阅读说明：本技术 用多普勒超声监测消融进展的方法 (Method for monitoring ablation progress by Doppler ultrasound ) 是由 陈驾宇 于 2018-04-30 设计创作，主要内容包括：本发明公开了用于治疗组织的系统和方法。靶组织被消融。在所述消融期间生成所述靶组织的实时图像。从所述实时图像确定所述靶组织的实时血液灌注水平，并将所述血液灌注水平与所述靶组织的初始血液灌注水平进行比较。所述比较提供了所述消融的进展的度量，并且当所述实时血液灌注相对于所述初始血液灌注水平降至阈值水平以下时，停止消融。(Systems and methods for treating tissue are disclosed. The target tissue is ablated. Generating a real-time image of the target tissue during the ablation. Determining a real-time blood perfusion level of the target tissue from the real-time image and comparing the blood perfusion level to an initial blood perfusion level of the target tissue. The comparison provides a measure of the progress of the ablation, and ablation is stopped when the real-time blood perfusion falls below a threshold level relative to the initial blood perfusion level.)

1. A method of treating a target tissue, the method comprising:

ablating the target tissue;

generating a real-time image of the target tissue during the ablation, the image showing blood perfusion of the target tissue as the target tissue is ablated; and

displaying the image showing blood perfusion of the target tissue, thereby indicating to a user a progress of the ablation.

2. The method of claim 1, further comprising determining a real-time blood perfusion level of the target tissue and determining whether the real-time blood perfusion level is below a threshold amount.

3. The method of claim 2, further comprising determining an initial blood perfusion level of the target tissue.

4. The method of claim 3, wherein the initial blood perfusion level comprises an initial Doppler ultrasound signal within the target tissue.

5. The method of claim 3, wherein the threshold amount is 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less of the initial blood perfusion level of the target tissue.

6. The method of claim 3, wherein the real-time blood perfusion level comprises a real-time Doppler ultrasound signal within the target tissue.

7. The method of claim 2, further comprising instructing the user to stop the ablation of the target tissue in response to the real-time blood perfusion level being below the threshold amount.

8. The method of claim 2, further comprising stopping the ablation of the target tissue in response to the real-time blood perfusion level being below the threshold amount.

9. The method of claim 1, further comprising fixing a position of an imaging source relative to the target tissue.

10. The method of claim 9, wherein the real-time image of the target tissue is generated during the ablation, wherein the position of the imaging source is fixed relative to the target tissue.

11. The method of claim 10, wherein the target tissue is ablated with an ablation element.

12. The method of claim 11, wherein the imaging source is fixedly coupled to the ablation element.

13. The method of claim 11, wherein the imaging source is removably coupled to the ablation element.

14. The method of claim 1, wherein generating the real-time image of the target tissue comprises generating at least one ultrasound image of the target tissue.

15. The method of claim 14, wherein the at least one ultrasound image comprises one or more of a contrast-enhanced ultrasound image, a B-mode ultrasound image, or a doppler ultrasound image.

16. The method of claim 15, wherein the at least one ultrasound image comprises a B-mode ultrasound image and a doppler ultrasound image overlaid on each other.

17. The method of claim 1, wherein the target tissue is ablated with one or more of RF energy, thermal energy, cryogenic energy, ultrasound energy, HIFU energy, light energy, laser energy, X-ray energy, or microwave energy.

18. The method of claim 1, wherein ablating the target tissue comprises extending at least one ablation element to the target tissue.

19. The method of claim 18, wherein the at least one ablation element comprises one or more of at least one needle or at least one rake tine.

20. The method of claim 1, wherein the target tissue comprises a myoma, a uterine fibroid, a myoma tissue, a tumor, tissue hyperplasia, or unwanted scar tissue.

21. A method of treating a target tissue, the method comprising:

ablating the target tissue;

monitoring the progress of the ablation of the target tissue by viewing real-time images of the target tissue to monitor blood perfusion of the target tissue.

22. The method of claim 21, wherein monitoring the progress of the ablation of the target tissue by viewing the real-time image of the target tissue to monitor blood perfusion of the target tissue comprises determining an initial blood perfusion level of the target tissue, determining a real-time blood perfusion level of the target tissue, and comparing the initial blood perfusion level and the real-time blood perfusion level of the target tissue.

23. The method of claim 22, wherein comparing the initial blood perfusion level and a real-time blood perfusion level of the target tissue comprises determining whether the real-time blood perfusion level of the target tissue is below the initial blood perfusion level by a threshold amount.

24. The method of claim 23, further comprising stopping the ablation of the target tissue once the blood perfusion of the target tissue is below the threshold amount.

25. The method of claim 23, wherein the threshold amount is 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less of the initial blood perfusion amount of the target tissue.

26. The method of claim 22, wherein the initial blood perfusion level comprises an initial doppler ultrasound signal within the target tissue.

27. The method of claim 22, wherein the real-time blood perfusion level comprises a real-time doppler ultrasound signal within the target tissue.

28. The method of claim 21, further comprising fixing a position of an imaging source relative to the target tissue.

29. The method of claim 28, wherein the real-time image of the target tissue is generated during the ablation, wherein the position of the imaging source is fixed relative to the target tissue.

30. The method of claim 29, wherein the target tissue is ablated with an ablation element.

31. The method of claim 30, wherein the imaging source is fixedly coupled to the ablation element.

32. The method of claim 30, wherein the imaging source is removably coupled to the ablation element.

33. The method of claim 21, wherein the real-time image of the target tissue comprises at least one ultrasound image of the target tissue.

34. The method of claim 33, wherein the at least one ultrasound image comprises one or more of a contrast-enhanced ultrasound image, a B-mode ultrasound image, or a doppler ultrasound image.

