Patent Application
20230405364
The subject of this patent application relates generally to ablation devices, and more particularly to an ultrasound ablation apparatus and associated methods of use for facilitating navigation, ablation, and ablation monitoring.
Applicant hereby incorporates herein by reference any and all patents and published patent applications cited or referred to in this application.
By way of background, ablation is a minimally invasive surgical technique where a surgical probe (such as a needle, for example) is inserted into or near offending tissue—such as a cancerous lesion, damaged nerve, or nerve(s) with abnormal neuronal activity, malfunctioning cardiac tissue, disruptive growths such as uterine fibroids, etc. (hereinafter referred to generally as “target material” for simplicity purposes)—and energy is delivered through the tip of the probe, which destroys the target material. A number of technologies have been used to deliver such energy at the tip of the probe, including RF energy, microwave energy, steam, and cold. However, existing ablation techniques suffer from several limitations that limit the surgeon's ability to (1) confirm the location of the ablation tool in relation to the target material, and (2) control and confirm the extent of energy delivery throughout the target material. These limitations cause surgeons to make a number of tradeoffs when it comes to delivering therapy. For example, in cancer therapy, the inability to precisely control the treatment zone leads to a risk of not completely treating the target material. Thus surgeons often choose to over-deliver energy to ensure the entire extent of the target material is destroyed. Similarly, over-delivery of energy can be used to overcome lack of precision in positioning the ablation tool directly in the center of the target material. This has the obvious drawback of destroying healthy tissue and limiting the utility of such techniques.
One solution to this lack of precision has been to use external imaging, both to image the location of the ablation tool with respect to the target material, as well as identify the extent of energy delivery in real time. An example of such a technique is MRI thermometry, where an ablation procedure is performed within the bore of an MM, and the MRI can detect temperature changes within tissue due to a range of temperature sensitive magnetic resonance parameters (e.g., T1 and T2 relaxation times and proton resonance frequency). However, MRI guided procedures suffer from two shortcomings: an increase in procedure complexity due to the need for MM compatible surgical tools, and the limited availability of MRIs. Other external 3D imaging modalities with similar resolutions, such as CT scanning, also cause related procedural burdens (i.e., difficulty of carrying out surgery in a CT scanner, exposure of patient and clinical staff to harmful radiation, and limited availability of equipment).
Another external imaging approach to aid both localization and temperature monitoring has been to use ultrasound imaging. Ultrasound is a viable temperature monitoring modality since acoustic properties of tissue—such as speed of sound and attenuation—are temperature dependent. In addition to these intrinsic temperature dependent properties, as tissue is ablated, its stiffness also changes, which can be detected by ultrasound. A number of different strategies have been investigated to monitor ablation procedures by exploiting these various contrast mechanisms; however, they are fundamentally limited in several ways. First, ultrasound imaging loses resolution when imaging deeper into tissue. Second, ultrasound requires a continuous region of tissue with similar stiffness between the transducer and the structure being imaged (an “acoustic window”); thus, ultrasound-based ablation monitoring is limited to applications in superficial anatomical structures (e.g., breast). Third, the temperature dependent tissue properties being exploited for ultrasound thermometry are subtle (e.g., <˜5% change for speed of sound over clinically relevant temperature changes). Combined with the non-linearities and diffraction present in ultrasound propagation, the temperature accuracy achieved with traditional ultrasound thermometry has limited clinical utility.
Furthermore, the use of a separate, non-integrated monitoring system, such as those described above, still presents significant challenges. For example, it requires the clinicians to react to observed temperature changes and adjust treatment as needed (e.g., change power settings, physically move surgical probes, etc.). This type of reactive nature further limits the benefits of the pairing of external imaging and current ablation devices.
Ablation devices can only be used as a first line treatment option if they can simultaneously satisfy 3 functions: (1) local tool-tip placement with respect to the target material, (2) precise ablation shaping, and (3) real-time ablation treatment monitoring. Specifically, the latter two features must be integrated in a closed-loop manner to achieve the desired benefit. The current state of the art has focused on combining various applicators with external imaging, such as CT, Mill, and traditional ultrasound. However, the known prior art has failed to successfully combine the above three functions into a single integrated surgical device.
Existing needle-based ablations deliver energy locally, with the needle central in the region of delivered energy. This has several limitations. First, when placing the needle into a tumor, this can cause an increase in the tumor interstitial pressure, increasing the likelihood of tumor rupture. Second, placing the needle within the tumor can cause tumor cells to attach to the needle, leading to needle track seeding (where tumor cells are distributed along the path of needle insertion, outside of the tumor body), thus limiting the ability of the clinician to reuse the needle during the same operation at a new location. This is one of the reasons multiple needles are required per operation, increasing costs of the operation.
All current local solid tumor treatments, including ablation, rely on identifying the physical anatomic location of the tumor within the body. Ideally, this identification is sensitive, specific, spatially accurate, can be carried out without harm to the patient, and can be carried out simultaneously with therapy delivery to accurately guide the therapy. Unfortunately, however, current diagnostic tools each provide only a fraction of these features. Clinicians therefore combine multiple approaches, which increases complexity, inaccuracy, and likelihood of error. For example, CT scans provide a high resolution 3D image of a person's anatomy, and certain cancers appear as variations in intensity within that image. However, the intensity variation of the tumor with respect to the surrounding tissue may be indistinct. While contrast enhanced imaging can improve the intensity difference, the image still represents a single moment in time. Thus, the spatial configuration of the tumor and the surrounding soft tissue changes when delivering therapy (especially surgical manipulations). Also, the intensity variation observed does not correlate exactly with the extent of the cellular boundary of the tumor, nor are the intensity variations highly sensitive and specific to metastatic (as opposed to benign) growths. Finally, a CT scan exposes patients to significant doses of radiation. Similarly, tissue biopsies provide a different set of tradeoffs for characterizing and locating tumors. They are the gold standard for sensitivity and specificity, and for certain therapies there is an opportunity to take a biopsy at the time of therapy delivery. However, arriving at a characterization decision from a tissue sample is slow (from 20-60 minutes), which limits utility when guiding therapy decisions mid-therapy. Further, the biopsy is at a single spatial location, so is poorly suited to characterizing the spatial distribution of metastatic cells. Finally, lab based diagnostics can be very sensitive and specific to certain pathological indicators, but again require a slow process of drawing blood, then sending to a dedicated lab facility for preparation and analysis.
One critical gap in these diagnostic and characterization methods is the in-situ ability to assess spatial distributions of tissue structure in relation to other anatomy (e.g., proximity to other organs), that includes overall shape of pathological tissue distributions, and at a cellular level of resolution. Histological analysis of biopsy tissue achieves cellular level resolution and understanding of cellular morphology, but removed from a shape and location understanding of the anatomy. CT scans and other 3D imaging modalities such as MM give an understanding of larger scale anatomy and pathology location, but poor spatial resolution and tissue discrimination abilities. Another gap is the in-situ ability to understand functional relationships and responses. For all methods described above, each measurement is taken at a single moment in time. It is difficult to characterize tissue over time; nor can the tissue or pathology be characterized in response to a stimulus. Thus, there remains a need for an apparatus that is capable of combining cellular resolution evaluation similar to biopsies, while also understanding larger scale pathological tissue distributions and relationships with other anatomy, delivering this understanding over time, while in-situ, and concomitant with therapy delivery. If measured with the therapy delivery, and/or paired with outcome measurements over time, these measurements could also be used to predict efficacy of certain treatments. Furthermore, if such an apparatus could derive these measurements simultaneously with the existing state of the art (i.e., biopsies+3D imaging), that would provide a bridge of clinical evidence leading to adoption.
