ELECTROSURGICAL DEVICES WITH A SINGLE CONDUCTIVE TUBULAR ELEMENT FOR ACCESSING ANATOMICAL STRUCTURES
An electrosurgical medical device may include a conductive tubular element disposed about an outer surface of an elongate tubular member at a distal portion of the tubular member. The conductive tubular member may be delivered to a treatment site of a gastrointestinal (GI) tract of a patient and electrically activated. While electrically activated, the conductive tubular element may create an opening in a wall of the GI tract and a pseudocyst. After the incision is made, the conductive tubular element may be withdrawn from the treatment site and a drainage device may be positioned in the incision for drainage of the pseudocyst.
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This application is a U.S. Non-Provisional application, which claims the benefit of co-pending U.S. Provisional Application No. 62/368,639, filed Jul. 29, 2016. The contents of U.S. Provisional Application No. 62/368,639 are incorporated by reference in their entirety.
TECHNICAL FIELDThe present invention relates generally to medical devices, and more particularly to electrosurgical devices, systems, and related methods for using a tubular conductive element to electrosurgically create an opening for gaining access into an anatomical structure of a patient.
BACKGROUNDA cystotome is an electrosurgical medical device that cuts tissue through application of electrical current in order to gain access into for example a pancreatic pseudocyst. Once the tissue is cut and access into the pseudocyst is obtained, a subsequent procedure may be performed on the pseudocyst, such as insertion of a stent into and/or draining of fluid from the pseudocyst.
The cystotome 100 may include three elongate coaxial components: a conductive needle knife 110, an inner catheter 112 disposed over the needle knife 110, and an outer catheter 114 disposed over the inner catheter 112. A ring-shaped conductive member 116 may be attached to a distal end 118 of the outer catheter 114. The conductive member 116 may be referred to as a conductive distal tip 116 of the outer catheter 114. The inner catheter 112 may function to electrically insulate the needle knife 110 from the conductive distal tip 116. In a particular embodiment of the cystotome 100, the needle knife 110 may have a diameter of 0.038 inches (0.9652 millimeters), the inner catheter 112 may have an outer diameter of 5 French (Fr) (1.667 millimeters), and the outer catheter 114 may have an outer diameter of 10 French (3.333 millimeters). A maximum diameter of the conductive distal tip 116 may also be or relatively close to 10 French.
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In some situations, insertion of a stent or other drainage device in a range from five French to ten French may be desirable. However, the size of the incision 122 after being enlarged by the ten French conductive tip 116 may be too large for such a stent or other drainage device to be securely maintained in the pseudocyst. At the same time, the size of the incision 122 made by the needle knife 110 may be too small. Merely reducing the diameter of the conductive tip 116 to be smaller than ten French may not be feasible since the power required to cut through the wall 108 and into the pseudocyst 106 (e.g, 80-120 Watts) may cause such a reduced-size conductive tip to generate heat at a level that melts the solder attaching the conductive tip 116 to the wire 126, which in turn may cause the distal tip 116 to lose its electrical connection with the wire 126 and ultimately the power source. Additionally, having to perform two cuts with two different conductive elements (i.e., the needle knife 110 and the conductive tip 116) to form the incision 122 is time consuming and cumbersome. As such, it may be desirable for a cystotome to have a single conductive element to perform the cutting and make a sufficiently-sized incision that allows a five-to-ten French stent or other drainage device to be inserted into and securely maintained in the pseudocyst.
BRIEF SUMMARYBy way of introduction, the below embodiments relate to electrosurgical devices, systems, and methods for using a tubular conductive element to electrosurgically create an opening for gaining access into an anatomical structure of a patient. In a first embodiment, an electrosurgical device includes an elongate tubular member, a conductive tubular element, and an elongate conductive member. The elongate tubular member extends from a proximal portion to a distal portion and includes a body and a wireguide lumen longitudinally extending in the body from the proximal portion to the distal portion. The body includes an insulating material. The conductive tubular element is affixed to the body and disposed about an outer surface of the body at the distal portion. The insulating material of the body insulates the wireguide lumen from the conductive tubular element. The elongate conductive member longitudinally extends adjacent the body from the proximal portion to the distal portion. A distal portion of the elongate conductive member is attached and electrically connected to the conductive tubular element.
In some embodiments, the conductive tubular element is disposed over the distal portion of the elongate conductive member.
In some embodiments, the conductive tubular element includes a conductive cannula.
In some embodiments, the conductive tubular element includes a conductive coil.
In some embodiments, the conductive coil and the elongate conductive member are integral components of a same wire.
In some embodiments, the conductive coil and the elongate conductive member are parts of different wires.
