Expandable Mesh Platform for Large Area Ablation
An ablation device and a method of ablating a tissue are provided. The ablation device includes a first elongate shaft having a proximal portion, a distal portion and a lumen extending at least partially therethrough and a second elongate shaft having a proximal portion, a distal portion and a lumen extending at least partially therethrough. The first elongate shaft is coaxially positioned and longitudinally movable relative to the second elongate shaft. The ablation device further includes a mesh member including a proximal portion and a distal portion. The proximal portion of the mesh member is operably connected to the distal portion of the second elongate shaft and the distal potion the mesh member is operably connected to an inner surface of the distal portion of the first elongate shaft. The mesh member includes a conductive portion configured to contact a surface for ablation.
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This application is a division of U.S. patent application Ser. No. 14/184,438 filed Feb. 19, 2014, which claims the benefit under 35 U.S.C. § 119 of U.S. Patent Application No. 61/767,067 filed Feb. 20, 2013; which are incorporated by reference in their entirety.
BACKGROUNDEndoscopic treatment of gastrointestinal disorders often requires the need to coagulate tissue for the purpose of hemostasis and/or marking of the tissue. Areas of diseased tissue within the gastrointestinal tract may also be treated using an ablation device. Some ablation devices may be delivered endoscopically.
Radiofrequency ablation (RFA) is one method that can be used to deliver energy for treating or marking the tissue. A bipolar probe is a commonly used RFA device, for example, the Quicksliver Bipolar Probe (Cook Medical, Inc., Bloomington, Ind.) Typical RFA probes are 7 to 10 Fr with electrodes mounted on a ceramic tip on the distal end of the device. One drawback of these probes is that the size of the ablation zone is dependent on the size of the catheter and cannot be altered by the user. In addition, the user must use caution when applying energy when using this type of bipolar probe. Since all the force is distributed across a small (7 or 10 Fr) surface area, an area of high pressure is created increasing the risk of perforation of the tissue at the treatment site.
What is needed in the art is an ablation treatment device that is simple to use, reduces the risk of tissue perforation and is expandable and collapsible to treat larger tissue areas.
BRIEF SUMMARYAccordingly, it is an object of the present invention to provide a device and a method having features that resolve or improve on one or more of the above-described drawbacks.
An ablation device is provided. In some embodiments, the ablation device includes a first elongate shaft having a proximal portion, a distal portion and a lumen extending at least partially therethrough and a second elongate shaft having a proximal portion, a distal portion and a lumen extending at least partially therethrough. The first elongate shaft is coaxially positioned and longitudinally movable relative to the second elongate shaft. The ablation device further includes a mesh member including a proximal portion and a distal portion. The proximal portion of the mesh member is operably connected to the distal portion of the second elongate shaft and the distal potion the mesh member is operably connected to an inner surface of the distal portion of the first elongate shaft. The mesh member includes a conductive portion configured to contact a surface for ablation.
In some embodiments the ablation device includes a mesh member including a proximal portion and a distal portion, the mesh member having a first diameter and a second diameter greater than the first diameter such that the mesh member is movable to the second diameter by moving the proximal portion relative to the distal portion. The mesh member includes a plastic material and a conductive portion, the conductive portion comprising an ink covering at least a portion of the plastic material and the conductive portion is positionable to contact a surface for ablation.
In another embodiment, a method of ablating a tissue is provided. The method includes inserting a distal portion of an ablation device into a lumen of a patient. The ablation device includes a first elongate shaft having a proximal portion, a distal portion and a lumen extending at least partially therethrough and a second elongate shaft having a proximal portion, a distal portion and a lumen extending at least partially therethrough. The first elongate shaft is coaxially positioned and longitudinally movable relative to the second elongate shaft. The ablation device further includes a mesh member including a proximal portion and a distal portion. The proximal portion of the mesh member is operably connected to the distal portion of the second elongate shaft and the distal potion the mesh member is operably connected to an inner surface of the distal portion of the first elongate shaft. The mesh member includes a conductive portion configured to contact a surface for ablation. The method further includes positioning a portion of the mechanically expandable ablation member at a treatment site, moving the first elongate shaft relative to the second elongate shaft to move the ablation device to an expanded configuration having the second diameter, pressing an end face of the mesh member against the surface and applying energy to the tissue from an energy source.
