WO2013103364A1

WO2013103364A1 - Method of manufacturing a needle and a needle for reducing a force, such as for a non-coring port access needle or a spinal needle

Info

Publication number: WO2013103364A1
Application number: PCT/US2012/031194
Authority: WO
Inventors: Anthony C. Arrigo; Donald D. Solomon
Original assignee: Arrigo Anthony C; Solomon Donald D
Priority date: 2012-01-05
Filing date: 2012-03-29
Publication date: 2013-07-11

Abstract

A method of manufacturing a needle includes diluting a lubricant, that is biocompatible and soluble in a solvent, with a solvent, that includes one of an aliphatic hydrocarbon, an aromatic hydrocarbon and a chlorinated solvent; mixing the lubricant and the solvent to obtain a coating; and inserting a needle into a container housing the coating. The needle may include a hollow tube. When the needle is inserted into the container housing the coating, at least a portion of the hollow tube may be covered with the coating. A needle for reducing a force during insertion in a body includes a hollow tube configured to enter a body and a coating coupled to at least a portion of the hollow tube. The coating comprises a lubricant that is biocompatible and is soluble in a solvent and a solvent including one of an aliphatic hydrocarbon, an aromatic hydrocarbon and a chlorinated solvent.

Description

METHOD OF M ANUFACTURING A NEEDLE AND A NEEDLE FOR REDUCING A FORCE, SUCH AS FOR A NON-CORING PORT ACCESS

NEEDLE OR A SPINAL NEEDLE

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 61/583,460, filed January 5, 2012, and the entire disclosure of which is hereby incorporated by reference herein in its entirety.

BACKGROUND

Field of Embodiments

[0002] The disclosed embodiments relate generally to a method of manufacturing a needle and a needle for reducing a force during insertion in a body.

Description of Related Art

(0003] Needles are often inserted into the body during medical procedures for therapeutic and diagnostic purposes. The needles may cause discomfort to a patient when the needle enters or leaves the patient's body. Such discomfort can result from the force exerted by the needles during insertion and/or retraction of the needle into the body due to friction between the surface of the needle and the part of the body with which the needle interacts when entering the body. Additionally, it may be difficult to insert the needles. Difficulty in insertion may occur due to interaction of the needle with other media through which it needs to pass, such as a port.

[0004] A need exists for improved technology that solves one or more of the

aforementioned problems.

SUMMARY

[0005] According to one embodiment, a method of manufacturing a needle comprises diluting a lubricant, that is biocompatible and soluble in a solvent, with a solvent. The solvent may comprise one of an aliphatic hydrocarbon, an aromatic hydrocarbon and a chlorinated solvent. The method may also comprise mixing the lubricant and the solvent to obtain a coating and inserting a needle into a container housing the coating. The needle may include a hollow tube. When the needle is inserted into the container housing the coating, at least a portion of the hollow tube may be covered with the coating.

|OO06] According to yet another embodiment, a needle for reducing a force during insertion in a body comprises a hollow tube and a coating. The hollow tube is configured to enter a body. The coating is coupled to at least a portion of the hollow tube. The coating comprises a lubricant that is biocompatible and is soluble in a solvent and a solvent. The solvent comprises one of an aliphatic hydrocarbon, an aromatic hydrocarbon and a chlorinated solvent.

BRIEF DESCRIPTION OF THE DRAWINGS

[0007] These and other features, aspects and advantages of the disclosed embodiments will become apparent from the following description, appended claims and the accompanying drawings, which are briefly described below.

[0008] Figure 1 is a side view of a needle and a container that contains a coating.

[0009] Figure 2 is a side view of the needle and container of Figure 1 and an attachment mechanism before being attached to the needle.

[0010J Figure 3 is a side view of the needle and container of Figures 1 -2 after the needle is attached to the attachment mechanism.

[0011] Figure 4 is a side view of the needle, container and attachment mechanism of Figures 3 after a sheath is removed from the needle.

[0012] Figure 5 is a side view of the needle, container and attachment mechanism of Figure

4 before the needle is coated with the coating.

[0013] Figure 6 is a side view of the needle, container and attachment mechanism of Figure

5 as the needle is inserted into the coating. [0014] Figure 7 is a side view of the needle, container and attachment mechanism of Figure

6 when a substantial portion of the needle is inserted into the coating.

[0015] Figure 8 is a side view of the needle, container and attachment mechanism of Figure

7 after the needle is removed from the coating.

[0016] Figure 9 is a side perspective view of a rack holding a plurality of needles.

[0017] Figure 10 is a top perspective view of a needle.

[0018] Figure 1 1 is a top perspective view of the needle of Figure 10 after a sheath is removed from the needle.

[0019] Figure 12 is a side view of a portion of the needle of Figure 10 attached to an attachment mechanism.

[0020] Figure 13 is a side view of a portion of the needle and attachment mechanism of Figure 12 as the needle is coated with a coating in a container.

