HOLLOW NEEDLE FOR ACCESS IN NON-LINEAR PATH

Abstract

A hollow needle, for use in medical and other areas where thin hollow needles are used to inject or aspirate fluids and gases, is provided and comprises of a thin, rigid tube body that is open on both ends and throughout the length with one sharp end. The needle body is designed and can be manufactured with a curved shape and or other geometric features, can be drawn to a desired curvature with heat, or can be curved afterwards, to specific specifications depending on the application. The needle so configured advantageously allows the user to circumvent an obstacle and or obstacles that otherwise inhibit direct linear access to a point-of-interest by providing a device that can take the sharp point of a needle on an indirect path towards the desired therapy delivery point.

Claims

19. A hollow needle comprising: a generally rigid tube, having a generally circular cross section, comprising a first segment defining a first opening and a second segment characterized as having a portion of the generally rigid tube cutaway, at a distal end, to form a profile wherein a sharpened point and an opening are created, with a hollow shaft therebetween; the generally rigid tube haying a proximal portion comprising a straight segment of shaft defining a shaft longitudinal axis, and a distal portion which is curved relative to the shaft longitudinal axis, such that the curved distal end of the shaft and the sharpened point are curved assay from the shaft longitudinal axis and the adjacent opening opens to the inside of the curve; and wherein the sharpened point of the hollow needle can penetrate a surface, at a desired location, followed by the generally rigid tube, the sharpened point and tube then being forced through a non-linear path from the surface penetration point around an obstruction and to a desired point in the body.

20. The hollow needle of claim 19, wherein the distal end of the shaft and point curve between 5 degrees and 90 degrees away from the shaft longitudinal axis.

21. The hollow needle of claim 19, wherein the shaft and point curve 45 degrees away from the shaft longitudinal axis.

22. The hollow needle of claim 19, wherein the distal end of the shaft is further curved to give the distal end of the needle a compound curvature in a varied direction.

23. The hollow needle of claim 19, wherein a diameter of the generally rigid tube is consistent throughout a length of the needle.

24. The hollow needle of claim 19, wherein the opening adjacent the sharpened point is generally oval shaped.

25. The hollow needle of claim 19, wherein the needle is cast with the curve.

26. The hollow needle of claim 19, wherein the needle is heated and drawn to a desired curvature.

27. The hollow needle of claim 19, wherein the needle is bent further after primary manufacture.

28. The hollow needle of claim 19, wherein the needle is made of a material allowing the needle to be bent further, and retain the new bend, after manufacture and just prior to penetration.

29. The hollow needle of claim 28, wherein such bending is done using methods and devices that can cause a desired bend while maintaining the structural integrity of the needle.

30. The method of use of a partially curved needle having both a curved section and a sharpened point at a distal end of the needle and having a straight section at the proximal end the sharpened point being curved away from a longitudinal axis of the straight section of the partially curved needle and having an opening adjacent thereto, the opening placed on the concave part of the curve of the needle, to reach a point of interest within a surface or barrier, including the steps of: placing the sharpened point of the needle upon the barrier or surface to be pierced; and, applying force to the proximal end of the needle to cause the sharpened point to pierce the barrier or surface and pushing the sharpened point and attendant shaft around an obstacle and towards the point-of-interest.

31. The method of use of claim 30, wherein the sharpened point is placed on a finger, having at least a tendon and a pulley, and the sharpened point of the needle is pushed between the pulley of the finger and the at least one tendon of the finger to reach the point-of-interest.

32. The hollow needle of claim 19, wherein the needle is attached at its proximal end to a Luer fitting

33. The hollow needle of claim 19, wherein the curve of the distal portion of the generally rigid tube defines a center of curvature defining an inner concave curve and an outer convex curve, the sharpened point at the distal end of the tube being located substantially on the outer convex curve of the generally rigid tube, the generally oval opening being located on the inner concave curve of the generally rigid tube.

