WO2018204244A1 - Ensemble dispositif de fixation et ensemble dispositif de fixation et de pansement et procédé d'application desdits ensembles - Google Patents
Ensemble dispositif de fixation et ensemble dispositif de fixation et de pansement et procédé d'application desdits ensembles Download PDFInfo
- Publication number
- WO2018204244A1 WO2018204244A1 PCT/US2018/030163 US2018030163W WO2018204244A1 WO 2018204244 A1 WO2018204244 A1 WO 2018204244A1 US 2018030163 W US2018030163 W US 2018030163W WO 2018204244 A1 WO2018204244 A1 WO 2018204244A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- adhesive
- removable
- layer
- securement device
- device assembly
- Prior art date
Links
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- 239000000758 substrate Substances 0.000 claims abstract description 63
- 239000010410 layer Substances 0.000 claims description 92
- 239000012790 adhesive layer Substances 0.000 claims description 82
- 239000002390 adhesive tape Substances 0.000 claims description 8
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- 238000004388 gamma ray sterilization Methods 0.000 claims 1
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- HNPSIPDUKPIQMN-UHFFFAOYSA-N dioxosilane;oxo(oxoalumanyloxy)alumane Chemical compound O=[Si]=O.O=[Al]O[Al]=O HNPSIPDUKPIQMN-UHFFFAOYSA-N 0.000 description 1
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- NLYAJNPCOHFWQQ-UHFFFAOYSA-N kaolin Chemical compound O.O.O=[Al]O[Si](=O)O[Si](=O)O[Al]=O NLYAJNPCOHFWQQ-UHFFFAOYSA-N 0.000 description 1
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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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/02—Holding devices, e.g. on the body
-
- 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
- A61F13/0246—Adhesive bandages or dressings characterised by the skin-adhering layer
- A61F13/025—Adhesive bandages or dressings characterised by the skin-adhering layer having a special distribution arrangement of the adhesive
-
- 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
-
- 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
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/02—Holding devices, e.g. on the body
- A61M2025/0266—Holding devices, e.g. on the body using pads, patches, tapes or the like
Definitions
- the invention relates generally to securement device assemblies, and, more particularly to assemblies that can be used as securement and dressing devices in the medical profession.
- Securement devices are used in the medical profession to secure needles and catheters inserted within patients to prevent dislodgement, phlebitis, damage to surrounding tissue, and the ingress of bacteria at the insertion site, and damaging surrounding tissue.
- Medical grade tape can be used as a securement device or to supplement a securement device.
- Safe and effective securement devices are particularly critical for the treatment of chronic conditions, such as kidney failure, which requires constant dialysis treatment for removing waste from a patient's blood.
- an intravenous catheter is one method that may be used to gain access to the blood.
- Catheter access consists of a plastic catheter with two lumens which is inserted into a large vein to allow large flows of blood to be withdrawn from one lumen, to enter the dialysis circuit, and to be returned via the other lumen.
- the constant site technique is being increasingly employed, where a blunted needle is inserted in exactly the same site, so as to develop "buttonhole" accesses that may be used repeatedly.
- the skin surrounding a buttonhole access is continually irritated and is susceptible to infection. Since existing securement devices are primarily opaque, healthcare providers are unable to visualize the entire insertion site. Thus, tape application, removal, and reapplication can be cumbersome.
- United States Patent Application Publication No. 2010/0198161 discloses a window dressing having an integral anchor.
- the window dressing disclosed includes a fabric layer having juxtaposed insertion site viewing and anchor member portions.
- the fabric layer has an adhesive side and an opposite non-adhesive side.
- the insertion site viewing portion is defined by an opening in the fabric layer.
- a transparent film layer having an adhesive skin-adhering side and an opposite non-adhesive side is adhered to the fabric layer adhesive side and closes the opening in the fabric layer.
- the anchor member portion includes a reinforcing structure disposed on the fabric layer and having an adhesive side and an opposite non-adhesive side.
- the reinforcing structure adhesive side is adhered to the fabric layer non-adhesive side such that the reinforcing structure is on top of the fabric layer.
- the Propp reference discloses an assembly that is mostly opaque fabric having only a small opening through which the insertion site may be viewed.
- the Propp reference discloses layers having sides which are either completely coated with adhesive or not coated at all.
- United States Patent No. 4,704, 177 discloses a medicator securing device utilizing a thin, transparent plastic film coated on one side with an adhesive and having a border frame at least along three sides. No adhesive is present on the exposed surfaces of the border frame and are available to be grasped so as to provide ready separation of the adhesive surfaces of the facing films when brought together.
- the Vaillancourt reference discloses a sheet having sides which are either continuously coated with adhesive or not coated at all.
- a latex-free, hypoallergenic paper tape is available from 3M Corporate
- a securement device assembly comprising an adhesive layer having a top surface and a bottom surface, wherein said adhesive layer includes at least two apertures, a non-adhesive substrate secured to said bottom surface of said adhesive layer to form an integral unit, and a plurality of perforations within said integral unit.
