Patent Description:
The present invention generally relates to medical devices, systems and said medical devices and systems for use in methods for performing surgical procedures, and more particularly to reusable, biocompatible, cellulose-free medical hydrophilic or hydrophobic devices, systems, and said medical devices and systems for use in methods for cleaning the absorption of blood and body fluids, temporary packings, hydration of tissues, tissue protection, organ transportation, dressings and the like in an operative site used during medical and surgical procedures.

Accordingly, the invention is directed to a medical device, and method of making the same that substantially obviates one or more of the problems due to limitations and disadvantages of the related art.

The scope of this invention is defined by the claims. Embodiments in the description relating to methods of treatment are not covered by the claims. Any "embodiment" or "example" which is disclosed in the description but is not covered by the claims should be considered as presented for illustrative purpose only.

An advantage of the invention is to provide a system that allows for a reduction of medical waste, e.g., reducing the number of medical sponges or medical gauze used in a procedure.

Yet another advantage of the invention is to provide a reusable sponge or wipe in the same procedure.

Another advantage of the invention is to provide a medical device that is cellulose- and lint-free with ultra-low particle count.

Additional features and advantages of the invention will be set forth in the description which follows, and in part will be apparent from the description, or may be learned by practice of the invention. The objectives and other advantages of the invention will be realized and attained by the structure particularly pointed out in the written description and claims hereof as well as the appended drawings.

The present invention is directed towards a reusable multi-use surgical medical device for use during a medical procedure as defined in independent claim <NUM>. The medical device comprises a laundered hydrophilic polyurethane foam material comprising a reticulated foam that is a cellulose free, latex free, a bisphenol A (BPA) free and a di(<NUM>-ethylhexyl)phthalate (DEHP) free and having an ultra-low number of particles before use, wherein the laundered hydrophilic polyurethane foam material comprises a reticulated foam material that was laundered in aqueous solution of low particulate water (LPW) to reduce manufacturing particulates, wherein the laundered hydrophilic polyurethane foam material is configured to absorb bodily fluids and configured to be reused repetitively during the procedure; a plurality of scratch resistant radiopaque (RO) ink markers printed onto a surface of the laundered hydrophilic foam material, wherein the scratch resistant radio opaque (RO) printed ink markers are configured to be visible under an imaging device at various orientations, wherein the laundered hydrophilic polyurethane foam material has bacterial endotoxin level below at least <NUM> EU/medical device, and wherein the laundered hydrophilic polyurethane foam material does not contain a surfactant or any other coatings.

This Summary section is neither intended to be, nor should be, construed as being representative of the full extent and scope of the present disclosure. Additional benefits, features and embodiments of the present disclosure are set forth in the attached figures and in the description hereinbelow, and as described by the claims. Accordingly, it should be understood that this Summary section may not contain all of the aspects and embodiments claimed herein.

Additionally, the disclosure herein is not meant to be limiting or restrictive in any manner. Moreover, the present disclosure is intended to provide an understanding to those of ordinary skill in the art of one or more representative embodiments supporting the claims.

Persons skilled in the art will readily appreciate that various aspects of the present disclosure can be realized by any number of methods and articles configured to perform the intended functions. Stated differently, other methods and articles can be incorporated herein to perform the intended functions. It should also be noted that the accompanying figures referred to herein are not all drawn to scale, but may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the figures should not be construed as limiting. Finally, although the present disclosure may be described in connection with various principles and beliefs, the present disclosure should not be bound by theory. The following detailed description describes a medical device, method of using and making, and is presented to enable any person skilled in the art to make and use the disclosed subject matter in the context of one or more particular implementations. Various modifications, alterations, and permutations of the disclosed implementations can be made and will be readily apparent to those skilled in the art, and the general principles defined may be applied to other implementations and applications, without departing from scope of the disclosure. The present disclosure is not intended to be limited to the described or illustrated implementations, but to be accorded the widest scope consistent with the described principles and features.

In order to more fully appreciate the present disclosure and to provide additional related features, the following documents are referred to:.

