WO2009089090A2

WO2009089090A2 - Thermally regulated hypodermic needles, methods of use, and kits

Info

Publication number: WO2009089090A2
Application number: PCT/US2009/030014
Authority: WO
Inventors: Paul Sand; Bryce Way
Original assignee: Vertos Medical, Inc.
Priority date: 2008-01-03
Filing date: 2009-01-02
Publication date: 2009-07-16
Also published as: WO2009089090A3

Abstract

The invention describes needles having a first tubular member having a first tubular member lumen, a second tubular member coaxially disposed within the first tubular member lumen having a second tubular member lumen therein; and a flow passage formed between the first and the second tubular members which are adapted and configured to heat or cool a material to be delivered via the needle.

Description

THERMALLY REGULATED HYPODERMIC NEEDLES, METHODS OF USE, AND KITS

CROSS-REFERENCE

[0001] This application claims the benefit of U.S. Provisional Application No. 61/018,743, filed January 3, 2008, which application is incorporated herein by reference.

BACKGROUND OF THE INVENTION

Field of the Invention

[0002] The present invention relates generally to devices and methods for percutaneously injecting or withdrawing a substance during a surgical procedure. More particularly, the present invention relates to needles that are thermally regulated to control the temperature of the needle while disposed in a patient. Background of the Invention

[0003] Hypodermic needles are hollow needles used by medical professionals or patients to percutaneously inject a substance into the body. For instance, hypodermic needles are commonly used to percutaneously deliver drugs into the body. In addition, hypodermic needles may be used to withdraw a substance from the body. For instance, hypodermic are commonly used to take a blood sample from a vein in venipuncture. [0004] Most conventional hypodermic needles are made from a stainless- steel tube drawn through progressively smaller dies. The diameter of the needle is indicated by the needle gauge, and a variety of needle lengths are available for any given gauge. Depending on the application, the medical professional can choose the appropriate length and gauge needle. Although hypodermic needles may be reusable, most hypodermic needles used for medical applications are single-use, disposable needles.

[0005] Some medical procedures utilize thermally sensitive substances designed to change phase and/or viscosity at a predetermined temperature. Such thermally sensitive substances may be injected into and/or withdrawn from a specific location in the patient. For instance, U.S. Patent Pub. US 2007/0276390 entitled "Ipsilateral Approach to Minimally Invasive Ligament," and U.S. Patent Pub. US 2006/0036272 entitled "Spinal Ligament Modification," disclose procedures that utilize substances that are liquid at ambient temperatures and can be injected through a hypodermic needle, but that become more viscous when warmed to body temperatures after being injected. In some cases, the injected medium may be capable of a reversible change. For instance, the injected medium may have a low viscosity at ambient temperature upon injection, then become more viscous after injection once warmed to body temperatures, and then be returned to a low-viscosity state by localized cooling to facilitate withdraw of the medium from the body with a hypodermic needle. One example of such an injectable substance or medium is Omnipaque® 240 available from Nycomed, New York. [0006] For thermally sensitive substances, the inability to maintain the temperature within a defined temperature range may detrimentally impact the ability of the medial professional to control the viscosity and phase of the substance. For instance, if the temperature of the needle is not sufficiently controlled when it is disposed in the body, a thermally sensitive substance to be injected may increase in viscosity as it flows towards the distal tip of the needle, potentially clogging or slowing flow through the needle. As another example, if the temperature of the needle is not sufficiently controlled when withdrawing an injected thermally sensitive substance from the body, the substance may not decrease in viscosity sufficiently to be effectively withdrawn.

[0007] Accordingly, there remains a need in the art for a hypodermic needle adaptable for distal application with a wide variety of proximal control mechanisms whose temperature can be controlled. Such hypodermic needles would be particularly well received if their temperature could be regulated within a narrow temperature range when disposed in the body.

