Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150015—Source of blood
  • A61B5/150022—Source of blood for capillary blood or interstitial fluid
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150015—Source of blood
  • A61B5/15003—Source of blood for venous or arterial blood
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
  • A61B5/150259—Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150351—Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150381—Design of piercing elements
  • A61B5/150389—Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150381—Design of piercing elements
  • A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
  • A61B5/150427—Specific tip design, e.g. for improved penetration characteristics
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150381—Design of piercing elements
  • A61B5/150473—Double-ended needles, e.g. used with pre-evacuated sampling tubes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150381—Design of piercing elements
  • A61B5/150503—Single-ended needles
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
  • A61B5/150633—Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
  • A61B5/150641—Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves comprising means to impede repositioning of protection sleeve from covering to uncovering position
  • A61B5/150656—Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves comprising means to impede repositioning of protection sleeve from covering to uncovering position semi-automatically triggered, i.e. in which the triggering of the protective sleeve requires a deliberate action by the user, e.g. manual release of spring-biased extension means
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150732—Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150885—Preventing re-use
  • A61B5/150908—Preventing re-use by disconnecting components, e.g. breaking or rupturing of connected parts, e.g. piston and rod
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/14—Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
  • A61B5/1405—Devices for taking blood samples
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
  • A61B5/150572—Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
  • A61B5/150694—Procedure for removing protection means at the time of piercing
  • A61B5/150717—Procedure for removing protection means at the time of piercing manually removed
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150801—Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/155—Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals

