FRONT LOADABLE FLUID TRANSFER ASSEMBLY AND ASSOCIATED MEDICAL FLUID TRANSFER SYSTEMS AND METHODS - Patent application

Abstract

An apparatus for transferring fluid to or from a subject includes a plunger assembly coupled or coupleable to a cannula assembly, which allows the target fluid to be "front loaded" into the distal end of the cannula assembly simultaneously with retracting the stylet a distance to create a vacuum and define a flow path.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of and priority to U.S. Provisional Patent Application No. 62 / 950,521, filed December 19, 2019, and U.S. Provisional Patent Application No. 63 / 076,008, filed September 9, 2020, the contents of which are incorporated by reference as if fully set forth herein.

[0002] The present invention relates generally to medical devices and systems, and more particularly to devices and systems for delivering and / or removing materials within a living body. [Background technology]

[0003] In a variety of therapeutic and diagnostic procedures, it is necessary to deliver (e.g., inject) or aspirate a substance to a prescribed site in a patient (e.g., to an internal target using a delivery device). It may be important or critical that the delivery or removal of the substance be precisely to the target site within the patient and without causing undue trauma to the patient. Summary of the Invention [Problem to be solved by the invention]

[0004] The present invention has been made to solve the problems in the conventional techniques described above. [Means for solving the problem]

[0005] It should be understood that this Summary is provided to introduce some concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the disclosure, nor is it intended to limit the scope of the invention.

[0006] SUMMARY OF THE DISCLOSURE Embodiments of the present invention are directed to a front-loadable fluid transfer assembly for transferring fluid to or from a subject.

[0007] An embodiment of the present invention is directed to a surgical plunger assembly including a stylet including opposed proximal and distal ends, a Luer connector including an internal seal coupled to the stylet, and a support body coupled to the Luer connector and extending above the distal end of the stylet. The support body encloses a sub-length of the stylet, and the stylet is capable of longitudinal movement relative to the support body between a first position and a second position. The proximal end of the stylet is closer to the Luer connector when in the first position than when in the second position.

[0008] The plunger assembly further includes a plunger including a first segment coupled to or defined by the stylet and a second segment having a cross-sectional size larger than the first segment. The second segment may be connected to an outer plunger flange. A support body may enclose the first segment and at least a portion of the second segment, and the first segment and the second segment may be capable of longitudinal movement relative to the support body. When the plunger is in the first position, the stylet is in the first position and the second segment of the stylet is closer to the luer connector than when the stylet is in the second position.

[0009] The plunger assembly may further include a drive screw at least partially within the support body and coupled to the proximal end of the stylet.

[0010] The plunger assembly may further include a collar coupled to the support body and the drive screw, the collar may be rotatable in a clockwise and counterclockwise direction to translate the stylet.

[0011] The plunger assembly may further include a support tube inside the support body and coupled to the luer connector above the seal. The stylet may be slidably coupled to the support tube for retracting and extending inside the support tube, while the support body slidably retracts and extends around an outer wall of the support tube in conjunction with the stylet.

[0012] An embodiment of the present invention is directed to a surgical plunger assembly including a stylet having opposing proximal and distal ends, a luer connector having an internal seal near the proximal end of the stylet, a support body coupled to the luer connector and extending above the distal end of the stylet, and a plunger having a first segment coupled to or defined by the stylet and a second segment having a cross-sectional size larger than the first segment. The second segment is connected to an outer plunger flange. The support body encloses the first segment and at least a portion of the second segment, and the first segment and the second segment are capable of longitudinal movement relative to the support body. When the plunger is in the first position, the second segment is closer to the luer connector than when the plunger is in the second position.

[0013] The stylet may have a length outside the support body in the range of 6 inches to 10 feet in one or both of the first and second positions.

[0014] The stylet may have a length outside the support body ranging from 6 inches to 10 feet when the plunger is in each of the first and second positions.

[0015] The stylet may be formed from an MRI compatible material and may have a maximum outer diameter in the range of about 0.005 to 0.020 inches.

[0016] The stylet may be formed from Nitinol.

[0017] The stylet may be formed from fused silica.

[0018] Another embodiment is directed to an intracorporeal fluid transfer system including a cannula assembly having a proximal end with a luer connector and a longitudinally opposed distal end with an open channel extending therethrough, and a plunger assembly coupled to the cannula assembly. The plunger assembly may have a stylet that extends within the open channel of the cannula assembly to position a distal end of the stylet proximate the distal end of the cannula assembly. The open channel and the stylet cooperate to define a fluid channel that extends from the distal end of the cannula assembly and is optionally in the range of about 1-30 cm in length.

[0019] When the plunger is in a first position corresponding to a ready-to-take-fluid position or a completed-injection position, the distal end of the stylet may be flush with or extend beyond the distal end of the cannula assembly.

[0020] Fluid to be dispensed to the patient may be held in the fluid channel at a location between the distal end of the cannula assembly and an intermediate portion of the cannula assembly.

[0021] The plunger assembly may further include a luer connector having an internal seal proximate the stylet. The luer connector of the plunger assembly may be attached to the luer connector of the cannula assembly. The plunger assembly may further include a support body coupled to the luer connector of the plunger assembly and extending above a distal end of the stylet, a plunger having a first segment coupled to or defined by the stylet and a second segment having a cross-sectional size larger than the first segment. The second segment may be connected to an outer plunger flange. The support body may enclose the first segment and at least a portion of the second segment, and the first segment and the second segment may be capable of longitudinal movement relative to the support body. When the plunger is in the first position, the second segment may be closer to the luer connector than when the plunger is in the second position.

[0022] The body fluid transfer assembly may further include a drive screw at least partially within the support body and coupled to the proximal end of the stylet.

[0023] The body fluid transfer assembly may further include a collar coupled to the support body and the drive screw, The collar may be rotatable in a clockwise and counterclockwise direction to translate the stylet.

[0024] The body fluid transfer assembly may further include a support tube inside the support body and coupled to the luer connector above the seal. The stylet may be slidably coupled to the support tube for retracting and extending inside the support tube, while the support body slidably retracts and extends around an outer wall of the support tube in conjunction with the stylet.

[0025] The stylet may have a length outside the support body ranging from 6 inches to 10 feet when the plunger is in each of the first and second positions.

[0026] The stylet may be formed from an MRI compatible material and may have a maximum outer diameter in the range of about 0.005 to 0.020 inches.

[0027] The stylet may be formed from Nitinol.

[0028] The stylet may be formed from fused silica.

[0029] Another embodiment is directed to a method of transferring a fluid into or out of a subject. The method includes providing a cannula assembly having a luer connector at a proximal end and a distal end at an opposite longitudinal end, and providing a plunger assembly matable or coupled to the cannula assembly. The plunger assembly has a stylet extending from the proximal end to a position proximate to, flush with, or distal to the distal end of the cannula assembly. The method further includes generating a vacuum by retracting the stylet from the distal end of the cannula assembly, and drawing a target fluid into the distal end of the cannula assembly in response to the vacuum generated by the stylet and cannula assembly.