34. A hollow needle, comprising: a generally rigid tube, having a generally circular cross section, comprising a first segment defining a first circular opening, and a second segment having a sharpened point defining a second opening, with a hollow shaft therebetween; the generally rigid tube having a proximal portion comprising a straight segment of shaft defining, a shaft longitudinal axis, the generally-rigid, tube having a central portion which is multiply-curved, wherein, a first curve, relative to the shaft longitudinal axis occurs such that a proximal end of the central portion of the shaft curves away from the shaft longitudinal axis about a second axis, generally perpendicular to the shaft longitudinal axis, and a second curve occurs, relative to the second axis, such that a distal portion section of the central portion is curved relative to a third axis that is offset to the shaft longitudinal axis, to allow the sharpened point of the hallow needle to penetrate a surface, at a location, followed by the tube, the sharpened point and tube then being forced through a non-linear path from the surface penetration point around one or more obstructions and to a desired place in the body for deposit or collection of fluids, through the hollow needle, or both.

35. The hollow needle of claim 34, wherein the tube is further curved so that the third axis is generally perpendicular to the shaft longitudinal axis.

36. The hollow needle of claim 34, wherein the tube is further curved so that the third axis is generally parallel to the shaft longitudinal axis.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0016] A better understanding of the present invention may be obtained with reference to the following description in conjunction with the drawings in which:

[0017] FIG. 1 is a front elevational view of a hollow needle of the prior art.

[0018] FIG. 1A is a cross sectional view of the hollow needle of FIG. 1, taken along the line 1A-1A of FIG. 1.

[0019] FIG. 2 is a front elevational view of a prior art hollow needle, shown in two potential start positions towards endeavoring to access the point-of-interest.

[0020] FIG. 3 is a front elevational view of one embodiment of the hollow needle of the present invention.

[0021] FIG. 3A is a cross sectional view of the hollow needle of FIG. 3, taken along the line 3A-3A of FIG. 3.

[0022] FIG. 3B is a front elevational view of another embodiment of the hollow needle of the present invention.

[0023] FIG. 3C is a bottom plan view of the needle of FIG. 3B.

[0024] FIG. 4 is a front elevational view of one embodiment of the hollow needle of the present invention in the start position prior to accessing the point-of-interest under the skin.

[0025] FIG. 5 is a front elevational view of one embodiment of the hollow needle of the present invention in the end position while accessing the point-of-interest under the skin by avoiding the obstructions.

DETAILED DESCRIPTION OF THE ILLUSTRATIVE EMBODIMENT

[0026] While the present invention is susceptible of embodiment in various forms, there is shown in the drawings a number of presently preferred embodiments that are discussed in greater detail hereafter. It should be understood that the present disclosure is to be considered as an exemplification of the present invention, and is not intended to limit the invention to the specific embodiments illustrated. It should be further understood that the title of this section of this application (“Detailed Description of the Illustrative Embodiment”) relates to a requirement of the United States Patent Office, and should not be found to limit the subject matter disclosed herein.

[0027] Referring to FIGS. 1 and 1A, a needle or cannula 10 of the prior art is shown and includes a straight hollow needle tube 12 and a leading cutting edge 14. Needles 10 are typically made of three parts, the hub 8, the shaft 12 and the bevel 14. The hub 8 is at one end of the needle and is the part that attaches to a syringe or other medical apparatus. The shaft 12 is the long slender stem of the needle 10 that is beveled 14 at one end to form a point. The hollow bore of the needle is known as the lumen 13. Needle 10 is generally cylindrical and has comprises an inner generally cylindrical hollow section or lumen 13 therewithin, running the entire length of the needle 10. FIG. 1A, clearly shows the cross sectional view including the exterior surface 10a of the needle 10 and interior surface 10b of the hollow section 13 of the needle 10. It will be seen that the prior art needle is generally straight and when used as designed, provides access, to among other things, the interior of a body, by the puncturing of the skin or other barrier and thereby provides straight line access between an item connected to the needle and a body.