SUMMARY OF THE INVENTION

[0008] An aspect of the invention is directed to needles. The needles can include, for example, a first tubular member having a first tubular member lumen; a second tubular member coaxially disposed within the first tubular member lumen having a second tubular member lumen therein; and one or more flow passages formed between the first and the second tubular members. The needle can have a radial outer surface of the second tubular member engages the radially inner surface of the first tubular member. In some embodiments, the second tubular member is fixed to the first tubular member by an interference fit. The second tubular member can, in some cases also include a recess on its outer radial surface that defines the flow passage. In some configurations, the flow passage is formed between the first and second tubular members and is adapted to receive a thermally conductive material. The thermally conductive material can transfer heat to a second tubular member lumen. Thus, for example, the heat transferred to the second tubular member lumen can heat a material disposed within the second tubular member lumen. In other configurations, the thermally conductive material transfers heat from a second tubular member lumen. In that case, the heat transferred from the second tubular member lumen cools a material disposed within the second tubular member lumen. A temperature controller can also be provided. The needle can be configured to engage a temperature controller. In some embodiments, the needle is adapted to engage or operate with a catheter. In other configurations, the needle is adapted to engage, permanently or removeably, a syringe. Where a dual flow passage is provided for, one can be adapted to deliver a heating material while a second passage is adapted to deliver a cooling material.

[0009] Another aspect of the invention is directed to a method for delivering a temperature controllable material. A suitable method includes, for example: delivering a needling having a first tubular member having a first tubular member lumen, a second tubular member coaxially disposed within the first tubular member lumen having a second tubular member lumen therein; and a flow passage formed between the first and the second tubular members; delivering a temperature transfer fluid through the flow passage; delivering a delivery material through the second tubular member lumen; and controlling a temperature of the delivery material by the temperature transfer fluid. The method can also include the step of activating a temperature controller to heat a heat transfer material. The method can also include the step of activating the temperature controller to heat the heat transfer material is performed prior to the step of delivering a temperature transfer fluid through the flow passage. The method can further include the step of activating a temperature controller to cool a heat transfer material. The step of activating the temperature controller can, in some cases, be activated to cool the heat transfer material is performed prior to the step of delivering a temperature transfer fluid through the flow passage. In some instances, the delivered material has a first temperature at a proximal end of the first tubular member and a second temperature at a distal end of the first tubular member.

[0010] Yet another aspect of the invention is directed to a kit comprising a needle. The needles of the kits can further have a first tubular member having a first tubular member lumen; a second tubular member coaxially disposed within the first tubular member lumen having a second tubular member lumen therein; and a flow passage formed between the first and the second tubular members. The kit can comprise one or more heat controllable materials, and a proximal control mechanism such as a catheter and/or a removable syringe.

INCORPORATION BY REFERENCE

[0011] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] For a more complete understanding of the invention, reference is made to the accompanying drawings, wherein:

[0013] FIG. 1 is a perspective view of a needle;

[0014] FIG. 2 is a cross-sectional view of a needle;

[0015] FIG.3 is an enlarged side view of a portion of an embodiment of a needle constructed in accordance with the principles described herein;

[0016] FiG. 4 is a cross-sectional view of a needle of FiG.3;

[0017] FΓG. 5 is a side view of the inner tubular of a hypodermic needle of FiG.3;

[0018] FiG. 6 is a cross-sectional view taken along line 6-6 of a hypodermic needle of FiG. 3;

[0019] FIG. 7 is a cross-sectional view taken along line 7-7 of a hypodermic needle of FiG. 3;

[0020] FIG. 8 is a cross-sectional view of an embodiment of the invention wherein a needle is incorporated with a standard syringe and is connected to a pump and a temperature controller external to the syringe;

[0021] FiG. 9 is a cross-sectional view of a distal tip of a needle connected to a pump and a temperature controller;

[0022] FIGS. 10A-D are cross-sectional views of a catheter adapted for use in combination with a needle similar to the configuration of FiG. 3; and

[0023] FIGS. 11A-D are enlarged cross-sectional views of a catheter adapted for use in combination with a needle similar to the configuration of FiG.3.

