METHODS AND SYSTEMS FOR CONTROLLED DEPLOYMENT OF NEEDLES IN TISSUE

Abstract

Needles are deployed in tissue under direct ultrasonic or other imaging. To aid in deploying the needle, a visual needle guide is projected on to the image prior to needle deployment. Once the needle guide is properly aligned, the needle can be deployed. After needle deployment, a safety boundary and treatment region are projected on to the screen. After confirming that the safety boundary and treatment regions are sufficient, the patient can be treated using the needle.

Claims

1. A method for facilitating treatment of uterine anatomy, the method comprising: positioning a probe proximate to the uterine anatomy; using the probe to provide an image of the uterine anatomy; overlaying the image with projected treatment region and a safety boundary based on an estimated or actual position of a tissue treatment device, wherein the projected treatment region includes at least a portion of uterine anatomy to be treated; and aligning the projected treatment region on the image so that the projected treatment region includes at least a portion of the uterine anatomy to be treated and so that a sensitive anatomical structure is outside of the safety boundary.

2. The method of claim 1, wherein aligning the projected treatment region comprises positioning the tissue treatment device to align with the projected treatment region.

3. The method of claim 1, further comprising overlaying the image with a projected position of the tissue treatment device.

4. The method of claim 1, wherein the tissue treatment device comprises a deployable needle configured to ablate the uterine anatomy.

5. The method of claim 1, wherein the probe comprises the tissue treatment device.

6. The method of claim 5, wherein the tissue treatment device comprises a RF ablation needle.

7. The method of claim 1, wherein the probe is delivered transvaginally into a uterus of a subject comprising the uterine anatomy.

8. The method of claim 1, wherein using the probe to provide the image of the uterine anatomy comprises using the probe to provide a real time image of a uterine fibroid to be treated, wherein the sensitive anatomical structure comprises serosa, and wherein the projected treatment region includes at least a portion of a uterine fibroid to be treated.

9. A method for facilitating treatment of uterine anatomy, the method comprising: positioning a probe proximate to the uterine anatomy; using the probe to provide an image of the uterine anatomy; overlaying the image with a projected treatment region based on an estimated or actual position of a tissue treatment device, wherein the projected treatment region includes at least a portion of uterine anatomy to be treated; and aligning the projected treatment region on the image so that the projected treatment region includes at least a portion of the uterine anatomy to be treated.

10. The method of claim 9, wherein aligning the projected treatment region comprises positioning the tissue treatment device to align with the projected treatment region.

11. The method of claim 9, further comprising overlaying the image with a projected position of the tissue treatment device.

12. The method of claim 9, wherein the probe is used to provide an image of a uterine fibroid to be treated, and the projected treatment region includes at least a portion of a uterine fibroid to be treated.

13. The method of claim 9, wherein the tissue treatment device comprises a deployable needle configured to ablate uterine anatomy.

14. The method of claim 9, wherein the tissue treatment device is included on the probe.

15. The method of claim 9, wherein the probe is delivered transvaginally into a uterus of a subject comprising the uterine anatomy.

16. A method for facilitating treatment of uterine anatomy, the method comprising: positioning a probe proximate to the uterine anatomy; using the probe to provide an image of the uterine anatomy including a sensitive anatomical structure; overlaying the image with a safety boundary based on an estimated or actual position of a tissue treatment device; and adjusting the safety boundary on the image so that the sensitive anatomical structure is outside of the safety boundary.

17. The method of claim 16, wherein the probe comprises the tissue treatment device.

18. The method of claim 16, wherein the tissue treatment device comprises an array of RF ablation needles.

19. The method of claim 16, wherein the tissue treatment device comprises a deployable needle configured to ablate the uterine anatomy.

20. The method of claim 19, wherein the safety boundary is based on a position of the deployable needle prior to the needle being deployed.

21. The method of claim 19, wherein the safety boundary is based on a position of the deployable needle after the needle is deployed.

22. The method of claim 16, wherein adjusting the safety boundary on the image comprises positioning the tissue treatment device to adjust the safety boundary.

23. The method of claim 16, further comprising overlaying the image with a projected position of a tissue treatment device.

24. The method of claim 16, wherein the sensitive anatomical structure comprises serosa.

25. The method of claim 16, wherein the uterine anatomy comprises a uterine fibroid.

26. The method of claim 16, wherein the safety boundary comprises an oval line.

27. The method of claim 16, wherein the safety boundary is between 1 cm and 3 cm outward of a projected treatment region boundary.

28. The method of claim 16, wherein the probe is delivered transvaginally into a uterus of a subject comprising the uterine anatomy.

29. The method of claim 16, wherein the probe comprises the tissue treatment device, wherein the tissue treatment device comprises an array of RF ablation needles, wherein the uterine anatomy comprises a uterine fibroid, and wherein the sensitive anatomical structure comprises serosa.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0023] FIG. 1 is a schematic illustration of the system comprising a system controller and a needle treatment probe constructed in accordance with the principles of the present invention.