[0021] Figure 14 is a side view of a portion of the needle of Figure 10 and a port before the needle punctures a septum of the port.

[0022] Figure 15 is a side view of a portion of the needle of Figure 10 and a port while the needle punctures a septum of the port.

[0023] Figure 16 is a top perspective view of the port of Figure 14.

[0024] Figure 17 is a top view of the port of Figure 14.

[0025] Figure 18 is a table showing the maximum load and average force for various non- coated non-coring port access needles.

[0026] Figure 19 is a table showing the maximum load and average force for various coated non-coring port access needles.

[0027] Figure 20 is a graph comparing the results of Figures 18 and 19.

[0028] Figure 21 is a top view of a needle and catheter.

[0029] Figure 22 is a top view of the needle and catheter of Figure 21 when the catheter is inserted into the needle and the needle includes a sheath. (0030] Figure 23 is a top view of the needle and catheter of Figure 22 after the sheath is removed.

[0031 ] Figure 24 is a top view of the bevel of the needle of Figure 23.

10032 J Figure 25 is a table with data comparing coated spinal needles to non-coated spinal needles.

[00331 Figure 26 is a chart showing some of the data presented in Figure 25.

DETAI LED DESCRIPTION

[0034] Embodiments are illustrated in the drawings. An effort has been made to use the same or like reference numbers throughout the drawings to refer to the same or like parts. The disclosure relates to a method of manufacturing a needle and a needle for reducing a force (i.e. penetration, drag, insertion, retraction force) during insertion in a body. A needle may be coated with a coating to ensure that the needle causes little to no discomfort to a patient when the needle enters the body or to otherwise facilitate insertion of the needle so as to reduce a force exerted on the material with which it interacts during insertion into the body. While the disclosure specifically discusses non-coring port access needles (e.g. a huber non-coring needle, a chemotherapy needle) and a spinal needle (e.g. a quincke needle), the needle may be any suitable needle. For example, the needle may include a guide wire introducer needle, a biopsy needle for cells such as histology needles or a biopsy needle for soft tissue.

[0035] As shown in Figures 1 -17 and 21 -24, a needle 1 , 101 , 201 for reducing a force exerted on a the body may include a hollow tube 2, 102, 202 (e.g. cannula) configured to enter a body and a coating 6 coupled (i.e. that adheres) to at least a portion of the hollow tube 2, 102, 202. The body may be a part of the body or any other suitable material. The part of the body may be the spine, an arm or a leg. Other suitable material may be a port.

[0036[ The hollow tube 2, 102, 202 may include an inner hollow tube portion surface (e.g. inner cannula surface) and an outer hollow tube portion surface 17, 1 17, 217 (e.g. outer cannula surface), such that the hollow tube first portion 3, 103, 203 and the hollow tube second portion 4, 104, 204 may have a common outer hollow portion surface 17, 1 17, 217 (Figures 8, 1 1 and 21 ) and a common inner hollow tube portion surface (not shown). The inner and outer hollow tube portion surfaces may extend along a substantial or entire length of the hollow tube 2, 102, 202. The coating 6 may adhere (e.g. couple) to the outer hollow tube portion 17, 1 17, 217 and not the inner hollow tube portion surface to prevent contamination of the inner hollow tube portion surface and/or an element within, or configured to be received by, the inner hollow tube portion surface.

(0037] As shown in Figures 5, 7-8, 13 and 21 , the hollow tube 2, 102, 202 may include a first hollow tube portion 3, 103, 203 (e.g. first cannula portion) and a second hollow tube portion 4, 104, 204 (e.g. second cannula portion). The first hollow tube portion 3, 103, 203 is located on that portion of the needle 1 , 101 , 201 that is the closest to a person or mechanism holding the needle when the needle enters a body. The second hollow tube portion 4, 104, 204 may extend from the first hollow tube portion 3, 103, 203 and may be configured to enter a body.

[0038] The first and second hollow tube portions 3, 4, 103, 104, 203, 204 may be made of any suitable material. For example, the first and second hollow tube portions 3, 4, 103, 104, 203, 204 may comprise a 304, 304L, 316, 316L stainless steel hypodermic tube or any other suitable material used to manufacture a needle, such as for instance nitinol. The first and second hollow tube portions 3, 4, 103, 104, 203, 204 may comprise the same or different materials. Preferably, the first and second hollow tube portions 3, 4, 103, 104, 203, 204 comprise the same material and are integral.

[0039] As shown in Figures 5, 1 1 and 21 , the second hollow tube portion 4, 104, 204 may include a tissue piercing tip segment 15, 115, 215 (e.g. cannula tip portion). The tissue piercing tip segment 15, 1 15, 215 may be curved (Figure 1 1) or straight (Figures 5 and 21) such that the tissue piercing tip segment 15, 1 15, 215 does not or does extend along the same axis as the hollow tube first portion 3, 103, 203. The tissue piercing tip segment 15, 115, 215 is on the end of the second hollow tube portion 4, 104, 204 that is most distal from the first hollow tube portion 3, 103, 203 so that the tissue piercing tip segment 15, 1 15, 215 is the first part of the needle 1 , 101 , 201 that enters the body.