[0024] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

DETAILED DESCRIPTION OF THE INVENTION

[0025] The following discussion is directed to various embodiments of the invention. Although one or more of these embodiments may be preferred, the embodiments disclosed should not be interpreted, or otherwise used, as limiting the scope of the disclosure, including the claims. In addition, one skilled in the art will understand that the following description has broad application, and the discussion of any embodiment is meant only to be exemplary of that embodiment, and not intended to intimate that the scope of the disclosure, including the claims, is limited to that embodiment. I. DEVICES

[0026] FIGS. 1-2 illustrate a hand operable syringe 10 forming a proximal control mechanism 90 in an embodiment of a suitable control mechanism suitable for use with a needle according to the invention. The syringe has a hollow cylinder or barrel 12 which is capable of holding an internal supply of delivery material. A flange 14 can be attached to the barrel 12 to facilitate handling and operation of the syringe 10. A piston 16 is slideably engaged within the barrel 12 and serves to advance the delivery material through the barrel 12. The piston 16 can be configured such that it has two narrow grooves 18, 20 cut into its outer surface and extending around its entire periphery. The grooves 18, 20 can be adapted to catch and trap material flowing in a reverse direction and act as a seal in order to maintain the content of the delivery material within a reservoir of the syringe prior to delivery. An elongated rod 22 can be provided which is integrally attached to piston 16. A hollow needle 28, or trocar, is provided which facilitates accessing the target tissue to deliver material or to withdrawn fluid. Suitable syringes include any device consisting of, for example, a glass, metal, or hard rubber tube, narrowed at its outlet, and fitted with either a piston or a rubber bulb for drawing in a quantity of fluid or for ejecting fluid in a stream, for cleaning wounds, injecting fluids into the body, etc. Syringes are suitable for pumping and/or straying liquids through a small aperture or for injecting or withdrawing fluids into, for example, a mammalian body.

[0027] Elongated rod 22 can be configured such that it is integrally attached to piston 16 and has a threaded portion extending from barrel 12 and beyond flange 14. A circular, internally threaded nut 24 can also be provided that is mounted on threaded rod 22. Circular nut 24 can be used, for example, to meter the delivery of a pre-determined amount of material by positioning it an appropriate distance from flange 14 and then advancing rod 22 until nut 24 meets flange 14. Thumb pad 26 can also be provided, of course, to receive thumb pressure to advance rod 22 and piston 16 as syringe 10 is held by the syringe operator. [0028] Referring now to FIGS. 3-4, an embodiment of a distal tip of a needle 10 is shown. Needle 10 has a central axis 115 and comprises a beveled needle tip 112, an inner tubular member 120, and an outer tubular member 130 coaxially disposed about inner tubular member 120. Since needle 10 comprises an inner tubular member 120 and an outer tubular member 130, needle 10 may also be described as a double-walled needle. The needle 10 can, for example, be a hypodermic needle characterized in that it is adapted and configured for the introduction of medicine or drugs under the skin of a mammal, or for the withdrawal of bodily fluid from under the skin of a mammal.

[0029] Inner tubular member 120 includes a beveled distal tip 125, a radial outer surface 121 of the inner tubular member and a radial inner surface 126 of the inner tubular member that defines a central bore 150 though needle 10. It should be appreciated that the delivery substance or medium to be injected into and/or withdrawn from the patient flows through central bore 150. Surfaces 121, 126 are generally parallel cylindrical surfaces. Outer tubular member 130 includes a beveled distal tip 135, a radial inner surface 136 and a radial outer surface 131 defining the outer diameter and gauge of needle 10. Surfaces 131, 136 are generally parallel cylindrical surfaces. Beveled tips 125, 135 are aligned to form beveled needle tip 112. In some embodiments, an insulating material may be provided on outer surface 131.

