# Patent

## Title
Screw-driven handles and systems for fiducial deployment

## Abstract

Embodiments include a fiducial deployment system with a handle configured for actuation of same. A fiducial may include one or more protuberances configured to engage one or more slots in a needle of the system. The needle may be configured to deliver a plurality of fiducials to a target location in serial fashion, one at a time. In certain embodiments, echogenic placement of fiducials may present certain advantages. The handle includes an actuation mechanism with rotatable housing portion or member configured for incrementally or otherwise controlledly deploy one or more fiducials at a time by advancing a stylet through and/or retracting the body of a slotted needle in which fiducials are disposed with a fiducial protrusion extending into the needle slot, which also includes retaining structures that do not impede the needle lumen.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a U.S. non-provisional application which claims priority under 35 USC §119 to U.S. provisional application Ser. No. 62/009,587, filed Jun. 9, 2014, which is incorporated by reference herein in its entirety.


TECHNICAL FIELD
Embodiments disclosed herein relate generally to a medical device system including one or more fiducials and methods of use for same. More particularly, the disclosed embodiments pertain to handle mechanisms and systems including same for endoscopically deploying fiducials, and methods of use for same.
BACKGROUND
Medical procedures often require locating and treating target areas within a patient. Focused, dose-delivery radiation therapy requires locating the target with a high degree of precision to limit damaging healthy tissue around the target. It is particularly important to know or estimate the precise location of the target in radiation oncology because it is desirable to limit the exposure of adjacent body parts to the radiation in a patient already suffering the depredations of cancer. However, in all treatment procedures, whether radiologic or otherwise, it is most desirable to be able to accurately target a region to be treated.
In many applications, it is not possible to directly view a treatment target or portion thereof (such as, for example, a cancerous tumor, cyst, pseudocyst, or other target) that needs to be acted on in some manner. As one example, when treating a lung or pancreatic tumor with radiation, it may not possible to view the actual tumor within the patient immediately before the radiation treatment. It is therefore highly advantageous to have some mechanism for permitting the tumor to be located accurately so that the radiation treatment can be targeted at the tumor while avoiding damage to healthy tissue.
Even for target regions that may be visualized using CAT (computer-assisted tomography) scans, MRI (magnetic resonance imaging), x-rays, ultrasound, or other techniques, difficulties often arise in targeting a treatment. This is particularly true for target regions within a torso of a patient and soft tissue regions. Due to the mobility of tissues in those regions (e.g., movement of internal organs during respiration and/or digestion, the movement of breast tissue with any change of body position, etc.), a target region may not remain fixed relative to anatomical landmarks and/or to marks that can be placed onto an external surface of a patient's body during one of those visualization procedures.
Several techniques have been developed to address this problem. One such technique is to place markers into the patient along the margins of the target region. The markers may be active (e.g., emitting some kind of signal useful in targeting a therapy) or passive (e.g., non-ferromagnetic metallic markers—called fiducials—that can be used for targeting under ultrasound, MRI, x-ray, or other targeting techniques, which may be included in a treatment device).
A fiducial is typically formed of a radio-opaque material that the target can be effectively located and treated with a device that targets a site using the fiducials as positional markers under radiographic detection. Typically, the fiducials may be inserted into the patient during a simple operation. Percutaneous placement is most commonly used. However, use of minimally-invasive placement via an endoscope has recently developed for fiducial placement into a patient's internal organs. For example, percutaneous placement of fiducials along the margins of a pancreatic tumor can be complex and painful (particularly for obese patients, where the needle size is necessarily larger). Another process using percutaneously implanted objects in a patient is brachytherapy. In brachytherapy, radioactive sources or “seeds” are implanted into and/or adjacent a tumor to provide a high dose of radiation to the tumor, but not the healthy tissue surrounding the tumor.
FIGS. 1A and 1B show longitudinal sectional views of a two-piece introducer 100 of the prior art useful for placement of brachytherapy seeds or fiducials. Referring first to FIG. 1A, the introducer 100 includes a needle 102 and a stylet 104 slidably disposed within the needle 102. The stylet 104 includes a first handle 101 and a blunt distal end 106. The needle 102 includes a second handle 103 and a bevel-tipped cannula 108 extending through the second handle 103. The cannula 108 is configured to hold a seed/fiducial 110. The cannula 108 has a distal tip 105 configured for percutaneous implantation of the seed/fiducial 110 into the patient.
In a “pre-loaded configuration,” the seed/fiducial 110 is retained in the cannula 108 by a plug 112 made from bone wax or other suitable bio-compatible material(s). This is typically accomplished by a “muzzle-loading” technique where the fiducial is placed into the distal needle and then held in place by the bone wax plug. This can present some challenges, as the bone wax plug 112 can be visible as an artifact in the patient, potentially interfering with clear visualization of body structures or treatment devices. With this configuration, the cannula 108 must be withdrawn and reloaded after delivery of each seed/fiducial 110. If the target locations for the fiducials are very far apart, use of a single percutaneous introducer cannula/trocar for multiple introductions of the cannula 108 may not be possible. In such a circumstance, the patient must endure several percutaneous punctures (and the increased attendant risk of infection for each).
To implant the desired arrangement of seeds/fiducials 110 at a target location in a patient, an operator pushes the cannula 108 in a first direction (arrow A) to insert the tip 105 into the patient (typically under fluoroscopic visualization). The operator then pushes the second handle 103 further in the first direction to position the tip 105 at the desired depth within the patient where a seed/fiducial 110 is to be implanted. Throughout this motion, the operator moves the needle 102 and the stylet 104 together as a unit. At the desired depth/location, the operator grasps the first handle 101 with one hand and the second handle 103 with the other hand. Then, the operator holds the first handle 101 stationary while simultaneously sliding the second handle 103 back in a second direction (arrow B) toward the first handle 101. As shown in FIG. 1B, this movement causes the cannula 108 to retract over the seed/fiducial 110 to implant it in the patient. Alternatively, the operator may move the first handle 101 in the first direction (arrow A) while sliding the second handle 103 back in the second direction (arrow B). This causes the stylet 104 to push the seeds 110 out of the cannula 108. The procedure is then repeated to place other seeds/fiducials 110. When being used for targeting of radiation therapy, a minimum of three fiducials is typically required.
As will be appreciated from the disclosed structure, after deploying one fiducial, one may alternatively reload the introducer 100 from the proximal end by completely withdrawing the stylet 104, then placing another fiducial into the needle lumen and advancing it therethrough to a second location to which the distal needle tip 105 has been directed (a “breech-loading” technique). Provided that the fiducial target sites are sufficiently close together to allow this technique, it can reduce the number of percutaneous punctures or other access procedures needed to place more than one fiducial. However, it creates a problem for procedures where ultrasound is being used or is to be used in the near-future because it introduces air pockets into the tissue and related fluids. Those air pockets with tissue and/or fluid are echogenic in a manner that can interfere with ultrasound visualization of a target area and/or tools being used to diagnose or treat in/around the area. In some brachytherapy techniques, a series of fiducials may be preloaded into the needle—either separately or connected by a suture or similar device—then placed together in fairly close proximity; however, such a technique typically is not effective for placing three or more fiducials in sufficiently disparate locations to use for targeting a treatment relative to, for example, margins of a tumor. This may also be true for multifiducial systems that rely upon a distal plug to retain fiducials, which are thereafter released freely, in contrast with systems according to the present invention, which are configured for controlled serial release (e.g., one at a time, two at a time, or some other user-controlled retention and release of a pre-determined number of fiducials).
The process is similar when implemented endoscopically in the manner developed rather recently, except that the needle and stylet are of the type known in the art for use through the working channel of an endoscope. One limitation of current endoscopic techniques is the size of fiducial that can be introduced. With the size limitation of endoscope working channels, the largest needle that can typically be used without risking bending, crimping, curving or otherwise damaging a needle (that does not have an internal stylet or other support) during advancement out of the endoscope to an anatomical target is a 19-gauge needle. This limits the size of the fiducial that can be introduced through the needle lumen using current, cylindrical fiducials. The endoscopic technique generally suffers from the same reloading problems as described above. Even though the external percutaneous punctures are not an issue, having to withdraw and reload takes up valuable time and complicates the procedure, potentially requiring additional personnel, whether only the stylet is withdrawn for “breech-loading” or the entire device is withdrawn for “muzzle-loading.”
It would be desirable to use ultrasound, and particularly endoscopic ultrasound (EUS) for navigation and placement of fiducials. As such it would be desirable to provide and use the largest possible fiducial that will provide improved echogenicity based on its size and echogenic profile. It would be desirable to provide multiple fiducials in a needle that can be introduced in a controlled serial manner (one, or some other pre-determined number, at a time) rather than requiring manual reloading after placement of each fiducial.
BRIEF SUMMARY
Embodiments of a fiducial deployment system described herein may include one or more of: one or a plurality of fiducials having one or more protuberances, a slotted needle configured for delivering a plurality of fiducials in serial fashion where the slot receives the fiducial protuberances without a detent that occupies any internal diameter needle lumen portion, a handle configured for controlling the serial delivery by user-operated deployment of a predetermined number of fiducials, and a method of delivering fiducials to a target region.