[0040] As shown in Figure 24, the second hollow tube portion 4, 104, 204 may also include a bevel 21 1. The bevel 21 1 may include a pair of substantially parallel or parallel extending sides 248, the tissue piercing tip segment 15, 1 15, 215 and a heel segment 242. The sides 248 may connect the tissue piercing tip segment 1 15, 215 to the heel segment 242.

[0041] The tissue piercing tip segment 15, 1 1 5, 21 5 and the bevel 21 1 may comprise any suitable material. For example, the tissue piercing tip segment 1 5, 1 15, 215 may comprise a 304, 304L, 3 1 6, 31 6L stainless steel hypodermic tube or any other suitable material used to manufacture a needle, such as for instance nitinol. The tissue piercing tip segment 15, 1 15, 21 5 and bevel 21 1 may comprise the same material or a different material from the first hollow tip portion 3, 1 03, 203 and/or second hollow tube portion 4, 104, 204. Preferably, the tip portion 15, 1 15, 215 and bevel 21 1 comprise the same material as the first and second hollow tube portions 3, 4, 103, 1 04, 203, 204 and are integral with the first and second hollow tube portions 3, 4, 103, 104, 203, 204.

[0042] The hollow tube 2, 102, 202 may be any suitable size and may be configured to receive any suitable element, such as a catheter 2 1 I (Figures 21 -22), catheter-like device or guide-wire. For example, the hollow tube 2, 102, 202 may be a 1 8-24 gauge needle.

[0043] The coating 6 coupled to the hollow tube 2, 102, 202 may be coupled to the second hollow tube portion 4, 104, 204. When coupled to the second hollow tube portion 4, 104, 204, the coating 6 may not couple to the first hollow tube portion 3, 1 03, 203. As the second hollow tube portion 4, 104, 204 includes the tip portion 15, 1 1 5, 215, the coating may also be coupled to the tip portion 1 5, 1 15, 215. The first hollow tube portion 3, 103, 203 may be approximately 6.35 mm (i.e. approximately a ¼ inch) long so that approximately 6.35 mm of the hollow tube portion 2, 102, 102 (i.e. the first hollow tube portion 3 , 103, 203) is not coupled to the coating. The first hollow tube portion 3, 1 03, 203 may not be covered with the coating 6 because the first hollow tube portion 3, 103, 203 generally does not enter a body. Alternatively, the coating 6 may couple to some or all the first and second hollow tube portions 3, 103, 203, 4, 104, 204.

[0044] The coating 6 (Figures 1 -5, 7-8 and 13) may include any coating capable of decreasing the frictional resistance between a needle and the body where the needle is inserted and/or retracted. Preferably, the frictional resistance of the coated needle, such as the coated needles described herein, is reduced by as much as 90 to 95% relative to an uncoated needle. 100451 The coating 6 may include a lubricant. The lubricant may be any lubricant that preferably has one or more characteristics. The characteristics include (1) having a high molecular weight to prevent the lubricant from migrating away from the needle once the needle enters the body, (2) having the ability to cling to the surface of the needle that is being coated with the lubricant to help prevent leakage of the lubricant in the body, (3) being biocompatible, (4) being soluble in a solvent with an easy flash point and (5) performing within at least 25% less penetration/drag/insertion force when a standard lubricity test is undergone to determine the lubricity properties of the lubricant using an instron type measuring system. Any suitable lubricant may be used. A presently pre erred lubricant is silicone, such as NuSil MED-4162 medical grade silicone fluid, or another type of viscous polymer. Other suitable lubricants may be used.

[0046] The coating 6 may also include a solvent. The solvent may be any solvent that is capable of diluting the lubricant. The solvent may be used to dilute the lubricant so that the lubricant can evenly coat (e.g couple to, adhere to) the needle without leaving voids or uneven surfaces of coating on the needle. Examples of a solvent include one of an aliphatic hydrocarbon, an aromatic hydrocarbon and a chlorinated solvent. A presently preferred solvent is hexane, such as an aliphatic hydrocarbon that comprises hexane.

[0047] The solvent may include a first solvent and a second solvent. The second solvent may be different from the first solvent. The second solvent may be any suitable solvent. The second solvent may include one of an aliphatic hydrocarbon, an aromatic hydrocarbon and a chlorinated solvent.

[0048] The needle may be one of a spinal needle (Figures 21-24) and a non-coring port access needle (Figures 10-15). The non-coring port access needle 101 (Figures 12-15) may be a huber (non-coring) needle or a chemotherapy needle. The non-coring port access needle, such as a huber needle, may be a hollow needle with a tip designed to pierce through a person's skin and the septum 120 (Figures 14-17) of a port 121 (Figures 14-17) without removing a core, of for example silicone, from the port 121. The port 121 includes the septum 120. As shown in Figure 15, the septum 120 receives the non-coring port access needle 101. The port l21 is usually surgically inserted under a person's skin. Together, the non-coring port access needle 101 and the port 121 can deliver things, such as chemotherapy drags, vitamins and medications, to a patient. The spinal needle 201 (Figures 21 -24) may be any spinal needle with a bevel (Figures 23-24) that is configured to receive a catheter 21 1 or catheter-like device (Figures 21-23). The needle may also be another type of needle, such as a guide wire introducer needle (Figures 1 -8) or a biopsy needle.

