Patent Application
20220313347
The present disclosure relates generally to medical devices, and, more particularly, to tissue ablation devices configured to achieve coagulation, or hemostatic sealing, of a tissue.
13% of the global population suffers from cancer and is expected to rise by approximately 70% over the next few decades based on statistics published by the World Health Organization (WHO). Many of the medical procedures related to cancer diagnosis and treatment require surgery to cut or carry soft tissue away. For example, during hepatic transection, one or more lobes of a liver containing abnormal tissue, such as malignant tissue or fibrous tissue caused by cirrhosis, are cut away. Regardless of the electrosurgical device used, extensive bleeding can occur, which can obstruct the surgeon's view and lead to dangerous blood loss levels, requiring transfusion of blood, which increases the complexity, time, and expense of the procedure, as well as the recovery time of the patient.
In order to prevent extensive bleeding or accumulation of fluid during surgery and to promote healing after surgery, hemostatic mechanisms, such as blood inflow occlusion, coagulants, as well as energy coagulation (e.g., electrosurgical coagulation or argon-beam coagulation) can be used. Unlike resection, which involves application of highly intense and localized heating sufficient enough to break intercellular bonds, energy coagulation of tissue involves the application of low level current that denatures cells to a sufficient depth without breaking intercellular bonds, i.e., without cutting the tissue.
However, current energy coagulation devices include needle-like devices, which can only generate small regions of heat, requiring frequent repositioning of the device in order to treat larger areas. As such, great care must be taken when using such energy coagulation devices in order to reduce charring of tissue, avoid tissue from becoming stuck on the device, and most importantly, to minimize the increase of tissue resistance, so as to avoid reducing the efficiency of the overall procedure. Unfortunately, regardless of the care taken, the current energy coagulation modalities result in long procedure times and variable ablation depths, making it nearly impossible to maintain hemostasis at the treatment site.
The present invention relates to ablation devices configured to destroy large surface areas of tissue in a consistent manner in an effort to achieve coagulation. The systems and methods described herein can be used during a resection procedure to coagulate cross-sectional tissue of the resection site so as to prevent or stop fluid accumulation (e.g., blood from vessel(s)) as a result of the resection of tissue. Accordingly, the ablation device of the present invention may be particularly useful during or after procedures involving the removal of unhealthy, or otherwise undesired, tissue from any part of the body. Thus, tumors, both benign and malignant, may be removed via a surgical intervention, and the ablation devices described herein can then be used to coagulate the tissue of the resection site. The ablation devices are configured to be applied to tissue in a sweeping motion, thus allowing for real-time assessment of progress of ablation, without needing to pause to assess the progress.
In particular, the present disclosure is generally directed to a tissue ablation system including an ablation device to be used on large surface areas of tissue and emit non-ionizing radiation, such as radiofrequency (RF) energy, to treat surface lesions. The tissue ablation device of the present invention generally includes a probe including an elongated shaft configured as a handle and adapted for manual manipulation and a nonconductive distal portion coupled to the shaft. The nonconductive distal portion is a rigid arcuate body and includes an electrode array positioned along the arcuate body's convex exterior surface. The distal portion, including the electrode array, can be delivered to a resection site and the convex side of the distal portion can be swept along the surface of cross-sectional tissue (e.g., tissue remaining after tumor removal) and configured to coagulate the tissue (via RF energy) in contact therewith.
In one aspect, the electrode array is composed of a plurality of conductive members (e.g., conductive wires) electrically isolated and independent from one another. Thus, in some embodiments, each of the plurality of conductive wires, or one or more sets of a combination of conductive wires, is configured to independently receive an electrical current from an energy source (e.g., ablation generator) and independently conduct energy, the energy including RF energy. This allows energy to be selectively delivered to a designated conductive wire or combination of conductive wires. This design also enables the ablation device to function in a bipolar mode because a first conductive wire (or combination of conductive wires) can deliver energy to the surrounding tissue through its electrical connection with an ablation generator while a second conductive wire (or combination of conductive wires) can function as a ground or neutral conductive member.
The independent control of each wire or sets of wires allows for activation (e.g., emission of RF energy) of corresponding portions of the electrode array. For example, the electrode array may be partitioned into specific portions which may correspond to clinical axes or sides of the distal portion of the device. In one embodiment, the electrode array may include at least two distinct portions (i.e., individual or sets of conductive wires) corresponding to one side of the distal portion (e.g., the convex side or two quadrants of the arcuate body).
The ablation device is configured to provide RF ablation via a virtual electrode arrangement, which includes distribution of a fluid along a convex exterior surface of the hemispherical body of the distal tip and, upon activation of the electrode array, the fluid may carry, or otherwise promote, energy emitted from the electrode array to the surrounding tissue. For example, the nonconductive distal portion of the ablation device includes an interior chamber retaining at least a hydrophilic insert. The interior chamber of the distal portion is configured to receive and retain a fluid (e.g., saline) therein from a fluid source. The hydrophilic insert is configured to receive and evenly distribute the fluid through the distal tip by wicking the saline against gravity. The distal portion may generally include a plurality of ports or apertures configured to allow the fluid to pass therethrough, or weep, from the interior chamber to a convex exterior surface of the distal portion.
