THERAPEUTIC INFUSION NEEDLE

Abstract

Devices and methods useful for injecting therapeutics into the body of a patient are illustrated and described herein. In certain aspects, needle assemblies comprising a needle having a needle shaft with one or more side openings and a needle sheath slidably moveable along the needle shaft to selectively expose or cover all or a portion of the one or more side openings are provided. Such assemblies may include an interference fit between the needle sheath and the needle shaft and/or a seal positioned around the needle shaft proximal of the plurality of one or more side openings and configured to prevent fluid from leaking between the needle sheath and the needle shaft and beyond a proximal end of the needle sheath.

Claims

1. A needle assembly, comprising: a needle defining a lumen, the needle having a needle shaft extending from a hub; the needle shaft having a proximal portion and a distal portion; the distal portion having a distal tip and one or more side openings; a needle sheath positioned around the needle shaft and slidable therealong, wherein the needle sheath is slidably configurable from a first configuration in which the needle sheath sealingly covers the one or more side openings to a second configuration in which the one or more side openings is/are at least partially uncovered by the needle sheath; and wherein the needle sheath has an interference fit around the needle shaft.

2. The needle assembly of claim 1, wherein the needle sheath includes a seal positioned around the needle shaft proximal of the one or more side openings and configured to prevent fluid from leaking between the needle sheath and the needle shaft and beyond a proximal end of the needle sheath.

3. The needle assembly of claim 2, wherein the seal comprises an o-ring positioned around the needle shaft.

4. The needle assembly of claim 2, wherein the seal comprises a tuohy borst valve.

5. The needle assembly of claim 2, wherein the assembly is effective to prevent fluid from leaking between the needle sheath and the needle shaft with a static fluid pressure of at least 50 mmHg in the lumen when the one or more side openings of the needle shaft is/are covered by the needle sheath and the needle assembly is in 1 atm.

6. The needle assembly of claim 2, wherein the assembly is effective to prevent fluid from leaking between the needle sheath and the needle shaft with a static fluid pressure of at least 250 mmHg in the lumen when the one or more side openings of the needle shaft is/are covered by the needle sheath and the needle assembly is in 1 atm.

7. The needle assembly of claim 2, wherein the proximal portion of the needle shaft includes indicia including a first mark adjacent to a second mark; wherein when the needle sheath is in the first configuration, a proximal portion of the needle sheath is aligned with the first mark; and wherein when the needle sheath is in the second configuration, the proximal portion of the needle sheath is aligned with the second mark.

8. The needle assembly of claim 7, wherein the one or more side openings is a first side opening of the needle shaft; and wherein the first mark is spaced from the second mark a distance equal to spacing between a distal-most edge of the first side opening and a distal-most edge of an adjacent second side opening of the needle shaft.

9. The needle assembly of claim 1, comprising a pressure monitor coupled to the needle and configured to measure pressure of fluid entering the lumen.

10. The needle assembly of claim 1, comprising an injector configured to inject fluid into the lumen.

11. The needle assembly of claim 1, comprising an RF power supply and a ground electrode, wherein the RF power supply is in electrical communication with the needle shaft and the ground electrode and is configured to generate a voltage difference between the needle shaft and the ground electrode.

12. The needle assembly of claim 1, wherein the distal tip is a closed, tissue-penetrating tip.

13. The needle assembly of claim 1, wherein the lumen is free of a movable tube positioned therein.

14. The needle assembly of claim 1, comprising a protective cover positioned around the needle sheath and the needle shaft with the needle sheath positioned around the needle shaft.

15. A kit comprising the needle assembly of claim 1 and a volume of liquid containing a suspension of cells therein.

16. A method of infusing a therapeutic agent into a volume of tissue, comprising: i. inserting a distal portion of a needle assembly into the volume of tissue in a first configuration, the needle assembly comprising a needle shaft and a needle sheath, the needle shaft having a length, a distal tip, and one or more side openings in the the distal portion, the needle sheath slidably positioned around the needle shaft, the needle sheath configurable from the first configuration in which the needle sheath sealingly covers the one or more side openings to a second configuration in which the one or more side openings is/are at least partially uncovered; ii. configuring the needle assembly into the second configuration within the volume of tissue; iii. infusing a therapeutic through the needle shaft in the second configuration and out of the exposed one or more side openings into the volume of tissue; iv. configuring the needle assembly into the first configuration within the volume of tissue by withdrawing the needle shaft relative to the needle sheath such that the needle shaft moves a greater distance relative to the volume of tissue than the needle sheath; and v. retracting the needle shaft in the first configuration from the volume of tissue.

17. The method of claim 16, wherein configuring the needle assembly into the second configuration comprises withdrawing the needle sheath relative to the needle shaft such that the needle sheath moves a greater distance relative to the volume of tissue than the needle shaft.

18. The method of claim 16, wherein configuring the needle assembly into the second configuration comprises advancing the needle shaft from the needle sheath such that the needle shaft moves a greater distance relative to the volume of tissue than the needle sheath.