[0030] Referring now to FiGS.3-7, tubular members 120, 130 forming the needle 10 can be coupled by, for example, an interference fit. In particular, tubular members 120, 130 are sized such outer surface 121 of inner tubular member 120 positively engages inner surface 136 of outer tubular member 130 when inner tubular member 120 is coaxially disposed within outer tubular member 130. Consequently, tubular members 120, 130 do not move axially, radially, or rotationally relative to each other, and further, a fluid tight seal is formed between surfaces 121, 136. Although tubular members 120, 130 are described as being coupled by an interference fit, in general, tubular members 120, 130 may be coupled any suitable coupler mechanism including, without limitation, an interference fit, bonding, an adhesive, means for coupling, or combinations thereof.

[0031] Outer surface 121 of inner tubular member 120 includes a continuous recess 140 that defines a flow passage 145 between tubular members 120, 130. Flow passage 145 includes a flow inlet 145a, a flow outlet 145b, and a midsection 145c extending between inlet 145a and outlet 145b. Midsection 145c defines a generally tortuous flow path that weaves circumferentially back and forth along outer surface 121 generally perpendicular to central axis 15 towards distal tip 125. hi this embodiment, flow passage 145 has a substantially uniform width W and a generally rectangular cross-section. However, in general, the flow passage {e.g., flow passage 145) may have any suitable width {e.g., variable width) and any suitable cross-sectional shape {e.g., rectangular, curved, hemispherical, etc.). [0032] Turning now to FiG. 8, a cross-sectional view of an embodiment of the invention is illustrated wherein a needle 10 is incorporated with, for example, a standard syringe 100 which is connected to a pump 154 and a temperature controller 156. The needle 10 is removably attachable to the standard syringe via, for example, a Luer lock 152. The temperature controller 156 can be a device adapted to heat and/or cool a substance for delivery through the flow passage 145 of the needle 10. In alternative embodiments, the needle is permanently attachable. Additionally, the temperature controller and heat and/or cooler can be configured such that it is incorporated within the needle 10 and/or the syringe. [0033] Turning now to FlG. 9, a cross-sectional view of a distal tip of a needle connected to a pump 154, such as a circulating pump or suitable means for pumping a material, and a temperature controller 156, or suitable means for controlling temperature, is illustrated. Similar to previous embodiments, the temperature controller 156 can be a device adapted to heat and/or cool a substance or material, such as a fluid, for delivery through the flow passage 145 of the needle 10.

[0034] FiGS. 10A-D are cross-sectional views of a catheter adapted for use in combination with a needle similar to FiG. 3. The catheter provides a proximal control mechanism for controlling and operating the needle. The cross-sectional view of FIGS. 1OA-B illustrate an outer jacket 162 and an inner jacket 164 of the catheter along with the fluid flow path 145. The cross-sectional view of FiG. 10c illustrates an outer jacket 162 and an inner jacket 164, separated from the outer jacket, of a catheter along with an interiorly positioned fluid flow path 145'. Fluid travels down a central channel 151 and then reverses direction through a flow path 145 \ As will be appreciated by those skilled in the art, the system can be configured such that the fluid flows down the flow path 145' and then returns via the central channel 151. Turning to FIG. 1OD, the system can be configured as a dual temperature control channel system where, for example, a fluid flow path 145 is provided between an outer jacket 162, and in inner jacket 164. Additionally, a central channel 151 is provided that is adapted and configured to allow fluid flow. As described above, the dual fluid flow path system (145, 145') can be configured such that one path provides a cooling material while the secondary path provides a heating material. Alternatively, both paths can deliver cooling material or heating material. Moreover, the system can be configured such that cooling or heating material is delivered for a period of time followed by delivery of a material having the opposite property for a second period of time. [0035] FIGS. 11A-D are cross-sectional views of catheters shown in FIGS. 10A-D, showing the various fluid flow paths 145, 145'. [0036] II. METHODS OF USE

[0037] Syringe 10 can be operated as follows: Piston 16 is withdrawn from barrel 12 by grasping flange 14 and pulling pad 26 rearwardly. Delivery material is then inserted into barrel 12, e.g. via a delivery canister, after which piston 16 is reinserted and moved in the forward direction until it contacts the material or the delivery canister. Other methods of operating the syringe to deliver a delivery material can be employed without departing from the scope of the invention. As previously mentioned, circular nut 24 can be used as a metering indicator or to assist in generating more force on piston 16 although this is usually not necessary. After the desired amount of thermoplastic material has been extruded, the power supply is inactivated.

