MINIMALLY INVASIVE ASSEMBLY FOR LUNG ABLATION
20200367962 ยท 2020-11-26
Inventors
Cpc classification
A61B18/1492
HUMAN NECESSITIES
A61B2018/167
HUMAN NECESSITIES
A61B18/1487
HUMAN NECESSITIES
A61B2018/1475
HUMAN NECESSITIES
A61B2034/301
HUMAN NECESSITIES
A61B2018/00982
HUMAN NECESSITIES
A61B2018/00214
HUMAN NECESSITIES
International classification
Abstract
The present disclosure is directed to a minimally invasive medical assembly including a delivery device in the form of a sheath configured to be delivered to a target site in a patient by being advanced through tortuous anatomy to deliver surgical and ablative devices to a target site (e.g. a lung tumor), to remove and ablate the target tissue. The invention allows for the delivery of various surgical and ablative devices to a target site without the need to surgically open and release the patient's chest cavity.
Claims
1. A medical assembly for ablating a target site in the tissue of a subject, comprising a sheath having a proximal end and a distal end, the distal end of the sheath configured to provide access to the target site; a coring device configured to be inserted into the proximal end of the sheath and access the distal end of the sheath, the coring device configured to surgically create a cavity in the target site; an extraction device configured to be inserted into the proximal end of the sheath and access the distal end of the sheath, the extraction device configured to remove tissue from the cavity created by the coring device; and an ablation device configured to be inserted into the proximal end of the sheath and access the distal end of the sheath, the ablation device configured to enter the cavity created by the coring device and conduct and deliver energy for ablation to the target site.
2. The medical assembly of claim 1, wherein the extraction device is configured to use suction force to remove the tissue from the cavity created by the coring device.
3. The medical assembly of claim 1, wherein the ablation device comprises: an inflatable member configured to transition from a collapsed configuration to an expanded configuration, the inflatable member having an interior surface and an exterior surface, the inflatable member configured to conduct and deliver the energy for ablation to the exterior surface of the inflatable member and to the target site when in the expanded configuration.
4. The medical assembly of claim 3, further comprising at least one lumen configured to extend from the proximal end of the sheath to the distal end of the sheath when the ablation device has accessed the distal end of the sheath, wherein: the inflatable member is configured to be in fluid communication with the at least one lumen to allow passage of a fluid from the at least one lumen to the interior surface of the inflatable member, the inflatable member comprises a plurality of perforations to allow the passage of a fluid from the interior surface of the inflatable member to the exterior surface of the inflatable member; and the ablation device is configured to conduct the energy for ablation to be delivered by the fluid passing through the plurality of perforations to the target site when in the expanded configuration.
5. The medical assembly of claim 3, further comprising one or more conductive wires disposed along at least a portion of an exterior surface of the inflatable member, the one or more conductive wires configured to conduct the energy for ablation to the target site.
6. The medical assembly of claim 3, wherein the energy for ablation is monopolar energy.
7. The medical assembly of claim 6, wherein the medical assembly further comprises a monopolar return member configured to be placed on the exterior of the subject and the ablation device is configured to conduct energy for ablation from the exterior surface of the inflatable member through the target tissue in the direction of the monopolar return member.
8. The medical assembly of claim 1, wherein the ablation device comprises: an expandable mesh assembly having a self-expanding mesh body configured to transition between a collapsed configuration and an expanded configuration, in which the mesh body expands into a predefined shape, the mesh body comprising an electrically conductive material and configured to conduct and deliver the energy for ablation to the target tissue when in the expanded configuration.
9. The medical assembly of claim 1, wherein the sheath is configured to provide access to the target site by entering into and articulating along the interior of one or more vessels in the target tissue to reach the target site.
10. The medical assembly of claim 9, further comprising a controller that is configured to control articulation of the sheath.
11. The medical assembly of claim 9, wherein the controller is configured to control the operation of one or more of the coring device, the extraction device, and the ablation device.