35. The method of claim 34, wherein the at least one ultrasound image comprises a B-mode ultrasound image and a doppler ultrasound image overlaid on one another.

36. The method of claim 21, wherein the target tissue is ablated with one or more of RF energy, thermal energy, cryogenic energy, ultrasound energy, HIFU energy, light energy, laser energy, X-ray energy, or microwave energy.

37. The method of claim 21, wherein ablating the target tissue comprises extending at least one ablation element to the target tissue.

38. The method of claim 37, wherein the at least one ablation element comprises one or more of at least one needle or at least one rake tine.

39. The method of claim 21, wherein the target tissue comprises a myoma, a uterine fibroid, a myoma tissue, a tumor, tissue hyperplasia, or unwanted scar tissue.

40. The method of claim 21, further comprising introducing a contrast agent to the target tissue prior to the ablating.

41. A system for treating a target tissue, the system comprising:

a treatment probe comprising a handle, a probe body, an imaging source coupled to the probe body, and an ablation element coupled to the probe body and configured to ablate the target tissue;

a real-time display coupled to the therapy probe; and

a controller coupled to the imaging source and the real-time display of the treatment probe, the controller comprising a computer-readable non-transitory storage medium including (i) instructions for the imaging source to generate a real-time image of the target tissue during ablation of the target tissue, and (ii) instructions for the real-time display to display the real-time image showing blood perfusion of the target tissue, thereby indicating a progress of the ablation to a user.

42. The system of claim 41, wherein the ablation element comprises a needle structure extendable from the treatment probe to the target tissue.

43. The system of claim 42, wherein the ablation element further comprises a plurality of needles extendable from the needle structure to the target tissue.

44. The system according to claim 43, wherein the computer-readable non-transitory storage medium further comprises instructions for the real-time display to display a representation of the position of one or more of the needle structure or plurality of tines on the real-time image.

45. The system of claim 41, wherein the computer-readable non-transitory storage medium further comprises instructions for determining a real-time blood perfusion level of the target tissue and determining whether the real-time blood perfusion level is below a threshold amount.

46. The system of claim 45, wherein the computer-readable non-transitory storage medium further comprises instructions for determining an initial blood perfusion level of the target tissue.

47. The system of claim 46, wherein the threshold amount is 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less of the initial blood perfusion amount of the target tissue.

48. The system of claim 46, wherein the initial blood perfusion level comprises an initial Doppler ultrasound signal within the target tissue.

49. The system of claim 45, wherein the real-time blood perfusion level comprises a real-time Doppler ultrasound signal within the target tissue.

50. The system of claim 45, wherein the computer-readable non-transitory storage medium further comprises instructions for instructing the user to stop the ablation of the target tissue in response to the real-time blood perfusion level being below the threshold amount.

51. The system of claim 45, wherein the computer-readable non-transitory storage medium further comprises instructions for stopping the ablation of the target tissue in response to the real-time blood perfusion level being below the threshold amount.

52. The system of claim 41, wherein a position of the imaging source during the ablation of the target tissue is configured to be fixed relative to the target tissue.

53. The system of claim 52, wherein the real-time image of the target tissue is generated during the ablation, wherein the position of the imaging source is fixed relative to the target tissue.

54. The system of claim 41, wherein the imaging source is configured to be in a fixed position relative to the ablation element.

55. The system of claim 41, wherein the imaging source is configured to be movable relative to the ablation element.

56. The system of claim 41, wherein the real-time image of the target tissue comprises at least one ultrasound image of the target tissue.

57. The system of claim 56, wherein the at least one ultrasound image comprises one or more of a contrast-enhanced ultrasound image, a B-mode ultrasound image, or a Doppler ultrasound image.

58. The system of claim 57, wherein the at least one ultrasound image comprises a B-mode ultrasound image and a Doppler ultrasound image overlaid on one another.

59. The system of claim 41, wherein the ablation element is configured to ablate the target tissue with one or more of RF energy, thermal energy, cryogenic energy, ultrasound energy, HIFU energy, optical energy, laser energy, X-ray energy, or microwave energy.

60. The system of claim 41, wherein the target tissue comprises a myoma, a uterine fibroid, a myoma tissue, a tumor, tissue hyperplasia, or unwanted scar tissue.

1. Field of the invention

The present invention relates generally to medical methods and devices. More particularly, the present invention relates to a method and system for displaying images of tissue to be treated in real time so that treatment can be controlled.

Current medical treatments for organs and tissues within a patient's body often use needles or other elongate bodies to deliver energy, therapeutic agents, and the like. Typically, these methods use ultrasound imaging to view and identify treatment targets before, during, and/or after.

Of particular interest to the present invention are the recently proposed treatments for uterine fibroids that rely on transvaginal or laparoscopic positioning of a treatment probe or device within the uterus of a patient. A radiofrequency or other energy or therapeutic delivery needle is deployed from the device near or directly into the fibroid, and delivers energy and/or therapeutic substances for ablating or treating the fibroid. To facilitate positioning of the fibroid and placement of the needle within the fibroid, the treatment device includes an ultrasound imaging array having an adjustable field of view, typically in a forward or lateral direction relative to an axial shaft carrying the needle. A needle is advanced from the shaft and across the field of view such that the needle can be visualized and guided into tissue and target sarcomas.

While effective and highly beneficial to patients, such needle ablation and treatment protocols face several challenges. Although the position of the needle may be observed on an ultrasound or other visual image, it may be difficult to predict the treatment zone resulting from energy or other therapeutic delivery. One of the reasons may be that energy propagation within tissue may depend primarily on the tissue structure and the distribution of blood vessels acting as "heat sinks". Due to the distribution of blood vessels, the size of the coagulation introduced by RF ablation may vary from tumor to tumor. Current coagulation size and safety margins are generally based on static size predictions that may affect the efficacy or even safety of treatment. The physician's experience may help determine the appropriate ablation endpoint, but it is desirable to reduce the need to make decisions and guesses.