Aspects of the present invention fulfill these needs and provide further related advantages as described in the following summary.
It should be noted that the above background description includes information that may be useful in understanding aspects of the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.
Aspects of the present invention teach certain benefits in construction and use which give rise to the exemplary advantages described below.
The present invention solves the problems described above by providing an ultrasound ablation apparatus for facilitating navigation, ablation, and ablation monitoring relative to an at least one target material positioned within or adjacent to a tissue of a patient. In at least one embodiment, the apparatus provides an instrument portion and a base portion engaged with a proximal end of the instrument portion. An opposing distal end of the instrument portion provides a plurality of ultrasound transducers configured for both obtaining an at least one ultrasound image of the target material and selectively emitting acoustic energy to heat, destroy and/or perturb the target material, the transducers arranged so as to form an at least one array. The distal end of the instrument portion further provides an at least one acoustically matched covering positioned and configured for extending over top of the transducers so as to not inhibit the functionality of the transducers.
In at least one other embodiment, the apparatus provides an instrument portion and a base portion engaged with a proximal end of the instrument portion. An opposing distal end of the instrument portion provides a plurality of ultrasound transducers configured for both obtaining an at least one ultrasound image of the target material and selectively emitting acoustic energy to heat and destroy the target material, the transducers arranged so as to form an at least one array positioned on a sidewall of the instrument portion. The sidewall provides an at least one acoustically matched covering positioned and configured for extending over top of the transducers so as to not inhibit the functionality of the transducers while retaining a substantially circular cross-section for the distal end of the instrument portion. The at least one covering is in fluid communication with an at least one reservoir containing an acoustic medium configured for facilitating acoustic communication between the transducers and the target material.
In at least one other embodiment, the apparatus provides an instrument portion and a base portion engaged with a proximal end of the instrument portion. An opposing distal end of the instrument portion provides a plurality of ultrasound transducers configured for both obtaining an at least one ultrasound image of the target material and selectively emitting acoustic energy to heat and destroy the target material, the transducers arranged so as to form an at least one array positioned on a terminal face of the distal end of the instrument portion. The terminal face of the distal end of the instrument portion provides an at least one acoustically matched covering positioned and configured for extending over top of the transducers so as to not inhibit the functionality of the transducers. The at least one covering is in fluid communication with an at least one reservoir containing an acoustic medium configured for facilitating acoustic communication between the transducers and the target material.
In use, the apparatus is capable of precisely focusing acoustic energy toward the target material to achieve a desired ablation shape, based on data gathered from the at least one ultrasound image.
Other features and advantages of aspects of the present invention will become apparent from the following more detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of aspects of the invention.
The accompanying drawings illustrate aspects of the present invention. In such drawings:
The above described drawing figures illustrate aspects of the invention in at least one of its exemplary embodiments, which are further defined in detail in the following description. Features, elements, and aspects of the invention that are referenced by the same numerals in different figures represent the same, equivalent, or similar features, elements, or aspects, in accordance with one or more embodiments.
Turning now to
In at least one embodiment, as discussed in greater detail below, the apparatus 20 incorporates components to facilitate navigation, ablation, and ablation monitoring relative to an at least one target material 26. In that regard, it should be noted that while certain embodiments of the apparatus 20 are illustrated in the accompanying drawings for illustrative purposes, in further embodiments, the apparatus 20 may take on any other size, shape or dimensions, or may be constructed out of any material (or combination of materials), now known or later developed.
In at least one embodiment, the apparatus 20 is in selective communication with at least one of an at least one computing device 22 and an at least one imaging display 24, the at least one computing device 22 and imaging display 24 configured for receiving and displaying the ultrasound images transmitted by the apparatus 20. In at least one embodiment, the at least one computing device 22 is further configured for storing the ultrasound images transmitted by the apparatus 20. It should be noted that communication between each of the apparatus 20, at least one computing device 22, and at least one imaging display 24 may be achieved using any wired- or wireless-based communication protocol (or combination of protocols) now known or later developed. As such, the present invention should not be read as being limited to any one particular type of communication protocol, even though certain exemplary protocols may be mentioned herein for illustrative purposes. It should also be noted that the term “computing device” is intended to include any type of computing or electronic device now known or later developed having a display screen (or at least in communication with a display screen), such as desktop computers, mobile phones, smartphones, laptop computers, tablet computers, personal data assistants, gaming devices, wearable devices, etc. As such, the present invention should not be read as being limited to use with any one particular type of computing device, even though certain exemplary devices may be mentioned or shown herein for illustrative purposes. Additionally, the term “imaging display” is intended to include any type of standalone display device now known or later developed, such as a television, a display screen, heads-up-display enabled glasses or goggles, etc. As such, the present invention should not be read as being limited to use with any one particular type of imaging display, even though certain exemplary devices may be mentioned or shown herein for illustrative purposes.
In at least one embodiment, the apparatus 20 provides a base portion 28 and an instrument portion 30 engaged with the base portion 28. In at least one embodiment, a proximal end 32 of the instrument portion 30 is removably engaged with the base portion 28. In at least one alternate embodiment, the proximal end 32 of the instrument portion 30 is permanently engaged or otherwise integral with the base portion 28. In at least one embodiment, as illustrated in
In at least one embodiment, the transducers 36 are positioned on a sidewall 46 of the distal end 34 of the instrument portion 30, so as to be arranged in a “side facing” configuration—i.e., where the sidewall 46 is to be positioned adjacent to the target material 26. In at least one such embodiment, as illustrated in
Maintenance of acoustic contact between the at least one transducer 36 and the target material 26 is critical to efficient functioning of the apparatus 20. Accordingly, in at least one embodiment, the sidewall 46 provides an at least one acoustically matched covering 56 positioned and configured for extending over top of the transducers 36 so as to not inhibit the functionality of the transducers 36 while retaining a substantially circular cross-section for the distal end 34 of the instrument portion 30. In at least one such embodiment, as illustrated in
Referring again to
In at least one embodiment, as illustrated in
In at least one alternate embodiment, as illustrated in
In at least one embodiment, the apparatus 20 utilizes several techniques that enable a small, compact configuration. In at least one embodiment, as illustrated in
In several embodiments described above, use of non-acoustic sensors are used to enhance the apparatus 20. In at least one such embodiment, where each transducer 36 is a CMUT, these sensors, including temperature and force sensors, can be integrated into the same fabrication as the CMUT. In several embodiments described above, particularly where the instrument portion 30 is configured as a needle, needle flexibility is required. In at least one such embodiment, the transducers 36 are mounted or otherwise connected to an at least one flexible conductive backing 88 (similar to flexible PCBs), thereby allowing the backing 88 (along with the transducers 36) to be wrapped around the instrument portion 30, as illustrated in
As mentioned above, in at least one embodiment, the at least one transducer 36 is configured for operating in a pulse-echo configuration, which enables the apparatus 20 to capture acoustic information from the surrounding tissue 40 near the distal end 34 of the instrument portion 30. The high-frequency content of this data may then be used to discriminate the different tissue 40 and the target material 26, thus providing the information needed to navigate the instrument portion 30 to the desired final position in relation to the target material 26. A number of processing techniques of this pulse-echo data (including but not limited to quantitative ultrasound, harmonic imaging, and statistical analysis) as well as modes of operation (including but not limited to doppler, plane wave imaging, shear wave imaging) can improve the discrimination ability of the apparatus 20 based on the at least one ultrasound image captured by the at least one transducer 36. A key advantage of such embodiments is that, because the distal end 34 of the instrument portion 30 is near the tissue 40 and target material 26, both traditional diagnostic frequencies (5-20 MHz) as well as very high frequency ultrasound can be used (20-70 MHz) to resolve finer detail of the surrounding tissue 40, which would not be accessible to prior art external ultrasound equipment due to the poor penetration depth of high frequency. Further, because a range of frequencies are available for analysis, use of frequency dependent tissue 40 properties can allow for increased discrimination ability.
