INTRODUCER NEEDLE AND RELATED SYSTEMS AND METHODS
20200324086 ยท 2020-10-15
Inventors
Cpc classification
A61B5/1535
HUMAN NECESSITIES
A61M5/3286
HUMAN NECESSITIES
A61M5/158
HUMAN NECESSITIES
International classification
Abstract
A distal end of a needle may include a distal tip. The distal end may also include a first beveled surface, a second beveled surface, and a third beveled surface, which may each extend proximally from the distal tip. The first beveled surface may converge with the second beveled surface to form a first cutting edge, the second beveled surface may converge with the third beveled surface to form a second cutting edge, and the third beveled surface may converge with the first beveled surface to form a third cutting edge. The first cutting edge may be offset from the second cutting edge by about 120 degrees, the second cutting edge may be offset from the third cutting edge by about 120 degrees, and the third cutting edge may be offset from the first cutting edge by about 120 degrees.
Claims
1. A catheter insertion device, comprising: a needle, comprising a distal end, a proximal end, and an elongated body extending between the distal end and the proximal end, wherein the distal end comprises: a distal tip; a first beveled surface extending proximally from the distal tip; a second beveled surface extending proximally from the distal tip; and a third beveled surface extending proximally from the distal tip, wherein the first beveled surface converges with the second beveled surface to form a first cutting edge, wherein the second beveled surface converges with the third beveled surface to form a second cutting edge, wherein the third beveled surface converges with the first beveled surface to form a third cutting edge, wherein the first cutting edge is offset from the second cutting edge by about 120 degrees, wherein the second cutting edge is offset from the third cutting edge by about 120 degrees, wherein the third cutting edge is offset from the first cutting edge by about 120 degrees; and a catheter, comprising a distal end, a proximal end, and a lumen extending through the distal end of the catheter and the proximal end of the catheter, wherein the needle extends through the catheter.
2. The catheter insertion device of claim 2, wherein the needle further comprises a flash groove, wherein the flash groove comprises a distal end proximate the first beveled surface, the second beveled surface, or the third beveled surface, wherein the flash groove further comprises a proximal end disposed proximal to the distal end of the catheter.
3. The catheter insertion device of claim 1, wherein the needle comprises a lumen extending through the proximal end of the needle, wherein the first beveled surface, the second beveled surface, or the third beveled surface comprises a hole in fluid communication with the lumen of the needle.
4. The catheter insertion device of claim 1, wherein a perimeter of the first beveled surface includes the first cutting edge, the third cutting edge, and a first proximal edge extending between the first cutting edge and the third cutting edge, wherein a perimeter of the second beveled surface includes the first cutting edge, the second cutting edge, and a second proximal edge extending between the second cutting edge and the third cutting edge, and wherein a perimeter of the third beveled surface includes the second cutting edge, the third cutting edge, and a third proximal edge extending between the second cutting edge and the third cutting edge.
5. The catheter insertion device of claim 4, wherein a first portion of the elongated body disposed between the first proximal edge and the second proximal edge is chamfered, a second portion of the elongated body between the second proximal edge and the third proximal edge is chamfered, or a third portion of the elongated body disposed between the second proximal edge and the third proximal edge is chamfered.
6. The catheter insertion device of claim 4, wherein a length of the first beveled surface from the distal tip to an apex of the first proximal edge is equal to a length of the second beveled surface from the distal tip to an apex of the second proximal edge is equal is a length of the third beveled surface from the distal tip to an apex of the third proximal edge.
7. The catheter insertion device of claim 4, wherein the perimeter of the first beveled surface, the perimeter of the second beveled surface, and the perimeter of the third beveled surface are equal.
8. The catheter insertion device of claim 4, wherein a length of the first beveled surface from the distal tip to an apex of the first proximal edge is greater than a length of the second beveled surface from the distal tip to an apex of the second proximal edge.
9. The catheter insertion device of claim 1, wherein the first beveled surface, the second beveled surface, and the third beveled surface are each planar.
10. The catheter insertion device of claim 1, wherein the needle is oriented within the catheter such that the first beveled surface, the second beveled surface, or the third beveled surface faces downwardly.
