WO2016028652A1

WO2016028652A1 - Annular water sleeve to facilitate hypodermic needle injection and uses thereof

Info

Publication number: WO2016028652A1
Application number: PCT/US2015/045430
Authority: WO
Inventors: Timothy J. Nedwed
Original assignee: Nedwed Timothy J
Priority date: 2014-08-16
Filing date: 2015-08-15
Publication date: 2016-02-25

Abstract

The present invention describes a drug delivery system for delivering drug solutions consisting of a simple syringe that incorporates an annular low-viscosity fluid sleeve system. The syringe comprises an annular sleeve for low-viscosity fluid located on the wall of the syringe needle and a core area for the drug located in the center of the syringe needle. The syringe further comprises of an annular plunger for water and a core plunger for the drug solution. The low-viscosity fluid may be preloaded in the annular sleeve or loaded through the discharge side of the syringe. The drug solution may be preloaded in the core of the syringe or loaded though the discharge side of the syringe.

Description

ANNULAR WATER SLEEVE TO FACILITATE HYPODERMIC NEEDLE INJECTION AND USES THEREOF

Federal Funding Legend

This invention was not created using federal funds.

BACKGROUND OF THE INVENTION

Cross Reference to Related Application

This PCT application claims benefit of provisional application U.S. Serial No. 62/038,248 filed on August 16, 2014.

Field of the Invention

The present invention generally relates to a drug delivery system that can deliver drugs using smaller bore needles. More specifically, the present invention is directed to a drug delivery system that can deliver drugs of lower viscosity, higher viscosity or a combination thereof with lower pressure drop through a needle by incorporating an annular water sleeve system in a simple syringe.

Description of the Related Art

Doctors and veterinarians face a difficult task when they have to deliver drugs of higher viscosity to their patients. Injection of drugs using a hypodermic needle is limited to the use of low-viscosity solutions because more viscous liquids produce too much pressure drop. This limits the concentration of the active drug ingredient that is injected because higher concentrations of the active drug results in viscous solutions, which are hard to deliver using a syringe and hypodermic needle actuated by a human hand. This impedes drug delivery especially in cases where there is need to deliver higher concentrations of the active drug ingredient. Thus, there is a significant unmet need in the art for a drug delivery system that will efficiently deliver drugs of higher viscosity and is actuated solely by a human hand.

In addition, even lower viscosity drugs may require large bore needles to minimize the pressure drop through the needle to allow delivery with a standard syringe. The size of the bore of the needle determines how much discomfort an individual experiences when given an injection. Smaller bore needles cause less discomfort. Thus, there is a significant unmet need in the art for a drug delivery system that will efficiently deliver drugs through smaller bore needles using a standard syringe that is actuated by a human hand. The present invention fulfills these longstanding needs in the art.

SUMMARY OF THE INVENTION

In a preferred embodiment, the present invention is directed to a drug delivery system.

In another embodiment, the drug delivery system comprises means to hold water (or another suitable low-viscosity fluid) and a drug solution, the means comprising a barrel; means to draw the water into the barrel; means to draw the drug solution into the barrel; a needle; means that allows the water and drug solution to flow into and out of the needle; and means that allows the drug solution to flow through a core space in the needle and the water to flow as an annular sleeve outside the core space for the drug solution. The annular sleeve of water in the needle causes the drug solution to flow with a pressure drop close to that of pure water rather than the pressure drop that would be required for a more viscous drug solution alone. This in turn allows actuation of the plunger of a syringe with much less force. In yet another embodiment, the barrel comprises an annular section to hold the water to reduce pressure drop through the needle attached to the delivery system; and an inner core section to hold the drug solution. In still yet another embodiment, the means to draw the water into the delivery system comprises a plunger for the annular section of the barrel. In yet another embodiment, the means to draw the drug solution into the drug delivery system comprises a plunger for the core section of the barrel.