Additionally, because certain target material 26 (such as cancerous lesions, for example) are often characterized by an increase in local stiffness, a number of mechanical features can be incorporated into the apparatus 20 to support stiffness estimation. In at least one such embodiment, the instrument portion 30 incorporates an at least one active mechanical deformation element (such as an embedded force sensor 92, for example), which can apply forces to the local tissue 40. Using the at least one transducer 36 to image the tissue 40 throughout this applied deformation, along with image processing techniques to align the image regions over the course of the deformation, can enable estimation of the spatial distribution of tissue 40 stiffness throughout the local region of tissue 40. Embedded force sensors 92 can also improve the stiffness estimate by providing known forces at the distal end 34 of the instrument portion 30. Again, this stiffness estimation map can be combined with other imaging results and presented to a user of the apparatus 20 to allow an assessment of the location of the instrument portion 30 relative to the target material 26 and surrounding anatomy.
The position and orientation estimate of the instrument portion 30 may also be enhanced through several methods; namely, the registration of a preoperative image and/or one or more intraoperative imaging modalities (such as x-ray, intraoperative CT, traditional 2d/3d ultrasound, video and stereo imaging, and depth imaging, for example). These additional imaging modalities, which provide additional information as to the location of anatomic configuration of the target material 26 within the body, can be aligned using several methods based on image content, or user-aided steps such as the manual identification of anatomic landmarks. The localization of the at least one ultrasound image captured by the at least one transducer 36 with the additional set of imaging can be supported by dedicated real-time tool tracking hardware, such as magnetic sensors 114 (
In at least one embodiment, based on the local tissue 40 data provided by the at least one transducer 36, the apparatus 20 precisely focuses acoustic energy to achieve the desired ablation shape. Focusing and steering energy at the distal end 34 of the instrument portion 30 is important to achieve a precise ablation region. Known prior art devices and techniques primarily depend on conductive thermal propagation to achieve the desired size of the ablation. However, as tissue 40 coagulation occurs, thermal propagation is significantly reduced, requiring the use of very high temperatures (often greater than 80-90 degrees Celsius) to achieve the needed ablation sizes. These high temperatures further limit the ability to precisely deliver ablation, and increase the risk of using such devices near critical anatomy. In at least one embodiment, the apparatus 20 is capable of precisely focusing acoustic energy using one or more of phase modulation, frequency modulation, and pulse shape modulation. Modulating these parameters allows the shaping of an ablation zone in multiple degrees of freedom (e.g., penetration depth, axial and lateral ablation width). In at least one further embodiment, in addition to focusing acoustic energy using one or more of the above noted electrical means, focusing of acoustic energy may be achieved via combined mechanical means such as articulation to change focal depth and rotation of sensors. For example, in at least one embodiment, the distal end 34 of the instrument portion 30 is flexible and configured for selectively moving between a substantially planar shape (
As discussed above, in at least one embodiment, the at least one first transducer 42 is configured for obtaining an at least one ultrasound image of the target material 26 (along with surrounding tissue 40), while the at least one second transducer 44 is configured for selectively emitting acoustic energy to heat, destroy and/or perturb the target material 26. In at least one such embodiment, the at least one first transducer 42 operates simultaneously or intermittently relative to the operation of the at least one second transducer 44. Additionally, in at least one such embodiment, the apparatus 20 is capable of identifying the heated zones by sensing the changes in acoustic properties via a pulse-echo technique. The speed of sound and acoustic attenuation of tissue 40 is temperature dependent, thus impacting the reflected (“echo”) signal as the temperature changes. In addition, as tissue 40 coagulates its mechanical properties change. Thus as part of the emitted pulse in at least one embodiment, shear waves are induced in the tissue 40 of interest (i.e., the tissue 40 proximal to the target material 26) to measure the elasticity or stiffness of the tissue 40. In another embodiment, the distal end 34 of the instrument portion 30 is configured for selectively applying a mechanical stress in the region of interest to cause small deformations that can then be processed to monitor the stiffness change due to the ablation. This deformation portion may be the same deformation actuation that enables mechanical focusing. These applied mechanical stresses may also be monitored by a collection of embedded force sensors 92, as well as displacement sensors on the actuation method, to provide the means to estimate stiffness. Because many of the acoustic properties relate to an assumption of the speed of sound through distinct tissue 40 types, an initial ultrasound image, along with an estimation of tissue 40 types being imaged, may improve the estimation of the speed of sound, and thus the positional accuracy of the ultrasound image. In at least one embodiment, as energy is delivered and tissue 40 properties change, the initial ultrasound image can be registered (i.e., aligned) with subsequent ultrasound images, with a deformable image model. The degree of deformation needed relates to both the speed of sound changes as well as geometric changes in the tissue 40 (e.g., tissue 40 expansion). Use of the deformation signal can thus provide additional information as to geometric changes if speed of sound changes due to temperature are derived from another source or estimated thermal model. In at least one embodiment, using additional ultrasound modes (such as quantitative ultrasound, or doppler, for example) to further improve the spatial estimation of tissue 40 types (and thus the speed of sound) can further enhance the ultrasound image. Further, in at least one embodiment, a mechanical deformation or reconfiguration of the instrument portion 30 such that some of the transducers 36 lie in a straight line configuration (i.e., not pulse-echo, but transmissive) to other transducers 36 can enable direct estimation of speed of sound through tissue 40. The method by which this mechanical deformation occurs can also be the actuation in certain embodiments as described herein for navigation to region of interest, stiffness estimation, mechanical focusing, or shear wave generation. Embodiments where the at least one transducer 36 is a CMUT in close proximity to the tissue 40 of interest have the unique advantage of being able to capture wideband data from a more homogeneous region when compared to traditional ultrasound thermometry techniques. Reflected wideband acoustic data that has not propagated through multiple tissue 40 types is key to accurate local ablation monitoring as many temperature effects are tissue 40 dependent, non-linear, and frequency dependent. For example, many tissues 40 exhibit a shift in reflected acoustic energy between speckle generators (i.e., sub-wavelength components in tissue 40 that are highly reflective) and normal tissue 40, depending on temperature and frequency. By examining these distributions over time, in at least one embodiment, the apparatus 20 can estimate the temperature throughout the tissue 40.
To further improve the accuracy of the ablation monitoring, in at least one embodiment, a thermal propagation model is used to process the acoustic data—either locally by the apparatus 20 or by the at least one computing device 22 in selective communication with the apparatus 20. An initial ultrasound image that combines quantitative ultrasound with doppler ultrasound techniques will provide an estimate of the thermal properties of the region of interest by identifying the various tissue 40 types. This information combined with the sensing of the changing acoustic properties increases the signal to noise ratio by taking into account the relative change in temperature specifically due to the rate of delivered energy. This model may be continuously updated with deformation estimates from registration, estimates from intensity analysis over time, mechanical deformation aided tissue 40 property estimates, and direct measurements of temperature using a collection of embedded temperature sensors. This method thereby significantly improves the accuracy of the ablation zone monitoring. Accuracy at temperatures between 40-55 degrees Celsius is important for the precision delivery of ablation therapy. While cell death starts to occur at ˜43 degrees Celsius, phase changes in tissue 40 occur past that point (˜60 degrees Celsius), changing tissue 40 thermal propagation properties. For many tissues 40, this change limits the amount of thermal energy propagated, which can increase the burden on the apparatus 20. All of the described methods above can also be used to estimate tissue 40 phase change (for further confirmation of ablation zone coverage and cell death). Because the apparatus 20 has the ability to deliver pressures that can cause mechanical changes in the tissue 40 (e.g., cavitation) in at least one embodiment, this can additionally be used to enhance the ability to interrogate temperature changes, where the apparatus 20 generates cavitation bubbles with one acoustic intensity, then monitor the resorption rate (using imaging) which will correlate with temperature or tissue 40 function or water content.