11. A needle, comprising: a distal end, comprising: a distal tip; a first beveled surface extending proximally from the distal tip; a second beveled surface extending proximally from the distal tip; and a third beveled surface extending proximally from the distal tip, wherein the first beveled surface converges with the second beveled surface to form a first cutting edge, wherein the second beveled surface converges with the third beveled surface to form a second cutting edge, wherein the third beveled surface converges with the first beveled surface to form a third cutting edge, wherein the first cutting edge is offset from the second cutting edge by about 120 degrees, wherein the second cutting edge is offset from the third cutting edge by about 120 degrees, wherein the third cutting edge is offset from the first cutting edge by about 120 degrees; a proximal end; and an elongated body extending between the distal end and the proximal end.
12. The needle of claim 11, wherein the needle is solid.
13. The needle of claim 12, wherein the needle further comprises a flash groove extending proximally from the first beveled surface, the second beveled surface, or the third beveled surface.
14. The needle of claim 11, wherein the needle comprises a lumen extending through the proximal end of the needle, wherein the first beveled surface, the second beveled surface, or the third beveled surface comprises a hole in fluid communication with the lumen of the needle.
15. The needle of claim 11, wherein a perimeter of the first beveled surface includes the first cutting edge, the third cutting edge, and a first proximal edge extending between the first cutting edge and the third cutting edge, wherein a perimeter of the second beveled surface includes the first cutting edge, the second cutting edge, and a second proximal edge extending between the second cutting edge and the third cutting edge, and wherein a perimeter of the third beveled surface includes the second cutting edge, the third cutting edge, and a third proximal edge extending between the second cutting edge and the third cutting edge.
16. The needle of claim 15, wherein the perimeter of the first beveled surface, the perimeter of the second beveled surface, and the perimeter of the third beveled surface are equal, and the distal tip is aligned with a central axis of the needle.
17. The needle of claim 15, wherein the perimeter of the first beveled surface, the perimeter of the second beveled surface, and the perimeter of the third beveled surface are not equal, and the distal tip is not aligned with a central axis of the needle.
18. A needle, comprising: a distal end, comprising: a distal tip; a first beveled surface extending proximally from the distal tip; and a second beveled surface extending proximally from the distal tip, wherein the distal end is closed along a central axis of the needle to prevent fluid from entering the distal end along the central axis.
19. The needle of claim 18, wherein the needle is solid.
20. The needle of claim 18, wherein the needle comprises a lumen extending through the proximal end of the needle, wherein the first beveled surface or the second beveled surface, comprises a hole offset from the central axis of the needle and in fluid communication with the lumen of the needle.
Description
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0022] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
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DESCRIPTION OF EMBODIMENTS
[0051] As used in the present disclosure, the term distal refers to a portion of a needle or a catheter assembly or component thereof that is farther from a user, and the term proximal refers to a portion of a needle or a catheter assembly or component thereof that is closer to the user. As used in the present disclosure, the term user may refer to a clinician, doctor, nurse, or any other care provider and may include support personnel.
[0052] Referring now to
[0053] In some embodiments, the distal end 12 of the needle 10 may include a distal tip 16, a first beveled surface 18 extending proximally from the distal tip 16, a second beveled surface 20 extending proximally from the distal tip 16, and a third beveled surface 22 extending proximally from the distal tip 16. In some embodiments, the distal tip 16 may include a sharp point for penetrating skin and the vein of the patient. In some embodiments, the distal tip 16 may be disposed radially inward from an outer surface of the elongated body 14.
[0054] In some embodiments, the first beveled surface 18 may converge with the second beveled surface 20 to form a first cutting edge 24. In some embodiments, the second beveled surface 20 may converge with the third beveled surface 22 to form a second cutting edge 26. In some embodiments, the third beveled surface 22 may converge with the first beveled surface 18 to form a third cutting edge 28. In some embodiments, one or more of the first beveled surface 18, the second beveled surface 20, and the third beveled surface 22 may be symmetrical. In some embodiments, two of the first beveled surface 18, the second beveled surface 20, and the third beveled surface 22 may be inverted bevels.
[0055] As illustrated in
[0056] In some embodiments, a perimeter of the first beveled surface 18 may include the first cutting edge 24, the third cutting edge 28, and a first proximal edge 30. In some embodiments, the perimeter of the first beveled surface 18 may include no more than the first cutting edge 24, the third cutting edge 28, and the first proximal edge 30. In some embodiments, the first proximal edge 30 may extend between the first cutting edge 24 and the third cutting edge 28.
[0057] In some embodiments, a perimeter of the second beveled surface 20 may include the first cutting edge 24, the second cutting edge 26, and a second proximal edge 32. In some embodiments, the perimeter of the second beveled surface 20 may include no more than the first cutting edge 24, the second cutting edge 26, and the second proximal edge 32. In some embodiments, the second proximal edge 32 may extend between the second cutting edge 26 and the third cutting edge 28.