In still yet another embodiment, the means to draw the water into the barrel and the means to draw the drug solution into the barrel operate either independently or simultaneously. In another embodiment, the independent operation of the means to draw the water and the means to draw the drug solution allows drawing the water and the drug solution into different sections of the barrel. In yet another embodiment, the means to draw the water and the means to draw the drug solution operate simultaneously when the means to draw the water and the means to draw the drug solution are depressed to inject the drug solution.

In another embodiment, the means that allows the water and the drug solution to flow into the needle causes the water to form an annular sleeve inside the needle and the drug solution to flow in the core of the needle.

In still yet another embodiment, the means that allows the water to flow into the needle comprises a needle hub, where the water flows into the needle as an annular sleeve that surrounds the drug solution that flows in the core. In yet another embodiment, the drug solution delivered by the drug delivery system comprises a drug of low viscosity, high viscosity or a combination thereof. In another preferred embodiment, the present invention is directed to a kit comprising the delivery system described above.

In yet another preferred embodiment, the present invention is directed to a method of delivering drug solution to an individual using the delivery system described above.

In another embodiment, the method comprises the steps of placing tip of the barrel of the delivery system without the needle into a reservoir containing water of appropriate purity, salinity, and sterility; pulling the plunger for the annular section of the barrel away from the barrel to draw water into the annular section of the barrel, thereby loading the annular section of the barrel with the water; removing the tip of the barrel from the reservoir of water; placing the tip of the barrel of the delivery system without needle into a reservoir containing the drug solution; pulling the plunger for the core section of the barrel away from the barrel to draw the drug solution into the core section of the barrel, thereby loading the core section of the barrel with the drug solution; placing the needle and the needle hub onto the loaded barrel; inserting the needle into skin of the individual; and depressing the plungers for the annular section and the core section together by hand, thereby delivering the drug solution to the individual.

In yet another embodiment, the water and the drug solution are loaded into the drug delivery system at the same time. In still yet another embodiment, the water is loaded at a manufacturing facility of the drug delivery system and the drug solution is loaded just prior to injecting into the individual. In another embodiment, the water and drug solution are loaded at a manufacturing facility of the drug delivery system or at a separate drug solution manufacturing facility. In another embodiment, the drug solution comprises a drug of viscosity greater than 1 centipoise (cP), greater than 10 cP, greater than 100 cP, greater than 1,000 cP, or greater than 10,000 cP.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings and their description are provided herein to help understand the invention and are not to be meant to limit the scope of the invention.

Figure 1 shows a side view of the syringe system as it would appear when loaded with the viscous drug solution in the core section and the water in the annular section of the barrel.

Figure 2 shows a top view of the syringe system.

Figure 3 shows a side view of the syringe system as it would appear when only the annular space of the barrel of the syringe system is loaded with water while the core section of the barrel is yet to be loaded with viscous drug solution.

Figure 4 shows a side view of the syringe system as it would appear when both the plunger for the annular section and the plunger for the core section of the barrel have been fully depressed to deliver the viscous drug solution.

Figure 5 shows a flow chart of one embodiment of a method of utilizing the syringe system to deliver viscous drug solution.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is directed to a drug delivery system that operates like a standard syringe and hypodermic needle that is actuated by a human hand. Figure 1 shows the side view of an exemplary illustration of the drug delivery system 100 as it would appear when loaded with the drug solution in the core section 190 and with water in the annular section 195 of the barrel 125. The drug delivery system 100 includes a hypodermic needle 110 and needle hub 120 that includes one of many methods of attaching and detaching it from the barrel 125. The needle hub 120 includes a core space 121 and an annular space 122 that directs the flow of the drug solution and water from the annular section 195 and core section 190 of the barrel 125 when the annular plunger 160, the annular plunger seal for water 140, the core plunger 165 and the central plunger seal for the drug solution 130 are depressed by pressing on the annular plunger handle 170 and the core plunger handle 180 simultaneously with a human thumb in the standard way of operating a hypodermic syringe. The drug delivery system 100 includes the annular plunger rod 160, the annular plunger seal for water 140, the core plunger rod 165 and the core plunger seal for the drug solution 130 that can be operated independently by pulling on the annular plunger handle 170 or the core plunger handle 180 at different times. The annular plunger 160 also comprises a slot 150 for the core plunger handle 180 that allows the core plunger rod 165 and the core plunger seal 130 for the drug solution to travel up and down when the annular plunger seal 140 is fully up and the annular section 195 in the barrel 125 is filled with water.

