Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/31—Details
  • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
  • A61M5/329—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles characterised by features of the needle shaft
  • A61M5/3291—Shafts with additional lateral openings
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/42—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
  • A61M5/427—Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/46—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for controlling depth of insertion

Definitions

• the present invention is directed to a cannula for subcutaneous injection of a medicament.
• the cannula described herein is designed to subcutaneously inject a high dose of one or more medicaments into a patient through at least one orifice located on the cannula wall.
• United States Patent No. 8,333,734 discloses a method and apparatus for facilitating peripheral nerve block procedures comprising a needle with a plurality of fenestrations that enable local anesthetic to be administered simultaneously at several points surrounding an affected nerve. This approach provides a number of flow paths that are located around a single focal point. In contrast, the invention disclosed is designed to provide wide distribution of medicament along the length of the cannula.
• the present invention proposes various designs to physically or mechanically disperse the injectable volume with the aim of minimizing local high subcutaneous pressure which would otherwise potentially produce pain or injection size leakage.
• the result of these approaches would permit delivery of larger volumes (>2 mL) in shorter injection times, with lower injection forces and utilizing simple and standard needle and syringe options.
• tuning the volumetric flow rate and fluid velocities from each orifice to more broadly distribute the injected volume relative to the traditional hypodermic needle with a single orifice is possible.
• cannulas for subcutaneous dispensing of medicaments, wherein the cannula has a cannula wall, a distal end and a proximal end and wherein the cannula comprises a single orifice in the cannula wall, proximal to the distal end of the cannula or two or more orifices in the cannula wall, proximal to the distal end of the cannula.
• the cannula has a single orifice in the cannula wall, proximal to the distal end of the cannula.
• the cannula comprises a single orifice in the cannula wall, proximal to the distal end of the cannula or two or more orifices in the cannula wall, proximal to the distal end of the cannula, wherein the orifice or two or more orifices are in the shape of a circle.
• the cannula has a single orifice in the cannula wall, proximal to the distal end of the cannula, wherein the orifice is in the shape of a circle.
• the cannula comprises two or more orifices in the cannula wall, proximal to the distal end of the cannula, wherein the two or more orifices are in the shape of a circle.
• the cannula has a single orifice in the cannula wall, proximal to the distal end of the cannula and wherein the orifice has a long axis
• the long axis of the single orifice is not parallel to the axis of the cannula.
• the single orifice is oriented at an angle to the axis of the cannula between 5° and 90°.
• the cannula has two or more orifices in the cannula wall, proximal to the distal end of the cannula and wherein the two or more orifices have long axes
• the long axes of each of the two or more orifices are not parallel to the axis of the cannula.
• the two or more orifices are oriented at an angle to the axis of the cannula between 5° and 90°.
• the cannulas described herein is removably attached to a syringe.
• the removeable connection between the cannula and the syringe is a Luer connection. In other embodiments, the removeable connection between the cannula and the syringe is a threaded connection.
• the cannula described herein is an integral part of the syringe.
• the single orifice or at least one of the two or more is in the shape of an ellipse. In other embodiments, the single orifice or the or two or more orifices is in the shape of a polygon. In certain embodiments, the polygon is an elongated polygon. In certain embodiments, the two or more orifices comprise a combination of elliptical, and polygonal shapes. In certain embodiments, the length of the elongated polygon spans range between 1% and 80% of the length of the cannula. In certain embodiments, the long axis of the elongated polygon is oriented at an angle to the axis of the cannula between 0° and 45°.
• the single orifice or two or more orifices are not closed such that a portion of the perimeter of the opening of the orifice or two or more orifices intersects with the distal end of the cannula.
• the two or more orifices are oriented at a range of angles from one another, wherein the angles range from 0° to 180° when viewed in cross section along the axis of the cannula.
• the two or more orifices are spaced an unequal distance apart along the axis of the cannula. In certain embodiments, the two or more orifices are spaced at increasing distances apart in the distal direction along the axis of the cannula. In other embodiments, the two or more orifices are spaced at decreasing distances apart in the distal direction along the axis of the cannula. In certain embodiments of the cannulas described herein, the single orifice or the two or more orifices each comprise an area between 0.000001 sq. in to 0.015 sq. in.
