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1. (WO2017151807) PUNCTURE NEEDLE
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PUNCTURE NEEDLE

FIELD OF THE DISCLOSURE

The present disclosure relates, in some embodiments, to a puncture needle.

BACKGROUND OF THE DISCLOSURE

Puncture needles may be configured as disclosed in, for example, Japanese Patent Laying-Open No. 2005-95571. However, a need has arisen for puncture needles with improved properties and/or performance.

SUMMARY

Existing puncture needles may not effectively prevent coring. Accordingly, a need has arisen for an improved puncture needle. The present disclosure relates, in some embodiments, to a solution for the aforementioned problem. The present disclosure provides, in some embodiments, a puncture needle that may reduce or prevent coring.

A puncture needle, according to the present disclosure, may comprise a cannula provided with a lumen. The cannula has a blade surface, the blade surface has: a sharp region located on a tip side of the blade surface and provided with a sharp edge on inner and outer circumferences of the blade surface; and a blunt region located on a base end side of the blade surface and provided with a blunt edge on the inner and outer circumferences of the blade surface, and a tip of the blade surface is provided with a thick portion formed by a boundary between two surfaces, and the boundary forms an edge.

A puncture needle may provide access to a space through or across a barrier. However, coring may occur when insertion of a needle results in a portion of a barrier (e.g., a disc or plug of barrier material) being released. A released portion of a barrier may occlude and/or obstruct a needle and/or a line to which it may be connected. Accordingly, a need has arisen for annular tools (e.g., puncture needles) with reduced coring.

The present disclosure relates, according to some embodiments, to systems, apparatuses, and/or methods for accessing a space (e.g., a lumen) using an annular tool (e.g., a needle) with reduced (e.g., without or substantially without) barrier material being released in the cavity defined by the annulus of the tool (e.g., within the cavity defined by the wall of the needle).

For example, the present disclosure relates in some embodiments to a puncture needle comprising a cannula provided with a lumen and the cannula having a blade surface. In some embodiments, a blade surface may have (a) a sharp region (i) located on a tip side of said blade surface and (ii) provided with a sharp edge on inner and outer circumferences of the blade surface, and/or (b) a blunt region (i) located on a base end side of said blade surface and (ii) provided with a blunt edge on the inner and outer circumferences of said blade surface. According to some embodiments, a tip of a blade surface may be provided with a thick portion formed by a boundary between two surfaces, where the boundary forms an edge. A blunt region, in some embodiments, may be formed to extend over a half or more of a height of the cannula. In some embodiments, a blade surface may have a first surface located on a base end side and a second surface located on a tip side, and a side surface ridge line which is a boundary between a first surface and a second surface may be located in the blunt region. According to some embodiments, a length of a sharp region may be less than or equal to 40% of a length of a blade surface. A blade surface of a second surface may have a shape having a curvature that becomes gradually smaller from the tip side toward the base end side. In some embodiments a second surface may have a right-side second surface and a left-side second surface, and an angle formed by the right-side second surface with respect to the left-side second surface may be greater than or equal to 66° and less man or equal to 114°. A ratio of a length of a second surface to a length of a blade surface may be greater than or equal to 35% and less than or equal to 50%, according to some embodiments. A sharp edge may be formed on an inner and an outer circumference of a blade surface in a range where a length from a tip of the blade surface is greater than or equal to 30% and less than or equal to 40% of the length of the blade surface, in some embodiments. In some embodiments, an angle formed by a right-side second surface with respect to a left-side second surface may be: (a) greater than or equal to 66° and less than or equal to 94° or (b) greater than or equal to 66° and less than or equal to 74°. A length of a second surface in some embodiments may be greater than or equal to 46% and less man or equal to 54% of a length of a blade surface. In a range where a length from a tip of a blade surface is greater than or equal to 26% and less than or equal to 34% of the length of the blade surface, a sharp edge may be formed on the inner and outer circumferences of the blade surface. In some embodiments a blunt region is formed by blast treatment, and an area of a surface subjected to blast treatment may be larger on a base end side than on a tip side in a first surface, and larger on the base end side than on the tip side in a second surface. According to some embodiments a cannula may be exposed from a hub having a linear shape.

Further the present disclosure relates, in some embodiments, to a puncture needle comprising a needle wall defining a central longitudinal axis, the central longitudinal axis positioned within a first plane and within a second plane that perpendicularly intersects the first plane. A needle wall may comprise: an inner needle wall surface; an outer needle wall surface; a first zone with a circumferentially contiguous tubular configuration that fully encircles a central longitudinal axis; a second zone that partially encircles the central longitudinal axis; and a third zone that only partially encircles the central longitudinal axis and forms a needle tip, the third zone adjoining and extending contiguously from the second phase of the second zone.

According to some embodiments, a second zone may comprise (a) a first phase that adjoins and extends contiguously from the first zone, (b) a second phase that adjoins and extends contiguously from the first phase, and (c) a lateral opening spanning the first and second phases, defining a blade surface consisting of a first portion positioned in the first phase and a second portion positioned in the second phase, and defining an inner blade circumference and an outer blade circumference. In some embodiments, a first portion of a blade surface may be positioned in a third plane with the third plane being oblique to a central longitudinal axis, oblique to a first plane, and perpendicular to a second plane. A second portion of a blade surface may be positioned generally in a plane curve, the plane curve oblique to a central longitudinal axis, oblique to a first plane, perpendicular to a second plane, and oblique to a third plane. In some embodiments a section of a needle tip, perpendicular to a longitudinal axis and taken anywhere in a third zone, may form a partial Reuleaux triangle in which a base is a circular segment of radius (Rx) defined by an outer surface and two straight sides, each defined by a blade surface, and together defining an angle abp with a length of the two straight sides and a circumference of the circular segment generally decreasing in successive sections perpendicular to a central longitudinal axis moving toward a distal extent of the needle tip. In some embodiments a first portion of a blade surface may be roughened.