[0024] FIGS. 2 through 4 illustrate an exemplary needle treatment probe which may be used in the methods and systems of the present invention for the treatment of uterine fibroids.

[0025] FIG. 5 is a flowchart illustrating an exemplary treatment protocol in accordance with the principles of the present invention.

[0026] FIGS. 6A and 6B illustrate use of the needle treatment probe of FIGS. 2 through 4 in the treatment of a uterine fibroid in accordance with the principles of the present invention.

[0027] FIG. 7 illustrates exemplary dimensions for a treatment region and a safety boundary for the needle deployment probe of FIGS. 2 through 4.

[0028] FIGS. 8A through 8G illustrate exemplary images which might be viewed by a treating physician when deploying the needle deployment probe of FIGS. 2 through 4 in treating a uterine fibroid generally as shown in FIGS. 6A and 6B.

DETAILED DESCRIPTION OF THE INVENTION

[0029] As illustrated in FIG. 1, a system 10 constructed in accordance with the principles of the present invention includes both a system controller 12 and treatment probe 14. The system controller 12 will include a processing and power unit 16 and a display screen 18. The controller 12 will further include means for the treating physician to input information, such as a keyboard, touch screen, control panel, or the like. The processing and power unit 16 will usually include a radiofrequency, microwave, vapor, treatment plasma, or other circuitry or mechanisms for delivering the treatment energy or other treatment agents to the treatment probe 14. Conveniently, the system controller 12 could comprise a conventional desktop or laptop computer to provide both the screen and logic and be connected to a separate radiofrequency, microwave, HIFU, liquid infusion, plasma infusion, vapor, cryotherapy or other source to provide the desired treatment.

[0030] The treatment probe 14 typically includes a shaft 20 having a handle 22 at its proximal end. A needle 24 and imaging array 26 are provided at the distal end of the shaft 20, as described in more detail with reference to FIGS. 2 through 4. The treatment probe 14 shown in FIGS. 2 through 4 is described in more detail in copending provisional application No. 60/938,140 (Attorney Docket No. 025676-001700US), filed on May 15, 2007, the full disclosure of which has previously been incorporated herein by reference.

[0031] The probe 14 generally includes a rigid or other delivery shaft 20, an ultrasound imaging transducer 26, and an echogenic curved needle 24 with an artifact/feature 100 at a distal end 51 (FIG. 3) thereof. As shown, the artifact is a corner cut type retroreflector. The handle 22 is attached to a proximal end 21 of the shaft 20. A distal end 23 of the shaft 20 has a bent or deflectable distal tip, as best seen in FIG. 4. The ultrasound imaging transducer 26 comprises a linear ultrasound array disposed in a flat viewing window 36 (FIG. 3) which images in a field of view 46 (FIG. 4). Although only a single straight needle 24 is illustrated, the probe may carry multiple needles in arrays and/or the needles may be straight or have any other configuration.

[0032] The needle 24 is a solid tip electrically conductive needle intended for radiofrequency tissue ablation. As discussed elsewhere, it could also be intended for delivery of other forms of energy or be a hollow core needle intended for substance delivery or injection. The exemplary needle 24 generally comprises a two-piece construction including an elongate hollow body 48 (as best seen in FIG. 3) and a solid distal tip 50 at a distal end thereof. The distal tip 50 may be laser welded to the hollow tubular body 48. The solid tip 50 may also be attached via alternative means, for example adhesives or mechanical features or fits. The hollow tube 48 will generally have a length in a range from about 20 cm to about 45 cm. In some embodiments, the hollow tube will have an oval cross section having a thickness generally in a range from about 0.5 mm to about 2 mm and a wideness generally in a range from about 1 mm to about 3 mm. This flattened oval cross sectional shape, when present, is intended to inhibit lateral deflection during deployment or penetration of the needle 24. FIG. 3 also illustrates a representative laser cut hole 60 within the distal end of the tubular body 48 for the infusion of agents (e.g., electrolytes, drugs, etc.) so as to enhance the therapeutic effect of the needle 14 prior to or during ablation treatment. The infusion hole 60 may be aligned on one side of the tubular body 48 and generally has length in a range from about 0.5 mm to about 2 mm and a width in a range from about 0.5 mm to about 2 mm. It should be noted that hole 60 may comprise one or a plurality of holes, and each may be used for a different purpose.