• the cannula of the embodiments described herein is tapered.
• the inner diameter of the cannula increases from the distal end of the cannula to the proximal end.
• the inner diameter of the cannula increases from the distal end of the cannula to the proximal end, wherein the increase in inner diameter occurs along the entire length of the cannula.
• the inner diameter of the cannula increases from the distal end of the cannula to the proximal end, wherein the increase in inner diameter occurs along one or more discrete portions of the length of the cannula.
• the cannula further comprises a guide for controlling the angle and depth of insertion of the cannula.
• the guide limits the range of insertion depths of the distal end of the cannula between 1 ⁇ 4 inches and 3 inches.
• the guide limits the insertion angle between the axis of the cannula and the surface of the patient’s skin ranging from 5° to 90°.
• FIGURE 1 shows an embodiment of a cannula described herein, where the cannula is attached to the syringe by means of a removeable attachment.
• FIGURE 2 shows an embodiment of a cannula that is permanently attached to the syringe.
• FIGURE 3 shows a detail an embodiment of a cannula with a single orifice.
• FIGURE 4 shows an embodiment of a cannula with a rectangular orifice.
• FIGURE 5 shows an embodiment of a cannula with a polygonal orifice wherein the long axis of the polygon is generally oriented at an angle a to the axis of the cannula.
• FIGURE 6 shows an embodiment of a cannula with a polygonal orifice wherein the polygon is generally oriented at an angle b to the axis of the cannula and the length of the polygon and the angle to the axis of the cannula enable the polygon to describe a helical shape around the cannula.
• FIGURE 7 shows an embodiment of a cannula with a polygonal orifice wherein opposing sides of the polygon are not parallel to each other.
• FIGURE 8 shows an embodiment of a portion of the perimeter of the orifice intersects with the tip of the cannula.
• FIGURE 9 shows an embodiment of a cannula with transverse orifices wherein the orifices are located coaxially.
• FIGURE 10 shows an embodiment of a cannula wherein the axes of transverse orifices are be non-perpendicular to the axis of the cannula.
• FIGURE 11 shows an embodiment of a cannula wherein the orifices are equally-spaced along the length of the cannula.
• FIGURE 12 shows an embodiment of a cannula wherein spacing between orifices increases along the length of the cannula from the distal end to the proximal end.
• FIGURE 13 shows an embodiment of a cannula wherein spacing between orifices increases along the length of the cannula from the proximal end to the distal end.
• FIGURE 14 shows an embodiment of a cannula wherein the orifices are oriented such that their axes are in a single plane that intersects the axis of the cannula.
• FIGURE 15 shows an embodiment of a cannula wherein the orifices are oriented such that their axes are each located in planes that are oriented in a range of angles relative to one another.
• FIGURE 16 shows an embodiment of a cannula wherein the cross-sectional area of each orifice varies based on its location relative to the distal end of the cannula.
• FIGURE 17 shows an embodiment of a cannula wherein the cross-sectional area of each orifice varies based on its location relative to the distal end of the cannula.
• FIGURE 18A shows a view of a cannula wherein the cannula has a ground bevel tip.
• FIGURE 18B shows a magnified section view of the embodiment of a cannula shown in Figure 18A with a plugged distal end and a ground bevel tip.
• FIGURE 19A shows a view of an embodiment a cannula wherein the distal end is ground to an axially symmetrical point.
• FIGURE 19B shows a magnified section view of the embodiment of a cannula shown in Figure 19A with a plugged distal end and a tip ground to an axially symmetrical point.
• FIGURE 20 shows a magnified section view of the embodiment of a cannula with an occluded distal end and a tip ground to a point that is offset from the axis of the cannula.
• FIGURE 21 shows an embodiment of an insertion guide that attaches to the skin and guides the insertion of the cannula to the desired depth at the desired angle.
• FIGURE 22 shows a cross-section of the insertion guide, syringe, and cannula, wherein the location and angle of the syringe by the guide are illustrated,
• FIGURE 23 shows an embodiment of an insertion guide for the cannula alone, wherein the guide controls the angle and depth of insertion of the cannula.
