Source: https://patents.google.com/patent/US20020072716A1/en
Timestamp: 2018-10-15 16:25:40
Document Index: 49425364

Matched Legal Cases: ['art 140', 'art 140', 'art 120', 'art 130', 'art 130', 'art 130', 'art 130', 'art 130', 'art 130', 'art 400', 'art 400', 'art 410', 'arts 416', 'art 400', 'art 416', 'arts 416', 'art 400', 'arts 400', 'arts 424', 'arts 424', 'art 410', 'art 410', 'art 400', 'art 410', 'art 410', 'arts 400', 'art 130', 'art 400', 'art 410', 'art 400', 'art 410', 'art 400', 'art 400', 'art 410', 'art 410', 'arts 446']

US20020072716A1 - Safety shield for medical needles - Google Patents
US20020072716A1
US20020072716A1 US10016276 US1627601A US2002072716A1 US 20020072716 A1 US20020072716 A1 US 20020072716A1 US 10016276 US10016276 US 10016276 US 1627601 A US1627601 A US 1627601A US 2002072716 A1 US2002072716 A1 US 2002072716A1
US7438703B2 (en )
This patent application is a continuation-in-part of U.S. patent application Ser. No. 09/892,593, filed in the U.S. Patent and Trademark Office (USPTO) on Jun. 27, 2001 by Ferguson et al., and claims priority to U.S. Provisional Application Serial No. 60/254,506 filed in the USPTO on Dec. 8, 2000 by Thorne et al., and U.S. Provisional Application Serial No. 60/296,968 filed in the USPTO on Jun. 8, 2001 by Barrus et al., the entire contents of each of these applications being hereby incorporated by reference herein.[0001]
Huber needles may be particularly difficult to remove from a needle access port which can result in hazardous exposure of the needle to a patient and a clinician. This is due, at least in As part, to the fact that access port septums exhibit forces associated with needle entry and removal, which are much greater than forces normally associated with other medical needle insertion and removal (e.g., with syringes or phlebotomy needles). “Rebound” injuries are typically encountered with Huber needles because of the force required to overcome resistance of the septum of the access port. Further, other factors can contribute to the septum's resistance, such as, for example, the needle tip may become barbed, skin may adhere to the needle shaft, etc. [0009]
FIG. 4 is a side view of the safety shield apparatus shown in FIG. 1 in an extended position; [0023]
FIG. 24 is a perspective view of the safety shield apparatus shown in FIG. 23 fully extended and having the foam disc separated; [0047]
FIG. 25 is a perspective view of the safety shield apparatus shown in FIG. 19 showing an alternate embodiment of a linear bearing and the shield separated from the needle hub and wing assembly; [0048]
FIG. 34 is a side cross-sectional view of an alternate embodiment of a needle and hub. [0057]
Referring to FIGS. 7B and 8, right-side disposed members [0070] 173, of elongated part 140, may include an outwardly disposed, elongated side rail 174 and a medially disposed elongated side rail 176. Defining an axis along the length of elongated rails 174 and 176 to be a y axis of an x,y,z coordinate system, rails 174 and 176 are mutually displaced along an x axis to cooperatively form a guide channel 178. Elongated rails 174 and 176 may be mutually displaced, as shown in FIG. 8, along a z axis to provide an offset which facilitates injection mold manufacture, as one skilled in the fabrication arts.
Similar to right-side disposed members [0073] 173, left-side disposed members 185 of elongated part 140 may comprise an outwardly disposed, elongated side rail 194 and a medially disposed elongated side rail 196, as shown in FIG. 6. Elongated rails 194 and 196 define the y axis and rails 194 and 196 may be mutually displaced along the x axis to cooperatively form a guide channel 198. Elongated rails 194 and 196 may be mutually displaced along the z axis to provide an offset which facilitates injection mold manufacture.