[0049) The needle 1 , 101 , 201 may include a sheath 9, 109, 209 (Figures 3, 10 and 22) configured to cover the hollow tube 2, 102, 202 and to prevent the needle 1 , 101 , 201 from becoming contaminated before and/or after the coating 6 couples to the hollow tube 2, 102, 202. The sheath 9, 109, 209 is typically removed from the needle 1 , 101 , 201 before the needle 1 , 101 , 201 is dipped into the coating 6 and placed back on the needle 1 , 101 , 201 after the coating 6 dries on the needle 1 , 101 , 201. The sheath 9, 109, 209 also would typically be removed before use of the needle 1 , 101 , 201 (i.e. before the needle 1 , 101 , 201 enters a body). In the case of a needle that receives an object, such as a spinal needle 201 that receives a catheter 21 1 or catheter-like device or a guide wire introducer needle 1 that includes a guide-wire, the object may be inserted into the needle 1 , 101 , 201 before or after the sheath 9, 109, 209 covers the needle 1, 101 , 201.

[0050] A method of manufacturing a needle 1 , 101 , 201 may include diluting a lubricant, such as a lubricant having one or more of the characteristics discussed in paragraph [0045], with a solvent, such as the solvent discussed in paragraphs [0046] - [0047]. The lubricant may be diluted with the solvent a plurality of times using any suitable method. The method of diluting the lubricant one time, such as a first time, may be different from diluting the solvent another time, such as a second time.

[0051] The first time that the lubricant is diluted with the solvent, the lubricant may be diluted to obtain a concentration of lubricant of approximately 40% to 60% (or 40% to 60%). For example, the lubricant may be diluted with a solvent to obtain a concentration of lubricant of approximately 50% (or 50%). To obtain a concentration of lubricant of approximately 40% to 60%, the lubricant may be poured from a first container (e.g. first container housing) to a second container (e.g. second container housing) and, once in the second container, solvent may be poured into the first and then second container. The lubricant is preferably slowly poured into the second container and is not heated at any time. Heating may reduce the viscosity of the lubricant. [0052] Solvent may be poured from the first container to the second container at least one time. For example, if the solvent is poured from the first to second container more than once, the solvent may be poured five times, such that a first batch of solvent is poured from the first to second container, then a second batch of solvent is poured from the first to second container, and so on until a fifth batch of solvent is poured from the first to second container.

[0053| The second container may be at least two times the size of the first container and the first and second containers may be any suitable container. For example, the second container may be 2.5 times the size of the first container such that if the first container holds 100 ml of liquid, the second container holds at least a quart of liquid. Moreover, the first container may be a graduated cylinder and the second container may be a clean chemical glass container having a lid liner of any suitable material. For example, the material of the lid liner may be polyolefin. Preferably, the material of the lid liner is not paper because paper will not generally be able to withstand the viscosity of the lubricant.

[0054] During the first time that the lubricant is diluted with the solvent, any suitable amount of solvent may be poured into the second container to obtain the concentration of lubricant of approximately 40% to 60%. Any suitable amount of lubricant may be diluted with the solvent to obtain the concentration of lubricant of approximately 40% to 60%. For example, if the lubricant is diluted with the solvent to obtain an approximately 50% concentration, 200 ml of lubricant and 200 ml of solvent may be poured into the second container. Alternatively, 273.2 ml of lubricant and 273.2 ml of solvent may be poured into the second container. If small increments of the solvent are poured and the total amount of solvent eventually poured is 200 ml, the lubricant may be diluted with 40 ml of the solvent, then another 40 ml of the solvent and so on until 200 ml of the solvent have been poured into the lubricant. Alternatively, the entirety of the solvent may be poured from the first container to the second container one time. For example, if the total amount of solvent eventually poured is 200 ml, then all 200 ml may be poured once.

[0055] When pouring the solvent from the first to the second container, the solvent may be mixed in the first container before being poured into the second container. The mixing may occur by any suitable mechanism, such as shaking the first container. [0056] To ensure that the second container is clearly identified as containing the desired concentration of lubricant, such as approximately 50% concentration of lubricant, a label may be added to the second container. For example, when the desired concentration is approximately 50% concentration of lubricant, the label for the second container may say approximately 50% concentration of lubricant.