• FIGURE 24 shows a cross-section of the insertion guide of Figure 24, showing the interaction between the guide and cannula, and showing schematically the connection between the cannula and syringe pump.
• FIGURE 25 shows an embodiment of the cannula, wherein the inner diameter of the cannula is gradually tapered along the entire length of the cannula.
• FIGURE 26 shows an embodiment wherein the internal diameter of the cannula increases along the entire length of cannula.
• FIGURE 27 shows an embodiment wherein the internal diameter of cannula increases in more than one discrete portions of cannula.
• FIGURE 28 is a graph which shows injection pressure, measured in Volts, over time of Omnipaque material injected into minipigs using three cannulas described herein compared to a standard 25 gauge needle.
• proximal refers to a direction away from the body of the patient and towards the cannula.
• distal refers to a direction towards the body of the patient and away from the cannula.
• axis of the cannula refers to the long axis of the cannula, i.e. the axis running from the proximal end to the distal end.
• ifice means an opening in the distal end of a cannula or through the wall of a cannula for fluid discharge from the cannula.
• oriented parallel means that the axis of an orifice is parallel to the axis of the cannula.
• polygon means a plane figure with at least three straight sides and angles.
• elongated polygon means that one or more sides of a polygon is significantly longer than the remaining sides of the polygon.
• a cannula for injecting medicament into a patient through at least one orifice located on the cannula wall to allow for broader and/or more even distribution of a medicament compared to a traditional cannula having an opening at the distal tip of the cannula.
• Orifices can be created in the cannula wall of a cannula in multiple forms for improving distribution of a medicament in tissue. Specific requirements based on the location of the injection, the depth of insertion, and the properties of the fluid to be injected can influence the number and configuration of the orifices.
• a cannula for the dispensing of medicaments, wherein the cannula has a cannula wall, a distal end and a proximal end and wherein the cannula comprises a single orifice in the cannula wall, proximal to the distal end of the cannula or two or more orifices in the cannula wall, proximal to the distal end of the cannula.
• a cannula for the dispensing of medicaments, wherein the cannula has a cannula wall, a distal end and a proximal end and wherein the cannula comprises a single orifice in the cannula wall, proximal to the distal end of the cannula or two or more orifices in the cannula wall, proximal to the distal end of the cannula, wherein the longest axes of the two or more orifices are not oriented parallel to the long axis of the cannula.
• a cannula for the dispensing of medicaments, wherein the cannula has a cannula wall, a distal end and a proximal end and wherein the cannula comprises a single orifice in the cannula wall, proximal to the distal end of the cannula or two or more orifices in the cannula wall, proximal to the distal end of the cannula, wherein the shortest axes of the two or more orifices are not oriented parallel to the long axis of the cannula.
• the cannula for the dispensing of medicaments, has a cannula wall, a distal end and a proximal end and wherein the cannula comprises a single orifice in the cannula wall, proximal to the distal end of the cannula.
• the orifices can be any shape that allows the desired dispensing of the medicament.
• Suitable orifice shapes can include, but are not limited to, polygonal shapes such as square, rectangle, rhombus, quadrilateral, pentagonal; circular, such as circle, ellipse, or oval; helical; or any non-symmetrical shape to allow the desired dispensing of the medicament.
• the single orifice or at least one of the two or more orifices in the cannula wall of the cannulas described herein can be a circular hole.
• the single orifice or at least one of the two or more orifices in the cannula wall of the cannulas described herein can be an ellipse. In certain embodiments, the single orifice or at least one of the two or more orifices in the cannula wall of the cannulas described herein can be a polygon. In certain embodiments, the single orifice or at least one of the two or more orifices in the cannula wall of the cannulas described herein can be an elongated polygon.
• the single orifice or at least one of the two or more orifices in the cannula wall of the cannulas described herein can be an elongated polygon; wherein the elongated polygon spans between 1% to 80% of the length of the cannula.
• the two or more orifices can be different geometric shapes, including but not limited to, a combination of circular, elliptical, and polygonal shapes.