Definitions

• This invention is a medical device useful for drawing blood from person or animal.
• the subject device is often referred to as a“blood collection tube holder” or “blood tube holder.” because it is configured for use in combination with conventional, commercially available“blood collection tubes” or“blood tubes” that are manufactured and marketed by several different companies.
• the invention also relates to a single use blood collection tube holder having a single needle that is retractable into a confined space inside the device following use to protect a patient and healthcare workers from accidental needle sticks and thereby reduce the associated likelihood of pathogenic contamination resulting from an accidental stick.
• One aspect of the invention relates to a blood collection tube holder having a body comprising substantially parallel and laterally spaced apart barrel and needle retraction cavities separated by a partial wall that facilitates lateral movement of a retractable single needle from the barrel cavity into alignment with the needle retraction cavity to initiate needle retraction.
• Another aspect of the invention relates to a blood collection tube holder having a barrel and a frontal attachment that are cooperatively configured to facilitate relative sliding movement between them in a direction that is transverse to the longitudinal axis through the needle.
• Some such devices have two separate needles including a venipuncture needle pointing forwardly and a discharge needle pointing rearwardly.
• the discharge needle penetrates a stopper disposed in the front of a blood collection tube when the tube is inserted into the open rear end of a barrel.
• the blood collection tube is removed from the barrel of the blood tube holder, and a polymeric sheath expands to cover the rearwardly facing needle tip to prevent bodily fluid from leaking out the open back of the barrel.
• a hinged cap is provided at the back of the barrel, and closing the cap following removal of the blood collection tube triggers retraction of both the discharge needle and the venipuncture needle rearwardly into the barrel, whereby the device is rendered “safe” and non- reusable.
• blood collection tube holders comprise a longer, rearwardly biased single needle having both forwardly and rearwardly facing pointed ends.
• needle retraction is initiated by depressing an actuator containing a needle retraction cavity that is moved to a position where it is sufficiently aligned with the needle that both ends of the needle are biased backwardly into the needle retraction cavity of the device, whereby the device is rendered“safe” and non- reusable.
• blood collection tube holders comprise separate venipuncture and discharge needles, and a retraction cavity for the venipuncture needle that is disposed beside and parallel to the barrel, either as a separate chamber that is made integrally with the barrel or as part of a frontal attachment to the barrel.
• the venipuncture needle is rearwardly biased and retraction of the venipuncture needle is initiated by transverse sliding movement of at least part of the frontal attachment to the barrel. During such movement the forwardly projecting venipuncture needle is moved laterally out of alignment with the rearwardly facing discharge needle into substantially coaxial alignment with the needle retraction cavity.
• the rearwardly directed biasing force causes the venipuncture needle to be withdrawn to a“safe” position inside the device while the discharge needle remains disposed in its original position inside the barrel.
• the blood collection tube can be removed from the barrel, and an elastomeric sheath expands over the rearwardly facing tip of the discharge needle to prevent bodily fluid from leaking out the open rear end of the barrel.
• a blood collection tube hold that comprises a single needle which can be retracted following use by lateral sliding movement of a frontal attachment relative to the barrel to reposition the whole needle into substantially coaxial alignment with a full-length needle retraction cavity that is made integrally with the barrel.
• a blood collection tube holder comprising a substantially cylindrical body, a frontal attachment, and a retractable single needle comprising oppositely directed venipuncture and fluid discharge ends or tips.
• the body and the frontal attachment are cooperatively configured to facilitate sliding lateral movement of the body relative to the single needle prior to needle retraction.
• the body further comprises a substantially cylindrical barrel cavity and an integrally formed needle retraction cavity that are substantially parallel and separated by a partial wall.
• the partial wall is desirably configured to facilitate sliding lateral movement of the fluid discharge end of the single needle from a first position where it is substantially centered inside of and coaxially aligned with the barrel cavity to a second position where it is substantially aligned with the needle retraction cavity.
• the barrel cavity is configured to receive and support a conventional blood collection tube in operative engagement with the fluid discharge end of the single needle.
• the venipuncture end of the single needle projects forwardly from the frontal attachment and is desirably covered by a selectively releasable needle cap prior to use.
• the frontal attachment further comprises a tube holder connector that frictionally engages and partially covers the open front end of the barrel, and a slide member that slidably engages the tube holder connector along an axis that is substantially transverse to the longitudinal axis through the single needle.
• the slide member is configured to seat and support a rearwardly biased needle holder attached in fixed relation to the single needle.
• the tube holder connector further comprises a transverse slot that facilitates relative lateral movement of the single needle between the first and second positions when oppositely directed manual pressure is applied to the body and slide member for the purpose of substantially aligning the needle holder and needle retraction cavity to initiate retraction of the single needle into the needle retraction cavity.
• the selectively releasable needle cap further comprises a locking arm that prevents the slide member and the needle retraction cavity from becoming substantially aligned and thereby initiating retraction of the single needle prior to use.
• FIG. 1 is a front perspective view of one embodiment of the blood collection tube holder of the invention
• FIG. 2 is a front perspective view of the blood collection tube holder of FIG. 1 with the needle cap removed;
• FIG. 3 is a rear perspective view of the blood collection tube holder of FIG. 1 ;
• FIG. 4 is a top plan view of a blood collection tube holder substantially as shown in FIGS. 1 and 3 except that indicia are also shown in dashed outline in FIG. 4;
• FIG. 5 is a front view of the blood collection tube holder of FIG. 1 but rotated 90 degrees in a clockwise direction around its longitudinal axis;
• FIG. 6 is a rear view of the blood collection tube holder of FIG. 5;
• FIG. 7 is a top plan view of the blood collection tube holder of FIG. 4 with the needle cap removed;
• FIG. 8 is a right side elevation view of the blood collection tube holder of FIGS. 1 and 3;
• FIG. 9 is a left side elevation view of the blood collection tube holder of FIG. 1 rotated 180 degrees in a clockwise direction around its longitudinal axis;
• FIG. 10 is a cross-sectional view taken along line A— A of FIG. 5;
• FIG. 11 is an exploded perspective view of the blood collection tube holder of
• FIG. 1 is a diagrammatic representation of FIG. 1 ;
• FIG. 12 is the blood collection tube holder of FIG. 7 with the venipuncture needle retracted;
• FIG. 13 is the blood collection tube holder of FIG. 5 with the needle cover removed and the venipuncture needle retracted;
• FIG. 14 is a cross-sectional view taken along line C— C or FIG. 13;
• FIG. 15 is the blood collection tube holder of FIG. 2 with the needle retracted
• FIG. 16 is an enlarged detail view of the needle support member of FIG. 11 ;
• FIG. 17 is a rear perspective view of the needle support member of FIG. 16 rotated 180 degrees in a clockwise direction around the longitudinal axis through the subject blood collection tube holder;
• FIG. 18 is an enlarged detail view of the tube holder connector of FIG. 11 ;
• FIG. 19 is a rear perspective view of the tube holder connector of FIG. 18 rotated 180 degrees in a clockwise direction around the longitudinal axis through the subject blood collection tube holder;
• FIG. 20 is an enlarged cross-sectional view taken along line B— B of FIG. 4.
• blood collection tube holder 10 comprises body 12, a frontal attachment further comprising tube holder connector 24 and slide member 38, needle cap 40 (FIGS. 1 and 3), and retractable single needle 30 (FIG. 2).
• Body 12 further comprises barrel 16, barrel cavity 14, needle retraction chamber 20 and rear flange 22 disposed around the rear opening of barrel 16.
• retractable single needle 30 projects forwardly from needle support member 46 of slide member 38 of the frontal attachment.
• blood collection tube holder 10 is depicted in its pre-use position in which selectively removable needle cap 40 is installed over retractable single needle 30 and frictionally engages axially extending, circumferentially spaced ribs disposed around needle support member 46 (visible in FIG. 7).
• Locking support arm 42 (visible in FIGS. 10-11 ) is provided to prevent relative sliding movement between body 12 and slide member 38 prior to using retractable single needle 30 to draw blood from a patient.
• Slide member 38 further comprises front surface 44 from which needle support member 46 projects forwardly around part of retractable single needle 30 as best seen in FIG. 7.
• retractable single needle 30 further comprises forwardly facing venipuncture end 32 and rearwardly facing fluid discharge end 34.
• a blood collection tube not shown
• blood collection tube holder 10 Prior to insertion of a blood collection tube (not shown) into barrel cavity 14 and use of blood collection tube holder 10 for collecting blood from a patient, selectively releasable needle cap 40 is in place as discussed above, and collapsible elastomeric sheath 26 covers fluid discharge end 34 of retractable single needle 30 to shield fluid discharge end 34 from inadvertent contamination.
• retractable single needle 30 is desirably attached in fixed axial relation to needle holder 28, 92, which further comprises a rearwardly extending annular projection 94 provided for use in frictionally engaging the forwardly extending end of collapsible elastomeric sheath 26, which is preferably a rubber sleeve.
• a biasing member such as compressible coiled spring 36 is desirably seated inside bore 60 (FIG. 16) of needle support member 46 around a centrally disposed portion of needle 30 and the forwardly facing shaft portion of needle holder 26, and when compressed during assembly of blood collection tube holder 10, abuts and engages the front side of head 92 of needle holder 28.
• head 92 of needle holder 28 is biased rearwardly relative to the frontal attachment and body 12 of blood collection tube holder 10.
• slide member 38 of the frontal attachment to body 12 further comprises opposed positioning blocks 54, 56 that are engageable with cooperatively configured head 92 of needle holder 28 (FIG. 11 ) to move needle holder 28 laterally as discussed below.
• Laterally extending top and bottom rails 50, 52, respectively, are cooperatively configured and slidably engageable with laterally extending top and bottom rails 68, 70 of tube holder connector 24.
• projections 96, 98 (FIG.
• FIGS. 17) on slide member 38 are desirably provided to engage cooperatively configured and aligned recesses 100 (bottom recess not visible) of tube holder connector 24 to properly position retractable single needle 30 within slot 72 of tube holder connector 24 during assembly and use of blood collection tube holder 10.
• circumferentially extending arcuate ring 64and cooperating circular wall 62 of tube holder connector 24 are provided to establish frictional engagement between tube holder connector 24 and the forwardly facing edge of barrel 16 of body 12. The frictional engagement is desirably sufficient that tube holder connector 24 remains attached to the front end of barrel 16 as oppositely directed pressure is applied to textured touch surfaces 74, 48 as discussed below.
• FIGS. 5-6 and 13 further depict opposed flat edges 84, 86 in relation to opposed arcuate edges 88, 90 of flange 22 and the relative positions of slide member 38 and tube holder connector 24 whenever needle 30 is in the unretracted and retracted positions, respectively.
• slide member 38 and tube holder connector 24 of the frontal attachment to body 12 are provided with textured touch pads 48, 74, respectively, to facilitate the application of oppositely directed manual pressure to each touch pad to produce lateral sliding movement of body 12 relative to slide member 34, needle holder 28, compression spring 36 and retractable single needle 30.
• This movement is desirably in a transverse direction that causes discharge needle end 34 of retractable single needle 30 to move laterally past reduced height portion 80 of partial wall 82 (FIG. 10) until needle 30 is substantially aligned with needle retraction cavity 76, which allows needle holder 28 and discharge needle end 34 to move rearwardly into needle retraction cavity 76 as compressed coil spring 36 expands to the position shown in FIG. 14.
• retractable single needle 30 is desirably such that venipuncture end 32 of needle 30 is fully contained inside needle support member 46 of slide member 38 when in the position as shown in FIG. 14.
• FIGS. 12-15 depict blood collection tube holder 10 of the invention with retractable single needle 30 in the fully retracted position.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Engineering & Computer Science (AREA)
• Medical Informatics (AREA)
• Surgery (AREA)
• Hematology (AREA)
• Biophysics (AREA)
• Pathology (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Veterinary Medicine (AREA)
• Molecular Biology (AREA)
• Physics & Mathematics (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Manufacturing & Machinery (AREA)
• Dermatology (AREA)
• Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)