In some embodiments, the device is configured so that a constant flow of fluid is not needed. For example, the distal tip may be defined by a first halve having at least a concave portion and a second halve having at least a convex portion complementary to the concave portion of the first halve, wherein the halves are nested together to form a rigid arcuate body having at least an exterior cavity and an interior chamber. The exterior cavity may be configured to receive fluid from an external fluid source. The external fluid source may be any type of container containing the fluid, such as a bottle or bowl and the fluid may be poured directly into the cavity of the device from the container. The exterior cavity may be configured to have a plurality of receiving ports. The receiving ports may be configured to pass the fluid from the exterior cavity into the interior chamber of the hemispherical body containing the hydrophilic insert. The hydrophilic insert is shaped and sized to maintain sufficient contact with the surface of the interior chamber of the distal tip wall, and specifically in contact with one or more fluid receiving ports and one or more ports of the convex side of the arcuate body to uniformly distribute the fluid to the ports of the convex side.
In some other embodiments, the device is configured to receive fluid from an internal fluid source. For example, the hemispherical body of the distal tip may be defined by a first halve having at least a solid and relatively planar portion and a second halve having at least a convex portion, the halves are coupled together to form a rigid arcuate body having at least an interior chamber retaining at least a spacer member and the hydrophilic insert. In some embodiments, the spacer member is shaped and sized so as to maintain the hydrophilic insert in contact with the interior surface of the distal tip wall, and specifically in contact with the one or more perforations on the convex portion of the arcuate body, such that the hydrophilic insert provides uniformity of saline distribution to the perforations.
It should be noted that, in some embodiments, the arcuate body is generally in the form of a hemispherical shape, while in other embodiments, the arcuate body may include a hemi ellipsoidal shape or a hemiovoidal shape.
Accordingly, upon positioning the convex side of the distal portion within a target site (e.g., tissue to be ablated), the electrode array can be activated. The fluid weeping through the perforations to the convex outer surface of the distal portion is able to carry energy from electrode array, thereby creating a virtual electrode. Accordingly, upon the fluid weeping through the perforations, a pool or thin film of fluid is formed on the convex exterior surface of the distal portion and is configured to ablate surrounding tissue via the RF energy carried from the electrode array.
Features and advantages of the claimed subject matter will be apparent from the following detailed description of embodiments consistent therewith, which description should be considered with reference to the accompanying drawings, wherein:
For a thorough understanding of the present disclosure, reference should be made to the following detailed description, including the appended claims, in connection with the above-described drawings. Although the present disclosure is described in connection with exemplary embodiments, the disclosure is not intended to be limited to the specific forms set forth herein. It is understood that various omissions and substitutions of equivalents are contemplated as circumstances may suggest or render expedient.
By way of overview, the present disclosure is generally directed to a tissue ablation system including an ablation device to be delivered to a target site to achieve coagulation of tissue. In some aspects, ablation devices may have an arcuate rigid head configured to be applied to tissue and to ablate large surface areas of tissue, and in other aspects ablation devices with a deployable applicator head are configured to be applied to tissue and delivered into a tissue cavity and ablate marginal tissue surrounding the tissue cavity.
A tissue ablation system consistent with the present disclosure may be well suited for treating larger surface areas of tissue, such as the cross-section of a resected liver lobe. Accordingly, the ablation device of the present invention may be particularly useful during procedures involving the removal of unhealthy, or otherwise undesired, tissue from any part of the body. Thus, tumors, both benign and malignant, may be removed via a surgical intervention and the ablation devices described herein can be used to coagulate the tissue of the resection site. The tissue system of the present disclosure can also be used on large surface areas of tissue to treat surface lesions.
In particular, the present disclosure is generally directed to a surface tissue ablation system including an ablation device to be delivered to the surface of tissue to emit non-ionizing radiation, such as radiofrequency (RF) energy, in a desired shape or pattern so as to deliver treatment for the ablation and coagulation of large surface areas of tissue.
The tissue ablation device of the present invention generally includes a probe including an elongated shaft configured as a handle and adapted for manual manipulation and a nonconductive distal portion coupled to the shaft. The nonconductive distal portion is a rigid arcuate body and includes an electrode array positioned along a convex exterior surface of the body. The distal portion, including the electrode array, can be delivered to a resection site and the convex side of the distal portion can be swept along the surface of cross-sectional tissue (e.g., tissue remaining after tumor removal) and configured to coagulate the tissue (via RF energy) in contact therewith.