The manufacture of safety shield apparatus [0082] 10 parts may be accomplished by injection is molding of hub assembly 30 and shield assembly 40, both of which may be injection molded using synthetic resinous material, such as polypropylene. Medical tubing 50 may be selected from medical tubing currently commercially available. To assemble safety shield apparatus 10, slider parts may be displaced into slideable containment in an associated guide channel, such as slider part 120 being displaced into guide channel 178. In FIG. 6, a tubing channel 240 may be formed by separation of juxtaposed rails 176 and 196. Tubing 50 may be displaced through channel 240 and into bore hole 50, as previously disclosed. End 80 of medical needle 20 is displaced into tubing 50 and securely affixed thereat.
Stabilizer part [0092] 130′ may include an anchor part 130″ both having a centrally disposed hole 154 for passage of medical needle 20. Anchor part 130″ may have a sufficient diameter to provide a base for struts 162 and 164 and a secure attachment to stabilizer part 130′. Stabilizer part 130′ may be mechanically affixed, injection molded, adhered, etc., to anchor part 130″. Stabilizer part 130′ may be fabricated from materials such as polyolefin, polyurethane film, woven or non-woven fabrics, synthetic foam, etc.
A needle hub assembly [0094] 330, may include an appendage 100′ by which hub assembly 330 can be grasped and displaced, and a hub body section 110′ into which end 80 of medical needle 20 is securely affixed. Hub assembly 330 may include a pin hinge 360 whereby hub assembly 330 is hingeably affixed to shield assembly 340. Living hinges are also contemplated.
Referring to FIGS. 17 and 18, shield assembly [0095] 340 may include a first articulating part 400 having an end 402 which is joined to hub assembly 320 via pin hinge 360. Articulating part 400 may be hingeably associated with a second articulating part 410, at a first end 412 through a pin hinge 414. Living hinges are also contemplated.
Articulating part [0096] 400 may be symmetrical about a longitudinal axis having a pair of side parts 416 and 418, as shown in FIG. 18. Articulating part 400 may also be single sided. A bridging member 420 may join and support separation of side part 416 and 418 and thereby defines a rectangular space 422 between parts 416 and 418.
Articulating part [0097] 410 may be shorter than part 400 and includes side members 424 and 426, as seen in FIG. 18. Parts 400,410 may be of varying relative dimension. A bridging member 430 joins and supports separation of side parts 424 and 426. Side parts 424 and 426 are separated such that articulating part 410 may be foldably disposed within space 422, permitting shield 340 to be compacted into a low silhouette, as shown in FIG. 13. Disposed in articulating part 410, between bridging member 430 and bridging member 420 of articulating part 400, may be an opening 432. Opening 432 permits a clip 434 to be molded into articulating part 410, as shown in FIG. 17. Clip 434 may have a stem section 436 coupled to a latch 437 which is displaced beyond medical needle 20 when shield assembly 340 is extended, as shown in FIGS. 15-17. Latch 437 catches medical needle 20 to affix shield assembly 340 in a protective position about medical needle 20 and sharpened tip 60, as disclosed in detail hereafter. Other clips may be used within the scope of the present disclosure.
At a second end [0098] 438, part 410 may be hingeably affixed to a linear guide 440. Linear guide 440 may include a medially disposed through hole 444 which is slidably disposed about medical needle 20 (FIGS. 14 and 17) and acts as a guide for shield assembly 340 as articulating parts 400 and 410 are unfolded to provide a protective sheath for medical needle 20 and sharpened tip 60. As shown in FIG. 18, distal from hinge 442, linear guide 440 may include a flattened plate 446, similar to stabilizer part 130, discussed above.
A thin resilient disk [0099] 450 may include an accessible surface 452 and, thereby, provides for tactilely sensing disposition of a target implant and for distributing tactile forces across a broader surface area than that which is accessible through finger contact alone. By making disk 450 of transparent or material through which medical needle 20 may be seen, an insertion site may be more easily viewed during a percutaneous entry procedure. Also, a resilient disk 450 may be folded about hub assembly 320 to provide an unobstructed view during the entry procedure.