[0030] The method may further include positioning the cannula assembly, having the plunger assembly coupled thereto and holding the fluid, within a trajectory guide of the surgical navigation system such that a proximal end portion of the plunger assembly is above the trajectory guide and a distal end of the cannula assembly and stylet are within the patient's body to transfer the fluid into the patient.

[0031] The fluid may include stem cells.

[0032] The method may further include the step of delivering a fluid to a target site in the brain in preparation for said transferring step.

[0033] It should be noted that aspects of the invention described with respect to one embodiment may be incorporated in another embodiment not specifically described. That is, all embodiments and / or features of any embodiment may be combined in any manner and / or combination. Applicant reserves the right to modify any originally filed claims or to submit any new claims accordingly, including the right to amend any originally filed claim to depend on and / or incorporate any feature of any other claim not originally so claimed. These and other objects and / or aspects of the invention are described in detail below. [Brief description of the drawings]

[0034] [Figure 1] FIG. 2 is a top perspective view of an example of a cannula assembly in accordance with an embodiment of the present invention. [Diagram 2] FIG. 2 is a top view of an example of a plunger assembly according to an embodiment of the present invention. [Diagram 3] 3 is an assembled view of the plunger assembly and cannula assembly shown in FIGS. 1 and 2 forming a fluid transfer assembly according to an embodiment of the present invention. FIG. [Figure 4] FIG. 4 is a partial enlarged view of the proximal end portion of the assembled components shown in FIG. [Figure 5A] 3 is a side perspective view of the proximal end portion of the cannula assembly shown in FIG. 1 and the distal end of the plunger assembly shown in FIG. 2 in a first assembly configuration. [Figure 5B] 5B shows the proximal end portion of the cannula assembly shown in FIG. 5A with the plunger assembly shown further assembled from FIG. 5A. [Figure 6A] 5C illustrates an embodiment of the present invention in which the luer connector of the cannula assembly of FIG. 1 is attached to the luer connector of the plunger assembly of FIG. 2 after further insertion from the configuration shown in FIG. 5B. [Figure 6B] FIG. 4 is a greatly enlarged end perspective view of the distal end of the assembled device shown in FIG. 3. [Figure 7] FIG. 4 is a side perspective view of the proximal end portion of the assembled device shown in FIG. 3 with the plunger in an actuated position for admitting fluid at the distal end of the assembled device in accordance with an embodiment of the present invention. [Figure 8] FIG. 8 is a side perspective view of the proximal end portion of the assembled device shown in FIG. 7 with the plunger in a second, actuated position for dispensing / injecting fluid at the distal end of the assembled device in accordance with an embodiment of the present invention. [Figure 9A] FIG. 8 is an enlarged perspective view of the distal end showing the assembled device in the position of FIG. 7. [Figure 9B] FIG. 9 is an enlarged perspective view of the distal end showing the assembled device in the position of FIG. 8. [Figure 10A] FIG. 13 is a partial enlarged perspective view of a proximal end of another example of a plunger assembly in accordance with an embodiment of the present invention. [Figure 10B] FIG. 10B is a partial cross-sectional view showing the internal bond between the support tubing and the plunger wire in the plunger assembly shown in FIG. 10A according to an embodiment of the present invention. [Figure 10C] FIG. 10B is a partial cross-sectional view of the plunger assembly shown in FIG. 10A in accordance with an embodiment of the present invention. [Figure 11] FIG. 13 is a partial enlarged perspective view of another embodiment of a plunger assembly in accordance with an embodiment of the present invention. [Figure 12] 12 is a greatly enlarged cross-sectional view of a segment of the proximal end portion of the plunger assembly shown in FIG. 11. [Figure 13] 1 is a schematic diagram of a medical internal fluid transfer system operable in an image-guided surgical navigation system, according to an embodiment of the present invention. [Figure 14] 4 is an enlarged partial cross-sectional view of an example cannula and plunger assembly shown in FIG. 3 being held by a trajectory guide for placement within the body, in accordance with an embodiment of the present invention. [Figure 15] 4 is a flowchart of exemplary actions that can be performed according to embodiments of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0035] The present invention will now be described in more detail with reference to the accompanying drawings, in which several embodiments of the present invention are shown, in which: The present invention may, however, be embodied in many different forms and should not be construed as being limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.

[0036] Like reference numbers refer to like elements throughout. In the drawings, the thickness of certain lines, layers, components, elements or features may be exaggerated for clarity. In this specification and / or the drawings, the terms "FIG." and "Fig." are used interchangeably with the word "Figure."

[0037] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms "a," "an," and "the" are intended to encompass the plural forms as well, unless the context clearly contradicts otherwise. It is further understood that the words "comprises" and / or "comprising," as used herein, specify the presence of stated features, steps, operations, elements, and / or components, and do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0038] Unless otherwise defined, the meaning of all terms (including technical and scientific terms) used herein is the same as that commonly understood by those skilled in the art to which the present invention belongs. It should be further understood that words, for example, words defined in commonly used dictionaries, should be interpreted as having a meaning consistent with the meaning of those words in the context of the present specification and the related art, and should not be interpreted as an idealized meaning or an overly formal meaning unless expressly defined as such in the present specification. Well-known functions or structures may not be described in detail for brevity and / or clarity.

[0039] It will be understood that when an element is referred to as being "adjacent," "attached," "connected," "coupled," "in contact," or the like, the element may be directly adjacent, connected, coupled, or in contact with the other element, or there may be intervening elements. In contrast, when an element is referred to as being "directly adjacent," "directly attached," "directly connected," "directly coupled," or "in direct contact" with another element, there are no intervening elements present. Additionally, as will be understood by those skilled in the art, when a structure or feature is referred to as being "adjacent" to another feature, the reference may include portions that overlap or underlie the adjacent feature.

[0040] Spatially relative terms such as "under," "below," "lower," "over," "upper," and the like may be used herein for ease of description when describing the relationship of one element or feature to another element or feature as depicted in the figures. It should be understood that these spatially relative terms are intended to encompass other orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures were inverted, an element described as being "under" or "beneath" another element or feature would be oriented "over" that other element or feature. Thus, for example, the term "under" may encompass both an orientation of "over" and "under." The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, terms such as "upwardly," "downwardly," "vertical," "horizontal," etc. are used herein for descriptive purposes only, unless otherwise specified.

[0041] The term "about" when used herein in relation to a value or numerical value means that the value or numerical value can vary by ±20%.

[0042] The term "monolithic" means that a component (eg, an internal capillary or needle) is molded from one homogenous material.

[0043] The term "MRI visible" means that the device is visible, either directly or indirectly, in an MRI image. Visibility may be indicated by a high signal-to-noise ratio of the MRI signal in proximity to the device (the device may act as an MRI receiving antenna collecting signals from local tissue) and / or by the device actually generating an MRI signal itself (e.g., by means of a suitable hydrobased coating and / or a channel or lumen filled with a fluid, typically an aqueous solution).