- a securement and dressing device assembly comprising an adhesive layer having a top surface and a bottom surface, wherein said adhesive layer includes at least two apertures, a non-adhesive substrate, comprising at least one absorption element secured to said non-adhesive substrate, and arranged in registration with a first of said apertures, and at least one permeable element secured to said non-adhesive substrate, and arranged in registration with a second of said apertures, wherein said non-adhesive substrate is secured to said bottom surface of said adhesive layer to form an integral unit, and a plurality of perforations arranged within said integral unit.
- a method for securing a needle assembly to a person using a tape assembly comprising the steps of inserting said needle assembly into a vessel of said person, said needle assembly comprising a tube connected to a needle and a wing fixedly secured thereto, adhering a first strip of material under said tubing proximate said wing of said needle, wherein said first strip of material has a first end and a second end, folding said first end and said second end of said first strip of material such that said first and second ends traverse said wing of said needle, adhering said first and second ends of said first strip of material to said person, and adhering a second strip of material atop of said wing and said first strip of material.
- a securement and dressing device assembly comprising an adhesive layer having a top surface and a bottom surface, wherein said adhesive layer includes at least two apertures, a non-adhesive substrate secured said bottom surface of said adhesive layer to form an integral unit, and a plurality of perforations operatively arranged within said integral unit, said plurality of perforations forming a first portion having a plurality of removable strips and a second portion having at least one absorption element and at least one permeable element.
- a securement device assembly comprising a non-adhesive substrate having a first top surface and a first bottom surface, an adhesive layer having a second top surface and a second bottom surface, said adhesive layer secured to said first top surface along said second bottom surface, a plurality of adhesive blockers arranged on the second top surface, wherein the non-adhesive substrate, the adhesive layer, and the plurality of adhesive blockers form an integral unit, and a plurality of perforations within said integral unit separating said integral unit into a plurality of sections.
- a securement device assembly comprising a non-adhesive substrate having a first top surface and a first bottom surface, an adhesive layer having a second top surface and a second bottom surface, said adhesive layer secured to said first top surface along said second bottom surface, a plurality of adhesive blockers arranged on the second top surface, wherein the non-adhesive substrate, the adhesive layer, and the plurality of adhesive blockers form an integral unit, and a plurality of perforations within said integral unit separating said integral unit into a plurality of sections.
- a securement device assembly comprising a non-adhesive substrate including a first top surface and a first bottom surface, a removable layer including a second top surface and a second bottom surface, said second top surface including an adhesive and said removable layer secured to said first top surface along said second top surface, and one or more adhesive blockers arranged on the second top surface, wherein the non-adhesive substrate, the removable layer, and the one or more adhesive blockers form an integral unit.
- the primary object of the invention is to provide a tape assembly which is completely transparent to allow for medical personal to observe a medical procedure.
- a further object of the invention is to provide a tape assembly with adhesive in certain locations to allow for easy adjustment and readjustment of the tape assembly.
- Yet another object of the invention is to provide a transparent tape assembly having a minimal amount of adhesive such that the tape assembly is effective yet minimally abrasive to the skin of a patient.
- Another object of the invention is to provide a tape assembly for securing a needle within a patient's arm and for dressing the cannulation site after the needle has been removed.
- Figure la is a top view of the assembly of the present invention.
- Figure lb is a fragmentary exploded view of a first embodiment of the assembly shown in Figure la;
- Figure lc is a cross-sectional view of the first embodiment of the assembly taken generally along line lc-lc in Figure la;
- Figure 2 is a perspective view of a needle within a patient's arm
- Figure 3 is a perspective view of the needle secured to the patient's arm shown in Figure
- Figure 4 is a perspective view of the needle secured to the patient's arm shown in Figure
- Figure 5 is a perspective view of the needle assembly shown in Figure 4, except the transparent strip is further positioned proximate the patient's arm;
- Figure 6 is a perspective view of the needle secured to the patient's arm shown in Figure 5 except the transparent strip is adhered to the patent's arm;
- Figure 7a is a fragmentary exploded view of the assembly shown in Figure la;
- Figure 7b is a cross-sectional view of the tape assembly taken generally along line 7b-7b in Figure la;
- Figure 7c is a cross sectional view of the tape assembly taken generally along line 7c-7c in Figure la;
- Figure 8 is a perspective view of the tape assembly dressed
- Figure 9 is a cross sectional view of the dressing of the assembly shown in Figure 8 taken generally along line 9-9 in Figure 8;
- Figure 10a is a fragmentary exploded view of a second embodiment of the assembly shown in Figure la;
- Figure 10b is a cross-sectional view of the second embodiment of the assembly taken generally along line lc-lc in Figure la;
- Figure 1 la is a fragmentary exploded view of a third embodiment of the assembly shown in Figure la;
- Figure l ib is a cross-sectional view of the third embodiment of the assembly taken generally along line lc-lc in Figure la.
- the term “substantially” is synonymous with terms such as “nearly,” “very nearly,” “about,” “approximately,” “around,” “bordering on,” “close to,” “essentially,” “in the neighborhood of,” “in the vicinity of,” etc., and such terms may be used interchangeably as appearing in the specification and claims.