19. The method of claim 16, wherein the one or more side openings is a first side opening of the needle shaft; and wherein in the second configuration a second side opening is positioned proximally of the first side opening and is sealingly covered by the needle sheath.

20. The method of claim 16, comprising applying RF energy to the volume of tissue from the needle shaft in the second configuration.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0061] FIG. 1 is a cross-sectional view of an exemplary needle assembly of the present disclosure.

[0062] FIG. 2 is a cross-sectional view of a needle sheath of a needle assembly.

[0063] FIG. 3 is another cross-sectional view of an exemplary needle assembly.

[0064] FIG. 4 is a plan view of a needle assembly without a protective cover.

[0065] FIGS. 5, 6, 7, and 8 illustrate various configurations of a needle assembly.

[0066] FIGS. 9, 10, and 11 illustrate fluid flow through a needle assembly in various configurations.

[0067] FIGS. 12, 13, 14, 15, 16, and 17 illustrate a method of using a needle assembly.

[0068] FIG. 18 illustrates a needle assembly comprising a pressure monitor and an injector.

[0069] FIG. 19 illustrates a needle assembly having an elongate side opening with a major axis extending helically around the longitudinal axis of the needle shaft.

[0070] FIG. 20 illustrates a needle assembly having an elongate side opening with a major axis extending parallel to the longitudinal axis of the needle shaft.

[0071] FIG. 21 is a cross-sectional view of another exemplary needle assembly of the present disclosure.

[0072] FIGS. 22 and 23 illustrate a method of using a needle assembly.

[0073] FIG. 24 is a side view of an exemplary needle assembly and sheath lock.

[0074] FIG. 25 is a side view of another exemplary needle assembly and sheath lock.

DESCRIPTION OF THE SELECTED EMBODIMENTS

[0075] For the purpose of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any alterations and further modifications in the described embodiments, and any further applications of the principles of the invention as described herein are contemplated as would normally occur to one skilled in the art to which the invention relates. One embodiment of the invention is shown in great detail, although it will be apparent to those skilled in the relevant art that some features that are not relevant to the present invention may not be shown for the sake of clarity.

[0076] With respect to the specification and claims, it should be noted that the singular forms “a”, “an”, “the”, and the like include plural referents unless expressly discussed otherwise. As an illustration, references to “a device” or “the device” include one or more of such devices and equivalents thereof. It also should be noted that directional terms, such as “up”, “down”, “top”, “bottom”, and the like, are used herein solely for the convenience of the reader in order to aid in the reader's understanding of the illustrated embodiments, and it is not the intent that the use of these directional terms in any manner limit the described, illustrated, and/or claimed features to a specific direction and/or orientation.

[0077] The drawing figures referred to herein are provided for illustrative purposes only. They should not be construed as limiting the scope of the invention defined by the claims, including that they may not necessarily be drawn to scale. For example, the needle assembly in any of the illustrated embodiments may be a catheter needle assembly (e.g., the needle may be a catheter needle and/or the needle sheath may be a catheter)—especially one having length sufficient for use through an endoscope.

[0078] FIG. 1 illustrates a needle assembly 100. The needle assembly comprises a needle 102 and a needle sheath 104. The needle includes a needle shaft 110 and a hub 112. The needle sheath is slidably positioned along the needle shaft 110.

[0079] The needle shaft is a hollow, elongate member. The needle shaft has a proximal portion 114 and a distal portion 116. The proximal portion is affixed to the hub. The needle shaft extends distally from the hub and terminates at a distal tip 118. The needle shaft defines a longitudinal axis 119.

[0080] Positioned in the distal portion proximally of the distal tip 118 are a plurality of side openings 120 defined by a sidewall 122 of the needle shaft. The side openings 120 extend from an inner surface 126 of the sidewall to an outer surface 128 of the sidewall. The side openings define an infusion section 130. The inner surface defines a lumen 134 extending along a length of the needle shaft and in fluid communication with the hub.

[0081] The distal tip of the needle shaft may have a closed-tip. For example, the distal tip may include a trocar 140 that closes a distal-most end of the lumen of the needle shaft. The trocar may extend at least partially into the lumen. The trocar may have a triple bevel.

[0082] The needle sheath is slidable along a length of the needle shaft. The needle sheath includes a wall 150 having an inner surface 152 and an outer surface 154. As shown in FIG. 2, the needle sheath may include a seal 160. The seal extends circumferentially around the needle shaft and is arranged to resist fluid from passing between the needle shaft and the needle sheath beyond the proximal end of the needle sheath. The seal may include an O-ring 162 or a valve, such as a tuohy borst valve. The seal may be retained in association with the needle sheath by a seal housing 166 affixed to a proximal end 170 of the wall. Advantageously, the seal housing may also provide a handle for operation by a medical professional during use.

[0083] In a distal end 172 of the needle sheath, the wall may taper inwardly such that the needle sheath and/or a lumen of the needle sheath has a smaller cross-sectional dimension in the distal end than in the proximal end of the needle sheath.