As one who is skilled in injection mold manufacture and parts molding understands, hub assembly [0100] 320 and shield assembly 340 may be molded from a single injection molded part, as such may be preferred to reduce the cost of manufacture of safety shield apparatus 310. Medical grade polypropylene may be used to mold assemblies 320 and 340. Assemblies 320 and 340 are generally symmetrical about an axial midline defined by a shaft 460 of medical needle 20 (FIG. 14).
As shown in FIG. 14, hub assembly [0101] 320 may comprise a through hole 470 which is narrowed toward disposition of bend 70 of medical needle 20 and is enlarged toward an attachment site 472 between medical needle 20 and tubing 50. An abrupt edge 474 retards the length of insertion of tubing 50 such that when tubing 50 is adhesively affixed to medical needle 20 about end 80, a combination of such adhesion and bend 70 securely affixes medical needle 20 in needle hub assembly 320. Other needle to tubing joints are possible within the scope of the present disclosure. With shield assembly 340 hingeably affixed to hub assembly 320 as shown in FIG. 18, safety shield apparatus 310 may be assembled by displacing medical needle 20 through space 422 in articulating part 400, through hole 444 in guide 440 of articulating part 410 and through a pair of medially disposed holes 476 and 478 of plate 446 and disk 450, respectively, as shown in FIG. 14.
In an alternate embodiment, to assure shielding of sharpened tip [0102] 60, medical needle 20 may be captured and held within a rigid structure, a triangular frame is formed having sides made up of portions of medical needle 20, hub body section 110′, articulating part 400 and that portion of articulating part 410 which includes latching structure associated with clip 434. As shown in FIG. 17, a triangle 480 is formed by dashed lines which represent legs 482, 484 and 486 of triangle 480. Leg 484 is defined by end points at bend 70 and pin hinge 360. Leg 486 is disposed parallel to radius of angle of rotation of articulating part 400 and is defined by an end point at pin hinge 360 and intersection with shaft 460 of needle 20. Leg 482 is defined by an end point at bend 70 and point of intersection with line 486. For clarity, each internal angle of triangle 480 is referenced as an included angle between adjacent legs (e.g., the internal angle at bend 70 between shaft 460 of medical needle 20 and leg 484 toward pin hinge 360 is referenced by angle 482/484).
When shield assembly [0103] 340 is unfolded and part 400 is articulated away from stabilizer parts (plate 446 and disk 450) and part 410 is rotated into alignment with shaft 460 as shown in FIGS. 15-17, clip 434 catches and affixes part 410 relative to needle 20. So affixed, triangle 480 is defined. Thus, triangle 480 establishes a rigid structure assuring protective cover for needle 20 and tip 60 which is then protected by shaft 460 surrounding guide 440. Angle 482/484 is fixed by structure associated with bend 70 and pin hinge 360. Angle 484/486 is determined by clip 434 being disposed to latch shaft 460. Angle 482/486 is defined because the other two angles of triangle 480 are so defined. Thus, an attempt to force hub assembly 320 toward stabilizer parts 446 and 450 and thereby to drive sharpened end 60 outwardly through holes 476 and 478 is defeated, and medical needle 20 is safely contained within shield assembly 340. Shield assembly 340 may be constructed such that angle 482/486 is zero when clip 434 is affixed to shaft 460.
Referring to FIGS. [0104] 19-30, an embodiment of a safety shield apparatus 744 is shown including a port access needle 746 including a shield 750 of hingedly connected segments 612′ and 614′ for protecting distal end 747 of needle 746 after use in a medical procedure. Needle 746 may be oriented in two axes such that a distal needle portion 746A is oriented at an axis 90 degrees relative to an axis defined by a proximal needle portion 746B. It is contemplated that distal needle portion 746A and proximal needle portion 746B may be oriented at various angular displacements. As shown in FIGS. 19-29, segments 612′ and 614′ may be configured for a low profile such that the segments may be folded into each other in a pre-use state as a result of either segment having smaller dimensions than the other.