[0028] FIG. 2 illustrates a prior art hollow needle 15 shown in at least two positions, designated as positions 48 and 50 for ease of review. Position 48 shows a needle being driven at an angle towards a surface 44. It will be understood by persons having ordinary skill in the art that such a needle can be driven towards a surface at any angle relative to the surface, the illustrated position being only an example of such an angel. Position 50 shows a needle being driven at generally perpendicular to surface 36, which is of course one of the angels noted above, but is shown here to provide an example. Returning to FIG. 2, the needles in each of the two positions 48, 50 are being driven in an endeavor to access the point-of interest 34 by penetrating the skin 36. In position 48, an obstruction 44 is shown outside the skin 36 and blocks the straight access to point-of-interest 34. Similarly, in position 50, hollow needle 15 is inhibited from accessing the point-of-interest due to the embedded obstruction 42. Persons having ordinary skill in the art will recognize obstructions 42 and 44 can be of any type known, including natural occurring blocks such as tissue, organs, bone, tendons etc., as well as man made blockages such as implants, casts, bandages, etc.; further, the obstruction that blocks access externally can be a result of the position of the patient relative to the point-to-be accessed.

[0029] Referring now to FIGS. 3, 4 and 5, a hollow needle 20 of the present invention is illustrated, comprising a thin, rigid tube body or shaft 22 receiving a syringe attachment mechanism (commonly a luer lock is used) 24 at end 26. Although this embodiment describes the use of a luer lock, other attachment mechanisms or hubs may be used for connection of the hollow needle 20 to a syringe or other medical device as known to persons having ordinary skill in the art. The most common connection of medical needles is a syringe, which typically comprises a cylindrical tube within which a plunger moves along its longitudinal axis 17 in a cavity designed to hold or receive liquids to inject or retract a substance from or into the syringe through the lumen 13 of needle 20 to or from a point-of-interest 34 under the skin 36. At the other end 28 of the body or shaft 22 there is a sharp tip 30 that is typically beveled, serrated, pronged, or otherwise configured to facilitate penetration of the skin 36 and other tissue and or substances 38 that's between the skin and the point-of-interest 34. Along the body or shaft 22 the hollow needle 20 of the present invention is provided with a curvature 32. The nature and dimensions of the curvature 32 is driven by the relative locations of the penetration point 40, the embedded obstruction 42, the outside obstruction 44, and the point-of-interest 34. It will be understood that the curvature 32 can have a variety of geometric features. Force and guidance is applied to the hollow needle at the starting position 40 to enable the hollow needle to penetrate the skin 36, to penetrate the other tissue and or substances 38, to circumvent the embedded obstruction 42, to circumvent the outside obstruction 44, to access the point-of-interest 34. All the time it will be understood that the direction of movement always follows the sharp tip 30 so as to cause the least harm to the tissue being penetrated. When tip 30 reaches the point-of-interest 34 the ending position 46 is achieved and the plunger on the syringe is engaged to commence aspiring and or injecting and or drawing. At the conclusion of the aspiring and or injecting and or drawing, the hollow needle 20 is retracted; pulled from the surface in a slow deliberate manner that allows the needle to retrace the insertion path on its way out, so as to cause as little harm as possible to the tissue. It will be understood by persons having ordinary skill in the art, that the use of a syringe to inject or remove fluids is an example of what can be done with the needle of the present invention and that any task which is facilitated by the use of a needle can be accomplishes with the present invention, including but not limited to injection, aspiration, catheterization, fluid insertion such as through intravenous drip and others, without departing from the novel scope of the present invention.

[0030] It will be seen that in at least one embodiment, the curvature of the needle is between 5 and 90 degrees relative to the center-line 17 of the needle and the degree of curvature is determined by the use of the needle and the needs of the body into which it is driven. In a preferred embodiment, the curvature of the needle is 45 degrees relative to the center-line 17 of the needle. It will be understood by persons having ordinary skill in the art that a bend between 0 degrees and 90 degrees, in any incremental angle, can be made without departing from the novel scope of the present invention. In the illustrative embodiment of the present invention, the curved portion 20c of the needle 20 occurs in the lower third of the shaft 22. It will be understood by persons having ordinary skill in the art that as needed, the curved portion 20c of a needle can be made at any point in the shaft 22 as required by the point-of-interest and the difficulty of approach. Persons having ordinary skill in the art will understand that the manufacture of the curve in a needle needs to be made in such a manner that the internal lumen is curved with the tube and that the lumen is not diminished significantly in diameter throughout the straight and curved sections of the needle. Such methods as drawing under heat or forcefully bending after packing an agent within the lumen and then using pipe-bending techniques to gradually curve the needle and then removing the packing to clear the lumen prior to use are but two of the many techniques that can be used to bend the needle of the present invention. Additionally the needle can be cast to the desired curve or can be heated until the meal is pliable and then bent are among the variety of ways that needles of the present invention can be formed with a curve.

