WO1998013092A1 - Guide de penetration intra-tissulaire - Google Patents

Guide de penetration intra-tissulaire Download PDF

Info

Publication number
WO1998013092A1
WO1998013092A1 PCT/US1997/016813 US9716813W WO9813092A1 WO 1998013092 A1 WO1998013092 A1 WO 1998013092A1 US 9716813 W US9716813 W US 9716813W WO 9813092 A1 WO9813092 A1 WO 9813092A1
Authority
WO
WIPO (PCT)
Prior art keywords
penetration guide
guide
tissue
penetration
distance
Prior art date
Application number
PCT/US1997/016813
Other languages
English (en)
Inventor
Michael Jay Gast
Original Assignee
American Home Products Corporation
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
Application filed by American Home Products Corporation filed Critical American Home Products Corporation
Priority to AU43573/97A priority Critical patent/AU4357397A/en
Publication of WO1998013092A1 publication Critical patent/WO1998013092A1/fr

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
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0069—Devices for implanting pellets, e.g. markers or solid medicaments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/46—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for controlling depth of insertion

Definitions

  • This application concerns a tissue penetration guide designed to facilitate the proper insertion of an instrument or device into a desired position under or inside the tissue in question. More particularly, the present invention relates to a novel means for assuring that particularly-directed medical instruments, such as trocars, needles, tubes, probes, etc., can be placed into a desired position under or inside a particular tissue.
  • the tissue penetration guide is most particularly appropriate for directing such medical devices into a desired position for subcutaneous insertion, placement, probing, injections, implantations, depositions, etc.
  • U.S. Patent No. 4,451,253 (Harman) teaches an implant injector with a stable obturator held secured within the injector body and a retractable, hollow needle or trocar. In its initial position the needle is extended such that an implant rests inside the needle against the distal end of the stable obturator. After the needle is injected into the desired position, the retractable needle is withdrawn along the obturator to uncover and deposit the implant.
  • Gall et al. provides an injector which utilizes a syringe-like, distally-protruding coaxial plunger and a side- loading opening for placing implants in the injector.
  • the Gall et al. devices also include a staggered channel passing through the external surface of the device's body, with each section of the channel corresponding roughly in length to that of the implants.
  • a laterally protruding knob on the plunger slides between points within the staggered channel to facilitate implantation of one pellet at a time.
  • U.S. Patent No. 4,900,304 (Fujioka et al.) teaches another standard plunger, side-loading injector. The Fujioka et al.
  • U.S. Patent No. 4,402,308 describes an implant injector having a hollow, slotted needle or trocar rotatably mounted inside a sheath, the sheath being retractable to expose any portion of the slotted needle.
  • U.S. Patent No. 4,941,874 (Sandow et al.) provides for a transparent injector with a protective covering to protect the plunger rod and prevent it from falling out.
  • U.S. Patent No. 2,577,481 (Piechaczek) set forth an apparatus comprising, generally, a flattened base to be placed against a patient's skin and adjustable means for altering the angle at which a hypodermic needle passes through the plane of the base.
  • U.S. Patents Nos. 5,024,665 and 4,966,589 (both to Kaufman) describes a composite catheter assembly which secures the body and needle of an inserting device such that its angle of penetration into the body is substantially maintained during operation.
  • 5,192,271 discloses a device for delivering an injection to a penis, the device comprising a ring designed to encircle the penis, the ring having one or more tubular extensions protruding from the ring such that a hypodermic needle passing through the tube and ring is guided to the central erectile tissue.
  • U.S. Patent No. 5,395,317 provides a method of treating a herniated disc, the method including a jig which utilizes substantially parallel channels in a jig and an original guide passing through one channel to align subsequent linear devices and direct them toward the desired location in relation to the disc.
  • 4,403,987 discloses an injection aid comprising, in general terms, a hypodermic syringe, an angled ramp means, and a base, the base being designed to secure the syringe and slide down the ramp means at the prescribed angle to make a desired injection into a limb.
  • U.S. Patents Nos. 3,324,854 (Reese) and 2,660,169 (Malm) disclose syringe attachments which protrude from the needle end of a syringe and allow the user to guide the syringe's needle into a specified, upraised portion of skin.
  • 5,300,079 (Niezink et al.) teaches a spring operated injector designed to implant objects such as transponders used for identifying hogs.
  • the injector utilizes a positioning means comprising a pin which is set against a body as a guide for an insertion needle to be passed parallel to the pin and into and out of the body.
  • an insertable, substantially linear device such as a cannula, hypodermic needle, trocar, catheter, probe, tube, etc.
  • an insertable, substantially linear device such as a cannula, hypodermic needle, trocar, catheter, probe, tube, etc.
  • Examples include subcutaneous hypodermic injections and the subcutaneous implantation of solid, time-release medicaments, including con ⁇ -aceptive implants.
  • reconstructive or cosmetic implants such as the veterinary implants described in U.S. Patent No. 4,147,164 (Behney), mentioned above.
  • a portion of the device is inserted at a particular angle to reach a prescribed location relative to the surface of the surrounding tissue.
  • the present invention comprises a penetration guide to be used in conjunction with a device designed to be inserted under a layer of tissue or tissues, substantially parallel to the surface of that tissue or tissues, the device having an extended, substantially linear portion designed to be inserted into or under the tissue.