- proximate is synonymous with terms such as “nearby,” “close,” “adjacent,” “neighboring,” “immediate,” “adjoining,” etc., and such terms may be used interchangeably as appearing in the specification and claims.
- the term “approximately” is intended to mean values within ten percent of the specified value.
- Figure la is a top view of assembly 10.
- Assembly 10 broadly includes, from bottom to top, transparent non-adhesive substrate 11, transparent adhesive layer 12, and removable layer 13. Of these three layers, only removable layer 13 is visible from the top view shown in Figure la.
- the bottom side of removable layer 13 is adhered to the top side of transparent adhesive layer 12, and the top side of transparent non-adhesive substrate 11 is adhered to the bottom side of transparent adhesive layer 12.
- Transparent non-adhesive substrate 11 and transparent adhesive layer 12 are arranged such that they remain adhesively joined.
- Removable layer 13 is arranged such that it is removable from transparent adhesive layer 12 and transparent non-adhesive substrate 11.
- assembly 10 can include perforations.
- perforation lines 20, 21, 22, 23, 24, 25, 26, and 27 are included to separate assembly 10 into removable sections 31, 32, 33, 34, 35, 36, 38, 38', 39, and 39'. It should be appreciated that assembly 10 is divisible into removable sections 31, 32, 33, 34, 35, 36, 38, 38', 39, and 39' while transparent non-adhesive substrate 11, transparent adhesive layer 12, and removable layer 13 remain assembled.
- removable sections 31, 32, and 33 are separated from removable sections 34, 35, 36, 38, 38', 39, and 39' along perforation line 22, removable sections 31, 32, and 33 remain joined and include the corresponding portions of transparent non-adhesive substrate 11, transparent adhesive layer 12, and removable layer 13.
- sections 34, 35, 36, 38, 38', 39, and 39' remain joined and include the corresponding portions of transparent non-adhesive substrate 11, transparent adhesive layer 12, and removable layer 13.
- Removable layer 13 includes apertures 40, 41, 42, 43, 44, 45, 46, and 47
- transparent adhesive layer 12 includes apertures 50, 51, 52, 53, 54, 55, 56, and 57. Said apertures represent the absence of material within removable layer 13 and transparent adhesive layer 12, respectively.
- Figure la shows removable layer 13 apertures 40, 41, 42, 43, 44, 45, 46, and 47.
- Transparent adhesive layer 12 apertures 50, 51, 52, 53, 54, 55, 56, and 57 are aligned directly below, and are identical in size to, removable layer 13 apertures 40, 41, 42, 43, 44, 45, 46, and 47, respectively.
- apertures are cut into removable layer 13 and transparent adhesive layer 12 after they have been secured together, but before transparent non-adhesive substrate 11 is assembled. This ensures that apertures 40, 41, 42, 43, 44, 45, 46, and 47 are precisely aligned with, and identical in size to, apertures 50, 51, 52, 53, 54, 55, 56, and 57, respectively. Thus, describing the dimensions and orientation of removable layer 13 apertures sufficiently describes the respective transparent adhesive layer 12 apertures.
- Aperture 40 extends from perforation line 20 to perforation line 24 and spans removable sections 32, 33, 34, and 35 of assembly 10.
- Aperture 43 is substantially similar to aperture 40, as it also extends from perforation line 20 to perforation line 24 and spans removable sections 32, 33, 34, and 35.
- apertures 40 and 43 are substantially parallel.
- Apertures 41 and 42 are located between apertures 40 and 43.
- Aperture 41 extends from perforation line 21 to perforation line 23 and spans removable sections 33 and 34.
- Aperture 42 is substantially similar to aperture 41, as it also extends from perforation line 21 to perforation line 23 and spans removable sections 43 and 44.
- apertures 41 and 42 are substantially parallel.
- apertures 40, 41, 42, and 43 are substantially parallel.
- perforation lines 20, 21, 22, 23, 24, 25, 26, and 27 and apertures 40, 41, 42, and 43 do not need to be parallel and can be of any shape.
- perforation lines 20, 21, 22, 23, 24, 25, 26, and 27 could be represented by lines with an oscillating wave pattern and apertures 40, 41, 42, and 43 could be of any shape such as an oval or circle.
- Figure lb is a fragmentary exploded view of a first embodiment of assembly 10.
- Subassembly 10A is the adhesive strip portion of assembly 10.
- Subassembly 10A includes removable sections 31, 32, 33, 34, 35, and 36, which can be separated from removable sections 38, 38', 39, and 39' along perforation line 25. Also included in subassembly 10A are perforation lines 20, 21, 22, 23, and 24.
- Removable sections 31, 32, 33, 34, 35, and 36 each include respective portions of transparent non-adhesive substrate 11, transparent adhesive layer 12, and removable layer 13.
- transparent adhesive layer 12 has adhesive sections 31A, 32A, 32B, 32C, 33A, 33B, 33C, 33D, 33E, 34A, 34B, 34C, 34D, 34E, 35A, 35B, 35C, and 36A.
- Transparent adhesive layer 12 also has apertures 50, 51, 52, and 53, which are identical in dimension to, and are precisely aligned with, removable layer 13 apertures 40, 41, 42, and 43, respectively. Said apertures represent the absence of material within transparent adhesive layer 12 and removable layer 13, respectively.