[0057] The second time that the lubricant is diluted with the solvent, the lubricant may be diluted to obtain a concentration of lubricant of approximately 4% to 6% (or 4% to 6%). For example, the second time that the lubricant is diluted with the solvent, the lubricant may be diluted to obtain approximately a 5% concentration (or 5%) of lubricant. An example of the 5% concentration of lubricant formula is [( 1 0 ml of 50% concentration lubricant) ÷ (1 0 ml 50% concentration lubricant + 90 ml solvent)] x 100 x 0.5 (accounting for the 50%

concentration lubricant)].

[0058] The second time that the lubricant is diluted with the solvent, a syringe or other suitable device may be used to transfer some of the approximately 40% to 60%, such as 50%, concentration lubricant into the first container. Any suitable amount of the approximately 50% concentration of lubricant may be transferred to the first container. For example, approximately 10 ml of the approximately 50% concentration l ubricant may be transferred to the first container. The syringe that transfers the lubricant may be any suitable syringe. For example, the syringe may be a 20 ml luer slip plastic syringe. While transferring the lubricant to the syringe, care should be taken to avoid drawing bubbles into the syringe and lubricant.

[0059] After transferring some of the approximately 40% to 60%, such as 50%,

concentration lubricant into the first container, the 40% to 60% concentration lubricant may be diluted with the solvent, such as the solvent discussed in paragraphs [0046] - [0047]. The approximately 40% to 60% concentration lubricant may be diluted with the solvent until approximately 100 ml of lubricant and solvent is in the first container. Alternatively, more or less lubricant and solvent may be in the first container after the approximately 50%

concentration lubricant is diluted with the solvent. To obtain such an amount, the

approximately 40% to 60% concentration lubricant may be diluted with the solvent at least once. For example, the approximately 40% to 60% concentration lubricant may be diluted with the solvent four times, such that if the approximately 40% to 60 concentration lubricant is diluted with approximately 80 ml of solvent, the approximately 40% to 60 concentration lubricant is diluted with approximately 20 ml of solvent, then another 20 ml of solvent and so on until all 80 ml have been added.

[0060] The solvent may be transferred to the first container using the syringe that transferred the approximately 40% to 60%, such as 50%, concentration lubricant into the first container. The solvent transferred to the first container may initially be housed in a third container. The third container may be any suitable container. For example, the third container may be a 150 ml beaker.

[0061 J After diluting the lubricant with the solvent, the lubricant may be mixed with the solvent to obtain the coating 6. The resulting solution after mixing of the lubricant and solvent, such as the solution resulting after the lubricant di luted with the solvent the second time is mixed, is the coating 6. The lubricant is preferably mixed with the solvent until there are no "wavy" optical areas in the mixture. To ensure that there are no "wavy" optical areas, the lubricant may be mixed with the solvent for at least approximately 1.5 hours. If the lubricant is diluted a plurality of times, the lubricant and solvent may be mixed after one or more of these times. For example, if the lubricant is diluted twice, then the lubricant may be mixed after the first and/or second time.

[0062] The lubricant may be mixed with the solvent by stirring the lubricant and the solvent with one or more suitable mechanisms. For example, the lubricant and the solvent may be stirred by a bar. The bar may be a magnetic bar, such as a plastic encapsulated magnetic mixing bar, or a mixing rod, such as a 304.8 mm (i.e., 12 inch) glass mixing rod. If the bar is a magnetic bar, the magnetic bar may be placed in the container that houses the diluted lubricant and solvent and the container may be placed on a magnetic mixing plate so that the magnetic bar automatically stirs the diluted lubricant and solvent. If the bar is a mixing rod, the mixing rod may be manually stirred in the container that houses the diluted lubricant and solvent.

[0063] After stirring the lubricant and solvent, the resulting solution may be poured from the container housing the lubricant and solvent to another, clean container to ensure complete mixture of the lubricant and solvent. The resulting solution may be poured back-and-forth from the container housing the lubricant and solvent to the clean container more than once. Preferably, the resulting solution is poured from the container to another, clean container after the second time that the lubricant is diluted with the solvent and/or after using the mixing rod. The clean container may be any suitable container. For example, the clean container may be a 200 ml beaker.

[0064] Once the coating 6 is prepared, the container 5 (e.g. housing) that houses the coating 6 may be levelly secured so that it does not tip over and the needle 1 , 101 , 201 can be coated manually, such as by an operator, or automatically using mechanisms known to one skilled in the art. The container 5 may be levelly secured by placing the container 5 at a level that an operator can view so that the operator can clearly see or the machine can clearly detect how much of the needle 1 , 101 , 201 is immersed in the coating 6 when the needle 1 , 101 , 201 is inserted into the coating 6. The container 5 that houses the coating 6 may be the same container 5 that the lubricant and solvent were mixed in to obtain the coating 6 or a different container 5. If the container 5 is the same container 5, the container 5 may be covered by any suitable element to prev ent contamination of the coating 6 between when the coating 6 is prepared and used to coat a needle 1, 101 , 201. The suitable element may be any suitable element, such as aluminum foil. If the needle 1 , 101 , 201 is coated manually, the operator preferably wears non-latex gloves to coat the needle 1 , 101 , 201.