  • the tissue penetration guide of this invention comprises a substantially linear, preferably linear, extension of material maintained substantially parallel to, preferably parallel to, and separated from the extended portion of the device designed to make the insertion in question.
  • the guide is designed to remain on or near the surface of tissue to be entered and guide the insertable portion of the device or instrument to its desired inserted position.
  • the present invention provides a guiding means separated from and substantially parallel to the insertable portion of the device or instrument such that the device may be passed into the tissue only to a certain depth and, if the instrument is not inserted substantially parallel to the surface of the tissue, it must be oriented substantially parallel to the surface of the tissue before further forward progress can be achieved.
  • the amount of tissue corresponding to the desired depth passes between the tissue penetration guide and the insertable portion of the instrument in question.
  • the distance between the guide and insertable portion of the instrument will preferably be only that which allows the tissue to pass between and in close proximity to both the guide and the instrument. In cases where the depth of insertion is critical, this distance may be defined such that the tissue inserted touches both the guide and the instrument as it passes between them. While some flexibility may be preferable for certain uses where the depth of insertion of the insertable is not as critical, it is most preferred that the tissue penetration guide be relatively rigid and inflexible to restrict the motion and insertion of the device's insertable portion to the intended position.
  • the penetration guide may have any physical shape which allows the activity just described, preferably having dimensions which will not catch, bind or irritate the tissue in question or hinder the intended insertion.
  • These shapes may include, but are not limited to, rods or columnar projections.
  • the projections may be designed such that, in lateral cross-section, they are circular, elliptical, square, rectangular, or any other design which does not lead to unwanted effects on the tissue or inhibit the desired insertion.
  • the penetration guide does not extend along the full length of the insertable portion of the instrument. Rather, the most extended portion of the instrument projects beyond the guide such that this instrument may create an opening in the tissue, or be passed through a pre-existing opening or incision, before the guide contacts the external surface of the tissue and directs further insertion of the instrument substantially parallel thereto.
  • the distal or most extended portion of the device to be inserted projects beyond the distal or most extended portion of the tissue penetration guide by a distance slighdy greater than the thickness of the tissue in question. This difference in lengths allows the instrument to be inserted under the tissue and may act as a lever to lift the tissue from the underside as the instrument is angled for the desired insertion. With the tissue so elevated, the instrument may then be inserted with a diminished chance of grasping and tearing or ripping the tissue.
  • distal refers to those portions of the device normally held away from the operator during use, such as the sharpened end of a trocar or hypodermic needle
  • proximal refers to those portions of the device normally held toward the operator during use.
  • the present invention comprises a skin penetration guide to be used in conjunction with a device designed to make subcutaneous insertions in a mammal, preferably in a human.
  • the tissue penetration guide comprises a substantially linear, more preferably linear, extension of material maintained parallel to and separated from the extended portion of the device designed to make the subcutaneous insertion.
  • the guide is designed to remain on or near the surface of skin to guide the inserted portion of the device or instrument to its desired position.
  • Devices of this embodiment include those syringes and injectors particularly useful for making subcutaneous injections or implantations of solid medicaments, particularly solid, time-release medicaments, including contraceptives.
  • the devices in question will have a skin penetration guide which is separated from their insertable portions by a distance designed to accommodate the passage of skin between them. It is understood that the space of this separation will vary from species to species depending upon the thickness of animal's skin.
  • a space of between 0.05 and 0.10 inches (1.25 to 2.5 mm), preferably about 0.075 inches and about 0.095 inches (1.88 to 2.41 mm) between the penetration guide and the insertable portion is preferred for devices used to make subcutaneous injections or implantations in humans, most preferably a space of between about 0.080 inches and about 0.090 inches (2.03 to 2.29 mm).
  • the insertable portions may include, but are not limited to, trocars and the syringe cannulas used for injections, including both sharpened cannulas, such as hypodermic needles, and blunt cannulas.
  • Fig. 1 provides a cross-sectional side view of an implant injector utilizing a tissue penetration guide of the present invention.
  • Fig. 2 provides a cross-sectional side view of the implant injector of Figure 1 with its trocar inserted through the skin of an animal.
  • Fig. 3 presents an additional cross-sectional side view of the implant injector of Fig. 2 after it has been further inserted subcutaneously.
  • FIG. 1 An embodiment of the present invention can be seen in the cross-sectional, side view of a subcutaneous implantation device utilizing a tissue penetration guide in Fig 1.
  • the implantation device comprises a tubular needle or attached trocar (2) secured to the device's body (1) such that a tubular channel (3) passes co-axially through them, the channel (3) having internal dimensions sufficient to accommodate the passage of a solid columnar or cylindrical subcutaneous implant (4).
  • the term "trocar” is understood to refer to a distally sharpened cannula secured by its proximal end to the injector body (1).
  • the trocar (2) in these figures is intended to remain secured to the device's body and is not left in its inserted position in a tissue once the injector body has been removed from its injection or insertion position.