An embodiment of the invention is a medical device configured as a hydrophilic sponge with an open-cells with imaging features configured to be visible under x-ray, ultrasound wands or other imaging devices. The medical device is durable, moldable, lint free, cellulose free, ultra-low particles, washable and reusable within the same surgical case, non-toxic based on cytotoxicity reports, and has bacterial endotoxin levels below <NUM> EU/device. The standard for finished medical devices is a bacterial endotoxin limit not of more than <NUM> EU/device. In addition, the bacterial endotoxin limit for medical devices in contact with cerebrospinal fluid is not more than <NUM> EU/device and the endotoxin limit for medical devices in contact with intraocular ophthalmic devices is not more than <NUM> EU/device. In one embodiment, the medical bacterial endotoxin limit is below <NUM> EU/device, in a preferred embodiment the limit is below <NUM> EU/device and in a more preferred embodiment the limit is below <NUM> EU/device.

The medical device can be used to clean other medical devices, instruments or used in the manufacturing of other medical devices to avoid particulate contamination.

In one implementation, the device is configured in a pre-hydrated package such that the foam material is saturated or partially saturated with a fluid, e.g., sterile saline, pharmacological agent, and the like. The pharmacological agent can include one or more of antibiotic, saline, heparin sodium, anti-thrombotic, thrombotic agent, analgesic, anti-inflammatory, anesthetic, and others or combinations of the same. In one implementation, the pre-hydrated package includes at least <NUM> grams of fluid or more.

In one implementation, the medical device is configured to prevent contamination, e.g., fiber contamination, particulate or particle contamination and other contamination, and related complications and risks during medical procedures, e.g., invasive procedures.

In one implementation, the medical device is configured to resist abrasion and falling apart during use.

According to the claimed invention, the medical device includes a hydrophilic foam material that is laundered to reduce contaminants and particulates and particles. The laundering is done with low particulate water (LPW) that is filtered with a twin <NUM> micron filter system and repeated for a predetermined number of times.

In one implementation, the medical device includes a foam material configured to be used in a medical procedure, e.g., for the removal of blood, contrast and other contaminants from sterile instruments and medical devices.

The medical device includes a foam material constructed from a polyurethane material, or a combination of a polyester material and a polyurethane material. The foam material is reticulated foam.

In one implementation, the foam material may have one or more of the following physical properties determined by ASTM Standards as known in the art, e.g., ASTM D3574. The properties include one or more of a pore size in a range from about <NUM> to about <NUM> ppi, with a pore size of <NUM>-<NUM> ppi in a preferred embodiment; a density in range from about <NUM> lb/ft<NUM> to about <NUM> lb/ft<NUM>, with a density of about <NUM> lb/ft<NUM> to about <NUM> lb/ft<NUM> in a preferred embodiment; a tensile strength in a range from about <NUM> psi to about <NUM> psi, with a tensile strength of <NUM> psi in a preferred embodiment; an elongation in range from about <NUM> to <NUM> percent, with an elongation of about <NUM> percent in a preferred embodiment; and a compression set at <NUM>% of about <NUM> percent to about <NUM> percent, with a compression set of about <NUM> percent in a preferred embodiment. Hereby <NUM> psi equals <NUM> kPa, and <NUM> lb/ft<NUM> equals <NUM>/m<NUM>.

In another embodiment, the foam material was polyurethane reticulated foam with open celled pores having one or more of the following physical properties determined by ASTM Standards as known in the art, e.g., ASTM D3574: a pore size of about <NUM> to about <NUM> ppi, density of about <NUM> to about <NUM> lb/ft<NUM>, tensile strength of <NUM> psi, elongation of <NUM> percent, tear strength <NUM> lbs/in, CLD @ <NUM>% R of about <NUM> psi, CLD @ <NUM>% R of about <NUM> psi, and compression set @ <NUM>% of about <NUM> percent max. Hereby <NUM> psi equals <NUM> kPa, and <NUM> lb/ft3 equals <NUM>/m3.

In one embodiment, the medical device is extremely pliable, soft, and non-abrasive after rehydration with a solution, e.g., saline, and other solutions described herein.

In one embodiment, the foam material described herein has the ability of a material to absorb energy when it is deformed elastically, and release that energy upon unloading. That is, the material is also configured in a predetermined shape and will return to its predetermined shape after the application of force has been removed. That is, the material can be deformed with force, but will return to its condition after the removal of force.

According to the claimed invention, the medical device includes a foam material that does not include a latex material, does not include bisphenol A (BPA), does not include di(<NUM>-ethylhexyl)phthalate (DEHP), and does not include cellulose. Accordingly, the medical device is a biocompatible material and it is believed the use of the medical device described herein with the foam material will reduce surgical site infections (SSI) and/or reduce hospital acquired infections (HAI) as compared to traditional sponges and/or gauze materials.

