A mixing and spraying assembly for a tissue sealant includes a mixing assembly, a spray tip assembly, and a malleable section having a proximal end connected with the mixing assembly and a distal end connected with the spray tip assembly for enabling the spray tip assembly to be angulated relative to the mixing assembly. The malleable section includes a flexible shaft having a length, a malleable wire conduit that extends along the length of the flexible shaft, and a malleable wire disposed in the malleable wire conduit. The malleable wire is longer than the flexible shaft and has a proximal end that is connected to the mixing assembly and a distal end that is connected to the spray tip assembly. First and second fluids are mixed within the mixing assembly to form a tissue sealant that is delivered through the malleable section for being expressed from the spray tip assembly.
A61B 17/00 - Surgical instruments, devices or methods
2.
SYSTEMS, DEVICES AND METHODS FOR RECONSTITUTING THERAPEUTIC POWDERS, MIXING PRECURSOR SOLUTIONS, AND EXPRESSING SEALANTS FOR CONTROLLING BLEEDING AND SEALING FLUID AND AIR LEAKS
Disclosed herein are two-component flowable compositions comprised of: (i) a powder of: oxidized cellulose, fibrinogen and thrombin, with the weight ratio of the oxidized cellulose to the fibrinogen ranging from about 1: 5 to about 2: 1, respectively; and (ii) a dispersant comprised of glycerol and an aqueous solution, the composition being in the form of a pasty suspension at a room temperature. Also disclosed are uses of the compositions for treating a bleeding tissue, and methods for making the compositions.
The present invention is directed to multi-layered wound dressings having a carrier layer, at least two sublayers, wherein each sublayer contains at least one reactive, cross-linkable component and the at least two reactive, cross-linkable components are co-reactive with the other and at least one reactive, cross-linkable has a protective leaving group and a buffering salt agent.
A61L 15/20 - Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing organic materials
A61L 15/22 - Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
A61L 15/42 - Use of materials characterised by their function or physical properties
The present invention is directed to an absorbable hemostatic patch that utilizes a biocompatible fibrous, fabric substrate that is melt-blown and napped or loosened at the surface, with the substrate having a low-profile, high flexibility, strength and porosity that is suitable for coating cross-linkable active molecules and ultimately effective for use as a hemostat in situations of problematic bleeding.
An inflatable central distractor is inserted in to a disc space between two vertebral endplates. A perimeter balloon is inserted into the disc space in such a manner as to surround the central inflatable distractor. The perimeter balloon and the central inflatable distractor are simultaneously expanded such that as the central inflatable distractor expands the perimeter balloon surrounds the central inflatable distractor and such that the central inflatable distractor and the perimeter balloon, when expanded, contribute to forcing adjacent vertebral endplates apart.
The present invention is directed to an absorbable hemostatic nonwoven patch that utilizes a biocompatible substrate comprised of melt-blown microfibers as webbed sheets that are layered and bonded/entangled in descending density and ascending porosity; with the substrate having a high flexibility, strength and porosity that is suitable for coating cross-linkable active molecules and ability for laparoscopic use or trocar deployment, ultimately for functional use as a highly effective hemostat in addressing problematic bleeding during both open and minimally invasive surgical procedures.
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
9.
TRANSESOPHAGEAL CATHETER FOR THERMAL PROTECTION OF THE ESOPHAGUS
A system comprising: a fluid supply configured for the delivery of a fluid; a hollow body in fluid-communication with the fluid supply, the hollow body configured to be disposed between a first biological surface and a second biological surface; and a mechanism configured to control delivery of fluid from the fluid supply and through the hollow body to create separation between the first biological surface and the second biological surface.
A61B 18/00 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
10.
FLUID DELIVERY SYSTEM FOR CREATING SEPARATION BETWEEN BIOLOGICAL SURFACES
A system comprising: a fluid supply configured for the delivery of a fluid; a hollow body in fluid-communication with the fluid supply, the hollow body configured to be disposed between a first biological surface and a second biological surface; and a mechanism configured to control delivery of fluid from the fluid supply and through the hollow body to create separation between the first biological surface and the second biological surface.
A61B 18/00 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
A61B 90/00 - Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups , e.g. for luxation treatment or for protecting wound edges
11.