In some embodiments, the conductive tubular element includes a conductive coil and a conductive cannula disposed over the conductive coil.
In some embodiments, the elongate conductive member longitudinally extends outside and along an outer surface of the body from the proximal portion to the distal portion.
In some embodiments, the elongate conductive member longitudinally extends inside the body from the proximal portion to the distal portion. The distal portion of elongate conductive member extends from inside to outside of the elongate tubular member to be attached to the conductive tubular member.
In some embodiments, the elongate conductive member is embedded in the body.
In some embodiments, the elongate conductive member is in a straightened configuration while embedded in the body.
In some embodiments, the elongate conductive member is in a coiled configuration while embedded in the body.
In some embodiments, the wireguide lumen includes a first lumen, and the elongate tubular member further includes a second lumen longitudinally extending in the body from the proximal portion to the distal portion. The elongate tubular member longitudinally extends in the second lumen from the proximal portion to the distal portion.
In some embodiments, an outer diameter of the conductive tubular element is greater than five French (one and two-thirds millimeters) and less than ten French (three and one-third millimeters).
In some embodiments, the outer diameter of the conductive tubular element is six French.
In another embodiment, a method of gaining access into an anatomical structure may be performed. The method may include delivering a conductive tubular element to a treatment site in a patient; electrically activating the conductive tubular element; and creating an opening in the anatomical structure by initially cutting the anatomical structure with the electrically activated conductive tubular element.
In some embodiments, creating the opening includes creating an incision in the anatomical structure.
In some embodiments, creating the opening includes enlarging an initial opening of the anatomical structure.
In some embodiments, creating the opening includes creating the opening with only the electrically activated conductive tubular element.
In some embodiments, initially cutting into the anatomical structure comprises distally advancing a distal end of the conductive tubular element into the anatomical structure while the conductive tubular element is electrically activated.
In some embodiments, initially cutting into the anatomical structure includes initially cutting into the anatomical structure with a side surface defining a distal end of the conductive tubular element.
In some embodiments, the method further includes: after creating the opening, positioning a drainage device in the opening for drainage of the anatomical structure.
In some embodiments, the method further includes: before positioning the drainage device in the opening, distally advancing a distal portion of a wireguide through the opening to within the anatomical structure; and distally advancing the drainage device over the wireguide to the treatment site in order to position the drain device in the opening.
In some embodiments, the conductive tubular element is disposed about an elongate tubular member, distally advancing the distal portion of the wireguide comprises distally advancing the distal portion through a wireguide lumen of the elongate tubular member.
In some embodiments, an outer diameter of the conductive tubular element is greater than five French (one and two-thirds millimeters) and less than ten French (three and one-third millimeters).
In some embodiments, the conductive tubular element includes at least one of a conductive cannula or a conductive coil.
In some embodiments, the method further includes: delivering electrical current in a range of 80-120 Watts to the conductive tubular element while the conductive tubular element is cutting into the anatomical structure to create the opening.
In some embodiments, delivering the conductive tubular element to the treatment site comprises delivering the conductive tubular element disposed over an elongate tubular member comprising a body and a wireguide lumen longitudinally extending through the body, where the body includes an insulating material that electrically insulates the wireguide lumen from the conductive tubular element.
In some embodiments, the treatment site is in a gastrointestinal tract of the patient.
In some embodiments, the anatomical structure is adjacent a wall of the gastrointestinal tract, and the method further includes cutting into the wall before cutting into the anatomical structure in order to create the opening.
In some embodiments, the anatomical structure includes a pseudocyst.
In some embodiments, the pseudocyst is adjacent a wall outside the gastrointestinal tract.
Other embodiments are possible, and each of the embodiments can be used alone or together in combination. Accordingly, various embodiments are described below with reference to the attached drawings.
The present disclosure describes various exemplary embodiments of an electrosurgical device that includes a conductive distal tip that is configured to create an opening in order to gain access into an anatomical structure, such as one that is in or adjacent to the gastrointestinal tract of a patient. The present disclosure also describes related methods of gaining access into anatomical structure using the various exemplary embodiments of the electrosurgical device.
The conductive distal tip may include a conductive tubular or cylindrical element disposed about an outer surface of an elongate tubular member, such as a catheter, at a distal portion of the elongate tubular member. The cylindrical conductive distal tip may be made of a conductive material, such as stainless steel or copper as non-limiting examples. Other conductive materials may be possible. In some example embodiments, the conductive tubular element may be a cannula that is a continuous, solid structure and/or that has a generally smooth outer surface over its longitudinal length. In other example embodiments, the conductive tubular element may be a coil or coiled structure, such as a coiled wire, that is a discontinuous structure over its longitudinal length and/or that has a generally ribbed outer surface over its longitudinal length as formed by the coils. In still other example embodiments, the conductive tubular element may be combination of the cannula and the coil. A longitudinal length of the conductive tubular element may be in a range from three to eight millimeters, although other longitudinal lengths may be possible.