• the two or more orifices can be spaced an equal distance apart along the axis of the cannula. In another embodiment, wherein the cannula has two or more orifices in the cannula wall, the two or more orifices can be unevenly spaced along the axis of the cannula. In other embodiments, the two or more orifices are spaced at increasing distances apart in the distal direction along the axis of the cannula. In still other embodiments, the two or more orifices are spaced at decreasing distances apart in the distal direction along the axis of the cannula.
• the two or more orifices are not aligned in a column along the length of the cannula. In certain embodiments, wherein the cannula has two or more orifices in the cannula wall, the two or more orifices are distributed around the circumference of the cannula and varying distances from each other. In certain embodiments, wherein the cannula has two or more orifices in the cannula wall, the two or more orifices are unevenly distributed along the circumference of the cannula. In certain embodiments, wherein the cannula has two or more orifices in the cannula wall, the two or more orifices are unevenly distributed along the circumference of the cannula having varying distances from each other.
• the orifices can be any size that allows the desired dispensing of the medicament.
• Orifice area is a function of several factors, including but not limited to the volume of medicament dispensed, the viscosity of the medicament, the inner diameter of the cannula, and the process used to generate the orifices.
• a practical limit for the diameter, minor axis, or shortest side of an orifice is 0.002 inches.
• a practical upper limit for diameter of an orifice, the minor or major axis of an orifice, or the side of a polygon-shaped orifice generally perpendicular to the axis of the cannula is 75% of the outer diameter of the cannula.
• the orifices can each comprise an area between 0.000001 sq. in. to 0.015 sq. in.
• the cannula 10 has a cannula wall 20 a proximal end 30 and a distal end 40.
• the cannula 10 has a single orifice 50 in the cannula wall 30, proximal to the distal end 40.
• the distal end 40 of cannula 10 comprises a typical sharpened ground bevel tip 12.
• the distal end 40 of cannula 10 would comprise a distal opening 14 for additional discharge of medicament, in addition to the orifice 50.
• the cannula 10 can be attached to a syringe 60.
• the cannula can be removably attached to a syringe.
• cannula 10 is removably attached to a syringe 60 by Luer connection 70.
• other attachment means would comprise, but not be limited to, a threaded connection.
• the cannula can be permanently attached to or an integral part of the syringe.
• cannula 10 would be permanently attached to syringe 60, as shown in FIGURE 2.
• the orifice 50 is circular in shape. In alternate embodiments, the orifice can be a different shape.
• FIGURE 3 shows a cannula 10 with a cannula wall 20, wherein the cannula wall 20 has an orifice 52 that is elliptical in shape, proximal to the distal end 40 of the cannula. In other embodiments, the orifice can be polygonal in shape.
• FIGURE 4 shows a cannula 10 with a cannula wall 20, wherein the cannula wall 20 has an orifice 53 that is polygonal, having a rectangular shape. Such a rectangular orifice 53 may be parallel to the axis of the cannula, as shown in FIGURE 4, or oriented on a slight angle a to the axis of the cannula 10, as shown in FIGURE 5.
• the orifice or orifices can be oriented at an angle to the axis of the cannula between, and including, 5° to 90°. In certain embodiments, the orifice or orifices can be oriented at a 5° angle to the axis of the cannula. In certain embodiments, the orifice or orifices can be oriented at a 10° angle to the axis of the cannula. In certain embodiments, the orifice or orifices can be oriented at a 15° angle to the axis of the cannula.
• the orifice or orifices can be oriented at a 20° angle to the axis of the cannula. In certain embodiments, the orifice or orifices can be oriented at a 25° angle to the axis of the cannula. In certain embodiments, the orifice or orifices can be oriented at a 30° angle to the axis of the cannula. In certain embodiments, the orifice or orifices can be oriented at a 35° angle to the axis of the cannula. In certain embodiments, the orifice or orifices can be oriented at a 40° angle to the axis of the cannula.
• the orifice or orifices can be oriented at a 45° angle to the axis of the cannula. In certain embodiments, the orifice or orifices can be oriented at a 50° angle to the axis of the cannula. In certain embodiments, the orifice or orifices can be oriented at a 55° angle to the axis of the cannula. In certain embodiments, the orifice or orifices can be oriented at a 60° angle to the axis of the cannula. In certain embodiments, the orifice or orifices can be oriented at a 65° angle to the axis of the cannula.