[0065] Once the coating 6 is prepared, a needle 1, 101 , 201 may be inserted into a container 5 (Figures 1 ,-2, 5, 7-8 and 13) housing the coating 6 to coat (e.g. cover) the hollow tube 2, 102, 202 with the coating 6. The coating 6 may only coat the second hollow tube portion 4, 104, 204 and not the first hollow tube portion 3, 103, 203. The needle 1 , 101 , 201 may be inserted into the coating 6 manually, such as by an operator, or automatically, such as by a machine.

[0066] When inserting the needle 1, 101, 201 into the coating 2, 102, 202, care may be taken to ensure that substantially only the outer hollow tube portion surface 17, 1 17, 217 of the hollow tube 2, 102, 202 is coated with the coating 6. In this way, the inner hollow tube portion of the hollow tube 2, 102, 202 and any element within the needle 1 , 101 , 201, such as a guide wire, catheter or catheter-like device, avoid being contaminated by being covered with the coating 6. 100671 To cause substantially only the outer hollow tube portion surface 17, 1 17, 217 (i.e. outside of the needle) to be coated, an attachment mechanism 7, 107 (Figures 2-4, 6, 8 and 13) may be attached to the needle 1 , 101 , 201 before and during coating of the hollow tube portion 4, 104, 204. The attachment mechanism 7, 107 (Figures 2-4, 6, 8 and 13) may be any suitable mechanism that is configured to prevent the coating 6, 106 from entering an inner hollow tube portion surface (i.e. inside) of the hollow tube 2, 102, 202 of the needle 1 , 101 , 201 after the attachment mechanism 7, 107 attaches to the needle 1 , 101 , 201. For example, the attachment mechanism 7, 107 may be a syringe, such as a 10 ml luer slip plastic syringe (Figures 2-4, 6, 8 and 13). If the attachment mechanism 7, 107 is a syringe, the attachment mechanism 7, 107 may attach to an end 9, 191 , 291 (Figures 2, 5, 13 and 21 ) of the needle 1, 101 , 201 that is distal from the second hollow tube portion 4, 101 , 204. For example, the attachment mechanism 7, 107 may attach to a hub 8, 108, 208 (Figures 3, 8, 1 1-12 and 21) of the needle 1 , 101 , 201. Alternatively, the attachment mechanism may be any other mechanism that maintains air or other fluid within the inside of the needle 1 , 101 , 201 to prevent any substantial amount of coating 6 from contaminating the inside of the needle 1, 101 , 201. Preferably, the attachment mechanism 7, 107 attaches to the end 9, 191 , 291 of the needle 1 , 101 , 201 .

[0068] The attachment mechanism 7, 107 may be attached to the needle 1 , 101 , 201 at any time prior to when the second hollow tube portion 4, 104, 204 enters the coating 6. For example, the attachment mechanism 7, 107 may be attached to the needle 1 , 101 , 201 before or after the needle 1 , 101 , 201 enters the container 5 housing the coating 6.

[0069] To ensure that the attachment mechanism 7, 107 prevents the coating 6 from entering the inner hollow tube portion surface, the attachment mechanism 7, 107 may not be detached from the needle 1 , 101 , 201 until after the hollow tube 2, 102, 202 portion coated with the coating 6 (i.e. inserted into the coating 6), such as the second hollow tube portion 4, 104, 204, is removed from the coating. The detachment may occur before or after the portion of the hollow tube 2, 102, 202 coated with the coating 6 exits the container 5 housing the coating 6.

[0070] The portion of the hollow tube 2, 102 inserted into the coating 6 may be removed from the coating 6 with a smooth, but rapid upward motion to prevent excess coating 6 from depositing on the needle 1 , 101 , 201. Preferably, the portion of the hollow tube 2, 102 being coated with the coating 6 remains in the coating 6 for no longer than approximately 5 seconds before it is removed from the coating 6.

100711 After the needle 1 , 101 , 201 is coated with the coating 6, the needle 1 , 101 , 201 may be placed in a holding mechanism 10 (Figure 9) to permit drying, and therefore coupling, of the coating 6, 106 to the needle 1 , 101 , 201 and to allow any excess coating 6 to fall off the needle 1 , 101 , 201. The holding mechanism 10 may be any mechanism capable of holding the needle 1 , 101 , 201 upright and of providing an area in which a flat part of the needle 1 , 101 , 201 can rest so that the needle 1 , 101 , 201 stably rests on the holding mechanism 10. For example, the holding mechanism 10 may be a holding rack 10 (e.g. rack). Drying of the coating 6 to the needle 1 , 101 , 201 may take at least approximately 10 minutes.