In some embodiments of the disclosure, an angle atp may be from about 70° to about

110°. An angle abp may be constant across the third zone. According to some embodiments, a section of a second phase of a second zone of a puncture needle may be perpendicular to a longitudinal axis and taken anywhere in the second phase of the second zone may form an annular sector defined by an outer needle wall surface sector, an inner needle wall surface sector, a left blade surface, and a right blade surface, lines extending from the left and right blade surfaces intersecting to form an angle Θ. An angle Θ may be from about 70° to about 110°, according to some embodiments. In some embodiments an angle Θ may be constant across a third zone.

Some embodiments of the present disclosure describe a puncture needle comprising a cannula provided with a lumen, the cannula comprising a puncture portion, and the puncture portion comprising: (a) a first surface, across left- and right-sides, distal to a tip of the puncture portion; (b) a left-side second surface proximal to the tip of the puncture portion; and (c) a right-side second surface proximal to the tip of the puncture portion. In some embodiments, a first surface may connect to a left-side second surface via a left ridge and may connect to the right-side second surface via a right ridge. A left-side second surface and the right-side second surface may intersect at a sharp edge extending from a tip of a puncture portion to a tip-end of a lumen 3, according to some embodiments. In some embodiments, both inner and outer circumferences of a left-side second surface are recessed and curved, and both inner and outer circumferences of the right-side second surface are recessed and curved, from the perspective of a plane defined by the sharp edge and a longitudinal direction of the cannula. In some embodiments a length of a first surface along a longitudinal direction may be between about 46% and about 54% of a length of a puncture portion along the longitudinal direction.

According to some embodiments a first surface may be blast-treated for reducing coring, and part of a left-side second surface and of a right-side second surface mat extends from a tip may not be blast-treated. In some embodiments, 70% of a puncture portion, by length along the longitudinal direction, may be blast-treated with the blast-treated part being distal to the tip.

In some embodiments of the disclosure an inclination angle of a sharp edge (a), with respect to a longitudinal direction, may be: (a) greater than an inclination angle of a first surface (β) or (b) greater than an inclination angle of the inner circumference of the left-side second surface, at the tip-end of the lumen, with respect to the longitudinal direction. In some embodiments an inclination angle of a first surface (β) may be smaller than an inclination angle of the inner circumference of a left-side second surface at a left ridge, with respect to a longitudinal direction. In some embodiments, from the perspective of a cross-sectional plane perpendicular to a longitudinal direction, a left-side second surface may

define a first line, a right-side second surface may define a second line, and an angle between the first and second lines may be no less than about 70° and no greater than about 110°.

Further, the present disclosure relates, in some embodiments, to a puncture needle comprising a cannula, with the cannula comprising a puncture portion for insertion into a septum. A puncture portion may comprise a blade surface inclined with respect to a longitudinal direction of the cannula, the blade surface comprising: (a) a first surface proximal to a base-end of the blade surface; (b) a left-side second surface proximal to a tip of the blade surface; and (c) a right-side second surface parallel to the left-side second surface with respect to the longitudinal direction of the cannula. In some embodiments part of a blade surface distal to a tip of a puncture portion is blast-treated, and part of the blade surface extending from the tip of the puncture portion is not blast-treated. A first surface may intersect both a left-side second surface and a right-side second surface with at least one common angle less than 180°. According to some embodiments, at least part of a first surface may be blast-treated for reducing coring and parts of a left-second surface and a right-side second surface extending from the tip of the blade surface may not be blast-treated.

The present disclosure further relates, according to some embodiments, to a puncture needle comprising a cannula provided with a lumen, the cannula comprising a blade surface with an inner edge circumference and an outer circumference. According to some embodiments, a blade surface may comprise: (a) a blunt region located on a base-end side of the blade surface and (b) a sharp region located on a tip side of the blade surface. A blunt region may comprise, in some embodiments, (i) a first blunt edge on an inner edge circumference of the blade surface and (ii) a second blunt edge on an outer circumference of the blade surface. A sharp region may comprise (i) a first sharp edge on an inner edge circumference of the blade surface and (ii) a second sharp edge on an outer circumference of the blade surface.

According to some embodiments, a sharp region may further comprise a left-side surface and a right-side surface with the left-side surface and the right-side surface intersecting with an angle between about 66° to about 114°, at a straight boundary line extending from a tip end of an outer circumference to a tip end of an inner edge circumference. An inclination angle of a straight boundary line, with respect to a longitudinal direction of a cannula, may be greater than (1) an inclination angle of an outer circumference at a tip end of the outer circumference and (2) an inclination angle of an inner edge circumference at the tip end of the inner edge circumference, according to some

embodiments. In some embodiments, a left-side surface and a right-side surface may have a recessed, curved profile in a side view that is parallel to a plane defined by a straight boundary line and the longitudinal direction of the cannula. According to some embodiments, a blunt region may intersect a left-side surface at a first ridge and may intersect a right-side second surface at a second ridge. A length of a sharp region may be between about 46% and about 54% of a length of a blade surface along a longitudinal direction of a cannula, in some embodiments. Inclination angles of a first and second sharp edges of a sharp region may be greater than inclination angles of a first and second blunt edge of a blunt region, respectively, with respect to a longitudinal direction of a cannula at a first and second ridges, according to some embodiments. In some embodiments, at least part of a blunt region distal to a tip end of an outer circumference may be blast-treated for reducing coring. And in some embodiments, a sharp region extending from a tip end of an outer circumference may not be blast-treated.

Hie foregoing and other objects, features, aspects and advantages of the present disclosure will become more apparent from the following detailed description of the present disclosure when taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Some embodiments of the disclosure may be understood by referring, in part, to the present disclosure and the accompanying drawings, wherein:

FIGURE 1 is a plan view of a puncture needle according to a specific example embodiment of the disclosure;

FIGURE 2A is a side view of the puncture needle shown in FIGURE 1;

FIGURE 2B is a side view of the puncture needle shown in FIGURE 1;

FIGURE 3 is a cross-sectional view taken along line III-III in FIGURE 2A;

FIGURE 4 is a cross-sectional view taken along line 1V-IV in FIGURE 2A;

FIGURE 5 is a cross-sectional view taken along line V-V in FIGURE 2A;

FIGURE 6 is a photograph of a plane of a puncture needle following a blast treatment according to a specific example embodiment of the disclosure;

FIGURE 7 is an enlarged planar photograph of a jaw portion of the puncture needle shown in FIGURE 6;