  • a tissue penetration guide (8) of the present invention extends from the implantation device's body (1) substantially parallel to and separated from the trocar (2) by a pre-determined space (9). In the embodiment illustrated in Figure 1, the guide (8) does not extend along the full length of the needle or trocar (2).
  • the subcutaneous implantation device's trocar is directed toward the patient's skin with trocar (2) between the skin and the tissue penetration guide.
  • the trocar (2) is then inserted through the skin (10) at the desired location and angled such that its further progress is underneath and substantially parallel to the surface of the skin (10).
  • the penetration guide (8) is oriented relative to the distal end of the trocar such that it contacts the external surface of the skin (10) and inhibits further forward progress of the trocar (2) ( Figure 2) unless the device is brought to a more appropriate angle relative to the skin such that the trocar (2) passes under and substantially parallel to the skin (10), with the layer of skin (10) passing into the space (9) separating the guide (8) and the trocar (2) ( Figure 3).
  • Passage of the trocar under the skin (10) creates an opening into which the solid implant (4) can be deposited.
  • Deposition is accomplished by grasping the obturator by its handle (7) or rod (5) portions and retaining it in a stable position while withdrawing the injector's trocar (2) from its inserted position.
  • the forward or distal end (6) of the obturator contacts the implant (4) and maintains it in position under the skin as the injector is withdrawn.
  • Figs. 1-3 illustrate an injector design with a single solid implant (4) contained therein, it will be understood that the penetration guide of the present invention may be used with implantation devices of various body styles designed to accommodate a plurality of implants.
  • the penetration guide extends along the entire length of, or extends beyond, the insertable portion of medical instrument.
  • Such embodiments are particularly useful for insertions in which the insertable portion of the device is not required to make the initial puncture through the tissue. They may also be preferred for those activities where the depth the insertable portion is allowed to pass below the surface tissue is to be particularly limited.
  • the penetration guides of the present invention may be maintained at the desired distance from the insertable portion of the device by any means which does not hinder the activities of the desired insertion.
  • the guide will be coupled directly to the device itself and may be releasable.
  • the coupling may occur directly to the insertable portion of the instrument, with the means of coupling being located sufficiently from the most extended or distal portion of the instrument to be inserted to allow the desired insertion.
  • the penetration guide may be narrower or wider than the insertable portion of the device.
  • the penetration guide may also be longer or shorter or the same length as the device's insertable portion, i.e. in their working orientation the guide may extend beyond the insertable portion, or vice versa.
  • the most proximal or terminal portions of both may extend substantially the same distance from the medical device.
  • the penetration guide may also be adjustable in length so as to alter the extension with respect to the insertable position.
  • the penetration guide will more preferably be secured to a portion of the device other than the insertable portion, such as on the body or housing of the device.
  • the guide be an extension of the main body of the injector, preferably as an integral, solid, molded portion of the body, itself.
  • the penetration guide be coupled, releasably or otherwise, to the body of the syringe or to the hub bearing the syringe's cannula.
  • the guide may be coupled to the device at any location and in any manner which allows the desired actions and uses of the device.
  • the penetration guide can be molded as an extension of the syringe's cannula hub.
  • Such means may include any design which allows the penetration guide to be separated from the insertable portion by set distances or by any distance over a specified range.
  • the penetration guide may comprise a plurality of substantially parallel extensions from the housing or body, each substantially parallel to and, preferably, equidistant from the insertable portion of medical instrument. Most preferably, the penetration guide is a single extension.
  • the penetration guide may also be designed to allow only a single distance between itself and the insertable portion of medical instrument or the penetration guide may be adjustable to allow the operator to set the distance between the two according to the thickness of tissue or tissues in question.
  • the distance or gap between the penetration guide and the insertable portion of medical instrument may be any separating distance which allows the tissue to pass between the two and limits the insertion of the insertable portion of medical instrument to the desired depth under the tissue or tissues.
  • the penetration guide is separated from the insertable portion of medical instrument by a distance of between about 0.075 inches and about 0.095 inches (1.88 to 2.41 mm), most preferably by a distance of between about 0.080 inches and about 0.090 inches (2.03 to 2.29 mm).
  • the penetration guides of this invention may be made from any material sufficiently rigid to accomplish the intended functions.
  • the material will preferably be a moldable polymer, such as nylon 66 or a polyacrylic.
  • a clear material, such as a polyacrylic may be advantageous for methods in which the ability to view the tissue through the guide is an advantage. If the materials are clear, such as with glass or a polyacrylic material, the top and bottom surfaces of the penetration guide may be rounded convexly or concavely to alter the angle and/or magnification of light passing through the guide.
  • lines, markings, raised or indented po ⁇ ions or other visible markers on or in the surface of the penetration guide to serve as indicators to the depth of penetration of the device.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Medical Informatics (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)