- Removable sections 31, 32, and 33 have substantially similar adhesive sections to that of removable sections 36, 35, and 34, respectively, as assembly 10 is designed to secure two needles.
- transparent adhesive layer 12 is comparable to double-sided adhesive tape in that it has adhesive on both its bottom surface, to which transparent non-adhesive substrate 11 is secured, and also its top surface, to which removable layer 13 secured.
- transparent adhesive layer 12 is a double-sided adhesive tape, such as 3MTM 1577 Two in One Double Coated Tape, consisting of a transparent polyester backing, coated on both sides with a hypoallergenic, pressure sensitive, synthetic rubber based adhesive on the face side and a acrylate adhesive on the linear side.
- 3MTM 1577 Double Coated Tape is supplied with silicone treated, bleached Kraft-Glassine paper liners assembled to both surfaces.
- removable layer 13 is a translucent. It is important to note that both adhesive side of 3MTM 1577 Double Coated Tape have different adhesive strengths when compared to one another.
- the synthetic rubber adhesive has greater adhesive strength that the acrylate adhesive. This is to aid in the removal of the tape from a patient's skin when treatment is completed and to reduce the amount of irritation on a patient's skin from the tape.
- transparent adhesive layer 12 is a medical adhesive transfer tape, such as 3MTM 1504XL Hi-Tack Transfer Adhesive, consisting of a synthetic rubber-based adhesive supplied in tape form on an extended two-sided siliconized white paper release liner.
- 3MTM 1504XL Hi-Tack Transfer Adhesive consisting of a synthetic rubber-based adhesive supplied in tape form on an extended two-sided siliconized white paper release liner.
- the top surface liner of double-sided adhesive tape and adhesive transfer tape will contain removable layer 13 apertures 40, 41, 42, and 43. Apertures 40, 41, 42, and 43 can be eliminated to promote the easy removal of removable layer 13 after assembly 10 is divided into individual removable sections.
- the top surface liner containing apertures 40, 41, 42, and 43 is removed.
- Removable layer 13 a single continuous liner substantially identical in dimension to transparent non-adhesive substrate 11, is then secured atop transparent adhesive layer 12.
- transparent adhesive layer 12 is adhesive applied directly atop transparent non-adhesive substrate 11 at the locations shown in Figure lb. Any suitable method of applying the adhesive, such as spraying, may be used.
- transparent non-adhesive substrate 11 is made of polyester, however, any suitable alternative, such as ethylene vinyl acetate (EVA) or polypropylene, can be used.
- removable layer 13 is silicone release paper operatively arranged to be removable from transparent adhesive layer 12 while preserving the adhesive top surface of transparent adhesive layer 12.
- removable layer 13 can be any suitable alternative.
- assembly 10 is arranged to be subdivided into corresponding removable sections before detachment of removable layer 13. Removable layer 13 maintains the adhesive strength and sterility, and should be removed immediately before application to prevent contamination.
- Assembly 10 further comprises perforated elements 60 and 61 and fabric elements
- perforated elements 60 and 61 are positioned within removable sections 38 and 38' of assembly 10, respectively.
- Fabric elements 70 and 71 are positioned within removable sections 39 and 39' of assembly 10, respectively.
- Subassembly 10B comprises removable sections 38, 38', 39, and 39', which can be separated from subassembly 10A, comprising removable sections 31, 32, 33, 34, 35, and 36, along perforation line 25.
- Subassembly 10B also comprises perforation lines 26 and 27.
- Removable sections 38 and 38' can be separated from removable sections 39 and 39', respectively, along perforation line 26.
- Removable sections 38 and 39 can be separated from removable sections 38' and 39', respectively, along perforation line 27.
- FIG lc shows a cross-sectional view of a first example embodiment of assembly 10 taken generally along line lc-lc shown in Figure la.
- Assembly 10 comprises, from bottom to top, transparent non-adhesive substrate 11, transparent adhesive layer 12, and removable layer 13.
- transparent adhesive layer 12 has a width which is smaller than the width of transparent non-adhesive substrate 11 to ensure that removable sections do not have adhesive on flaps. This allows attendants to easily grasp removable sections to readjust during use on patient's arm 1 without removing their gloves. Substantially similar flaps occur on every removable section of assembly 10.
- Removable section 31 contains flaps 31B and 31C
- removable section 32 contains flaps 32D and 32E
- removable section 33 contains flaps 33F and 33G
- removable section 34 contains flaps 34F and 34G
- removable section 35 contains flaps 35D and 35E
- removable section 36 contains flaps 36B and 36C.
- Figure lc shows that removable layer 13 apertures 40, 41, 42, and 43 are aligned with transparent adhesive layer 12 apertures 50, 51, 52, and 53, respectively. In one embodiment, apertures are cut into removable layer 13 and transparent adhesive layer 12 before transparent non-adhesive substrate 11 is assembled, but after transparent adhesive layer 12 and removable layer 13 are secured together.
