WO2019010578A1

WO2019010578A1 - Coaxial needle system

Info

Publication number: WO2019010578A1
Application number: PCT/CA2018/050848
Authority: WO
Inventors: Louis Miguel FERREIRA; David Brian O'GORMAN; Pouyan AHANGAR
Original assignee: The University Of Western Ontario
Priority date: 2017-07-13
Filing date: 2018-07-11
Publication date: 2019-01-17

Abstract

A multi-stage needle assembly that creates an aseptic lumen from the skin to a target tissue. The aseptic lumen created with the multi-stage needle assembly of the present invention can be used to advance tools such as hypodermic needles and endoscopes to perform medical procedures in the target tissue. The multi-stage needle assembly circumvents the problem of contaminating joints and deep tissues with skin microbiota by separating the high contamination risk skin puncture from the puncture of the joint capsule or other deep tissue target.

Description

COAXIAL NEEDLE SYSTEM

FIELD OF THE INVENTION

The present invention relates to a needle assembly system and to a process of creating an aseptic passageway from the skin surface to a joint space using the needle assembly system. BACKGROUND OF INVENTION

It has been well documented in the literature that normal skin microbiota, which includes many different bacterial species, can persist in the deeper layers of the skin despite adequate surface sterilization before medical procedures in the joints, and these bacteria are a major source of postprocedure joint infections. Existing joint injection methods require a single sterile hypodermic needle to travel from the skin surface to the joint space in a single pass and can potentially cause devastating infections of joints by introducing these surface or deep skin bacteria into the joint space. Current literature suggests that contamination of shoulder joint with deep skin bacteria, such as P. Acnes/C. Acnes, is most commonly caused by surgical procedures of the shoulder joints including injections. Treatment requires a combination of surgery and a prolonged antibiotic treatment regimen to successfully eliminate the remaining bacteria. (Achermann, Y, et al., Clin. Microbiol. Rev. July 2014 vol. 27 no. 3 419-440.)

U.S. Pat. No. 4,793,363 discloses a two-stage biopsy needle. While the first stage would create a path from the skin to the bone marrow, contaminated debris and skin microbiota can potentially be pushed and extend the contamination down to the bone marrow and subsequently be introduced into the bone marrow by the biopsy needle.

U.S. Pat. No. 6,808,505 discloses a two-stage system for performing diagnostic needle arthroscopy. As illustrated in Figs. 4 and 7 of this document, the cannula having reference number 48, penetrates the skin, reaches the joint capsule and even crosses the joint capsule into the interior joint space. As such, cannula 48 would push the contamination from the skin into the interior joint space. SUMMARY OF INVENTION

In one embodiment, the present invention discloses a multi-stage needle assembly including: (a) a first stage comprising: a first tube having (i) a lumen and (ii) a tapered end, and a first rod having (i) an outer diameter that allows for a tight fit within the lumen of the first tube, and (ii) a sharp pointed distal end that extends beyond the tapered end of the first tube when the first rod is assembled inside the lumen of the first tube, and forms a piercing tip with the tapered end of the first tube; (b) a second stage comprising: a second tube having (i) an outer diameter that is substantially similar to the outer diameter of the first rod, (ii) a lumen and (iii) a tapered end that extends beyond the distal end of the first tube when the second tube is assembled inside the lumen of the first tube, and a second rod having (i) an outer diameter that allows for a tight fit within the lumen of the second tube, and (ii) a sharp pointed or blunt distal end that extends beyond the tapered end of the second tube when the second rod is assembled inside the lumen of the second tube, and forms a second piercing tip with the tapered end of the second tube; and (c) a third stage comprising a hypodermic needle, the hypodermic needle having (a) an outer diameter that is substantially similar to the outer diameter of the second rod, and (ii) a sharp pointed distal end that extends beyond the distal end of the second tube when the hypodermic needle is assembled inside the lumen of the second tube.

In one embodiment of the multi-stage needle assembly, the distal end of the second rod is a sharp pointed end or a blunt end. In another embodiment of the multi-stage needle assembly, the third stage needle is a hypodermic needle.

The present invention, in another embodiment, discloses a multi-stage needle assembly as shown in any one of FIGs. 1 to 5.