SPRAY DEVICES HAVING SIDE-BY-SIDE SPRAY TIPS FOR DISPENSING TWO FLUIDS THAT CHEMICALLY REACT TOGETHER
A spray device includes a first spray tip having a first fluid pathway defining a first flow area, and a second spray tip includes a second fluid pathway that defines a second flow area that is larger than the first flow area of the first spray tip. The first and second spray tips are side-by-side and spaced from one another at a distal end of the spray device. When a first fluid having a volumetric flow rate is introduced into the first spray tip and a second fluid having the same volumetric flow rate is introduced into the second spray tip, the first fluid will flow through the first fluid pathway at a greater velocity than the second fluid will flow through the second fluid pathway.
A61B 17/00 - Surgical instruments, devices or methods
B05B 1/34 - Nozzles, spray heads or other outlets, with or without auxiliary devices such as valves, heating means designed to influence the nature of flow of the liquid or other fluent material, e.g. to produce swirl
B05B 7/10 - Spray pistolsApparatus for discharge producing a swirling discharge
12.
DISPENSING SYSTEMS AND DEVICES HAVING ANTI-CLOGGING SPRAY TIPS FOR DISPENSING TWO OR MORE FLUIDS THAT REACT TOGETHER
A spray tip for dispensing fluids that react together includes a first lumen for a first fluid, a second lumen for a second fluid, and a dispensing cap located at distal ends of the respective first and second lumens and defining a distal end of the spray tip. The dispensing cap includes a distal end wall defining a closed end of the dispensing cap, a first spray opening formed in the distal end wall that is in fluid communication with the first lumen, a second spray opening formed in the distal end wall that is in fluid communication with the second lumen, and an external dividing wall that projects distally from the distal end wall of the dispensing cap and that extends between the first and second spray opening for forming a barrier between the first and second spray openings.
An expandable biodegradable hemostatic matrix comprised of oxidized cellulose, and having a density ranging from about 0.8 to about 1.2 gr/cm3 is disclosed herein. The matrix may be expandable to at least 3 times its original volume within 4 sec upon contact with an aqueous solution room temperature. Further disclosed are methods for making the hemostatic matrix as well as method of treating a wound.
The invention relates to a biocompatible, flexible, haemostatic sheet comprising: a cohesive fibrous carrier structure comprising a three-dimensional interconnected interstitial space; and distributed within the interstitial space, a plurality of reactive polymer particles comprising (i) a water-soluble electrophilic polymer carrying at least 3 reactive electrophilic groups that are capable of reacting with amine groups in tissue and blood under the formation of a covalent bond and (ii) a nucleophilic cross-linking agent that contains at least two reactive nucleophilic groups that are capable of reacting with the reactive electrophilic groups of the electrophilic polymer under the formation of a covalent bond, said reactive polymer particles having a diameter in the range of 0.5-100 pm and being present in an amount of at least 3% by weight of the fibrous carrier structure. When blood is absorbed by the haemostatic sheet of the present invention, the water-soluble electrophilic polymer in the reactive polymer particles starts dissolving as soon as these particles are 'wetted' by the blood, thereby allowing the electrophilic polymer to react with reactive nucleophilic groups in the blood and tissue, as well as with reactive nucleophilic groups of the nucleophilic cross-linking agent, thereby inducing blood coagulation and tissue sealing, both of which contribute to haemostasis.
A61L 15/22 - Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
A61L 15/42 - Use of materials characterised by their function or physical properties
A61L 15/64 - Use of materials characterised by their function or physical properties specially adapted to be resorbable inside the body
15.
METHOD FOR RECONSTITUTING A DRY THROMBIN USING FIRST AND SECOND SYRINGES AND USE FOR PREPARING A HAEMOSTATIC COMPOSITION
The present disclosure relates to a method for preparing a haemostatic composition comprising thrombin, the method comprising the step of reconstituting a dry thrombin directly in a paste, such as a paste comprising a biocompatible polymer. The haemostatic composition comprising thrombin may be prepared from a dry thrombin composition and a paste in a single step operation and be used for treatment of a wound.
An adapter manifold and syringe applicator, wherein the adapter body has substantially parallel inlet ports and substantially parallel exit ports, the inlet ports spaced an axial distance apart which is different from an axial distance between the exit ports, to accommodate the syringe applicator which has multiple substantially parallel syringes, and substantially parallel syringe connectors in fluid communication with the inlet ports having Luer-type receivers on proximal ends thereof, wherein the syringe connectors are biased toward a proximal end of the adapter body.
A dispensing device and cartridge for simultaneous delivery and mixing of multiple co-reactive materials, the cartridge having proximal and distal ends, and having an elongated holder body with substantially parallel longitudinal voids. Multiple syringe bodies are disposed parallel within the voids and multiple co-reactive materials are separately disposed in the syringe bodies. The dispensing device also includes a longitudinal housing which is structured and arranged to receive the cartridge.