The invention is described with reference to the drawings in which like elements are referred to by like numerals. The relationship and functioning of the various elements of this invention are better understood by the following detailed description. However, the embodiments of this invention are not limited to the embodiments illustrated in the drawings. It should be understood that the drawings are not to scale, and in certain instances details have been omitted which are not necessary for an understanding of the present invention, such as conventional fabrication and assembly.
As used in the specification, the terms proximal and distal should be understood as being in the terms of a physician delivering the ablation device to a patient. Hence the term “distal” means the portion of the ablation device that is farthest from the physician and the term “proximal” means the portion of the ablation device that is nearest to the physician.
The mesh member 20 is operably connectable to the inner catheter 14, the outer catheter 12 and the drive cable 16. As the inner catheter 14 and the outer catheter 12 are moved relative to each other, the shape of the mesh member 20 changes. In some embodiments, a distal end portion 38 of the mesh member 20 may be extended over a distal end 39 of the inner catheter 14, inverted into the lumen 36 of the inner catheter 14 and operably connected to an inner surface 41 of the distal end portion 34 of the inner catheter 14. The drive cable 16 may also be operably connected to the mesh member 20 to move the mesh member 20 and the inner catheter 14 relative to the outer catheter 12. The drive cable 16 may also act as the active wire to transmit current from an electrosurgical unit (ESU) to the mesh member 20 and to the tissue (described in more detail below). A proximal end portion 40 of the mesh member 20 may be operably connected to the distal end portion 26 of the outer catheter 12.
An end view of the end face 56 of the mesh member 20 in the expanded configuration 54 is shown in
A control handle 70 is provided at a proximal portion 72 of the ablation device 10. An exemplary control handle 70 is shown in
The handle 70 may include a lock 76 shown in
In some embodiments, the ablation device 10 may include an outer sheath 70 that is positionable over the outer catheter 12 and the mesh member 20 when the ablation device is in the retracted configuration 68 as shown in
In some embodiments, the ablation device 10 may be provided as a monopolar device or a bipolar device where the mesh member 20 includes a conductive portion 72. The mesh member 20 itself, when formed from an electrically conductive material may be the conductive portion 72 or portions of the mesh member 20 may be conductive portions 72 with non-conductive portions 73 being coated with an insulating material. For example, in a bipolar ablation device 10, an insulating material is used between the active and return portions. The insulating material can also be used to form patterns for ablation, where conductive portions 72 of the mesh member 20 may be activated and non-conductive portions 73 of the mesh member 20 remain inactive. See for example,
In some embodiments, the conductive portions 72 of the mesh member 20 may comprise conductive ink that is applied to the exterior of the mesh member 20. The conductive ink may be applied in any pattern and spacing to be used for tissue treatment. In some embodiments, the conductive ink may be a silver-based ink. An exemplary silver-based ink may be obtained from Conductive Compounds (product number AG-510, Hudson, N.H.). However, other types of conductive ink may also be used, such as platinum-based, gold-based and copper-based inks. The inks may be epoxy-based inks or non-epoxy inks, such as urethane inks. In some embodiments, the active portions of the mesh member 20 may comprise conductive polymers. The conductive ink may be applied to the mesh member 20 with a variety of printing processes, such as pad printing, ink jet printing, spraying, marker striping, painting or other like processes. In some embodiments, the conductive ink may be applied to the mesh member with by spraying, dipping, painting or an electrostatic coating process.