The present invention, in another embodiment, discloses a method of creating an aseptic passageway from a skin surface to a target tissue, including: (a) providing a first stage assembly comprising a first tube having (i) a lumen and (ii) a tapered end, and a first rod having (i) an outer diameter that allows for a tight fit within the lumen of the first tube, and (ii) a sharp pointed distal end that extends beyond the tapered end of the first tube when the first rod is assembled inside the lumen of the first tube, and forms a piercing tip with the tapered end of the first tube, and advancing the piercing tip through the skin, (b) removing the first rod, whereby the lumen of the first tube provides for a first aseptic lumen though the skin, (c) providing a second stage assembly comprising a second tube having (i) an outer diameter that is substantially similar to the outer diameter of the first rod, (ii) a lumen and (iii) a tapered end that extends beyond the distal end of the first tube when the second tube is assembled inside the lumen of the first tube, and a second rod having (i) an outer diameter that allows for a tight fit within the lumen of the second tube, and (ii) a distal end that extends beyond the tapered end of the second tube when the second rod is assembled inside the lumen of the second tube, and forms a second tip with the tapered end of the second tube, and advancing the second tip until the sharp pointed or blunt distal end of the second rod reaches the target tissue, and (d) removing the second rod whereby the lumen of the second tube provides for the aseptic lumen from the skin to the target tissue.

In one embodiment of the method of creating an aseptic passageway from a skin surface to a target tissue, the distal end of the second rod is a sharp pointed distal end, and the second tip is a piercing tip, and wherein prior to step (d) the method further comprises piercing the target tissue with the piercing tip, whereby the lumen of the second tube provides for an aseptic lumen from the skin to the inside of the target tissue.

In another embodiment of the method of creating an aseptic passageway from a skin surface to a target tissue, the method further comprises advancing a tool through the aseptic lumen from the skin to the inside of the target tissue, and performing a medical procedure of the target tissue with the tool.

In another embodiment of the method of creating an aseptic passageway from a skin surface to a target tissue, the tool is a hypodermic needle or an endoscope.

In another embodiment of the method of creating an aseptic passageway from a skin surface to a target tissue, the distal end of the second rod is a blunt distal end, and the second tip is a blunt tip, and wherein prior to step (d) the method further comprises detecting a surface of the target tissue with the blunt tip.

In another embodiment of the method of creating an aseptic passageway from a skin surface to a target tissue, the method further comprises advancing a needle through the second aseptic lumen to the surface of the target tissue, and piercing the surface of the target tissue with the needle. In another embodiment of the method of creating an aseptic passageway from a skin surface to a target tissue, the target tissue is a joint having a joint capsule and a joint space, and wherein the needle is advanced through the joint capsule into the joint space through the aseptic lumen from the skin to the joint capsule. In one embodiment, the present invention provides for a method of performing a medical procedure in a target tissue, the method including: (a) providing a first stage assembly comprising a first tube having (i) a lumen and (ii) a tapered end, and a first rod having (i) an outer diameter that allows for a tight fit within the lumen of the first tube, and (ii) a sharp pointed distal end that extends beyond the tapered end of the first tube when the first rod is assembled inside the lumen of the first tube, and forms a piercing tip with the tapered end of the first tube, and advancing the piercing tip through the skin, (b) removing the first rod, whereby the lumen of the first tube provides for a first aseptic lumen though the skin, (c) providing a second stage assembly comprising a second tube having (i) an outer diameter that is substantially similar to the outer diameter of the first rod, (ii) a lumen and (iii) a tapered end that extends beyond the distal end of the first tube when the second tube is assembled inside the lumen of the first tube, and a second rod having (i) an outer diameter that allows for a tight fit within the lumen of the second tube, and (ii) a distal end that extends beyond the tapered end of the second tube when the second rod is assembled inside the lumen of the second tube, and forms a second tip with the tapered end of the second tube, and advancing the second tip until the distal end of the second rod reaches the target tissue, (d) removing the second rod whereby the lumen of the second tube provides for the aseptic lumen from the skin to the target tissue, and (e) advancing a tool through the aseptic lumen of the second tube to the target tissue and performing the medical procedure in the target tissue with the tool.

BRIEF DESCRIPTION OF THE DRAWINGS Embodiments will be described, by the way example only, with the reference to the drawings, in which:

FIG. 1 Side view of the components of a coaxial biopsy system in accordance to one embodiment of the present invention. FIG. 2A Longitudinal cross-sectional view of Stage I, Stage II and Stage III assemblies in accordance to one embodiment of the present invention.

FIGs. 2B to 21 cross sectional view the components of the coaxial biopsy system illustrated in FIGs. 1 and 2A; FIGs. 2B and 2C are cross sectional views of Stage I tube and Stage I rod along dashed line a of FIG. 1; FIG. 2D is a cross sectional view of Stage 1 assembly along dashed line b of FIG. 2A; FIGs. 2E and 2F are a cross sectional views of Stage II tube and Stage II rod along dashed line a of FIG. 1; FIG. 2G is a cross sectional view of Stage II assembly along dashed line b of FIG. 2A; FIG. 2H is a cross sectional view of the Stage III hypodermic needle along dashed line a of FIG. 1; and FIG. 21 is a cross sectional view of Stage III Assembly along dashed line b of FIG. 2A.