A package for a medical device includes a folder having bottom and top panels, the bottom panel including a leading edge, a trailing edge, and at least one medical device securing element. The top panel has a leading edge, and a trailing edge joined with the trailing edge of the bottom panel. The folder has an unfolded configuration in which the leading edges of the top and bottom panels face in opposite directions, and a folded configuration in which the top panel is folded over the bottom panel so that the leading edges of the top and bottom panels face in the same direction and are aligned with one another. The folder is insertable into a sealable pouch having a seal with a first leg whereby the leading edges of the folder are abutted against the first leg of the seal of the pouch.
A61B 50/30 - Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
The present invention is directed to a hemostatic material comprising a compacted, hemostatic aggregates of cellulosic fibers. In some aspects, the hemostatic material further includes additives, such as carboxymethyl cellulose (CMC) or other polysaccharides, calcium salts, anti-infective agents, hemostasis promoting agents, gelatin, collagen, or combinations thereof. In another aspect, the present invention is directed to a method of making the hemostatic materials described above by compacting a cellulosic-based material into hemostatic aggregates. In another aspect, the present invention is directed to a method of treating a wound by applying hemostatic materials described above onto and/or into the wound of a patient.
The present invention is directed to a device for the expression of a hemostatic powder having an elongated reservoir with a manual air pump, such as a bellows, at a proximal end and an expression port at a distal end. A porous filter is slidably disposed within the reservoir between the bellows and plunger and the expression port, and a spring is disposed within the reservoir between the air pump and the plunger. The powder is disposed within the reservoir between the porous filter and the expression port, and the pump is in a fluid communication with the expression port through the porous filter and through the powder.
An apparatus and method for delivery of fluids, particularly biological, reactive fluids. The apparatus provides an opening when force is acted on the apparatus, and closure when no force is acted thereon. The apparatus provides a cleaning mechanism to remove fluids and other materials from a mixing space after use.
A61B 17/00 - Surgical instruments, devices or methods
B01F 23/45 - Mixing liquids with liquidsEmulsifying using flow mixing
B01F 25/452 - Mixers in which the materials to be mixed are pressed together through orifices or interstitial spaces, e.g. between beads characterised by elements provided with orifices or interstitial spaces
B01F 35/45 - Closures or doors specially adapted for mixing receptaclesOperating mechanisms therefor
A wound closure device (330) includes a flexible filament (332) having a first end (334), a second end (336), and a longitudinal axis extending between the first and second ends. A plurality of barbs (338) project outwardly from the flexible filament. Each barb has a base connected with the flexible filament, a blunt tip (344) spaced from the base, a leading edge (340) extending between the base and the blunt tip and facing toward the first end of the flexible filament, and a trailing edge (342) extending between the base and the tip and facing toward the second end of the flexible filament. The trailing edge of the barb and the longitudinal axis of the flexible filament define an angle of at least 68° that opens toward the second end of the flexible filament.
A61B 17/04 - Surgical instruments, devices or methods for closing wounds or holding wounds closedAccessories for use therewith for suturing woundsHolders or packages for needles or suture materials
A61B 17/06 - NeedlesHolders or packages for needles or suture materials
The invention described herein is a device (10) for dripping a tissue sealant and/or adhesive that comprises a) first and second barrels or syringes (12) that contain first and second biocomponents that are disposed between proximal and distal ends; b) a plunger (24) in each barrel and c) a drip tip comprising i) a support (68) having distal and proximal ends and at least two fluid passageways from the distal to the proximal end that are in fluid communication with one of the barrels of the dispensing device on the proximal end; and ii) an endcap (82) that fits over the support having at least two flexible flaps(83, 85). The present invention is also directed to an assembly for mixing and drip dispensing two reactive biologic components as tissue sealant and/or hemostatic agent and to methods for delivering biologic components to achieve hemostasis and/or tissue sealant by drip dispensing from the device described above.
A61B 17/00 - Surgical instruments, devices or methods
B05C 17/015 - Hand tools or apparatus using hand-held tools, for applying liquids or other fluent materials to, for spreading applied liquids or other fluent materials on, or for partially removing applied liquids or other fluent materials from, surfaces for discharging material through an outlet orifice by pressure with pneumatically actuated piston or the like
B05C 21/00 - Accessories or implements for use in connection with applying liquids or other fluent materials to surfaces, not provided for in groups
24.