According to the claimed invention, the medical device includes a foam material that is a hydrophilic material, e.g., the foam material is formed with highly absorbent material, e.g., absorbent foam. Highly absorbent foam means a versatile hydrophilic foam that will absorb up to five times or more of its weight in fluids. In one implementation, highly absorbent foam means a versatile hydrophilic foam that will absorb up to ten times or more of its weight in fluids. In one implementation, highly absorbent foam means a versatile hydrophilic foam that will absorb up to <NUM> times or more of its weight in fluids. Hydrophilic means the property of attracting or associating with water molecules, possessed by polar radicals or ions, as opposed to hydrophobic.

In one embodiment, the medical device with the hydrophilic foam material can absorb up to twenty times its weigh in saline solution. The medical device is configured for the removal of blood, contrast, and other contaminants from medical devices such as sterile instruments, guidewires, and other devices. The medical devices are easy to handle and are bendable, conformable, durable and non-shredding.

In one embodiment, the edge includes one or more of a chamfered edge or a beveled edge. A chamfered edge is a transitional edge between two adjoining right-angled faces of the foam material. A beveled edge is an edge that are not perpendicular to one another of the foam material. A chamfer edge is technically a type of bevel edge, but the difference between the two is that a bevel is an edge that is sloped and a chamfer is an edge that connects two surfaces at a <NUM>-degree angle, while a bevel's slope can be any angle except <NUM> or <NUM> degrees.

As used herein particulate is a manufacturing particulate or particle and is something that occurs in the manufacturing process and is not a cellulose, e.g., plant-based, particulate.

Table <NUM> shows the number of particles associated with medical devices described with reference to reference-embodiments and related art devices. Each of the medical devices were tested for particles as described herein.

Referring to Table <NUM>, the related art medical devices made from cellulose including gauze, Telfa non-adherent pads, Lap Pad and Raytec each have a much higher number of particles at various sizes compared to the embodiments of medical devices described herein. Moreover, it is believed the higher the number of particles is evidence of contamination and potential related medical complications and risks to patients during invasive medical procedures. For example, the high number of particles can also be indicative of fibers or other contaminates.

The related art devices of cotton gauze and Telfa pads contain cellulose and fibers. It has been found that fibers associated with the related art medical devices, e.g., cotton gauze and Telfa pads, can stick to guide wires, sheaths, catheters, or other medical components/devices used in a medical procedure. Also, the fibers, particles or other contaminates may be found in syringes and saline bowls used during medical procedures. For example, if cotton gauze or Telfa pads are used to clean a guidewire or stent the fibers can be transferred to the stent or guidewire and end up in the patient. The fibers of the cotton gauze or Telfa pads can also snowplow or pile up in location of a guidewire or other medical device making the guidewire difficult to use or potentially unusable. In addition, it is believed one or more of these complications can occur in patients with related art device cotton gauze if fiber is transferred to the patient: inflammation, granuloma, occlusive granuloma, thrombus formation, e.g., myocardial infarction and stroke, adhesions, restenosis, infection, necrosis, kidney problems or failure, allergic reactions, and misdiagnosed carcinomas.

It is believed that transmission of the fibers, particles, or other contaminates to the patient by related art devices, e.g., cotton gauze or Telfa pads, can occur by cleaning or wiping medical devices. Also, soaking the related art devices, e.g., cotton gauze or Telfa pads, in procedure bowls and drawing up the flush into a syringe and injecting it into catheters or sheaths to clear or to flush the catheter lumen may transfer the containments to the patient. Moreover, handling the related art devices, e.g., cotton gauze or Telfa pads, with sterile gloves may result in subsequent transfer of fibers from the gloves to the medical devices used in the procedure.