- FIG. 2 is a perspective view of patient's arm 1 with needle 2 inserted into either a vein or artery, depending on the insertion requirements of the procedure being performed. Also shown in Figure 2, needle 2 contains wings 4 and tube 3. Typically, infusion needles contain wings to ensure a firm grip during placement. Winged infusion needles often contain flexible wings that can be squeezed together during placement. Once the needle has been inserted, the wings are folded down onto the skin and adhesive tape is placed over the wings.
- the flexible wings form to the contours of the patient's arm to ensure maximum surface contact, providing surface friction.
- needle 2 will dislodge from patient's arm 1.
- Figure 2 shows needle 2 with wings 4 secured in patient's arm 1 by needle 2 only. This arrangement is not suitable.
- an attendant In order to secure needle 2, an attendant must hold needle 2 in patient's arm 1 by applying pressure to wings 4. This application technique is dangerous because holding needle 2 within patient's arm 1 could place additional stress on the injection site, which can cause the patient extreme discomfort and may even cause damage to a vein or artery in the event that needle 2 shifts within patient's arm 1.
- FIG 3 is a perspective view of needle 2 inserted in patient's arm 1 and secured with removable section 32.
- removable section 32 is positioned substantially perpendicular to inserted needle 2, with transparent adhesive layer 12 directed toward patient's arm 1.
- Removable section 32 comprises adhesive sections 32A, 32B, and 32C with adhesive section 32B securing wings 4 of needle 2. This prevents internal blood pressure from dislodging needle 2 from arm 1.
- an attendant removes adhesive strips along perforation lines and applies them to patient's arm 1.
- flaps 32D and 32E and transparent adhesive layer 12 apertures 50 and 53.
- transparent adhesive layer 12 does not extend to non-adhesive flaps 32D and 32E, which promotes easy readjustment of adhesive strip 32.
- FIG. 4 is a perspective view of needle 2 inserted in patient's arm 1 with removable section 32 securing wings 4 of needle 2. Also shown in Figure 4 is the application of removable section 33, which is positioned proximate patient's arm 1.
- Removable section 33 comprises adhesive sections 33A, 33B, 33C, 33D, and 33E with adhesive section 33C securing removable section 33 to tube 3 of needle 2.
- Removable section 33 is positioned substantially perpendicular to tube 3, with transparent adhesive layer 12 directed away from patient's arm 1.
- Adhesive section 33C is positioned on the underside of tube 3, opposite the side of tube 3 on which adhesive section 32B is positioned on.
- An attendant would release removable section 33 from assembly 10 after already positioning removable section 32 on patient's arm 1.
- An attendant would then position removable section 33 on the underside of tube 3 and position adhesive strip 33 in an appropriate location before applying adhesive section 33C to tube 3.
- Figure 5 and 6 are perspective views of needle 2 inserted in patient's arm 1 with adhesive strip 32 securing wings 4 of needle 2 and adhesive strip 33 securing tube 3 of needle 2.
- adhesive section 33C on tube 3
- removable section 33 can be positioned on a patient's arm 1 to form the chevron shape prior to the securement of removable section 32 on wings 4 of needle 2.
- the orientation and securement of removable sections 32 and 33 is an extremely important factor for ensuring securement of needle 2 within patient's arm 1.
- removable section 33 under tube 3 prevents rotation of needle 2 within patient's arm 1 during treatment.
- the placement of the distal ends of removable section 33 provides force that pulls needle 2 forward, into patient's arm 1, to prevent internal pressure from dislodging needle 2 from patient's arm 1.
- Figure 6 shows a preferred embodiment of the positioning of adhesive strips 32 and 33 applied proximate patient's arm 1 and needle 2 inserted therein.
- the positioning of removable section 33 on tube 3, the force applied to needle 2 by removable section 33, and the distance with which the distal ends of removable section 33 are spaced apart proximate needle 2 are based on the procedure being performed and the patient's physical characteristics.
- removable section 33 would have distal ends positioned in a wide arrangement for a high pressure injection site such as for an artery to ensure needle 2 is fully secured within arm 1.
- a high pressure injection site such as for an artery
- an attendant can grasp removable section 33 at flaps 33F and 33G and reposition the distal ends of adhesive strip 33 in the appropriate locations to ensure proper securement of needle 2 and to maximize patient comfort.
- Figure 7a shows an exploded perspective view of subassembly 10B.
- Subassembly 10B is the portion of assembly 10 that includes removable sections 38, 38', 39, and 39'.
- Subassembly 10B broadly includes, from bottom to top, transparent non-adhesive substrate 11, transparent adhesive layer 12, and removable layer 13.
- Assembly 10 is arranged such that transparent non-adhesive substrate 11 and transparent adhesive layer 12 remain adhesively bonded while removable layer 13 is removed from transparent adhesive layer 12.
- transparent non-adhesive substrate 11 is made of polypropylene.
- removable layer 13 is silicone release paper operatively arranged to be removable from transparent adhesive layer 12 while preserving the adhesive qualities of transparent adhesive layer 12.
- removable layer 13 can be any suitable alternative.
- assembly 10 is arranged to be subdivided into its corresponding removable sections before removable layer 13 is removed from transparent adhesive layer 12.