12. The medical assembly of claim 11, wherein the controller is a surgical robot.
13. The medical assembly of claim 9, wherein the target site is lung tissue.
14. The medical assembly of claim 13, wherein the one or more vessels are bronchioles.
15. The medical assembly of claim 14, wherein the channel is configured to be inserted into the trachea and articulated to reach the interior of the bronchioles.
16. The medical assembly of claim 1, wherein the target site is a tumor.
17. A medical assembly for ablating a target site in the tissue of a subject, comprising a sheath having a proximal end and a distal end, the distal end of the sheath configured to provide access to the target site; an ablation device configured to be inserted into the proximal end of the sheath and access the distal end of the sheath, the ablation device comprising a first arm and second arm configured to be articulated to and apply pressure to a first point and a second point at the target site, the ablation device further configured to conduct and deliver energy for ablation from the first arm through the target site to the second arm when the pressure is applied.
18. The medical assembly of claim 17, wherein the energy for ablation is bipolar energy.
19. The medical assembly of claim 17, wherein the first arm and second arm are connected at a central point.
20. The medical assembly of claim 17, wherein the sheath is configured to provide access to the target site by entering into and articulating along the interior of one or more vessels in the target tissue to reach the target site.
21. The medical assembly of claim 22, wherein articulation of the sheath is used to articulate the first arm and the second arm to apply pressure to the first point and the second point at the target site.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] 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:
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[0040] 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.
DETAILED DESCRIPTION
[0041] The present disclosure is generally directed to a minimally invasive medical assembly including a delivery device in the form of a sheath configured to be delivered to a target site in a patient by being advanced through tortuous anatomy to deliver surgical and ablative devices to a target site (e.g. a lung tumor), to remove and ablate the target tissue. The invention allows for the delivery of various surgical and ablative devices to a target site without the need to surgically open and release the patient's chest cavity.
[0042] As will be described in greater detail herein, each of the devices of the present invention are configured to be advanced to the target site and transition between a delivery configuration, shaped and sized to fit within and pass through the sheath and thereby a pathway (i.e., bronchial airway), and a deployed configuration, in which the device is deployed from the distal end of the sheath and configured to perform its function. For example, with regard to the inflatable ablation device, in a deployed configuration the inflatable device is conjured to be expanded and is shaped and sized in such a manner to contact tissue at the target site and provide energy for ablation, such as non-ionizing radiation, such as radiofrequency (RF) energy, to treat the target tissue, specifically a diseased tissue, such as a cancerous tumor. For example, the inflatable ablation device may generally include an electrode array positioned along an external surface thereof, wherein the electrode array is configured to receive an electrical current from an energy source and conduct energy, the energy including RF energy. The parameters of the ablation, such elapsed time, total energy output, specific energy output pattern, etc., can be controlled and delivered based on the needs at the target site.
[0043] For ease of description and explanation, the following description focuses on the use of the articulating assembly within the tortuous passageways of the lung of a patient. However, it should be noted that the present invention can be used in any other organs which may include tortuous pathways, such as the heart or the vascular system.
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[0047] During an ablation treatment, the ablation device may be controlled by the controller 10 by determining output from the RF generator 35 to the ablation device. The RF generation 35 may generally provide RF energy (e.g., electrical energy in the radiofrequency (RF) range (e.g., 350-800 kHz). At the same time, saline may also be provided to the saline port 39 of the controller 10 and released through one or more lumens to the ablation device.
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[0049] The sheath and various devices may further include sensors or the like to assist in providing visualization of the sheath to a surgeon during a procedure. Thus, in some embodiments, the sheath or devices inserted within the sheath may include a sensor, including, for example, an ultrasound transducer positioned along the sheath 5 adjacent to a distal end thereof or placed upon the body of the patient, wherein a line providing signal from the sensor may be housed within a sheath 5.