In at least one embodiment, such real-time ablation monitoring can be used to directly guide the ablation, as opposed to simply presenting the information to the user (i.e., surgeon, clinician, etc.). This, combined with tissue 40 type discrimination, means that the desired area will be ablated precisely, completely destroying the target material 26 and preserving nearby healthy tissue 40. In at least one such embodiment, an additional optimal control component is provided by the apparatus 20, where the optimal heat application from the instrument portion 30 is calculated to bring about the desired ablation zone. Multiple approaches can be utilized in such embodiments, including but not limited to optimal thermal control strategies, treating the region as a lumped thermal model, and running multiple versions of a forward-running simulation and choosing the one with the most ideal outcome, and/or choosing the one that matches closest with observation. In such embodiments, the user is able to input a desired ablation plan, and maintain supervisory control during the execution of that plan. Because the apparatus 20 has the ability to deliver pressures that can cause mechanical changes in the tissue 40 (e.g., cavitation) in at least one embodiment, this can additionally be used to enhance the ability to deliver energy more efficiently into tissue 40, where the apparatus 20 generates cavitation bubbles initially, then those bubbles absorb and heat incoming ultrasound pressure waves more efficiently than tissue 40 alone.
In at least one embodiment, the precision ablation capabilities of the apparatus 20 may be utilized in the context of nerve ablation, where neural structures are destroyed to change regulation of a particular body function. While the embodiments described herein can be used to target neural anatomy as well as pathology, the ultrasound functionality of the instrument portion 30 can also be used to deliver energy to stimulate nerves. This stimulation can be used to localize nerves of a particular function, or assess nerve function. This assessment can help guide and inform a user during an ablation procedure.
Additionally, in at least one embodiment, as illustrated in
Aspects of the present specification may also be described as the following embodiments:
1. An ultrasound ablation apparatus for facilitating navigation, ablation, and ablation monitoring relative to an at least one target material positioned within or adjacent to a tissue of a patient, the apparatus comprising: an instrument portion; a base portion engaged with a proximal end of the instrument portion; an opposing distal end of the instrument portion providing a plurality of ultrasound transducers configured for both obtaining an at least one ultrasound image of the target material and selectively emitting acoustic energy to heat, destroy and/or perturb the target material, the transducers arranged so as to form an at least one array; and the distal end of the instrument portion further providing an at least one acoustically matched covering positioned and configured for extending over top of the transducers so as to not inhibit the functionality of the transducers; whereby, the apparatus is capable of precisely focusing acoustic energy toward the target material to achieve a desired ablation shape, based on data gathered from the at least one ultrasound image.
2. The ultrasound ablation apparatus according to embodiment 1, wherein the base portion is removably engaged with the proximal end of the instrument portion.
3. The ultrasound ablation apparatus according to embodiments 1-2, wherein the base portion is permanently engaged or otherwise integral with the proximal end of the instrument portion.
4. The ultrasound ablation apparatus according to embodiments 1-3, wherein the transducers are configured for operating in a pulse-echo configuration.
5. The ultrasound ablation apparatus according to embodiments 1-4, wherein the plurality of transducers includes an at least one first transducer configured for obtaining the at least one ultrasound image of the target material, and an at least one second transducer configured for selectively emitting acoustic energy to heat, destroy and/or perturb the target material.
6. The ultrasound ablation apparatus according to embodiments 1-5, wherein the at least one first transducer and at least one second transducer are arranged in an alternating pattern on the distal end of the instrument portion.
7. The ultrasound ablation apparatus according to embodiments 1-6, wherein each of the transducers is a high-bandwidth, low-profile, high-efficiency transducer.
8. The ultrasound ablation apparatus according to embodiments 1-7, wherein each of the transducers is a capacitive micromachined ultrasound transducer (“CMUT”).
9. The ultrasound ablation apparatus according to embodiments 1-8, wherein the at least one array is positioned on a sidewall of the instrument portion so as to be arranged in a substantially “side facing” configuration.
10. The ultrasound ablation apparatus according to embodiments 1-9, wherein the at least one array is positioned on a terminal face of the distal end of the instrument portion so as to be arranged in a substantially “forward facing” configuration.
11. The ultrasound ablation apparatus according to embodiments 1-10, wherein the transducers are arranged in a one-dimensional array along a length of the sidewall.
12. The ultrasound ablation apparatus according to embodiments 1-11, wherein the transducers are arranged in a two-dimensional array along both a length and a circumference of the sidewall.
13. The ultrasound ablation apparatus according to embodiments 1-12, wherein the sidewall provides an at least one substantially flat cut-out on which the at least one array of transducers is positioned.
14. The ultrasound ablation apparatus according to embodiments 1-13, wherein the at least one covering extends over top of the at least one cut-out and is shaped for retaining a substantially circular cross-section for the distal end of the instrument portion.
15. The ultrasound ablation apparatus according to embodiments 1-14, wherein the at least one covering is shaped as a substantially hemispherical dome and positioned to extend over top of the terminal face.
16. The ultrasound ablation apparatus according to embodiments 1-15, wherein the distal end of the instrument portion is positioned within an internal passage of a needle.
17. The ultrasound ablation apparatus according to embodiments 1-16, wherein the distal end of the instrument portion is configured for selectively extending a distance toward a terminal opening of the internal passage of the needle in order to observe, heat, destroy and/or perturb the target material when the needle is inserted into the tissue, then subsequently retracting back into the internal passage prior to the needle being withdrawn from the tissue.
18. The ultrasound ablation apparatus according to embodiments 1-17, wherein the terminal face of the distal end of the instrument portion is configured as a stepped needle providing a plurality of circumferential, coaxially aligned steps oriented in a “forward facing” direction, with each of the steps having a diameter relatively smaller than a diameter of an immediately preceding one of the steps.
19. The ultrasound ablation apparatus according to embodiments 1-18, wherein the terminal face of the distal end of the instrument portion further provides a plurality of transducers radially arranged along each of the steps.
20. The ultrasound ablation apparatus according to embodiments 1-19, wherein the at least one covering is positioned and configured for extending over top of each of the steps and associated transducers so as to cooperate with the distal end of the instrument portion to form a substantially conical shape.
21. The ultrasound ablation apparatus according to embodiments 1-20, wherein the at least one covering is a rigid shield configured for being selectively retractable when the transducers are positioned proximal the target material, thereby temporarily exposing the transducers to a volume of bodily fluids surrounding the target material, such that the bodily fluids facilitate acoustic communication between the transducers and the target material.
22. The ultrasound ablation apparatus according to embodiments 1-21, wherein the distal end of the instrument portion is configured for selectively delivering an acoustic medium configured for facilitating acoustic communication between the transducers and the target material.