In addition to being disposed about the elongate tubular member, the conductive distal tip may also be affixed to the elongate tubular member. By being affixed to the elongate tubular member, the distal tip may longitudinally move with the elongate tubular member. In other words, the elongate tubular member may be longitudinally moved in order to longitudinally move the conductive distal tip.
The tubular conductive distal tip may have an outer diameter, and/or the tubular conductive distal tip in combination with the elongate tubular member, may have a total outer diameter that is greater than five French (1.67 millimeters) and less than 10 French (3.33 millimeters). In one example, the total outer diameter is 6 French. In some example embodiments, the elongate tubular member itself may have an outer diameter of five French, and the total outer diameter of the conductive distal tip and the elongate tubular member may be five French plus the thickness of the conductive distal tip. An example thickness of the conductive distal tip may be four one-thousandths of an inch (0.1016 millimeters), although other thicknesses may be possible. With an outer diameter in between five French and ten French, the tubular conductive distal tip may be suitably sized to make an optimally sized incision into a pseudocyst for insertion of a stent or other drainage device having a size or outer diameter of less than ten French, without the need to additionally use other-sized conductive elements to assist in making the incision.
The conductive distal tip may be attached and electrically connected to an elongate conductive member, such as a wire, that longitudinally extends with the elongate tubular member from a proximal portion to the distal portion. Like the conductive distal tip, the elongate conductive member may be made of a conductive material, such as stainless steel or copper as non-limiting examples. The conductive distal tip may be fixedly attached to the elongate conductive member through one or more attachment mechanism other than solder. The attachment mechanism(s) used may depend on the configuration of the conductive distal tip. Where the conductive distal tip includes a cannula, the cannula may be crimped to the elongate conductive member, welded to the elongate conductive member, or a combination thereof. Where the conductive distal tip includes a coil, the coil and the elongate conductive member may be part of and/or formed from different wires, in which case the coil may be crimped and/or welded to the elongate conductive member, similar to how the cannula is attached to the elongate conductive member. Alternatively, the coil and the elongate conductive member may be part of and/or formed from the same wire, in which case the coil and the elongate conductive member are attached to each other by virtue of being part of and/or formed from the same wire.
The elongate conductive member may longitudinally extend with and/or adjacent to the body of the elongate tubular member in various ways. In some example embodiments, the elongate conductive member may extend along the outer surface and/or outside of the elongate tubular member. In other example embodiments, the elongate conductive member may longitudinally extend within the elongate tubular member. When extending within the elongate tubular member, a distal portion of the elongate conductive member may extend to outside of the elongate tubular member, where it may be attached and electrically connected to the conductive distal tip. Additionally, for some embodiments where the elongate conductive member extends within the elongate tubular member, the elongate conductive member may be embedded in a body of the elongate tubular member. For other embodiments, the elongate conductive member may be disposed and longitudinally extend in a lumen of the elongate tubular member. Where the elongate conductive member is embedded in the body, the conductive member may longitudinally extend in the body in a generally straightened configuration or in a coiled configuration.
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The electrosurgical device 202 may include an elongate tubular member 206, such as a catheter, that longitudinally extends from a proximal portion 208 to a distal portion 210. The elongate tubular member 206 may include a body 212 and a wireguide lumen 214 longitudinally extending in the body 212 from the proximal portion 208 to the distal portion 210. The wireguide lumen 214 may be sized to have a wireguide movably disposed therein. An example size (i.e., diameter) of the wireguide lumen 214 may be in a range of about 0.010 inches to 0.040 inches. Particular example sizes may include 0.035 inches or 0.038 inches. The body 212 may be made of an insulating material such as polyether ether ketone (PEEK) or polytetrafluoroethylene (PTFE) as examples, although other insulating materials may be possible.