[0084] The needle assembly may include a protective cover 200, illustrated in FIGS. 1 and 3, for shipping and/or storage purposes. The protective cover may have an inner surface 202 and an outer surface 204. When assembled onto the needle, the protective cover contacts the needle hub and/or needle sheath. Preferably, the protective cover extends distally beyond the distal tip of the needle assembly to protect against unintentional needle sticks during handling.

[0085] As illustrated in FIG. 4, side openings may at least partially overlap one another along the infusion section. For example, a distal-most edge 220 of a first side opening 222 is positioned distally of a proximal-most edge 226 of a second side opening 228 adjacent to and positioned distally of the first side opening. It contemplated, however, that a distal-most edge of a first side opening may be aligned or longitudinally spaced proximally of a proximal-most edge of a second side opening adjacent-to and positioned distally of the first side opening.

[0086] Also illustrated in FIG. 4, side openings spread around the circumference of the distal portion. For example, side openings can be spread helically around a longitudinal axis of the distal portion. Such side openings may extend along a helix having a helix angle 238. While the side openings shown in FIG. 4 extend along a helix having a constant helix angle along the infusion section, it is contemplated that the helix angle may vary along a length of the infusion section.

[0087] The figures herein also illustrate a needle assembly having side openings of circular cross-sectional shape and equal cross-sectional area along the infusion section. It is contemplated, however, that side openings can have any of a variety of cross-sectional shapes and/or cross-sectional area of side openings may vary along the distal portion, as described elsewhere herein.

[0088] Turning now to a discussion of the operation of the needle assembly, FIGS. 5-8 show various configurations of the needle assembly. In one configuration, the needle sheath may be positioned proximally of the side openings of the needle shaft, as shown in FIG. 5. In another configuration, shown in FIGS. 6 and 7, the needle sheath may be positioned distally along the needle shaft such that one or more side openings of the plurality of side openings, such as side opening 240, are sealingly covered by the needle sheath to prevent fluid from exiting the covered side opening(s) of the needle shaft. In yet another configuration, the needle sheath extends distally beyond a distal-most side opening 242 of the plurality of side openings such that the plurality of side openings are all covered and sealingly closed by the needle sheath. In such a configuration, the lumen of the needle shaft is fluid-tight with the exception of communication with the hub at the proximal portion of the needle shaft and communication with the lumen of the needle sheath through the side openings.

[0089] During use of the needle assembly, the distal portion of the needle shaft and a distal portion of the needle sheath will be positioned within tissue of a patient. Accordingly, a medical professional will be unable to visualize side openings without assistance from specialized imaging technology, such as ultrasound or radiography. Notably, however, proximal portions of the needle shaft and needle sheath will be positioned outside of the patient's body.

[0090] To aid in an operator knowing the number and/or area of side openings exposed in the distal end of the distal portion of the needle shaft, the needle may include indicia 250 near the proximal end of the needle sheath. Indicia may include at least a first mark 252. The first mark, when aligned with a corresponding portion of the needle sheath, such as the proximal most end of the needle sheath, can indicate to an operator that all side openings of the needle shaft are covered and sealingly closed by the needle sheath. Indicia 250 may also include marks 254, 256 and 258 that indicate different numbers and/or areas (e.g., lengths) of side openings that are exposed in the distal portion of the needle shaft (i.e., those uncovered by the needle sheath). Advantageously, allowing the operator to adjust the number and/or area of side openings exposed in the distal portion of the needle shaft can facilitate delivery of therapeutic agent to targeted tissue, such as abnormal tissue, without exposing healthy and/or untargeted tissue to the therapeutic agent.

[0091] As shown in FIGS. 9-11, when the needle sheath is positioned over a side opening the needle sheath may sealingly close the side opening so as to prevent fluid from exiting the side opening and/or traveling distally and/or proximally between the needle sheath and the needle shaft. Additionally, by selectively covering side openings located near the proximal end of the distal section, an operator may increase the fluid pressure and/or velocity of fluid exiting the distally located side openings that are not covered by the needle sheath without having to increase the pressure and/or velocity of fluid entering the proximal portion of the needle shaft.

[0092] FIGS. 12-17 illustrate a method of using needle assemblies disclosed herein. As shown in FIG. 12, the needle assembly is initially located outside of the body of the patient 1000. In a provided configuration, the needle sheath may be retracted along the needle shaft to have one or more side openings of the plurality of side openings exposed in the distal portion of the needle shaft (shown in FIG. 12). Such an arrangement may be desirable to facilitate flushing of the needle lumen prior to insertion into the patient (e.g., flushing with saline).

[0093] Prior to inserting the needle into the body of the patient (e.g., through the skin 1002 of the patient), the needle sheath may be advanced distally relative to the needle shaft so as to cover the side openings of the needle shaft, as shown in FIG. 13. With the needle sheath covering the side openings, the needle assembly is inserted into the body of the patient to a location wherein the portion of the needle containing side openings is positioned within the target area 1004, such as a tumor as shown in FIG. 14. With the side openings located within the target area, the needle sheath is retracted relative to the needle to expose one or more side openings located within the target area, as shown in FIG. 15. Preferably, the distal-most side opening is positioned within the target area and/or the needle sheath is retracted so that a proximal-most exposed side opening is also positioned within the target area. Preferably, no side openings of the needle sheath are exposed outside of the target area.