23. The ultrasound ablation apparatus according to embodiments 1-22, wherein the acoustic medium is at least one of a fluid and a gel.
24. The ultrasound ablation apparatus according to embodiments 1-23, wherein the acoustic medium is contained in an at least one reservoir in fluid communication with the distal end of the instrument portion via an at least one delivery channel extending therebetween.
25. The ultrasound ablation apparatus according to embodiments 1-24, wherein the sidewall provides a plurality of coverings each positioned and configured for extending over top of a subset of the transducers, with each of the coverings being in fluid communication with the at least one reservoir via a separate at least one delivery channel.
26. The ultrasound ablation apparatus according to embodiments 1-25, wherein at least one reservoir is positioned within at least one of the instrument portion and the base portion.
27. The ultrasound ablation apparatus according to embodiments 1-26, wherein the at least one reservoir is positioned external to the apparatus.
28. The ultrasound ablation apparatus according to embodiments 1-27, wherein the instrument portion provides a first delivery channel and a second delivery channel each extending between the at least one reservoir and the distal end of the instrument portion so as to circulate the acoustic medium therethrough.
29. The ultrasound ablation apparatus according to embodiments 1-28, wherein the distal end of the instrument portion further provides an at least one temperature sensor positioned and configured for detecting a temperature of the distal end of the instrument portion along with the tissue proximal thereto, whereby, upon the detected temperature reaching a pre-defined threshold, the apparatus is configured for selectively circulating the acoustic medium through the distal end of the instrument portion so as to cool the tissue proximal to the distal end of the instrument portion.
30. The ultrasound ablation apparatus according to embodiments 1-29, wherein the at least one temperature sensor is positioned within the at least one covering.
31. The ultrasound ablation apparatus according to embodiments 1-30, wherein each of the first delivery channel and second delivery channel terminates proximal one of a first end or an opposing second end of the array of transducers.
32. The ultrasound ablation apparatus according to embodiments 1-31, wherein: the first delivery channel terminates proximal a first end of the array of transducers; and the second delivery channel terminates proximal an opposing second end of the array of transducers.
33. The ultrasound ablation apparatus according to embodiments 1-32, wherein the at least one covering is a deformable enclosure configured for maintaining the acoustic medium over top of the transducers.
34. The ultrasound ablation apparatus according to embodiments 1-33, wherein the enclosure is in fluid communication with the at least one delivery channel.
35. The ultrasound ablation apparatus according to embodiments 1-34, wherein the enclosure is pre-filled with the acoustic medium.
36. The ultrasound ablation apparatus according to embodiments 1-35, wherein the enclosure is constructed out of a solid, deformable acoustic medium.
37. The ultrasound ablation apparatus according to embodiments 1-36, wherein the distal end of the instrument portion further provides an at least one contact sensor positioned and configured for detecting the presence of acoustic contact between the transducers and the target material.
38. The ultrasound ablation apparatus according to embodiments 1-37, wherein the at least one contact sensor is positioned within the at least one covering.
39. The ultrasound ablation apparatus according to embodiments 1-38, wherein the instrument portion further provides an at least one magnetic sensor.
40. The ultrasound ablation apparatus according to embodiments 1-39, wherein the instrument portion is configured as a needle.
41. The ultrasound ablation apparatus according to embodiments 1-40, wherein the instrument portion is configured for being inserted into and traversing through a catheter, endoscope or similar structure.
42. The ultrasound ablation apparatus according to embodiments 1-41, wherein the instrument portion is configured as a laparoscopic surgical tool.
43. The ultrasound ablation apparatus according to embodiments 1-42, wherein the base portion provides an insertion motor in mechanical communication with the instrument portion and configured for selectively driving the distal end of the instrument portion a distance into, and subsequently out of, the tissue during use of the apparatus.
44. The ultrasound ablation apparatus according to embodiments 1-43, wherein the base portion provides a rotation motor in mechanical communication with the instrument portion and configured for selectively rotating the distal end of the instrument portion in order to align the at least one transducer with the target material.
45. The ultrasound ablation apparatus according to embodiments 1-44, wherein the instrument portion provides a plurality of conductors positioned and configured for electrically interconnecting an at least one electronic driver with the transducers.
46. The ultrasound ablation apparatus according to embodiments 1-45, wherein the transducers are multiplexed, such that a first set of wires allows access to each of an at least one row of the at least one array of transducers, and a second set of wires allows access to each of an at least one column of the at least one array of transducers.
47. The ultrasound ablation apparatus according to embodiments 1-46, wherein the distal end of the instrument portion provides a plurality of arrays of transducers with each array separately multiplexed.
48. The ultrasound ablation apparatus according to embodiments 1-47, wherein each transducer provides a plurality of independent transducer cells.
49. The ultrasound ablation apparatus according to embodiments 1-48, wherein some of the transducer cells are configured for obtaining the at least one ultrasound image of the target material, while other of the transducer cells are configured for selectively emitting acoustic energy to heat, destroy and/or perturb the target material.
50. The ultrasound ablation apparatus according to embodiments 1-49, wherein the transducers are mounted or otherwise connected to a flexible conductive backing, thereby allowing the backing, along with the transducers, to be wrapped circumferentially around the distal end of the instrument portion.
51. The ultrasound ablation apparatus according to embodiments 1-50, wherein the distal end of the instrument portion is flexible and configured for selectively moving between a substantially planar shape and a substantially hemispherical shape.
52. The ultrasound ablation apparatus according to embodiments 1-51, wherein the instrument portion provides a plurality of substantially laterally-oriented, spaced apart grooves positioned and configured for allowing a length of the instrument portion to resiliently flex along the grooves.
53. The ultrasound ablation apparatus according to embodiments 1-52, wherein the transducers are positioned along the distal end of the instrument portion between one or more of the spaced apart grooves.
54. The ultrasound ablation apparatus according to embodiments 1-53, wherein the distal end of the instrument portion provides an internal wire positioned and configured for selectively articulating the distal end of the instrument portion into the hemispherical shape.
55. The ultrasound ablation apparatus according to embodiments 1-54, wherein the distal end of the instrument portion provides an at least one pull cable positioned and configured for selectively articulating the distal end of the instrument portion into the hemispherical shape.
56. The ultrasound ablation apparatus according to embodiments 1-55, wherein the distal end of the instrument portion provides a first pull cable and a second pull cable attached at different points within the distal end, thereby increasing a number of points of articulation in the distal end.
57. The ultrasound ablation apparatus according to embodiments 1-56, wherein the distal end of the instrument portion is pre-stressed so as to achieve a substantially hemispherical shape after extending through a curved path in the tissue.
58. The ultrasound ablation apparatus according to embodiments 1-57, wherein the instrument portion provides an at least one active mechanical deformation element positioned and configured for selectively applying forces to the tissue proximal the target material.
59. The ultrasound ablation apparatus according to embodiments 1-58, wherein the at least one active mechanical deformation element is a force sensor embedded within the distal end of the instrument portion.
60. The ultrasound ablation apparatus according to embodiments 1-59, wherein the distal end of the instrument portion is rigidly configured as a substantially hemispherical shape in cross-section so as to achieve transmissive propagation of the ultrasound.
61. The ultrasound ablation apparatus according to embodiments 1-60, wherein the apparatus is in selective communication with each of a computing device and an imaging display.