The electrosurgical device 202 may further include a conductive cannula 216 disposed on or about an outer surface 218 of the elongate tubular member 206 at the distal portion 210. In one example embodiment, as shown in
The conductive cannula 216 may be configured to be electrically activated by the power source 204 via an elongate conductive member 220, such as a wire. The elongate conductive member 220 may longitudinally extend along or adjacent to the outer surface 218 from the proximal portion 208 to the distal portion 210. At the distal portion 210, a distal end 222 of the elongate conductive member 220 may be fixedly attached and electrically connected to the conductive cannula 216. As shown in
The electrosurgical device 202 may further include a handle assembly 224 operatively coupled to proximal ends 226, 228 of the elongate tubular member 206 and the elongate conductive member 220. The elongate conductive member 220 may be electrically coupled to the power source 204 via the handle assembly 224. For example, as shown in
For some example configurations, the elongate tubular member 206 may be an inner elongate tubular member 206, and the electrosurgical device 202 may further include an outer elongate tubular member 238 coaxial with the inner elongate tubular member 206. The outer elongate tubular member 238 may longitudinally extend from the proximal portion 208 to the distal portion 210, and a proximal end 240 may be coupled to the handle assembly 224. The outer elongate tubular member 238 may include a body 242 and a central lumen 244 longitudinally extending in the body 242. The inner elongate tubular member 206 may longitudinally extend within the central lumen 244 from the proximal portion 208 to the distal portion 210. The elongate conductive member 220 may longitudinally extend in between the outer surface 218 of the inner elongate tubular member 206 and an inner surface 246 of the body 240 of the outer elongate tubular member 238 defining the central lumen 242.
The handle assembly 224 may be configured to longitudinally move the inner elongate tubular member 206, the conductive cannula 216, and the elongate conductive member 220 relative to the outer elongate tubular member 238. During operation, when the distal portion 206 is being delivered to a treatment site within a patient, the handle assembly 224 may move the inner and outer elongate tubular members 206, 238 relative to each other so that the conductive cannula 216 is disposed inside the outer member 238, such as within the central lumen 244. Subsequently, at the treatment site, the handle assembly 224 may move the inner and outer elongate tubular members 206, 238 relative to each other so that the conductive cannula 216 is distally past a distal end 248 of the outer member 238 and exposed to its outer surroundings so that the conductive cannula 216 may contact tissue to perform the electrosurgical procedure. For other example configurations, the electrosurgical device 202 may not include the outer elongate tubular member 238.
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A method of gaining access by creating an opening into an anatomical structure that is in, adjacent to, and/or accessible from a treatment site of a patient is described with reference to
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In addition, when the conductive cannula 216 is at the treatment site 1500, the conductive cannula 216 may be electrically activated by activating the power source 204. When activated, the power source 204 may deliver electrical current from the output port 236, through the cabling 234, through the conductive coupling component 230, through the elongate conductive member 220, and to the conductive cannula 216. Power associated with the electrical current that is delivered may be in a range of between 80-120 Watts, although other power settings may be possible. Also, the frequency of the electrical current may be a frequency used for electrosurgery, which may be in the radio frequency (RF) range. An example frequency range may include 350 kiloHertz (kHz) to 4 Megahertz (MHz), although other frequencies used for electrosurgery outside of this range may be possible.
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The drainage device 1504 may have an outer diameter of less than 10 French. As described above, the conductive cannula 216 may have an outer diameter in between 5 French and 10 French, such as 6 French, which may provide a suitable size of the opening 1508 for the drainage device 1514 to be securely held and/or maintained inside the pseudocyst 1502. Also, in the example method described with reference to
After the drain device 1514 is inserted into the opening 1508, the wireguide 1510 may be removed from the treatment area 1500 and drainage of the pseudocyst 1502 may be performed via the drainage device 1514.
The foregoing description of various embodiments of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise embodiments disclosed. Numerous modifications or variations are possible in light of the above teachings. The embodiments discussed were chosen and described to provide the best illustration of the principles of the invention and its practical application to thereby enable one of ordinary skill in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. All such modifications and variations are within the scope of the invention as determined by the appended claims when interpreted in accordance with the breadth to which they are fairly, legally, and equitably entitled.
Claims
1. An electrosurgical device comprising:
- an elongate tubular member that extends from a proximal portion to a distal portion, the elongate tubular member comprising a body and a wireguide lumen longitudinally extending in the body from the proximal portion to the distal portion, the body comprising an insulating material;
- a conductive tubular element affixed to the body of elongate tubular member and disposed about an outer surface of the body at the distal portion, wherein the insulating material of the body insulates the wireguide lumen from the conductive tubular element; and
- an elongate conductive member longitudinally extending adjacent the body from the proximal portion to the distal portion, wherein a distal portion of the elongate conductive member is attached and electrically connected to the conductive tubular element.
2. The electrosurgical device of claim 1, wherein the conductive tubular element is disposed over the distal portion of the elongate conductive member.
3. The electrosurgical device of claim 1, wherein the conductive tubular element comprises a conductive cannula.
4. The electrosurgical device of claim 1, wherein the conductive tubular element comprises a conductive coil.
5. The electrosurgical device of claim 4, wherein the conductive coil and the elongate conductive member are integral components of a same wire.
