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AssigneeAccess Vascular, Inc.
InventorsDaniel T. Donahue, Nikolaos Pipis, Mark Thomas Doherty
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Articles and/or integrated articles comprising a body portion (e.g., a catheter) and a component (e.g., a cuff) physically integrated with the body portion arc generally provided. For example, materials, methods, and uses are set forth herein for forming a body portion comprising a first material physically integrated with a component comprising a second material, same or different, than the first material. The disclosed compositions and devices may be useful for administration to a subject (e.g., a patient). Advantageously, the compositions and/or devices described herein may be substantially non-thrombogenic, lubricious, and/or biocompatible. In some embodiments, the devices described herein may be useful for the delivery of a biologically active agent (e.g., a therapeutic agent such as a drug) to a subject. Methods for forming such compositions and/or devices are also provided.
An article, comprising:
An article, comprising:
An article, comprising:
A method of forming an integrated article, comprising:
A method of forming an integrated article, comprising:
A method of forming an integrated article, comprising:
An article, comprising:
The article or method of any preceding claim, wherein the solvent comprises the water-soluble polymer at a concentration less than the concentration of the water-soluble polymer used to form the first material.
The article or method of any preceding claim, wherein the solvent comprises water and polyvinyl alcohol, the polyvinyl alcohol present in the solvent in an amount of greater than or equal to 0.1 wt % and less than or equal to 25 wt %.
The article or method of any preceding claim, wherein the solvent has hydrolysis levels of greater than or equal to 80%, such that the solvent comprises less than or equal to 20% acetate groups.
The article or method of any preceding claim, wherein the solvent comprises water.
The article or method of any preceding claim, wherein the solvent comprises water and the water-soluble polymer.
The article as in any preceding claim, wherein the article comprises a lumen.
The article as in any preceding claim, wherein the article comprises a hemodialysis catheter, a peripherally inserted central catheter (PICC), a central venous catheter, a midline catheter, a peripheral catheter, a urinary catheter, a neurological catheter, a peritoneal catheter, and/or an infusion port.
The article as in any preceding claim, wherein the article is configured for use with a medical article such as a catheter, a balloon, a shunt, a wound drain, an infusion port, a drug delivery article, a tube, a contraceptive article, a feminine hygiene article, an endoscope, a grafts, a pacemaker, an implantable cardioverter-defibrillator, a cardiac resynchronization article, a cardiovascular article lead, a ventricular assist article, an endotracheal tube, a tracheostomy tube, an implantable sensor, a ventilator pump, and an ophthalmic article
The article or method as in any preceding claim, wherein the polymeric material is free of covalent crosslinking agents.
The article or method as in any preceding claim, wherein the polymeric material has a Young's modulus of 5-100 MPa at equilibrium water content (EWC).
The article or method as in any preceding claim, wherein the article comprises a plurality of interconnected pores.
The article or method as in any preceding claim, wherein the component comprises a plurality of fibers.
The article or method as in any preceding claim, wherein the component is a catheter cuff.
The article or method as in any preceding claim, wherein the body portion comprises a second material, comprising the first water-soluble polymer at a concentration less than the concentration of first water-soluble polymer in the first material.
The article or method as in any preceding claim, wherein the water-soluble polymer may entrain non-soluble compounds selected from the group consisting of therapeutics, biologically active compounds, woven textiles, metallic mesh, color indicators, radiopacifiers, and reactive indicators.
The article or method as in any preceding claim, wherein the water-soluble polymer is incorporated with conductive indicators to aid in detection of an electrocardiogram p-wave.
The article or method as in any preceding claim, wherein the water-soluble polymer is entrained with a woven textile selected from the group consisting of Dacron® (Poly ethylene terephthalate aka polyester), electrospun PVA, cotton, wool, Polypropylene (atactic, syndiotactic, isotactic), and polyethylene (LLDPE, LDPE, HDPE).
The article or method as in any preceding claims, wherein the intended use of said article or method is selected from the group consisting of binding bandages, tissue growth, stents, shunts, braided tubing, and wall stents, to another PVA substrate.
The article or method as in any preceding claim, wherein the first water-soluble polymer and second water-soluble polymer are bonded together to create a new geometry or to reinforce the one or more components physically integrated with the body portion.
The article or method as in any preceding claim, wherein heating causes the first water-soluble polymer to flow into the second water-soluble polymer.