62. An ultrasound ablation apparatus for facilitating navigation, ablation, and ablation monitoring relative to an at least one target material positioned within or adjacent to a tissue of a patient, the apparatus comprising: an instrument portion; a base portion engaged with a proximal end of the instrument portion; an opposing distal end of the instrument portion providing a plurality of ultrasound transducers configured for both obtaining an at least one ultrasound image of the target material and selectively emitting acoustic energy to heat and destroy the target material, the transducers arranged so as to form an at least one array positioned on a sidewall of the instrument portion; the sidewall providing an at least one acoustically matched covering positioned and configured for extending over top of the transducers so as to not inhibit the functionality of the transducers while retaining a substantially circular cross-section for the distal end of the instrument portion; and the at least one covering in fluid communication with an at least one reservoir containing an acoustic medium configured for facilitating acoustic communication between the transducers and the target material; whereby, the apparatus is capable of precisely focusing acoustic energy toward the target material to achieve a desired ablation shape, based on data gathered from the at least one ultrasound image.
63. An ultrasound ablation apparatus for facilitating navigation, ablation, and ablation monitoring relative to an at least one target material positioned within or adjacent to a tissue of a patient, the apparatus comprising: an instrument portion; a base portion engaged with a proximal end of the instrument portion; an opposing distal end of the instrument portion providing a plurality of ultrasound transducers configured for both obtaining an at least one ultrasound image of the target material and selectively emitting acoustic energy to heat and destroy the target material, the transducers arranged so as to form an at least one array positioned on a terminal face of the distal end of the instrument portion; the terminal face of the distal end of the instrument portion providing an at least one acoustically matched covering positioned and configured for extending over top of the transducers so as to not inhibit the functionality of the transducers; and the at least one covering in fluid communication with an at least one reservoir containing an acoustic medium configured for facilitating acoustic communication between the transducers and the target material; whereby, the apparatus is capable of precisely focusing acoustic energy toward the target material to achieve a desired ablation shape, based on data gathered from the at least one ultrasound image.
64. An ultrasound ablation system for facilitating navigation, ablation, and ablation monitoring relative to an at least one target material positioned within or adjacent to a tissue of a patient, the system comprising: an ultrasound ablation apparatus comprising: an instrument portion; a base portion engaged with a proximal end of the instrument portion; an opposing distal end of the instrument portion providing a plurality of ultrasound transducers configured for both obtaining an at least one ultrasound image of the target material and selectively emitting acoustic energy to heat, destroy and/or perturb the target material, the transducers arranged so as to form an at least one array; and the distal end of the instrument portion further providing an at least one acoustically matched covering positioned and configured for extending over top of the transducers so as to not inhibit the functionality of the transducers; and an imaging display in selective communication with the ultrasound ablation apparatus and configured for receiving and displaying the ultrasound images transmitted by the ultrasound ablation apparatus; whereby, the ultrasound ablation apparatus is capable of precisely focusing acoustic energy toward the target material to achieve a desired ablation shape, based on data gathered from the at least one ultrasound image.
65. The ultrasound ablation system according to embodiment 64, wherein the base portion is removably engaged with the proximal end of the instrument portion.
66. The ultrasound ablation system according to embodiments 64-65, wherein the base portion is permanently engaged or otherwise integral with the proximal end of the instrument portion.
67. The ultrasound ablation system according to embodiments 64-66, wherein the transducers are configured for operating in a pulse-echo configuration.
68. The ultrasound ablation system according to embodiments 64-67, wherein the plurality of transducers includes an at least one first transducer configured for obtaining the at least one ultrasound image of the target material, and an at least one second transducer configured for selectively emitting acoustic energy to heat, destroy and/or perturb the target material.
69. The ultrasound ablation system according to embodiments 64-68, wherein the at least one first transducer and at least one second transducer are arranged in an alternating pattern on the distal end of the instrument portion.
70. The ultrasound ablation system according to embodiments 64-69, wherein each of the transducers is a high-bandwidth, low-profile, high-efficiency transducer.
71. The ultrasound ablation system according to embodiments 64-70, wherein each of the transducers is a capacitive micromachined ultrasound transducer (“CMUT”).
72. The ultrasound ablation system according to embodiments 64-71, wherein the at least one array is positioned on a sidewall of the instrument portion so as to be arranged in a substantially “side facing” configuration.
73. The ultrasound ablation system according to embodiments 64-72, wherein the at least one array is positioned on a terminal face of the distal end of the instrument portion so as to be arranged in a substantially “forward facing” configuration.
74. The ultrasound ablation system according to embodiments 64-73, wherein the transducers are arranged in a one-dimensional array along a length of the sidewall.
75. The ultrasound ablation system according to embodiments 64-74, wherein the transducers are arranged in a two-dimensional array along both a length and a circumference of the sidewall.
76. The ultrasound ablation system according to embodiments 64-75, wherein the sidewall provides an at least one substantially flat cut-out on which the at least one array of transducers is positioned.
77. The ultrasound ablation system according to embodiments 64-76, wherein the at least one covering extends over top of the at least one cut-out and is shaped for retaining a substantially circular cross-section for the distal end of the instrument portion.
78. The ultrasound ablation system according to embodiments 64-77, wherein the at least one covering is shaped as a substantially hemispherical dome and positioned to extend over top of the terminal face.
79. The ultrasound ablation system according to embodiments 64-78, wherein the distal end of the instrument portion is positioned within an internal passage of a needle so as to be configured as a forward facing spherical probe.
80. The ultrasound ablation system according to embodiments 64-79, wherein the distal end of the instrument portion is configured for selectively extending a distance toward a terminal opening of the internal passage of the needle in order to observe, heat, destroy and/or perturb the target material when the needle is inserted into the tissue, then subsequently retracting back into the internal passage prior to the needle being withdrawn from the tissue.
81. The ultrasound ablation system according to embodiments 64-80, wherein the terminal face of the distal end of the instrument portion is configured as a stepped needle providing a plurality of circumferential, coaxially aligned steps oriented in a “forward facing” direction, with each of the steps having a diameter relatively smaller than a diameter of an immediately preceding one of the steps.
82. The ultrasound ablation system according to embodiments 64-81, wherein the terminal face of the distal end of the instrument portion further provides a plurality of transducers radially arranged along each of the steps.
83. The ultrasound ablation system according to embodiments 64-82, wherein the at least one covering is positioned and configured for extending over top of each of the steps and associated transducers so as to cooperate with the distal end of the instrument portion to form a substantially conical shape.
84. The ultrasound ablation system according to embodiments 64-83, wherein the at least one covering is a rigid shield configured for being selectively retractable when the transducers are positioned proximal the target material, thereby temporarily exposing the transducers to a volume of bodily fluids surrounding the target material, such that the bodily fluids facilitate acoustic communication between the transducers and the target material.
85. The ultrasound ablation system according to embodiments 64-84, wherein the distal end of the instrument portion is configured for selectively delivering an acoustic medium configured for facilitating acoustic communication between the transducers and the target material.
86. The ultrasound ablation system according to embodiments 64-85, wherein the acoustic medium is at least one of a fluid and a gel.
87. The ultrasound ablation system according to embodiments 64-86, wherein the acoustic medium is contained in an at least one reservoir in fluid communication with the distal end of the instrument portion via an at least one delivery channel extending therebetween.
88. The ultrasound ablation system according to embodiments 64-87, wherein the sidewall provides a plurality of coverings each positioned and configured for extending over top of a subset of the transducers, with each of the coverings being in fluid communication with the at least one reservoir via a separate at least one delivery channel.
89. The ultrasound ablation system according to embodiments 64-88, wherein at least one reservoir is positioned within at least one of the instrument portion and the base portion.
90. The ultrasound ablation system according to embodiments 64-89, wherein the at least one reservoir is positioned external to the apparatus.