FIGURE 8 is an enlarged perspective photograph of the jaw portion of the puncture needle shown in FIGURE 6;

FIGURE 9 is an enlarged planar photograph of a jaw portion of a puncture needle that is not subjected to blast treatment;

FIGURE 10 is an enlarged perspective photograph of the jaw portion of the puncture needle shown in FIGURE 9;

FIGURE 11 is an enlarged planar photograph of the jaw portion of the puncture needle shown in FIGURE 9;

FIGURE 12 is an enlarged perspective photograph of the jaw portion of the puncture needle that is not subjected to blast treatment;

FIGURE 13 is an enlarged planar photograph of a side removal portion of the puncture needle according to a specific example embodiment of the disclosure;

FIGURE 14 is an enlarged perspective photograph of the side removal portion of the puncture needle shown in FIGURE 13;

FIGURE IS is an enlarged planar photograph of a side removal portion of a puncture needle that is not subjected to blast treatment;

FIGURE 16 is an enlarged perspective photograph of the side removal portion of the puncture needle shown in FIGURE IS;

FIGURE 17 is an enlarged planar photograph of the side removal portion of the puncture needle shown in FIGURE 15;

FIGURE 18 is an enlarged perspective photograph of the side removal portion of the puncture needle shown in FIGURE 15;

FIGURE 19 is a view showing a nozzle shift according to a specific example embodiment of the disclosure;

FIGURE 20 is a view showing a nozzle shift according to a specific example embodiment of the disclosure;

FIGURE 21 is a photograph showing blast masking according to a specific example embodiment of the disclosure;

FIGURE 22 is a photograph showing a blast treatment range before nozzle shift (heavy line) according to a specific example embodiment of the disclosure;

FIGURE 23 is a photograph showing a blast treatment range before (heavy line) and after (thin line) nozzle shift according to a specific example embodiment of the disclosure;

FIGURE 24 is a plan view of a puncture needle showing a blast masking range (M2=30%) according to a specific example embodiment of the disclosure;

FIGURE 25 is a side view of a puncture needle in which a ratio between a length Ml of a region subjected to blast treatment and a length M2 of a region not subjected to blast treatment is 50:50 according to a specific example embodiment of the disclosure;

FIGURE 26 is a plan view of a puncture needle in which the ratio between length Ml of the region subjected to blast treatment and length M2 of the region not subjected to blast treatment is 60:40 according to a specific example embodiment of the disclosure;

FIGURE 27 is a side view of a puncture needle in which a ratio between a length SI of first surface 10 and a length S2 of second surface 20 is 65:35 according to a specific example embodiment of the disclosure;

FIGURE 28 is a front view showing cannula 6 as a whole and hub 60 for holding cannula 6 according to a specific example embodiment of the disclosure;

FIGURE 29 is a cross-sectional view of an embedded port according to a specific example embodiment of the disclosure;

FIGURE 30 is a graph showing the force necessary for insertion of the puncture needle according to a specific example embodiment of the disclosure;

FIGURE 31 is a side view of a puncture needle according to a specific example embodiment of the disclosure; and

FIGURE 32 is a plan view of the puncture needle shown in FIGURE 31.

Table 1 below includes the reference numerals used in mis application. The thousands and hundreds digits correspond to the figure in which the item appears while the tens and ones digits correspond to the particular item indicated. Similar structures share matching tens and ones digits.

Table 1


DETAILED DESCRIPTION

The present disclosure relates, in some embodiments, to systems, apparatuses, and/or methods for accessing a space (e.g., a lumen) using an annular tool (e.g., a needle) with reduced (e.g., without or substantially without) barrier material being released in the cavity defined by the annulus of the tool (e.g., within the cavity defined by the wall of the needle). According to some embodiments, an annular tool (e.g., a needle) as described herein may be used in connection with any medical, therapeutic, or other treatment of subjects (e.g., human or animals). For example, an annular tool (e.g., a needle) may be used as or used to create or provide a subcutaneous injection port, an infusion line, a mixed injection tube in a blood circuit, a blood collection tube, a chemical container such as a vial container, and/or combinations thereof.

1. Structure of Puncture Needle

According to some embodiments, a puncture needle may comprise a cannula provided with a lumen. A cannula may comprise a blade surface, the blade surface including: a sharp region located on a tip side of the blade surface and provided with a sharp edge on inner and outer circumferences of the blade surface; and a blunt region located on a base end side of the blade surface and provided with a blunt edge on the inner and outer circumferences of the blade surface, and a tip of the blade surface is provided with a thick portion formed by a boundary between two regions of the blade surface, and the boundary forms an edge.

A vertex of a thick portion may form, in some embodiments, the edge, while such edge is not formed in a one-plane-cut blade surface. Due to the shape of the tip, a rubber stopper may be cleaved along the blade surface. Thereafter, when the rubber stopper reaches the blunt edge portion, the rubber becomes less likely to break and is cleaved. As a result, coring may be suppressed. Furthermore, since a thick portion is provided, a cannula may have increased strength according to some embodiments. The rubber is less likely to break on the outside since, in some embodiments, the outside of the cannula is blunt.

In some embodiments, a blunt region is configured to extend over a half or more of a height of a cannula. Accordingly, a cleaving end formed in the rubber stopper is less likely to become larger than a semicircle and thereby a rubber stopper may be less likely to break.

According to some embodiments, a blade surface a blade surface may have a first surface located on a base end side and a second surface located on a tip side, and a side surface ridge line which is a boundary between a first surface and a second surface may be located in a blunt region. When a rubber surface hits a sharp side surface ridge line, the rubber may deflect and may be cleaved excessively. However, when a side surface ridge line is blunt, cleaving may be less likely to occur.

In some embodiments, a length of a sharp region is less than or equal to 40% of a length of a blade surface. Since a cleaving end formed in the rubber stopper may be reduced in size, a rubber stopper may be less likely to break and the needle can pass through the rubber stopper.

According to some embodiment, a blunt region may be formed by blast treatment, and an area of a surface subjected to blast treatment is larger on a base end side than on a tip side on a first surface, and larger on the base end side than on the tip side on the second surface (i.e., the blast treatment is performed more intensely on the base end side than on the tip side). Therefore, the blade surface of the second surface may have a shape having a curvature that becomes gradually smaller from the tip side toward the base end side. In a blunt region, a blade surface may be formed to become gradually blunter toward the base end direction, and thus, coring may be suppressed more reliably.