OXIDIZED REGENERATED CELLULOSE HEMOSTATIC POWDERS AND METHODS OF MAKING
The present invention is directed to hemostatic material containing compacted ORC powder comprising particles having an average aspect ratio from about 1 to about 18, wherein said compacted ORC powder have preferably been processed in a compaction device, such as a ball milled ORC powder. The present invention further relates to methods of making the hemostatic material and a method of treating a wound by applying the hemostatic powder onto and/or into the wound of a patient.
ABSTRACT The present invention is directed to hemostatic material containing compacted ORC powder comprising particles having an average aspect ratio from about 1 to about 18, wherein said compacted ORC powder have preferably been processed in a compaction device, such as a roller compaction processed ORC powder, or hammer mill processed ORC powder. The present invention further relates to methods of making the hemostatic material and a method of treating a wound by applying the hemostatic powder onto and/or into the wound of a patient. CAN_DMS: X135501754X1 Date Recue/Date Received 2020-09-24
The present invention is directed to a synthetic fabric comprising a multi-layered nonwoven fabric made from staples of a polyglycolide/polylactide copolymer, each layer having a different density. The multi-layer fabric can be used as a reinforced absorbable hemostat medical device.
The present invention is directed to a reinforced absorbable hemostat comprising at least one hemostatic agent in a single layer of nonwoven synthetic fabric having a mixture of compressed fiber staples of a polyglycolide/polylactide copolymer and a polydioxanone.
A surgical suture (100) includes an elongated core (106) having a first leg (102) and a second leg (104), a first set of barbs (108) projecting from the first leg of the core, and a second set of barbs (110) projecting from the second leg of the core. The suture has a stop (114) projecting from the core that is located between the first and second sets of barbs, and a braid (450) surrounding the elongated core and the stop for strengthening the suture. The suture includes a pledget (440) having first (438A) and second (438B) openings extending therethrough, with the first leg extending through the first pledget opening, the second leg extending through the second pledget opening, and the stop extending between the first and second pledget openings.
A method of making a packaged antimicrobial suture having improved shelf life. The method comprising the steps of providing an inner package having a source of antimicrobial agent, providing an adsorbent material effective to adsorb a portion of the antimicrobial agent over time, positioning a suture within the inner package, the suture comprising one or more surfaces, covering the inner package with an outer package having an inner surface and subjecting the suture, the inner package and the inner surface of the outer package to time, temperature and pressure conditions sufficient to vapor transfer an effective amount of the antimicrobial agent from the antimicrobial agent source to the suture and the inner package, thereby substantially inhibiting bacterial colonization on the suture and the inner package, wherein the packaged antimicrobial suture exhibits improved shelf life. A packaged antimicrobial suture and a method of increasing the shelf life of a packaged antimicrobial medical device are also provided.
A method of making a packaged antimicrobial suture. The method in-cludes the steps of providing a containment compartment molded from a polymeric resin comprising a polymeric material and an antimicrobial agent, positioning a su-ture within the containment compartment, the suture comprising one or more sur-faces; covering the containment compartment having the suture in an outer package cover having an inner surface, and subjecting the outer package, the containment compartment and the suture to time, temperature and pressure conditions sufficient to vapor transfer an effective amount of the antimicrobial agent from the containment compartment to the suture, while retaining an effective amount of the antimicrobial agent on the containment compartment, thereby substantially inhibiting bacterial col-onization on the suture and the containment compartment. A packaged antimicrobial suture is also provided.
A method formaking a curved tungsten alloysuture needle comprising the stepof heating tungsten alloy needleblanks or a tungsten alloy sutureneedle to a temperature belowthe recrystallization temperatureof the alloy. The tungsten alloysuture needles described hereinhave a desirable combination ofstiffness, strength, ductility, andsurface color.
The present invention is directed to a multilayered fabric comprising a first absorbable nonwoven fabric and a second absorbable woven or knitted fabric, and its method of manufacture.