Tissue heating or cooling may be affected by adjacent vasculature as the blood vessels can dissipate thermal energy and cause changes in the calculated coagulation size. Thus, the magnitude of thermal ablation and the effectiveness of cytotoxicity may decrease with the proximity and size of adjacent vessels. An increase in the local recurrence rate of tumors adjacent to large vessels (>3mm) may demonstrate a significant effect of dissipating heat energy. Approximately one-third of the ablations may present a deformation of the vessel periphery. The degree of heat dissipation may be significantly related to the size of the blood vessel. Several studies also examined the effect of modulating liver perfusion and found that ablation size increased with decreasing blood flow. Developing better methods to estimate or monitor ablation size would benefit the effectiveness and safety of treatment.

For these reasons, it is desirable to provide improved systems and methods for deploying energy delivery and other needles within an ultrasound or other imaging field of view in an energy delivery or other treatment regimen. It would be particularly useful to provide the treating physician with information that helps determine the real-time progress of ablation. It is also desirable to provide feedback to the physician to assist in accurately predicting the treatment area. Such information should allow the physician to terminate the ablation plan at the appropriate time when the desired target tissue has been completely ablated or nearly completely ablated while reducing accidental ablation of non-target tissue, if necessary. Furthermore, it is desirable to provide feedback to the physician to allow the physician to assess a safety margin so as not to damage sensitive tissue structures. All such feedback or other information is preferably provided visually on an ultrasound or other imaging screen so that the physician can start, pause, and stop the treatment. At least some of these objects will be attained by the invention described hereinafter.

Background

Disclosure of Invention

The present disclosure provides systems and methods for treating tissue structures. In particular, systems and methods for ablating tissue structures and monitoring ablation are provided. A real-time image of a target tissue structure, such as a uterine fibroid, may be displayed. The real-time images may also show blood flow and/or perfusion within the target tissue structure. For example, the real-time images may include doppler ultrasound images and/or contrast enhanced ultrasound imaging (CEUS) to show blood perfusion. The image showing blood perfusion may be overlaid with an image showing the morphology and/or density of the target tissue structure. As the target tissue is ablated, the blood perfusion of the target tissue may decrease and/or the size of the reduced blood perfusion area may increase. By displaying real-time images of the target tissue showing tissue morphology and blood perfusion during ablation to the physician or user, the physician or user can track the progress of the treatment. For example, once the target subject's blood perfusion is reduced by a threshold amount compared to its initial blood perfusion level, and/or once the size of the reduced blood perfusion region reaches a threshold size, the user may stop ablation to ensure complete or near complete ablation of the target tissue structure, and to minimize undesired ablation of non-target subjects. Furthermore, the effectiveness and safety of the treatment can be ensured by displaying real-time images of the target tissue, which may allow for real-time monitoring of the movement of the perfusion boundary, the effective margin of ablation.

Aspects of the present disclosure provide exemplary methods of treating a target tissue. The target tissue can be ablated. Real-time images of the target tissue may be generated during the ablation. The image may show blood perfusion of the target tissue as the target tissue is ablated. An image showing blood perfusion of the target tissue may be displayed, indicating to a user the progress of the ablation.

A real-time blood perfusion level of the target tissue may be determined, and it may be determined whether the real-time blood perfusion level is below a threshold amount. An initial blood perfusion level of the target tissue may be determined, and the threshold amount may be 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less of the initial blood perfusion level of the target tissue. A user may be instructed or instructed to stop the ablation of the target tissue in response to the real-time blood perfusion level being below the threshold amount. Alternatively or in combination, the ablation of the target tissue may be stopped (e.g., automatically stopped) in response to the real-time blood perfusion level being below the threshold amount. The initial blood perfusion level may comprise an initial doppler ultrasound signal within the target tissue, and the real-time blood perfusion level may comprise a real-time doppler ultrasound signal within the target tissue.

The position of the imaging source may be fixed relative to the target tissue. The real-time image of the target tissue may be generated during the ablation, wherein a position of the imaging source is fixed relative to the target tissue. The target tissue can be ablated with an ablation element. The imaging source may be fixedly coupled to the ablation element. Alternatively or in combination, the imaging source may be removably coupled to the ablation element.

The real-time image of the target tissue may be generated by generating at least one ultrasound image of the target tissue. The at least one ultrasound image may include one or more of a contrast-enhanced ultrasound image, a B-mode ultrasound image, or a doppler ultrasound image. The at least one ultrasound image may include a B-mode ultrasound image and a doppler ultrasound image overlapped with each other. Common anatomical markers in the two images can be identified and mapped to each other to generate an overlapping image. In some cases, a contrast agent may be introduced to the target tissue prior to the ablation to provide a more enhanced ultrasound image.

The target tissue may be ablated with one or more of RF energy, thermal energy, cryogenic energy, ultrasound energy, HIFU energy, optical energy, laser energy, X-ray energy, or microwave energy. The target tissue may be ablated by extending at least one ablation element to the target tissue. The at least one ablation element may comprise one or more of at least one needle or at least one tine. The target tissue may include fibroids, uterine fibroids, fibroid tissue, tumors, tissue hyperplasia, or unwanted scar tissue.

Aspects of the present disclosure provide additional methods of treating the target tissue. The target tissue can be ablated. Monitoring the progress of the ablation of the target tissue by viewing real-time images of the target tissue to monitor blood perfusion of the target tissue.