[0038] During use of the syringe, a temperature transfer fluid is flowed through flow passage 145 to control and regulate the temperature of tubular members 120, 130. In particular, the temperature transfer fluid can be delivered with the use of a pump and can heat or cool a material via a temperature controller to a desired temperature and then flowed into flow passage 145 via inlet 145a. The temperature controller can be adapted to receive energy from a suitable energy source, such as a battery, where energy is required to operate the temperature controller. In general, the temperature transfer fluid may be flowed to inlet 145a by any suitable mechanism such as by a flexible tubular (not shown) having on end connected to inlet 145a. As the temperature transfer fluid flows through midsection 145c, any temperature differential between the temperature transfer fluid and tubular members 120, 130 will result in conductive and/or convective heat transfer between the temperature transfer fluid and tubular members 120, 130. If the temperature of the temperature transfer fluid is greater than the temperature of tubular members 120, 130, thermal energy will flow from the temperature transfer fluid into tubular members 120, 130, thereby increasing the temperature of tubular members 120, 130 and decreasing the temperature of the temperature transfer fluid. After transferring some of its thermal energy to tubular members 120, 130, the temperature transfer fluid exits flow passage 145 at outlet 145b. On the other hand, if the temperature of the temperature transfer fluid is less than the temperature of tubular members 120, 130, thermal energy will flow from tubular members 120, 130 into the temperature transfer fluid, thereby decreasing the temperature of tubular members 120, 130 and increasing the temperature of the temperature transfer fluid. After taking some of the thermal energy from tubular members 120, 130, the warmed temperature transfer fluid exits flow passage 145 at outlet 145b. In general, the temperature transfer fluid may be flowed from outlet 145b by any suitable means such as by a flexible tubular (not shown) having on end connected to outlet 145b. Upon exiting outlet 145b needle 10, the temperature of the cooled or warmed temperature transfer fluid may be adjusted (e.g., reheated or cooled) as desired external to needle 10, and then re-circulated back into inlet 145a. This process may be repeated to regulate the temperature of members 120, 130. Since needle 10 includes a mechanism for transferring thermal energy between two substances (e.g. , the temperature transfer fluid and tubular members 120, 130), needle 10 may be described as comprising a heat exchanger. It should be appreciated that the tortuous path defined by midsection 145c increases the contact surface area between tubular members 120, 130 and the temperature transfer fluid, thereby offering the potential to enhance the heat transfer therebetween.

[0039] As previously described, embodiments described herein can be configured to include a temperature controller configured to control and regulate the temperature of tubular members 120, 130, and hence, needle 10 prior to an after insertion into a patient. However, it should also be appreciated that by controlling and regulating the temperature of members 120, 130, any substance or medium in bore 150 and/or proximal tip 112 may also be regulated. More specifically, any temperature differential between inner tubular members 120 and a medium or substance within bore 150 will result in conductive and/or convective heat transfer therebetween and associated temperature changes. Likewise, any temperature differential between tubular members 120, 130 and a medium or substance proximal tip 112 will result in conductive and/or convective heat transfer therebetween and localized cooling or heating proximal needle distal tip 112. In this manner, embodiments described herein offer the potential to control and regulate the temperature of tubular member 120, 130, as well as any substance or medium within bore 150 and/or proximal tip 112. As will be appreciated by those skilled in the art, the needle configurations can be adapted to be applied and operated with a variety of proximal and deployment mechanisms, including the syringe and catheter configurations described above. [0040] Although needle 10 may be employed to inject and/or withdraw any substance into/from a patient via bore 150, embodiments of needle 10 are particularly suited for use in injecting and/or withdrawing a thermally sensitive substance that changes phase and/or viscosity at a predetermined temperature. For instance, U.S. Patent Pubs. US 2006/0036272 and US 2007/0276390 describe procedures that employ such temperature sensitive substances. In some cases, it may be desirable to utilize a thermally sensitive substance that has a relatively low viscosity at ambient temperature and a higher viscosity at body temperatures. One example of such an injectable substance or medium is Omnipaque® 240 available from Nycomed, New York. Alternatively, in other cases, it may be desirable to utilize a thermally sensitive substance that has a relatively high viscosity at ambient temperature and a lower viscosity at body temperatures. In either case, it may be desirable to limit and/or prevent the viscosity change until the temperature sensitive substance is disposed at the desired location in the body. However, in many conventional hypodermic needles, the temperature of the distal tip is not controlled at all, or may be insufficiently controlled. Consequently, upon insertion into the patient, the needle is warmed by thermal energy transferred from the patient's tissue immediately surrounding the needle. Although the thermally sensitive substance may be at an ambient temperature prior to injection, as it flows through the warmed needle, it may acquire sufficient thermal energy from the needle to undesirably change phase and/or viscosity before reaching its target location in the patient. However, by controlling and regulating the temperature of tubular members 120, 130, even after insertion into the patient, embodiments described herein offer the potential to reduce the likelihood of a phase and/or viscosity change before the thermally sensitive substance reaches its target.

