WO2009098024A2 - Hollow needle - Google Patents

Hollow needle Download PDF

Info

Publication number
WO2009098024A2
WO2009098024A2 PCT/EP2009/000698 EP2009000698W WO2009098024A2 WO 2009098024 A2 WO2009098024 A2 WO 2009098024A2 EP 2009000698 W EP2009000698 W EP 2009000698W WO 2009098024 A2 WO2009098024 A2 WO 2009098024A2
Authority
WO
WIPO (PCT)
Prior art keywords
needle
beneath
liquid
stratum granulosum
distal tip
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/EP2009/000698
Other languages
English (en)
French (fr)
Other versions
WO2009098024A3 (en
Inventor
Bernard Hertzog
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=40823100&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2009098024(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Individual filed Critical Individual
Priority to JP2010544649A priority Critical patent/JP5518742B2/ja
Priority to CN2009801040944A priority patent/CN101939037A/zh
Priority to BRPI0907448-1A priority patent/BRPI0907448A2/pt
Priority to EP09708469A priority patent/EP2249906A2/en
Priority to US12/865,560 priority patent/US20100324530A1/en
Publication of WO2009098024A2 publication Critical patent/WO2009098024A2/en
Publication of WO2009098024A3 publication Critical patent/WO2009098024A3/en
Anticipated expiration legal-status Critical
Priority to US13/715,134 priority patent/US20130102956A1/en
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3287—Accessories for bringing the needle into the body; Automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2053—Media being expelled from injector by pressurised fluid or vacuum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/329—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles characterised by features of the needle shaft
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/329—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles characterised by features of the needle shaft
    • A61M5/3291—Shafts with additional lateral openings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00792—Plastic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M2005/341—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub angularly adjustable or angled away from the axis of the injector
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/42—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
    • A61M5/422—Desensitising skin