• the orifice or orifices can be oriented at a 70° angle to the axis of the cannula. In certain embodiments, the orifice or orifices can be oriented at a 75° angle to the axis of the cannula. In certain embodiments, the orifice or orifices can be oriented at an 80° angle to the axis of the cannula. In certain embodiments, the orifice or orifices can be oriented at a 85° angle to the axis of the cannula. In certain embodiments, the orifice or orifices can be oriented at a 90° angle to the axis of the cannula.
• the cannula described herein comprises a cannula wall comprising a single orifice or two or more orifices, wherein the single orifice or at least one of the two or more of the orifices is shaped as an elongated polygon, wherein the longest axis of the elongated polygon is oriented at an angle to the axis of the cannula between 0° and 45°.
• orifices may be oriented such that their axes are not in a single plane 110 that intersects the axis of cannula 10, as shown in FIGURE 6.
• a rectangular orifice 54 may have an angle b between its long edges 80 and the axis of the cannula 10 wherein the orifice is sufficiently long that it acquires a helical shape 90, as shown in FIGURE 6, wherein the pitch of the helix is a function of the angle b and the diameter of the cannula 10.
• polygonal orifices with long edges may comprise an angle Q between the two long edges of the polygon, wherein the polygon results in an orifice 55 that widens along its length, as shown in FIGURE 7.
• the orifice is not completely defined by the cannula wall. In certain embodiments, a portion of the perimeter of an orifice intersects with the distal end of the cannula. In certain embodiment, a cannula 10 having a cannula wall 20 comprises an orifice 56 wherein, a portion of the perimeter of the orifice intersects with the cannula tip 100 located at the distal end 40 of the cannula 10, as shown in FIGURE 8.
• a cannula for the dispensing of medicaments, wherein the cannula has a cannula wall, a distal end and a proximal end and wherein the cannula comprises two or more orifices in the cannula wall, proximal to the distal end of the cannula, wherein the two or more orifices are not oriented parallel to the axis of the cannula.
• transverse orifices 57 are located directly opposite from each other, such that two diametrically opposed openings would be created.
• transverse orifices 58 of cannula 10 are not located directly opposite each other but are offset from each other.
• orifices 59 may be created wherein they are equally-spaced along the length of the cannula 10, as shown in FIGURE 11 (distance is shown as X’).
• spacing of orifices 61 may vary according to a schedule wherein spacing between orifices 61 increases along the length of the cannula 10 from distal end 40 to the proximal end 30, as shown in FIGURE 12 (different lengths shown as Z’, Y’ and X’).
• spacing of openings may vary according to a schedule wherein spacing between orifices 62 decreases along the length of the cannula 10 from distal end 40 to proximal end 30, as shown in FIGURE 13.
• X’ represents the longest length of space between two orifices
• Z’ represents the shortest length of space between to orifices
• Y’ represents a length of space between Z’ and X’.
• all orifices 63 may be oriented such that their axes are in a single plane 110 that intersects the axis of cannula 10, as shown in FIGURE 14.
• the axes of orifices 64 may be located at a range of angles relative to one another, as shown in FIGURE 15.
• the cross-sectional area of the orifices may be constant for all orifices.
• the cross-sectional area of each orifices 64 may vary based on its location on the cannula 10, as shown in FIGURE 16 and FIGURE 17. In FIGURE 16, the diameter of the orifices increases from the distal to the proximal end. In FIGURE 17, the diameter of the orifices decreases from the distal to the proximal end.
• the cannula can be augmented such that the orifices in the cannula wall are the only means of distributing medicament.
• the distal end 40 of cannula 10 comprises a sharpened ground bevel tip 12 comprising an occluded distal end 16 to prevent flow of medicament thru the distal end 40 of the cannula 10.
• the occluded tip may be used to locate the intramuscular layer, ensuring that the cannula and the orifices do not enter the intramuscular layer.
• the medicament is dispersed only within the subcutaneous layer.