A61L 31/06 - Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
A61L 31/14 - Materials characterised by their function or physical properties
A61L 31/16 - Biologically active materials, e.g. therapeutic substances
B32B 5/08 - Layered products characterised by the non-homogeneity or physical structure of a layer characterised by structural features of a layer comprising fibres or filaments the fibres or filaments of a layer being specially arranged or being of different substances
B32B 27/08 - Layered products essentially comprising synthetic resin as the main or only constituent of a layer next to another layer of a specific substance of synthetic resin of a different kind
B32B 33/00 - Layered products characterised by particular properties or particular surface features, e.g. particular surface coatingsLayered products designed for particular purposes not covered by another single class
D04H 1/44 - Non-woven fabrics formed wholly or mainly of staple fibres or like relatively short fibres from fleeces or layers composed of fibres without existing or potential cohesive properties the fleeces or layers being consolidated by mechanical means, e.g. by rolling
A dispensing device configured to operate with an adhesive backed mesh and backing film for tissue bonding is disclosed. The dispensing device provides for low-friction, low force pay-out of a desired length of an adhesive backed mesh to a wound site. The device prevents or eliminates distortion of the mesh prior to application to the wound site, and includes means for reducing or eliminating binding during use. The dispensing device is configured to operate in a "forward" mode (substrate to which mesh is applied passes beneath applicator after mesh is applied) to provide essentially an unobstructed view of the wound site during use.
A cassette for a sterilizer has one or more cells containing a sterilant. Packaging for the cassette includes and outer fluid impermeable envelope and an absorbent web wrapped around the cassette to absorb and contain any sterilant which may leak out of the cassette. The absorbent web includes a superabsorbent polymer.
The present inventions includes a plurality of packed particles that contain interstitial pores, where the interstitial pores have a pore volume and a median pore diameter effective to provide improved absorption of physiological fluids or an aqueous media when placed in contact therewith, compared to a plurality of unpacked particles of the same material, where the particles are made of a biocompatible material and hemostatic agents and have an average diameter suitable for use in providing hemostasis to a site of a body of a mammal requiring hemostasis, hemostatic compositions containing such plurality of packed particles, methods of making such particles and compositions and medical devices suitable for delivering and containing the hemostatic plurality of particles and/or composition to a site of a body.
A cassette handling system for sterilant filled cassettes employs RFID or other electromagnetic signal technology to track the cassettes. A method for tracking the sterilant cassettes includes the steps of reading for the presence of a cassette within a cassette processing area of the sterilizer by transmitting a non-optical electromagnetic signal between the cassette and a receiver on the sterilizer, via the electromagnetic signal transmitting identifying information between the cassette and the receiver, and verifying that a proper cassette is loaded into the sterilizer based upon the identifying information.
A tissue bonding article includes a flexible material, an adhesive substance applied over at least a portion of a bottom side of the flexible material, and a polymerizable adhesive composition permeated throughout at least a portion of the flexible material.
A61B 17/04 - Surgical instruments, devices or methods for closing wounds or holding wounds closedAccessories for use therewith for suturing woundsHolders or packages for needles or suture materials
The present invention includes both sterilized and unsterilized hemostatic compositions that contain a biocompatible liquid having particles of a biocompatible polymer suitable for use in hemostasis and which is substantially insoluble in the liquid, up to about 20 percent by weight of glycerol and about 1 percent by weight of benzalkonium chloride, each based on the weight of the liquid, all of which are substantially homogenously dispersed throughout the liquid to form a substantially homogenous composition, methods for making such compositions, medical devices that contain such hemostatic compositions disposed therein and methods of making such devices.
The present invention is an apparatus for equipping a surgical stapling device with a surgical buttress in order to provide reinforced surgical fastener suture lines and includes means for aligning the apparatus with the surgical staple device, an elastomeric foam surgical buttress contained within the alignment means and means for retaining the foam buttress within the alignment means, which alignment means is formed as a unitary body containing a frame, guide channel walls and means for receiving the elastomeric foam surgical buttress.
The present invention includes sterilized hemostatic compositions that contain a continuous, biocompatible liquid phase having a solid phase of particles of a biocompatible polymer suitable for use in hemostasis and that is substantially insoluble in the liquid phase, and sterile thrombin, each of which is substantially homogenously dispersed throughout the continuous liquid phase, and methods for making such compositions.
The present invention is directed to processes of making flowable hemostatic compositions and devices that include the flowable hemostatic composition disposed therein, where a volume of biocompatible liquid, a volume of a biocompatible gas, and an amount of solid particles of a biocompatible polymer are mixed together to form a substantially homogenous composition including a discontinuous gas phase and the solid particles substantially homogenously dispersed throughout a continuous liquid phase to form a flowable hemostatic composition, and the composition then transferred into a device suitable for applying the flowable hemostatic composition to a site of a body requiring hemostasis under conditions effective to maintain the substantially homogenous dispersion of the gas phase and the solid particles throughout the liquid phase.
A61K 31/715 - Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkagesDerivatives thereof, e.g. ethers, esters
patents