The tissue ablation device of the present disclosure is configured to allow surgeons, or other medical professionals, to deliver controlled doses of RF energy at consistent depths to large surface areas of tissue to achieve coagulation in a quick and efficient manner. Importantly, the devices are configured to be applied to tissue in a sweeping motion, thus allowing for real-time assessment of progress of ablation, without the need to stop treatment to assess the progress. By using a sweeping or painting technique, the device is able to cover large surface areas of tissue in a short amount of time. For example, after liver resection, the device may be used to paint the entire cross-section of a resected liver lobe without pausing to assess the progress of the ablation.
In other aspects, a tissue ablation system consistent with the present disclosure may also be well suited for treating hollow body cavities, such as irregularly-shaped cavities in breast tissue created by a lumpectomy procedure. For example, once a tumor has been removed, a tissue cavity remains. The tissue surrounding this cavity is the location within a patient where a reoccurrence of the tumor may most likely occur. Consequently, after a tumor has been removed, it is desirable to destroy the surrounding tissue (also referred herein as the “margin tissue” or “marginal tissue”).
The tissue ablation system of the present disclosure can be used during an ablation procedure to destroy the thin rim of marginal tissue around the cavity in a targeted manner. In particular, the present disclosure is generally directed to a cavitary tissue ablation system including an ablation device to be delivered into a tissue cavity and configured to emit non-ionizing radiation, such as radiofrequency (RF) energy, in a desired shape or pattern so as to deliver treatment for the ablation and destruction of a targeted portion of marginal tissue around the tissue cavity.
The tissue ablation device of the present invention generally includes a probe including an elongated shaft configured as a handle and adapted for manual manipulation and a nonconductive distal portion coupled to the shaft. The nonconductive distal portion includes an electrode array positioned along an external surface thereof. The distal portion, including the electrode array, can be delivered to and maneuvered within a tissue cavity (e.g., formed from tumor removal) and configured to ablate marginal tissue (via RF energy) immediately surrounding the tissue cavity in order to minimize recurrence of the tumor. The tissue ablation device of the present disclosure is configured to allow surgeons, or other medical professionals, to deliver precise, measured doses of RF energy at controlled depths to the marginal tissue surrounding the cavity.
Accordingly, a tissue ablation device consistent with the present disclosure may be well suited for treating hollow body cavities, such as irregularly-shaped cavities in breast tissue created by a lumpectomy procedure. It should be noted, however, that the devices of the present disclosure are not limited to such post-surgical treatments and, as used herein, the phrase “body cavity” may include non-surgically created cavities, such as natural body cavities and passages, such as the ureter (e.g. for prostate treatment), the uterus (e.g. for uterine ablation or fibroid treatment), fallopian tubes (e.g. for sterilization), and the like. Additionally, or alternatively, tissue ablation devices of the present disclosure may be used for the ablation of marginal tissue in various parts of the body and organs (e.g., skin, lungs, liver, pancreas, etc.) and is not limited to treatment of breast cancer.
As will be described in greater detail herein, the device controller 18 may be used to control the emission of energy from one or more conductive members of the device 14 to result in ablation. In other embodiments, the device controller 18 may also control the delivery of fluid to the applicator head 16 so as to control subsequent weeping of fluid from the head 16 during an RF ablation procedure. In some embodiments, the applicator head 16 may receive the fluid from an external source, such as by pouring the fluid from a container into the head 16. In some cases, the device controller 18 may be housed within the ablation device 14. The ablation generator 20 may also be connected to a return electrode 15 that is attached to the skin of the patient 12.
As will be described in greater detail herein, during an ablation treatment, the ablation generator 20 may generally provide RF energy (e.g., electrical energy in the radiofrequency (RF) range (e.g., 350-800 kHz)) to an electrode array of the ablation device 14, as controlled by the device controller 18. At the same time, saline may also be released from the head 16. The RF energy travels through the blood and tissue of the patient 12 to the return electrode 15 and, in the process, ablates the region(s) of tissues adjacent to portions of the electrode array that have been activated.
It should further be noted that the distal portion or tip 16, specifically body 26 is not limited to a spheroid or hemispherical shape. Rather, the distal portion or tip 16 consistent with the present disclosure described herein, can be in the form of various arcuate shapes. For example, the body 26 may include a spherical shape, including, but not limited to, an oblate spheroid, a prolate spheroid, and various forms therebetween. The body 26 may also include other arcuate shapes, such as an elliptical shape, an oval shape, and various forms thereof, as will be described in greater detail herein, particularly with regard to
In some examples, the spheroid body 26 includes a non-conductive material (e.g., a polyamide) as a layer on at least a portion of an internal surface, an external surface, or both an external and internal surface. In other examples, the spheroid body 26 is formed from a non-conductive material. Additionally or alternatively, the spheroid body 26 material can include an elastomeric material or a shape memory material.