[0094] Preferably, the exposed side openings span at least 80% of the target area along a longitudinal axis of the needle. More preferably, the exposed side openings span at least 90% of the target area along a longitudinal axis of the needle

[0095] With the needle assembly in position and the desired area and number of side openings exposed within the target tissue, therapeutic agent may be infused through the lumen of the needle and out of the side openings into the target area, as shown in FIG. 16. Additionally, RF energy may be applied by an RF power supply 300 to the target area through use of one or more electrodes. For example, the RF power supply may be electrically coupled to the needle shaft and a surface electrode 306 so that the target area tissue may heated prior to, during, and/or after infusion of therapeutic agent. Preferably, the target area tissue is heated to a temperature of less than 45° Celsius to avoid ablation of target area tissue. It is believed that heating the target area tissue to a temperature of up-to but less than 45° Celsius can increase the cellular uptake of therapeutic agent delivered into the target area.

[0096] After delivery of therapeutic agent and/or RF power to the target area is complete, the needle shaft can be retracted relative to the needle sheath to sealingly cover and close the side openings, as shown in FIG. 17. An operator may then wait a period of time (e.g., one to five minutes) to allow the needle track 1112 within the target area tissue to close and the surrounding tissue to further uptake therapeutic agent that may have remained in the needle tract prior to withdrawing the needle assembly from the patient. Advantageously, this can aid in reducing therapeutic agent from leaking out of the target area into the surrounding tissue through the needle tract.

[0097] Turning now to FIG. 18, the needle assembly may include a pressure monitor 400 and/or an injector 500, each in fluid communication with the lumen of the needle. Preferably, the pressure monitor measures the pressure of fluid being infused from the injector into the lumen of the needle assembly. Advantageously, such arrangements can allow an operator to maintain the pressure below a threshold that may cause necrosis of certain therapeutic agent, e.g., cells.

[0098] FIGS. 19 and 20 illustrate other needle arrangements envisioned for any of the above-mentioned assemblies and/or methods. FIG. 19 illustrates a needle assembly having an elongate side opening with a major axis that extends helically around the longitudinal axis of the needle shaft. FIG. 20 illustrates a needle assembly having an elongate side opening with a major axis extending parallel to the longitudinal axis of the needle shaft.

[0099] FIG. 21 illustrates an embodiment having a needle shaft having a first outer diameter along a first length and a second outer diameter along a second length. The first outer diameter can be defined by an outer surface of an outer sleeve 402 positioned around an inner needle 404 and longitudinally fixed thereto (e.g., soldered). The second outer diameter, in this instance, can be defined by an outer surface of the inner needle.

[0100] Between the first length and the second length is a shoulder 408 having a surface extending transverse to the outer surface of the first length and second length. The shoulder has an outer dimension (e.g., diameter) greater than that of the second length and, therefore, is believed to plug an end of a tissue tract created by the second length (e.g., when the shoulder contacts patient tissue) and/or plug an end of the needle sheath lumen to resist therapeutic agent from passing from the second length to the first length along the needle shaft. When positioned with in the needle sheath, the outer extent of the shoulder preferably fills the cross-sectional area of the needle sheath. And, in instances when the needle sheath is retracted such that the tapered distal portion of the needle sheath lies along the shoulder, the shoulder provides a greater surface area contacting the tapered inner surface of the sheath to provide greater resistance to fluid flowing proximally of the shoulder between the needle shaft and the needle sheath.

[0101] FIG. 21 also illustrates a spacer (e.g., a clip) 420 that retains the needle sheath in position relative to the needle shaft, and vice versa. The spacer has a distal-facing surface 424 that contacts a proximally-facing surface 426 of the hub of the needle sheath. And, the spacer has a proximally-facing surface 430 that contacts a distally-facing surface 432 of the hub of the needle (which is fixedly attached to the needle shaft). Accordingly, the column strength of the spacer resists the hub of the sheath from moving towards the hub of the needle.

[0102] The spacer can be removable from the hub of the needle sheath and/or the needle. Preferably, the spacer is made of a resilient material. The spacer can extend partially around a proximal portion 440 of the hub of the needle sheath and/or partially around a distal portion 444 of the hub of the needle such that the spacer can be “clipped” onto and/or off the hub(s).

[0103] FIG. 21 also illustrates a lock 460 for securing the needle sheath to the needle shaft at a desired location. In FIG. 21, the lock is illustrated as a setscrew 464 that extends through the hub of the needle sheath and contacts the needle shaft. The setscrew has a handle 466 to facilitate rotation of the setscrew using one's figures. The lock is preferably located proximally of the seal of the needle sheath.