- assembly 10 includes perforation lines to separate assembly 10 into removable sections 38, 38', 39, and 39'.
- assembly 10 includes perforation lines 26 and 27.
- Perforation line 26 separates removable sections 38 and 38' from removable sections 39 and 39', respectively.
- Perforation line 27 is positioned substantially perpendicular to perforation line 26, and separates removable sections 38 and 39 from removable sections 38' and 39', respectively.
- assembly 10 is divisible into removable sections 38, 38', 39, and 39' while transparent non-adhesive substrate 11, transparent adhesive layer 12, and removable layer 13 remain assembled.
- Removable sections 38 and 38' are identical and removable sections 39 and 39' are identical, as assembly 10 is designed to secure two needles. Upon removal of each needle, perforated elements 60 and 61 and fabric elements 70 and 71 promote clotting and dressing at the injection sites.
- removable sections 38 and 38' include corresponding portions of removable layer 13, adhesive sections 38A and 38A' of transparent adhesive layer 12, and perforated elements 60 and 61 and corresponding portions of transparent non-adhesive substrate 11, respectively.
- Perforated elements 60 and 61 are located within corresponding portions 38 and 38' of transparent non-adhesive substrate 11, respectively.
- Removable sections 39 and 39' include corresponding portions of removable layer 13, adhesive sections 39A and 39A' of transparent adhesive layer 12, and fabric elements 70 and 71 and corresponding portions of transparent non-adhesive substrate 11, respectively.
- Fabric elements 70 and 71 are located within corresponding portions 39 and 39' of transparent non-adhesive substrate 11, respectively.
- perforated elements 60 and 61 and fabric elements 70 and 71 are rectangular, with perforated elements 60 and 61 having substantially identical dimensions and fabric elements 70 and 71 having substantially identical dimensions.
- shape and dimensions of perforated elements 60 and 61 and fabric elements 70 and 71 can be varied.
- transparent adhesive layer 12 is comparable to double-sided tape in that it is adhesive on its bottom surface, to which transparent non-adhesive substrate 11 is attached, and also on its top surface, to which removable layer 13 is attached.
- the perforations of perforated elements 60 and 61 are cuts made into transparent non-adhesive substrate 11 in such a way that they do not have frayed edges such as a stamped out circle. Instead the perforations are cuts made in a '+' shape to ensure material can pass through perforated elements 60 and 61. It should be appreciated, however, that the use of different perforation styles is possible and to be considered within the scope of the claimed invention.
- Removable layer 13 includes apertures 44, 45, 46, and 47 and transparent adhesive layer 12 includes apertures 54, 55, 56, and 57. Said apertures represent the absence of material within removable layer 13 and transparent adhesive layer 12, respectively. Apertures 44 and 54 and apertures 45 and 55 are located within removable sections 38 and 38', respectively. Apertures 46 and 56 and apertures 47 and 57 are located within removable sections 39 and 39', respectively. In a preferred embodiment, apertures and elements are rectangular shaped, with apertures 44, 45, 54, and 55 and perforated elements 60 and 61 having substantially identical dimensions, and apertures 46, 47, 56, and 57 and fabric elements 70 and 71 having substantially identical dimensions.
- apertures 44, 45, 54, and 55 of removable sections 38 and 38' and apertures 46, 47, 56, and 57 of removable sections 39 and 39' are fully contained within the boundaries set by perforation lines 26 and 27. This ensures that when removable layer 13 is removed from transparent adhesive layer 12, an adhesive border completely surrounds perforated elements 60 and 61 and fabric elements 70 and 71. As shown in Figure 7a, perforated elements 60 and 61 will have adhesive borders provided by adhesive sections 38A and 38A', respectively, and fabric elements 70 and 71 will have adhesive borders provided by adhesive sections 39A and 39A', respectively.
- perforated elements 60 and 61 When assembling transparent non-adhesive substrate 11, perforated elements 60 and 61 must be precisely aligned with transparent adhesive layer 12 apertures 54 and 55, respectively, and fabric elements 70 and 71 must be precisely aligned with transparent adhesive layer 12 apertures 56 and 57, respectively.
- apertures are created after the bottom surface of removable layer 13 is secured to the top surface of transparent adhesive layer 12. This ensures that removable layer 13 apertures 44, 45, 46, and 47 are precisely aligned with transparent adhesive layer 12 apertures 54, 55, 56, and 57, respectively.
- assembly 10 is designed so that transparent non-adhesive substrate 11 and removable layer 13 have substantially identical exterior dimensions, and the dimensions and location of apertures 44, 45, 46, and 47 within removable layer 13 are substantially identical to the dimensions and location of elements 60, 61, 70, and 71 within transparent non-adhesive substrate 11, respectively.
- the top surface of transparent non-adhesive substrate 11 is positioned about the bottom surface of transparent adhesive layer 12 so edges of transparent non-adhesive substrate 11 are precisely aligned with edges of removable layer 13, respectively.