Monitoring the progress of the ablation of the target tissue by viewing the real-time image of the target tissue to monitor blood perfusion of the target tissue, including that an initial blood perfusion level of the target tissue can be determined, a real-time blood perfusion level of the target tissue can be determined, and the initial blood perfusion level and the real-time blood perfusion level of the target tissue can be compared. To compare an initial blood perfusion level and a real-time blood perfusion level of the target tissue, it may be determined whether the real-time blood perfusion level of the target tissue is below the initial blood perfusion level by a threshold amount. Stopping the ablation of the target tissue once the blood perfusion of the target tissue is below the threshold amount. The threshold amount may be 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less of the initial blood perfusion amount of the target tissue. The initial blood perfusion level may comprise an initial doppler ultrasound signal within the target tissue. The real-time blood perfusion level may comprise a real-time doppler ultrasound signal within the target tissue.

The position of the imaging source may be fixed relative to the target tissue. The real-time image of the target tissue may be generated during the ablation, with the position of the imaging source fixed relative to the target tissue. The target tissue can be ablated with an ablation element. The imaging source may be fixedly coupled to the ablation element. Alternatively or in combination, the imaging source may be removably coupled to the ablation element.

The real-time image of the target tissue may include at least one ultrasound image of the target tissue. The at least one ultrasound image may include one or more of a contrast-enhanced ultrasound image, a B-mode ultrasound image, or a doppler ultrasound image. The at least one ultrasound image may include a B-mode ultrasound image and a doppler ultrasound image overlapped with each other. Common anatomical markers in the two images can be identified and mapped to each other to generate an overlapping image. In some cases, a contrast agent may be introduced to the target tissue prior to the ablation to provide a more enhanced ultrasound image.

The target tissue may be ablated with one or more of RF energy, thermal energy, cryogenic energy, ultrasound energy, HIFU energy, optical energy, laser energy, X-ray energy, or microwave energy. The target tissue may be ablated by extending at least one ablation element to the target tissue. The at least one ablation element may comprise one or more of at least one needle or at least one tine. The target tissue may include fibroids, uterine fibroids, fibroid tissue, tumors, tissue hyperplasia, or unwanted scar tissue.

Aspects of the present disclosure also provide a system for treating a target tissue. The treatment system may include a treatment probe, a real-time display, and a controller. The treatment probe can include a handle, a probe body, an imaging source coupled to the probe body, and an ablation element coupled to the probe body and configured to ablate the target tissue. The real-time display may be coupled to the therapy probe. The controller may be coupled to the imaging source and the real-time display of the treatment probe. The controller may include a computer-readable non-transitory storage medium comprising: (i) instructions for the imaging source to generate a real-time image of the target tissue during ablation of the target tissue, and (ii) instructions for the real-time display to display a real-time image showing blood perfusion of the target tissue, thereby indicating to a user a progress of the ablation.

The ablation element may include a needle structure extendable from the treatment probe to the target tissue. The ablation element may further include a plurality of needles extendable from the needle structure to the target tissue. The computer-readable non-transitory storage medium may further include instructions for a real-time display to display a representation of the position of one or more of the needle structure or plurality of tines on the real-time image.

The computer-readable non-transitory storage medium may further include instructions for determining a real-time blood perfusion level of the target tissue and determining whether the real-time blood perfusion level is below a threshold amount. The computer-readable non-transitory storage medium may further include instructions for determining an initial blood perfusion level of the target tissue. The threshold amount may be 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less of the initial blood perfusion amount of the target tissue. The computer-readable non-transitory storage medium may further include instructions for instructing the user to stop the ablation of the target tissue in response to the real-time blood perfusion level being below the threshold amount. The initial blood perfusion level may comprise an initial doppler ultrasound signal within the target tissue. The real-time blood perfusion level may comprise a real-time doppler ultrasound signal within the target tissue.

The position of the imaging source may be fixed relative to the target tissue. The real-time image of the target tissue may be generated during the ablation, wherein a position of the imaging source is fixed relative to the target tissue. The target tissue can be ablated with an ablation element. The imaging source may be fixedly coupled to the ablation element. Alternatively or in combination, the imaging source may be removably coupled to the ablation element.

The real-time image of the target tissue may include at least one ultrasound image of the target tissue. The at least one ultrasound image may include one or more of a contrast-enhanced ultrasound image, a B-mode ultrasound image, or a doppler ultrasound image. The at least one ultrasound image may include a B-mode ultrasound image and a doppler ultrasound image overlapped with each other. Common anatomical markers in the two images can be identified and mapped to each other to generate an overlapping image. In some cases, a contrast agent may be introduced to the target tissue prior to the ablation to provide a more enhanced ultrasound image.

The target tissue may be ablated with one or more of RF energy, thermal energy, cryogenic energy, ultrasound energy, HIFU energy, optical energy, laser energy, X-ray energy, or microwave energy. The target tissue may be ablated by extending at least one ablation element to the target tissue. The at least one ablation element may comprise one or more of at least one needle or at least one tine. The target tissue may include fibroids, uterine fibroids, fibroid tissue, tumors, tissue hyperplasia, or unwanted scar tissue.

Is incorporated by reference

All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.

Drawings

The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

fig. 1 is a schematic diagram of a system of the present disclosure including a system controller, an image display, and a treatment probe having a deployable needle structure and an imaging sensor.

Fig. 2 is a perspective view of a treatment probe of the present disclosure.

FIG. 3 is a view of the treatment probe of FIG. 2 showing the imaging assembly separated from the needle assembly with portions removed and portions enlarged.

FIG. 3A illustrates the distal end of the needle assembly connected to the distal end of the imaging assembly.

Fig. 4 illustrates a schematic view of a treatment probe of the present disclosure.

