WO2007106068A2 - Pièce pour site de ponction - Google Patents

Pièce pour site de ponction Download PDF

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Publication number
WO2007106068A2
WO2007106068A2 PCT/US2006/006865 US2006006865W WO2007106068A2 WO 2007106068 A2 WO2007106068 A2 WO 2007106068A2 US 2006006865 W US2006006865 W US 2006006865W WO 2007106068 A2 WO2007106068 A2 WO 2007106068A2
Authority
WO
WIPO (PCT)
Prior art keywords
spacer
puncture site
membrane
face
skin
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/US2006/006865
Other languages
English (en)
Other versions
WO2007106068A3 (fr
Inventor
Robert L. Watson
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
Application filed by Individual filed Critical Individual
Priority to PCT/US2006/006865 priority Critical patent/WO2007106068A2/fr
Publication of WO2007106068A2 publication Critical patent/WO2007106068A2/fr
Publication of WO2007106068A3 publication Critical patent/WO2007106068A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/023—Adhesive bandages or dressings wound covering film layers without a fluid retention layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/0276—Apparatus or processes for manufacturing adhesive dressings or bandages
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00365—Plasters use
    • A61F2013/00412—Plasters use for use with needles, tubes or catheters
    • A61F2013/00417—Plasters use for use with needles, tubes or catheters pierced by needle