[0058] In some embodiments, a perimeter of the third beveled surface 22 may include the second cutting edge 26, the third cutting edge 28, and a third proximal edge 34. In some embodiments, the perimeter of the third beveled surface 22 may include no more than the second cutting edge 26, the third cutting edge 28, and a third proximal edge 34. In some embodiments, the third proximal edge 34 may extend between the second cutting edge 26 and the third cutting edge 28.
[0059] In some embodiments, the first cutting edge 24, the second cutting edge 26, and the third cutting edge 28 may be straight or linear. In some embodiments, the first cutting edge 24, the second cutting edge 26, and the third cutting edge 28 may intersect at the distal tip 16. In some embodiments, one or more of the following may be generally proximal edge-shaped: the first proximal edge 30, the second proximal edge 32, or the third proximal edge 34. In some embodiments, one or more of the following may include an arc: the first proximal edge 30, the second proximal edge 32, and the third proximal edge 34, which may facilitate smooth entry of the needle 10 through the skin and vein. In some embodiments, one or more of the following may be straight or linear: the first proximal edge 30, the second proximal edge 32, and the third proximal edge 34.
[0060] In some embodiments, one or more of the first perimeter, the second perimeter, and the third perimeter may be equal. In some embodiments, one or more of the first beveled surface 18, the second beveled surface 20, and the third beveled surface 22 may have equal shapes or contours, as illustrated, for example in
[0061] In some embodiments, a length 38 of the first beveled surface 18 from the distal tip to an apex of the first proximal edge 30 may be equal to a length 40 of the second beveled surface 20 from the distal tip 16 to an apex of the second proximal edge 32, which may be equal to a length 42 of the third beveled surface 22 from the distal tip 16 to an apex of the third proximal edge 34. In some embodiments, a length 44 of the first beveled surface 18 from a proximal end of the first cutting edge 24 to a proximal end of the third cutting edge 28 may be equal to a length 46 of the second beveled surface 20 from a proximal end of the first cutting edge 24 to a proximal end of the second cutting edge 26, which may be equal to a length 48 of the third beveled surface 22 from the proximal end of the second cutting edge 26 to the proximal end of the third cutting edge 28.
[0062] In some embodiments, a symmetrical nature of the distal end 12 may aid the user, who may be inexperienced in orientation of a needle for insertion into the patient. In some embodiments, the needle 10 may be solid. In some embodiments, the needle 10 may be constructed of metal, steel, or another suitable material. In some embodiments, the needle 10 may be monolithically formed as a single unit. In some embodiments, the distal tip 12 may not include an opening aligned with the central axis 36 of the needle 10. In some embodiments, the distal tip 12 may be closed and may not allow fluid to flow therethrough.
[0063] Referring now to
[0064] In some embodiments, the length 38 of the first beveled surface 18, the length 40 of the second beveled surface 20, and the length 46 of the second beveled surface 20 may be about half or less of a length of the bevel of the other needle 52. In some embodiments, the length 38 of the first beveled surface 18, the length 40 of the second beveled surface 20, and the length 46 of the second beveled surface 20 may facilitate entry of a distal end 54 of the catheter 50 into the vein 49 before the distal tip 16 transfixes or damages an interior surface of a wall of the vein 49 opposite a point of entry of the needle 10 into the vein 49. In some embodiments, because the length 38 of the first beveled surface 18, the length 40 of the second beveled surface 20, and the length 46 of the second beveled surface 20 may be about half of the length of the bevel of the other needle 52, the distal tip 16 may be twice as far away from the interior surface of the wall of the vein 49 opposite the point of entry when the distal end 54 of the catheter 50 penetrates the vein 49.
[0065] In some embodiments, the distal end 12 of the needle 10 may be configured for difficult venous access, where a diameter of the vein is small, without damaging or transfixing the vein. In some embodiments, a distance 55 between an uppermost surface of the distal end 54 of the catheter 50 and a lowermost surface of the distal end 12 of the needle 10 may be half as much as a distance between an uppermost surface of the distal end 54 of the catheter 50 and a lowermost surface of a distal end of the other needle 52. In some embodiments, a distance 55 between an uppermost surface of the distal end 54 of the catheter 50 and a lowermost surface of the distal end 12 of the needle 10 may be about 1.1 mm or between 1.0 and 1.2 mm when the needle 10 is 20 gauge and configured for use with an 18 gauge catheter inserted at an insertion angle of 20 to 30 degrees. In some embodiments, a distance 55 between an uppermost surface of the distal end 54 of the catheter 50 and a lowermost surface of the distal end 12 of the needle 10 may be within three (3) standard deviations of a normal distribution of human vein diameters.