The high number of particles or fibers in the related art are also believed to be a factor in surgical site infections (SSI) or hospital acquired infections (HAI). For example, it is believed the cellulose is not digested by tissue, macrophages, or other cells. A cascade of inflammatory reactions can occur from the contaminants, e.g., cellulose, particles, or other, forming foreign body granulomas and contribute to post-operative complications, e.g., adhesions, SSI, and HAI. Unintentional foreign body emboli remain common in modern angiographic practice and are underappreciated clinically and particulate embolization, e.g., fiber, is present in as many as <NUM>% resected arteriovenous malformations. Moreover, a stent study found that forty-two percent of patients with stent thrombosis had particulates (glove powder and lint fibers) enmeshed with the thrombi. Gauze fibers have been found adhered to a guide wire between the tip of a balloon catheter and the y-adapter. Gauze fibers have been found lodged on a stent strut from handling with sterile gloves. Particulate entry points to the patient include at least blood vessels, open wounds, closed wounds via sheath, inhalation, and a medical device during handling. Some particulate transmission methods to a patient include wiping various medical devices or instruments with sponges or gauzes, contacting the patient with those sponges or gauzes or instruments and medical devices that have been in contact with those sponges or gauzes, fluid injection, airborne particulates and with surgical gloves that have come in contact with the sponges or gauzes.

Also, embolization of cotton fibers during coronary and neuro interventional procedures has been shown to cause arterial thrombosis potentially leading to myocardial infarction and/or stroke.

The medical devices having foam material as described in embodiments and Table <NUM> do not contain cellulose and have reduced or ultra-low particles, thereby these medical devices are believed to reduce post-operative complications, SSI, HAI. These complications increase medical costs significantly and overall health care costs.

In addition, the medical devices having foam material as described in embodiments and Table <NUM> are re-usable during a medical procedure. In one embodiment, the medical device may be reused by washing in a surgical bowl with saline or other solution described herein. In contrast, the cotton gauze or other related art devices are not reusable, thereby increasing the amount of medical waste. Medical waste is costly to dispose and thereby the related art devices are more expensive to use as there is more medical waste. Also, the related art devices, e.g., cotton gauze and Telfa pads, are not reusable, thereby also increasing the total number of particles or fibers per procedure as more than one is typically used, e.g., <NUM> medical device reused vs. <NUM> of the related art devices.

In one embodiment, the medical device with foam material is reusable and hydrophilic and has no cellulose, ultra-low particle levels, no latex, no bisphenol A (BPA), no di(<NUM>-ethylhexyl)phthalate (DEHP), bacterial endotoxin less than <NUM> EU/device, and is non-cytotoxic. In one embodiment, the medical device is lint free. In one embodiment, the medical device has no cytotoxins. In one embodiment, the medical device has bacterial endotoxins below about <NUM> EU/medical device and in a more preferred embodiment below about <NUM> EU/medical device. In one embodiment, the medical device is non-abrasive and configured to not disintegrate with use.

In one embodiment, the foam material can be configured into any two-dimensional or three dimensional geometric dimension, e.g., round shape, ball shape, triangle shape, square shape, rectangle shape, oval shape, diamond, and combinations of the same and the like.

In one embodiment, the foam material can be configured into any preformed dimension or design such as a curved shape, block shape, circle shape, trench shape, triangle shape and combinations of the same and the like.

In one embodiment, the foam material is configured as a glove or mitten to allow it to be worn by a user in any conventional size, e.g., small, medium, large, and extra-large. The glove may include slots for one or more fingers, e.g., one finger, two fingers, three fingers, etc., or be a mitten. In one implementation, the glove or mitten can be used to clean out a wound, e.g., absorb blood or other fluids. Optionally or alternatively, the foam material is configured into a shape that covers or partially covers one finger, e.g., a finger sock or two fingers.

In one implementation, the foam material may include any type of pattern or texture on a surface of the foam material, e.g., cross-hatched pattern, three-dimensional pattern, wave pattern, linear pattern, non-linear pattern, and combinations of the same. The texture or pattern can be formed with a laser, heat, or during the manufacturing process.

In one implementation, the foam material can be configured into one of a <NUM> inch by <NUM> inch dimension, <NUM> inch by <NUM> inch dimension, a <NUM> inch by <NUM> inch dimension, or a twelve inch by <NUM> inch dimension with a thickness in a range from about <NUM> inch to <NUM> inch or greater. Hereby <NUM> inch equals <NUM>. The thickness can vary throughout the dimension.