BRIEF DESCRIPTION OF THE DRAWINGS
FIGS. 1A-1B show a prior art fiducial introducer and method of use;
FIGS. 2A-2C show an embodiment of a fiducial from, respectively, top, side, and transverse section views;
FIG. 3 shows a top view of a slotted needle embodiment;
FIG. 3A shows a top view of another slotted needle embodiment;
FIGS. 4-4B show, respectively, a top perspective view, a longitudinal section view, and a transverse section view of a distal fiducial deployment system portion;
FIGS. 5A-5C show a method of placing fiducials;
FIGS. 6A-6B show a handle embodiment for a fiducial deployment system;
FIGS. 7-7D show, respectively, an external view, an internal-component view, a top-perspective view of the internal components, a second internal component view, and a longitudinal section view of an advancement mechanism embodiment for a fiducial deployment system; and
FIGS. 8-8D show, respectively, an external view, an internal components view, two longitudinal section views, and a top-perspective view of the internal components of a second advancement mechanism embodiment for a fiducial deployment system.



DETAILED DESCRIPTION
The terms “proximal” and “distal” are used herein in the common usage sense where they refer respectively to a handle/doctor-end of a device or related object and a tool/patient-end of a device or related object.
A variety of fiducial and needle configurations may be used in keeping with the present embodiments including those described in U.S. Pat. App. Publ. Nos. 2010/0280367; 2011/0152611 to Ducharme et al.; 2013/0006101 to McHugo et al.; 2013/0006286 to Lavelle et al.; and 2013/0096427 to Murray et al., each of which is incorporated by reference herein in its entirety. One embodiment, illustrated with reference to FIGS. 2A-2C, of a fiducial 400 has a generally columnar body that is generally cylindrical with a generally circular transverse cross-section. A longitudinal surface face of the body may be dimpled to enhance its ability to reflect ultrasound waves and thereby provide a desirable echogenic profile. This dimpled characteristic may alternatively be embodied as a different irregular, patterned, or textured surface feature (e.g., knurled, ribbed) that may enhance the echogenicity of the fiducial 400, which will aid in visualizing it during EUS-guided placement, and allow it to be used in ultrasound visualization of a target site being marked by one or more fiducials 400 (e.g., a tumor).
Such a fiducial 400 preferably will be formed of a radio-opaque, non-ferromagnetic material such as, for example, gold, platinum, palladium, iridium, or alloys thereof, with one preferred embodiment including an alloy of palladium with rhenium (advantages of which may include desirable radio-opacity, market-price stability superior to gold, and ultrasound-reflectivity/echogenicity due to density). Being radio-opaque will allow the fiducial to be used in deployment techniques using fluoroscopy, as well as making it detectable/visualizable by radiographic means during a treatment or other procedure where it may be desirable to know the location(s) of one or more fiducials. Being non-ferromagnetic will lessen the likelihood that visualization techniques or other procedures employing magnetic fields such as, for example, MRI, will re-orient or otherwise dislodge a fiducial. Echogenic construction of a fiducial or needle may be enhanced by surface texture, but can also be provided by structural inclusions such as embedded bubbles or beads that provide for a different ultrasound reflectivity than material surrounding them. Fiducials may also be coated with a material (e.g., parylene) configured to reduce backscatter during radiography.
In a preferred embodiment, the fiducial 400 is configured and dimensioned for passage through and release from a needle lumen. For an endoscopic delivery system, the fiducial body 402 (exclusive of the protuberance) preferably will have an outer diameter (OD) of about the same or less than the inner diameter (ID) of a needle lumen, but the OD of the fiducial body preferably will be no greater than the needle ID. As used herein, the OD of the fiducial refers to an imaginary circle (or other geometric shape) whose outermost boundaries all fit within the ID of the needle lumen. In other words, it is preferable that the fiducial is dimensioned to fit slidably into the needle lumen, except the protuberance, which projects into the slot.
The longer body portion distal of the protuberance can help make certain that, during deployment through a needle, a first fiducial distal of this second fiducial will be fully advanced out of the needle before that second fiducial is positioned for deployment, as will be made clearer with reference to FIGS. 7-8D below. Accordingly, in many preferred embodiments, the fiducial protuberance (of the second and successive fiducials) will be nearer its proximal end than its distal end, so that the distal fiducial body portion projects sufficiently distally that it will advance the preceding first fiducial completely out of the needle lumen by the time that the second fiducial is in a position to be deployed (see FIGS. 4A-4C, 7-8D, and corresponding text). It should be appreciated that, even if all surfaces of the central fiducial portion 402 and protuberance 408 are generally smooth, the preferred materials forming the fiducial 400 and the presence of the protuberance 408 may provide a desirable echogenic profile that is readily visualizable under ultrasound at a resolution sufficient for locating and/or navigating it in a patient's body.
The fiducial 400 has a generally cylindrical body 402 formed as a mass with a generally circular transverse cross-section along its proximal and distal end sections. A protuberance 408 projects from the longitudinal circumferential face 406 of the fiducial body 402. As viewed from the top, the protuberance 408 is generally obround. The irregular shape and increased surface area (as compared to a typical cylindrical fiducial of the type used in plug-ended systems and/or systems with some type of lumen-occupying detent) preferably enhances the echogenicity of the fiducial, which preferably will already be desirably high due in part to its composition.
The protuberance 408 includes protuberance end faces 407 that may provide one or more of chamfered, filleted, and radiused transition to the outer face 406 of the body 402. The body 402 is generally a right cylinder, but for the protuberance 408. In this embodiment, the protuberance 408 is rounded and substantially parallel to the longitudinal central axis of the fiducial body, and it is about one half the length of the body 402, and it is centered along the body length. In a preferred embodiment, the fiducial 400 is configured and dimensioned for passage through and release from a needle lumen. For an endoscopic delivery system, the fiducial body (exclusive of the protuberance) will have an outer diameter (OD) of about the same or less than the inner diameter (ID) of a needle lumen, but the fiducial body OD preferably will be no greater than the needle ID. The protuberance 408 will engage and ride along through a needle slot.