Fig. 5 illustrates a distal portion of a treatment probe introduced into the uterine cavity to image fibroids in the myoma of the uterine musculature.

Fig. 6A, 7A, 8A, 9A, 10A, and 11A illustrate "screenshots" of the real-time image display as the treatment and safety boundaries are adjusted and the ablation elements of the treatment probe are advanced into the target tissue, in accordance with the principles of the present disclosure.

Fig. 6B, 7B, 8B, 9B, 10B, and 11B illustrate manipulation of the handle, which corresponds to repositioning of the projection images of the treatment boundary and safety boundary on the real-time images of fig. 6A, 7A, 8A, 9A, 10A, and 11A, respectively.

Figure 12 illustrates a system diagram in which a B-mode ultrasound data stream (showing tissue morphology) is combined with a doppler-mode ultrasound data stream to generate a real-time image in accordance with the present disclosure.

Fig. 13 illustrates a flow chart of a method of treating tissue according to the present disclosure.

Fig. 14A, 14B, 14C, and 14D illustrate a plurality of real-time images of a target tissue structure as ablated in accordance with the present disclosure.

Detailed Description

As shown in FIG. 1, a system 10 constructed in accordance with the principles of the present invention includes a system controller 12, an imaging display 14, and a treatment probe 16. The system controller 12 will typically be a microprocessor-based controller that allows the treatment parameters and imaging parameters to be set in a conventional manner. The display 14 will typically be included with the controller 12 in a common housing 18, but may also be provided in a separate housing. The treatment probe 16 includes an imaging sensor 20, the imaging sensor 20 being connected to the controller 12 by an imaging cable 24. The controller 12 supplies power to the therapy probe via the therapy cable 22. The treatment probe 16 may also communicate with the controller 12 via a treatment cable 22, such as to provide one or more of a control signal, a feedback signal, a position signal, or a status signal, to name a few. The controller 12 will also typically include an interface for the attending physician to input information to the controller 12, such as a keyboard, touch screen, control panel, mouse, joystick, directional keys (i.e., D-pad), and the like. Alternatively, the touchpad may be part of the imaging display 14. The energy delivered by the controller 12 to the treatment probe 16 may be Radio Frequency (RF) energy, microwave energy, therapeutic plasma, heat, cold (cryotherapy), or any other conventional energy-mediated treatment modality. Alternatively or additionally, treatment probe 16 may be adapted to deliver drugs or other therapeutic agents to the tissue anatomy to be treated. In some embodiments, the probe 16 is inserted into an ultrasound system and into a separate Radio Frequency (RF) generator. An interface line connects the ultrasound system and the RF generator.

Referring now to fig. 2 and 3, the treatment probe 16 may include a needle assembly 26 and an imaging assembly 28. Needle assembly 26 and imaging assembly 28 are constructed as separate units or assemblies that can be removably attached to one another for use. After use, the needle assembly 26 may be separated and typically will be discarded, while the imaging assembly 28 will be sterilized for reuse. The treatment probe 16 is shown in its fully assembled configuration in fig. 2 and in its disassembled configuration in fig. 3. In other embodiments of the present invention, the needle assembly 26 and the imaging assembly 28 may be combined into a single, integrated handle unit.

The needle assembly 26 may include a handle portion 27, the handle portion 27 having control elements 30 on an upper surface thereof. The control element 30 may include a joystick, directional keys (i.e., D-pad), or other user interface. The control element 30 may communicate with the controller 12 to adjust the display 14, adjust treatment parameters, adjust the size and/or location of a target area and/or safety area shown on the display 14, and/or perform other functions, as will be described in greater detail below.

The needle 56 may be deployed from the needle shaft 34 and the needle and optional tines together may form a needle structure, which may be constructed, for example, as described previously in commonly owned U.S. patent nos. 8,206,300 and 8,262,574, the entire disclosures of which are incorporated herein by reference.

The handle portion 27 of the needle assembly 26 also includes a fluid injection port 32, which port 32 allows saline or other fluid to be injected through the needle shaft 34 into a target area in the tissue being treated, such as the uterus. Needle handle 27 may also include a needle slider 36, a needle release 38, and a tine slider 40 for deploying a needle 56 and tines 57. The needle slider 36 can slide forward to advance the needle 56 and can slide backward to retract the needle 56. Tine slide 40 may slide forward to advance tines 57 and may slide rearward to retract tines 57. In some embodiments, needle 56 and tines 57 may be coupled to one or more servos within the body of handle portion 27 that are configured to actuate needle 57 and tines 57, and needle 56 and tines 57 may be actuated by manipulating control element 30 and/or controller 12. In many embodiments, the needle 56 must be deployed first, and then the tines 57 may be deployed. As previously described, the imaging cable 24 may be attached at a proximal end of the handle portion 27 of the imaging assembly 28 for connection to the controller 12.

Imaging assembly 28 may include a handle portion 29 and an imaging shaft 44. The deflection lever 46 on the handle portion 29 may be retracted to deflect the imaging sensor 20 downward, as shown in phantom in fig. 3. The needle assembly release lever 48 may be coupled to a pair of latches 50, the pair of latches 50 engaging a catch 52 on the underside of the handle portion 27 of the needle assembly 26. As shown in fig. 3A, needle assembly 26 may be releasably attached to imaging assembly 28 by first capturing a pair of tabs 58 (only one of which is shown in fig. 3) on needle shaft 34 below a hook 60 on imaging shaft 44. The bottom surface of the needle handle portion 27 may then be lowered over the upper surface of the imaging handle portion 29 so that the hooks 52 engage the latches 50 to form a complete assembly of the treatment probe 16, wherein the handle portions together form a complete handle for use in surgery. After use, the needle assembly release lever 48 may be pulled to release the catch 52 from the latch 50, allowing the handle portion 27 to be separated from the handle portion 29.