[0044] The term "MRI compatible" means that the device is safe for use in an MRI environment and / or capable of operating as intended in an MRI environment without producing MR signal artifacts, and therefore, when placed in a high field strength region of the magnetic field, is typically made of non-ferromagnetic MRI compatible materials suitable for existence and / or operation in high magnetic field environments.

[0045] The term "high-magnetic field" refers to a magnetic field strength greater than about 0.5T (Tesla), typically greater than 1.0T, and more typically between about 1.5-10T.

[0046] The term "near real time" refers to both low latency and high frame rate. Latency is generally measured as the time from when an event occurs until the event is displayed (total processing time). For tracking, the frame rate can range from about 100 fps to the image frame rate. In some embodiments, tracking is updated at the image frame rate. For near "real time" imaging, the frame rate is typically about 1-20 fps, and in some embodiments, about 3-7 fps. The low latency required to be considered "near real time" is generally about 1 second or less. In some embodiments, the latency for tracking information is about 0.01 seconds, and typically about 0.25-0.5 seconds when image data is interleaved. Thus, with respect to tracking, visualization of known intracorporeal devices with their position, orientation, and / or morphology can be updated with low latency of about 1-100 fps. With respect to imaging, visualizations using near real-time MR image data can be presented with low latency, typically from about 0.01 milliseconds to less than about 1 second, and typically at frame rates of about 1-20 fps. At the same time, the system can dynamically present the anatomical structures and one or more intracorporeal devices in a near real-time visualization using the tracking signal data and the image signal data. In some embodiments, tracking signal data is acquired and associated spatial coordinates are determined while MR image data is acquired, resulting in a visualization having an intracorporeal device (e.g., a stylet) and a near real-time MR image.

[0047] The term "sterile" is used herein to mean that the device, kit, and / or packaging meets or exceeds US / Federal Drug Administration and / or other medical-surgical cleanliness regulatory guidelines and is typically free of live bacteria or other microorganisms.

[0048] The embodiments of the invention can be used for any desired internal part of a subject using any suitable imaging modality (typically MRI) and / or with various diagnostic or interventional devices and / or therapies in an MRI scanner or MRI intervention suite. However, CT or other imaging modalities may also be used. The subject may be any subject, particularly suited to a subject animal and / or subject (e.g., for animal testing and / or veterinary treatment or human treatment). In some embodiments, a therapy is delivered to the spine. In some embodiments, a therapy is delivered to treat or stimulate a desired part of the sympathetic chain. Other applications within or outside the brain, nervous system, or spinal cord include treatment of physiological conditions, chemotherapy, stem cell replacement, gene therapy, or drug delivery for drugs including replicative therapeutics. Some embodiments may be used to treat tumors.

[0049] The term "substance" as used herein means a liquid for the treatment of a condition or to facilitate diagnosis, and may include bioins, stem cells, or other target cells to a site-specific region in the body (e.g., a neurological region), nerve, or other target site, etc. In some embodiments, stem cells and / or other remodeling cells or remodeling products may be delivered into spinal, brain, or heart tissue (e.g., the heart wall) by a minimally invasive MRI-guided procedure while the heart is beating (i.e., without the need to stop the heart from beating by placing the patient on a heart-lung machine). Examples of known stimulation treatments and / or target internal sites are described in U.S. Patent Nos. 6,708,064, 6,438,423, 6,356,786, 6,526,318, 6,405,079, 6,167,311, 6539,263, 6,609,030, and 6,050,992, the contents of which are incorporated by reference herein as if fully set forth.

[0050] The term "fluid" refers to the soft tissue, foreign material, and biological material (including cellular material and cellular fluids) within the subject, with respect to the fluid being withdrawn from the subject.

[0051] The term "infusion" and its derivatives refer to the delivery of a substance (whether a single substance or a mixture) relatively slowly to allow the substance to infuse around a target site, and thus the term "infusate" refers to a substance so delivered.

[0052] The term "semi-rigid" refers to a device that is rigid enough to have a self-supporting fixed shape (typically a straight tubular or cylindrical shape) when no bending forces are applied, while still allowing the device to function as a trajectory guide (e.g., Figure 14 By this definition, we mean that the catheter is sufficiently flexible to be able to bend or deflect without breaking in response to forces applied thereto during insertion or removal from a catheter (see 1250t in US Pat. No. 6,313,325) and then return to its original, self-supporting shape when the forces are removed.

[0053] The term "flexible" means that the device is not rigid enough to have a fixed shape without support, and can, for example, be rolled, coiled, or bent.

[0054] The subject may be any subject, and may be particularly suitable as an animal and / or human subject (eg, for animal testing, and / or veterinary treatment or human therapy).

[0055] In some embodiments, fluid is aspirated from a target internal site (e.g., the brain). For example, the target structure can be debulked by aspirating fluid from the target structure. Debulking the structure can relieve surrounding pressure, which can be desirable in a less invasive manner than surgical resection. See U.S. Patent Application Serial No. 16 / 217,222, the contents of which are incorporated herein by reference as if fully set forth herein.

[0056] The embodiments herein are capable of delivering therapy to the spine.

[0057] In embodiments of the invention, it is possible to deliver a therapy to treat or stimulate a desired site in the sympathetic chain. Other applications include treatment of physiological conditions, chemotherapy, stem cell replacement, gene therapy, or drug delivery for drugs including replicative therapeutics, inside or outside the brain, nervous system, or spinal cord. Some embodiments may be used to treat patients with one or more tumors.

[0058] In the following, embodiments of the present invention will be described in more detail with reference to the drawings. FIG. 1 illustrates an exemplary cannula assembly 10. The cannula assembly 10 is configured to transfer bodily fluids. FIG. 2 illustrates an exemplary plunger assembly 100. FIG. 3 illustrates the plunger assembly 100 coupled to the cannula assembly 10 to define a transfer assembly 200. Once assembled, the plunger assembly 100 extends completely through the cannula assembly 10. The distal end 100d of the plunger assembly 100 may be proximate to the distal end 10d of the cannula assembly 10, e.g., about 1 mm inward relative to the distal end 10d, and / or may be flush with and / or extend beyond the distal end 10d, and the proximal end 100p of the plunger assembly 100 extends beyond the proximal end 10p of the cannula assembly 10. The distal end 100d of the plunger assembly 100 may be configured to extend a short distance (e.g., less than 1 mm, typically a distance in the range of about 0 to 0.5 mm, for example) beyond the distal end 10d of the cannula assembly 10 in the ready-to-load and / or ready-to-dispense positions. The proximal end 10p of the cannula assembly 10 may include a luer connector 11.

[0059] In some embodiments, the plunger assembly 100 is configured in conjunction with the cannula assembly 10 to allow the assembled device 200 to be "front loaded." The purpose of front loading the cannula assembly 10 is to minimize and / or eliminate "dead space" when loading the target fluid into the delivery device. The term "dead space" refers to a condition in which an undesirable amount of agent remains in the syringe or lumen of the cannula after delivery (e.g., injection) is complete. This condition may be particularly undesirable when there is a limited supply of the target agent for delivery (such as with stem cells) and / or when the cell sample obtained from the patient is very small.