FIG. 2J Longitudinal cross-sectional view of an assembled coaxial biopsy system in accordance to another embodiment of the present invention.

FIG. 2K Longitudinal cross-sectional view of Stage I, Stage II and Stage III assemblies in accordance to another embodiment of the present invention. FIG. 3 Longitudinal cross-sectional view of tube for in vitro testing of the coaxial biopsy system of the present invention.

FIG. 4 Side view photograph of an assembled coaxial biopsy system of the present invention.

FIG. 5 Side view photograph illustrating the operation of the coaxial biopsy system of the present invention. FIG. 6 Longitudinal cross-sectional view illustrating Stage I tube and full Stage III assembly with layers of skin in accordance with one embodiment of the present invention.

DETAILED DESCRIPTION OF INVENTION

I. Definitions

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Also, unless indicated otherwise, except within the claims, the use of "or" includes "and" and vice versa. Non-limiting terms are not to be construed as limiting unless expressly stated or the context clearly indicates otherwise (for example "including", "having" and "comprising" typically indicate "including without limitation"). Singular forms included in the claims such as "a", "an" and "the" include the plural reference unless expressly stated otherwise. All relevant references, including patents, patent applications; government publications, government regulations, and academic literature, and including the priority document, are hereinafter detailed and incorporated by reference in their entireties. In order to aid in the understanding and preparation of the within invention, the following illustrative, non-limiting, examples are provided.

For the purposes of this specification and appended claims, unless otherwise indicated, all numbers expressing amounts, sizes, dimensions, proportions, shapes, formulations, parameters, percentages, parameters, quantities, characteristics, and other numerical values used in the specification and claims, are to be understood as being modified in all instances by the term "about" even though the term "about" may not expressly appear with the value, amount or range. Accordingly, unless indicated to the contrary, the numerical parameters set forth in the following specification and attached claims are not and need not be exact, but may be approximate and/or larger or smaller as desired, reflecting tolerances, conversion factors, rounding off, measurement error and the like, and other factors known to those of skill in the art depending on the desired properties sought to be obtained by the presently disclosed subject matter. For example, the term "about," when referring to a value can be meant to encompass variations of, in some embodiments, ±100% in some embodiments ±50%, in some embodiments ±20%, in some embodiments ±10%, in some embodiments ±5%, in some embodiments ±1%, in some embodiments ±0.5%, and in some embodiments ±0.1% from the specified amount, as such variations are appropriate to perform the disclosed methods or employ the disclosed compositions.

Further, the term "about" when used in connection with one or more numbers or numerical ranges, should be understood to refer to all such numbers, including all numbers in a range and modifies that range by extending the boundaries above and below the numerical values set forth. The recitation of numerical ranges by endpoints includes all numbers, e.g., whole integers, including fractions thereof, subsumed within that range (for example, the recitation of 1 to 5 includes 1, 2, 3, 4, and 5, as well as fractions thereof, e.g., 1.5, 2.25, 3.75, 4.1, and the like) and any range within that range. As used herein, the term "substantially" includes exactly the term it modifies and slight variations therefrom. Thus, the term "substantially conical tip" or "conical tip" means exactly a conical tip and slight variations therefrom, while the term "substantially similar to the outer diameter" means exactly the outer diameter and slight variations thereof. The term "blunt" as used herein means a rod having a worn-down point; not sharp.

The term "sharp" as used herein, means a rod or a tube or a needle having an edge or point that is able to pierce something, such as a tissue.

P. acnes: Propionibacterium acnes (currently being re-classified as Cutibacterium acnes (C. acnes). In this document the term "tool" refers to an instrument that can be advanced through the lumen of the second tube 22 to perform a medical procedure in a target tissue. Tools may include a hypodermic needle or an endoscope, such as an arthroscope that is inserted into the joint.

In this document, the term "medical procedure" is used to refer to a therapeutic procedure or examination of a target tissue using a tool. As such the terms "medical procedure" can refer to the injection of a therapeutic or diagnostic substance within a target tissue using a hypodermic needle, the removal of cells or a solution from the target tissue using a hypodermic needle, or viewing the target tissue using an endoscope. Medical procedures may include treatment or diagnosis of a target tissue for therapeutic, preventive or research purposes.

References: 100: Three-Stage system in accordance to one embodiment of the present invention.