The non-conductive portion 73 of the mesh member 20 may be an insulating portion to separate conductive portions 72 of the mesh member 20. In some embodiments, a coating may be applied to the mesh member 20 to form the non-conductive portions 73 in a quantity that is sufficient to insulate the conductive portions 72 from each other or to coat portions of the mesh member 20 when the mesh member 20 itself is formed of a conductive material. In some embodiments, the insulating coating may be made from parylene-N (poly-p-xylylene). Other xylylene polymers, and particularly parylene polymers, may also be used as a coating within the scope of the present invention, including, for example, 2-chloro-p-xylylene (Parylene C), 2,4-dichloro-p-xylylene (Parylene D), poly(tetraflouro-p-xylylene), poly(carboxyl-p-xylylene-co-p-xylylene), fluorinated parylene, or parylene HT® (a copolymer of per-fluorinated parylene and non-fluorinated parylene), alone or in any combination. Preferred coatings will include the following properties: low coefficient of friction (preferably below about 0.5, more preferably below about 0.4, and most preferably below about 0.35); very low permeability to moisture and gases; fungal and bacterial resistance; high tensile and yield strength; high conformality (ready application in uniform thickness on all surfaces, including irregular surfaces, without leaving voids); radiation resistance (no adverse reaction under fluoroscopy); bio-compatible/bio-inert; acid and base resistant (little or no damage by acidic or caustic fluids); ability to be applied by chemical vapor deposition bonding/integrating to wire surface (bonding is intended to contrast to, for example, fluoroethylenes that form surface films that are able to be peeled off an underlying wire); and high dielectric strength.
Operation of the ablation device 10 will be explained with reference to
The above Figures and disclosure are intended to be illustrative and not exhaustive. This description will suggest many variations and alternatives to one of ordinary skill in the art. All such variations and alternatives are intended to be encompassed within the scope of the attached claims. Those familiar with the art may recognize other equivalents to the specific embodiments described herein which equivalents are also intended to be encompassed by the attached claims.
Claims
1. A method of ablating a tissue, the method comprising:
- inserting a distal portion of an ablation device into a lumen of a patient, the ablation device comprising: a first elongate shaft having a proximal portion, a distal portion and a lumen extending at least partially therethrough; a elongate shaft having a proximal portion, a distal portion and a lumen extending at least partially therethrough, the first elongate shaft coaxially positioned and movable relative to the second elongate shaft; and
- a mesh member comprising a proximal portion and a distal portion, the proximal portion of the mesh member operably connected to the distal portion of the second elongate shaft and the distal potion the mesh member operably connected to an inner surface of the distal portion of the first elongate shaft, the mesh member having a first diameter and a second diameter greater than the first diameter and the mesh member comprising a conductive portion configured to contact a surface for ablation;
- positioning at least a portion of the mesh member at a treatment site;
- moving the first elongate shaft relative to the second elongate shaft to move the ablation device to an expanded configuration having the second diameter;
- pressing an end face of the mesh member against the surface; and
- applying energy to the tissue from an energy source.
2. The method according to claim 1, comprising longitudinally moving the first elongate shaft relative to the second elongate shaft to move the ablation device to an extended configuration having substantially the first diameter wherein the end face is configured to be pressed against the surface.
3. The method according to claim 1, comprising longitudinally moving the first elongate shaft relative to the second elongate shaft to move the ablation device to retracted configuration where the distal portion of the mesh member is positioned within the lumen of the second elongate shaft and the proximal portion of the mesh member remains operably connected to the outer surface of the distal end of the second elongate shaft.
4. The method according to claim 1, comprising moving the ablation device to a second treatment site in the retracted configuration and expanding the mesh member at the second site by longitudinally moving the first elongate shaft relative to the second elongate shaft.
5. The method according to claim 1, comprising delivering the ablation device to the treatment site using an endoscope.
Type: Application
Filed: Jun 26, 2018
Publication Date: Nov 1, 2018
Applicant: Cook Medical Technologies LLC (Bloomington, IN)
Inventor: Tyler E. McLawhorn (Winston-Salem, NC)
Application Number: 16/019,184