Dimensions of one exemplary embodiment are also described with reference to FIGS. 2A-2C. In one exemplary embodiment the body 402 is about 0.12 inches (3.05 mm) long and has an OD of about 0.034 inches (0.86 mm). The protuberance 408 is about 0.06 inches (1.5 mm) long and is aligned along a midline of the body. The protuberance 408 projects about 0.008 inches (0.2 mm) above the OD of the body 402 and is about 0.011 inches (0.28 mm) wide. These measurements and proportions may be varied in other embodiments while remaining within the scope of the presently-claimed material. For example, the protuberance may be more distally or proximally located, and may be at an angle relative to the midline such that it partially spirals around the outer surface of the body.
FIG. 2C shows an end view of a transverse section taken along line 2C-2C of FIG. 2A. It shows one embodiment of general proportions of a fiducial body and protuberance of the present system.
FIG. 3 shows an embodiment of a fiducial introduction needle 800. The needle 800 is illustrated with a beveled distal tip 802. Its tubular cannula body 804 includes a longitudinal needle slot 806 along a distal end region of the cannula 804. The slot 806 preferably includes at least one detent including at least one detent surface, and more preferably two detents. The slot 806 is shown as being open through the entire wall of the cannula 804, but it should be appreciated that the slot may extend less than the thickness of the needle wall, such that it is embodied as a groove.
In the embodiment of FIG. 3, the detent is formed as a narrowed portion 807 of the slot 806 between two tabs 808. The tabs 808 are generally trapezoidal, but may have a different geometry in other embodiments. As shown in FIG. 3A, in certain preferred embodiments, the tabs 808 may be located immediately adjacent the distal bevel (e.g., to maximize efficiency of advancing a fiducial past them and out of the needle while minimizing residual overlap of a deployed fiducial with the beveled portion of the distal needle tip). Each of the transitions between the edge 806a of the needle slot 806, the proximal tab edge 808a, central tab edge 808b, and distal tab edge 808c may be cornered (e.g., chamfered or filleted) or rounded (e.g., radiused). The tabs 808 preferably are near the distal end of the slot 806.
The body wall cannula 804 generally circumferentially defines a needle lumen 810 configured to allow sliding passage therethrough of a fiducial such as, for example, a fiducial (e.g., as shown in FIGS. 2A-2C or others that would readily pass through the needle lumen 810, preferably with controllable retention of the fiducial(s) by the tabs 808). The needle may be constructed from a nickel-titanium alloy, cobalt-chromium (CoCr) alloy, stainless steel or any other suitable material. Its tip may have a different geometry than the beveled configuration shown. In an alternative embodiment, the tabs 808 may meet such that they will be forced to flex upward and/or outward to a greater degree to allow passage of a protuberance on a fiducial. And, the outer surface of the needle may be dimpled or otherwise textured to provide enhanced echogenicity.
An exemplary needle embodiment is also described with reference to FIG. 3, which exemplary needle embodiment may be configured and dimensioned for use with the exemplary fiducial embodiment described above with reference to FIGS. 2A-2C. In one such exemplary needle embodiment, the ID of the needle lumen is at least about 0.034 inches (0.86 mm). The OD of the needle is about 0.042 inches (1.07 mm; about 19-gauge), with a wall-thickness of about 0.008 inches (0.2 mm). The slot portion proximal of the tabs is about 0.02 inches (0.5 mm) wide and about 0.42 inches (about 10.7 mm) long. Each of the tabs extends about 0.06 inches (0.15 mm) out of the slot edge and has a slot-facing edge that is about 0.02 inches (0.5 mm) long (not including the proximal and distal angled transitions from the slot edge, which are radiused at about 0.005 inches (0.13 mm)). These measurements and proportions may be varied in other embodiments, including those illustrated herein, while remaining within the scope of the presently-claimed material. For example, the particular dimensions of a slot, tabs, and fiducial may be configured for use with a 22-gauge needle having a desirable balance of flexibility and stiffness, as well as including a distal needle tip bevel of about 30°, a slot width of about 0.014 inches (about 0.36 mm) with slot tabs separated only by about 0.006 inches (about 0.15 mm) across the slot, and echogenicity-enhancing surface dimpling disposed along the needle exterior adjacent and generally parallel with at least a distal length of the slot.
The distal end portion of a fiducial deployment system 1000 is described with reference to FIG. 4, which is an external view, FIG. 4A which is a longitudinal section view taken along line 4A-4A of FIG. 4, using the needle 800 and fiducial 400 described above, and FIG. 4B, which shows a transverse section view along line 4B-4B of FIG. 4A. The system 1000 includes a flexible elongate needle sheath 1002. The needle 800, including a more flexible proximal body portion 820 extends through a sheath lumen 1004. At least one fiducial 400, illustrated here as a plurality of fiducials 400, is disposed slidably removably in a distal region of the needle lumen 810 of the needle's cannular body. The central longitudinal body portion 402 substantially occupies the inner diameter of the needle lumen 810. The protuberance 408 of each fiducial 400 has a height that may be about the same as the thickness of the needle wall, including the slot 806 into which the protuberances 408 project.
The protuberance 408 of the distal-most fiducial 400 is captured against the tabs 808 of the needle 800. A stylet 1006 configured for use as a pusher is disposed through a portion of the needle lumen 810 and preferably is configured for actuation from the proximal end, whereby it can be used to distally advance/push out the fiducials and/or hold them in place as the needle is withdrawn from around them. The presence of the fiducials and stylet in the needle 800 preferably improve its columnar strength reduce the likelihood that it will get bent, crimped, or otherwise damaged as it is navigated through and out of the distal end of an endoscope working channel (not shown).
FIG. 4B shows a transverse section end view of a section of a needle 800 (as in FIG. 3) and a fiducial 400 (as in FIGS. 2A-2C). This view shows the preferred close tolerances and a preferred orientation of the fiducial body relative to the needle lumen 810 and the protuberance 408 relative to the needle slot 806.
Several different handle embodiments may be used to effect advancement and release of one or more fiducials. Certain handle embodiments are described with reference to FIGS. 7-8D below, including with reference to the structure and method described below with reference to FIGS. 4-4B and 5A-5C.
A method of using the fiducial deployment needle of FIGS. 4-4B is described with reference to FIGS. 5A-5C, with reference to the structures shown in greater detail in FIGS. 4-4B. In a preferred method of use, an endoscope 1100 is provided, including a working channel 1102. In one preferred method, the endoscope is an EUS endoscope including a distal ultrasound array 1104 configured for ultrasound imaging. The endoscope 1100 preferably also includes a video element 1106 (e.g., CCD, optical camera, or other means for optical visualization). The methods below are described with reference to placing fiducials 400 at the margins of a tumor 1152 of a patient's pancreas 1150, such that the needle body will be of sufficient length and navigability (e.g., pushability and flexibility) to perorally be directed through a patient's gastrointestinal tract to a target site, including doing so via a working channel of an endoscope such as a gastric endoscope, colonoscope, anuscope, or other visualization/procedure-assisting device.