[0066] In contrast, the bevel of the other needle 48 may be so long as to make it difficult for the user to insert the distal end 54 of the catheter 50 into the vein 49 without damaging or transfixing the vein 49. Transfixing may occur when a needle enters a top of the vein 49 and then punctures a bottom of the vein 49 too. Damage to the vein 49, including transfixing the vein 49, may accelerate clotting and thrombosis. In some embodiments, a needle tip geometry of the needle 10 as described may provide a reduced risk of transfixing a vein 49 of a patient when the needle 10 is inserted into the vein 49 of the patient and may provide more reliable placement of the catheter 50 within the vein 49.
[0067] In some embodiments, the bevel of the other needle 52 may cause the other needle 52 to drop or dive at a steeper insertion angle as the other needle 52 is inserted through the skin and into the vein 49. The user may try to compensate for the steeper insertion angle by guessing at how much to lower the insertion angle. In some embodiments, the distal end 12 of the needle 10 may be symmetrical, which may provide zero drop upon insertion of the needle 10 into the patient.
[0068] In some embodiments, one or more of the first beveled surface 18, the second beveled surface 20, and the third beveled surface 22 may be generally planar. In some embodiments, the needle 10 may be oriented within the catheter 50 such that the first beveled surface 18, the second beveled surface 20, or the third beveled surface 22 faces downwardly or towards an interior wall of the vein 49 opposite a point of entry of the needle 10 into the vein 49, which may reduce a risk of transfixing the vein 49. Further, in some embodiments, use of the needle 10 may result in a cut or slit in the skin and the vein 49 a same or similar size as that of the other needle 52.
[0069] Referring now to
[0070] Referring now to
[0071] Referring now to
[0072] Referring now to
[0073] In some embodiments, the flash grooves 56 may each include a distal end 71 proximate the first beveled surface 18, the second beveled surface 20, or the third beveled surface 22. In some embodiments, the distal end 71 may intersect a particular apex of a particular proximal edge. In some embodiments, the flash grooves 56 may each include a proximal end 73 disposed proximal to the distal end 54 of the catheter 50. In some embodiments, the flash grooves 56 may be in fluid communication with the lumen of the catheter 50. In some embodiments, blood traveling through the flash grooves 56 and into the lumen of the catheter 50 may be visible to the user.
[0074] As illustrated in
[0075] Referring now to
[0076] In some embodiments, the length 38 of the first beveled surface 18 from the distal tip to the apex of the first proximal edge 30 may be greater than the length 40 of the second beveled surface 20 from the distal tip 16 to the apex of the second proximal edge 32 and/or the length 42 of the third beveled surface 22 from the distal tip 16 to the apex of the third proximal edge. In some embodiments, the length 40 of the second beveled surface 20 from the distal tip 16 to the apex of the second proximal edge 32 may be greater than the length 38 of the first beveled surface 18 from the distal tip 16 to the apex of the first proximal edge 30 and/or the length of the third beveled surface 22 from the distal tip 16 to the apex of the third proximal edge 34. In some embodiments, the length 42 of the third beveled surface 22 from the distal tip 16 to the apex of the third proximal edge 34 may be greater than the length 42 of the second beveled surface 20 from the distal tip 16 to the apex of the second proximal edge 32 and/or the length 38 of the first beveled surface 18 from the distal tip 16 to the apex of the first proximal edge 30.
[0077] As illustrated in
[0078] Referring now to
[0079] In some embodiments, the catheter assembly 72 may include a straight or non-integrated catheter assembly. In some embodiments, the catheter assembly 72 may include an integrated catheter assembly. In further detail, in some embodiments, a catheter adapter 74 of the catheter assembly 72 may include an integrated extension tube, such as, for example, the BD NEXIVA Closed IV Catheter System, the BD NEXIVA DIFFUSICS Closed IV Catheter System, or the Becton Dickinson PEGASUS Safety Closed IV Catheter System.