[0060] 2-4, as shown, plunger assembly 100 includes a support body 106, which may optionally be cylindrical (or other shape, e.g., polygonal or triangular) and includes a luer hub 105 at its distal end. Plunger assembly 100 may also include a plunger support flange 108 at an opposite proximal end.

[0061] The plunger assembly 100 may also include a plunger flange 110 that defines a proximal end 100p of the plunger assembly 100.

[0062] As also shown, the plunger assembly 100 includes an elongated stylet 101. The elongated stylet 101 is elongated and has a (longitudinal) length L that is greater than the length of the support body 106. Typically, Plunger AssemblyPlunger assembly 100 extends over an overall length L that may be longer than the overall length L of cannula assembly 10, for example, in the range of about 1 to 10 feet, including about 1.5 feet, about 2 feet, about 2.5 feet, about 3 feet, about 3.5 feet, about 4 feet, about 4.5 feet, about 5 feet, about 5.5 feet, about 6 feet, about 6.5 feet, about 7 feet, about 7.5 feet, about 8 feet, about 8.5 feet, about 9 feet, about 9.5 feet, and about 10 feet. If long enough, plunger assembly 100 can be actuated from outside of bore 1350b (FIG. 13) of magnet 1350 of MRI scanner 1220, thereby allowing for efficient delivery during image-guided surgical procedures.

[0063] The stylet 101 may be configured to fit any target inner diameter of the particular cannula assembly 10. The plunger assembly 100 may be flexible enough to be able to change shape from a straight to a curved configuration, as shown in FIGS.

[0064] Cannula assembly 10 may have an inner diameter in the range of about 0.008 to 0.021 inches, which may be particularly suitable for certain injection applications.

[0065] When the operator pulls on plunger 102, stylet 101 similarly retracts creating a vacuum that draws / sucks fluid, such as a medicament, from distal end 10d of cannula assembly 10 into cannula assembly 10 around stylet 101. Typically, the "front-loaded" medicament is upstream from distal end 10d of cannula 10 by a distance corresponding to the stroke distance of plunger 102 and / or a distance in the range of about 1-30 cm, or about 5-15 cm. The distance may be, for example, about 1 cm, about 2 cm, about 3 cm, about 4 cm, about 5 cm, about 6 cm, about 7 cm, about 8 cm, about 9 cm, about 10 cm, about 11 cm, about 12 cm, about 13 cm, about 14 cm, about 15 cm, about 16 cm, about 17 cm, about 18 cm, about 19 cm, about 20 cm, about 21 cm, about 22 cm, about 23 cm, about 24 cm, about 25 cm, about 26 cm, about 27 cm, about 28 cm, about 29 cm, about 30 cm. The stroke travel distance is below the luer connector 11 and / or the luer hub 105 and / or the support body 106, and more typically between the distal end 10d of the cannula assembly 10 and an intermediate position 10m of the cannula assembly 10.

[0066] As the plunger 102 advances towards the distal end 10d of the cannula assembly 10, the stylet 101 expels fluid (eg, a medication) from the cannula assembly 10 and into the target location (eg, the brain or heart).

[0067] 5A, 5B, 6A, and 6B, the connection of plunger assembly 100 to cannula assembly 10 may be made by inserting stylet 101 into proximal end 10p of cannula assembly 10, advancing stylet 101 through / pushing it to distal end 10d of cannula assembly 10, and coupling (typically locking) plunger assembly 100 to cannula assembly 10 at luer connector 11 (FIG. 6A), like a syringe. When fully attached, distal end 100d of plunger assembly 100 may rest at distal end 10d of cannula 10, and in some particular embodiments may protrude a distance in the range of about 0-0.5 mm (FIG. 6B).

[0068] FIG. 7 shows the plunger / cannula assembly 200 in a ready-to-take configuration in which the plunger flange 110 is proximate to the support body flange 108, the first segment 102a of the plunger 102 is within the support body 106 for a shorter length than in the position shown in FIG. 8, and the second segment 102b is closer to the seal 103 and luer hub 105 in the ready-to-take configuration of FIGS. 7 and 9A than in the retracted and loaded position shown in FIGS. 8 and 9B (in which the stylet 101 is retracted from the distal end 10d of the cannula assembly).

[0069] In the configuration shown in FIG. 8, assembly 200 may be inserted through a stereotactic guidance system, such as trajectory guide 1250t (FIG. 14), with plunger flange 110 accessible for movement up and down relative to the patient, and fluid F may be delivered to or obtained from the patient using assembly 200.

[0070] The plunger assembly 100 may be provided as a kit for assembly to the cannula assembly 10.

[0071] Plunger assembly 100 may be provided as a separate component in a package together with cannula assembly 10 or in a separate package from cannula assembly 10.

[0072] The agent may be provided separately from the plunger assembly 10 and / or the cannula assembly 100, and is typically loaded on-site prior to delivery.

[0073] In some embodiments, for MRI conditional use (safe for use around the MRI scanner room where the magnet is generating a magnetic field, but not inserted during an MRI scan), the stylet 101 may comprise nitinol wire. In some embodiments, for MRI safe use (safe for use inside the MRI scanner room even during a scan), the stylet 101 may comprise fused quartz.

[0074] In some embodiments, other materials may be used for CT or other imaging modalities, preferably materials that are biocompatible and inert to the target agent or fluid.

[0075] The stylet 101 defines or is attached to the plunger 102. The plunger 102 and stylet 101 are capable of longitudinally extending and retracting (together / in conjunction) relative to the cannula assembly 10 and / or relative to a luer hub 105 attached to the plunger assembly 100.

[0076] The luer hub 105 may have an internal seal 103. The internal seal 103 may define a fluid tight seal around the segment of the stylet 101 that defines the segment 102w of the plunger. The segment of the plunger defined by the stylet 101 may be a small diameter wire 102w.

[0077] In some embodiments, at least the elongated segments of the stylet 101 in the distal and intermediate (internal) portions of the cannula assembly 10 may be solid (may have a solid core) and may have an outer diameter in the range of approximately 0.005 to 0.020 inches.

[0078] The plunger 102 may include a first segment 102a and a contiguous, longitudinally extending second segment 102b. The second segment 102b may have a larger cross-sectional size than the first segment 102a within the support body 106. The second segment 102b may be in close, slidable engagement with the support body 106, but need not be fluid-tight relative to the support body 106. The support body 106 may be configured to support the plunger 102, including at least a portion of the segments 102a, 102b, during actuation to prevent buckling.