1 : Stage I.

2: Stage II.

3 : Stage III hypodermic needle.

4: Hub of first tube 12.

5: Knob of first rod 10.

6: Hub of second tube 22.

7: Knob of second rod 20.

10: Stage I rod or first rod. 11 : Gap between the outer surface of the first rod 10 and the inner wall of the lumen of the first tube 12.

12: Stage I tube or first tube.

13 : Sharp pointed distal end of first rod 10.

14: Tapered distal end of first tube 12.

15: Tip formed by the combination of tapered 14 of distal end of first tube 12 and the sharp pointed distal end 13 of first rod 10.

16: Proximal end of first tube 12.

17: Proximal end of first rod 10.

18: Aperture at distal end of first tube 12.

19: Aperture at proximal end 16 of first tube 12.

20: Stage II rod or second rod (reference number 20 is used to refer to a second rod having a sharp end 23a, or a blunt end 23b).

21 : Gap between the outer surface of the second rod 20 and the inner wall of the lumen of the second tube 22.

22: Stage II tube or second tube.

23a: Sharp pointed distal end of second rod 20.

23b: Blunt distal end of second rod 20.

24: Tapered distal end of second tube 22.

25: Tip formed by the combination of tapered distal end 24 of second tube 22 and sharp pointed distal end 23a of second rod 20.

26: Proximal end of second tube 22.

27: Proximal end of second rod 20.

28: Aperture of distal end of second tube 22.

29: Aperture of proximal end of second tube 22.

30: Stage III hypodermic needle.

31 : Proximal end of hypodermic needle 30.

32: Hypodermic needle hub.

40: Tube for in vitro experiments.

41 : Top agar layer of tube 40.

42: Bacteria layer of tube 40. 43 : Lower agar layer of tube 40.

44: saline layer of tube 40.

62: skin and subcutaneous tissue.

64: muscle.

66: Joint capsule.

68: Joint Space.

Overview

The present invention provides for a system that circumvents the problem of contaminating joints and deep tissues with skin microbiota by separating the high contamination risk skin puncture from the puncture of the joint capsule or other deep tissue target.

The inventors have shown that using a single hypodermic needle will cause skin contaminants to be stored inside the hypodermic needle lumen and carried to deeper tissues, including the joint space. A risk also exists of pushing contaminants from the skin directly into the joint if a single needle were to be used in a single pass. The system of the present invention prevents contaminants from entering the needle lumen by inserting into the needles' lumen, tightly fitting guiding rods. By deploying a needle system assembly in at least 3 different stages, the system of the present invention prevents pushing contaminants from the skin into the join space by creating an aseptic passage right down to the joint capsule, allowing the main hypodermic biopsy needle to pierce the uncontaminated capsule and access the joint space. Although the dimensions described herein below address mainly a shoulder joint, of course the system of the present invention may be used in other joints or other target tissues as well.

Disclosed herein is a system and a method for creating an aseptic passageway from the skin and into a joint cavity to reduce the chance of infection, for example from Propionibacterium acnes (currently being re-classified as Cutibacterium acnes), during a medical procedure in the joint.

With reference to FIGs. 1 and 2 the components of a needle system 100 in accordance to one embodiment of the present invention include: stage I 1 guiding rod 10 and stage I tube 12, stage II 2 guiding rod 20 and stage II tube 22, and stage III 3 hypodermic needle 30.

Stage I Stage I 1 aims to provide a sterile lumen or passage through contaminated skin through which the needles and tubes of the subsequent stages can be introduced. This sterile lumen or passage eliminates direct contact of the eventual hypodermic needle with the contaminated skin surface. It is important for the Stage III hypodermic needle to remain sterile as this is a component that will come into contact with the joint space.

As shown in FIG. 1, Stage I includes the stage I tube 12, also referred to as first tube, for housing an inner guiding rod 10, also referred to as first rod, that can be slid inside the lumen of outer tube 12. The goal of the Stage I is to pierce the skin and penetrate right below it which probably is less than one centimeter throughout the body. As such, the length of the first tube 12 and the first rod 10 should be one that is stable enough that would remain in the skin while allowing it to be manipulated. The outer first tube 12 may be an about 0.5-1 inch (1.27 - 2.54 cm) long and may have a 14G outer tube housing a 16G inner guiding first rod 10. The circumferential gap 11 between the first rod's 10 outer surface and the inner wall of the second outer tube's 12 lumen is less than 0.1 mm, for example between about 0.05 mm and about 0.07 mm, allowing for a tight fit between the guiding first rod 10 and the outer first tube 12 when the first rod 10 is inside the first tube 12. The guiding first rod 10 occupies the first tube 12 lumen to prevent backflow of contaminants upon insertion and to provide a definite tip to the first tube 12 to allow easy penetration through tissue.