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Publications (1)

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Cited By (1)

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Citations (11)

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• 2018
  • 2018-12-13 US US16/219,094 patent/US12285253B2/en active Active
  • 2018-12-14 BR BR112020017770-9A patent/BR112020017770A2/pt unknown
  • 2018-12-14 ES ES18910038T patent/ES2991741T3/es active Active
  • 2018-12-14 KR KR1020207026831A patent/KR20200132877A/ko active Pending
  • 2018-12-14 WO PCT/US2018/065675 patent/WO2019177674A1/en not_active Ceased
  • 2018-12-14 MX MX2020009622A patent/MX2020009622A/es unknown
  • 2018-12-14 EP EP18910038.1A patent/EP3764900B1/en active Active
  • 2018-12-14 AU AU2018413357A patent/AU2018413357B2/en active Active
  • 2018-12-14 ES ES24179176T patent/ES3047861T3/es active Active
  • 2018-12-14 JP JP2020549662A patent/JP2021518189A/ja active Pending
  • 2018-12-14 EP EP24179176.3A patent/EP4400048B1/en active Active
  • 2018-12-14 CA CA3092721A patent/CA3092721A1/en active Pending
  • 2018-12-21 TW TW107146385A patent/TWI804546B/zh active
• 2019
  • 2019-02-01 CN CN202411462000.3A patent/CN119073981A/zh active Pending
  • 2019-02-01 CN CN201910105586.0A patent/CN110269629B/zh active Active
• 2023
  • 2023-11-09 JP JP2023191275A patent/JP7622954B2/ja active Active

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