[0079] At least a portion of the first segment 102a and a portion of the second segment 102b may be within the support body 106 when the distal end 100d is in a fully extended position outside the distal end 10d of the cannula assembly (FIGS. 7, 9A), and when the distal end 100d is in a retracted position for fluid loading / intake (FIGS. 8, 9B). Thus, the second segment 102b may move longitudinally relative to the support body 106, but not below the internal seal 103 and / or the luer hub 105 (FIG. 7). The stroke distance "d" between the fully extended and fully retracted operating positions (e.g., for fluid intake / loading relative to the fully assembled position (FIG. 7)) may be a distance in the range of about 1-30 cm or about 5-15 cm, depending on the desired amount of fluid to be loaded into the channel 10f of the assembled device 200 (FIGS. 3, 7, 8). The flow channel 10f can have an annular segment defined by the stylet and cannula assembly, and the stroke distance can be, for example, about 1 cm, about 2 cm, about 3 cm, about 4 cm, about 5 cm, about 6 cm, about 7 cm, about 8 cm, about 9 cm, about 10 cm, about 11 cm, about 12 cm, about 13 cm, about 14 cm, about 15 cm, about 16 cm, about 17 cm, about 18 cm, about 19 cm, about 20 cm, about 21 cm, about 22 cm, about 23 cm, about 24 cm, about 25 cm, about 26 cm, about 27 cm, about 28 cm, about 29 cm, or about 30 cm.

[0080] The distal end of the stylet 101 can move 1:1 with the proximal end of the plunger 102, allowing fluid to be drawn into the cannula 10 at a 1:1 ratio, e.g., a 1 cm movement of the plunger allows fluid to be drawn in a distance of 1 cm.

[0081] The stylet 101 and cannula assembly 10 may be sized and configured to generate a vacuum and utilize the vacuum to introduce and front-load fluid into the cannula assembly 10. The difference between the inner diameter of the cannula 10 and the outer diameter of the stylet 101 to generate the desired vacuum may be in the range of about 0.0005 to 0.10 inches, for example.

[0082] The cannula assembly 10 may include a continuous length of inner tube 10t and may have a constant inner diameter over at least a majority of its length. In some embodiments, the inner tube may be a single continuous piece of material (typically PEEK or fused silica) that extends from the distal end 10d to the connector 11.

[0083] 1, the stylet 101 may define a flow passage 10f (FIG. 9A) with an inner tube 10t. The flow passage 10f may have an outer diameter in the range of about 0.005-0.020 inches, or in the range of about 100-750 μm (e.g., about 200 μm), or in the range of about 0.20-0.05 mm (e.g., about 0.20 mm or about 0.053 mm).

[0084] The inner tube 10t may comprise fused silica or PEEK or other materials. The stylet 101 and inner tube 10t may be substantially, if not completely, inert and sterile so as not to cause any chemical interaction with any target fluid within the flow passage lumen (FIG. 9A).

[0085] 1, 6B, and 9B, the cannula assembly 10 may include an outer tube 12 that may be flush with the inner surface of the outer wall of the inner tube 10t to provide a fluid-tight interface to prevent backflow and / or flow therebetween.

[0086] 10A, the plunger assembly 100 may include depth / distance graduations on the support body 106. The support flange 108 may also include a flange 108 having a periphery 108p with a short side 108s joined to a long side 108l. The short side 108s may define a finger gripping surface. At least one of the long sides 108 may include a periphery 108p with a short side 108s joined to a long side 108l. l A locking member 118, such as a thumb screw, may be provided on the short side 108s. 108lThe short side 108s may be flat. The short side 108s may include a ridge 108r. The locking member 118 may be configured to be directly coupled to the outer surface 102s of the second segment 102b of the plunger 102 inside the support body 106. According to FIGS. 10B and 10C, the second segment 102b of the plunger 102 may include a sleeve 102s having a longitudinally extending channel 102c. The channel 102c may extend above the proximal end portion 101p of the stylet 101. The proximal end portion 101p of the stylet 101 may be secured to the channel 102c, whereby the sleeve 102s (plunger wire outer body) and the stylet 101 slide in unison.

[0087] 10B and 10C, the plunger assembly 100 may further include a support tube 1101 that is between the seal 103 of the luer hub 105 and the plunger flange 110 and surrounds a portion of the stylet 101. The support tube 1101 may have a distal end portion 1101d that is within the inwardly extending neck 105 of the luer hub 105 and is axially aligned with the channel 102c of the sleeve 102.

[0088] 10C , the proximal end portion 1101p of the support tube 1101 may terminate proximate the outer end of the support flange 108. The support tube 1101 may be inside the sleeve 102s and may not terminate at the proximal end portion 101p of the stylet 101. The proximal end portion 101p of the stylet 101 may be secured to the plunger flange 110 with adhesive 1112, inside the channel 102c below the plunger flange 110.

[0089] The stylet 101 may be configured to slide longitudinally inside the support tube 1101, and the sleeve 102 may slide longitudinally outside the support tube 1101. The support tube 1101 may have a fixed configuration inside the support body 106. At least one end portion of the support tube 1101 may be secured (e.g., with adhesive 1113) to the support tube 106 (as shown indirectly connected to the support tube 106) to secure the support tube 1101 in a fixed position within the plunger assembly 100.

[0090] 11 and 12, another embodiment of the plunger assembly 100' is shown. In this embodiment, a drive screw 220 may be used instead of the plunger 102 to translate the stylet 101, which allows for greater precision than manual plunger operation using a plunger flange. The stylet 101 may be coupled to the drive screw 220 inside the support body 106, above the luer hub 105 having the seal 103. The plunger assembly 100' may include a collar 210 secured to the screw 220. The drive screw 220 may be translated by rotating the collar 210, which causes the stylet 101 to be retracted or extended.

[0091] One complete rotation of the collar 210 can translate the stylet 101 a specified distance, such as a distance in the range of about 0.1-2 mm. In some embodiments, one rotation of the collar 210 can be configured to translate the stylet 101 longitudinally (retract or extend) about 1 mm.

[0092] The stylet 101 may be secured to the drive screw 220. The proximal end portion 101p of the stylet may extend into a channel of the screw 220. The proximal end portion 101p of the stylet 101 may be adhesively attached to the screw 220.

[0093] The collar 210 may be fixed to the support body 106. A set screw 240 may be provided within the support body 106. The set screw 240 may prevent the drive screw 220 from rotating inside the collar 210.

[0094] A dowel pin 230 may engage an internal groove 230g in the collar 210 to keep the collar 210 assembled to the support body 106 and / or to prevent the drive screw 220 from rotating. The collar 210 may have internal threads 212 that mate with threads 221 of the drive screw 220.

[0095] A proximal end portion 220p of the drive screw 220 may extend outside the collar 210. The threads 212 may extend inside the collar 210, over a sub-length thereof.

[0096] Although not shown, the support tube 1101 described above may be provided within the support body 106 below the drive screw 220 .

[0097] 14, the assembly 200 may extend through a tubular support 260 of a trajectory guide 1250t that may be held by a base or frame (e.g., a stereotactic frame that may be secured to a patient or to a holder above the patient). The assembly 200 may be secured in a desired position within the tubular support 260 using a lock 170 to position the distal end 10d at the target site A for removal or delivery of a substance F. For a description of patient planning and entry protocols and frames and trajectory guides, see, for example, U.S. Patent Nos. 8,315,689, 8,175,677, and 8,374,677, and U.S. Patent Application Publication No. 2010 / 0198052 (Attorney Docket No. 12 / 694,865), the contents of which are incorporated herein by reference as if fully set forth herein.