[0072] The process of coating a needle can be repeated, such that subsequent needles are coated in the same coating 6 separately or simultaneously. Preferably, the coating 6 is discarded after approximately 15,000 needles 1 , 101 , 201 are coated with the coating 6 or after three shifts. Regardless of the number of needles 1 , 101 , 201 coated, needles should not be placed into the coating 6 to be coated if the coating has remained dormant for more than 8 hours. If the coating 6 remains dormant for more than 8 hours, the solvent and the lubricant may separate, thereby preventing the coating 6 from evenly coating the needle 1 , 101 , 201. After the coating 6 remains dormant for more than 8 hours, the coating 6 should be discarded and a new coating 6 can be made. If the process of coating a needle 1 , 101 , 201 is repeated, one or more holding mechanisms 10 may be used to hold the needles 1 , 101 , 201. The filled holding mechanism(s) 10 may be placed in a different area from the needles 1 , 101 , 201 to be coated to prevent contamination of the coated needles with the non-coated needles. During the coating process, an exhaust mechanism (e.g. exhaust hood) may be placed over the area where the needles are coated and/or where the coating is prepared.

[0073] If the same coating 6 is used for more than one shift, such as for three shifts, solvent may be added to the coating 6 after each shift. For example, if the coating 6 starts with approximately 100 ml of coating, the amount of solvent added to the coating 6 may be enough so that approximately 100 ml of coating remains in the container 6, 106. After adding solvent, the coating 6 may be transferred to another container (e.g. a glass bottle) with a cover (e.g. a screw cap) rated for organic solvents. Preferably, the cover does not have a paper lid liner. If the coating 6 is transferred to another container, the container previously housing the coating may be covered by a cover configured to keep out contaminants, such as an aluminum foil cover.

1007 1 If the same coating 6 is used for more than one shift, the date and total number of needles coated with the coating 6, as well as the lot number of the lubricant and/or the expiration date of the lubricant, may be recorded at the end of each shift. The

aforementioned infomiation may be recorded on the container housing the coating 6. If the same coating is used for more than one shift, the container housing the coating may be cleaned and dried after at least every 5 shifts. If the same coating is used for more than one shift, the coating must be checked before each shift to make sure that the coating can be reused.

[0075] As shown in Figures 18-20, coated non-coring port access needles lb- 10b exert less force (i.e. penetration/insertion/drag force) than non-coated non-coring port access needles 1 a- 10a. The penetration/insertion/drag force is the force measured when the needle first enters the body or after a portion of the needle has entered the body. Figure 18 shows the maximum load and average drag force applied by ten non-coated non-coring port access needles l a- 10a (e.g. non-lubricated huber needles) that are 20 gauge by 2 inch. Specifically, Figure 18 shows that the maximum load and average drag force for the ten non-coated non- coring port access needles 1 a-10a range from about 32.4 - 49.3 gf and about 26.5 - 39.8 gf, respectively. Figure 19 shows the maximum load and average drag force applied by ten coated non-coring port access needles lb- 10b that are 20 gauge by 2 inch. Specifically, Figure 19 shows that the maximum load and average drag force for ten coated non-coring port access needles lb-l Ob range from about 27.9 - 43.5 gf and about 8.2 - 9.8 gf, respectively.

[0076] Figure 20 compares results for each tested non-coated non-coring port access needle, whose results were shown in Figure 18, with the results for each tested coated non- coring port access needle, whose results were shown in Figure 19. Specifically, Figure 20 compares the average drag force for each tested non-coated non-coring port access needle 1 a- 10a with the decrease in force exerted on a patient by each of the coated non-coring port access needles lb- 10b. Use of the coated non-coring port access needles results in about 62% - 76% less force exerted than a non-coated non-coring port access needle. The average decrease in exerted force was about 69%.

[0077] As shown in Figures 25-26, coated spinal needles 20b, 30b exert less force on an element than non-coated spinal needles 20a, 30a. Coated spinal needles 20b, 30b may exert about 70-75% less force than non-coated spinal needles 20a, 30a. As shown in Figures 25- 26, a 23 gauge by 3.5 inch non-coated spinal needle 20a, 30a may result in a drag force of about 9.664 - 1 1.440 gf at about 0.65 - 0.75 inches from the tip of the needle, a drag force of about 9.075 - 10.278 gf at about 0.9 - 1.0 inches from the tip of the needle and a drag force of about 9.064 - 9.140 gf at about 1.4 - 1.5 inches from the tip of the needle. The average drag force exerted may range from about 9.268 - 10.286 gf. For example, the average drag force may be about 9.777 gf. In contrast, a 23 gauge by 3.5 inch coated spinal needle 20b and 30b may result in a drag force of about 2.357 - 3.344 gf at about 0.65 - 0.75 inches from the tip of the needle, a drag force of about 2.358 - 2.821 gf at about 0.9 - 1 .0 inches from the tip of the needle and a drag force of about 2.893 - 3.218 gf at about 1.4 - 1.5 inches from the tip of the needle. The average drag force exerted may range from about 2.536 - 3.128 gf. For example, the average drag force may be about 2.832 gf. The coated spinal needle 20b, 30b, therefore, may result in about 71 % less force exerted on a patient than a non-coated spinal needle 20a, 30a. Figure 26 shows a graph depicting the results shown in Figure 25 where line A shows the results for needle 20a, line B shows the results for needle 30a, line C shows the results for needle 20b and line D shows the results for needle 30b.