• Such an occlusion can be achieved by, but not be limited to, welding means, including laser welding means, crimping means, or plug means. Typically, such occlusions would be created prior to sharpening the distal end 40 of cannula 10.
• distal end 40 of cannula 10 can be occluded and ground to an axially symmetrical point 16, as shown in FIGURE 19A and FIGURE 19B.
• the axis of the tip 18 would not coincide with the axis of the cannula 10, as shown in FIGURE 20.
• the depth of fluid dispersion is instrumental to optimized delivery of medicament.
• Control of the angle and depth of cannula insertion is critical for correct positioning of the orifice or orifices in the cannula wall.
• Use of a guide in combination with the cannula described herein can aid in controlling the angle and depth of cannula insertion.
• the cannula described herein further comprises a guide for controlling the angle and depth of insertion of the cannula.
• the guide can limit the insertion depths of the distal end of the cannula between 1/4" and 3”.
• the guide can limit the insertion angle between the axis of the cannula and the surface of the patient’s skin ranging from 5° to 90°.
• an insertion fixture, or guide 120 attaches to skin 140 at the location of insertion.
• Guide 120 comprises a linear opening 150 to accept the cannula 10 and syringe 60.
• cannula 10 is inserted to the full depth of opening 150 until the flange 160 of syringe 60 contacts a stop 170 adjacent to linear opening 150.
• the location of opening 150, the location of the stop 170, the length of cannula 10, and the angle d between the axis of opening 150 and skin 140 control the depth of insertion 180, this is shown in FIGURE 22.
• the guide may be constructed of a variety of materials, most notably metals and plastics.
• the guide may be machined, cast, or 3D printed in an appropriate metal including, but not limited to, stainless steel or titanium.
• the guide would be thermoformed from a variety of plastics including, but not limited to, PETG, Polypropylene, or ABS.
• the guide would be injection molded from a variety of plastic resins, including, but not limited to, ABS, Polypropylene, or Polyethylene.
• the guide may be affixed to the skin of the patient by means of one or more straps that encompass the circumference of an extremity, such as an arm or leg.
• the guide could be affixed to the patient’s skin by means of a pressure sensitive adhesive.
• adhesive could be selected from a group that includes, but is not be limited to, acrylic, hydrocolloid, urethane, or silicone adhesives.
• a separate pump 200 such as an infusion pump or a syringe pump may be used to displace medicament into the cannula 10.
• a smaller guide 190 may be used to locate cannula 10 in place without a syringe. The location of the stop 220 of the smaller guide 190 and the angle l between the axis of opening 230 and skin 140, and the length of cannula 10 would determine the depth of insertion 240 of cannula 10, as shown in FIGURE 23 and FIGURE 24.
• the inner diameter of the cannula is not constant along the length of the cannula.
• the inner cannulas described herein are tapered.
• “tapered” means that the inner diameter of the distal end of the cannula is smaller than the inner diameter of the proximal end of the cannula.
• the inner diameter may increase in diameter from the inner diameter at the distal end to the inner diameter at the proximal end. As shown in FIGURE 25, the inner diameter A of cannula 300 at the distal end 301 increases in size to diameter B at the proximal end 302 of the cannula 300.
• the increase in diameter from the distal end of the cannula to the proximal may have a range from an inner diameter of “X” mm at the distal end to an inner diameter of between 1.25X mm to 5X at the proximal end. In certain embodiments, the increase in diameter from the distal end of the cannula to the proximal may have a range from an inner diameter of “X” mm at the distal end to an inner diameter of 5X mm at the proximal end. In certain embodiments, the increase in diameter from the distal end of the cannula to the proximal may have a range from an inner diameter of “X” mm at the distal end to an inner diameter of 4.75X mm at the proximal end.
• the increase in diameter from the distal end of the cannula to the proximal may have a range from an inner diameter of “X” mm at the distal end to an inner diameter of 4.5X mm at the proximal end. In certain embodiments, the increase in diameter from the distal end of the cannula to the proximal may have a range from an inner diameter of “X” mm at the distal end to an inner diameter of 4.25X mm at the proximal end. In certain embodiments, the increase in diameter from the distal end of the cannula to the proximal may have a range from an inner diameter of “X” mm at the distal end to an inner diameter of 4X mm at the proximal end.