In use, as will be described in more detail below, the control element 30 may simultaneously be used to position (translate) and resize a virtual treatment area projected onto the display 14 of the system 10. For example, the control element 30 may be pressed forward (distal) and backward (proximal) in order to translate the position of the treatment/safety zone on the image. The control element 30 may be pressed left and/or right to adjust the size of the treatment/safety zone boundary. For example, control element 30 may be pressed to the left to narrow the boundary, while control element 30 may be pressed to the right to expand the boundary. Once the virtual boundaries of the treatment area/safe zone have been set on the real-time image, the needle and tines may be automatically advanced to the corresponding deployed positions, for example, as recommended by the stop, by moving the needle slider 36 and tine slider 40 until their movement is prevented by the user. Thus, advancement of the needle 56 and tines 57 using the slider 36 and slider 40 will result in proper placement of the needle and tines within the target tissue only if the treatment probe is held steady from the set boundary until the needle/tine advancement is completed. In a preferred embodiment, the control element 30 can also be manipulated to adjust the length of the treatment protocol and/or the power delivery during this period. For example, control element 30 may be pressed to select a different control menu from one of the control menus for adjusting the boundary, and one of the selectable menus may allow adjustment of the power delivery parameters, such as by pressing up/down to adjust the length of time of power delivery, and by pressing left/right to adjust the amount of power delivery. Another menu may include a menu for deploying the needle 56 and tines 57 by manipulating the control element 30, such as in embodiments in which the needle 56 and tines 57 are articulated using one or more servos within the handle member 27 of the needle assembly 26. Another menu may also be selected to allow control element 30 to move a cursor on display 14. Thus, the control element 30 may be used to virtually set the size of the treatment/safety zone based not only on the extent to which the tines have been advanced, but also on the amount of energy delivered to the target tissue.

Fig. 4 shows a schematic view of the needle assembly 26 of the treatment probe 16. As shown in fig. 4, the needle assembly 26 may include one or more needle position sensors 37 and one or more tine position sensors 41. A needle position sensor 37 may be coupled to the handle end of the needle deployment shaft 34. Thus, the advancement and retraction of the needle 56 by the slider 36 may be tracked by the needle position sensor 37. The needle position sensor 37 may generate a position signal of the needle deployment shaft 34, which may be sent to the controller 12 via the therapy cable 22, and from which the position of the needle 56 may be determined. Likewise, tine position sensor 41 may be coupled to a handle end of a tine deployment shaft disposed within needle deployment shaft 34. Thus, the advancement and retraction of the tines 57 by the slider 40 may be tracked by the needle position sensor 37. The tine position sensor 41 may generate a tine deployment shaft position signal that may be sent to the controller 12 via the treatment cable 22, and from which the position of the tines 56 may be determined. The needle position sensor 37 and the tine position sensor 41 may include any type of position sensor, such as a linear encoder, a linear potentiometer, a magnetic sensor, a Linear Variable Differential Transformer (LVDT) sensor, a rheostat-type sensor, or a pulse encoder, to name a few. The position of the needle 56 and/or tines 57 may be tracked in real time by the position sensors 37, 41 and controller 12. The calculated treatment and/or safety boundaries may be displayed and adjusted on the display unit 14 because the position of the needle 56 and tines 57 is tracked and optionally updated if moved. Alternatively or in combination, one or more servomotors may be used to translate the needle 56 and tines 57, which may additionally provide position information of the needle 56 and tines 57.

The physician can adjust the control element 30 to position the boundaries of the treatment area/safe zone as desired for display on the visual display 14.

One particular advantage of the method and system is that the physician can manipulate the treatment/safety margin on the target anatomy paper by moving the treatment margin/safety margin relative to (or within) the real-time image caused by manipulating (pressing forward/backward, pressing left/right) the control element 30 or by moving the entire real-time image relative to the target anatomy caused by manipulating the entire treatment probe 16 in order to move the treatment margin over the tumor and keep the safety margin away from sensitive anatomy. Thus, before the physician advances any needle into the patient tissue, they can use the virtual target interface to confirm in advance that ablation will be effective and safe.

Referring now to fig. 5, the system 10 of the present invention may be used to treat a myoma F in a myoma M of the uterus U underlying a uterine wall UW (endometrium) and surrounded by a serosal wall SW. The treatment probe 16 may be introduced transvaginally and transcervically (or alternatively laparoscopically) to the uterus, and the imaging sensor 20 may be deployed to image the fibroid within the field of view indicated by the dashed lines.

Once the fibroid is located on display 14, control elements 30 on handle assembly 27 may be used to locate and size treatment boundary TB and safety boundary SB, as shown in fig. 6A. Initially, as shown in fig. 6A, virtual boundary lines TB and SB may be neither positioned on nor appropriately sized to treat the fibroid, and control element 30 may be in an intermediate position, as shown in fig. 6B. Prior to actual deployment of the needle and tines, the physician may wish to locate and size the boundaries TB and SB for appropriate treatment. Since the imaging sensor 20 may already be positioned against the uterine wall UW, the only way to advance the treatment boundary TB and the safety boundary SB is to move the boundaries forward by manipulating the control element 30 as shown in fig. 7B, such as by pressing the control element 30 forward in the direction of arrow UP. This manipulation may cause treatment boundary TB and safety boundary SB to move forward along axis AL. This manipulation may also cause the virtual boundary on the real-time image display 14 to move over the image of the fibroid, as shown in fig. 7A. If retraction of the treatment boundary TB and safety boundary SB is desired, the control element 30 can be manipulated, such as by pressing the control element 30 rearwardly in the direction of arrow D, as shown in FIG. 7B.