The article or method as in any preceding claims, wherein heating causes second water-soluble polymer to flow into the first water-soluble polymer.
The article or method as in any preceding claim, wherein bonding further involves cooling the first and second water-soluble polymers.
The article or method as in any preceding claims, wherein cooling the polymers forms the integrated article.
The article or method as in any preceding claim, wherein the water-soluble polymer is hydrated is a solution until an equilibrium % hydration is obtained.
The article or method as in any preceding claim, wherein the equilibrium % hydration is between about 0.1% and 100%.
The article or method as in any preceding claim, wherein solution comprises phosphate buffered saline at a concentration between about 0.1 M and 10 M.
The article or method as in any preceding claim, wherein bonding is accomplished using a split die bonder, RF welder, or hot air station of a specific geometry.
The article or method as in any preceding claim, wherein the bonding temperature is between 60 C to 95 C.
The article or method as in any preceding claim, wherein bonding time is between 15 seconds and 5 minutes.
The article or method as in any preceding claim, wherein bonding is accomplished using FEP heat shrink formed to the appropriate size and shape for hot air processing.
The article or method as in any preceding claim, wherein bonding further comprises compressing the bond to increase chain entanglement of the materials to be bonded.
A method for reshaping a hydrophilic porous material, comprising:
An article, comprising:
A dual lumen article, comprising:
A method of forming a dual lumen article, comprising:
The article or method as in any preceding claim, further comprising one or more surface features (e.g., barbs, bulges) at an interface between the first body portion and the second body portion, the one or more surface features configured to mechanically reinforce the interface between the first body portion and the second body portion.
The article or method as in any preceding claim, further comprising one or more surface features (e.g., barbs, bulges) at an interface between the first body portion and the second body portion, the one or more surface features configured to mechanically reinforce the interface between the first body portion and the second body portion.
The article or method as in any preceding claim, wherein the article is shaped using thermal forming.
The article or method as in any preceding claim, wherein thermal forming occurs at a temperature greater than 90 C.
The article or method as in any preceding claim, wherein thermal forming comprising placing a wire into the lumen of the article, placing the article into a mold, and thermally heating the mold into a designed shape.
The article or method as in any preceding claim, wherein the article shape is curved, straightened, compressed, or stretched by restricting the dimensions of the initial component to the desired shape.
The article or method as in any preceding claim, wherein the article edges can be rounded to allow ease of fluid flow, reduction of abrasion, and reduction of surface area, which can aid placement, catheter longevity, and patient comfort.
The article or method of any preceding claim, wherein the solvent comprises water.
The article or method of any preceding claim, wherein the solvent comprises water and the water-soluble polymer.
The article or method of any preceding claim, wherein the solvent comprises the water-soluble polymer at a concentration less than the concentration of the water-soluble polymer used to form the first material.
The article or method of any preceding claim, wherein the solvent comprises water and polyvinyl alcohol, the polyvinyl alcohol present in the solvent in an amount of greater than or equal to 0.1 wt % and less than or equal to 25 wt %.
The article or method of any preceding claim, wherein the solvent has hydrolysis levels of greater than or equal to 80%, such that the solvent comprises less than or equal to 20% acetate groups.
The article as in any preceding claim, wherein the article comprises a lumen.
The article as in any preceding claim, wherein the article comprises a hemodialysis catheter, a peripherally inserted central catheter (PICC), a central venous catheter, a midline catheter, a peripheral catheter, a urinary catheter, a neurological catheter, a peritoneal catheter, and/or an infusion port.
The article as in any preceding claim, wherein the article is configured for use with a medical article such as a catheter, a balloon, a shunt, a wound drain, an infusion port, a drug delivery article, a tube, a contraceptive article, a feminine hygiene article, an endoscope, a grafts, a pacemaker, an implantable cardioverter-defibrillator, a cardiac resynchronization article, a cardiovascular article lead, a ventricular assist article, an endotracheal tube, a tracheostomy tube, an implantable sensor, a ventilator pump, and an ophthalmic article
The article or method as in any preceding claim, wherein the polymeric material is free of covalent crosslinking agents.
The article or method as in any preceding claim, wherein the polymeric material has a Young's modulus of 5-100 MPa at equilibrium water content (EWC).
The article or method as in any preceding claim, wherein the article comprises a plurality of interconnected pores.
The article or method as in any preceding claim, wherein the component comprises a plurality of fibers.