[0041] For some procedures, it may be desirable to trigger a phase and/or viscosity change of a thermally sensitive substance while it is in the patient to facilitate withdrawal from the patient. For instance, when utilizing a thermally sensitive substance that has a relatively high viscosity at body temperatures and a low viscosity at ambient temperatures, it may be desirable to cool the substance and reduce its viscosity to facilitate withdrawal with a hypodermic needle. Unlike many conventional hypodermic needles, the temperature of distal tip 112 of needle 10 may be controlled and regulated after insertion into the patient to enable localized heating or cooling in the patient proximal distal tip 112. For instance, distal tip 112 may be positioned adjacent to the thermally sensitive substance in the patient, and then cooled to reduce the temperature of the substance sufficiently to trigger a viscosity reduction and easier withdrawal through bore 150.

[0042] In general, the temperature transfer fluid may comprise any suitable fluid including, without limitation, water or a water based solution (e.g. , alcohol and water mixture), a saline solution, a glycol based liquid (e.g. propylene glycol), or combinations thereof. Preferably, the temperature transfer fluid has a freezing point below 32° F and a boiling point above 212° F. In some embodiments, the temperature transfer fluid may have a pressure above or below ambient. As previously described, flow passage 145 is preferably sealed such that the temperature transfer fluid is restricted from contaminating the substance in bore 150 and/or the patient within which needle 10 is disposed. However, to minimize any potential risk of injury resulting from an inadvertent injection of the temperature transfer fluid into the patient, the temperature transfer fluid may comprise purely biocompatible substances.

III. MANUFACTURE

[0043] The components of needle 10 (e.g., inner tubular member 120, outer tubular member ISO, etc.) may comprise any suitable materials, or combination of suitable materials, including, without limitation, metals, metal alloys, non-metals, composites, or combinations thereof. The components of needle 10 are preferably made from biocompatible materials suitable for insertion into a patient such as 400 series stainless steel (SS), 17 series SS, and 300 series SS, or nickel titanium alloy (e.g., Nitinol). Further, the various components of needle 10 may be extruded, machined, cast, molded, laser cut, Electronic Discharge Machining ("EMD"), etc. In some embodiments, electro polishing is used to sharpen certain parts, such as beveled needle tip 112. Surface treatments such as diamond knurl, sand blasting, bead blasting, media blasting, plasma etching, etc. may also be used. [0044] Although flow passage 145 is defined by recess 140 on outer surface 121 of inner tubular member 120 in this embodiment, in other embodiments, the recess (e.g., recess 140) defining the flow passage (e.g., flow passage 145) may be disposed at other suitable locations such as on the inner surface (e.g., inner surface 136) of the outer tubular member (e.g., outer tubular member 130). Further, in other embodiments, the flow passage may be defined by a separate component or conduit that is connected to the inner surface of the needle, the outer surface of the needle, or between the walls of a double-walled needle.