Definitions

  • the present invention relates to needles for delivering a liquid to the stratum granulosum and/or beneath the epidermis, preferably to an area consisting from the stratum granulosum (included) to reticular dermis (included) and more preferably beneath the papillary dermis during an injection procedure and more preferably during a cosmetic procedure.
  • a liquid beneath the epidermis is hyaluronic acid.
  • the needle may pass through the stratum papillaire.
  • the stratum papillaire contains a network of blood vessels that, if severed, may lead to facial bruising.
  • Injections of a liquid into the stratum granulosum and/or beneath the epidermis during a cosmetic procedure are traditionally carried out using a conventional sharp pointed needle.
  • a conventional sharp pointed needle is a 25G needle, which has a diameter of 0.5 mm. Due to its sharp tip, the depth of penetration is difficult to control, and the needle can cut the deep-lying tissues of the skin. In particular, the needle may sever the cellular tissues, the elastic and collagen fibers, and the fine blood and lymph vessels. As the depth of penetration is difficult to control, the administration may not be precise, and the cosmetic procedure may therefore be less effective than desired.
  • a cosmetic treatment to the skin may require several injections of a liquid. Before each injection with a conventional sharp-tipped needle, anaesthesia is required. This may require a block over a large area.
  • the present invention is based on the discovery that, by using a flexible needle with a blunt tip, liquid can be delivered over a large area of the stratum granulosum and/or beneath the epidermis, preferably to an area consisting from the stratum granulosum (included) to reticular dermis (included) and more preferably beneath the papillary dermis, through one micro-incision or preferably through a tiny hole previously made with a classic needle.
  • This means that the amount of anaesthesia needed before a cosmetic procedure may be reduced by 10 to 15- fold.
  • the needle is blunt and flexible, the risk of severing the blood vessels underneath the epidermis may also be reduced and the risk of intravascular injection is abolished.
  • the combination of this advantages leads to a shortening of the cosmetic procedure and of the period of recovery.
  • the present invention is a hollow needle for attachment to a syringe, through which a liquid can be delivered to the stratum granulosum and/or beneath the epidermis, preferably to an area consisting from the stratum granulosum (included) to reticular dermis
  • the needle comprising a distal tip and including a lateral aperture adjacent to the distal tip, wherein the liquid exits the needle via the lateral aperture, and wherein the needle is flexible.
  • the present invention is an apparatus for delivering a liquid to the stratum granulosum and/or beneath the epidermis, preferably to an area consisting from the stratum granulosum (included) to reticular dermis (included) and more preferably beneath the papillary dermis during a cosmetic procedure, comprising a syringe and a needle, as defined above.
  • the needle according to the invention is straight.
  • the present invention is a method of delivering a liquid to the stratum granulosum and/or beneath the epidermis, preferably to an area consisting from the stratum granulosum (included) to reticular dermis (included) and more preferably beneath the papillary dermis during a cosmetic procedure, using apparatus, as defined above.
  • the present invention is a method of treatment comprising the use of a method of delivering a liquid as defined above.
  • FIG. 1 shows a schematic lateral section of a needle embodying the present invention.
  • the needle (3) includes a hollow base section (4), which may be made of a plastics material. This base section (4) allows the needle to be attached to a syringe containing a liquid for subepidermal administration.
  • the needle (3) has a lateral aperture (2), through which the liquid is delivered.
  • the distal tip (1) of the needle is blunt.
  • the length of a needle according to the invention is preferably between 13 and 45 mm. In another preferred embodiment, the length of the needle is less than 50 mm, more preferably between 5 and 50mm. In a further preferred embodiment, the length of the needle is approximately 47, 40 mm, 37, 27, 20,17, 13 and 10 .
  • a needle according to the invention preferably has a diameter of between 0.3 and 0.7 mm. More preferably, the diameter is less 0.5, 0.4 or 0.3 mm. More preferably still, the needle has a diameter of approximately 0.5 mm, 0.4 mm, 0.3 mm, 0.2 mm, between 0.2 and 0.3 mm, between 0.3 and 0.4 mm. or between 0.4 and 0.5 mm. The fine diameter of the needle may help to reduce the risk of severing the blood vessels.
  • the tip of the needle is blunt.
  • the tip of needle is rounded. This may reduce the trauma to the patient.
  • the lateral length of the aperture is preferably approximately equal to 0.5 mm.
  • the aperture is located approximately 1 mm from the distal tip of the needle.
  • the aperture is located at most at 2mm from the distal tip of the needle and even more preferably between 0.05 mm and 2 mm from the distal tip of the needle and according to a definitely preferred embodiment between 0.05 mm and 0.5 mm from the distal tip of the needle.
  • the needle according to the invention has only one lateral aperture and has no aperture at its distal tip.
  • the size of the larger diameter of the lateral aperture is preferably comprised between 0.01 and 1 mm more preferably between 0.01 and 0.2 mm, even more preferably between 0.01 and 0.1 mm.
  • the one skilled in the art is able to determine the most accurate size in regard of the viscosity for each liquid to be injected and of the specific therapeutic use.
  • the hollow base section of the needle according to the invention further comprises a sign (e.g. a color spot) and preferably at the same radial position than the lateral aperture.
  • a sign e.g. a color spot
  • This sign allows knowing the position of the lateral aperture even when the needle is in position under the skin of a patient.
  • a needle of the invention is flexible, meaning that it may be able to glide through the layers of the skin without damaging the underlying tissues, or cutting the blood vessels. This may help to reduce the amount of bruising after a particular cosmetic procedure.
  • the term "flexible" means that the needle according to the invention can be bend to an angle of 60° relative to its longitudinal axis, by applying a force to the distal tips which is less than 5N .
  • the needle according to the invention can be made totally or partially in stainless steel.
  • a shape memory alloy SMA
  • the use of such SMA allows producing a needle which can return to a specific shape when it is submitted to the body temperature.
  • the needle of the invention is partially or totally made of nitinol . Due to the flexibility of a needle of the invention, and the resistance offered by the deeper layers of the skin, a liquid can be delivered to the stratum granulosum over a large area, and in an even manner, through one single micro-incision of the skin.
  • the tension of the deep- lying layers of skin prevents the blunt needle from penetrating into those layers, and causes it to "curve" into the stratum granulosum and/or beneath the epidermis, preferably to an area consisting from the stratum granulosum (included) to reticular dermis (included) and more preferably beneath the papillary dermis.
  • the user may be able to manipulate the needle in a "circular" motion, in order to maximize the area of delivery of the liquid. Due to the construction of the needle, it can glide under the skin with ease. This may significantly reduce the pain and trauma to the patient.
  • a dosage of anaesthetic to that single micro-incision site may provide sufficient anaesthesia for the injection of all the liquid required for the cosmetic procedure. If a conventional sharp-tipped, inflexible needle were used, several micro-incisions, and several dosages of anaesthetic would normally be required.
  • a cosmetic treatment using conventional sharp-tipped needles may require a dosage of anaesthetic at 20 different sites followed by 20 injections of a liquid such as hyaluronic acid, into each those sites.
  • the same procedure using a needle of the invention may require anaesthetic to be administered to a single site only, followed by a single injection of hyaluronic through one single micro-incision. Due to the construction of the needle, the same area can be treated, as if the procedure was carried utilising the conventional method. The requirement far one micro-incision only may greatly reduce the negative side-effects of the cosmetic procedure, such as bruising and scarring. The procedure may also be more precise, leading to more aesthetically pleasing results.
  • a kit comprising a needle of the invention and a syringe.
  • the syringe may contain the liquid medicament, an example al which is hyaluronic acid.
  • the medicament may be provided separately.
  • the needle of the invention and the syringe may be integral.
  • the present invention is a method of delivering a liquid to the stratum granulosum and/or beneath the epidermis, preferably to an area consisting from the stratum granulosum (included) to reticular dermis (included) and more preferably beneath the papillary dermis, using apparatus, as defined above.
  • the liquid to be delivered is a filler liquid and more preferably is hyaluronic acid.
  • the liquid to be delivered is a anaesthetic and more preferably is lidoca ⁇ n.
  • the present invention is a method of treatment comprising the use of a method of delivering a liquid as defined above.
  • the treatment is a cosmetic procedure or anaesthesia.
  • a small quantity Of anaesthetic is injected (10 tol5 times less than the usual amount when using conventional needles) .
  • One single micro- incision is then created using a conventional 25G or 26G needle. This micro-incision should be placed in the centre of the area to be treated.
  • the entire length of a needle according to the invention is then inserted laterally into the stratum granulosum through this micro-incision, and the desired liquid (for example, reticulated hyaluronic acid) is injected beneath the skin.
  • the injection is then repeated in a radial pattern, resembling the "spokes-of-a- wheel", always starting from the same initial micro- incision.
  • Bruising is greatly reduced compared with a conventional procedure, using sharp-tipped needles.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Cosmetics (AREA)
PCT/EP2009/000698 2008-02-04 2009-02-03 Hollow needle Ceased WO2009098024A2 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
JP2010544649A JP5518742B2 (ja) 2008-02-04 2009-02-03 中空針
CN2009801040944A CN101939037A (zh) 2008-02-04 2009-02-03 空心针
BRPI0907448-1A BRPI0907448A2 (pt) 2008-02-04 2009-02-03 Instrumentos.
EP09708469A EP2249906A2 (en) 2008-02-04 2009-02-03 Hollow needle
US12/865,560 US20100324530A1 (en) 2008-02-04 2009-02-03 Hollow needle
US13/715,134 US20130102956A1 (en) 2008-02-04 2012-12-14 Hollow needle