- Transparent non-adhesive substrate 11 is secured to the bottom surface of transparent adhesive layer 12, ensuring that transparent non-adhesive substrate 11 elements 60, 61, 70, and 71 are aligned with transparent adhesive layer 12 apertures 54, 55, 56, and 57, respectively. Also in a preferred embodiment, apertures 46, 47, 56, and 57 have smaller dimensions than apertures 44, 45, 54, and 55 to ensure that when applied to patient's arm 1, fabric elements 70 and 71 can be completely covered by perforated elements 60 and 61, respectively.
- FIGS 7b and 7c show cross-sectional views of assembly 10 taken generally along lines 7b-7b and 7c-7c shown in Figure la.
- transparent adhesive layer 12 has dimensions which are smaller than transparent non-adhesive substrate 11 to ensure that removable sections 38 and 38' do not have adhesive on flaps 38B and 38C, or flaps 38B' and 38C, respectively.
- removable sections 39 and 39' have no adhesive on flaps 39B and 39C, or 39B' and 39C, respectively. This lack of adhesive on flaps allows an attendant to easily grasp removable sections 38, 38', 39, and 39' to readjust during use on patient's arm 1 without removing their gloves.
- FIG. 8 is a perspective view of patient's arm 1 properly bandaged.
- Figure 9 is a cross-sectional view of patient's arm 1 properly bandaged taken along line 9-9 in Figure 8. After needle 2 is removed from patient's arm 1, the injection site must be covered to stop excessive bleeding.
- hemostasis element 80 is placed on top of perforated element 60 to reintroduce nutrients into the patient's blood stream. Hemostasis element 80 contains a substance that not only aids in the clotting of blood at the injection site, but also releases vital minerals and nutrients into the patient's blood stream. In a preferred embodiment, hemostasis element 80 is a potato-based mixture used to replenish a patient's calcium and potassium levels, which could be depleted during a procedure.
- hemostasis element 80 can be used within hemostasis element 80 and are considered to be within the scope of the invention as claimed.
- a substance which utilizes Icelandic shrimp shells can be used to promote blood clotting due to the presence of the natural mineral chitosan within the shells.
- Certain types of rare earth patches and minerals, including zeolite and kaolinite, when properly prepared can have similar hemostatic effects which can be utilized through this invention.
- a black pepper-based, or cayenne pepper-based, substance could be used to promote blood clotting.
- Assembly 10 is designed for two uses, and includes enough fabric elements, perforated elements, and adhesive sections to support securement of two injected needles and promote clotting and dressing of the injection site after the needles are removed.
- removable section 39 containing fabric element 70 and hemostasis element 80 can be combined by putting hemostat products within fabric element 70.
- fabric element 70 would be a gauze pad which contained a surgical hemostat such as VitagelTM.
- VitagelTM includes the biological component thrombin, an enzyme that assists in the clotting of blood when conventional means fail or are impractical. This would allow the hemostasis element 80 to be directly applied to a patient's skin where a needle was used and clot the blood faster than traditional means.
- assembly 10 is sterilized after assembly of each component to ensure infection does not spread to a patient.
- the methods for sterilizing assembly 10 include, but are not limited to, gamma ray, x-ray, and electron beam sterilization.
- Figure 10a and Figure 10b are a fragmentary exploded view and a cross-sectional view of a second embodiment of the assembly, respectively.
- transparent adhesive layer 12 does not contain apertures 50, 51, 52, and 53. Instead, transparent adhesive layer 12 completely covers transparent non-adhesive substrate 11 except for non-adhesive flaps 31B, 31C, 32D, 32E, 33F, 33G, 34F, 34G, 35D, 35E, 36B, and 36C.
- Adhesive blockers 90, 91, 92, and 93 are operatively arranged on transparent adhesive layer 12.
- adhesive blockers 90, 91, 92, and 93 creates adhesive sections 31A, 32A, 32B, 32C, 33A, 33B, 33C, 33D, 33E, 34A, 34B, 34C, 34D, 34E, 35A, 35B, 35C, and 36A and non-adhesive sections 90A, 91A, 92A, and 93A covered by adhesive blockers 90, 91, 92, and 93.
- the addition of adhesive blockers 90, 91, 92, and 93 does not alter the function of the second embodiment of assembly 10 when compared to the first embodiment of assembly 10. It should be appreciated that the second example embodiment of assembly 10, as shown in Figures 10a and 10b, is arranged to be connected to subassembly 10B.
- Figure 11a and Figure 1 lb are a fragmentary exploded view and a cross-sectional view of a third embodiment of the assembly, respectively.
- layer 112 comprises adhesive side 112A and non-adhesive side 112B.
- layer 112 is transparent single-sided adhesive tape.
- Layer 112 may comprise perforations or be precut along lines 120, 121, 122, 123, and 124.
- Layer 111 is a liner and comprises release side 111A (e.g., silicone release liner) and side 11 IB (e.g., paper). Layer 112 is arranged to be connected to liner 111.
- adhesive side 112A is connected to release side 111A.
- the length of layer 112 is less than the length of layer 111, thus creating tabs 111C and HID when layer 112 is connected to layer 111.
- layers 112 and 111 are the same length and layer 111 comprises no tabs.
- the length of layer 112 is greater than the length of layer 111. A user is then able to simply peel the adhesive strips of layer 112 from layer 111 and use them as needed.