[0104] FIGS. 22 and 23 illustrate an exemplary method of inserting the needle into a target area. As shown in FIG. 22, the side openings of the needle shaft are covered by the needle sheath when the spacer is attached the needle and the needle sheath. With the spacer attached, the needle assembly can be advanced into patient tissue until the distal tip of the needle sheath is proximate the periphery of the target area. As with any of the embodiments disclosed herein, the advancement of the needle assembly can, optionally, be through an endoscope 500 (e.g., a catheter needle assembly). In such instances, the distal tip of the needle (e.g., a catheter needle) may be positioned within the needle sheath (e.g., a catheter) during advancement through the endoscope to prevent the distal tip from the needle from engaging (e.g., scraping and/or gouging) the lumen wall of the endoscope, which may dull the needle tip and/or damage the endoscope. When the distal tip of the needle sheath is in the desired location (e.g., beyond a distal tip of the endoscope), the spacer can be removed and the needle (i.e., needle shaft) can be advanced distally (relative to the needle sheath) into the target area to expose side openings in the target area. Preferably the distal tip of the needle sheath is against and/or in patient tissue when the needle is advanced distally so that the needle sheath distal tip closes (e.g., plugs) a proximal end of the tract formed in patient tissue.

[0105] Advantageously, after the side openings have been exposed in the target area, the lock may be engaged to secure the needle shaft relative to the needle sheath with the desired number/area (e.g., length) of side openings exposed within the target area. Accordingly, during the duration of the infusion, the needle sheath and needle shaft will be less likely to move relative to one another and, thereby, change the size of the infusion area. After infusion, and prior to withdrawal of the needle, the lock may be disengaged to allow subsequent withdrawal of the needle into the needle sheath.

[0106] After an infusion, the needle assembly may be withdrawn using any of the methods disclosed herein. For example, the needle may be withdrawn in an order reverse to that which it was inserted (e.g., withdrawing needle from the target area into the needle sheath while retaining the needle sheath in a stationary location in the patient tissue, attaching the spacer, and then withdrawing the entire assembly from the patient). Preferably, after the needle shaft is withdrawn at least partially into the needle sheath, the physician holds the distal tip of the needle shaft at a proximal end of the tract within the target area for one to five minutes in order to allow the needle tract in the target area to close, at least partially, and to reduce the volume of therapeutic agent in the needle tract which may follow the needle assembly through healthy patient tissue (i.e., the tissue adjacent the target area) during withdrawal of the needle assembly from the patient.

[0107] FIG. 23 illustrates a clamp lock 480 as an alternative to the setscrew arrangement of FIG. 21. A button 482 of the clamp lock may be actuatable by an operator (e.g., pressed) to apply and/or release at least some compressive force on the needle shaft. Preferably, applying compressive force resists translation and/or rotation of the needle sheath hub (and/or needle sheath) relative to the needle shaft and releasing compressive force allows such translation and/or rotation. The clamp lock may by biased (e.g., by a spring) into a configuration that exerts compressive force on the needle shaft. For example, the clamp lock may comprise the device of U.S. Pat. No. 4,453,292. The clamp lock may also comprise the device of U.S. Pat. No. 8,647,261.

[0108] FIG. 24 illustrates an arrangement having a threaded needle shaft 486 and a floating nut 488 of the needle sheath hub engaging threads of the threaded needle shaft. Advantageously, such an arrangement can allow more precise movement of the needle sheath to relative to the needle shaft. Specifically, rotation of the floating nut relative to the needle shaft (or vice versa) can advance or retract the needle shaft relative to the needle sheath.

[0109] The following numbered clauses set out specific embodiments that may be useful in understanding the present invention:

[0110] 1. A needle assembly, comprising:

[0111] a needle defining a lumen, the needle having a needle shaft extending from a hub;

[0112] the needle shaft having a proximal portion and a distal portion;

[0113] the distal portion having a distal tip and one or more side openings;

[0114] a needle sheath positioned around the needle shaft and slidable therealong, wherein the needle sheath is slidably configurable from a first configuration in which the needle sheath sealingly covers the one or more side openings to a second configuration in which the one or more side openings is/are at least partially uncovered by the needle sheath;

[0115] wherein the needle sheath has an interference fit around the needle shaft.

[0116] 2. The needle assembly of clause 1, wherein the needle sheath includes a seal positioned around the needle shaft proximal of the one or more side openings and configured to prevent fluid from leaking between the needle sheath and the needle shaft and beyond a proximal end of the needle sheath.

[0117] 3. The needle assembly of clause 2, wherein the seal comprises an o-ring positioned around the needle shaft.

[0118] 4. The needle assembly of clause 2, wherein the seal comprises a tuohy borst valve.

[0119] 5. The needle assembly of any preceding clause, wherein the assembly is effective to prevent fluid from leaking between the needle sheath and the needle shaft with a static fluid pressure of at least 50 mmHg in the lumen when the one or more side openings of the needle shaft is/are covered by the needle sheath and the needle assembly is in 1 atm.

[0120] 6. The needle assembly of any preceding clause, wherein the assembly is effective to prevent fluid from leaking between the needle sheath and the needle shaft with a static fluid pressure of at least 250 mmHg in the lumen when the one or more side openings of the needle shaft is/are covered by the needle sheath and the needle assembly is in 1 atm.