Numerical ranges in each configuration are provided below. Some of these ranges may be preferred for certain applications in light of the coring results obtained in tests, the results of which are shown in Tables 2 and 3.

In some embodiments, a second surface may have a right-side second surface and a left-side second surface, and an angle formed by the right-side second surface with respect to the left-side second surface may be greater than or equal to 66° and less than or equal to 114°.

According to some embodiments, a ratio of a length of a second surface to a length of a blade surface may be greater than or equal to 35% and less than or equal to 50%.

A blast treatment, in some embodiments, may not be performed in a range where a length from a tip of a blade surface is greater than or equal to 30% and less than or equal to 40% of a length of the blade surface.

In some embodiments, an angle formed by a right-side second surface with respect to a left-side second surface may be greater than or equal to 66° and less than or equal to 94°.

According to some embodiments, a length of a second surface may be greater than or equal to 46% and less than or equal to 54% of a length of a blade surface.

An angle formed by a right-side second surface with respect to a left-side second surface may be greater than or equal to 66° and less than or equal to 74°, according to some embodiments.

In some embodiments, a blast treatment may not be performed in a range where a length from a tip of a blade surface is greater than or equal to 26% and less than or equal to 34% of a length of the blade surface.

FIGURE 1 illustrates a plan view of a puncture needle according to a specific example embodiment of the disclosure. FIGURE 2A illustrates a side view of the puncture needle shown in FIGURE 1. FIGURE 2B illustrates a side view of the puncture needle shown in FIGURE 1. FIGURE 3 illustrates a cross-sectional view taken along line III in FIGURE 2A. FIGURE 4 illustrates a cross-sectional view taken along line IV in FIGURE 2A. FIGURE 5 illustrates a cross-sectional view taken along line V in FIGURE 2A.

As shown in FIGURES 1 to 5, a puncture needle 1, according to some embodiments, may be provided with a puncture portion 4 having a blade surface 2 inclined with respect to longitudinal direction la, as shown by an alternating long and short dashed line. In some embodiments, puncture needle 1 may comprise cannula 6, and cannula 6 may be further provided with lumen 3. An opening surface of lumen 3 may be defined by an inner circumferential edge 35, according to some embodiments. An outer circumferential edge 36 of lumen 3 may be formed on an outside of an inner circumferential edge 35. For example, inner circumferential edge 35 and outer circumferential edge 36 of inclined blade surface 2 may be formed into an "r" (lower case) shape as a blunt region. Both inner circumferential edge 35 and outer circumferential edge 36 have a substantially oval shape, according to some embodiments. In some embodiments, an "r" (lowercase) shape may be formed by blast treatment. The "r" (lower case) shape is not formed on the side close to a tip portion 31. The "r" (lower case) shape is formed on the side close to a base end portion 32.

As shown in FIGURE 1, in some embodiments, inclined blade surface 2 may have a first surface 10 on a base end side and second surface 20 on a tip side connecting to first surface 10. As shown in FIGURE 2B, first surface 10 may be inclined at a first angle, B, with respect to lumen 3. Lumen 3 may be parallel to longitudinal direction la (shown by alternate long and short dash line) of cannula 6, in some embodiments. In some embodiments, first surface 10 may have a right-side first surface and a left-side first surface.

According to some embodiments, second surface 20 may be configured to connect to first surface 10. Second surface 20 may include right-side second surface 21 and left-side second surface 22. Second surface 20 define a convex curve relative to center line 23. Ridge 33 may form a boundary between right-side first surface 10 and right-side second surface 21, in some embodiments. In some embodiments, ridge 34 may form a boundary between left-

side first surface 10 and left-side second surface 22. Right-side second surface 21 and leftside second surface 22 may each comprise a center line 23. An edge 37 may be formed at a boundary between right-side second surface 21 and left-side second surface 22. As shown in FIGURE 2B, center line 23 may be formed by edge 37 and may form an angle, a, with respect to longitudinal direction la (shown by alternate long and short dash line) of cannula 6, in some embodiments. In some embodiments, a tip of blade surface 2 may comprise a thick portion 29 formed by a boundary between a right-side second surface 21 and a left-side second surface 22 with the boundary forming edge 37. A section of a tip of blade surface 2 taken perpendicular to longitudinal direction la may have the shape of a partial Reuleaux triangle in which the base is a circular segment of radius ("Rx") {e.g., radius equals the thickness of the cannula wall) and the two sides extending (e.g., two sides of equal length) from each end of the base are straight, as shown in FIGURES 4 and S. In some embodiments, second surface 20 (even if curved) may be generally inclined at a second angle with respect to longitudinal direction la of cannula 6. As shown in FIGURES 4 and S, illustrating cross-sectional views of FIGURE 2A cut along lines IV and V respectively, an angle formed by right-side second surface 21 and left-side second surface 22 is preferably greater than or equal to 70° and less than or equal to 110°, according to some embodiments. A ratio between a length of first surface 10 and a length of second surface 20 may be 50:50, in some embodiments.

In some embodiments, ridge 33, and ridge 34, and at least a portion of a first surface

10 may be subjected to blast treatment. All parts of a first surface 10 may be subjected to blast treatment in some embodiments. According to some embodiments, a blast treatment may be performed more intensely on a base end side than on a tip side of first surface 10, and a degree of cutting by the blast treatment may be higher on the base end side than on the tip side. A region near tip portion 31 is not subjected to blast treatment, in some embodiments. An edge 37 is formed at a boundary between right-side second surface 21 and left-side second surface 22. According to some embodiments, edge 37 is not subjected to a blast treatment. In some embodiments, a surface area subjected to blast treatment on a base end side is larger than an area subjected to blast treatment on a tip end side.

According to some embodiments, a new edge may be formed by a right-side first surface intersecting a left-side first surface at an angle. A new edge may be subjected to blast treatment, according to some embodiments.