In one embodiment, the medical device may have the one of the following dimensions, <NUM> × <NUM> × <NUM> inches, <NUM> × <NUM> × <NUM> inches, <NUM> × <NUM> × <NUM> inches, <NUM> × <NUM> × <NUM> inches, <NUM> × <NUM> × <NUM> inches, <NUM> × <NUM> × <NUM> inches, <NUM> × <NUM> × <NUM> inches, <NUM> × <NUM> × <NUM> inches, <NUM> × <NUM> × <NUM> inches, <NUM> × <NUM> × <NUM> inches, <NUM> × <NUM> × <NUM> inches, and <NUM> × <NUM> × <NUM> inches.

In another embodiment, the medical device can have a thickness dimension in a range from about <NUM> inch to about <NUM> inch or greater, a length dimension in range from about <NUM> inch to about <NUM> inches or greater and a width dimension in range from about <NUM> inch to about <NUM> inches or greater.

In one embodiment, the foam material is configured into any color or any combination of colors, e.g., any combination of red, yellow, and blue colors. In one implementation, the foam material includes one or more of a yellow color, an orange color, a pink color, a white color, and a fluorescent color.

In one implementation, the foam material is configured with one or more of a logo, brand, or combination, e.g., laser etched brands/logos, laser etched designs and combinations of the same.

In one implementation, the device can be preformed into sheets with perforations in a predetermined dimension to permit separation into individual units.

In one implementation, the device including the foam material can be cut into any desired shape.

In one implementation, the device including the foam material is foldable or malleable into various shapes and sizes during a procedure.

In one implementation, the medical device includes a foam material and includes a backing material to provide more rigidity to the medical device. The backing material can include a plastic material, a thermoplastic material, a paper material, a cardboard material, a cloth material, and combinations of the same, to give the medical device more rigidity.

In one implementation, the medical device includes a foam material that includes a graphic or pattern on a surface of the medical device. The graphic or pattern can be applied to the surface by any known means in that art, e.g., printed, adhered to a surface, stained on a surface, or combinations of the same. In one embodiment, the graphic may include dimensions, lines, grids, labels, or other measurement indica.

In one implementation, the medical device has a foam material that is coated with a pharmacological agent that can include one more of antibiotic, saline, heparin sodium, anti-thrombotic, thrombotic agent, analgesic, anti-inflammatory, anesthetic, and others or combinations of the same. In one implementation, the pre-hydrated package includes at least <NUM> grams of fluid or more.

As used herein a pyrogen is a substance, typically produced by a bacterium, which produces fever when introduced or released into the blood. As used herein particulates and particles of the same typically result from the manufacturing process.

According to the claimed invention, the foam material includes imaging markers in the form of scratch resistant radiopaque (RO) ink markers. The imaging markers are configured to be detectable or visible under x-ray imaging or other imaging device. The imaging markers are configured to prevent leaving the medical device in the patient after the procedure. For example, in order to ensure no medical devices are left in the body a user can image the patient with an imaging device that will detect the one of the imaging markers. If no imaging markers are detected then the user can verify that no medical devices are left in the user.

The markers may be arranged in a pattern configured to assist with the orientation of the device, e.g., up, down, side, etc. The markers may be arranged in any corner or all corners of the device. The markers may be arranged in a grid configured at predetermined distance, so they can be used to determine distances.

The radiopaque markers are applied as an ink. The RO ink can be applied as a continuous shape, a discontinuous shape, or a combination of the same. The line may be as dots, dashed and combination of the same. The RO including can be applied in various patterns, e.g., grid patterns. The grid pattern appears to show up clearly in with x-ray imaging. It is believed that applying the dots and/or dashes rather than a solid line of RO ink provides a more aesthetic appearance as the foam material of the medical device expands.

The RO ink is a radio opaque (RO) ink or a coating that can be applied by screen printing, printing, dipping, or other dispensing. The RO ink has excellent adhesion to the medical device foam material and is resistant to abrasion, scratching, flexing, and creasing. In one embodiment, the RO ink has a viscosity in a range from about <NUM> to about <NUM>,<NUM> mPa·s (about <NUM> to about <NUM>,<NUM> cps) and to paste cps, percent filter is greater than <NUM> percent. According to the claimed invention, the foam material does not contain a surfactant or any other coatings.

The foam material is constructed from a polyurethane material, or the foam material is a blend of polyester and polyurethane materials.

In one embodiment, the medical device is individually packaged, e.g., packaged in a hemostatic pouch, thermoplastic pouch, a Tyvek pouch or the like and boxed up. The sterilized packaged medical device has a shelf life of up to five years and the non-sterilized packaged medical device has a shelf life of up to <NUM> years.