The gap 11 tolerance chosen should allow for a tight fit while allowing easy insertion and removal. The inner wall of the tube 12 and the rod 10 may be of stainless steel material. The inner wall of the tube 12 and rod 10 may also be coated with a polymer compound to allow a tighter seal to prevent back flow.

The first tube 12 is provided with an aperture 19 at its proximal end and an aperture 18 in its distal end. The first tube 12 is provided with a taper 14 at its distal end. The first tube 12 receives the guiding first rod 10 through its aperture 19 at the proximal end. The guiding first rod 10 is provided with a sharp pointed distal end 13. The sharp pointed distal end 13 extends distally through distal aperture 18 when the first tube 12 and the first rod 10 are assembled together for penetrating the skin surface.

The taper 14 and the sharp end 13 of the first tube 12 and the first rod 10 form between them a substantially conical tip 15, for example of between 4-7mm after maximal insertion of the rod inside the tube.

As illustrated in FIG. 2K, at its proximal end 16, the outer first tube 12 may have a hub 4 and the proximal end 17 of the first rod 10 may be fitted with a knob 5, such that when the components are fully assembled, the guiding rod knob interlocks with the tube hub. The assembled Stage I needle allows for a seamless distal tip between the two components and for easy manipulation of both components by only holding the outer tubing hub.

An operator would insert the first rod 10 into the hub 4 and the tapered shape of the hub 4 will guide the first rod 10 to the aperture 19 of the first tube 12. The knob 5 on the proximal end 17 of the first rod 10 will interlock with the hub 4. The length difference between the first tube 12 and the first rod 10 takes into account the optimal amount of rod protrusion from the tube so that the tapers 14 on the first rod's 10 tip and tube line up perfectly forming one tip 15. When the first rod 10 is inserted maximally so that the knob 5 locks to the hub 4, the first rod's 10 tip 13 will be protruding at that optimal distance to allow a cohesive taper with the first tube 12. Stage II

Stage 2 creates a second inner sterile lumen or passage from outside the skin down to a joint capsule, such as a shoulder, knee, elbow, hip and so forth. Although Stage I prevents direct contact of subsequent stages with the skin, contaminated debris can be left over near the Stage I tube opening inside the tissue from the penetration process. This can potentially extend the contamination down to the joint capsule and subsequently be introduced into the joint space by the hypodermic needle if Stage I were to be advanced all the way to the capsule. As such Stage 1 1 is used to penetrate the superficial layers of tissue and Stage II 2 is used for further penetration into deep tissue. Stage II will allow extension of the sterile passage or lumen all the way down to the joint's capsule surface for the Stage III hypodermic needle to penetrate while protecting Stage III from any leftover contamination at the distal end of Stage I.

With continued reference to FIGs. 1 and 2, Stage II 2 has a substantial identical set up as Stage I 1, including a Stage II outer tube, or second tube 22 with an interlocking inner second guiding rod 20. The main difference between the components of Stage I and Stage II is that the second outer tube 22 is longer than first tube 12 (for example about 2-3 inch (5.08-7.62 cm) long) with a narrower bore diameter, such as 16G, and the inner second rod 20 having a narrower bore diameter than the first rod 10, for example the second rod 20 may be 18.5G. The second tube 22 has an outer diameter that is substantially similar to the outer diameter of the first rod 10, such that the second tube 22 can be inserted into the lumen of the first tube 12. The second rod 20 has an outer diameter that allows for a tight fit within the lumen of the second tube 22. The gap 21 between the second rod 20 and the inner wall of the lumen of the second tube 22 may be between about 0.05 mm-0.07 mm.

The second tube 22 is provided with an aperture 29 at its proximal end and an aperture 28 in its distal end. The lumen of the second tube 22 extends from the proximal end aperture 29 to the distal end aperture 28. The second tube 22 is provided with a taper 24 at its distal end. The second tube 22 receives the second guiding rod 20 through its aperture 29 in the hub 6 at the proximal end. The second guiding rod 20 is provided with either a sharp pointed distal end 23a or a blunt end 23b as shown in FIG. 2J. The sharp pointed distal end 23a or the blunt end 23b extends distally through distal aperture 28 when the second tube 22 and the second rod 20 are assembled together for penetrating the subcutaneous muscle and other tissues.