As shown in FIGURE 1 and FIGURE 2A, blade surface 2 may comprise a sharp region 39b disposed on a tip side of blade surface 2. In some embodiments, sharp region 39b may comprise a sharp edge disposed on an inner circumference of a tip side of blade surface 2 and a sharp edge disposed on an outer circumference of the tip side of blade surface 2. Blade surface 2, in some embodiments, may comprise blunt region 39a disposed on a base end side of blade surface 2. According to some embodiments, blunt region 39a may comprise a blunt edge disposed on an inner circumference of a base end side of blade surface 2 and a blunt edge disposed on an outer circumference of the base end side of blade surface 2.

As shown in FIGURES 2A and 2B, where H represents a height of cannula 6 (direction orthogonal to a central axis shown by alternate long and short dash line la), blunt region 39a may be greater than or equal to 1/2H. In some embodiments, first surface 10, second surface 22, and center line 23 together define an "R" (upper case) shape as illustrated in FIGURE 2A.

As shown in FIGURES 4 and 5, in some embodiments, inner circumferential edge 35 and outer circumferential edge 36 are configured to form a cross-section having an "r" shape. Forming a cross section having an "r" (lower case) shape may reduce cleaving of a septum and thereby reduce coring or a formation of a core piece.

In some embodiments, as shown in FIGURE 6, a length of second surface 20 may 35% of a length of blade surface 2. According to some embodiments, an "r" (lower case) shape may be formed by a blast treatment. Referring to FIGURES 7 and 8, a length A of a jaw portion subjected to blast treatment is 0.562 mm in some specific example embodiments.

As shown in FIGURE 6, a blade surface of a second surface may have a curvature that becomes smaller from the tip toward the base end. In other words, the blade surface of the second surface is the blade surface in which an area of the blunt region becomes gradually larger from the tip toward the base end. FIGURES 9 and 10 illustrate a comparative product without a blast treatment having a length A of a jaw portion of 0.681 mm. FIGURES 11 and 12 illustrate embodiments of the present disclosure prior to a blast treatment and having a length A of a jaw portion of 0.680 mm.

FIGURES 15 and 16 illustrate a comparative product without a blast treatment having a side removal portion with a width B of 0.803 mm. FIGURES 17 and 18 illustrate embodiments of the present disclosure prior to a blast treatment having a side removal portion with a width B of 0.779 mm. FIGURES 13 and 14 illustrate embodiments of the

present disclosure subsequent to a blast treatment, in which width B of a side removal portion of 0.562 mm.

FIGURE 28 shows a cannula 6 and a hub 60 for holding cannula 6. Cannula 6 exposed from hub 60 has a linear shape as a whole. Cannula 6 may have an L shape, in some embodiments. In some embodiments, a cannula 6 may have a shape that is configured to be bent in a non-linear shape, but is not configured to bend more than 90 degrees (e.g., L-shaped).

As illustrated in FIGURES 31 and 32, a puncture needle 1 may include, according to some embodiments, an elongate body 61 and/or an angular tip 62 at one or both ends. In some embodiments, a puncture needle 1 may comprise a needle wall 63, at least a portion of which may have an annular configuration encircling and/or defining a lumen 3 with a diameter, a length, and a central longitudinal axis. A needle wall 63 and the lumen it defines, lumen 3 may have an opening at one or both ends. A puncture needle 1 may comprise, in some embodiments, a blade 64 configured to facilitate insertion into and/or through a barrier material.

According to some embodiments, a puncture needle may have a needle wall defining a central longitudinal axis 71 positioned within a first plane X and also within a second plane Y that perpendicularly intersects the first plane. Thus, the axis is positioned at the intersection of these two planes. A puncture needle may include three zones along its length. For example, as shown in FIGURE 31, a first zone 65 may have a circumferentially contiguous tubular configuration and fully encircle a central longitudinal axis. A first zone may be configured to have a portion of the needle wall defining a lumen 3 and having an inner tubular wall with an inner tubular circumference and an inner tubular wall with an outer tubular surface. The radius of the inner and outer wall may be constant along the length of a first zone. For example, the inner wall may be free of wall spurs, bumps, ridges, or other projections into the lumen.

A second zone 66 may have a wall that only partially encircles (e.g., with respect to its outer circumference) a central longitudinal axis. A second zone 66 may have two distinct phases. A first phase of a second zone 66a may adjoin and extend contiguously from a first zone 65. A first phase of a second zone 66a may be configured to have a portion of the needle wall 63 with a lateral opening defining a first phase portion of a blade surface 72. A first phase portion of a blade surface 72 may have an outer blade circumference 69 (e.g., contiguous with the outer needle wall surface) and an inner blade circumference 70 (e.g., contiguous with the inner needle wall surface). A first phase portion of a blade surface may be within a third plane Z oblique to a central longitudinal axis and a first plane X and generally perpendicular to a second plane Y.

In some embodiments, radii extending to the inner surface and outer surfaces of needle wall along the length of a first phase of a second zone 66a may be (1) equal to radii extending to the inner and outer surface of needle wall along the length of the first zone, respectively, and/or (2) constant along the length of the first phase of a second zone. For example, the inner wall may be free of wall spurs, bumps, ridges, or other projections into the lumen.

A second phase of a second zone 66b may adjoin and extend contiguously from a first phase of a second zone 66a. A second phase of a second zone 66b may be configured to have a portion of the needle wall with a lateral opening defining a second phase portion of a blade surface 73. A second phase portion of a blade surface 73 may be configured to be contoured rather than planar. For example, a second phase portion of a blade surface 73 may be configured to generally convex relative to a central longitudinal axis and/or a line extended from and along tip edge (described below). A second phase portion of a blade surface 73 may define a contoured strip, the curvature of which changes along the length of second phase of a second zone 66b. Any tangent to a contoured strip may be oblique to a central longitudinal axis 71, oblique to a first plane X, oblique to a second plane Y, and oblique to a fourth plane ZZ.

In some embodiments, radii extending to the inner surface and outer surfaces of needle wall along the length of a second phase of a second zone may be respectively tapered relative to radii extending to the inner surface and outer surfaces of needle wall along the length of a first phase of a second zone. For example, as may be seen in FIGURE 32, inner radius r1 > inner radius r2 > inner radius r„, such that the inner surface is tapered. The inner wall may be free of wall spurs, bumps, ridges, or other projections into the lumen.