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
FR08/00583 2008-02-04
FR0800583A FR2926997B1 (fr) 2008-02-04 2008-02-04 Aiguilles souples fines pour injection sous cutanee sans douleur
US6650108P 2008-02-21 2008-02-21
US61/066,501 2008-02-21
EP08103053A EP2105155A1 (en) 2008-02-04 2008-03-28 Hollow needle
EP08103053.8 2008-03-28

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US13/715,134 Division US20130102956A1 (en) 2008-02-04 2012-12-14 Hollow needle

Publications (2)

Publication Number Publication Date
WO2009098024A2 true WO2009098024A2 (en) 2009-08-13
WO2009098024A3 WO2009098024A3 (en) 2009-10-01

Family

ID=40823100

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2009/000698 Ceased WO2009098024A2 (en) 2008-02-04 2009-02-03 Hollow needle

Country Status (7)

Country Link
US (2) US20100324530A1 (enExample)
EP (2) EP2105155A1 (enExample)
JP (1) JP5518742B2 (enExample)
CN (1) CN101939037A (enExample)
BR (1) BRPI0907448A2 (enExample)
FR (1) FR2926997B1 (enExample)
WO (1) WO2009098024A2 (enExample)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0365746A (ja) * 1989-08-04 1991-03-20 Nec Corp 入出力制御装置
JP2012020042A (ja) * 2010-07-16 2012-02-02 Japan Imposing Co Ltd 皮下注射針
JP2014527988A (ja) * 2011-09-30 2014-10-23 ザ・ユニバーシティ・オブ・シドニー 弾性繊維のｉｎｖｉｖｏ合成
US10842913B2 (en) 2012-12-10 2020-11-24 Allergan Pharmaceuticals International Limited Scalable three-dimensional elastic construct manufacturing

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* Cited by examiner, † Cited by third party
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GB201307262D0 (en) * 2013-04-23 2013-05-29 Chowdhury Dewan F H Device for containment and release of drug formulation
HRP20210151T1 (hr) 2015-04-13 2021-04-02 Bellus Medical, Llc Uređaj za stimulaciju kolagena
BR112019011964A2 (pt) 2016-12-19 2019-11-05 New World Medical Inc dispositivos de tratamento ocular e métodos de uso relacionados
CN110025483A (zh) * 2018-01-12 2019-07-19 杭州元力医疗器械有限公司 一种可入体柔软的温控记忆金属针灸针具及皮内针
US20210162134A1 (en) * 2018-07-30 2021-06-03 Kyoto University Microsyringe unit

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See also references of EP2249906A2

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0365746A (ja) * 1989-08-04 1991-03-20 Nec Corp 入出力制御装置
JP2012020042A (ja) * 2010-07-16 2012-02-02 Japan Imposing Co Ltd 皮下注射針
JP2014527988A (ja) * 2011-09-30 2014-10-23 ザ・ユニバーシティ・オブ・シドニー 弾性繊維のｉｎｖｉｖｏ合成
US10842913B2 (en) 2012-12-10 2020-11-24 Allergan Pharmaceuticals International Limited Scalable three-dimensional elastic construct manufacturing
US11077226B2 (en) 2012-12-10 2021-08-03 Allergan Pharmaceuticals International Limited Scalable three-dimensional elastic construct manufacturing

Also Published As

Publication number Publication date
BRPI0907448A2 (pt) 2015-07-14
EP2105155A1 (en) 2009-09-30
FR2926997A1 (fr) 2009-08-07
WO2009098024A3 (en) 2009-10-01
CN101939037A (zh) 2011-01-05
US20130102956A1 (en) 2013-04-25
JP5518742B2 (ja) 2014-06-11
FR2926997B1 (fr) 2012-06-29
EP2249906A2 (en) 2010-11-17
US20100324530A1 (en) 2010-12-23
JP2011510715A (ja) 2011-04-07

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