The taper 24 and the sharp end 23a of the second tube 22 and the second rod 20 form between them a substantially conical tip 25, such as of 3.5 mm - 4.5 mm, after maximal insertion of the second rod 20 inside the second tube 22. The second tube 22 and second rod 20 are fitted with the same connectors as stage I, that is at its proximal end 26, the second tube 22 may have a hub 6 and the proximal end 27 of the second rod 20 may be fitted with a knob 7, and are assembled in the same manner as in Stage I as illustrated in FIG. 2K. The Stage II outer second tube 22 has the same outer diameter as the Stage I first rod 10 to allow a tight fit and prevent backfiow of contaminants between the tube surfaces. The blunt end 23b may be advantageous in preventing piercing of a joint capsule. Having a second rod 20 with a blunt end that can make detection of a target tissue, such as the joint capsule, easier, while having a second rod 20 with a sharp distal end form a piercing tip with the tapered second tube 22 end that can make piercing the target tissue easier.

An operator would insert the second rod 20 into the hub 6 and the tapered shape of the hub 6 will guide the second rod 20 to the aperture 29 of the second tube 22. The knob 7 on the proximal end 27 of the second rod 20 will interlock with the hub 6. The length difference between the second tube 22 and the second rod 20 takes into account the optimal amount of rod protrusion from the tube so that the tapers 24 on the second rod's 20 tip and tube line up perfectly forming one tip 25. When the second rod 20 is inserted maximally so that the knob 7 locks to the hub 6, the second rod's 20 tip 23a,b will be protruding at that optimal distance to allow a cohesive taper with the second tube 22.

The Stage II second rod's 20 and second tube's 22 length are longer than Stage 1 first rod 10 and first tube 12, allowing for adjusting the insertion depth of Stage II in accordance with anatomical variations of different individuals. Stage II length allows enough manipulation room while ensuring adequate penetration depth.

Stage III

With continued reference to FIGs. 1 and 2, stage III comprises a hypodermic needle 30, such as a 4 inch long 18.5 G Quincke tip hypodermic needle. The proximal end 31 of needle 30 may be fitted with a generic hypodermic needle hub 32 (shown in FIG 4.) that allows fastening to a syringe. The biopsy needle having (a) an outer diameter that is substantially similar to the outer diameter of the second rod 20 such that it can fit within the lumen of the second tube 22, and (b) a sharp pointed distal end that extends beyond the distal end of the second tube when the biopsy needle is assembled inside the lumen of the second tube 22.

A complete assembly of the present invention is illustrated in the photograph of FIG. 4.

Operation

FIG. 6 is a diagram showing a cross section from the skin 62 to the joint capsule 68 with the Stage I shown on the left side of the diagram, and Stage III assembly on the right side of FIG. 6. For in vivo operation, Stage 1 1 components may be preassembled prior to use. The assembled first tube 12 and first rod 10 can be manipulated using the operator's fingers over the hub 4 and knob 5 to make sure pressure on the first rod 10 tip does not dislodge the knob 5 from the hub 4. The assembly of Stage I will be advanced through sterilized skin over the particular joint being tested. The initial insertion should ideally be through a patch of skin clear of any hair to about a 5mm radius depending on the patient. One major contamination risk is piercing a hair follicle during the insertion. It would be difficult, if not impossible, to know where the hair follicles are as they lie in the dermis deep in the skin. However, making the effort to not penetrate directly into a hair root on the skin surface can potentially decrease the risk of penetrating any hair follicles deep to the area. The first tube 12 will be advanced until the distal end of the Stage 1 hub 4 sits flush with the skin preventing further penetration (shown in FIG. 6). This will ensure an about 0.5 to 1 inch (1.27 - 2.54 cm) penetration through the skin and subcutaneous tissue 62 as to ensure complete clearance of the skin layer. The first rod 10 will be subsequently unlocked from the proximal hub and removed from the tube exposing the lumen of the Stage I first tube 12 into subcutaneous tissue 62 walled by the sterile inner wall of first tube 12, as shown on the left side of FIG. 6. The lumen of the Stage I first tube 12 will be used for coaxial insertion of Stage II to allow further penetration through muscle 64 down to the joint capsule surface 66. The inserted Stage I first tube 12 depth may not need to be supported by the operator after full insertion of Stage II as compression from surrounding tissue will keep the Stage I tube in position, allowing for the operator' s hands to focus on handling Stage II and Stage III with each hand.