[0121] 7. The needle assembly of any preceding clause, wherein the proximal portion of the needle shaft includes indicia including a first mark adjacent to a second mark;

[0122] wherein when the needle sheath is in the first configuration, a proximal portion of the needle sheath is aligned with the first mark; and

[0123] wherein when the needle sheath is in the second configuration, the proximal portion of the needle sheath is aligned with the second mark.

[0124] 8. The needle assembly of clause 7, wherein the one or more side openings is a first side opening of the needle shaft; and wherein the first mark is spaced from the second mark a distance equal to spacing between a distal-most edge of the first side opening and a distal-most edge of an adjacent second side opening of the needle shaft.

[0125] 9. The needle assembly of any preceding clause, comprising a pressure monitor coupled to the needle and configured to measure pressure of fluid entering the lumen.

[0126] 10. The needle assembly of any preceding clause, comprising an injector configured to inject fluid into the lumen.

[0127] 11. The needle assembly of any preceding clause, comprising an RF power supply and a ground electrode, wherein the RF power supply is in electrical communication with the needle shaft and the ground electrode and is configured to generate a voltage difference between the needle shaft and the ground electrode.

[0128] 12. The needle assembly of any preceding clause, wherein the distal tip is a closed, tissue-penetrating tip.

[0129] 13. The needle assembly of any preceding clause, wherein the lumen is free of a movable tube positioned therein.

[0130] 14. The needle assembly of any preceding clause, comprising a protective cover positioned around the needle sheath and the needle shaft with the needle sheath positioned around the needle shaft.

[0131] 15. A kit comprising the needle assembly of any preceding clause and a volume of liquid containing a suspension of cells therein.

[0132] 16. A method of infusing a therapeutic agent into a volume of tissue, comprising:

[0133] i. inserting a distal portion of a needle assembly into the volume of tissue in a first configuration, the needle assembly comprising a needle shaft and a needle sheath, the needle shaft having a length, a distal tip, and one or more side openings in the the distal portion, the needle sheath slidably positioned around the needle shaft, the needle sheath configurable from the first configuration in which the needle sheath sealingly covers the one or more side openings to a second configuration in which the one or more side openings is/are at least partially uncovered;

[0134] ii. configuring the needle assembly into the second configuration within the volume of tissue;

[0135] iii. infusing a therapeutic through the needle shaft in the second configuration and out of the exposed one or more side openings into the volume of tissue;

[0136] iv. configuring the needle assembly into the first configuration within the volume of tissue by withdrawing the needle shaft relative to the needle sheath such that the needle shaft moves a greater distance relative to the volume of tissue than the needle sheath; and

[0137] v. retracting the needle shaft in the first configuration from the volume of tissue.

[0138] 17. The method of clause 16, wherein configuring the needle assembly into the second configuration comprises withdrawing the needle sheath relative to the needle shaft such that the needle sheath moves a greater distance relative to the volume of tissue than the needle shaft.

[0139] 18. The method of clause 16, wherein configuring the needle assembly into the second configuration comprises advancing the needle shaft from the needle sheath such that the needle shaft moves a greater distance relative to the volume of tissue than the needle sheath.

[0140] 19. The method of clause 16, 17, or 18, wherein the one or more side openings is a first side opening of the needle shaft; and

[0141] wherein in the second configuration a second side opening is positioned proximally of the first side opening and is sealingly covered by the needle sheath.

[0142] 20. The method of clause 16, 17, 18, or 19, comprising applying RF energy to the volume of tissue from the needle shaft in the second configuration.

[0143] 21. A needle assembly, comprising:

[0144] a needle defining a lumen, the needle having a needle shaft extending from a hub;

[0145] the needle shaft having a proximal portion and a distal portion;

[0146] the distal portion having a distal tip and one or more side openings spaced along a length of the distal portion; and

[0147] a needle sheath slidably positioned around the needle shaft, wherein the needle sheath is configurable from a first configuration in which the needle sheath sealingly covers the one or more side openings to a second configuration in which the one or more side openings is/are at least partially uncovered;

[0148] wherein the needle sheath is effective to prevent fluid from leaking from the one or more side openings with a static fluid pressure of at least 50 mmHg in the lumen when the one or more side openings is/are covered by the needle sheath and the needle assembly is in 1 atm.

[0149] 22. The needle assembly of clause 21, wherein the needle sheath is effective to prevent fluid from leaking from the one or more side openings with a static fluid pressure of at least 250 mmHg in the lumen when the one or more side openings is/are covered by the needle sheath and the needle assembly is in 1 atm.

[0150] 23. The needle assembly of clause 21 or 22, comprising a seal positioned around the needle shaft proximal of the one or more side openings and configured to prevent fluid from leaking between the needle sheath and the needle shaft and beyond a proximal end of the needle sheath.

[0151] 24. The needle assembly of clause 23, wherein the seal comprises an o-ring positioned around the needle shaft.

[0152] 25. The needle assembly of clause 23, wherein the seal comprises a tuohy borst valve.