In one embodiment, the medical device is sterilized by one or more of gamma radiation and ethylene oxide. Optionally and/or alternatively, the medical device can be non-sterile and placed on a tray and then sterilized with one or more of gamma radiation and ethylene oxide.

Described herein, but not part of the claimed invention, is a method for performing a medical procedure with a reusable multi-use surgical medical device by providing the reusable multi-use surgical medical device including an open-celled reticulated foam material having an ultra-low number of particles and a plurality of radio opaque (RO) ink markers adhered to a surface of the reticulated foam material configured to be visible under an imaging device at various orientations. The medical device has a bacterial endotoxin level below at least <NUM> EU/medical device. The method further includes initially applying a solution to the reusable multi-use surgical medical device to condition for use and removing the reusable multi-use surgical medical device from the solution and releasing residual solution by manual wringing. The method further includes manipulating the conditioned reusable multi-use surgical medical device through a lumen of a trocar to clean the lumen of the trocar or condition the trocar. During this method, the conditioned multi-use surgical medical device does not fragment.

Further described herein, but not forming part of the claimed invention, is a method for performing a medical procedure with a reusable multi-use surgical medical device including providing the reusable multi-use surgical medical device comprising an open-celled reticulated foam material having an ultra-low number of particles, a plurality of radio opaque (RO) ink markers adhered to a surface of the reticulated foam material configured to be visible under an imaging device at various orientations, and having a bacterial endotoxin level below at least <NUM> EU/medical device. The method further includes initially applying a solution to the reusable multi-use surgical medical device to condition it for use and removing the reusable multi-use surgical medical device from the solution and releasing residual solution by manual wringing. The method further includes manipulating the conditioned reusable multi-use surgical medical device in an operating field to absorb blood, body fluids, water and other aqueous liquids in an operative site of the operating field. The method further includes returning the now used reusable multi-use surgical medical device to the solution to clean and rinse it and repeating steps, as necessary.

Also described herein, but not forming part of the claimed invention, is a method for performing a medical procedure with a reusable multi-use surgical medical device including providing the reusable multi-use surgical medical device comprising an open-celled reticulated foam material having an ultra-low number of particles, a plurality of radio opaque (RO) ink markers adhered to a surface of the reticulated foam material configured to be visible under an imaging device at various orientations, and having a bacterial endotoxin level below at least <NUM> EU/medical device. The method further includes initially applying a solution to the reusable multi-use surgical medical device to condition for use and removing the reusable multi-use surgical medical device from the solution and releasing residual solution by manual wringing. The method further includes hydrating a tissue or organ of a patient by arranging the conditioned reusable multi-use surgical medical device adjacent to the organ or tissue during the medical procedure.

Further described, but not forming part of the claimed invention, is a method for performing a medical procedure with a reusable multi-use surgical medical device including providing the reusable multi-use surgical medical device comprising an hydrophilic open-celled reticulated foam material having an ultra-low number of particles, a plurality of radio opaque (RO) ink markers adhered to a surface of the reticulated foam material configured to be visible under an imaging device at various orientations, and having a bacterial endotoxin level below at least <NUM> EU/medical device. The method further includes initially applying a solution to the reusable multi-use surgical medical device to condition it for use. The method further includes removing the reusable multi-use surgical medical device from the solution and releasing residual solution by manual wringing. The method further includes arranging the reusable multi-use surgical medical device under a medical instrument to protect and hydrate the tissue or organ of a patient by during the procedure.

One embodiment is directed towards a medical kit including one or more medical devices as described with reference to any embodiment herein and instructions for use.

In one embodiment, the medical device is for use as an absorbent sponge in a variety of medical procedures. It can be rinsed in saline and fluid or blood can be squeezed out. A variety of different solutions may be utilized with the medical device such as antibiotic solution, antiseptics, coagulants, anticoagulants, or other solutions.

In one embodiment, the medical device can be used to estimate blood loss and/or body fluids of a patient during a trauma or procedure. For example, the medical device can be used to absorb blood and/or body fluids of a patient during trauma or procedure. Next, the device is squeeze or wrung out into a measuring bowl or other measuring apparatus and the volume of retrieved blood and/or body fluids is obtained. The measured volume of blood and/or body fluid can then be used to estimate the blood loss and/or body fluids of the patient.