However, as shown in fig. 7A, the size of the treatment boundary TB may not be sufficient to treat the fibroid because the boundary does not extend throughout the image of the fibroid. Thus, as shown in fig. 8B, it may be necessary to enlarge the treatment boundary TB by manipulating the control element 30, such as by pressing the control element 30 to the right in the direction of arrow R +. This may expand both the treatment boundary TB and the safety boundary SB, as shown in fig. 8A. While the enlarged virtual treatment boundary TB may be sufficient to treat the fibroid, the safety boundary SB has been extended onto the serosal wall SW, as also shown in fig. 8A. Thus, there is a risk that the treatment will affect more sensitive tissue around the uterus, and as shown in fig. 9B, it may be necessary to retract the virtual safety boundary SB by again manipulating the control element 30 in the opposite direction, such as by pressing the control element 30 to the left in the direction of arrow L-direction. As shown in fig. 9A, this operation may reduce the size of both the safety boundary SB and the treatment boundary TB, and the physician may confirm that the treatment may be effective because the treatment boundary TB completely surrounds the fibroid on the real-time image display, and that the treatment will be safe because the safety boundary SB is within the myometrium M and does not cross the serosal wall SW on the real-time image display.

While the treatment probe 16 remains stable, the physician may then advance the needle sled 36 as shown in fig. 10B, resulting in the needle 56 extending to the fibroid F as shown in fig. 10A. The illustration of fig. 10A includes a representation of the treatment probe 16, which may correspond to a physical probe present in the patient. The remainder of fig. 10A corresponds to the image present on the target display 14. Treatment boundary TB and safety boundary SB may determine a virtual stop indicator or fiducial point 142 for needle 56. The target display 14 may include a position indicator 140 of the needle 56, in many cases the tip of the needle 56. In some cases, the position of the virtual stop indicator or fiducial point may be related to the size and location of the treatment boundary TB and the safety boundary SB. In other cases, the position of the virtual stop indicator or fiducial point may be adjusted independently with respect to the treatment boundary TB and the safety boundary SB.

After the needle 56 has been fully deployed as indicated by the overlap of the needle position indicator 140 and the stop reference point 142, the tines 57 may be deployed by advancing the tine slide 40, as shown in fig. 11B. Optionally, treatment probe 16 may be rotated about a central axis (generally aligned with the axis of needle 56) to confirm treatment boundary TB and safety boundary SB in all viewing planes around the fibroid. The needle 56 and tines 57 may be held in place relative to the fibroid F while the remainder of the treatment probe 16 is rotated about the fibroid F. The display 14 may show the location of the treatment boundary TB and the safety boundary SB relative to the target fibroid F and serosal wall SW in real time. The tines may be configured as shown in fig. 11A, and power may be supplied to the tines 57 (and optionally to the needles 56) to effect treatment within the boundary delineated by the virtual treatment boundary TB. Again, fig. 11A may blend the virtual image that would be present on the display 14 with the physical presence of the treatment probe 16.

With the needle 56 and tines 57 in the desired position, the treatment probe 16 can be operated to begin ablation of the target fibroid F. The position of the imaging sensor 20 relative to the target fibroid F may be fixed throughout the ablation process. Due to the fixed relative position of the imaging sensor 20, for example, real-time images of the treatment volume including the target fibroid F and serosal wall SW may be accurately compared at different points in time during the ablation process.

Fig. 12 shows a diagram of a tissue treatment system 1200. The user US may operate the controller 12, and the controller 12 may be coupled to the treatment probe 16 as described above to advance or retract the needle structure 56 and the plurality of tines 57 (i.e., the ablation elements), as shown by ablation element advancement control 16 a. The user US may also in many cases operate the controller 12 via the treatment probe 16 to start or stop ablation with the needle structure 56 and the plurality of tines 57, as shown by the ablation controller 16 b. As further shown in fig. 12, the controller 12 may also operate the imaging source 20 to acquire one or more ultrasound images. In many embodiments, the imaging source 20 acquires both one or more B-mode ultrasound images and one or more doppler-mode ultrasound images, wherein the controller 12 can direct the system display 14 to display a combined image showing both tissue morphology and blood perfusion. The imaging source 20 may be directed to acquire B-mode ultrasound images and doppler-mode ultrasound images at intervals. For example, ultrasound images may be acquired at a rate of 1 to 100 frames per second, with the frames alternating between B-mode and Doppler-mode.

Fig. 13 illustrates a method 1300 for treating tissue according to the present disclosure. The systems and apparatus described herein may be used to implement method 1300, including any combination of steps or sub-steps thereof.

In step 1301, a target tissue structure, such as target myoma F, can be located.

In step 1306, a real-time representation of the target tissue structure may be displayed as described herein. In some embodiments, contrast agents may be introduced to the target tissue to enhance the images of structural and morphological features of the target tissue so that they may be better tracked during ablation. In some embodiments, the characteristics of doppler ultrasound images indicative of blood perfusion may also be enhanced. Potentially suitable contrast agents may include some commercially available contrast agents, such as

And

and so on.

In step 1311, one or more ablation elements (e.g., needle structure 56 and plurality of tines 57) may be advanced into the target tissue.

In step 1316, an initial blood perfusion level of the target tissue may be determined, such as by observing and/or quantifying a doppler ultrasound image that may be taken by imaging source 20.

In step 1321, the target tissue may be ablated for a predetermined period of time, for example, between 0.5 and 20 minutes for a single ablation.

In step 1326, a blood perfusion level of the target tissue may be determined after a predetermined treatment period. For example, the user may make this determination manually by viewing an updated real-time image that includes doppler ultrasound and/or contrast enhanced ultrasound information. Alternatively or in combination, the controller 12 may include a display configured to quantify the current blood perfusion level and direct the display 14 to show the quantified amount of blood perfusion.