IV. KITS

[0045] The hypodermic needle described above can be included in a kit. Suitable kits comprise, for example, one or more of the needle devices disclosed herein and packaging. Additional components include at least one of a standard syringe, a catheter. Moreover, the kits can be sterilized as part of the packaging processing using known techniques. Additional components of suitable kits include, but are not limited to, for example, one or more injectable media, such as a contrast medium; one or more hydrophilic-lipophilic block copolymer gels; one or more temperature transfer fluids. [0046] While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

CLAIMSWHAT IS CLAIMED IS:

1. A needle comprising: a first tubular member having a first tubular member lumen; a second tubular member coaxially disposed within the first tubular member lumen having a second tubular member lumen therein; and a flow passage formed between the first and the second tubular members.

2. The needle of claim 1 wherein the needle further comprises a second flow passage.

3. The needle of any of the preceding claims wherein the radial outer surface of the second tubular member engages the radial inner surface of the first tubular member.

4. The needle of any of the preceding claims wherein the second tubular member is fixed to the first tubular member by an interference fit.

5. The needle of claim 4 wherein the second tubular member comprises a recess on its outer radial surface that defines the flow passage.

6. The needle of any of the preceding claims wherein the flow passage formed between the first and second tubular members is adapted to receive a thermally conductive material.

7. The needle of claim 6 wherein the thermally conductive material transfers heat to a second tubular member lumen.

8. The needle of claim 7 wherein the heat transferred to the second tubular member lumen heats a material disposed within the second tubular member lumen.

9. The needle of claim 6 wherein the thermally conductive material transfers heat from a second tubular member lumen.

10. The needle of claim 9 wherein the heat transferred from the second tubular member lumen cools a material disposed within the second tubular member lumen.

11. The needle of any of the preceding claims further comprising a temperature controller.

12. The needle of any of the preceding claims wherein the needle is adapted to engage a catheter.

13. The needle of any of the preceding claims wherein the needle is adapted to engage a syringe.

14. A method for delivering a temperature controllable material comprising: delivering a needle having a first tubular member having a first tubular member lumen, a second tubular member coaxially disposed within the first tubular member lumen having a second tubular member lumen therein; and a flow passage formed between the first and the second tubular members; delivering a temperature transfer fluid through the flow passage; delivering a delivery material through the second tubular member lumen; and controlling a temperature of the delivery material by the temperature transfer fluid.

15. The method for delivering a temperature controllable material of claim 14 further comprising the step of activating a temperature controller to heat a temperature transfer material.

16. The method for delivering a temperature controllable material of claim 15 wherein the step of activating the temperature controller to heat the heat transfer material is performed prior to the step of delivering a temperature transfer fluid through the flow passage.

17. The method for delivering a temperature controllable material of claim 15 further comprising the step of activating a temperature controller to cool a heat transfer material.

18. The method for delivering a temperature controllable material of claim 17 wherein the step of activating the temperature controller to cool the heat transfer material is performed prior to the step of delivering a temperature transfer fluid through the flow passage.

19. The method for delivering a temperature controllable material of claim 14 wherein the delivered material has a first temperature at a proximal end of the first tubular member and a second temperature at a distal end of the first tubular member.

20. The method for delivering a temperature controllable material of claim 15 further comprising the steps of variably activating a temperature controller to heat or a transfer material.

21. The method for delivering a temperature controllable material of claim 15 further comprising the steps of delivering a second temperature transfer fluid through a second flow passage.

22. The method for delivering a temperature controllable material of claim 21 further comprising the step of controlling a temperature of the second temperature transfer fluid independently of the step of controlling the temperature transfer fluid.

23. A kit comprising a needle having a first tubular member having a first tubular member lumen; a second tubular member coaxially disposed within the first tubular member lumen having a second tubular member lumen therein; and a flow passage formed between the first and the second tubular members.

24. A kit of claim 23 further comprising one or more temperature controllable materials.

25. A kit of claim 23 further comprising a catheter.

26. A kit of claim 23 comprising a removable syringe.