In some examples, the spheroid body 26 or the hemispherical body (e.g., as illustrated in
The distal tip 16 of the ablation device 14 further includes an electrode array positioned thereon. The electrode array includes at least one conductive member 28. As illustrated in the figures, the electrode array may include at least eight conductive members 28. Accordingly, the electrode array may include a plurality of conductive members 28. The plurality of conductive members 28 extend within the distal tip 16, through a channel 32 and along an external surface of the spheroid body 26. The conductive members 28 extend along the longitudinal length of the distal tip 16 and are radially spaced apart (e.g., equidistantly spaced apart) from each other. These conductive members transmit RF energy from the ablation generator and can be formed of any suitable conductive material (e.g., a metal such as stainless steel, nitinol, or aluminum). In some examples, the conductive members 28 are metal wires. Accordingly, for ease of description, the conductive member(s) will be referred to hereinafter as “conductive wire(s) 28”.
As illustrated, one or more of the conductive wires 28 can be electrically isolated from one or more of the remaining conductive wires 28. This electrical isolation enables various operation modes for the ablation device 14. For example, ablation energy may be supplied to one or more conductive wires 28 in a bipolar mode, a unipolar mode, or a combination bipolar and unipolar mode. In the unipolar mode, ablation energy is delivered between one or more conductive wires 28 on the ablation device 14 and the return electrode 15, as described with reference to
The electrode array may further include one or more stabilizing members 30 configured to provide support for the plurality of conductive wires 28. The one or more stabilizing member 30 generally extend along a surface (e.g., external or internal) of the distal tip 16 so as to circumscribe the spheroid body 26. The stabilizing members 30 can, in some examples, electrically connect to one or more conductive wires 28. In other examples, the stabilizing members 30 are non-conductive. The stabilizing members 30 can be formed of a suitably stiff material (e.g., metal such as stainless steel, nitinol, or aluminum). In some implementations, the stabilizing members 30 can be integral with a portion of the spheroid body 26 (e.g., as a rib). While, the distal tip 16 is generally shown with one or more stabilizing members, in some implementations, the distal tip 16 is free of stabilizing members.
To further aid in illustrating the arrangement of the conductive wires 28 and the non-conductive spheroid body 26,
As shown, the distal tip 16 may be coupled to the ablation generator 20 and/or irrigation pump 22 via an electrical line 34 and a fluid line 38, respectively. Each of the electrical line 34 and fluid line 38 may include an adaptor end 36, 40, respectively, configured to couple the associated lines with a respective interface on the ablation generator 20 and irrigation pump 22. In some examples, the ablation device 14 may further include a user switch or interface 19 which may serve as the device controller 18 and thus, may be in electrical communication with the ablation generator 20 and the ablation device 14, as well as the irrigation pump 22 for controlling the amount of fluid to be delivered to the tip 16.
The switch 19 can provide a user with various options with respect to controlling the ablation output of the device 14, as will be described in greater detail herein. For example, the switch 19, which may serve as the device controller 18, may include a timer circuit, or the like, to enable the conductive wires 28 to be energized for a pre-selected or desired amount of time. After the pre-selected or desired amount of time elapses, the electrical connection can be automatically terminated to stop energy delivery to the patient. In some cases, the switch 19 may be connected to individual conductive wires 28. For example, in some embodiments, the switch 19 may be configured to control energy delivery from the ablation generator 20 so that one or more individual conductive wires, or a designated combination of conductive wires, are energized for a pre-selected, or desired, duration.
In some examples, each conductive wire 28 can extend through a different distal port 46, which allows the conductive wires 28 to remain electrically isolated from one another. In other examples, one or more conductive wires can extend through the same distal port 46.
Upon passing through a distal port 46, each conductive wire 28 can extend along an external surface of the distal tip 16. In some examples, the length of the conductive wire 28 extending along the external surface is at least 20% (e.g., at least, 50%, 60%, 75%, 85%, 90%, or 99%) of the length of the spheroid body 26. The conductive wire 28 can then re-enter the lumen 42 of the distal tip 16 through a corresponding proximal port 44. For example, as shown in
In some examples, each conductive wire 28 can extend through a different associated proximal port 44, which allows the conductive wires 28 to remain electrically isolated from one another. In other examples, one or more conductive wires can extend through the same proximal port. Yet still, as will be described in greater detail herein, particularly with reference to the devices 14a, 14b and 14c illustrated in
In some embodiments, the spheroid body 26 may be configured to transition between a collapsed state and an expanded state, which may allow for a surgeon to introduce the distal portion 26 into certain areas of the body that may have reduced openings and could be difficult to access with when the spheroid body is in the default shape.
As shown, when in a delivery configuration, the spheroid body 26 may generally have a prolate-spheroid shape, thereby having a reduced size (e.g., equatorial diameter) relative to the deployed configuration size (e.g., equatorial diameter). In some embodiments, the spheroid body 26 may be configured to transition between the delivery and deployed configurations via manipulation of one or more of the conductive wires. For example, as shown in
In some implementations, the catheter shaft 17 can be configured as a handle adapted for manual manipulation. In some examples, the catheter shaft 17 is additionally or alternatively configured for connection to and/or interface with a surgical robot, such as the Da Vinci® surgical robot available from Intuitive Surgical, Inc., Sunnyvale, Calif. The catheter shaft 17 may be configured to be held in place by a shape lock or other deployment and suspension system of the type that is anchored to a patient bed and which holds the device in place while the ablation or other procedure takes place, eliminating the need for a user to manually hold the device for the duration of the treatment.