- Assembly 110 may further comprise adhesive blockers 190, 191, 192, and 193, which are operatively arranged on transparent adhesive layer 112, specifically on adhesive side 112A.
- adhesive blockers 190, 191, 192, and 193 creates adhesive sections therebetween. Specifically, the placement of adhesive blockers 190, 191, 192, and 193 creates adhesive sections 131A-E, 132A-E, 133A-E, 34A-E, 135A-E, and 136A-E and non-adhesive sections 190A, 191A, 192A, and 193A covered by adhesive blockers 190, 191, 192, and 193. It should be appreciated that any number of blockers may be used to create any number of adhesive and non-adhesive sections on each adhesive strip. Additionally, blockers 190, 191, 192, and 193 are shown extending the entire width of layer 112.
- Blockers 190, 191, 192, and 193 need not extend the entire width of layer 112 and comprise any geometry suitable to create the desired adhesive and non-adhesive shape of each adhesive strip.
- Assembly 110 may further comprise adhesive strips 195A and 195B connected to layer 111, specifically paper side 11 IB.
- Adhesive strips 195A-B are arranged to allow the user the option to mount assembly 110 to a surface or object to enable two hand use when removing and applying the adhesive strips.
- Adhesive strips 195A-B are preferably double- sided adhesive tape that extends the entire width of layer 111.
- adhesive strips 195A-B further comprise a liner to protect the exposed adhesive side facing away from paper side 11 IB.
- adhesive strips 195A-B may comprise hook and loop fastener, adhesive, suction cups, etc.
- assembly 110 is arranged to be connected to subassembly 10B.
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Abstract
La présente invention concerne un ensemble dispositif de fixation, comprenant un substrat non adhésif comprenant une première surface supérieure et une première surface inférieure, une couche amovible comprenant une seconde surface supérieure et une seconde surface inférieure, ladite seconde surface supérieure comprenant un adhésif et ladite couche amovible fixée à ladite première surface supérieure le long de ladite seconde surface supérieure, et un ou plusieurs dispositifs de blocage adhésifs disposés sur la seconde surface supérieure, le substrat non adhésif, la couche amovible, et lesdits dispositifs de blocage adhésifs formant une unité intégrale.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US15/584,689 US10758671B2 (en) | 2016-02-29 | 2017-05-02 | Securement device assembly and securement and dressing device assembly and method of applying said device assemblies |
US15/584,689 | 2017-05-02 |
Publications (1)
Publication Number | Publication Date |
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WO2018204244A1 true WO2018204244A1 (fr) | 2018-11-08 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/US2018/030163 WO2018204244A1 (fr) | 2017-05-02 | 2018-04-30 | Ensemble dispositif de fixation et ensemble dispositif de fixation et de pansement et procédé d'application desdits ensembles |
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WO (1) | WO2018204244A1 (fr) |
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US20050043686A1 (en) * | 2002-05-14 | 2005-02-24 | Tollini Dennis R. | Winged catheter securing tape |
US20080039760A1 (en) * | 2006-08-14 | 2008-02-14 | Joseph John Lesko | Removable gauze bandage with perforated adhesive strips to adjust bandage |
US20100198161A1 (en) * | 2009-02-03 | 2010-08-05 | Centurion Medical Products Corporation | Window dressing having integral anchor |
US20130116645A1 (en) * | 2011-11-07 | 2013-05-09 | Tyco Healthcare Group Lp | Absorbent Foam Tape And Related Methods Thereof |
US20130310754A1 (en) * | 2012-05-18 | 2013-11-21 | John Henry Kutsch | Window Dressing Having Force Concentrating Adhesion Elements |
US20140005607A1 (en) * | 2012-06-29 | 2014-01-02 | Centurion Medical Products Corporation | Multi-layer medical dressings |
US20150224285A1 (en) * | 2012-09-07 | 2015-08-13 | C.R.Bard, Inc. | Medical Article Securement Systems |
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2018
- 2018-04-30 WO PCT/US2018/030163 patent/WO2018204244A1/fr active Application Filing
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US20050043686A1 (en) * | 2002-05-14 | 2005-02-24 | Tollini Dennis R. | Winged catheter securing tape |
US20080039760A1 (en) * | 2006-08-14 | 2008-02-14 | Joseph John Lesko | Removable gauze bandage with perforated adhesive strips to adjust bandage |
US20100198161A1 (en) * | 2009-02-03 | 2010-08-05 | Centurion Medical Products Corporation | Window dressing having integral anchor |
US20130116645A1 (en) * | 2011-11-07 | 2013-05-09 | Tyco Healthcare Group Lp | Absorbent Foam Tape And Related Methods Thereof |
US20130310754A1 (en) * | 2012-05-18 | 2013-11-21 | John Henry Kutsch | Window Dressing Having Force Concentrating Adhesion Elements |
US20140005607A1 (en) * | 2012-06-29 | 2014-01-02 | Centurion Medical Products Corporation | Multi-layer medical dressings |
US20150224285A1 (en) * | 2012-09-07 | 2015-08-13 | C.R.Bard, Inc. | Medical Article Securement Systems |
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