Figure 2 is a top view of an exemplary illustration of the viscous drug delivery system. It shows the core plunger handle 180, the annular plunger handle 170 and the slot 150 for the core plunger rod 150. The view illustrates how the core plunger handle 180 extends beyond the perimeter of the annular plunger handle 170. This allows an index finger and a middle finger to be placed under the core plunger handle 180 in order for the fingers to pull up on it to pull the core plunger 165 and the core plunger seal 130 to load the core section 195 of the barrel 125 with a drug solution. Figure 1 illustrates how the annular plunger handle 170 extends beyond the annular plunger rod 160 to allow the same operation with an index and middle finger.

Figure 3 is a side view of an exemplary illustration of the viscous drug delivery system 100 as it would appear when only the annular section 195 in the barrel 125 is loaded with water while the core section 190 is yet to be loaded with a viscous drug.

Figure 4 is a side view of an exemplary illustration of the viscous drug delivery system 100 as it would appear after the core plunger 165, core plunger seal 130, annular plunger 160 and annular plunger seal 140 have been fully depressed into the barrel 125 to deliver the drug solution. The figure also illustrates how the drug solution forms a core of the injected fluids 196 while the water forms an annulus 197. The system is designed such that this separate annular water flow and core drug flow is established immediately in the needle 110 when the core plunger 165, core plunger seal 130, annular plunger 160 and annular plunger seal 140 are actuated simultaneously. In this way, the water wets the inside wall of the needle 110 to allow the viscous drug to flow with a pressure drop close to that of pure water rather than the pressure drop that would be needed to deliver the higher viscosity drug solution. This allows delivery of the drug solution with a lower pressure drop.

Figure 5 is a flow chart that shows how the delivery system operates. The first step of the operation is to load the annular section 195 of the barrel 125 with water by placing the tip of the barrel 125 into a reservoir of water with both the annular plunger 160 and the core plunger 165 fully depressed as shown in Figure 4. Then step two is to pull the handle of the annular plunger 170 away from the barrel 125 to draw water into the annular space 195. The next step is to remove the barrel 125 tip from the reservoir of water and place it in a reservoir of drug solution. In the next step, the core plunger handle 180 is pulled away from the barrel 125 to draw the drug solution into the core section 190. The next step is to place the needle 1 10 onto the needle hub 120 of the loaded drug delivery system 100. The drug delivery system 100 and the hypodermic needle 110 are now ready for injection through an individual's skin in a standard way using a human hand.

The unique aspect of the invention is that the barrel is constructed in such a way that it produces an annular water sleeve in the needle that surrounds the drug solution as they simultaneously pass through the needle. This water sleeve acts to reduce the pressure drop through the needle allowing the drug solution to pass through the needle with approximately the same pressure drop as water. This allows the plunger of a syringe loaded with a viscous drug solution to be depressed with lower force.

The unique aspects of this drug delivery system has great benefits. Generally, drugs that have very high a viscosity cannot be injected using a standard hypodermic syringe because such injection would require too much pressure drop for hand actuation of the plunger or would require a needle with a bore that is too large for an individual to tolerate penetration through the skin in order to obtain low pressure drop. The drug delivery system described herein will allow injection of a drug regardless of its viscosity to be injected using a standard hypodermic syringe by reducing the pressure drop for injection of the drug. Additionally, the drug delivery system described herein allows use of a needle of lower bore, which will reduce the discomfort that an individual may experience when a drug is injected using larger bore needle.

One potential method of developing the water sleeve is to construct the barrel of the syringe with an annular section that is separated from the inner section (core section). Water can then be placed in the annular section of the barrel and the drug solution can be placed in the core section of the barrel. The plunger of the syringe consists of a plunger for the core section and an annular plunger for the annular section of the barrel. These plungers can operate independently as described above. The plungers operate independently to allow the water and the drug solution to be pulled into the barrel separately, and they operate together when the plungers are being depressed while injecting the drug solution into an individual.