[0080] In some embodiments, the catheter adapter 74 may include a distal end 76, a proximal end 78, a lumen 80 extending between the distal end 76 and the proximal end 78. In some embodiments, the catheter 50 may be secured to the catheter adapter 74 and may extend distally from the catheter adapter 74. In some embodiments, the catheter 50 may be held in place within the catheter adapter 74 via a wedge 87 or another suitable means. In some embodiments, the catheter 50 may include a PIVC, a midline catheter, or a PICC. In some embodiments, the catheter 50 may include the distal end 54, a proximal end 84, and a lumen 86 extending through the distal end 82 of the catheter 50 and the proximal end 84 of the catheter 50.
[0081] In some embodiments, the catheter assembly 72 may include a needle hub 88, in which the proximal end 65 of the needle 10 may be secured. In some embodiments, when the catheter assembly 72 is in an insertion position, ready for insertion into the patient, the needle 10 may extend through the catheter 50 such that the distal end 12 of the needle 10 is distal to the distal end 54 of the catheter 50. In some embodiments, after the catheter 50 is inserted into the vein of the patient, the needle 10 and the needle hub 88 may be removed from the catheter adapter 74, leaving the catheter 50 in the vein as the needle 10 is discarded. In some embodiments, a septum 91 and/or a septum actuator 92 may be disposed within the lumen 80 of the catheter adapter 74.
[0082] Flashback is the visibility of blood that confirms entry of the distal tip 16 into the vein. In some embodiments, flashback may be seen through the catheter 50 as blood travels through the flash grooves 56 (see, for example,
[0083] In some embodiments, the needle 10 may be used with non-catheter medical devices and/or for any medical purpose, including as a spinal needle. In some embodiments, the needle 10 can also be used for other procedures, such as procedures where it is desired to reduce needle bending caused by a long bevel needle. In some embodiments, the needle 10 may be used for introducing and/or withdrawing fluid from a patient. In some embodiments, the needle 10 may be used for aspiration of blood, spinal fluid, or other fluids from a patient.
[0084] Referring now to
[0085] In some embodiments, the needle 10 may be used in coordination with various technologies. For example, in some embodiments, the distal tip 12 may be magnetic or magnetized and may allow ultrasound guidance and interaction with an ultrasound system to track a location of the distal tip 12.
[0086] In some embodiments, the needle 10 may include one or more features further described in U.S. patent application Ser. No. 15/286,223, filed Oct. 5, 2016, entitled COMPLIANT CATHETER ADAPTER HAVING SELF-SLITTING NEEDLE, which is hereby incorporated by reference in its entirety. In some embodiments, the needle 10 may include one or more features further described in U.S. patent application Ser. No. 15/286,162, filed Oct. 5, 2016, entitled INTEGRATED CATHETER WITH INDEPENDENT FLUID PATHS, which is hereby incorporated by reference in its entirety.
[0087] In some embodiments, the needle 10 may be used with a catheter having an asymmetric tip, as further described, for example, in U.S. patent application Ser. No. 15/286,261, filed Oct. 5, 2016, entitled CATHETER WITH AN ASYMMETRIC TIP, which is hereby incorporated by reference in its entirety. In some embodiments, the needle 10 may be used with a strain relief feature, which may be described, for example, in U.S. patent application Ser. No. 15/285,601, filed Oct. 5, 2016, entitled CATHETER ADAPTER WITH DISTAL INNER DIAMETER CURVATURE PROVIDING KINK RESISTANCE, which is hereby incorporated by reference in its entirety.
[0088] Referring now to
[0089] Referring now to
[0090] In some embodiments, the four beveled surfaces, the five beveled surfaces, or the six beveled surfaces may have equal shapes or contours. In some embodiments, the distal end 12 may be symmetric. In other embodiments, the distal end 12 may be asymmetrical, such as, for example, with a beveled surface of the four beveled surfaces, the five beveled surfaces, or the six beveled surfaces being longer than another beveled surface of the four beveled surfaces, the five beveled surfaces, or the six beveled surfaces. In some embodiments, one or more particular beveled surface of the four beveled surfaces, the five beveled surfaces, or the six beveled surfaces may include the holes 66.
[0091] All examples and conditional language recited herein are intended for pedagogical objects to aid the reader in understanding the invention and the concepts contributed by the inventor to furthering the art, and are to be construed as being without limitation to such specifically recited examples and conditions. Although embodiments of the present inventions have been described in detail, it should be understood that the various changes, substitutions, and alterations could be made hereto without departing from the spirit and scope of the invention.