The endoscope 1100 is shown in FIG. 5A as having been directed through a patient's duodenum 1140 until its distal end portion is adjacent the Sphincter of Oddi 1142, which provides access to the common bile duct 1144 from which the pancreatic duct 1146 branches and leads to the pancreas 1150.
As shown in FIG. 5A, the sheath 1002 has been advanced to the duodenal wall and the needle 800 has been pierced therethrough, extending near the pancreatic duct 1146 to a location adjacent the tumor 1152 in the pancreas 1150. As shown in FIG. 5B, the needle 800 is directed to a first target site at a margin of the tumor 1152 (preferably under ultrasound guidance, which can be replaced, complemented, and/or verified by fluoroscopy or another visualization technique). Once the distal end 802 of the needle 800 is positioned at the first target, the distal-most fiducial 400 therein is deployed. In one aspect, the deployment may be accomplished by positioning the distal needle end 802 and the fiducial 400 therein at the first target, then retracting the needle 800 while retaining the position of the stylet 1006 such that the fiducial 400 remains in the desired first target position. In another aspect, the deployment may be accomplished by positioning the distal needle end 802 and the fiducial 400 therein adjacent the first target, then holding the needle 800 in position while advancing the stylet 1006 such that the fiducial 400 is advanced into the desired first target position.
As will be appreciated from the structure of the needle 800 and fiducials 400 as shown in FIGS. 4-4B, a user preferably will be able to control advancement/deployment of the fiducials to one at a time, such that a plurality of fiducials (without any spacers) may serially—but separately and independently—directed into different locations. Then the fiducial 400 is in a “ready to deploy” position, its distal protuberance face 408a is engaged against the proximal tab edges 808a. To deploy the fiducial 400, the user must move one of the stylet 1006 or needle 800 relative to the other with sufficient force to advance the protuberance 408 through the tabs 808.
The user preferably will have a tactile sense of resistance as the protuberance 408 passes through the tabs 808, which resistance will decrease immediately as soon as the protuberance clears the tabs. Then the user preferably continues the relative motion of stylet and needle until resistance is again encountered, indicating that the next fiducial behind the distal-most one has met the proximal tab edges 808a. 
It will often be preferred that the fiducials (and the protuberances thereon) be proportioned such that complete deployment of a distal-most fiducial includes it substantially clearing the distal needle tip 802 and coincides with the protuberance of the next distal-most fiducial meeting the proximal tab edges 808a. As such, it may be advantageous in some fiducial embodiments to position the protuberance more proximally on the fiducial body such that a fiducial body portion distal of the protuberance is longer than a body portion proximal of the protuberance. It should be appreciated that the protuberance of almost any fiducial embodiment in keeping with principles of the present invention may be disposed near the proximal end up to and including flush with the proximal end of the fiducial body). FIG. 5C shows the fiducial in place, with the needle withdrawn away from it.
Next, the user may retract the needle 800 into the sheath 1002 to a sufficient distance allowing it to be re-extended to a second target site, where the procedure described above may be repeated. These steps may be repeated for placement of third, fourth, and further fiducials. As is known in the art, these fiducials may be used for “positive targeting” and/or “negative targeting” of a therapy such as radiation therapy (“positive targeting” indicating “treat here”, and “negative targeting” indicating “do not treat here”). The present system presents numerous advantages. For example, consider a patient already undergoing an endoscopy procedure to biopsy a located but undiagnosed tissue mass. The endoscopic biopsy can be taken and a tissue slide prepared immediately. If a diagnosis is made (in conjunction with whatever other data are available and pertinent) that the tissue mass will benefit from a treatment where placement of fiducials is indicated, the physician can immediately deploy fiducials in the manner described above.
The ability to complete the method using direct/video and ultrasound imaging with little or no use of fluoroscopy presents an advantage of minimizing the radiation exposure of the patient (who may, for example, have to undergo radiation therapies where the total amount of exposure to radiation is desired to be minimized to that which is therapeutically and diagnostically necessary). Advantages of time and expense for the patient, physician and other treating/diagnostic personnel, and the treatment facility are likely as implementation of the present method may prevent all of those entities from having to schedule and conduct a second endoscopic procedure, and/or to extend the initial diagnostic procedure with the time-consuming methods and materials currently available in the prior art as described. It should also be appreciated that, when informed by the present disclosure, those of skill in the art may utilize and/or adapt the presently-disclosed embodiments for percutaneous use while remaining within the scope of one or more claims.
Fiducials with generally cylindrical or otherwise generally regular geometry may migrate after having been placed in a desired location, including that—over the course of multiple treatments of a target area delineated by fiducials—they may migrate with changes in the condition of surrounding tissues. For circumstances where it may be advantageous to minimize migration, a fiducial may be used that includes one or more anchoring projections.
FIGS. 6A-6B show a handle embodiment 1600 that may be used with a fiducial deployment system. The handle 1600 includes a sheath-attached handle member 1602 with a needle-attached handle member 1604 longitudinally slidably disposed on its proximal end. A handle member 1606 (which may be configured for scope-attachment) is slidably attached to the distal end of the sheath-attached handle member 1602. The sheath-attached handle member 1602 is attached to the needle sheath 1612 and the needle-attached handle member 1604 is attached to the needle 1614 (which may be configured in the manner of any of the needles disclosed herein or later developed in accordance with principles of the present disclosure). The scope-attachment handle member 1606 is configured for incrementally fixable, longitudinally-adjustable (relative to the other handle components) attachment to the exterior of an endoscope working channel (not shown) using, for example, a threaded cavity 1616. The scope-attachment handle member 1606 allows a user to determine the distance by which the sheath 1612 will extend from a standard-length endoscope, and it may include numerical or other indicia 1617 corresponding to that relative length and an adjustable engagement structure 1618 allowing a user to select a length and engage the scope-attachment handle member 1606 accordingly. It should be appreciated that embodiments of the handle described and claimed herein may be practiced within the scope of the present invention without including a scope-attachment member.