6. The electrosurgical device of claim 4, wherein the conductive coil and the elongate conductive member are parts of different wires.
7. The electrosurgical device of claim 1, wherein the conductive tubular element comprises a conductive coil and a conductive cannula disposed over the conductive coil.
8. The electrosurgical device of claim 1, wherein the elongate conductive member longitudinally extends outside and along an outer surface of the body from the proximal portion to the distal portion.
9. The electrosurgical device of claim 1, wherein the elongate conductive member longitudinally extends inside the body from the proximal portion to the distal portion, and wherein the distal portion of elongate conductive member extends from inside to outside of the elongate tubular member to be attached to the conductive tubular member.
10. The electrosurgical device of claim 9, wherein the elongate conductive member is embedded in the body.
11. The electrosurgical device of claim 10, wherein the elongate conductive member is in a straightened configuration while embedded in the body.
12. The electrosurgical device of claim 11, wherein the elongate conductive member is in a coiled configuration while embedded in the body.
13. The electrosurgical device of claim 9, wherein the wireguide lumen comprises a first lumen, the elongate tubular member further comprising a second lumen longitudinally extending in the body from the proximal portion to the distal portion, wherein the elongate tubular member longitudinally extends in the second lumen from the proximal portion to the distal portion.
14. The electrosurgical device of claim 1, wherein an outer diameter of the conductive tubular element is greater than five French (one and two-thirds millimeters) and less than ten French (three and one-third millimeters).
15. The electrosurgical device of claim 14, wherein the outer diameter of the conductive tubular element is six French.
16. A method of gaining access into an anatomical structure, the method comprising:
- delivering a conductive tubular element to a treatment site in a patient;
- electrically activating the conductive tubular element; and
- creating an opening in the anatomical structure by initially cutting the anatomical structure with the electrically activated conductive tubular element.
17. The method of claim 16, wherein creating the opening comprises creating an incision in the anatomical structure.
18. The method of claim 16, wherein creating the opening comprises enlarging an initial opening of the anatomical structure.
19. The method of claim 16, wherein creating the opening comprises creating the opening with only the electrically activated conductive tubular element.
20. The method of claim 16, wherein initially cutting into the anatomical structure comprises distally advancing a distal end of the conductive tubular element into the anatomical structure while the conductive tubular element is electrically activated.
21. The method of claim 16, wherein initially cutting into the anatomical structure comprises initially cutting into the anatomical structure with a side surface defining a distal end of the conductive tubular element.
22. The method of claim 16, further comprising: after creating the opening, positioning a drainage device in the opening for drainage of the anatomical structure.
23. The method of claim 22, further comprising:
- before positioning the drainage device in the opening, distally advancing a distal portion of a wireguide through the opening to within the anatomical structure; and
- distally advancing the drainage device over the wireguide to the treatment site in order to position the drain device in the opening.
24. The method of claim 23, wherein the conductive tubular element is disposed about an elongate tubular member, and
- wherein distally advancing the distal portion of the wireguide comprises distally advancing the distal portion through a wireguide lumen of the elongate tubular member.
25. The method of claim 16, wherein an outer diameter of the conductive tubular element is greater than five French (one and two-thirds millimeters) and less than ten French (three and one-third millimeters).
26. The method of claim 16, wherein the conductive tubular element comprises at least one of a conductive cannula or a conductive coil.
27. The method of claim 16, further comprising:
- delivering electrical current in a range of 80-120 Watts to the conductive tubular element while the conductive tubular element is cutting into the anatomical structure to create the opening.
28. The method of claim 16, wherein delivering the conductive tubular element to the treatment site comprises delivering the conductive tubular element disposed over an elongate tubular member comprising a body and a wireguide lumen longitudinally extending through the body, the body comprising an insulating material that electrically insulates the wireguide lumen from the conductive tubular element.
29. The method of claim 16, wherein the treatment site is in a gastrointestinal tract of the patient.
30. The method of claim 29, wherein the anatomical structure is adjacent a wall of the gastrointestinal tract, the method further comprising:
- cutting into the wall before cutting into the anatomical structure in order to create the opening.
31. The method of claim 16, wherein the anatomical structure comprises a pseudocyst.
32. The method of claim 31, wherein the pseudocyst is adjacent a wall outside the gastrointestinal tract.
Type: Application
Filed: Jul 27, 2017
Publication Date: Feb 1, 2018
Applicant: Cook Medical Technologies LLC (Bloomington, IN)
Inventors: Fionan Keady (Limerick), Margaret Long (Limerick)
Application Number: 15/661,670