91. The ultrasound ablation system according to embodiments 64-90, wherein the instrument portion provides a first delivery channel and a second delivery channel each extending between the at least one reservoir and the distal end of the instrument portion so as to circulate the acoustic medium therethrough.
92. The ultrasound ablation system according to embodiments 64-91, wherein the distal end of the instrument portion further provides an at least one temperature sensor positioned and configured for detecting a temperature of the distal end of the instrument portion along with the tissue proximal thereto, whereby, upon the detected temperature reaching a pre-defined threshold, the apparatus is configured for selectively circulating the acoustic medium through the distal end of the instrument portion so as to cool the tissue proximal to the distal end of the instrument portion.
93. The ultrasound ablation system according to embodiments 64-92, wherein the at least one temperature sensor is positioned within the at least one covering.
94. The ultrasound ablation system according to embodiments 64-93, wherein each of the first delivery channel and second delivery channel terminates proximal one of a first end or an opposing second end of the array of transducers.
95. The ultrasound ablation system according to embodiments 64-94, wherein: the first delivery channel terminates proximal a first end of the array of transducers; and the second delivery channel terminates proximal an opposing second end of the array of transducers.
96. The ultrasound ablation system according to embodiments 64-95, wherein the at least one covering is a deformable enclosure configured for maintaining the acoustic medium over top of the transducers.
97. The ultrasound ablation system according to embodiments 64-96, wherein the enclosure is in fluid communication with the at least one delivery channel.
98. The ultrasound ablation system according to embodiments 64-97, wherein the enclosure is pre-filled with the acoustic medium.
99. The ultrasound ablation system according to embodiments 64-98, wherein the enclosure is constructed out of a solid, deformable acoustic medium.
100. The ultrasound ablation system according to embodiments 64-99, wherein the distal end of the instrument portion further provides an at least one contact sensor positioned and configured for detecting the presence of acoustic contact between the transducers and the target material.
101. The ultrasound ablation system according to embodiments 64-100, wherein the at least one contact sensor is positioned within the at least one covering.
102. The ultrasound ablation system according to embodiments 64-101, wherein the instrument portion further provides an at least one magnetic sensor.
103. The ultrasound ablation system according to embodiments 64-102, wherein the instrument portion is configured as a needle.
104. The ultrasound ablation system according to embodiments 64-103, wherein the instrument portion is configured for being inserted into and traversing through a catheter, endoscope or similar structure.
105. The ultrasound ablation system according to embodiments 64-104, wherein the instrument portion is configured as a laparoscopic surgical tool.
106. The ultrasound ablation system according to embodiments 64-105, wherein the base portion provides an insertion motor in mechanical communication with the instrument portion and configured for selectively driving the distal end of the instrument portion a distance into, and subsequently out of, the tissue during use of the apparatus.
107. The ultrasound ablation system according to embodiments 64-106, wherein the base portion provides a rotation motor in mechanical communication with the instrument portion and configured for selectively rotating the distal end of the instrument portion in order to align the at least one transducer with the target material.
108. The ultrasound ablation system according to embodiments 64-107, wherein the instrument portion provides a plurality of conductors positioned and configured for electrically interconnecting an at least one electronic driver with the transducers.
109. The ultrasound ablation system according to embodiments 64-108, wherein the transducers are multiplexed, such that a first set of wires allows access to each of an at least one row of the at least one array of transducers, and a second set of wires allows access to each of an at least one column of the at least one array of transducers.
110. The ultrasound ablation system according to embodiments 64-109, wherein the distal end of the instrument portion provides a plurality of arrays of transducers with each array separately multiplexed.
111. The ultrasound ablation system according to embodiments 64-110, wherein each transducer provides a plurality of independent transducer cells.
112. The ultrasound ablation system according to embodiments 64-111, wherein some of the transducer cells are configured for obtaining the at least one ultrasound image of the target material, while other of the transducer cells are configured for selectively emitting acoustic energy to heat, destroy and/or perturb the target material.
113. The ultrasound ablation system according to embodiments 64-112, wherein the transducers are mounted or otherwise connected to a flexible conductive backing, thereby allowing the backing, along with the transducers, to be wrapped circumferentially around the distal end of the instrument portion.
114. The ultrasound ablation system according to embodiments 64-113, wherein the distal end of the instrument portion is flexible and configured for selectively moving between a substantially planar shape and a substantially hemispherical shape.
115. The ultrasound ablation system according to embodiments 64-114, wherein the instrument portion provides a plurality of substantially laterally-oriented, spaced apart grooves positioned and configured for allowing a length of the instrument portion to resiliently flex along the grooves.
116. The ultrasound ablation system according to embodiments 64-115, wherein the transducers are positioned along the distal end of the instrument portion between one or more of the spaced apart grooves.
117. The ultrasound ablation system according to embodiments 64-116, wherein the distal end of the instrument portion provides an internal wire positioned and configured for selectively articulating the distal end of the instrument portion into the hemispherical shape.
118. The ultrasound ablation system according to embodiments 64-117, wherein the distal end of the instrument portion provides an at least one pull cable positioned and configured for selectively articulating the distal end of the instrument portion into the hemispherical shape.
119. The ultrasound ablation system according to embodiments 64-118, wherein the distal end of the instrument portion provides a first pull cable and a second pull cable attached at different points within the distal end, thereby increasing a number of points of articulation in the distal end.
120. The ultrasound ablation system according to embodiments 64-119, wherein the distal end of the instrument portion is pre-stressed so as to achieve a substantially hemispherical shape after extending through a curved path in the tissue.
121. The ultrasound ablation system according to embodiments 64-120, wherein the instrument portion provides an at least one active mechanical deformation element positioned and configured for selectively applying forces to the tissue proximal the target material.
122. The ultrasound ablation system according to embodiments 64-121, wherein the at least one active mechanical deformation element is a force sensor embedded within the distal end of the instrument portion.
123. The ultrasound ablation system according to embodiments 64-122, wherein the distal end of the instrument portion is rigidly configured as a substantially hemispherical shape in cross-section so as to achieve transmissive propagation of the ultrasound.
124. The ultrasound ablation system according to embodiments 64-123, further comprising a computing device in selective communication with at least one of the ultrasound ablation apparatus and the imaging display.
In closing, regarding the exemplary embodiments of the present invention as shown and described herein, it will be appreciated that an ultrasound ablation apparatus and associated methods of use are disclosed and configured for facilitating navigation, ablation, and ablation monitoring. Because the principles of the invention may be practiced in a number of configurations beyond those shown and described, it is to be understood that the invention is not in any way limited by the exemplary embodiments, but is generally directed to an ultrasound ablation apparatus and is able to take numerous forms to do so without departing from the spirit and scope of the invention. It will also be appreciated by those skilled in the art that the present invention is not limited to the particular geometries and materials of construction disclosed, but may instead entail other functionally comparable structures or materials, now known or later developed, without departing from the spirit and scope of the invention.
Certain embodiments of the present invention are described herein, including the best mode known to the inventor(s) for carrying out the invention. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor(s) expect skilled artisans to employ such variations as appropriate, and the inventor(s) intend for the present invention to be practiced otherwise than specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described embodiments in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.
Groupings of alternative embodiments, elements, or steps of the present invention are not to be construed as limitations. Each group member may be referred to and claimed individually or in any combination with other group members disclosed herein. It is anticipated that one or more members of a group may be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims.