In one embodiment, a suture may be placed through the medical device.

In one embodiment, the medical device can be used in endoscopic and laparoscopic procedures. It can be placed, advanced and retrieved through trocars due to its conformability and flexibility and it is also resilient to avoid fragmentation and degradation.

In one embodiment, the medical device is hydrated with techniques known in the art and for use in preventing tissues from drying out during a procedure.

In one embodiment, the medical device is for use in wound packing and can pack off bleeding and is also used as trauma and wound dressing.

In one embodiment, the medical device can be used to protect tissues from instrument trauma, e.g., it can be used between a retractor and the tissue. Moreover, it can be hydrated with any pharmacologic agent described herein to also prevent tissue from drying out during procedures.

In one embodiment, the medical device can be used on the patient for cleaning, wiping, absorbing, and packing of a wound or cavity.

In one embodiment, the medical device can be used in dental or oral surgery procedures.

In one embodiment, the medical device can be used in veterinary applications or procedures.

In embodiment, the medical device can be used with a variety of different medical procedures for cleaning, wiping, absorbing, hydrating and other uses. The variety of different medical disciplines it can be used in include at least one or more of general surgery, coronary artery bypass graft (CABG) procedures, thoracic procedures, colorectal procedures, gastrointestinal procedures, trauma procedures, plastic surgery procedures, orthopedic procedures, neurosurgery procedures, burn surgeries and procedures, e.g., skin grafts, eye surgery procedures, robotic procedures, and a variety of other specialties and the like.

In one embodiment, the medical device can be used with an endoscope as an endoscopic sponge for cleaning or inserting through or into portions of the endoscope or its endoscope attachments.

In one embodiment, the medical device can be irrigated and suctioned through given the porosity, cell structure and pore size. It absorbs better than related art devices and is non-abrasive. It can also be used as a platform to hold up nerves, spinal cords, other medical devices, and instruments. For example, cannulas or needles for suturing can be inserted into the medical device to temporality secure them.

In one embodiment, the medical device can be used as a makeup remover or for other non-medical uses.

Reference will now be made in detail to an embodiment of the present invention, example of which is illustrated in the accompanying drawings.

<FIG> illustrates a magnified view of a cellulose laparotomy pad for the absorption of discharges according to the related art.

Referring to <FIG>, the magnified view is achieved with an electron microscope and the laparotomy pad is generally represented with reference to number <NUM>. As shown, the laparotomy pad <NUM> is manufactured with cellulose and includes a number of bundled fibers <NUM> and loose fibers <NUM> and other contaminants. The fibers, lint and other contaminants can be described as particulates or quantified. Referring to Table <NUM> and the Example section the medical device <NUM> has a high number of particulates as compared to medical device described with reference to several embodiments herein. This high number of particulates is believed to cause various medical complications, e.g., post-operative complications, SSIs, HAIs, and other complications described herein. These complications increase medical costs and overall health care costs significantly. Moreover, this device <NUM> is not reusable or washable leading to increased cost of a procedure to dispose of medical waste.

<FIG> illustrates a magnified view of a cellulose gauze for use with medical procedures according to the related art.

Referring to <FIG>, the magnified view of a cellulose gauze device <NUM> is achieved with an electron microscope. The device <NUM> is manufactured with cellulose and the fibers <NUM> can be seen. The fibers <NUM>, lint and other contaminants can be described or quantified as particulates. Referring to Table <NUM> and the Example section the device <NUM> has a high number of particulates as compared to the medical device described with reference to several embodiments herein. This high number of particulates is believed to cause various medical complications, e.g., post-operative complications, SSIs, HAIs, and other complications described herein. These complications increase medical costs and overall health care costs significantly. Moreover, this device <NUM> is not reusable or washable during a procedure.

<FIG> illustrates a non-magnified view of a non-adherent pad according to the related art. <FIG> illustrates a magnified view of a non-adherent pad according to the related art.

Referring to <FIG>, the non-magnified view and magnified with an electron microscope of a non-adherent pad <NUM>, e.g., a Telfa pad. As shown, the non-adherent pad <NUM> is manufactured from cellulose and includes a number of fibers <NUM>, <NUM> and <NUM> through a layer <NUM>. The device <NUM> has fibers <NUM>, <NUM> and <NUM>, lint and other contaminants can be described or quantified as particulates. Referring to Table <NUM> and the Example section the device <NUM> has a high number of particulates as compared to the medical device described with reference to several embodiments herein. This high number of particulates is believed to cause various medical complications, e.g., post-operative complications, SSIs, HAIs, and other complications described herein. These complications increase medical costs and overall health care costs significantly. Moreover, this device <NUM> is not reusable or washable.