Definitions

  • the present invention relates to an adhesive patch for use on humans or animals which is adhered to a patient's skin allowing a health care practitioner to puncture the patient's skin while minimizing the risk of contact with the patient's blood.
  • the practitioner may come into contact with the blood at several points during this procedure, such as when the needle first punctures the skin, when the needle is removed from the skin but before the pad is positioned over the puncture wound, or after the pad is applied over the puncture site because blood may ooze from or seep through the pad.
  • the '071 patch is a three layer system comprising a generally annular absorbent pad having a first surface to be placed against the skin of a patient around an intended injection site, a second surface opposite said first surface and a central opening; an elastomeric, self-sealing membrane through which an injection needle can penetrate, said membrane lying against said second surface and closing said central opening, said membrane, in use, being spaced from the patient's skin and forming a cavity between said membrane and said skin surrounded by said absorbent pad; and a cover layer having a central opening substantially aligned with said central opening of said pad and exposing a central portion of said membrane to identify the injection site.
  • the '641 patch is a three layer system comprising an absorbent pad having a first surface to be placed against the skin of a patient around an intended penetration site for injection or withdrawal and a central opening; a transparent, elastomeric, self-sealing membrane through which a needle can penetrate; and a transparent cover layer having an outer surface and an adhesive surface for holding said membrane in said central opening of said pad and for adhering said patch to skin of a patient, and having a central opening substantially aligned with the central opening of said pad to expose a central portion of the membrane allowing visual identification of a selected penetration site whereby a blood vessel can be located through the membrane and cover and a needle can be passed through said membrane and the patient's skin into a vessel for injection or blood withdrawal, and whereby, after injection or withdrawal, the needle is extracted, the membrane wipes the needle and forms a cavity with the pad and the patient's skin to contain blood from the penetration site until after hemostasis.
  • a protective patch for use during injections and blood withdrawal procedures that does not require complex registering of the layers, that is relatively easy and inexpensive to manufacture, that has a top surface that can be wiped with an antiseptic such as alcohol while using, and that may include a means for coagulating blood collected within the patch, thereby essentially eliminating the risk of unintended blood contact.
  • the present invention is for a puncture site patch for use on humans or on animals for confining blood from a needle wound and for a method of making the patch.
  • the patch comprises an essentially transparent membrane layer and a spacer having an aperture.
  • the membrane layer preferably is a transparent, self-sealing, non-coring elastomeric material through which an injection needle can penetrate and which is self-sealing when the needle is removed to prevent blood from flowing out through the puncture hole made by the needle in the membrane.
  • the membrane layer will not degrade if wiped with an antiseptic such as alcohol. This allows the clinician the option of wiping the surface of the patch immediately before injection in case the sterile field is breached and alleviates the need to individually wrap and sterilize each patch.
  • the membrane is comprised of polyurethane.
  • the spacer is a material sheet that is adhered to the membrane and that has an adhesive film on the opposite side to adhere the patch to a patient's skin. When the patch is secured on the patient's skin, a cavity is formed between the skin and the membrane, bounded by the spacer.
  • a coagulating agent is positioned along the inner edge of the spacer and is included at sufficient concentration that any blood which escapes into the cavity can be coagulated, or gelled, thereby preventing free flow of blood when the patch is removed from the patient's skin.
  • Figure 1 is a top view of the puncture site patch of the present invention
  • Figure 2 is an exploded perspective view of the patch of Figure 1 ;
  • Figures 3A and 3B are perspective views of the patch of Figure 1 positioned on a patient's arm; and
  • Figure 4 is a schematic view of a process by which the patch of Figure 1 can be made.
  • FIGs 1 and 2 show a puncture site patch indicated generally by the numeral 10 made in accordance with the invention.
  • the patch 10 includes a membrane 12 and a spacer 14, having an aperture 16.
  • the patch 10 is essentially circular, but other shapes can be used without departing from the scope of the present invention.
  • the patch 10 is applied to a patient's skin 90 over an intended injection site 92.
  • a cavity 20 forms between the skin 90 and the membrane 12 bounded by the spacer 14.
  • the membrane 12 of the patch 10 is an elastomeric material, preferably sterile, self-sealing, non-coring, non-latex and FDA-approved for direct contact with human or animal skin. More preferably, the membrane 12 is sufficiently transparent that the practitioner can observe the patient's skin 90 when the patch 10 is positioned over the intended injection site 92. Further, the membrane material is preferably selected such that it is essentially unaffected chemically or structurally if cleaned or disinfected with agents such as ethyl alcohol, betadine, or similar common disinfectants. In some embodiments, the membrane is comprised of a thermoplastic elastomer.
  • the membrane is comprised of a polyurethane, such as for example a polyether urethane.
  • the membrane 12 has an exterior face 11 and an interior face 13, which faces toward the patient's skin 90 when the patch 10 is applied.
  • the membrane 12 can have any convenient shape, but must have dimensions sufficient to cover the spacer 14.
  • the exterior peripheries of the membrane 12 and spacer 14 are essentially identical.
  • the spacer 14 is a thin material sheet having an outer face 15 and an inner face 17.
  • the spacer 14 can be composed of any material that can be sterilized and that can be used in direct contact with human skin, such as nylon, polyurethane, polyethylene, polypropylene, isoprene, cotton, linen, or combinations thereof.
  • the material for the spacer 14 may be selected on the basis of its ability to absorb blood and bodily fluids, although these absorptive properties are not required. However, if an absorbent material is used, it is preferable, but not required, that the material be somewhat resistant to wicking to minimize the risk of blood wicking from the cavity 20 to the outside edge 19 of the spacer 14.
  • the spacer 14 is secured by its outer face 15 to the interior face 13 of the membrane 12.
  • a variety of means known in the art can be used to secure the spacer 14 to the membrane 12, such as glue, hot melt adhesive, pressure sensitive adhesive, thermally sensitive adhesive, chemical bonding, acrylic cement, or a combination thereof, or any other means well known in the art.
  • the spacer 14 is positioned on the membrane 12 such that the membrane 12 covers the entire outer face 15 of the spacer 14.
  • the inner face 17 of the spacer 14 is coated with an adhesive film (not shown) for holding the patch 10 against the patient's skin 90.
  • the adhesive be an FDA- approved material because of the direct skin contact.
  • a protective sheet or release paper 18 can be used to protect the adhesive coating until the patch 10 is applied to the skin 90, with the release paper 18 being any of a variety of materials known in the art.
  • the release paper 18 may have a similar size and shape as the spacer 14, or it may be slightly larger than the spacer 14 thereby creating tabs 28 to allow for easy removal of the release paper 18 from the membrane 12 and spacer 14.
  • the spacer 14 further includes the aperture 16 near its 14 center.
  • the aperture 16 must have dimensions adequate to allow the practitioner to insert a needle through the membrane 12 and the aperture 16 without penetrating any part of the spacer 14.
  • the aperture 16 bounded by the skin 90, the membrane 12, and the spacer 14 forms the cavity 20. Because the needle passes through the cavity 20 during an injection or blood withdrawal procedure, any blood that is released from the skin will pool in the cavity 20.
  • the blood may dry within the cavity 20 over time, or it may be absorbed by the spacer 14 if the spacer 14 includes an absorbent material, or optionally, a coagulating agent may be applied to the spacer 14 adjacent to the aperture 16 to cause the blood to thicken and gel.
  • the spacer 14 is made from polyethylene, and the aperture edge of the spacer 14 is coated with oxidized regenerated cellulose or any other suitable coagulant as is generally known in the art to coagulate any blood that enters the cavity 20.
  • the dimensions of the aperture are such that the cavity 20 formed can contain up to about 0.3 cc of bodily fluids.
  • the patch 10 is secured and held directly against the patient's skin 90 along any portion of the inner face 17 of the spacer 14. While the secure attachment is beneficial to prevent blood leakage, it can be problematic for removing the patch from the skin after use.
  • the patch may further include pull tabs 24 that protrude from the spacer 14.
  • the pull tabs 24 are preferably unitary with the spacer 14.
  • the pull tabs 24 may or may not include adhesive on the inner face 17. Thus, the practitioner can easily grab the loose pull tab 24 to remove the patch from the patient's skin.
  • a patch made in accordance with the invention can also be used when inserting a catheter into a patient, when inserting a needle for biopsies, or whenever the patient's skin will be punctured by a sharp, needle-like object.
  • the cavity can accommodate bodily fluids other than blood, and a variety of antimicrobial agents may be substituted on the spacer for the coagulating agent if so desired.
  • the patch 10 is relatively easy and inexpensive to manufacture.
  • the patch 10 may be made using a continuous production process that includes creating apertures 16 at predetermined positions on a sheet of spacer material 14 that is pretreated with adhesive on both faces 15, 17 and that includes one sheet of protective paper 30 on the in outer face 15 and the sheet of release paper 18 on the inner face 17, then removing the protective paper 30 using a take-up roll 32 as the punched spacer material continues its forward motion, then securing a sheet of membrane material 12 to the outer face 15, then die cutting 34 the membrane / spacer / release paper in the desired configuration.
  • the process may be modified in a variety of ways without departing from the scope of the invention, such as applying the first adhesive to the membrane rather than the spacer sheet, applying the second adhesive to the release paper rather than the spacer sheet, using lasers to cut the layered material, layering and cutting the membrane and spacer before adding the release sheet, and combinations thereof.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Manufacturing & Machinery (AREA)
  • Materials For Medical Uses (AREA)