Abstract

L'invention concerne un guide (8) de pénétration intra-tissulaire, qui limite la plage de mouvements d'un dispositif (2) destiné à être introduit sous et sensiblement parallèlement à la surface d'un tissu particulier (10) ou d'une superposition de tissus, et donc permet d'insérer ledit dispositif à la profondeur désirée.
PCT/US1997/016813 1996-09-27 1997-09-23 Guide de penetration intra-tissulaire WO1998013092A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU43573/97A AU4357397A (en) 1996-09-27 1997-09-23 Tissue penetration guide

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US72193196A 1996-09-27 1996-09-27
US08/721,931 1996-09-27

Publications (1)

Publication Number Publication Date
WO1998013092A1 true WO1998013092A1 (fr) 1998-04-02

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ID=24899872

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1997/016813 WO1998013092A1 (fr) 1996-09-27 1997-09-23 Guide de penetration intra-tissulaire

Country Status (2)

Country Link
AU (1) AU4357397A (fr)
WO (1) WO1998013092A1 (fr)

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001026728A1 (fr) * 1999-10-12 2001-04-19 Durect Corporation Systeme d'echange ferme
WO2006077242A1 (fr) 2005-01-24 2006-07-27 N.V. Organon Appareil de pose d'implant
WO2007082889A1 (fr) * 2006-01-19 2007-07-26 N.V. Organon Nécessaire et méthode pour assembler un applicateur pour insérer un implant
KR101700384B1 (ko) * 2016-04-26 2017-01-26 심길섭 안경용 자석 임플란트 및 그 이식장치
KR101731580B1 (ko) 2016-02-16 2017-05-02 주식회사 덴티스 센서 삽입 시술 가이드 및 이를 이용한 센서 삽입 방법
EP3263056A1 (fr) * 2016-06-29 2018-01-03 BIOTRONIK SE & Co. KG Dispositif d'implantation de dispositifs médicaux
KR20180014814A (ko) * 2015-06-03 2018-02-09 인타르시아 세라퓨틱스 인코포레이티드 임플란트 배치 및 제거 시스템들
USD835783S1 (en) 2016-06-02 2018-12-11 Intarcia Therapeutics, Inc. Implant placement guide
USD860451S1 (en) 2016-06-02 2019-09-17 Intarcia Therapeutics, Inc. Implant removal tool
USD933219S1 (en) 2018-07-13 2021-10-12 Intarcia Therapeutics, Inc. Implant removal tool and assembly

Citations (9)

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DE635692C (de) * 1936-09-22 Herbert Zadow AErztliche Spritze
GB1476776A (en) * 1974-12-13 1977-06-16 Williams R Syringes
US4451253A (en) 1980-12-18 1984-05-29 Harman Sherman M Means and method for administering medicinals
GB2138298A (en) * 1983-04-21 1984-10-24 Hundon Forge Ltd Pellet implanter
US4661103A (en) 1986-03-03 1987-04-28 Engineering Development Associates, Ltd. Multiple implant injector
FR2612401A1 (fr) * 1987-03-16 1988-09-23 Denance Raymond Embout stabilisateur pour aiguille hypodermique comportant un moyen faisant office de bequille pour reguler la penetration en fonction de l'angle d'attaque de l'aiguille dans la peau
US4820267A (en) 1985-02-19 1989-04-11 Endocon, Inc. Cartridge injector for pellet medicaments
US4846793A (en) 1987-03-18 1989-07-11 Endocon, Inc. Injector for implanting multiple pellet medicaments
US4994028A (en) 1987-03-18 1991-02-19 Endocon, Inc. Injector for inplanting multiple pellet medicaments