[0153] 26. The needle assembly of any one of clauses 23-25, wherein the seal is effective to prevent fluid from leaking between the needle sheath and the needle shaft with a static fluid pressure of at least 50 mmHg in the lumen when the one or more side openings is/are covered by the needle sheath and the needle assembly is in 1 atm.

[0154] 27. The needle assembly of any one of clauses 23-25, wherein the seal is effective to prevent fluid from leaking between the needle sheath and the needle shaft with a static fluid pressure of at least 250 mmHg in the lumen when the one or more side openings is/are covered by the needle sheath and the needle assembly is in 1 atm.

[0155] 28. The needle assembly of any one of clauses 21-27, wherein the proximal portion of the needle shaft includes indicia including a first mark spaced from a second mark.

[0156] 29. The needle assembly of clause 27, wherein when the needle sheath is in the first configuration, a proximal portion of the needle sheath is aligned with the first mark.

[0157] 30. The needle assembly of clause 27 or 28, wherein when the needle sheath is in the second configuration, the proximal portion of the needle sheath is aligned with the second mark.

[0158] 31. The needle assembly of any one of clauses 21-30, comprising a pressure monitor coupled to the needle and configured to measure pressure of fluid entering the lumen.

[0159] 32. The needle assembly of any one of clauses 21-31, comprising an injector configured to inject fluid into the lumen.

[0160] 33. The needle assembly of clause 21, comprising an RF power supply and a ground electrode, wherein the RF power supply is in electrical communication with the needle shaft and the ground electrode and is configured to generate a voltage difference between the two.

[0161] 34. The needle assembly of clause 21, wherein the distal tip is a tissue penetrating tip free of an opening.

[0162] 35. The needle assembly of clause 21, wherein the lumen is free of a tube positioned therein.

[0163] 36. The needle assembly of clause 21, wherein the one or more side openings is a first side opening and the needle shaft has a second side opening; and wherein the first side opening and the second side opening are spaced from one another around a circumference of the needle shaft.

[0164] 37. A kit comprising the needle assembly of clause 21 and a volume of liquid containing a suspension of cells therein.

[0165] 38. A needle, comprising:

[0166] a needle hub and a needle shaft;

[0167] the needle shaft having a first outer diameter along a first length and a second outer diameter along a second length, the first outer diameter being greater than the second outer diameter, the second length being proximal of a tissue penetrating needle tip, and the first length being proximal of the second length; and

[0168] the needle shaft having a plurality of side openings along said second length.

[0169] 39. The needle of clause 38, wherein the needle shaft has an inner surface defining a lumen;

[0170] wherein the needle shaft has a wall thickness measured between the inner surface and the outer surface; and

[0171] wherein the wall thickness in said first length is greater than the wall thickness in said second length.

[0172] 40. The needle of clause 39, wherein the needle shaft includes an outer sleeve positioned around an inner needle along said first length, the outer sleeve longitudinally fixed to said inner needle;

[0173] said outer sleeve and inner needle defining said wall thickness.

[0174] 41. The needle of clause 40, wherein the outer sleeve is soldered to the inner needle.

[0175] 42. An assembly comprising the needle of any one of clauses 38-41 and a needle sheath positioned around the needle shaft and having a length less than the needle shaft.

[0176] 43. The assembly of clause 42, wherein the needle sheath has an inner surface defining a needle sheath lumen, and wherein the inner surface tapers inwardly in a distal portion of the needle sheath.

[0177] 44. An assembly comprising an endoscope and the needle assembly of any preceding clause having a length sufficient to extend through a lumen of the endoscope.

[0178] While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiment has been shown and described and that all changes, equivalents, and modifications that come within the spirit of the inventions defined by following claims are desired to be protected. All publications, patents, and patent applications cited in this specification are herein incorporated by reference as if each individual publication, patent, or patent application were specifically and individually indicated to be incorporated by reference and set forth in its entirety herein.

[0179] The language used in the claims and the written description is to only have its plain and ordinary meaning, except for terms explicitly defined below. Such plain and ordinary meaning is defined here as inclusive of all consistent dictionary definitions from the most recently published (on the filing date of this document) general purpose Merriam-Webster dictionary.

[0180] As used in the claims and the specification, the following terms have the following defined meanings:

[0181] The term “and/or” is inclusive here, meaning “and” as well as “or”. For example, “P and/or Q” encompasses, P, Q, and P with Q; and, such “P and/or Q” may include other elements as well.

[0182] The term “cells” as used herein refers to a microscopic mass of protoplasm bounded externally by a semipermeable membrane, usually including one or more nuclei and various other organelles. Use of the term “cells” in this disclosure includes cells suspended in fluid media (e.g., heparinized saline). For example, the cells/cellular material may be T-cells. The cells may be provided by a manufacturer preloaded in the device, or in a separate container or arrangement to be incorporated into or onto the delivery device prior to or during the cell delivery procedure. During infusion, the cells can be loaded into the needle assembly followed by flushing fluid (saline, media, etc.).

[0183] The terms “comprise”, “comprises”, “comprised” or “comprising” as used herein (including the claims) are to be interpreted as specifying the presence of the stated features, integers, steps or components, but not precluding the presence of one or more other features, integers, steps or components, or group thereof.