As previously described, conductive members 28 extend through a first port (e.g., the distal port 44), run along an external surface of the spheroid body 26 (e.g. within the groove 47) before re-entering the lumen of the distal tip 16 through another port (e.g., the proximal port 46). A conductive fluid, such as saline, may be provided to the distal tip 16 via the fluid line 38, wherein the saline may be distributed through the ports (e.g., to the distal ports 44, the proximal ports 46, and/or medial ports 45). The saline weeping through the ports and to an outer surface of the distal tip 16 is able to carry electrical current from electrode array, such that energy is promoted from the electrode array to the tissue by way of the saline weeping from the ports, thereby creating a virtual electrode. Accordingly, upon the fluid weeping through the ports, a pool or thin film of fluid is formed on the exterior surface of the distal tip 16 and is configured to ablate surrounding tissue via the electrical current carried from the electrode array.
As shown, the ablation device 14 may further include hydrophilic insert 54 aligned with the fluid delivery line 38 and positioned within the interior chamber formed between the two halves 16a, 16b. The hydrophilic insert 54 is configured to distribute fluid (e.g., saline) delivered from the fluid line 38 through the distal tip 16 by, for example, wicking the saline against gravity. This wicking action improves the uniformity of saline distribution to the device ports (e.g., to the proximal ports 44, the distal ports 46, and/or a medial ports 45). The hydrophilic insert 54 can be formed from a hydrophilic foam material (e.g., hydrophilic polyurethane).
As shown in
While various conductive wires 28 have generally been described such that individual conductive members are energized or that the desired combination of conductive members is energized for a pre-selected or desired duration, in some cases, the desired combination of conductive members can be based on desired contact region of the distal tip 16.
In other embodiments, where the distal tip 16 is a hemispherical body (i.e., one half of the spheroid body), as described in greater detail herein, the distal tip 16 can be divided into two sides, one side 72 being the convex portion of the hemispherical body, and the other side 70 being the planar side, with a top axis/side 66 and a bottom axis side 68. In such embodiments, the conductive wires 28 as described herein, only extend along the convex external surface of the distal tip 16 in a direction that is parallel to the longitudinal axis of the device in the configurations as described throughout.
The device 14a is configured to provide RF ablation via a virtual electrode arrangement, which includes distribution of a fluid along an exterior surface of the distal tip 16 and, upon activation of the electrode array, the fluid may carry, or otherwise promote, energy emitted from the electrode array to the surrounding tissue. For example, the nonconductive spheroid body 26 includes an interior chamber (when the first and second halves 26a, 26b are coupled to one another) for retaining at least a spacing member 96 (also referred to herein as “spacer ball”) and one or more hydrophilic inserts 98a, 98b surrounding the spacing member 96. The interior chamber of the distal tip 16 is configured to receive and retain a fluid (e.g., saline) therein from a fluid source. The hydrophilic inserts 98a, 98b are configured receive and evenly distribute the fluid through the distal tip 16 by wicking the saline against gravity. The hydrophilic inserts 98a and 98b can be formed from a hydrophilic foam material (e.g., hydrophilic polyurethane).
As previously described, the distal tip 16 may generally include a plurality of ports or apertures configured to allow the fluid to pass therethrough, or weep, from the interior chamber to an external surface of the distal tip 16. Accordingly, in some embodiments, all of the ports (e.g., proximal ports 44, medial ports 45, and distal ports 46) may be configured to allow for passage of fluid from the inserts 98a, 98b to the exterior surface of the distal tip 16. However, in some embodiments, only the medial ports 45 may allow for fluid passage, while the proximal and distal ports 44, 46 may be blocked via a heat shrink or other occlusive material.
The spacer member 96 may formed from a nonconductive material and may be shaped and sized so as to maintain the hydrophilic inserts 98a, 98b in sufficient contact with the interior surface of the distal tip wall, and specifically in contact with the one or more ports, such that the hydrophilic inserts 98a, 98b provides uniformity of saline distribution to the ports. In some embodiments, the spacer member 96 may have a generally spherical body, corresponding to the interior contour of the chamber of the spheroid body 26.
Accordingly, upon positioning the distal tip 16 within a target site (e.g., tissue cavity to be ablated), the electrode array can be activated and fluid delivery can be initiated. The fluid weeping through the ports to the exterior surface of the distal tip is able to carry energy from electrode array, thereby creating a virtual electrode. Accordingly, upon the fluid weeping through the port, a pool or thin film of fluid is formed on the exterior surface of the distal portion and is configured to ablate surrounding tissue via the RF energy carried from the electrode array.
As previously described herein, conductive wires 28 may generally extend through a first port (e.g., the distal port 44), run along an external surface of the spheroid body 26 before re-entering the lumen of the distal tip 16 through another port (e.g., the proximal port 46).