In step 1331, the current "post-ablation" blood perfusion level may be compared to an initial blood perfusion level. If the current blood perfusion level is not below the threshold compared to the initial blood perfusion level, then the step 1321 of ablating the target tissue, etc. may be repeated. If the current blood perfusion level is below the threshold, the protocol may proceed to step 1336, where ablation of the target tissue is ended. The threshold may include, for example, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less of the initial blood perfusion amount of the target tissue. In some embodiments, a 30% or more reduction in blood perfusion (i.e., the current blood perfusion level is 30% or less of the initial blood perfusion level) may be considered a successful treatment.

In some embodiments, perfusion monitoring of the ablation boundary during treatment is used as a treatment guidance tool. Ablation may be stopped if the user or system observes that the treatment region has spread beyond the target region. Contrast enhanced images may also facilitate such user viewing. Ablation may be interrupted or stopped manually or automatically to ensure patient safety.

Finally, in step 1341, the ablation elements (typically the needle structure 56 and rake teeth 57) can be retracted from the target tissue. The treatment probe 16 can then be fully retracted from the surgical field, or can be repositioned to treat another target tissue structure.

While the above steps illustrate a method 1300 of treating patient tissue according to many embodiments, one of ordinary skill in the art will recognize many variations based on the teachings described herein. The steps may be performed in a different order. Steps may be added or deleted. Some steps may include sub-steps. Many of the steps that are beneficial to treatment can be repeated often.

One or more steps of the method 1300 may be performed by circuitry within the controller 12, the treatment probe 16, or another system component. The circuitry may include one or more of a processor or logic circuitry (e.g., programmable array logic or field programmable gate array). The circuitry may be programmed to provide one or more steps in the method 1300, and the program may include program instructions stored on non-transitory computer readable memory or programming steps of logic circuitry (e.g., programmable array logic or field programmable gate array).

Fig. 14A-14D show exemplary real-time images of a target muscle tumor F during an ablation protocol as described herein. As described herein, these real-time images may include B-mode ultrasound images showing tissue morphology, which are overlaid with doppler-mode ultrasound images showing blood perfusion taken at various points in time.

Fig. 14A shows a first real-time image 1400a showing the uterus U and the target hysteromyoma F. A treatment boundary TB may have been established to surround the target uterine fibroid F. The treatment boundary TB may be centered about the location of the ablation element (e.g., the needle structure 56 and the plurality of tines 57 extending therefrom). The first real-time image 1400a shows the treatment volume before any ablation has occurred, and the doppler signal 1410 received and shown on the image 1400a is defined as the 100% initial doppler signal. The level of one or more doppler signals 1410 within the treatment boundary TB may be determined. In the first real-time image 1400a, for example, 80% of the initial doppler signal 1410 may be within the treatment boundary TB. As discussed herein, the doppler signal 1410 indicates a region of high blood perfusion. In some embodiments, the treatment boundary TB may be determined and/or adjusted based on the distribution and/or location of the doppler signal 1410 showing high blood perfusion. For example, the outer extent of the treatment boundary TB may be selected to capture the majority of the high blood perfusion regions, and/or the treatment boundary TB may be centered on the high perfusion regions as the core region of the ablation. As described above, the treatment boundary TB and the safety boundary SB can be adjusted by the controller 12 and/or the treatment probe 16.

Fig. 14B shows a second real-time image 1400B showing the uterus U and the target hysteromyoma F after a first ablation time period. As shown in the second real-time image 1400b, an ablation region 1450b may currently exist within the treatment boundary TB. The ablation region 1450B may be visible on a B-mode image component of the real-time image 1400B, and/or may be visible on a doppler-mode image component of the real-time image 1400B, with no doppler signals within the boundaries of the ablation region 1450B. After a first predetermined period of ablation, the level of the doppler signal 1410 may be reduced. In the second real-time image 1400b, for example, the total level of the doppler signal 1410 may be 75% of the initial level shown in fig. 14A. In some embodiments, the level of one or more doppler signals 1410 within the treatment boundary TB may be determined and compared to the initial level to determine the percentage of completion of the treatment.

Fig. 14C shows a third real-time image 1400C showing the uterus U and the target hysteromyoma F after a period of further ablation. As shown in the third real-time image 1400c, the ablation region 1450c within the treatment boundary TB may now be even larger than before, and there may now be 50% of the initial doppler signal 1410. Again, the level of one or more doppler signals 1410 within the treatment boundary TB may be determined and used to determine the percent completion of the treatment.

Fig. 14D shows a fourth real-time image 1400D showing the uterus U and the target hysteromyoma F after yet another ablation time period. As shown in the fourth real-time image 1400d, the ablation region 1450d within the treatment boundary TB may now nearly match the treatment boundary TB, and may be nearly free of the doppler signal 1410 from the treatment region TB, indicating that treatment or ablation of the uterine fibroid F has been completed. The relative level of the doppler signal within the treatment boundary may be used as an indicator of ablation or treatment completion. For example, if the doppler signal 1410 currently within the treatment boundary TB has decreased to 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 15% or less, 10% or less, or 5% or less of the initial level (i.e., blood perfusion) of the doppler signal 1410 within the treatment boundary TB, it may indicate that ablation or treatment is complete. The user may select the exact percentage based on his or her preferences. In some embodiments, the controller 12 may allow the user to enter the selection as an ablation parameter to be displayed and tracked. Additionally, the doppler signal 1410 may still be present outside the treatment boundary TB. As shown in fig. 4D, the total level of the doppler signal 1410 within the entire image is 20% of the initial level.

While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will occur to those skilled in the art without departing from the invention herein. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.