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE635692C (de) * 1936-09-22 Herbert Zadow AErztliche Spritze
GB1476776A (en) * 1974-12-13 1977-06-16 Williams R Syringes
US4451253A (en) 1980-12-18 1984-05-29 Harman Sherman M Means and method for administering medicinals
GB2138298A (en) * 1983-04-21 1984-10-24 Hundon Forge Ltd Pellet implanter
US4820267A (en) 1985-02-19 1989-04-11 Endocon, Inc. Cartridge injector for pellet medicaments
US4661103A (en) 1986-03-03 1987-04-28 Engineering Development Associates, Ltd. Multiple implant injector
FR2612401A1 (fr) * 1987-03-16 1988-09-23 Denance Raymond Embout stabilisateur pour aiguille hypodermique comportant un moyen faisant office de bequille pour reguler la penetration en fonction de l'angle d'attaque de l'aiguille dans la peau
US4846793A (en) 1987-03-18 1989-07-11 Endocon, Inc. Injector for implanting multiple pellet medicaments
US4994028A (en) 1987-03-18 1991-02-19 Endocon, Inc. Injector for inplanting multiple pellet medicaments

Cited By (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001026728A1 (fr) * 1999-10-12 2001-04-19 Durect Corporation Systeme d'echange ferme
WO2006077242A1 (fr) 2005-01-24 2006-07-27 N.V. Organon Appareil de pose d'implant
US8888745B2 (en) 2005-01-24 2014-11-18 Merck Sharp & Dohme B.V. Applicator for inserting an implant
EP1841492B1 (fr) 2005-01-24 2016-08-10 Merck Sharp & Dohme B.V. Appareil de pose d'implant
US10092739B2 (en) 2006-01-19 2018-10-09 Merck Sharp & Dohme B.V. Kit for and method of assembling an applicator for inserting an implant
WO2007082889A1 (fr) * 2006-01-19 2007-07-26 N.V. Organon Nécessaire et méthode pour assembler un applicateur pour insérer un implant
US11040184B2 (en) 2006-01-19 2021-06-22 Merck Sharp & Dohme B.V. Kit for and method of assembling an applicator for inserting an implant
US10821277B2 (en) 2006-01-19 2020-11-03 Merck Sharp & Dohme B.V. Kit for and method of assembling an applicator for inserting an implant
US10925639B2 (en) 2015-06-03 2021-02-23 Intarcia Therapeutics, Inc. Implant placement and removal systems
JP2018525047A (ja) * 2015-06-03 2018-09-06 インターシア セラピューティクス，インコーポレイティド インプラントの設置及び撤去システム
KR20180014814A (ko) * 2015-06-03 2018-02-09 인타르시아 세라퓨틱스 인코포레이티드 임플란트 배치 및 제거 시스템들
KR102650751B1 (ko) * 2015-06-03 2024-03-22 인타르시아 세라퓨틱스 인코포레이티드 임플란트 배치 및 제거 시스템들
KR101731580B1 (ko) 2016-02-16 2017-05-02 주식회사 덴티스 센서 삽입 시술 가이드 및 이를 이용한 센서 삽입 방법
KR101700384B1 (ko) * 2016-04-26 2017-01-26 심길섭 안경용 자석 임플란트 및 그 이식장치
USD835783S1 (en) 2016-06-02 2018-12-11 Intarcia Therapeutics, Inc. Implant placement guide
USD840030S1 (en) 2016-06-02 2019-02-05 Intarcia Therapeutics, Inc. Implant placement guide
USD860451S1 (en) 2016-06-02 2019-09-17 Intarcia Therapeutics, Inc. Implant removal tool
USD912249S1 (en) 2016-06-02 2021-03-02 Intarcia Therapeutics, Inc. Implant removal tool
USD962433S1 (en) 2016-06-02 2022-08-30 Intarcia Therapeutics, Inc. Implant placement guide
EP3263056A1 (fr) * 2016-06-29 2018-01-03 BIOTRONIK SE & Co. KG Dispositif d'implantation de dispositifs médicaux
USD933219S1 (en) 2018-07-13 2021-10-12 Intarcia Therapeutics, Inc. Implant removal tool and assembly

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