A first phase portion of a blade surface 72 may be contiguous with a second phase portion of a blade surface 73. Similarly an inner circumference and outer circumference of a first phase portion of a blade surface may be contiguous with, respectively, an inner circumference and an outer circumference of a second phase portion of a blade surface. Together, an inner circumference of a first phase portion of a blade surface and an inner circumference of a second phase portion of a blade surface may define an inner edge of a blade surface. Together, an outer circumference of a first phase portion of a blade surface and an outer circumference of a second phase portion of a blade surface may define an outer edge of a blade surface. An inner edge and an outer edge each may independendy have any

desired curvilinear shape. For example, an inner edge and an outer edge may form generally concentric curvilinear shapes (e.g., leaf, teardrop, and/or folium), each having a tip positioned at its most distal extent. An inner edge may define an opening to a needle lumen. In some embodiments, a blade may comprise at least a portion of an inner edge and/or at least a portion of an outer edge.

An inner circumference and/or an outer circumference within a first phase portion of a blade surface 72 may have, as may be seen in FIGURE 32, two ends and a parabolic shape, partial oval shape, an "ΓΊ" shape, semi-circular shape or any other desired shape. An inner circumference and/or an outer circumference within a second phase portion of a blade surface 73 may have two ends and a "V" shape, a rounded "V" shape, as may be seen in FIGURE 32, or any other desired shape. The ends of a first phase portion of a blade surface and a second phase portion of a blade surface may be joined to form opposing lateral ridges 33/34. Each lateral ridge may independently define a line oblique to the first and second planes and, optionally also oblique to the third plane. Each lateral edge may extend between an inner surface and an outer surface. Lateral ridges may be positioned on opposite or generally opposite sides of a needle wall opening. In some embodiments, opposing ridges may be toed in, wherein a proximal end (e.g., positioned closer to a first zone of the puncture needle) of a ridge is adjacent to an outer surface of a needle wall and a distal end (e.g., positioned farther from a first zone of the puncture needle) of a ridge is adjacent to an inner surface of the needle wall. Opposing ridges may be coplanar, according to some embodiments. Opposing ridges may be positioned (1) more distally along a central axis so a first phase of a second zone is larger than a second phase of the second zone, (2) more proximally along a central axis so a first phase of a second zone is smaller than a second phase of the second zone, or (3) so a first phase of a second zone is equal or substantially equal to a second phase of the second zone.

In some embodiments, sections of a second phase of a second zone taken perpendicular to a central longitudinal axis (e.g., anywhere along the length of the second phase of the second zone) may have an annular sector shape defined by an outer wall surface sector, an inner wall surface sector, and a left and right blade surface. Lines extending from a left and right blade surfaces intersect to form an angle Θ, which, in some embodiments may be from about 70° to about 110°. According to some embodiments, an angle Θ may be constant through successive sections along up to the full length of the second phase of the second zone. An angle Θ may vary, in some embodiments, through successive sections along up to the full length of the second phase of the second zone.

A third zone 67 may be configured to be a needle tip. A third zone 67 may have a wall that only partially encircles (e.g., with respect to its outer circumference) a central longitudinal axis. A third zone may adjoin and extend contiguously from a second phase of a second zone. A section of a tip perpendicular to a longitudinal axis taken anywhere in the third zone (i.e., between a puncture needle's distal extent and the beginning of the third annular sector zone) may define a partial Reuleaux triangle in which one side is a circular segment of radius ("Rx") (e.g., radius equals the radius of the inner surface of the cannula wall) and two sides (e.g., two sides of equal length) are straight. The two straight sides define an angle atip. The radius (r) and angle atip are constant in successive sections taken along the length of the second zone. The length of the two straight sides and the circumference of the circular segment generally decrease (but r and αηρ remain constant) in successive sections perpendicular to the longitudinal axis moving toward the distal extent of the tip. Each vertex formed by the straight sides (blade surfaces) in successive sections defines a tip edge. A tip edge and a central longitudinal axis may form an angle a. A third zone may begin where sections taken perpendicular to a central longitudinal axis transition from having an annular sector shape to a partial Reuleaux triangle (or vice versa).

2. Method of Manufacturing a Puncture Needle

The present disclosure relates, in some embodiments, to methods for making a puncture needle. For example, hollow puncture needle 1 for medical purposes, according to some embodiments of the disclosure, may be manufactured in accordance with the following method.

2-1 Selection of Material

According to some embodiments, a cannula (e.g., cannula 6) may be selected (e.g., as a raw tube subjected to primary molding processing). In some embodiments, a cannula may comprise any desired material including, for example, iron, steel, stainless steel, composites, and combinations thereof. A length, an inner diameter, and an outer diameter of a cannula may be selected in accordance with a target end product.

2-2 Grinding

According to some embodiments, a cannula may be processed to form a blade surface (e.g., blade surface 2 having first surface 10, right-side second surface 21, and left-side second surface 22). In some embodiments, processing may include grinding. For example, a disc-shaped (cylindrically-shaped) rotary grindstone having a prescribed thickness may be placed on a tip side of a cannula (e.g., cannula 6) and above a target first surface 10. Then, a rotation central axis of the rotary grindstone may be set in parallel with the target surface (e.g., first surface 10). The rotary grindstone may be arranged to produce a surface (e.g., first surface 10) having an angle (first angle) formed by the surface and a longitudinal axis (e.g., longitudinal direction la) of, for example, 10°. The rotary grindstone thus arranged may be rotationally driven around the rotation central axis thereof. In some embodiments, an entire tip surface of a cannula (e.g., cannula 6) may be subjected to grinding by an outer circumferential surface of a rotary grindstone, forming a first surface 10.

According to some embodiments, a cannula may be subjected to further processing by changing a relative position of a rotary grindstone relevant to the cannula (e.g., cannula 6) and grinding an additional tip surface. In some embodiments, a position of a rotary grindstone may be fixed, while a position of a cannula being worked may be non-fixed (e.g., alterable).