Abstract

Cette invention concerne une pièce élastomère pour site de ponction conçue pour coller à la peau et pour former une protection antiseptique sur la peau à un endroit où un objet pointu tel qu'une aiguille de seringue ou un cathéter intraveineux doit être introduit. La pièce se compose d'une membrane autoadhésive transparente élastomère et d'une séparation pourvue d'une ouverture. La séparation comporte un film adhésif sur la surface opposée à la membrane pour que la pièce colle à la peau. Lorsque la pièce est appliquée sur une zone de la peau, une enceinte est formée entre la peau et la membrane et délimitée par la séparation. En cours d'utilisation, la peau est désinfectée et la pièce est appliquée. L'aiguille de seringue ou un dispositif similaire transperce la membrane et la peau. A la fin de la procédure, l'aiguille est retirée et le sang éventuellement présent sur l'extérieur de l'aiguille ou s'échappant de la blessure est retenu dans l'enceinte, prévenant ainsi toute contamination de la zone au-delà de l'enceinte. Cette invention concerne également un procédé de fabrication de la pièce pour site de ponction.
PCT/US2006/006865 2006-02-27 2006-02-27 Pièce pour site de ponction Ceased WO2007106068A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US2006/006865 WO2007106068A2 (fr) 2006-02-27 2006-02-27 Pièce pour site de ponction