[0098] 13 shows an MRI-guided interventional system 500, which includes an MRI scanner 1220, a clinician workstation 1230 with at least one circuit 1230c, at least one display 1232, an MRI-compatible trajectory guide 1250t, and a fluid transfer assembly 200. The system 500 may be configured to render or generate a near-real-time or real-time visualization of a target anatomical space using MRI image data and predefined data of at least one surgical instrument (e.g., tubular cannula 20 and / or trajectory guide 1250t), segment the image data, and position the trajectory guide 1250t and cannula 20 in the rendered visualization in the correct orientation and position in 3D space (MRI surgical space in the case of MRI embodiments) anatomically registered with respect to the patient. The trajectory guide 1250t and cannula 20 may include or be associated with tracking, monitoring, and / or other interventional components.

[0099] The trajectory guide 1250t may be configured to provide one or more of XY and / or pitch and roll adjustments to precisely position the assembly 200 at a desired location within the patient. For further description of examples of suitable trajectory guides, see U.S. Patent No. 8,374,677, the contents of which are incorporated by reference as if fully set forth herein. Note, however, that other trajectory guide configurations may also be used, and embodiments of the present invention are not limited to the examples of trajectory guides described herein.

[0100] According to some embodiments, the system is configured to provide a relatively easy-to-use MRI guidance system that is mostly or semi-automated with defined workflow steps and interactive visualization. In a particular embodiment, the system defines and presents a workflow having separate steps of finding the target and entry sites, guiding the alignment of the cannula to the planned trajectory towards the target, monitoring the insertion of the cannula assembly 200, and adjusting the (XY) position if alignment correction is required. During the step where a particular MR scan is being performed, the circuitry or computer module may display the data of the center and angle of the scan plane to be input from the console. The workstation / circuitry may passively or actively communicate with the MR scanner. The system may also be configured to use functional patient data (e.g., fiber track, fMRI, etc.) to assist in planning or refining the target surgical site and / or access path.

[0101] System 500 may also include decoupling / tuning circuitry that allows for interfacing the system with the MRI scanner 1220, filters, etc. See, for example, U.S. Patent Nos. 6,701,176 and 6,904,307, and U.S. Patent Application Publication No. 2003 / 0050557, the contents of which are incorporated by reference herein as if fully set forth.

[0102] Assembly 200 may be configured to fluidly introduce, infuse, and / or inject a desired therapeutic agent (eg, an antigen, gene therapy, chemotherapy, or stem cells, or other therapeutic type therapeutic agent).

[0103] In some embodiments, the internal fluid transport assembly 200 is configured to deliver a drug therapy to the brain. The drug therapy may include a substance F delivered through the fluid channel / flow path 10f (FIG. 6B) to the target site or region A (FIG. 14), which may be any suitable desired substance for drug discovery, animal or human clinical trials, and / or approved medical treatment. According to some embodiments, the substance F is a liquid or slurry. In the case of a tumor, the substance may be a chemotherapeutic (cytotoxic) fluid. In some embodiments, the substance may include a specific type of advantageous cell that acts as a vaccine or other drug (e.g., antigen presenting cells such as dendritic cells). The dendritic cells may be pulsed with one or more antigens and / or with RNA encoding one or more antigens. Examples of antigens include tumor-specific antigens or pathogen-specific antigens. Examples of tumor-specific antigens include, but are not limited to, antigens from tumors such as renal cell tumors, melanoma, leukemia, myeloma, breast cancer, prostate cancer, ovarian cancer, lung cancer, and bladder cancer. Examples of pathogen-specific antigens include, but are not limited to, antigens specific for HIV or HCV. In some embodiments, substance F may include a radioactive substance, such as a radioactive seed. Substance F delivered to a target site according to embodiments of the present invention may include, but is not limited to, the following agents (including any combination thereof) listed in Table 1 below: [Table 1a] [Table 1b] [Table 1c] [Table 1d] [Table 1e] [Table 1f]

[0104] According to some embodiments, the intracorporeal fluid transfer system 200 may be configured as an infusate delivery system that delivers infusion fluid to a patient at an infusion rate in the range of approximately 1-3 μL / min.

[0105] The insertion of the surgical cannula assembly 200 (or any other surgical (e.g., delivery) cannula) may be tracked in near real time by referencing the gap in the patient tissue made by the surgical cannula assembly 200 and reflected in the MR images. In some embodiments, one or more MRI visible fiducial markers may be provided on the surgical tubular cannula 10, MR scanned and processed, and displayed on the UI. In some embodiments, each component of the surgical cannula assembly 200 may itself be molded from an MRI visible material, MR scanned and processed, and displayed on the UI.

[0106] According to some embodiments, the surgical cannula / plunger assembly 200 may include an implanted internal MRI antenna (not shown) configured to pick up MRI signals of local tissue during an MRI procedure. The MRI antenna may be configured to be at a distal end portion of the surgical cannula. In some embodiments, the antenna is configured to have a focal length or signal reception distance of about 1-5 cm and typically a viewing distance of about 1-2.5 cm for receiving MRI signals from the local tissue. The MRI antenna may be configured to include a coaxial antenna and / or a triaxial antenna. However, other antenna configurations may also be used, such as a whip antenna, a coil antenna, a loopless antenna, and / or a loop antenna. See, e.g., U.S. Patent Nos. 5,699,801, 5,928,145, 6,263,229, 6,606,513, 6,628,980, 6,284,971, 6,675,033, and 6,701,176, the contents of which are incorporated by reference herein as if fully set forth herein, and U.S. Patent Application Publication Nos. 2003 / 0050557, 2004 / 0046557, and 2003 / 0028095, the contents of which are incorporated by reference herein as if fully set forth herein.

[0107] Although the present devices have been described as illustrative delivery devices and methods for delivering a substance to a patient, in accordance with some embodiments of the present invention, the devices may be used to withdraw and / or aspirate a substance (e.g., cerebrospinal, cardiac, or neural fluids) from a patient. It will therefore be appreciated that the devices and methods disclosed herein may be used to transfer a substance into a patient and / or to transfer a substance out of a patient.

[0108] Although the device has been described herein primarily with respect to MRI-guided insertion and injection procedures, in some embodiments, the device may be used in procedures that do not involve MRI guidance, for example, in procedures that use other imaging modalities (e.g., but not limited to, CT imaging systems) where image-guided surgical navigation is required.

[0109] Although the cannula / plunger assembly 200 has been described with respect to the surgical assembly 200 coupled to a trajectory guide 1250t, other types of trajectory guides or stereotactic frames may be used, or no stereotactic frame or trajectory guide may be used.