In some embodiments, a cannula (e.g., cannula 6) and a rotary grindstone may be positioned relative to each other to form a second surface. For example, a cannula may be inclined such that an angle formed by a second surface with respect to longitudinal axis la is, for example, 18°. According to some embodiments, a cannula (e.g., cannula 6) may be circumferentially rotated counterclockwise by, for example, 55° around a line extending from and along a tip edge (e.g., center line 23) with respect to the rotary grindstone from a position where first surface 10 has been formed. A rotary grindstone may be brought into contact with the cannula to form a right-side second surface 21 by processing (e.g. , grinding).

A cannula (e.g., cannula 6) may be circumferentially rotated clockwise by, for example, 110° around a line extending from and along a tip edge (e.g., center line 23) with respect to the rotary grindstone from a right-side second surface (e.g., right-side second surface 21). In some embodiments, a rotary grindstone may be brought into contact with a cannula (e.g., cannula 6) to form a left-side second surface (e.g., right-side second surface 22) by processing (e.g., grinding). As a result, a puncture needle may have having a first angle (e.g., 10°), a second angle (e.g., 18°), and a rotation angle (e.g., 110°).

2-3 Blast Treatment

According to some embodiments, at least a portion of (but less than all of) a blade surface may be subjected to a treatment to roughen the surface and/or grind down sharp edges. For example, at the time when first surface 10 and second surface 20 are formed by the grinding processing, inner circumferential edge 35, outer circumferential edge 36 and ridges 33 and 34 may have a sharp shape, and thus, these are subjected to blast treatment to form an "r" (lower case) shape (curved shape).

In some embodiments, a blast treatment may comprise propelling an abrasive material through a nozzle (e.g., nozzle SO) toward a surface to be treated. A blast treatment may include shifting a nozzle (e.g., nozzle 50), for example as shown in FIGURES 19 and 20, to emit a powder onto a puncture needle. As shown in FIGURES 21-23, in some embodiments a tip portion (e.g., a region where a length is 30% of that of the blade surface) of a puncture needle may be masked and thereby protected from a blast treatment. Even if the powder is emitted onto the masked region, this portion is not protected from blast treatment. As shown in FIGURE 22, in some embodiments a nozzle shift is not used and a blast treatment is performed only in a limited range. In some embodiments, a nozzle shift is used and a blast treatment is performed in a wider range, as shown in FIGURE 23.

As shown in FIGURES 24 and 25, a blast treatment may be performed more intensely on a side close to base end portion 32 on at least one of first surface 10 and second surface 20. A ratio between a length Ml of a portion subjected to blast treatment and a length M2 of a portion not subjected to blast treatment can be changed as appropriate. A ratio between a length SI of first surface 10 and a length S2 of a second surface 20 can also be changed as appropriate. A blast region 39a in FIGURE 24 indicates the region subjected to blast treatment and a length thereof is 70% of the length of blade surface 2. FIGURE 25 shows puncture needle 1 in which a ratio between length Ml of a region subjected to blast treatment and length M2 of a region not subjected to blast treatment is 50:50.

FIGURE 26 shows puncture needle 1 in which the ratio between length Ml of a region subjected to blast treatment and length M2 of a region not subjected to blast treatment is 60:40. FIGURE 27 shows puncture needle 1 in which a ratio between length SI of first surface 10 and length S2 of second surface 20 is 65:35.

3. Tests

According to some embodiments, any desired test may be used to assess coring performance (e.g., septum material that may be scrapped off or otherwise released) of a puncture needle. One specific example performance test procedure is described below as applied to puncture needle 1

3-1 Coring Test

In medical treatment an embedded port may be used to administer one or more medicaments and/or remove patient fluids. An embedded port refers to a reservoir (e.g., reservoir 203) (normally accompanied with a catheter) placed under the skin as shown in FIGURE 29. The embedded port receives the needle through septum 201. The embedded port is often used for administration of a medicament. Reservoir 203 is formed within housing 202. An outlet tube 204 is connected to reservoir 203 and outlet tube 204 is connected to a catheter 205. (e.g., FIGURE 29) and is often associated with a housing (e.g., housing 202). Often an outlet tube (e.g., outlet tube 204) is connected to a reservoir (e.g., reservoir 203) and an outlet tube (e.g., outlet tube204) is connected to a catheter (e.g., catheter 205).

To access a reservoir, a needle may puncture a septum (e.g., septum 201). A septum (e.g., septum 201) may be configured to allow a puncture needle to access a reservoir a plurality of times. In some embodiments, a septum (e.g., septum 201) may comprise an elastic material. During puncture, a core piece may be generated (e.g., a quantity of a septum material generated when a puncture needle makes a hole in a septum). A coring test was performed to evaluate whether use of a needle as described in the present disclosure results in decreased coring (e.g., an absence of a core piece).

Blade surface 2 refers to an inclined portion of the needle. A tip thereof is sharp. Cannula 6 refers to a tube-like portion of the needle through which a liquid passes. A core piece refers to a small piece of the septum material generated when puncture needle 1 makes a hole in a septum 201 (FIGURE 29). The jaw portion refers to the cut surface rear side of the needle blade surface, and specifically to a region between inner circumferential edge 35 and outer circumferential edge 36 in base end portion 32. Lumen 3 is defined by an inner surface of cannula 6.

A stylet is a device inserted into lumen 3 to remove the core piece, and is desirably made of metal.

3-2 Overview of Test Procedure

An elastic silicon disc (denoted as "septum") was fixed in a septum holder. Assuming that septum 201 for testing was the embedded port, a tester accessed septum 201 for testing by using the needle. This test was classified into a failure/no-failure test. If the core piece was present in cannula 6, the result was determined as unacceptable.

This test is a test method for determining whether or not the needle is designed and manufactured to prevent the core piece from being generated when the needle accesses septum 201 for testing of the typical port.

The septum was a silicon disc and had a diameter of 0.70+0.01 inches and a thickness of 0.25010.005 inches. Prior to performing each test, a puncture surface (i.e., a flat surface that a puncture needle would puncture to access a reservoir) was evaluated for pitting and/or chipping. Only a smooth puncture surface was used for core testing. The septum was made of an elastic silicon material having a durometer hardness of 60A (ASTM D2240).