FIGS. 19 and 20 show safety shield apparatus [0105] 744 in a retracted position, while FIGS. 21 and 22 show the extended and protected position with shield 750 attached to needle 746 by means of a needle latch 754 shown in FIGS. 22, 26 and 27. Needle latch 754 has an arcuate outer surface 754A and a radial edge 754B. A deformable interior cavity 754C of latch 754 corresponds to outer surface 754A. Upon actuation of shield 750, needle 746 engages and travels along outer surface 754A until needle 754 becomes disposed over radial edge 754B. Outer surface 754A elastically deforms to facilitate movement of needle 746 thereover and extension of shield 750. Shield 750 is manipulated until the fully extended position is reached. Radial edge 754B prevents movement of needle 746 and consequently shield 750 to the retracted position, thereby locking shield 750 in the fully extended position. Movement of needle 746 is prevented due to the compressive forces created in outer surface 754A and tensile forces in 754B via engagement of needle 746 and radial edge 754B.
As shown in FIGS. 26 and 27, a rib [0106] 770 may be utilized for positioning the needle 746 with respect to needle latch 754. Needle 746 may be latched to shield 750 by various other means as set forth herein. For example, in an alternate embodiment, as shown in FIGS. 31 and 32, a needle latch 946 formed with shield 750. Needle latch 946 has a surface 950 on which needle 746 rests to lock shield 750 in the extended position. Surfaces 948 and 952 retain needle 746 with surface 950 in the locked and extended position. In operation, as shield 750 is manipulated to the fully extended position, needle 746 engages latch 946 and travels over latch arm 954, which biases permitting needle 746 to enter latch 946 and come to rest with surface 950. Latch arm 954 biases back, and in cooperation with surfaces 948, 952 retains needle 746, and correspondingly, shield 750 in the extended and locked position.
Shield [0107] 750 may further comprise a planar contact surface, such as, for example, disc 752 attached to linear bearing 638′, which may be permanently attached or releasably attached. Linear bearing 638′ may also be monolithically formed with disc 752. Disc 752 may further include foldable portions (not shown), such as by living hinges, for packaging purposes. Texturing may also be added to the top surface of disc 752 to enhance gripping of disc 752. Disc 752 may also be hingedly attached to distal segment 614′ through hinge 782, thereby leaving linear bearing 638′ free from communication with the disc 752. Linear bearing 638′ remains connected to distal segment 14′ through living hinge 78.
Referring to the embodiment shown in FIG. 28, an additional lockout feature may be added for securing safety shield apparatus [0108] 744 in the lockout mode. For the embodiment shown in FIG. 28, the lockout is accomplished by engagement of latches 776 disposed on distal segment 614′ to flanges 778 disposed on linear bearing 638′.
Shield [0109] 750 is passively activated upon withdrawal of the needle 746 from a patient, wherein wings 748 may be used to facilitate insertion and withdrawal of the safety shield apparatus 744. One method of withdrawing needle 746 from a patient includes the steps of holding disc 752 against a patient while pulling wings 748 away from the subject. Once the needle latch 754 engages the needle 746, the safety shield apparatus 744 may be removed. It is contemplated that disc 752 is adherently attached to the subject. Disc 752 may also be releasable from linear bearing 638′.
The hinges connecting segments [0110] 612′ and 614′ and linear bearing 638′ may be flexible living hinges 678, pinned hinges, or equivalents thereof that provide for hinged connections of segments 612′ and 614′ and the linear bearing 638′ (see, e.g., FIG. 26). Moreover, the number of hingedly connected segments depends upon needle 746 length and device length required to extend shield 744 beyond distal end 747 of needle 746. Embodiments of the safety shield apparatus 744 may, therefore, include two or more segments.