[0033] The handle 24 further includes a longitudinally movable slider 72 for enabling the advancement and retraction of the needle 14 to and from within a needle guide 44. The ultrasound imaging transducer 26 may optionally be present on an imaging insert replaceably disposed within the axial passage of the shaft 20. A sealing element 30 may be provided between the ultrasound imaging transducer 26 and the shaft handle 24 to ensure sufficient sealing around the insert at a proximal end. It will be appreciated that the above depictions are for illustrative purposes only and do not necessarily reflect the actual shape, size, or dimensions of the system 10. Furthermore, the ultrasound array may be parallel to an axis of the shaft 20 or may be slightly inclined as illustrated in FIG. 4. This applies to all depictions hereinafter. The array is typically a linear array with from 16 to 128 elements, usually having 64 elements. The length (azimuth) of array 12 usually ranges from about 5 mm to about 20 mm, normally being about 14 mm. The array may have a depth (elevation) ranging from about 1 mm to about 8 mm, normally being about 2 mm. In an embodiment, the ultrasound array transmits ultrasound waves at a center frequency ranging from about 2 MHz to about 15 MHz, typically from about 5 MHz to about 12 MHz, normally about 6.5 MHz.

[0034] Referring now to FIG. 5, an exemplary protocol for performing the needle positioning methods of the present invention for treating uterine fibroids will be described. After the probe 14 is positioned in the uterus, the treating physician scans the myometrium M in order to locate fibroids F, as shown in FIG. 6A. Shaft 20 is manipulated so that the field of view 46 of the transducer array 26 provides a visual image, such as that shown in FIG. 8A, on the screen 18 of the system 12. Once a fibroid F is located, the physician can scan the image for other anatomical features such as the treatment-sensitive serosa S, as also shown in FIG. 8A. It should be appreciated that the image being produced is “real time,” and that the image will change as the physician moves the shaft 20 within the uterus U so that the field of view 46 scans over different portions of the myometrium.

[0035] The next step in the protocol of FIG. 5 relies on aligning a needle guide overlay with the fibroid. The needle guide may be a simple pair of parallel lines 70, as shown in FIG. 8B. The parallel lines 70 will typically represent the limits of the most likely lateral needle advancement path. Thus, by aligning the lines 70 generally across the target fibroid F, as shown in FIG. 8C, the likelihood that the needle will be directed into the middle of the fibroid is increased.

[0036] The treating physician continues to visually assess the position of the needle guidelines 70 relative to the fibroid F until they are acceptably aligned, as shown in FIG. 8C. The physician then advances the actual needle into the tissue as shown in FIG. 6B, where the image of the actual needle is shown in FIG. 8D. After the image of the actual position of the needle appears, the physician marks a preselected position on the needle, either by moving a curser on the image and clicking, touching the screen, or the like. Such “marking” of the actual position allows the system to calculate or recalculate a projected safety boundary and a projected therapy region. For example, the system may be marked near the tip of the needle, as shown at location 80 on FIG. 8E.

[0037] Referring now to FIG. 7, an exemplary safety boundary 90 and treatment region 92 for a single needle fibroid ablation system will be described. A treatment needle 24 has an uninsulated treatment portion 96 having a length l in the range from 1 cm to 3 cm, typically being 2 cm. The safety boundary will be an oval line which is generally a distance s from the exposed exterior of the treating electrode portion 96. The distance s is usually in the range from 1 cm to 3 cm, typically being about 1.5 cm. A distance t between the exposed needle portion 96 and the treatment region boundary 92 will typically be about half that of the safety distance s, typically being in the range from 0.5 cm to 1.5 cm, usually being about 0.75 cm. Generally, the distance tt from the distal tip of the needle 24 and the safety boundary and the treatment region perimeter will be somewhat less because of the reduced energy density at the tip. Thus, the distance tt between the tip and the treatment region perimeter may be from 0.1 cm to 0.5 cm, usually being about 0.25 cm while the distance is between the tip and the safety boundary will be in the range from 0.5 cm to 1.5 cm, typically being about 1 cm.

[0038] Based on these desired clearance distances, the system projects treatment and safety overlays on the actual image of the needle 24, as shown in FIG. 8F. The physician can then visually assess whether sensitive tissue structures, such as the serosa S remain outside of the projected safety boundary 90. As shown in FIG. 8F, the serosa S is inside of the safety boundary 90, so it will be necessary to reposition or redeploy the needle 24 to move the serosa S beyond the safety boundary. It is noted that the position of the treatment perimeter 92 about the fibroid F is probably sufficient for treatment, but the needle needs to be deployed based on safety concerns.

[0039] Once the needle has been repositioned or redeployed so that the treatment region 92 sufficiently covers the fibroid F while the safety boundary does not encroach upon the serosa S as shown in FIG. 8G, the physician will enable the system for treatment. Usually, the system will require the physician to acknowledge that the needle has been properly positioned before allowing the system to power the needle. Once that is done, the physician can initiate treatment, as described generally in the prior applications which have been incorporated herein by reference.

[0040] While the above is a complete description of the preferred embodiments of the invention, various alternatives, modifications, and equivalents may be used. Therefore, the above description should not be taken as limiting the scope of the invention which is defined by the appended claims.