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[0052] In aspects of the invention, the inflatable ablation device may include an inner balloon (not shown) configured to receive a fluid or gas coupled to a source controllable via a controller 10, such as a valve or the like. Upon inflation of the inner balloon, the inflatable ablation device may correspondingly expand to assume the deployed configuration. In inflatable ablation device may be further coupled to one or more lumens of the sheath to provide a fluid line, in which the flow of conductive fluid from the controller 10 to the ablation device may be controlled manually via a valve or the like. Furthermore, the electrical line (not shown) coupling the RF generator 35 to an ablation device may further be housed within a separate sheath (not shown). The inflatable ablation device may include a design as described in U.S. Patent Publication No. 2016/0317221, the content of which is incorporated by reference herein in its entirety.
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[0054] The ablation device 73 may include an electrode array is composed of a plurality of conductive members (e.g., conductive wires) 55. In some embodiments, each of the plurality of conductive wires 55, or one or more sets of a combination of conductive wires 55, is configured to independently receive an electrical current from the RF generator 35 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 73 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 the RF generator while a second conductive wire (or combination of conductive wiress) can function as a ground or neutral conductive member. It is understood that where a mesh body is used, the body of the ablation device itself may compose the combination of conductive wires.
[0055] In some embodiments, the ablation device 73 is configurd to provide RF ablation via a virtual electrode arrangement, which includes distribution of a fluid along an exterior surface of the ablation device 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, as previously described, the ablation device includes an interior surface configured to receive the conductive fluid therein from the fluid source through one or more lumens of the sheap. The ablation device may include a plurality of ports, perforations, or apertures configured to allow the fluid to pass therethrough, or weep, from the interior surface to the external surface of the ablation device. Accordingly, upon positioning the ablation device at a target site and subsequently transitioning the device from a collapsed configuation 63 to an expanded configuration 73, the electrode array can be activated and fluid can be delivered to the internal surface of the ablation device. The fluid weeping through the perforations to the outer surface of the ablation device 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 exterior surface of the ablation device and is configured to ablate surrounding tissue via the RF energy carried from the electrode array.
[0056] Advantageously, the ablation devices of the present invention provide uniform ablation depth into the target site, for example uniform ablation depth of the target tumor 40 to avoid ablation of surrounding healthy tissue.
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[0063] In some embodiments, the ablation devices of the present invention may be further configurd to provide RF ablation via a virtual electrode arrangement, which includes distribution of a fluid along an exterior surface of the ablation device. Upon activation of the ablation device, the fluid may carry, or otherwise promote, energy emitted from the electrode array to the surrounding tissue. For example, the inflatable ablation device or mesh assembly may include a plurality of ports or apertures configured to allow the fluid to pass there through, or weep, from an interior surface of the device to an external surface of the device. Accordingly, the fluid may be a conductive fluid (e.g., saline).
[0064] The medical assembly may further include an imaging modality. For example, during a procedure, the imaging modality may provide an operator (e.g., surgeon) with a visual depiction of distal end of the delivery device during advancement towards the target site and may further provide visual depiction of the ablation devices during delivery and deployment thereof when positioning for subsequent ablation of target tissue. For example, in some embodiments, the imaging modality may be configured to receive sensing input from the delivery device (i.e. the sheath), the cutting device, the coring device, the extraction device, and the ablation devices (e.g., sensors on the scope or the devices, such as ultrasound, video, images, etc.) so as to provide an accurate display to the surgeon during a procedure. The imaging modality may provide a medical imaging procedure, including, but not limited to, ultrasound (US), wavelength detection, X-ray-based imaging, illumination, computed tomography (CT), radiography, and fluoroscopy, or a combination thereof, such that, when viewed under such a medical imaging procedure provided by the imaging modality, the visibility of the target site is enhanced and a surgeon can better maneuver the scope and each of the devices during a procedure.
[0065] 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.
[0066] 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.
INCORPORATION BY REFERENCE
[0067] References and citations to other documents, such as patents, patent applications, patent publications, journals, books, papers, web contents, have been made throughout this disclosure. All such documents are hereby incorporated herein by reference in their entirety for all purposes.
EQUIVALENTS
[0068] Various modifications and further embodiments are possible beyond what is shown and described herein. The subject matter herein contains information, exemplification, and guidance that can be adapted to create various other embodiments.