Unless otherwise indicated, all numbers expressing a characteristic, item, quantity, parameter, property, term, and so forth used in the present specification and claims are to be understood as being modified in all instances by the term “about.” As used herein, the term “about” means that the characteristic, item, quantity, parameter, property, or term so qualified encompasses a range of plus or minus ten percent above and below the value of the stated characteristic, item, quantity, parameter, property, or term. Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and attached claims are approximations that may vary. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical indication should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and values setting forth the broad scope of the invention are approximations, the numerical ranges and values set forth in the specific examples are reported as precisely as possible. Any numerical range or value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. Recitation of numerical ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate numerical value falling within the range. Unless otherwise indicated herein, each individual value of a numerical range is incorporated into the present specification as if it were individually recited herein. Similarly, as used herein, unless indicated to the contrary, the term “substantially” is a term of degree intended to indicate an approximation of the characteristic, item, quantity, parameter, property, or term so qualified, encompassing a range that can be understood and construed by those of ordinary skill in the art.
Use of the terms “may” or “can” in reference to an embodiment or aspect of an embodiment also carries with it the alternative meaning of “may not” or “cannot.” As such, if the present specification discloses that an embodiment or an aspect of an embodiment may be or can be included as part of the inventive subject matter, then the negative limitation or exclusionary proviso is also explicitly meant, meaning that an embodiment or an aspect of an embodiment may not be or cannot be included as part of the inventive subject matter. In a similar manner, use of the term “optionally” in reference to an embodiment or aspect of an embodiment means that such embodiment or aspect of the embodiment may be included as part of the inventive subject matter or may not be included as part of the inventive subject matter. Whether such a negative limitation or exclusionary proviso applies will be based on whether the negative limitation or exclusionary proviso is recited in the claimed subject matter.
The terms “a,” “an,” “the” and similar references used in the context of describing the present invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. Further, ordinal indicators—such as “first,” “second,” “third,” etc. —for identified elements are used to distinguish between the elements, and do not indicate or imply a required or limited number of such elements, and do not indicate a particular position or order of such elements unless otherwise specifically stated. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein is intended merely to better illuminate the present invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the present specification should be construed as indicating any non-claimed element essential to the practice of the invention.
When used in the claims, whether as filed or added per amendment, the open-ended transitional term “comprising” (along with equivalent open-ended transitional phrases thereof such as “including,” “containing” and “having”) encompasses all the expressly recited elements, limitations, steps and/or features alone or in combination with un-recited subject matter; the named elements, limitations and/or features are essential, but other unnamed elements, limitations and/or features may be added and still form a construct within the scope of the claim. Specific embodiments disclosed herein may be further limited in the claims using the closed-ended transitional phrases “consisting of” or “consisting essentially of” in lieu of or as an amendment for “comprising.” When used in the claims, whether as filed or added per amendment, the closed-ended transitional phrase “consisting of” excludes any element, limitation, step, or feature not expressly recited in the claims. The closed-ended transitional phrase “consisting essentially of” limits the scope of a claim to the expressly recited elements, limitations, steps and/or features and any other elements, limitations, steps and/or features that do not materially affect the basic and novel characteristic(s) of the claimed subject matter. Thus, the meaning of the open-ended transitional phrase “comprising” is being defined as encompassing all the specifically recited elements, limitations, steps and/or features as well as any optional, additional unspecified ones. The meaning of the closed-ended transitional phrase “consisting of” is being defined as only including those elements, limitations, steps and/or features specifically recited in the claim, whereas the meaning of the closed-ended transitional phrase “consisting essentially of” is being defined as only including those elements, limitations, steps and/or features specifically recited in the claim and those elements, limitations, steps and/or features that do not materially affect the basic and novel characteristic(s) of the claimed subject matter. Therefore, the open-ended transitional phrase “comprising” (along with equivalent open-ended transitional phrases thereof) includes within its meaning, as a limiting case, claimed subject matter specified by the closed-ended transitional phrases “consisting of” or “consisting essentially of.” As such, embodiments described herein or so claimed with the phrase “comprising” are expressly or inherently unambiguously described, enabled and supported herein for the phrases “consisting essentially of” and “consisting of.”
Any claims intended to be treated under 35 U.S.C. § 112(f) will begin with the words “means for,” but use of the term “for” in any other context is not intended to invoke treatment under 35 U.S.C. § 112(f). Accordingly, Applicant reserves the right to pursue additional claims after filing this application, in either this application or in a continuing application.
It should be understood that the logic code, programs, modules, processes, methods, and the order in which the respective elements of each method are performed are purely exemplary. Depending on the implementation, they may be performed in any order or in parallel, unless indicated otherwise in the present disclosure. Further, the logic code is not related, or limited to any particular programming language, and may comprise one or more modules that execute on one or more processors in a distributed, non-distributed, or multiprocessing environment. Additionally, the various illustrative logical blocks, modules, methods, and algorithm processes and sequences described in connection with the embodiments disclosed herein can be implemented as electronic hardware, computer software, or combinations of both. To clearly illustrate this interchangeability of hardware and software, various illustrative components, blocks, modules, and process actions have been described above generally in terms of their functionality. Whether such functionality is implemented as hardware or software depends upon the particular application and design constraints imposed on the overall system. The described functionality can be implemented in varying ways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the scope of this document.
The phrase “non-transitory,” in addition to having its ordinary meaning, as used in this document means “enduring or long-lived.” The phrase “non-transitory computer readable medium,” in addition to having its ordinary meaning, includes any and all computer readable mediums, with the sole exception of a transitory, propagating signal. This includes, by way of example and not limitation, non-transitory computer-readable mediums such as register memory, processor cache and random-access memory (“RAM”).
The methods as described above may be used in the fabrication of integrated circuit chips. The resulting integrated circuit chips can be distributed by the fabricator in raw wafer form (that is, as a single wafer that has multiple unpackaged chips), as a bare die, or in a packaged form. In the latter case, the chip is mounted in a single chip package (such as a plastic carrier, with leads that are affixed to a motherboard or other higher level carrier) or in a multi-chip package (such as a ceramic carrier that has either or both surface interconnections or buried interconnections). In any case, the chip is then integrated with other chips, discrete circuit elements, and/or other signal processing devices as part of either (a) an intermediate product, such as a motherboard, or (b) an end product. The end product can be any product that includes integrated circuit chips, ranging from toys and other low-end applications to advanced computer products having a display, a keyboard or other input device, and a central processor.
All patents, patent publications, and other publications referenced and identified in the present specification are individually and expressly incorporated herein by reference in their entirety for the purpose of describing and disclosing, for example, the compositions and methodologies described in such publications that might be used in connection with the present invention. These publications are provided solely for their disclosure prior to the filing date of the present application. Nothing in this regard should be construed as an admission that the inventors are not entitled to antedate such disclosure by virtue of prior invention or for any other reason. All statements as to the date or representation as to the contents of these documents is based on the information available to the applicant and does not constitute any admission as to the correctness of the dates or contents of these documents.
While aspects of the invention have been described with reference to at least one exemplary embodiment, it is to be clearly understood by those skilled in the art that the invention is not limited thereto. Rather, the scope of the invention is to be interpreted only in conjunction with the appended claims and it is made clear, here, that the inventor(s) believe that the claimed subject matter is the invention.
This application is a continuation of PCT Application No. PCT/US2021/042248, filed Jul. 19, 2021; which claims priority to Provisional Application No. 63/053,898, filed Jul. 20, 2020; which are incorporated herein by reference in their entirety and to which application we claim priority under 35 USC § 120.
| Number | Date | Country | |
|---|---|---|---|
| 63053898 | Jul 2020 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2021/042248 | Jul 2021 | US |
| Child | 18099240 | US |