[0110] 15 is a flow chart of exemplary actions that may be performed according to an embodiment of the present invention. A cannula assembly is provided having a luer connector at its proximal end and a distal end at an opposite longitudinal end (Block 600). A plunger assembly is provided that is connectable or connected to the cannula assembly. The plunger assembly includes a stylet that extends from the proximal end to a position proximate to, flush with, or distal to the distal end of the cannula assembly (Block 610). A target fluid is drawn into the distal end of the cannula assembly, around the stylet, and into a fluid channel / flow path created / defined by the stylet and cannula assembly (Block 620). The cannula assembly and plunger assembly in conjunction can generate a vacuum that draws fluid into the distal end portion and upstream thereof (but typically below the plunger luer hub).

[0111] The plunger assembly may include a drive screw at least partially inside the support body and coupled to the stylet, and a collar rotatably coupled to the drive screw and configured to retract or extend the stylet (block 617).

[0112] The cannula assembly, having the plunger assembly coupled thereto and holding the fluid, may be placed within a trajectory guide of the surgical navigation system such that the plunger flange is above the trajectory guide and the distal end of the cannula assembly and stylet are within the patient (block 622).

[0113] The fluid may be delivered to the target intracerebral location by pushing the plunger towards the distal end of the cannula assembly to dispense the entrapped fluid (block 624).

[0114] The plunger assembly includes a plunger flange that allows a user to push or pull the plunger to draw or dispense fluid (block 625).

[0115] The plunger assembly is configured to extend (simultaneously) from the proximal and distal ends of the cannula assembly (at least during a delivery / dispensing operation) (block 611).

[0116] The luer connector of the plunger assembly may be connected to the luer connector of the cannula assembly (block 613).

[0117] The plunger assembly includes an internal seal at the luer connector, and the stylet couples with the plunger segment or drive screw inside the support body (block 614).

[0118] The plunger segments may have a first segment of a first cross-sectional size and a second segment of a larger cross-sectional size, and optionally, the first segment may be a stylet and the second segment may be defined by a sleeve secured to the stylet (block 615).

[0119] The fluid includes stem cells (Block 627).

[0120] The above is an illustrative description of the present invention and should not be construed as limiting the present invention. Although a few exemplary embodiments of the present invention have been described, those skilled in the art will readily appreciate that various modifications can be made in those exemplary embodiments without substantially departing from the teachings and advantages of the present invention. Accordingly, all such modifications are intended to be included within the scope of the present invention as defined in the claims. The present invention is defined by the following claims, with equivalents of the claims intended to be encompassed therein. [Appendix 1] 1. A surgical plunger assembly comprising: a stylet including opposed proximal and distal ends; a luer connector including an internal seal coupled to the stylet; a support body coupled to the luer connector and extending above the distal end of the stylet; Including, the support body enclosing a sub-length of the stylet; the stylet is longitudinally movable relative to the support body between a first position and a second position, the proximal end of the stylet being closer to the luer connector when in the first position than when in the second position; Plunger assembly. [Appendix 2] 2. The plunger assembly of claim 1, further comprising a plunger including a first segment coupled to or defined by the stylet and a second segment having a cross-sectional size larger than the first segment, the second segment connected to an outer plunger flange, the support body enclosing the first segment and at least a portion of the second segment, the first segment and the second segment being capable of longitudinal movement relative to the support body, and when the plunger is in a first position, the stylet is in the first position and the second segment of the stylet is closer to the luer connector than when the stylet is in the second position. [Appendix 3] 2. The plunger assembly of claim 1, wherein the stylet has an outer length of the support body in the range of 6 inches to 10 feet. [Appendix 4] 2. The plunger assembly of claim 1, wherein the stylet comprises an MRI compatible material and has a maximum outer diameter in the range of approximately 0.005 to 0.020 inches. [Appendix 5] 5. The plunger assembly of claim 4, wherein the stylet comprises Nitinol. [Appendix 6] 5. The plunger assembly of claim 4, wherein the stylet comprises fused quartz. [Appendix 7] 2. The plunger assembly of claim 1, further comprising a drive screw, the drive screw at least partially within the support body and coupled to the proximal end of the stylet. [Appendix 8] 8. The plunger assembly of claim 7, further comprising a collar coupled to the support body and the drive screw, the collar being rotatable in a clockwise and counterclockwise direction to translate the stylet. [Appendix 9] 3. The plunger assembly of claim 2, further comprising a support tube inside the support body and connected to the luer connector above the seal, the stylet being slidably connected to the support tube for retracting and extending inside the support tube, while the support body slidably retracts and extends around an outer wall of the support tube in conjunction with the stylet. [Appendix 10] a cannula assembly including a proximal end having a luer connector and having a longitudinally opposed distal end and an open channel extending therethrough; a plunger assembly coupled to the cannula assembly, the plunger assembly including a stylet extending within the open channel of the cannula assembly to position a distal end of the stylet adjacent the distal end of the cannula assembly, the open channel and the stylet cooperating to define a fluid channel, the fluid channel extending from the distal end of the cannula assembly, optionally having a length in the range of about 1-30 cm; 16. An intracorporeal fluid transport system comprising: [Appendix 11] 11. The intracorporeal fluid transfer system of claim 10, wherein when the stylet is in a first position corresponding to a fluid intake ready position or an injection complete position, the distal end of the stylet is flush with or extends outside the distal end of the cannula assembly. [Appendix 12] 11. The intracorporeal fluid transfer system of claim 10, wherein the fluid to be dispensed to the patient is held within the fluid channel at a location between the distal end of the cannula assembly and an intermediate portion of the cannula assembly. [Appendix 13] the plunger assembly further comprising a luer connector including an internal seal adjacent the stylet, the luer connector of the plunger assembly being attached to the luer connector of the cannula assembly; a support body coupled to the luer connector of the plunger assembly and extending above the distal end of the stylet; Including, 7. An intracorporeal fluid transfer system as described in appendix 6. [Appendix 14] 14. The intracorporeal fluid transfer system of claim 13, further comprising a plunger comprising a first segment coupled to or defined by the stylet and a second segment having a cross-sectional size larger than the first segment, the second segment connected to an outer plunger flange, the support body sealing the first segment and at least a portion of the second segment, the first segment and the second segment being capable of longitudinal movement relative to the support body, and the second segment being closer to the luer connector when the plunger is in a first position than when the plunger is in a second position. [Appendix 15] 15. The intracorporeal fluid transfer assembly of claim 14, further comprising a drive screw, the drive screw being at least partially within the support body and coupled to the proximal end of the stylet. [Appendix 16] 16. The internal fluid transfer assembly of claim 15, further comprising a collar coupled to the support body and the drive screw, the collar being rotatable in a clockwise and counterclockwise direction to translate the stylet. [Appendix 17] 14. The internal fluid transfer assembly of claim 13, further comprising a support tube inside the support body and connected to the Luer connector above the seal, the stylet being slidably connected to the support tube for retracting and extending inside the support tube, while the support body slidably retracts and extends around an outer wall of the support tube in conjunction with the stylet. [Appendix 18] 14. The intracorporeal fluid transfer system of claim 13, wherein the stylet has an outer length of the support body in the range of 6 inches to 10 feet. [Appendix 19] 14. The intracorporeal fluid transfer system of claim 13, wherein the stylet comprises an MRI compatible material and has a maximum outer diameter in the range of about 0.005 to 0.020 inches. [Appendix 20] 14. The body fluid transfer system of claim 13, wherein the stylet comprises Nitinol. [Appendix 21] 14. The body fluid transfer system of claim 13, wherein the stylet comprises fused quartz. [Appendix 22] 1. A method of transferring a fluid into or out of a subject, comprising: providing a cannula assembly having a luer connector at a proximal end thereof and a distal end at an opposite longitudinal end; providing a plunger assembly matable or coupled to the cannula assembly, the plunger assembly including a stylet extending from the proximal end to a position proximate to, flush with, or distal to the distal end of the cannula assembly; generating a vacuum by retracting the stylet from the distal end of the cannula assembly; drawing a target fluid into the distal end of the cannula assembly in response to the vacuum generated by the stylet and the cannula assembly; The method includes: [Appendix 23] 23. The method of claim 22, further comprising positioning the cannula assembly, to which the plunger assembly is coupled and holding the fluid, within a trajectory guide of a surgical navigation system such that a proximal end portion of the plunger assembly is above the trajectory guide and the distal end of the cannula assembly and stylet are within a patient's body to transfer the fluid into the patient. [Appendix 24] 23. The method of claim 22, wherein the fluid comprises stem cells. [Appendix 25] 25. The method of claim 24, further comprising the step of delivering the fluid to a target site in a brain in preparation for the transferring step.