[0031] Furthermore, a needle can be curved in a first direction and then as needed curved again, with more than one bend and in more than one direction. Such is shown in FIGS. 3B and 3C, where in addition to the curve 32 shown in FIG. 3, the needle is then curved again 32a distally from the curve 32, so that its point 30, as shown in FIG. 3B, is turned generally so that the end can be seen coming out of the page. While multiple curves would provide a more specialized path into a body, it will be understood by persons having ordinary skill in the art that specialized planned curved needles can be made in accordance with the teachings of the present invention to provide access to points-of-interest that are otherwise difficult to reach without departing from the teachings of the present invention.

[0032] One simple example, to show the improved results of using the present invention, is in the treatment of stenosing tenosynovitis, commonly known as trigger finger. As is known, the tendons that bend the fingers glide easily with the help of the annular ligaments or pulleys. Annular ligaments are fibrous sheaths that are thick and strong as required by the repetitive use that such a system by nature necessitates. Trigger finger occurs when the pulley becomes too thick, such as through swelling due to repetitive use injury, so that the tendon cannot glide easily through the pulley; this often manifests itself in a finger that is locked in place, in a “trigger-like” shape. Treatments of trigger finger include surgery, to open a section of the thick and fibrous pulley so as to allow the easier passage of the tendon therein and injection of a steroid to reduce the swelling. Oftentimes a doctor will first choose to provide an injection of a steroid between the tendon and pulley to reduce the swelling of the tendon and allow the tendon to glide through the pulley before considering surgery. In conventional treatment, a doctor will use a straight needle to inject into the finger, in a generally perpendicular motion relative to the finger, through the pulley and tendon and often to the bone. The patient will then wiggle the finger to allow the doctor to retract the needle; stopping the retraction when the syringe attached to the needle no longer wiggles with the finger. This is an indication that the needle is no longer in the tendon, such that the doctor can inject the medicine in the space between the tendon and pulley.

[0033] This technique is problematic in that damage is done to the pulley and tendon by being pierced with the needle and the patient is subjected to pain. A better technique would be to use the same needle to pierce the finger horizontally and drive the needle between the pulley and tendon; however, a straight needle will not work for this, due to the angles that the needle will need to take, as a result of the compactness of the tendon and pulley system.

[0034] We have discovered that the needle of the present invention, which as described above, can pierce the skin at one location and as a result of its configuration, be driven around the impediment to provide an appropriate dose of medicament to the exact location of the problem. Such an action can provide relief with a single treatment and not damage the pulley or tendon. The bend in the needle of the present invention provides an appropriate angle to pierce the skin, and drive, generally horizontally, between the tendon and pulley and there deliver the medicine where needed. Little or no damage is then done to the pulley or tendon, and the patient has less discomfort as a result; treatment is completed more quickly and is more effective.

[0035] In the treatment of trigger finger it will be understood that a finger so affected is often caused, by the condition, to be bent so that the finger itself is a barrier to an injection between the pulley and the tendon. The bent condition, as is known to persons having medical experience, typically results because the swollen or enlarged part of the tendon is trapped within the thick and fibrous pulley such that a needle cannot reach the location of the swelling, both because of the position of the finger (bent back, over the palm of the hand) and because the point of interest is within the pulley.

[0036] In the use of the injection, it will be understood that because of the position of the finger, bent above the point of interest, and the pulley, which is thick and fibrous, each comprise a blockage of the space between the pulley and the tendon. For this reason, it is often the case that the space cannot be reached using the conventional treatment protocols noted above, resulting in the need for more than one treatment, causing more damage to the pulley and the tendon in an effort to provide sufficient medicament to arrive at the desired result. When the space cannot be reached, treatment may require surgery with all of the attendant issues and problems of surgery.

[0037] Although an illustrative embodiment of the invention has been shown and described, it is to be understood that various modifications and substitutions may be made by those skilled in the art without departing from the novel spirit and scope of the invention.