Depressing the plungers simultaneously causes both the water in the annular section of the barrel and the drug solution in the core section of the barrel to pass through the needle hub and into the hypodermic needle. The needle hub is further constructed in such a way as to enable the water to flow into the needle as an annular sleeve that is surrounding the drug solution.

The syringe barrel can be loaded with water and drug solutions by either loading the annular section of the barrel with water and the drug solution into the core section of the barrel at the same location, e.g., the manufacturing facility. Alternately, only the water could be loaded into the annular section of the barrel at a location, and the drug solution could be loaded sometime later, e.g., just prior to injection of the drug into an individual.

Thus, the invention described herein satisfies the long standing need in the art for a drug delivery system or device that efficiently dispenses drug solutions into an individual with low- pressure drop. The invention allows injection of drugs that are too viscous for standard hypodermic syringes and a reduction in the bore of the needles used for delivery of all drug solutions thereby reducing the discomfort experienced by an individual when the needle penetrates the skin. The syringe described herein can be used in a standard manner but is unique in that it is configured in a way that causes an annular sleeve of water (or another appropriate low-viscosity fluid) and a core drug solution to flow through a needle. Although alternative methods are possible, one method of doing this is with a barrel that has an annular section to hold water and a core section to hold the viscous drug solution. The syringe also comprises plungers that can operate one at a time to load both of these sections separately but also work at the same time to dispense the drug solution into an individual. The needle hub of the syringe is also constructed in such a way that it causes formation of a water sleeve that surrounds the viscous drug solution in the needle, thus allowing the viscous drug solution to be injected with much lower pressure drop to either allow injection of drugs that are too viscous or injection of drugs using smaller bore needles.

As used herein, the term "needle" is understood to mean a hypodermic syringe needle.

As used herein, the term "barrel" is understood to mean a hollow tube that is open at one end and tapers to an open tip at the other end. The barrel may consist of a core space for holding a drug and an annular space for holding an appropriate low viscosity fluid, such as water.

As used herein, the term "core plunger" is understood to mean a piston-type rod with a slightly cone-shaped tip that passes inside the core space of the barrel of the syringe.

As used herein, the term "annular plunger" is understood to mean a piston-type rod that passes inside the annular space of the barrel of the syringe and the rod has a hollow core that allows the core plunger to pass through.

As used herein, the "needle hub" is understood to mean the part of the drug delivery system that connects the barrel of the syringe to the needle. The needle hub is constructed in a way to cause formation of an annular sleeve of water that surrounds a core drug solution in the needle. One method of doing this is for the hub, like the barrel, to have an annular space and a core space. The annular space of the needle hub transfers water in the annular space of the barrel to the needle in such a way to form an annular sleeve of water around the drug in the needle. This results in wetting of the wall of the needle by the water when it flows through the needle. The drug flows in a core space and is in contact with the water sleeve as it passes through the needle.

As discussed herein "water of appropriate purity, salinity, and sterility" will be used for the drug delivery system. However, water is just an example of a low viscosity fluid that can be used in the annular space of the drug delivery system. Other low viscosity fluid includes but is not limited to an organic fluid.

As discussed herein "drug solution" is understood to include those drug solutions that are too viscous to be injected by a standard hypodermic needle or any drug solution injected or could potentially be injected by a hypodermic needle.

As used herein, the phrase "comprises" is to be construed as open ended and not to be construed as excluding the presence of other components, steps or features.

In the detailed description section, the specific embodiments of the present invention are described in connection with the preferred embodiments. However, to the extent that the following description is specific to a particular embodiment or a particular use of the present invention, this is intended to be for exemplary purposes only and simply provides a description of the exemplary embodiments. Accordingly, the invention is not limited to the specific embodiments described above, but rather, it includes alternatives, modifications and equivalents falling within the true spirit and scope of the appended claims.