Claims

1. 1. A surgical assembly comprising: A cannula assembly; a stylet including opposed proximal and distal ends, the stylet configured to slidably engage the cannula assembly; a luer connector including an internal seal coupled to the stylet; a support body coupled to the luer connector and extending above the distal end of the stylet; Including, the support body enclosing a sub-length of the stylet; the stylet is longitudinally movable relative to a support body between a first position and a second position, the proximal end of the stylet being closer to the luer connector when in the first position than when in the second position, and the stylet comprises or is attached to a drive member of the surgical assembly to controllably retract and extend the stylet relative to the cannula assembly, whereby longitudinal retraction of the stylet in an open channel of the cannula assembly creates a vacuum at a distal end of the cannula assembly sufficient to front-load the open channel with fluid. Surgical assembly.

2. 2. The surgical assembly of claim 1, further comprising a plunger including a first segment coupled to or defined by the stylet and a second segment having a cross-sectional size larger than the first segment, the second segment connected to an outer plunger flange, the support body enclosing the first segment and at least a portion of the second segment, the first segment and the second segment being capable of longitudinal movement relative to the support body, and when the plunger is in a first position, the stylet is in the first position and the second segment of the stylet is closer to the luer connector than when the stylet is in the second position.

3. The surgical assembly of claim 1 , wherein the stylet has a length outside the support body in the range of 15.24 centimeters to 3.048 meters.

4. The surgical assembly of any preceding claim, wherein the stylet comprises an MRI compatible material and has a maximum outer diameter in the range of approximately 0.0127 to 0.0508 centimeters.

5. The surgical assembly of claim 4 , wherein the stylet comprises Nitinol.

6. The surgical assembly of claim 4 , wherein the stylet comprises fused quartz.

7. The surgical assembly of claim 1 , further comprising a drive screw, the drive screw at least partially within the support body and coupled to the proximal end of the stylet.

8. The surgical assembly of claim 7, further comprising a collar coupled to the support body and the drive screw, the collar being rotatable in a clockwise and counterclockwise direction to translate the stylet.

9. 3. The surgical assembly of claim 2, further comprising a support tube, the support tube being inside the support body and coupled to the luer connector above the internal seal, the stylet being slidably coupled to the support tube for retracting and extending inside the support tube, while the support body slidably retracts and extends around an outer wall of the support tube in conjunction with the stylet.

10. a cannula assembly including a proximal end having a luer connector and having a longitudinally opposed distal end and an open channel extending therethrough; a plunger assembly coupled to the cannula assembly, the plunger assembly including a stylet extending within the open channel of the cannula assembly to position a distal end of the stylet adjacent the distal end of the cannula assembly, the open channel and the stylet cooperating to define a fluid channel, the stylet comprising or attached to a drive member of the plunger assembly to controllably retract and extend the stylet relative to the cannula assembly, whereby longitudinal retraction of the stylet in the open channel of the cannula assembly creates a vacuum at the distal end of the cannula assembly sufficient to front-load the open channel with fluid; 16. An intracorporeal fluid transport system comprising:

11. 11. The intracorporeal fluid transfer system of claim 10, wherein when the stylet is in a first position corresponding to a fluid intake ready position or an injection complete position, the distal end of the stylet is flush with or extends beyond the distal end of the cannula assembly.

12. The intracorporeal fluid transfer system of claim 10, wherein fluid is retained only within the fluid channel for dispensing to a patient, and the fluid channel is retained only at a location between the distal end of the cannula assembly and an intermediate portion of the cannula assembly.

13. the plunger assembly further comprising a luer connector including an internal seal defining a fluid-tight seal around a segment of the stylet, the luer connector of the plunger assembly being attached to the luer connector of the cannula assembly; a support body coupled to the luer connector of the plunger assembly and extending above the distal end of the stylet, the support body surrounding a sub-segment of the stylet; Including, The body fluid transfer system of claim 10.

14. 14. The system of claim 13, further comprising a plunger, the plunger defining the drive member whereby the plunger and the stylet move in unison in an interlocking manner, the plunger including a first segment coupled to or defined by the stylet and a second segment having a cross-sectional size larger than the first segment, the second segment connected to an outer plunger flange, the support body enclosing the first segment and at least a portion of the second segment, the first segment and the second segment being capable of longitudinal movement relative to the support body, and wherein when the plunger is in a first position, the second segment is closer to the luer connector of the plunger assembly and the luer connector of the cannula assembly than when the plunger is in a second position.

15. The system of claim 10 further comprising a drive screw defining the drive member.

16. 16. The system of claim 15, further comprising a collar coupled to the drive screw, the collar being rotatable in a clockwise and counterclockwise direction to translate the stylet.

17. 14. The intracorporeal fluid transfer system of claim 13, further comprising a support tube, the support tube being inside the support body and connected to the Luer connector of the plunger assembly above the internal seal, the stylet being slidably connected to the support tube for retracting and extending inside the support tube, while the support body slidably retracts and extends around an outer wall of the support tube in conjunction with the stylet.

18. 14. The system of claim 13, wherein the stylet has a length outside the support body in the range of 15.24 centimeters to 3.048 meters.

19. The system of claim 10, wherein the stylet comprises an MRI compatible material and has a maximum outer diameter in the range of approximately 0.0127 to 0.0508 centimeters.

20. The system of claim 10 , wherein the stylet comprises Nitinol.

21. The system of claim 10 , wherein the stylet comprises fused silica.

22. The surgical assembly of claim 1 , wherein the fluid comprises stem cells.

23. The intracorporeal fluid transfer system of claim 10 , wherein the fluid comprises stem cells.

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