An optical microscope achieving an optical magnification of at least 20 was required. SZ-CTV manufactured by OLYMPUS was used as a main body of the optical microscope and MHF-150L was used as a light source of the optical microscope, and observation was made under a magnification of 20.

3-3 Procedure

(1) The needle was taken out of a package. Each needle was tested only one time. (2) Septum 201 for testing was placed and clamped at a testing machine.

(3) A test tool was fixed to above a cylinder and a member (guide template) for causing the needle to vertically penetrate the septum placed on the test tool.

(4) Puncture needle 1 was inserted into the clamped septum along an outer edge of a circular opening of the guide template. At this time, the blade surface was directed to the circumferential direction as puncture needle 1 was inserted into the septum perpendicularly to the septum surface. The septum was punctured with only one needle at one time. Penetration was performed carefully so as to avoid the previous punctured portion.

(5) It was determined whether or not coring was occurring.

Furthermore, during the coring test, a resistance when puncturing the septum was investigated. The puncture resistance had a resistance of the blade edge and a resistance of the pipe, and these were read as shown in FIGURE 30, respectively.

A stylet (a wire) was used to push out of the needle the core piece that may be present in lumen 3. The stylet had an outer diameter that is greater than or equal to 70% (in size) of the inner diameter of cannula 6.

4. Results

The following tables show the presence or absence of coring and the puncture resistance. Tables 2 and 3 show the presence or absence of coring. Tables 4 and S show the puncture resistance in the first to third lots. Indicated gauge sizes satisfy IS09626. Specifically, the gauge size of 19G means that the outer diameter is 1.06510.035 mm and the inner diameter is 0.70410.056 mm. The gauge size of 21G means that the outer diameter is 0.81510.015 mm and the inner diameter is 0.518510.0285 mm. The gauge size of 22G means that the outer diameter is 0.71410.016 mm and the inner diameter is 0.41510.025 mm. All of the puncture needles are made of SUS304.

The first angle refers to the angle formed by first surface 10 and longitudinal direction la (e.g., FIGURE 1). The second angle refers to the angle formed by second surface 20 and longitudinal direction la (e.g., FIGURE 1). The rotation angle refers to the angle formed by right-side second surface 21 and left-side second surface 22 that form second surface 20 (e.g., FIGURE 3). A blade surface ratio refers to a ratio of the length of second surface 20 to the entire length of blade surface 2. Blast masking indicates a length of the masked region in second surface 20 with respect to the length of blade surface 2. Blast masking was performed over a prescribed length from tip portion 31 of second surface 20.

From the tables shown above, the frequency of occurrence of coring tended to increase as the gauge size became thicker.

As shown in Table 2 and Table 3, the frequency of coring tended to increase as the gauge size became thicker. Additionally, the frequency of coring tended to decrease when nozzle shift was present. The frequency of coring tended to decrease when a needle had a blast masking ratio of 30%. Further, a needle having a rotation angle of 70% showed decreased coring.

In some puncture needles, there were few variations and tendency difference between the manufacturing lots. However, as to the frequency of occurrence of coring in accordance with each factor, the occurrence of coring tended to decrease under the treatment conditions that the blast masking ratio was 30%, the blade surface ratio was 50% and the rotation angle was 70°.

As will be understood by those skilled in the art who have the benefit of the instant disclosure, other equivalent or alternative puncture needles, methods, and systems can be envisioned without departing from the description contained herein. Accordingly, the manner of carrying out the disclosure as shown and described is to be construed as illustrative only.

Persons skilled in the art may make various changes in the shape, size, number, and/or arrangement of parts without departing from the scope of the instant disclosure. In addition, the size of a device and/or system may be scaled up (e.g., to be used for adult subjects) or down (e.g., to be used for juvenile subjects) to suit the needs and/or desires of a practitioner. Each disclosed method and method step may be performed in association with any other disclosed method or method step and in any order according to some embodiments. Where the verb "may" appears, it is intended to convey an optional and/or permissive condition, but its use is not intended to suggest any lack of operability unless otherwise indicated. Where open terms such as "having" or "comprising" are used, one of ordinary skill in the art having the benefit of the instant disclosure will appreciate that the disclosed features or steps optionally may be combined with additional features or steps. Such option may not be exercised and, indeed, in some embodiments, disclosed systems, compositions, apparatuses, and/or methods may exclude any other features or steps beyond those disclosed herein. Elements, compositions, devices, systems, methods, and method steps not recited may be included or excluded as desired or required. Persons skilled in the art may make various changes in methods of preparing and using a composition, device, and/or system of the

disclosure. For example, a composition, device, and/or system may be prepared and or used as appropriate for animal and/or human use (e.g., with regard to sanitary, infectivity, safety, toxicity, biometric, and other considerations).

Also, where ranges have been provided, the disclosed endpoints may be treated as exact and/or approximations as desired or demanded by the particular embodiment. Where the endpoints are approximate, the degree of flexibility may vary in proportion to the order of magnitude of the range. For example, on one hand, a range endpoint of about SO in the context of a range of about S to about SO may include SO.S, but not S2.S or SS and, on the other hand, a range endpoint of about SO in the context of a range of about 0.S to about SO may include SS, but not 60 or 75. In addition, it may be desirable, in some embodiments, to mix and match range endpoints. Also, in some embodiments, each figure disclosed (e.g., in one or more of the examples, tables, and/or drawings) may form the basis of a range (e.g., depicted value +/- about 10%, depicted value +/- about 50%, depicted value +/- about 100%) and/or a range endpoint. With respect to the former, a value of 50 depicted in an example, table, and/or drawing may form the basis of a range of, for example, about 45 to about 55, about 25 to about 100, and/or about 0 to about 100. Disclosed percentages are weight percentages except where indicated otherwise.

All or a portion of a device and/or system for a puncture needle may be configured and arranged to be disposable, serviceable, interchangeable, and/or replaceable. These equivalents and alternatives along with obvious changes and modifications are intended to be included within the scope of the present disclosure. Accordingly, the foregoing disclosure is intended to be illustrative, but not limiting, of the scope of the disclosure as illustrated by the appended claims.

The title, abstract, background, and headings are provided in compliance with regulations and/or for the convenience of the reader. They include no admissions as to the scope and content of prior art and no limitations applicable to all disclosed embodiments.