As shown, the first conductive wire 28(1) extends within the lumen of the tip 16a and passes through proximal port 44(1), extends along the exterior surface of the spheroid body 26a towards the distal ports (generally parallel to longitudinal axis of device), passes through distal port 46(1), extends along the interior surface of the body 26a towards adjacent distal ports (generally transverse to longitudinal axis of the device), passes through distal port 46(2), extends along the exterior surface of the spheroid body 26a back towards the proximal ports, passes through proximal port 44(2), extends along the interior surface of body 26a towards adjacent proximal ports, passes through proximal port 44(5), extends along the exterior surface of the spheroid body 26a back towards the distal ports, passes through distal port 46(5), extends along the interior surface of the body 26a towards adjacent distal ports, passes through distal port 46(6), extends along the exterior surface of the spheroid body 26a back towards the proximal ports, passes through proximal port 44(6), and extends back through lumen of the tip 16a. Accordingly, the first conductive wire 28(1) has at least four portions that extend along the exterior surface of the spheroid body 26a.
The second conductive wire 28(2) extends within the lumen of the tip 16a and passes through distal port 44(3), extends along the exterior surface of the spheroid body 26a towards the distal ports (generally parallel to longitudinal axis of device), passes through distal port 46(3), extends along the interior surface of the body 26a towards adjacent distal ports (generally transverse to longitudinal axis of the device), passes through distal port 46(4), extends along the exterior surface of the spheroid body 26a back towards the proximal ports, passes through proximal port 44(4), and extends back through lumen of the tip 16a. Accordingly, the second conductive wire 28(2) has at least two portions that extend along the exterior surface of the spheroid body 26a.
As shown, the third conductive wire 28(3) extends within the lumen of the tip 16a and passes through proximal port 44(9), extends along the exterior surface of the spheroid body 26b towards the distal ports (generally parallel to longitudinal axis of device), passes through distal port 46(9), extends along the interior surface of the body 26b towards adjacent distal ports (generally transverse to longitudinal axis of the device), passes through distal port 46(10), extends along the exterior surface of the spheroid body 26b back towards the proximal ports, passes through proximal port 44(10), and extends back through lumen of the tip 16a. Accordingly, the third conductive wire 28(3) has at least two portions that extend along the exterior surface of the spheroid body 26b.
The fourth conductive wire 28(4) extends within the lumen of the tip 16b and passes through proximal port 44(7), extends along the exterior surface of the spheroid body 26b towards the distal ports (generally parallel to longitudinal axis of device), passes through distal port 46(7), extends along the interior surface of the body 26b towards adjacent distal ports (generally transverse to longitudinal axis of the device), passes through distal port 46(8), extends along the exterior surface of the spheroid body 26b back towards the proximal ports, passes through proximal port 44(8), extends along the interior surface of body 26b towards adjacent proximal ports, passes through proximal port 44(11), extends along the exterior surface of the spheroid body 26b back towards the distal ports, passes through distal port 46(11), extends along the interior surface of the body 26b towards adjacent distal ports, passes through distal port 46(12), extends along the exterior surface of the spheroid body 26b back towards the proximal ports, passes through proximal port 44(12), and extends back through lumen of the tip 16a. Accordingly, the fourth conductive wire 28(4) has at least four portions that extend along the exterior surface of the spheroid body 26b.
Furthermore, each of the four conductive wires 28(1)-28(4) remain electrically isolated and independent from one another such that, each, or one or more sets of a combination of, the conductive wires, can independently receive an electrical current from the ablation generator and independently conduct energy, the energy including RF energy. This allows energy to be selectively delivered to a designated conductive wire or combination of conductive wires. This design also enables the ablation device to function in a bipolar mode because a first conductive wire (or combination of conductive wires) can deliver energy to the surrounding tissue through its electrical connection with an ablation generator while a second conductive wire (or combination of conductive wires) can function as a ground or neutral conductive member.
The independent control of each wire or sets of wires allows for activation (e.g., emission of RF energy) of corresponding portions of the electrode array. For example, the electrode array may be partitioned into specific portions which may correspond to clinical axes or sides of the distal portion of the device. In one embodiment, the electrode array may include at least four distinct portions (i.e., individual or sets of conductive wires) corresponding to four clinical axes or sides of the distal portion (e.g., four sides or quadrants around spheroid body).
As previously described herein, the controller 18, 19 may be configured to provide a surgeon with the ability to control ablation, such as controlling the supply of power to one or more conductive wires as well as control the delivery of fluid to the device tip 16. Furthermore, the controller 18, 19 may provide device status (e.g., power on/off, ablation on/off, fluid delivery on/off) as well as one or more parameters associated with the RF ablation (e.g., energy output, elapsed time, timer, temperature, conductivity, etc.). Thus, in some instances, it may be important to monitor at least the temperature adjacent to the device tip 16 during the ablation procedure, as well as pre-ablation and post-ablation, as temperature may be indicative of the status of surrounding tissue that is being, or is intended to be, ablated. Furthermore, it may be important to monitor the temperature at certain distances from the device tip 14 and at certain angles. Current devices may include a thermocouple mechanism integrated into the device. However, such configurations lack the ability to obtain temperature measurement at specific distances and angles relative to the ablation tip. The mount 100 is configured to provide a surgeon with the ability to adjacent the angle at which the temperature probe is positioned relative to the device tip 16 as well as the distance from the device tip 16, thereby overcoming the drawbacks of integrated thermocouples.