[0184] The term “coupled” as used herein has the meaning, joined or linked directly or indirectly.

[0185] The term “distal” as used herein refers to the opposite of “proximal” (i.e., the patient end/treating end).

[0186] The term “electrode” as used herein refers to an electrical conductor used to establish electrical contact.

[0187] The term “hub” as used herein refers to the expanded portion of a hollow needle that serves as a handle for manipulation. The “hub” often includes at least one opening communicating with an interior lumen of the needle. Such openings may include sites for attachment of a syringe, infusion tube, and/or other appliance. For example, the openings may include a connector, such as a male or female Luer connector.

[0188] The term “interference fit” as used herein has the meaning a fit between parts in which the external dimension of a first part exceeds the internal dimension of a second part into which the first part fits.

[0189] The term “lumen” as used herein refers to the bore of a tube (as of a hollow needle or catheter).

[0190] The term “needle” as used herein refers to a slender hollow instrument for introducing material into or removing material from the body (as by insertion under the skin). Such “needles” are often formed of metal (e.g., stainless steel).

[0191] The term “patient” as used herein includes an individual awaiting or under medical care and treatment. The term is includes those of both human and veterinary nature.

[0192] The term “proximal” as used herein refers to an end or direction associated with a physician or other treating personnel during a device operation.

[0193] The term “power supply” as used herein refers to a device providing electrical power, including but not limited to, electrical power at a frequency between 350 kHz and 500 kHz.

[0194] The term “pressure monitor” as used herein refers to device capable of measuring fluid pressure, static pressure and/or dynamic pressure. The term includes, but is not limited, the electromechanical transducers.

[0195] The term “seal” as used herein refers to a member for preventing fluid leakage, such as an o-ring. The term can also include septums and valves, such as a tuohy borst valve, when arranged to prevent fluid leakage.

[0196] The term “side opening” as used herein refers to an opening in a side of the needle shaft. Such openings can include holes and slots. The opening(s) can be circular and/or polygonal in cross-section. The openings may be elongate (e.g., oblong). For example, the opening(s) may be oval or obround. The opening(s) may be space between coils, such as between coils of a helically-coiled wire defining a tube. The terms “side opening” and “side openings” as used herein may be a subset of a plurality of side openings of the needle shaft. For example, the term “side openings” may be a first group of a plurality of side openings. The plurality of side openings may include a second group of side openings. The second group of side openings can be positioned proximally of the first group of side openings.

[0197] The term “sheath” as used herein refers to a generally to a cover and includes hollow cylindrical members. Such members may be formed of a metal and/or polymeric material.

[0198] The term “slidable” as used herein can include longitudinally slidable and/or rotationally slidable.

[0199] The term “target area” as used herein refers to the volume in the patient intended to receive therapy, such as a lesion. Target areas can be malignant and/or benign. Exemplary target areas include tumors, polyps, and abscesses.

[0200] The term “therapeutic agent” as used herein means a substance useful in the treatment of a disease or disorder. It includes, but is not limited to small molecule drugs and contrast agents, nanoparticles, macromolecules, and cells. The term includes small molecule drugs useful for localized chemotherapy/oncology and/or vascular intervention such as dissolving thrombus and/or reducing vascular calcification. For example, drugs such as paclitaxel, rapamycin, myotropic/neurotropic antispasmodics, and anticalcificants such as phosphate binders are included. Contrast agents suitable for MRI, X-Ray, and/or ultrasound imaging are included, such as gadolinium, manganese, iron oxide, and iodine-based (ionic/non-ionic) contrast agents. Organic, inorganic, and/or complex/polymeric nanoparticles useful for thermal ablation and targeted drug-delivery are contemplated. This includes but is not limited to liposomes, micelles, perfluorocarbons, gold nanoparticles, superparamagnetic iron oxide nanoparticles (SPION), dendrimers and functionalized nanoparticles. Macromolecule proteins, peptides, and/or synthetic polymers useful for biochemical thrombectomy, cell adhesion, coercive morphogenesis, prolonged drug-release, and/or sealants are contemplated. This includes but is not limited to fibrinolytics (e.g., urokinase, tPA), adhesional proteins (e.g., Fn, Lama, Col), growth factors (e.g., VEGF, TGF, Insulin), drug-eluting gels, hydrogels and glues. Environmentally-responsive hydrogels that can transition from liquid to gel form at a desired temperature (e.g., at 37° C.) and concentration are contemplated. Cells including differentiated, stem/progenitor, and/or genetically modified cells useful for re-endothelialization, endothelial regeneration and/or cellular therapy are contemplated as well as antisense and monoclonal antibodies.

[0201] The term “tip” as used herein refers to an end-most point.

[0202] It will be understood that “syringe” and “needle” are exemplary modes, and substitutes for these components or alternative structures may be used in specific embodiments. For example, devices such as pumps, power injectors, indeflators, compressible bladders, and the like may all be used as a substitute for a syringe. Furthermore, the term “needle” may include hypodermic needles, cannulas, microneedles, and nanoneedles.