After completion of the Stage I process, the Stage II second tube 22 and second rod 20 assembly will be inserted through the now open lumen of the Stage I first tube 12. The angle of insertion will be the same as conventional joint injection approaches specific to the particular joint, such as shoulder joints. The stage II assembly 2 will be advanced until resistance from the joint capsule 66 is felt by the operator. At this point the Stage II second rod 20 is unlocked from the hub and removed, exposing the lumen of the Stage II second tube 22 for the final Stage III hypodermic needle 30. Throughout this process, Stage I 1 will be held in position through compression by surrounding tissue, allowing the operator to position and maintain Stage II 2 at the desired depth near the capsule surface with one hand while inserting Stage III hypodermic needle 30 with the other hand into the open lumen of the Stage II second tube 22.

At this stage, the system of the present invention has created an aseptic or sterile passage from the hub opening on the Stage II tube down to the surface of the shoulder joint capsule at the Stage II distal tube opening. Stage III hypodermic needle 30 will be inserted through the lumen of the Stage II second tube 22 and will penetrate the joint's capsule 66 gaining access to the shoulder joint space 68 and synovial fluid. Stage III hypodermic needle 30 will be removed with Stages I and II in place once the desired amount of synovial fluid has been obtained. Stages II and I will subsequently and sequentially be removed after complete removal of Stage III hypodermic needle 30.

Method

The present invention relates also to a method of creating an aseptic passageway from the skin to a joint's space. The method, in one embodiment, includes: (a) advancing the first stage assembly 1 through skin, (b) removing the first rod 10 whereby the lumen of the first tube 12 provides for a first aseptic lumen through skin, (c) advancing the second stage assembly 2 through the lumen of the first tube 12 until the distal end of the second rod 20 reaches a joint capsule, (d) removing the second rod 20 whereby the lumen of the second tube 22 provides for a second sterile lumen from skin to the joint capsule, and (e) advancing the hypodermic needle through the second aseptic lumen and penetrating the joint capsule thereby accessing the joint's space through an aseptic passage from the skin to the joint's space. The aseptic lumen to the joint's space can also be used to advance other tools, such as an arthroscope to examine the joint's space.

Advantages

The general purpose of the system of the present invention is to decrease rates of joint contamination with skin microbiota during joint injections. This method of hypodermic needle deployment can have many applications for different joints in the body. The main advantage of the system of the present invention is the ability to establish an aseptic path from the skin surface down to any joint capsule. Although the design described above is optimal for shoulder joints, the same methodology can be employed in other joints such as knees, hips, and vertebra with optimal component lengths determined through further research, and bundled as different joint specific kits.

In addition, the third stage of the present system can be very versatile as different tools can be safely inserted inside the joint once the aseptic path to the capsule is established. This allows for our deployment system to be used to perform a number of different j oint procedures such as joint steroid injections, joint fluid aspirations, and insertion of tissue biopsy instruments instead of the Stage 3 hypodermic needle described above.

The system of the present invention is not limited to fluid biopsy or injection. It can also be used with a soft tissue biopsy tool, such as in the case of breast tissue biopsy, or for hard tissues such as for bone coring. Many of these procedures are performed on an outpatient basis by a single operator without the use of imaging technologies such as Ultrasound or CT scans. The system of the present invention is configured to be deployed by a single operator using the same skills needed for current joint injection methods common to outpatient health care facilities. This allows the system of the present invention to be used at any facility that currently conduct joint injection procedures.

Examples

FIG. 3 is a diagram of a tube 40 having a top agar layer 41, a bacteria layer 42, a bottom saline layer 44 and a lower agar layer 43 located between the saline layer 44 and the bacteria layer 42. The tube depicted in FIG. 3 is used for in vitro testing of the system 100 of the present invention as illustrated in FIG. 2 and in FIG. 5. The top agar layer 41 and the bacteria layer 42 represent contaminated skin. The lower agar layer 43 represents tissue found between the skin and the joint capsule. The wave 45 interface between the lower agar layer 43 and the saline layer 44 represents the joint capsule. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein. Such equivalents are intended to be encompassed by the following claims.

The following claims are provided to add additional clarity to this disclosure. Future applications claiming priority to this application may or may not include the following claims, and may include claims broader, narrower, or entirely different from the following claims.