As shown, the mount 100 generally includes a body having a first end 108 configured to be releasably coupled to at least the proximal end of the device 14 by way of a clamping mechanism or latch-type engagement. The first end 108 includes a top guard member 110 configured to partially enclose at least the proximal end of the device 14, to further enhance securement of the mount 100 to the device 14. The mount 100 further includes an arm member 112 extending from the first end 108 and providing a second end 114 positioned a distance from the first end 108. The second end 114 is configured to hold the temperature probe 102 at a desired position, including a desired distance from the spheroid body 26 and a desired angle θ relative to the longitudinal axis of the ablation device. For example, in one embodiment, the second end 114 may include a bore or channel configured to receive and retain a portion of the temperature probe 102 within. The second end 114 may further allow for the temperature probe 102 to translate along the bore or channel, as indicated by arrow 116, to thereby adjust the distance of the temperature probe tip 104 relative to the spheroid body of the device tip. In some embodiments, the arm 112 and/or second end 114 may articulate relative to one another and/or the first end 108. Accordingly, the angle of the temperature probe 102 may also be adjusted as desired.
Accordingly, a tissue ablation devices, particularly the applicator heads described herein, may be well suited for treating hollow body cavities, such as cavities in breast tissue created by a lumpectomy procedure. The devices, systems, and methods of the present disclosure can help to ensure that all microscopic disease in the local environment has been treated. This is especially true in the treatment of tumors that have a tendency to recur.
The device 14b includes the distal tip 16 formed from two or more pieces (tip halves 16a and 16b) configured to be coupled to one another to form the unitary distal tip 16. Each half 16a and 16b includes at least cooperating neck portions 24a, 24b. The device 14b includes a hemispherical body 27 formed by at least one solid flat body 27a and one convex body 27b (i.e., one half of a spheroid body, 26b) configured so that the solid flat body 27a is coupled with the convex body 27b to form the hemispherical body 27. Both halves 16a and 16b are configured so as to fully enclose the interior of the distal tip 16.
As further illustrated, an electrical line 34 may be provided for coupling the conductive wires 28 to the controller 18 and ablation generator 20 and a fluid line 38 (not shown) may be provided for providing a fluid connection between the irrigation pump or drip 22 to the distal tip 16 so as to provide a conductive fluid (e.g., saline) to the tip 16. The electrical line 34 and/or the fluid delivery line 38 can be supported by a stabilizing element 62 within the device lumen. In some cases, the stabilizing element 62 may be integral with the neck 24 of the distal tip 16. For example, the nonconductive hemispherical body 27 includes an interior chamber (when the first and second halves 27a, 27b are coupled to one another) for retaining a hemispherical spacing member 96a (i.e., a half of the spacing member 96 described throughout) and a hydrophilic insert 98 (i.e., either 98a or 98b as described throughout) surrounding the convex side of the spacing member 96a.
The hemispherical spacer member 96a may formed from a nonconductive material and may be shaped and sized so as to maintain the hydrophilic insert 98 in sufficient contact with the interior surface of the distal tip wall, and specifically in contact with the one or more ports, such that the hydrophilic insert 98 provides uniformity of saline distribution to the ports. In some embodiments, the spacer member 96a may have a generally hemispherical body, corresponding to the interior contour of the chamber of the hemispherical body 27.
As further illustrated, an electrical line 34 may be provided for coupling conductive wires 28 to the controller 18. The electrical line 34 can be supported by a stabilizing element 62 within the device lumen. In some cases, the stabilizing element 62 may be integral with the neck 24 of the distal tip 16. In some embodiments of the invention, instead of receiving the fluid via a device lumen, the fluid is received from an external source, such as from a user inputting (e.g., pouring) the fluid to the device cavity 29. As previously described, the distal tip 16 may also generally include a plurality of ports or apertures configured to allow the fluid to pass therethrough, or weep, from the interior chamber to an external surface of the distal tip 16. In some embodiments of the invention, some the plurality of ports or apertures may be configured to receive the fluid (i.e., receiving ports 124) and transport it into the interior chamber, before the fluid is allowed to weep through the ports configured to do so.
As illustrated, the device 14c is configured to receive a fluid via the cavity 29 and to provide RF ablation via a virtual electrode arrangement, which includes distribution of the fluid along a convex exterior surface 120 of the hemispherical body 27 of the distal tip 16 and, upon activation of the electrode array, the fluid may carry, or otherwise promote, energy emitted from the electrode array to the surrounding tissue. For example, the nonconductive hemispherical body 27 includes an interior chamber 122 (shown in
The hydrophilic insert 98 is in sufficient contact with the surface of the interior chamber 122 of the distal tip wall, and specifically in contact with one or more of the receiving ports 124 and one or more of the ports of the convex body 27b (e.g., the medial ports 45), such that the hydrophilic insert 98 provides uniformity of saline distribution to the ports of the convex body 27b.