Claims

What is claimed is:

1. A drug delivery system, wherein said system comprises:

means to hold a low-viscosity fluid and a drug solution, said means comprising a barrel; means to draw a low-viscosity fluid into said barrel; means to draw the drug solution into said barrel; a needle; means that allows the low-viscosity fluid to flow into and through the needle in an annular space; and means that allows the drug solution to flow into and through the needle in a core space.

2. The drug delivery system of claim 1, wherein said low- viscosity fluid consists of water of the appropriate purity, salinity, and sterility.

3. The drug delivery system of claim 1, wherein said low- viscosity fluid consists of an organic fluid.

4. The drug delivery system of claim 1, wherein said barrel comprises: an annular section to hold the low-viscosity fluid to reduce pressure drop through the needle attached to the delivery system; and an inner core section to hold the drug solution.

5. The drug delivery system of claim 1, wherein said means to draw the low- viscosity fluid into the drug delivery system comprises a plunger for the annular section of the barrel.

6. The drug delivery system of claim 1, wherein said means to draw the drug solution into the delivery system comprises a plunger for the core section of said barrel.

7. The drug delivery system of claim 1, wherein said means to draw the low- viscosity fluid into said barrel and said means to draw the drug solution into said barrel operate independently and simultaneously.

8. The drug delivery system of claim 7, wherein said independent operation of said means to draw the low-viscosity fluid and said means to draw the drug solution allows drawing of said low-viscosity fluid and said drug solution into different sections of said barrel.

9. The drug delivery system of claim 7, wherein said means to draw the low-viscosity fluid and said means to draw the drug solution operate simultaneously when said means to draw low- viscosity fluid and said means to draw the drug solution are depressed to inject said drug solution.

10. The drug delivery system of claim 1, wherein said means that allows a low- viscosity fluid to flow into said needle comprises a needle hub, wherein said needle hub directs said low-viscosity fluid from said barrel into an annular space of said needle and directs said drug solution from said barrel into a core space of said needle.

11. The drug delivery system of claim 1 , wherein said needle hub is tapered with a large end that connects to said barrel and a small end that connects to said needle.

12. The drug delivery system of claim 1, wherein said tapered needle hub has a core space that directs said drug solution from said barrel to a core space in said needle and an annular space that directs said low-viscosity fluid from said barrel to an annular space in said needle.

13. The drug delivery system of claim 1, wherein said drug solution delivered comprises a drug of viscosity >1 centipoise (cP), >10 cP, >100 cP, >1,000 cP, or >10,000 cP.

14. A kit comprising said drug delivery system of claim 1.

15. A method of delivering a drug solution to an individual using the drug delivery system of claim 1.

16. The method of claim 15, said method comprising the steps of: placing the tip of the barrel of the drug delivery system without the needle and needle hub into a reservoir containing a low-viscosity fluid; pulling the plunger for the annular section of the barrel away from the barrel to draw the low-viscosity fluid into said annular section of said barrel, thereby loading the annular section of the barrel with the low- viscosity fluid; removing the tip of the barrel from said reservoir of low-viscosity fluid; placing the tip of the barrel of the drug delivery system without the needle into a reservoir containing the drug solution; pulling the plunger for the core section of the barrel away from the barrel to draw the drug solution into the core section of the barrel, thereby loading the core section of the barrel with the drug solution; placing the needle and needle hub onto the loaded barrel; inserting said needle into skin of said individual; and depressing said plungers for said annular section and said core section together by hand, thereby delivering said drug solution into said individual.

17. The method of claim 16, wherein said low-viscosity fluid and said drug solution are loaded into said delivery system at the same time.

18. The method of claim 16, wherein said low-viscosity fluid is loaded at a manufacturing facility of the drug delivery system and said drug solution is loaded just prior to injecting into said individual.

19. The method of claim 16, wherein said low-viscosity fluid and said drug solution are loaded at a manufacturing facility of the drug delivery system or at a separate drug solution manufacturing facility.

20. The method of claim 16, wherein the drug solution delivered comprises a drug of viscosity >1 centipoise (cP), >10 cP, >100 cP, >1,000 cP, or >10,000 cP.