The sheath-attached handle member 1602 includes numerical indicia 1608 and an adjustable ring 1609 that limits the movement of the needle-attached handle member 1604 and provides a way to select the distance to which the needle 1614 may be extended beyond the sheath 1612. By way of illustration, the configuration shown in FIG. 6A would allow the sheath to extend 5 units (e.g., inches, cm) beyond the distal end opening of an endoscope working channel, and the needle 1614 would not extend at all beyond the distal end of the sheath 1612. The configuration shown in FIG. 6B would allow the sheath to extend 3 units (e.g., inches, cm) beyond the distal end opening of an endoscope working channel, and the needle 1614 would be allowed to extend up to 6 units beyond the distal end of the sheath 1612, although its current position would be only about 4 units beyond the distal end of the sheath 1612.
A stylet 1610 extends through a lumen of the needle 1614 and has a stylet cap 1611 fixed on its proximal end. The stylet 1610 is shown as being retracted proximally in FIG. 6A, and extended beyond the distal end of the needle 1614 in FIG. 6B. The stylet 1610 may be manually advanced distally through the needle lumen in the same manner as described above (with reference to FIGS. 4-4B) for a stylet 1006. As such, a user may use the stylet to manually push fiducials out of a distal end of the needle 1614. If this method is used (e.g., in the manner described above for deployment of fiducials with reference to FIGS. 4-5C), a user may rely upon tactile feedback to determine when a fiducial has been advanced beyond any detents, which may be difficult through a long stylet—particularly if the detents are rounded such that the advancing motion is relatively smooth. Accordingly, it may be advantageous to provide an advancement mechanism configured to attach to (including being integrated with) the handle 1600 that provides improved control of stylet advancement.
FIGS. 7-7E show embodiments of advancement mechanisms that may be used with handle assembly configurations of a fiducial deployment system similar to those of FIGS. 6A-6B, or other handle configurations (including, for example, those disclosed in U.S. Pat. App. Publ. Nos.: 2010/0280367 and 2011/0152611 to Ducharme et al.; 2013/0006101 to McHugo et al.; 2013/0006286 to Lavelle et al.; and 2013/0096427 to Murray et al). FIGS. 7-7E show a screw-driven handle component 1700 for a fiducial deployment system. In this and other embodiments, the handle component 1700 may be removably or permanently attached to a proximal end 1605 of a handle, such as needle-attached handle member 1704, which may be the same as or operate similar to needle-attached handle member 1604 shown in FIGS. 6A-6B, where it will provide means for controlled advancement of a stylet (e.g., stylet 1760 or 1610) in lieu of direct and/or manual manipulation of the stylet cap 1611.
In some embodiments, the handle component 1700 (which may be configured for scope-attachment) may be removably or slidably attached to a proximal end of sheath-attached handle member 1602 and may be used in lieu of needle-attached handle member 1604. Sheath-attached handle member 1602 includes numerical indicia 1776 and an adjustable ring 1609 that limits the movement of the needle-attached handle member 1704 and provides a way to select the distance to which the needle may be extended beyond the sheath, such as needle sheath 1622.
Needle-attached handle member 1704 includes and defines a central longitudinal axis, a handle lumen, and a proximal end. Needle-attached handle member 1704 (which in some embodiments may replace or be attached to the proximal end 1605 of a handle, such as needle-attached handle member 1604) is attached to a needle 1714 (which may be configured in the manner of any of the needles disclosed herein or later developed in accordance with principles of the present disclosure) which extends through at least a portion of the needle-attached handle member 1704 and the handle lumen along or generally aligned with its central longitudinal axis. Needle-attached handle member 1704 may be attached to the needle 1714 by a needle connector, such as a connector 1716 which may be formed on or protrude laterally from the proximal end of needle-attached handle member 1704. At least a portion of needle-attached handle member 1704 is enclosed by or extends longitudinally through at least a portion of a rotatable housing member 1706 which includes and defines a central longitudinal axis, a housing lumen, and an inner wall. Rotatable housing member 1706 also includes and defines housing threads 1706a formed as helical grooves or ridges on the inner wall of the housing.
In some embodiments, the connector 1716 may form part of a single, integral handle member or may be formed as an individual component removably attached to the distal end of needle-attached handle member 1704. In other embodiments, the connector 1716 may be attached to the proximal end of the needle 1714 and retained or held in place by a tab or detent 1706b, such as, for example, formed as a longitudinally recessed portion of the inner wall of the rotatable housing member 1706, although those of skill in the art will appreciate that retention of needle 1714 with respect to the rotatable housing member 1706 and/or needle-attached handle member 1704 may be accomplished by a variety of means without exceeding the scope of the present disclosure. In some embodiments, the housing lumen of rotatable housing member 1706 may be substantially hollow and needle attached handle member 1704 may extend proximally into the housing lumen. Additionally, ball bearings or other control mechanisms may be disposed or provided in the housing lumen to reduce rotational friction and ensure that the needle does not rotate during fiducially deployment.
A stylet 1760 extends through at least a portion of the needle-attached handle member 1704 along or generally aligned with its central longitudinal axis and the handle lumen. Stylet 1760 likewise extends at least partially through a lumen of the needle 1714 and is operative to deploy to one or more fiducials from the distal end of the needle 1714. The proximal end of stylet 1760 extends through an opening formed on the proximal end of connector 1716 and is attached to a stylet screw 1720, which defines a distal end and screw threads 1720a formed as helical grooves or ridges on an outer portion of the screw. A guide bar 1722 is formed on or extends in a substantially distal direction from the distal end of stylet screw 1720 At least a portion of guide bar 1722 extends through a second opening formed on the proximal end of the connector 1716 and through at least a portion of the needle-attached handle member 1704 along or generally aligned with its central longitudinal axis, such that guide bar 1722 and stylet 1722 are longitudinally slidable and may be advanced in a substantially distal direction with respect to connector 1716 and needle-attached handle member 1704 during fiducial deployment.