As shown in the embodiment illustrated in FIG. 19, needle [0111] 746 has a proximal end and a distal end 747 with the proximal end of needle 746 affixed in a hub 758. Wings 748 may be affixed to the needle hub. In the embodiment shown in FIG. 25, safety shield apparatus 744 is assembled by inserting hub 758 into collar 760. Flared surfaces 762 may be included on hub 758 to engage collar 760. The needle hub may also be configured to attach an extension set tubing 736. In an alternate embodiment, as shown in FIG. 33, needle hub 758 and wings 748 include an opening 748A. Opening 748A permits linear bearing 638′ (see, e.g., FIG. 26) to extend farther into needle hub 758 and wings 748, and form a friction fit therewith, such that shield 750 can be maintained in the retracted position, as shown. This configuration advantageously provides greater stability and increased coverage of needle 746.
Referring to FIGS. 23 and 24, an embodiment of safety shield apparatus [0112] 744 is shown farther comprising a pad 756, which may be added underneath disc 752 for patient comfort and as a spacer between a patient's skin and disc 752. Pad 756 may be comprised of a foam material such as a closed-cell foam, polyurethane open-cell foam, or an equivalent crushed or densified, felted material. Pad 756 may be an absorbent, breathable material that may also be capable of wicking moisture. Pad 756 may also be impregnated with an antimicrobial agent, such as chlorhexidine or equivalent material. Pad 756 may also be comprised of a foam material with a thin film coating on either side including, but not limited to, polyolefin, breathable polyurethane, or other equivalent materials. The thin film coating may also be perforated.
Pad [0113] 756 may be separately packaged in a sterile container for use as a replacement pad for an existing dressing. Pad 756 may also be used as a dressing, which may replace or supplement a gauze dressing.
Pad [0114] 756 may have a friction fit capability for attachment to needle 746, with a possible slit 764 included for ease of attachment to safety shield apparatus 744. Pad 756 may also be permanently attached to safety shield apparatus 744. A notch 780 may be added to slit 764 to assist in guiding the pad 756 into the proper position on the needle 746. Holes 766 may be added to the pad 756 for purposes such as aiding in visibility and increasing air flow to the pad 756. Similar holes may be added to the disc 752 for the same purposes.
Referring to the embodiment shown in FIG. 29, safety shield apparatus [0115] 744 may be retained in the retracted position by a flange 772 disposed on proximal segment 612′ engaging notches 774 in a flange 778 disposed on linear bearing 638′. Alternative embodiments may include a flange disposed on the hub 758 or distal segment 674′ with corresponding notches located on an alternate segment or hub 758.
Referring to FIG. 34, another alternate embodiment of a safety shield apparatus [0116] 810, in accordance with the principles of the present disclosure, similar to the apparatus and methods of use of safety shield apparatus 10, 10″, 310 and 744 described above, is shown. Safety shield apparatus 810 includes a port access medical needle 820, a needle hub assembly 830, a shield assembly 840 of hingedly connected segments 842 and 844 for protecting a distal portion 860 of needle 820, and a section of medical tubing 50. Medical needle 820 has a linear shaft extending along a longitudinal axis c and a distal portion 860 and a proximal portion 880. Proximal portion 880 is mounted to needle hub assembly 830. The channel of fluid flow 852 in hub assembly 830 may be angled such that a relatively straight needle 820 may be utilized, rather than an angled needle as heretofore shown.
FIG. 34 shows safety shield apparatus [0117] 810 in the extended and protected position with shield 840 attached to needle 820 by means of a needle latch 846, similar to the needle latches described above.
Shield assembly [0118] 840 may further comprise a planar contact surface, such as, for example, disc 848 attached to linear bearing 850, which may be permanently attached or releasably attached. Linear bearing 850 may also be monolithically formed with disc 848. Shield assembly 840 is extensible between a retracted position and an extended position, similar to the embodiments described above, via fixed positioning of disc 848.
In another embodiment, the hub may be configured to include a luer fitting for attachment to various needle devices such as a syringe or IV set. [0119]
It will be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplification of the various embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto. [0120]
US20020072716A1 true true US20020072716A1 (en) 2002-06-13
US7438703B2 US7438703B2 (en) 2008-10-21
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