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2006/006865 WO2007106068A2 (fr) 2006-02-27 2006-02-27 Pièce pour site de ponction

Publications (2)

Publication Number Publication Date
WO2007106068A2 true WO2007106068A2 (fr) 2007-09-20
WO2007106068A3 WO2007106068A3 (fr) 2007-11-15

Family

ID=38509909

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2006/006865 Ceased WO2007106068A2 (fr) 2006-02-27 2006-02-27 Pièce pour site de ponction

Country Status (1)

Country Link
WO (1) WO2007106068A2 (fr)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014005140A1 (fr) * 2012-06-29 2014-01-03 Centurion Medical Products Corporation Pansements médicaux à plusieurs couches
WO2022223677A1 (fr) * 2021-04-23 2022-10-27 Mcas Design Limited Dispositif d'aide à la visualisation de veine
WO2022241161A1 (fr) * 2021-05-13 2022-11-17 Injection Safety Industries, LLC Timbre antimicrobien pour site de perforation avec scellement de sécurité post-injection
CN117320675A (zh) * 2021-05-13 2023-12-29 注射安全工业有限责任公司 具有注射后安全密封的抗菌穿刺部位贴片
US12005237B2 (en) 2016-01-21 2024-06-11 West Pharma. Services IL, Ltd. Medicament delivery device comprising a visual indicator
US12208246B2 (en) 2015-10-09 2025-01-28 West Pharma. Services IL, Ltd. Bent fluid path add on to a prefilled fluid reservoir
USD1070068S1 (en) 2022-05-12 2025-04-08 Injection Safety Industries, LLC Puncture site patch with post injection safety sealing
USD1084358S1 (en) 2022-05-12 2025-07-15 Injection Safety Industries, LLC Puncture site patch with post injection safety sealing

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2157040C (fr) * 1993-03-22 2007-12-11 Steven B. Heinecke Pansement et procede de fabrication
US5738641A (en) * 1996-07-31 1998-04-14 Watson; Robert L. Blood withdrawal patch

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014005140A1 (fr) * 2012-06-29 2014-01-03 Centurion Medical Products Corporation Pansements médicaux à plusieurs couches
US12208246B2 (en) 2015-10-09 2025-01-28 West Pharma. Services IL, Ltd. Bent fluid path add on to a prefilled fluid reservoir
US12005237B2 (en) 2016-01-21 2024-06-11 West Pharma. Services IL, Ltd. Medicament delivery device comprising a visual indicator
US12427261B2 (en) 2016-01-21 2025-09-30 West Pharma. Services IL, Ltd. Medicament delivery device comprising a visual indicator
WO2022223677A1 (fr) * 2021-04-23 2022-10-27 Mcas Design Limited Dispositif d'aide à la visualisation de veine
US20240382696A1 (en) * 2021-04-23 2024-11-21 Mcas Design Limited A vein visualisation aid device
CN117320675A (zh) * 2021-05-13 2023-12-29 注射安全工业有限责任公司 具有注射后安全密封的抗菌穿刺部位贴片
JP2024518984A (ja) * 2021-05-13 2024-05-08 インジェクション セーフティ インダストリーズ エルエルシー 注射後安全シールを有する抗菌性穿刺部位パッチ
GB2621511A (en) * 2021-05-13 2024-02-14 Injection Safety Ind Llc Antimicrobial puncture site patch with post injection safety sealing
AU2022274905B2 (en) * 2021-05-13 2025-06-05 Injection Safety Industries, LLC Antimicrobial puncture site patch with post injection safety sealing
WO2022241161A1 (fr) * 2021-05-13 2022-11-17 Injection Safety Industries, LLC Timbre antimicrobien pour site de perforation avec scellement de sécurité post-injection
USD1070068S1 (en) 2022-05-12 2025-04-08 Injection Safety Industries, LLC Puncture site patch with post injection safety sealing
USD1084358S1 (en) 2022-05-12 2025-07-15 Injection Safety Industries, LLC Puncture site patch with post injection safety sealing
USD1123171S1 (en) 2022-05-12 2026-04-21 Injection Safety Industries, LLC Puncture site patch

Also Published As

Publication number Publication date
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