• the increase in diameter from the distal end of the cannula to the proximal may have a range from an inner diameter of “X” mm at the distal end to an inner diameter of 3.75X mm at the proximal end. In certain embodiments, the increase in diameter from the distal end of the cannula to the proximal may have a range from an inner diameter of “X” mm at the distal end to an inner diameter of 3.5X mm at the proximal end. In certain embodiments, the increase in diameter from the distal end of the cannula to the proximal may have a range from an inner diameter of “X” mm at the distal end to an inner diameter of 3.25X mm at the proximal end.
• the increase in diameter from the distal end of the cannula to the proximal may have a range from an inner diameter of “X” mm at the distal end to an inner diameter of 3X mm at the proximal end. In certain embodiments, the increase in diameter from the distal end of the cannula to the proximal may have a range from an inner diameter of “X” mm at the distal end to an inner diameter of 2.75X mm at the proximal end. In certain embodiments, the increase in diameter from the distal end of the cannula to the proximal may have a range from an inner diameter of “X” mm at the distal end to an inner diameter of 2.5X mm at the proximal end.
• the increase in diameter from the distal end of the cannula to the proximal may have a range from an inner diameter of “X” mm at the distal end to an inner diameter of 2.25X mm at the proximal end. In certain embodiments, the increase in diameter from the distal end of the cannula to the proximal may have a range from an inner diameter of “X” mm at the distal end to an inner diameter of 2X mm at the proximal end. increase in diameter from the distal end of the cannula to the proximal may have a range from an inner diameter of “X” mm at the distal end to an inner diameter of 1.75X mm at the proximal end.
• the increase in diameter from the distal end of the cannula to the proximal may have a range from an inner diameter of “X” mm at the distal end to an inner diameter of 1.5X mm at the proximal end. In certain embodiments, the increase in diameter from the distal end of the cannula to the proximal may have a range from an inner diameter of “X” mm at the distal end to an inner diameter of 1.25X mm at the proximal end.
• value of “X” as the inner diameter of the cannula at the distal end can be the minimum inner diameter of a 10-34 gauge needle according to the Stainless Steel Needle Tubing for the Manufacture of Medical Devices - Requirements and test methods (ISO 9626:2016), incorporated herein by reference.
• cannula 300 is gradually tapered along the entire length of the cannula.
• FIGURE 26 shows an embodiment wherein the internal diameter of cannula 300 increases along a portion C of the length of cannula 300.
• FIGURE 27 shows an embodiment wherein the internal diameter of cannula 300 increases in more than one discrete portions D along the length of cannula 300.
• FIGURES 25 through 27 show a cannula 300 with a plugged distal end 303 and a tip 304 ground to an axially symmetrical point.
• the cannula can have an unplugged distal end and any type of point described herein may be employed with a tapered cannula embodiment.
• a suitable-sized cannula is laser drilled.
• a laser may be used to create orifices of desired sizes and shapes, with orifice widths ranging as small as 0.002 inches. It can be appreciated that such a precise means for cutting through the cannula wall can be utilized to create orifices of any shape determined to be beneficial to cannula performance. The depth of such cuts can be controlled by altering laser power and cutting speed to create an orifice on one cannula wall, or through both opposing walls.
• EDM Electrical discharge machining
• Mechanical drilling may also be employed to pierce one wall of the cannula or both opposing walls.
• Milling and grinding may also be employed to produce non-round orifice shapes, but with minimum orifice sizes again limited by the physical size of cutting tools.
• a variety of cutting means can therefore be employed to create orifices in a cannula, with the method of choice guided by speed, cost, and orifice shape requirements.
• FIGURE 28 shows the injection pressure, measured in PSI, over time of Omnipaque material injected into minipigs using Needles 10, 21 and 30 described herein compared to a standard 25 gauge needle. As shown in FIGURE 28, Needles 10, 21 and 30 all exhibited reduced injection pressure as compared to Needle 40, a standard 25 gauge needle.

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• 2021
  • 2021-02-09 EP EP21754150.7A patent/EP4103253A4/de active Pending
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