance, the CO2 hemisphere provides space, the saline hemisphere attenuates the microwave energy and the divider membrane 132 reflects microwave energy back toward target tissue “T” and away from neighboring tissue “NT.”
In use, the chamber 130a, i.e., the chamber that includes the conductive material 134 and, thus, configured to receive the CO2 therein, is positioned adjacent the neighboring tissue “NT” and chamber 130b, i.e., the chamber that is configured to receive the saline therein, is positioned adjacent the target tissue “T,” see FIG. 5. Subsequently, each of the chambers 130a and 130b are filled respectively with CO2 and saline to separate target tissue “T” from the neighboring tissue “NT.” Thereafter, the target tissue “T” is electrosurgically treated via the microwave antenna assembly 4. The conductive material 134 reflects the microwave energy that is not absorbed or attenuated by the saline in the chamber 130b.
From the foregoing and with reference to the various figure drawings, those skilled in the art will appreciate that certain modifications can also be made to the present disclosure without departing from the scope of the same. For example, in certain embodiments, the inflatable balloons 22/122 may be configured to inflate or “fill” in a specific manner to conform to a specific tissue structure. For example, and in certain instances, the inflatable balloon 22/122 may be configured to have a cupped surface in an inflated configuration that conforms to a shape of a kidney. In certain instances, the inflatable balloon 22/122 may be configured to have a flat or slightly curved surface in an inflated configuration that conforms to a shape of a liver.
While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.
Patent Application
20170056049