With this structure disclosed, those of skill in the art will appreciate a method of use. FIGS. 7A and 7C show internal component views and FIGS. 7B and 7D show, respectively, top-perspective and longitudinal views of the internal components for this embodiment. In order to distally advance stylet 1760 corresponding to a fiducial-deployment or other distal stylet movement action (see, e.g., FIGS. 5B-5C), rotatable handle member 1706 may be user actuated or rotated transversely with respect to the needle-attached handle member 1704. As the user rotates the housing of rotatable handle member 1706, helical housing threads 1706a formed on the inner wall of housing engage the helical screw threads 1720a formed on the outer portion of stylet screw 1720. The angle and bias of the helical threads on both the rotatable housing and the stylet screw cause the rotational force applied by the user to be converted to a linear force in order to advance or drive the stylet screw 1720 in a substantially distal direction with respect the rotatable handle member 1706 and needle-attached handle member 1704.
During user-actuated rotation of the rotatable handle member 1706, guide bar 1722 attached to the stylet screw 1720 provides stabilizing force preventing the stylet screw from rotating transversely with respect to the needle-attached handle member 1704, although those of skill in the art will appreciate that preventing rotation of stylet screw 1720 with respect to the rotatable housing member 1706 and/or needle-attached handle member 1704 may be accomplished by a variety of means without exceeding the scope of the present disclosure. Rotation of the stylet screw 1720 being prevented, the rotation force of the housing is efficiently converted to linear force to advance the stylet 1760 and the guide bar 1722 distally through the openings on the proximal end of connector 1716. Stylet 1760 is distally advanced through the handle lumen along or generally aligned with its central longitudinal axis. A controlled amount of rotation applied to the rotatable housing member 1706 will advance the stylet forward towards the distal end of the needle 1714—which may be placed at a target site in or near the gastrointestinal tract (e.g., liver, pancreas) or other location accessible by endoscopy (using a minimally invasive endoscope introduced through a natural patient orifice, e.g., mouth, anus, vagina)—the required distance to deploy one or more fiducials from the distal end of needle 1714, depending, in part, on the configuration of handle member 1606 and sheath-attached handle member 1602, as described further in connection with FIGS. 6A and 6B.
In some embodiments, the required rotation to deploy a pre-determined number of fiducials (e.g., one fiducial or two fiducials) may correspond to a predetermined amount of handle rotation (e.g., one full, 360 degree rotation). Upon completion of the required rotation, the stylet 1760 will have advanced distally sufficient distance towards the distal end of the needle 1614 to deploy the desired number of fiducials. In some configurations, the stylet will have advanced far enough to deploy one or more fiducials but may remain disposed at least partially within the needle 1614 and may have one or more additional fiducials disposed within needle 1614 awaiting deployment. In this scenario, subsequent numbers of fiducials may be deployed in a serial manner by additional, successive rotations of housing member 1706. Other configurations of the sheath-attached handle member 1602 and needle-attached handle member 1704 may likewise be used to affect fiducial deployment in a manner similar to as described in connection with FIGS. 6A and 6B. In one aspect, the mechanism may be considered as an alternative design for other incremental (e.g., one at a time, or “controlled plurality at a time”) fiducial deployment systems, where each actuation corresponding to a stylet advancement and/or change of exposed numerical indicia corresponds to deployment of a predetermined number of fiducials such as is shown, for example, in FIGS. 7A-7C of U.S. Pat. App. Pub. No. 2014/0243844 to Clancy et al., which is incorporated herein by reference in its entirety. Those of skill in the art will understand how to operate the present embodiments for controlled fiducial delivery (one at a time, or in a controlled, predetermined plurality) with reference to the present figures and description.
FIG. 8 shows an external view of a second screw-driven handle component 1850 for a fiducial deployment system. In this and other embodiments, the second handle component 1800 may be removably or permanently attached to a proximal end 1605 of a handle such as the one shown in FIGS. 6A-6B, where it will provide means for controlled advancement of a stylet (e.g., stylet 1610) in lieu of direct and/or manual manipulation of the stylet cap 1611. In some embodiments, the second handle component 1800 (which may be configured for scope-attachment) may be removably or slidably attached to a proximal end of sheath-attached handle member 1602 and may be used in lieu of needle-attached handle member 1604. Sheath-attached handle member 1602 includes numerical indicia 1608 and an adjustable ring 1609 that limits the movement of the needle-attached handle member 1804 and provides a way to select the distance that the needle may be extended beyond a needle sheath, such as needle sheath 1622.
FIGS. 8A-8D show an internal components view, two longitudinal section views, and a top-perspective view of the internal components of a second advancement mechanism embodiment for a fiducial deployment system. The second handle component 1800 may include a needle-attached handle member 1804, which includes and defines a central longitudinal axis, a handle lumen, and a proximal end. Needle attached handle member 1804 is attached to a needle 1814 (which may be configured in the manner of any of the needles disclosed herein or later developed in accordance with principles of the present disclosure) which extends through at least a portion of the needle-attached handle member 1804 and the handle lumen along or generally aligned with its central longitudinal axis. Needle-attached handle member 1804 may be attached to the needle 1814 by a laterally protruding portion 1804a of the handle member, which may be formed on or at the proximal end of needle attached handle member 1804 and may define an opening in the handle's proximal end. In some embodiments, the needle may be attached to a laterally protruding section or portion formed at the proximal end of a single, integral handle member. In other embodiments, the needle may be connected to the handle member 1804 by a removably attached connector plate.
Additionally, second handle component 1800 also includes a rotatable housing portion or rotatable housing member 1806, which includes and defines a central longitudinal axis, a housing lumen, and an inner wall. At least a portion of needle-attached handle member 1804 is enclosed by the rotatable housing portion or member 1806, which includes and defines housing threads 1806a formed as helical grooves or ridges on the inner wall of the housing and laterally protruding edges 1806b formed at the distal end of the housing. In the embodiment depicted in FIG. 8B, the laterally protruding portion 1804a of the handle member is engaged by the laterally protruding edges 1806b of rotatable housing portion or member 1806 in order to hold the rotatable housing in place on the proximal end of needle-attached handle member 1804.