[0078] As utilized herein, the terms "approximately," "about," "substantially," and similar terms are intended to have a broad meaning in harmony with the common and accepted usage by those of ordinary skill in the art to which the subject matter of this disclosure pertains. It should be understood by those of skill in the art who review this disclosure that these terms are intended to allow a description of certain features described and claimed without restricting the scope of these features to the precise numerical ranges provided. Accordingly, these terms should be interpreted as indicating that insubstantial or inconsequential modifications or alterations of the subject matter described are considered to be within the scope of the disclosure. 1007 1 It should be noted that the term "exemplary" as used herein to describe various embodiments is intended to indicate that such embodiments are possible examples, representations, and/or illustrations of possible embodiments (and such term is not intended to connote that such embodiments are necessarily extraordinary or superlative examples or preferred examples).

[0080] It should be noted that the orientation of various elements may differ according to other exemplary embodiments, and that such variations are intended to be encompassed by the present disclosure. It is recognized that features of the disclosed embodiments can be incorporated into other disclosed embodiments.

[0081] It is important to note that the constructions and arrangements of the needle or components thereof and the method of manufacturing as shown and described in the various exemplary embodiments are illustrative only. Although only a few embodiments have been described in detail in this disclosure, those skilled in the art who review this disclosure will readily appreciate that many modifications are possible (e.g., variations in sizes, dimensions, structures, shapes and proportions of the various elements, values of parameters, mounting arrangements, use of materials, colors, orientations, etc.) without materially departing from the novel teachings and advantages of the subject matter recited in the claims. For example, elements shown as integrally formed may be constructed of multiple parts or elements, the position of elements may be reversed or otherwise varied, and the nature or number of discrete elements or positions may be altered or varied. The order or sequence of any process or method steps may be varied or re-sequenced according to alternative embodiments. Other substitutions, modifications, changes and omissions may also be made in the design, operating conditions and arrangement of the various exemplary embodiments without departing from the scope of the present disclosure.

Claims

WHAT IS CLAIMED IS:

1. A method of manufacturing a needle, the method comprising:

diluting a lubricant, that is biocompatible and soluble in a solvent, with a solvent, the solvent comprising one of an aliphatic hydrocarbon, an aromatic hydrocarbon and a chlorinated solvent;

mixing the lubricant and the solvent to obtain a coating; and

inserting a needle, the needle including a hollow tube, into a container housing the coating to cover at least a portion of the hollow tube with the coating.

2. The method of claim 1 , wherein the diluting step includes diluting the lubricant with the solvent more than once,

3. The method of claim 1 , wherein the lubricant comprises silicone.

4. The method of claim 1 , wherein the solvent comprises a first solvent and a second solvent that is different from the first solvent.

5. The method of claim 1 , wherein the needle comprises one of a spinal needle and a non- coring port access needle.

6. The method of claim 1 , wherein the hollow tube includes a first hollow tube portion and a second hollow tube portion that extends from the first hollow tube portion, the second hollow tube portion configured to enter a body.

7. The method of claim 6, wherein the coating covers only the second hollow tube portion.

8. The method of claim 1 , further comprising attaching an attachment mechanism to the needle, the attachment mechanism configured to prevent the coating from entering an inner hollow tube portion surface of the hollow tube.

9. The method of claim 8, wherein the attachment mechanism comprises a syringe.

10. The method of claim 8, further comprising removing the hollow tube from the coating so that the coating couples to the hollow tube.

1 1 . The method of claim 10, further comprising detaching the attachment mechanism from the needle after removing the hollow tube from the coating.

12. A needle for reducing a force during insertion in a body, the needle comprising;

a hollow tube configured to enter a body;

a coating coupled to at least a portion of the hollow tube.

13. The needle of claim 12, wherein the coating comprises:

a lubricant that is biocompatible and is soluble in a solvent, and a solvent, the solvent comprising one of an aliphatic hydrocarbon, an aromatic hydrocarbon and a chlorinated solvent.

14. The needle of claim 13, wherein the needle comprises one of a spinal needle and a non- coring port access needle.

15. The needle of claim 13, wherein the hollow tube includes a first hollow tube portion and a second hollow tube portion that extends from the first hollow tube portion, the second hollow tube portion to configured to enter the body.

16. The needle of claim 14, wherein the coating is coupled to only the second hollow tube portion.

17. The needle of claim 13,

wherein the hollow tube includes an inner hollow tube portion surface and an outer hollow tube portion surface, and

wherein the coating is only coupled to the outer hollow tube portion surface.

18. The needle of claim 13, wherein the lubricant comprises silicone.

19. The needle of claim 13, wherein the aliphatic hydrocarbon comprises hexane.

20. The needle of claim 13, wherein the solvent comprises a first solvent and a second that is different from the first solvent.