Accordingly, upon positioning the convex body 27b portion of the distal tip 16 near a target site (e.g., tissue to be ablated), fluid can be delivered to the cavity 29 and then the electrode array can be activated. The fluid weeping through the ports of the convex body 27b to the convex exterior surface 120 of the distal tip 16 is able to carry energy from electrode array, thereby creating a virtual electrode. Accordingly, upon the fluid weeping through the ports of the convex body 27b, a pool or thin film of fluid is formed on the convex exterior surface 120 of the distal tip 16 and is configured to ablate surrounding tissue via the RF energy carried from the electrode array.
As previously described, the distal portion of a treatment device consistent with the present disclosure may include various shapes and/or sizes depending on the specific treatment to be provided and/or the specific site to which the treatment is to be applied. For example,
It should further be noted that the shapes illustrated in
The tissue ablation devices having hemispherical heads described herein are particularly useful for treating surface area tissue, such as resection tissue after removal of a tumor or a biopsy, or to treat surface lesions.
As used in any embodiment herein, the term “controller”, “module”, “subsystem”, or the like, may refer to software, firmware and/or circuitry configured to perform any of the aforementioned operations. Software may be embodied as a software package, code, instructions, instruction sets and/or data recorded on non-transitory computer readable storage medium. Firmware may be embodied as code, instructions or instruction sets and/or data that are hard-coded (e.g., nonvolatile) in memory devices. “Circuitry”, as used in any embodiment herein, may comprise, for example, singly or in any combination, hardwired circuitry, programmable circuitry such as computer processors comprising one or more individual instruction processing cores, state machine circuitry, and/or firmware that stores instructions executed by programmable circuitry. The controller or subsystem may, collectively or individually, be embodied as circuitry that forms part of a larger system, for example, an integrated circuit (IC), system on-chip (SoC), desktop computers, laptop computers, tablet computers, servers, smart phones, etc.
Any of the operations described herein may be implemented in a system that includes one or more storage mediums having stored thereon, individually or in combination, instructions that when executed by one or more processors perform the methods. Here, the processor may include, for example, a server CPU, a mobile device CPU, and/or other programmable circuitry.
Also, it is intended that operations described herein may be distributed across a plurality of physical devices, such as processing structures at more than one different physical location. The storage medium may include any type of tangible medium, for example, any type of disk including hard disks, floppy disks, optical disks, compact disk read-only memories (CD-ROMs), compact disk rewritables (CD-RWs), and magneto-optical disks, semiconductor devices such as read-only memories (ROMs), random access memories (RAMs) such as dynamic and static RAMs, erasable programmable read-only memories (EPROMs), electrically erasable programmable read-only memories (EEPROMs), flash memories, Solid State Disks (SSDs), magnetic or optical cards, or any type of media suitable for storing electronic instructions. Other embodiments may be implemented as software modules executed by a programmable control device. The storage medium may be non-transitory.
As described herein, various embodiments may be implemented using hardware elements, software elements, or any combination thereof. Examples of hardware elements may include processors, microprocessors, circuits, circuit elements (e.g., transistors, resistors, capacitors, inductors, and so forth), integrated circuits, application specific integrated circuits (ASIC), programmable logic devices (PLD), digital signal processors (DSP), field programmable gate array (FPGA), logic gates, registers, semiconductor device, chips, microchips, chip sets, and so forth.
Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
The terms and expressions which have been employed herein are used as terms of description and not of limitation, and there is no intention, in the use of such terms and expressions, of excluding any equivalents of the features shown and described (or portions thereof), and it is recognized that various modifications are possible within the scope of the claims. Accordingly, the claims are intended to cover all such equivalents.
This application claims the benefit of, and priority to, U.S. Provisional Application No. 62/850,316, filed May 20, 2019, the content of which is hereby incorporated by reference herein in its entirety. This application is also a continuation-in-part of U.S. Non-Provisional application Ser. No. 15/828,941, filed Dec. 1, 2017, which is a continuation of U.S. Non-Provisional application Ser. No. 15/624,327, filed Jun. 15, 2017 (now U.S. Pat. No. 9,839,472), which is a continuation of U.S. Non-Provisional application Ser. No. 15/337,334, filed Oct. 28, 2016 (now U.S. Pat. No. 9,848,936), which claims the benefit of, and priority to, U.S. Provisional Application No. 62/248,157, filed Oct. 29, 2015, and U.S. Provisional Application No. 62/275,984, filed Jan. 7, 2016, the contents of each of which are hereby incorporated by reference herein in their entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2020/033355 | 5/18/2020 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 62850316 | May 2019 | US |