A stylet 1860 extends through at least a portion of the needle-attached handle member 1804 along or generally aligned with its central longitudinal axis and the handle lumen. Stylet 1860 likewise extends at least partially through a lumen of the needle 1814 and is operative to deploy to one or more fiducials from the distal end of the needle 1814. The proximal end of stylet 1860 extends through an opening formed on the proximal end of needle-attached handle member 1804 and is attached to a stylet screw 1820, which defines a distal end and screw threads 1820a formed as helical grooves or ridges on an outer portion of the screw. A guide bar 1822 is formed on or extends in a substantially distal direction from the distal end of stylet screw 1820 At least a portion of guide bar 1822 extends through a second opening formed on the proximal end of the connector 1716 and through at least a portion of the needle-attached handle member 1804 along or generally aligned with its central longitudinal axis, such that guide bar 1822 and stylet 1822 are longitudinally slidable and may be advanced in a substantially distal direction during fiducial deployment along or generally aligned with the central longitudinal axis of the handle lumen of needle-attached handle member 1804.
With this structure disclosed, those of skill in the art will appreciate a method of use. FIGS. 8A and 8D show an internal components view and a top-perspective view of the internal components, respectively, of the second advancement mechanism embodiment for a fiducial deployment system. FIGS. 8B and 8C show longitudinal section views of the second advancement mechanism embodiment for a fiducial deployment system. In order to distally advance stylet 1860 corresponding to a fiducial-deployment or other stepwise/incremental distal stylet movement action (see, e.g., FIGS. 5B-5C), rotatable housing portion or member 1806 may be user actuated or rotated transversely with respect to the needle-attached handle member 1804. As the user rotates the housing of rotatable housing portion or member 1806, helical housing threads 1806a formed on the inner wall of housing engage the helical screw threads 1820a formed on the outer portion of stylet screw 1820. The angle and bias of the helical threads on both the rotatable housing and the stylet screw cause the rotational force applied by the user to be converted to a linear force in order to advance or drive the stylet screw 1820 in a substantially distal direction with respect the rotatable housing portion or member 1806 and needle-attached handle member 1804.
During user-actuated rotation of the rotatable housing portion or member 1806, guide bar 1822 attached to the stylet screw 1820 provides stabilizing force preventing the stylet screw from rotating transversely with respect to the needle-attached handle member 1804, although those of skill in the art will appreciate that preventing rotation of stylet screw 1820 with respect to the rotatable housing portion or member 1806 and/or needle attached handle member 1804 may be accomplished by a variety of means without exceeding the scope of the present disclosure. Rotation of the stylet screw 1820 being prevented, the rotation force of the housing is efficiently converted to linear force to advance the stylet 1860 and the guide bar 1822 distally through the opening on the proximal end of needle-attached handle member 1804 formed by the laterally protruding edges 1804a. Stylet 1860 is distally advanced through the handle lumen along or generally aligned with its central longitudinal axis. A controlled amount of rotation applied to the rotatable housing portion or member 1806 will advance the stylet forward towards the distal end of the needle 1814—which may be placed at a target site in or near the gastrointestinal tract (e.g., liver, pancreas) or other location accessible by endoscopy (using a minimally invasive endoscope introduced through a natural patient orifice, e.g., mouth, anus, vagina)—the required distance to deploy one or more fiducials from the distal end of needle 1814, depending, in part, on the configuration of handle member 1606 and sheath-attached handle member 1602, as described further in connection with FIGS. 6A and 6B.
In some embodiments, the required rotation to deploy a pre-determined number of fiducials (e.g., one fiducial or two fiducials) may correspond to a predetermined amount of handle rotation (e.g., one full, 360-degree rotation). Other configurations of the sheath-attached handle member 1602 and needle-attached handle member 1704 may likewise be used to affect fiducial deployment in a manner similar to as described in connection with FIGS. 6A and 6B. Upon completion of the required rotation, the stylet 1860 will have advanced distally sufficient distance towards the distal end of the needle 1614 to deploy the desired number of fiducials. In some configurations, the stylet will have advanced far enough to deploy one or more fiducials but may remain disposed at least partially within the needle 1614 and may have one or more additional fiducials disposed within needle 1614 awaiting deployment. In this scenario, subsequent numbers of fiducials may be deployed in a serial manner by additional, successive rotations of housing member 1806.
Those of skill in the art will appreciate with reference to the embodiments disclosed above that a predetermined number of fiducials may be released into a desired location by a single actuation of the lever, button, rotatable housing, or other actuation member. The predetermined number preferably will be one, but may include a plurality of fiducials. The configuration of the present embodiments provide clear advantages over prior designs that utilize releasable end-plugs in a needle to retain fiducials, and/or that use less refined means of controlling the fiducial release than the notch/tab needle design and/or actuation handles described herein. Drawings and particular features in the figures illustrating various embodiments are not necessarily to scale. Some drawings may have certain details magnified for emphasis, and any different numbers or proportions of parts should not be read as limiting, unless so-designated by one or more claims. Those of skill in the art will appreciate that embodiments not expressly illustrated herein may be practiced within the scope of the present invention, including that features described herein for different embodiments may be combined with each other and/or with currently-known or future-developed technologies while remaining within the scope of the claims presented here. For example, a needle and fiducials of the present system may be used percutaneously, including in another minimally invasive surgical procedure, such as a laparoscopic-type procedure, within the scope of the claimed invention. For example, a target site may be a location in or near the gastrointestinal tract (e.g., liver, pancreas) such as those locations that may be accessible by endoscopy (using a minimally invasive endoscope introduced through a natural patient orifice, e.g., mouth, anus, vagina). This includes—more broadly—sites reachable through NOTES (natural orifice translumenal endoscopic surgery) procedures. The present method and device may also be used with other minimally-invasive surgical techniques such as percutaneous endoscopic procedures (e.g., laparoscopic procedures) or percutaneous non-endoscopic procedures, but most preferably is used with less invasive endoscopy procedures. It is therefore intended that the foregoing detailed description be regarded as illustrative rather than limiting. And, it should be understood that the following claims, including all equivalents, are intended to define the spirit and scope of this invention.