The article or method as in any preceding claim, wherein the component is a catheter cuff.
The article or method as in any preceding claim, wherein the body portion comprises a second material, comprising the first water-soluble polymer at a concentration less than the concentration of first water-soluble polymer in the first material.
The article or method as in any preceding claim, wherein the water-soluble polymer may entrain non-soluble compounds selected from the group consisting of therapeutics, biologically active compounds, woven textiles, metallic mesh, color indicators, radiopacifiers, and reactive indicators.
The article or method as in any preceding claim, wherein the water-soluble polymer is incorporated with conductive indicators to aid in detection of an electrocardiogram p-wave.
The article or method as in any preceding claim, wherein the water-soluble polymer is entrained with a woven textile selected from the group consisting of Dacron® (Poly ethylene terephthalate aka polyester), electrospun PVA, cotton, wool, Polypropylene (atactic, syndiotactic, isotactic), and polyethylene (LLDPE, LDPE, HDPE).
The article or method as in any preceding claims, wherein the intended use of said article or method is selected from the group consisting of binding bandages, tissue growth, stents, shunts, braided tubing, and wall stents, to another PVA substrate.
The article or method as in any preceding claim, wherein the first water-soluble polymer and second water-soluble polymer are bonded together to create a new geometry or to reinforce the one or more components physically integrated with the body portion.
The article or method as in any preceding claim, wherein heating causes the first water-soluble polymer to flow into the second water-soluble polymer.
The article or method as in any preceding claims, wherein heating causes second water-soluble polymer to flow into the first water-soluble polymer.
The article or method as in any preceding claim, wherein bonding further involves cooling the first and second water-soluble polymers.
The article or method as in any preceding claims, wherein cooling the polymers forms the integrated article.
The article or method as in any preceding claim, wherein the water-soluble polymer is hydrated is a solution until an equilibrium % hydration is obtained.
The article or method as in any preceding claim, wherein the equilibrium % hydration is between about 0.1% and 100%.
The article or method as in any preceding claim, wherein solution comprises phosphate buffered saline at a concentration between about 0.1 M and 10 M.
The article or method as in any preceding claim, wherein bonding is accomplished using a split die bonder, RF welder, or hot air station of a specific geometry.
The article or method as in any preceding claim, wherein the bonding temperature is between 60 C to 95 C.
The article or method as in any preceding claim, wherein bonding time is between 15 seconds and 5 minutes.
The article or method as in any preceding claim, wherein bonding is accomplished using FEP heat shrink formed to the appropriate size and shape for hot air processing.
The article or method as in any preceding claim, wherein bonding further comprises compressing the bond to increase chain entanglement of the materials to be bonded.
An intravenous catheter, comprising:
A system comprising the intravenous catheter as in any preceding claim, and a component configured for administering a therapeutic agent and/or fluid to a subject, and/or drawing a bodily fluid from the subject.
A method, comprising:
A method, comprising:
The catheter or method as in any preceding claim, wherein the polymeric material is free of covalent crosslinking agents.
The catheter or method as in any preceding claim, wherein the article comprises a plurality of interconnected pores,
The catheter or method as in any preceding claim, wherein the polymeric material has a Young's elastic modulus of greater than or equal to 500 MPa in a dehydrated state and a Young's elastic modulus of less than or equal to 300 MPa and greater than or equal to 5 MPa at an equilibrium water content state.
The catheter or method as in any preceding claim, wherein the intravenous catheter is configured for insertion into a subject in the dehydrated state.
The catheter or method as in any preceding claim, wherein the intravenous catheter is configured for insertion into a subject in an at least partially hydrated state.
The catheter or method as in any preceding claim, further comprising administering a fluid to the subject via the intravenous catheter.
The catheter or method as in any preceding claim, further comprising drawing blood from the subject via the intravenous catheter.
The catheter or method as in any preceding claim, wherein the intravenous catheter exhibits hemolysis in an amount of less than or equal to 10%.
The catheter or method as in any preceding claim, wherein the intravenous catheter comprises a softening ratio for a 3-point ratio of at least 99% reduction in force in insertion versus final hydrated state.
The catheter or method as in any preceding claim, wherein the distal end of the catheter is tipped.
The catheter or method as in any preceding claim, wherein the catheter proximal end of the catheter is hubbed.
Dependencies are inferred from the claim text.