Claims

CLAIMS What is claimed is:

1. A multi-stage needle assembly comprising:

(a) a first stage comprising:

- a first tube having (i) a lumen and (ii) a tapered end, and

- a first rod having (i) an outer diameter that allows for a tight fit within the lumen of the first tube, and (ii) a sharp pointed distal end that extends beyond the tapered end of the first tube when the first rod is assembled inside the lumen of the first tube, and forms a piercing tip with the tapered end of the first tube;

(b) a second stage comprising:

- a second tube having (i) an outer diameter that is substantially similar to the outer diameter of the first rod, (ii) a lumen and (iii) a tapered end that extends beyond the distal end of the first tube when the second tube is assembled inside the lumen of the first tube, and

- a second rod having (i) an outer diameter that allows for a tight fit within the lumen of the second tube, and (ii) a distal end that extends beyond the tapered end of the second tube when the second rod is assembled inside the lumen of the second tube, and forms a second tip with the tapered end of the second tube; and

(c) a third stage comprising a needle, the needle having (a) an outer diameter that is substantially similar to the outer diameter of the second rod, and (ii) a sharp pointed distal end that extends beyond the distal end of the second tube when the needle is assembled inside the lumen of the second tube.

2. The multi-stage needle of claim 1, wherein the distal end of the second rod is a sharp pointed end or a blunt end.

3. The multi-stage needle of claim 1, wherein the third stage needle is a hypodermic needle.

4. A method of creating an aseptic passageway from a skin surface to a target tissue, the method comprising: (a) providing a first stage assembly comprising a first tube having (i) a lumen and (ii) a tapered end, and a first rod having (i) an outer diameter that allows for a tight fit within the lumen of the first tube, and (ii) a sharp pointed distal end that extends beyond the tapered end of the first tube when the first rod is assembled inside the lumen of the first tube, and forms a piercing tip with the tapered end of the first tube, and advancing the piercing tip through the skin,

(b) removing the first rod, whereby the lumen of the first tube provides for a first aseptic lumen though the skin,

(c) providing a second stage assembly comprising a second tube having (i) an outer diameter that is substantially similar to the outer diameter of the first rod, (ii) a lumen and

(iii) a tapered end that extends beyond the distal end of the first tube when the second tube is assembled inside the lumen of the first tube, and a second rod having (i) an outer diameter that allows for a tight fit within the lumen of the second tube, and (ii) a distal end that extends beyond the tapered end of the second tube when the second rod is assembled inside the lumen of the second tube, and forms a second tip with the tapered end of the second tube, and advancing the second tip until the sharp pointed or blunt distal end of the second rod reaches the target tissue, and

(d) removing the second rod whereby the lumen of the second tube provides for the aseptic lumen from the skin to the target tissue.

5. The method of claim 4, wherein the distal end of the second rod is a sharp pointed distal end, and the second tip is a piercing tip, and wherein prior to step (d) the method further comprises piercing the target tissue with the piercing tip, whereby the lumen of the second tube provides for an aseptic lumen from the skin to the inside of the target tissue.

6. The method of claim 5, wherein the method further comprises advancing a tool through the aseptic lumen from the skin to the inside of the target tissue, and performing a medical procedure in the target tissue with the tool.

7. The method of claim 6, wherein the tool is a hypodermic needle or an endoscope.

8. The method of claim 4, wherein the distal end of the second rod is a blunt distal end, and the second tip is a blunt tip, and wherein prior to step (d) the method further comprises detecting a surface of the target tissue with the blunt tip.

9. The method of claim 8, wherein the method further comprises advancing a needle through the second aseptic lumen to the surface of the target tissue, and piercing the surface of the target tissue with the needle.

10. The method of claim 9, wherein the target tissue is a joint having a joint capsule and a joint space, and wherein the needle is advanced through the joint capsule into the joint space through the aseptic lumen from the skin to the joint capsule.

11. A method of performing a medical procedure in a target tissue, the method comprising:

(a) providing a first stage assembly comprising a first tube having (i) a lumen and (ii) a tapered end, and a first rod having (i) an outer diameter that allows for a tight fit within the lumen of the first tube, and (ii) a sharp pointed distal end that extends beyond the tapered end of the first tube when the first rod is assembled inside the lumen of the first tube, and forms a piercing tip with the tapered end of the first tube, and advancing the piercing tip through the skin,

(c) providing a second stage assembly comprising a second tube having (i) an outer diameter that is substantially similar to the outer diameter of the first rod, (ii) a lumen and (iii) a tapered end that extends beyond the distal end of the first tube when the second tube is assembled inside the lumen of the first tube, and a second rod having (i) an outer diameter that allows for a tight fit within the lumen of the second tube, and (ii) a distal end that extends beyond the tapered end of the second tube when the second rod is assembled inside the lumen of the second tube, and forms a second tip with the tapered end of the second tube, and advancing the second tip until the distal end of the second rod reaches the target tissue, (d) removing the second rod whereby the lumen of the second tube provides for the aseptic lumen from the skin to the target tissue, and

(e) advancing a tool through the aseptic lumen of the second tube to the target tissue and performing the medical procedure in the target tissue with the tool.