## Claims

1. A screw-driven handle for a fiducial deployment system including a fiducial deployment needle extending distally from the screw-driven handle and retaining for distal deployment in a controlled serial manner a plurality of fiducials, the fiducial deployment needle including a single lumen; where the screw-driven handle comprises:
an advancement mechanism for said fiducial deployment system, the advancement mechanism comprising:
an elongate handle member defining a central longitudinal axis and a handle lumen;
an elongate rotatable housing member that encloses a portion of the elongate handle member and defining an inner wall having helical housing threads;
a screw member disposed in the elongate rotatable housing member and defining an outer wall having helical screw threads; and
a stylet disposed longitudinally through the single lumen of the fiducial deployment needle, extending proximally through the handle lumen and at least a portion of the elongate rotatable housing member, wherein the stylet is affixed to the screw member, and further comprising a guide bar, wherein the guide bar and the stylet are longitudinally slidable relative to the elongate handle member.

2. The screw-driven handle of claim 1, wherein the guide bar is formed on and extends in a distal direction from the screw member and extending proximally through at least a portion of the handle member, wherein the guide bar prevents rotation of the screw member relative to the stylet and prevents rotation of both the screw member and the stylet relative to the fiducial deployment needle.

3. The screw-driven handle of claim 1, wherein the screw member is longitudinally movable in a housing lumen of the elongate rotatable housing member.

4. The screw-driven handle of claim 3, wherein the screw member advances or withdraws longitudinally within the housing lumen when rotational force is applied to the elongate rotatable housing member as the elongate rotatable housing member's inner wall having helical housing threads interacts with the screw member's outer wall having helical screw threads.

5. The screw-driven handle of claim 4, wherein a single full rotation of the elongate rotatable housing member effects distal movement of the stylet by a distance corresponding to a distal-needle-end deployment of a predetermined number of the plurality of fiducials.

6. The screw-driven handle of claim 1, further comprising a connector plate formed at a proximal end of the elongate handle member.

7. The screw-driven handle of claim 6, wherein the elongate rotatable housing member further defines a recessed portion formed on the inner wall.

8. The screw-driven handle of claim 7, wherein the connector plate is held in place by the recessed portion formed on the inner wall of the elongate rotatable housing member.

9. The screw-driven handle of claim 1, wherein the elongate handle member extends longitudinally through at least a portion of the elongate rotatable housing member.

10. The screw-driven handle of claim 1, wherein the elongate handle member further defines a laterally protruding handle portion at a proximal end of the elongate handle member.

11. The screw-driven handle of claim 10, wherein the elongate rotatable housing member further defines a laterally protruding housing portion at the distal end of the housing member.

12. The screw-driven handle of claim 11, wherein the elongate rotatable housing member is rotatably engaged to the handle member by the laterally protruding housing portion engaging with the laterally protruding handle portion.

13. A medical device handle configured for controlled lengthwise stylet advancement through a cannula, the medical device handle comprising:
an elongate handle body defining a longitudinal handle lumen;
an elongate cannula attached directly or indirectly to a proximal end portion of the elongate handle body, the elongate cannula defining a longitudinal cannula lumen in mechanical communication with the longitudinal handle lumen;
a rotatable elongate housing body defining a longitudinal housing lumen, the elongate housing body enclosing a portion of the elongate handle body;
a threaded screw member disposed within the longitudinal housing lumen; and
a stylet extending distally from the threaded screw member into the longitudinal cannula lumen, configured such that rotation of the elongate housing body effects a longitudinal movement of the threaded screw member and the stylet relative to the longitudinal housing lumen and the longitudinal handle lumen, and further comprising a guide bar, wherein the guide bar and the stylet are longitudinally slidable relative to the elongate handle member.

14. The medical device handle of claim 13, wherein a 360-degree rotation of the elongate housing body is effective to move the stylet distally by a predetermined increment corresponding to the deployment of a predetermined number of fiducials from a distal end of the elongate cannula.

15. The medical device handle of claim 13, further comprising a connector portion formed at the proximal end of the elongate handle body.

16. The medical device handle of claim 15, wherein the elongate cannula is attached to the connector portion.

17. The medical device handle of claim 13, wherein the elongate handle body further defines a longitudinally protruding connector portion as an integral portion of the elongate handle body.

18. The medical device handle of claim 17, wherein the elongate cannula is attached to the longitudinally protruding connector portion.