<FIG> illustrates a magnified view of a medical device according to an implementation of the present disclosure.

Referring to <FIG>, the magnified view of the medical device <NUM> is achieved with an electron microscope. As shown, the medical device <NUM> is constructed from an open celled foam material of reticulated foam made from a material described herein. The foam material includes a number of open cells <NUM>. The foam material is described in greater detail herein and can be either hydrophilic (according to the claimed invention) or hydrophobic (not according to the claimed invention). The open cell foam <NUM> is permeable to fluids and can be suctioned through. The open cell foam has a plurality of pores <NUM> and the pore size can be in a range from about <NUM> ppi to about <NUM> ppi or greater.

The device <NUM> has ultra-low number of particulates as compared to the related art devices as shown in Table <NUM> and the Example section. The medical device <NUM> does not contain cellulose, lint, latex, bisphenol A (BPA), or di(<NUM>-ethylhexyl)phthalate (DEHP). In a preferred embodiment, the device does not contain butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), or diisobutyl phthalate (DIBP). The device has an endotoxicity level that is below <NUM> EU/device, and in a preferred embodiment, the endotoxicity level is below about <NUM> EU/device.

The device <NUM> is configured to reduce post-operative complications, SSI and HAI. These complications increase medical costs and overall health care costs significantly. The device <NUM> is reusable and washable during a medical procedure, thereby it is useable.

<FIG> illustrates an exemplary x-ray view of a medical device <NUM> with imaging markers according to an implementation in a first orientation of the present disclosure. <FIG> illustrates an exemplary x-ray view of the medical device of <FIG> with imaging markers in a second orientation. <FIG> illustrates an exemplary x-ray view of the medical device of <FIG> with imaging markers in a third orientation.

Referring to <FIG>, the medical device <NUM> includes a radio opaque (RO) imaging marker including a plurality of RO ink markers <NUM> (according to the claimed invention) and RO string marker <NUM> that is sewn into the foam material (not according to the claimed invention). As shown, the RO string marker <NUM> is hard to see as compared to the RO ink markers <NUM>. The RO ink markers <NUM> in this embodiment have different diameters arranged in a grid pattern. Optionally and/or alternatively, the array pattern can be uniform or non-uniform.

The diameter of the RO ink markers <NUM> can have a dimension in a range from. <NUM> to about <NUM> or greater or less. In a preferred embodiment, the diameter is in a range from <NUM> to about <NUM>. The RO ink markers are applied with a printed, deposited, or other application technique described herein. The RO ink is radio opaque that is configured to be detectable or visible under x-ray imaging, or other imaging device.

The RO ink markers <NUM> can have the same diameters or different diameters. The RO ink markers <NUM> can be applied in any geometric configuration, e.g., triangle, circle, square or rectangle. The RO ink is formed on a surface of the foam material. The RO ink can have a thickness in a range from about <NUM> or greater.

The RO markers <NUM> are readily visible at different orientations of the x-ray imaging. More specifically, <FIG> is an x-ray image of the medical device <NUM> at anterior projection (AP) orientation, <FIG> is an x-ray image of the medical device <NUM> at an AP projection, and <FIG> is an image of the medical device <NUM> at an right anterior oblique (RAO) projection. Referring to <FIG>, the RO ink markers <NUM> are clearly show in two separate orientations, e.g., AP and RAO. As shown and described herein the RO ink markers <NUM> have enhanced visualization as compared to the RO string marker <NUM>.

Referring <FIG>, the medical device is generally depicted with reference to <NUM>. The device <NUM> includes a hydrophilic foam material as described herein. The device <NUM> is configured as a glove or claw glove with a slot <NUM> for a thumb, an index finger slot <NUM> and the remaining fingers slot <NUM>.

Optionally and/or alternatively, the device <NUM> may be configured only to cover a finger, or more than one finger and thumb. In this embodiment, the device <NUM> has an opening <NUM> to receive a portion of the hand. The device <NUM> is constructed from a foam material as described herein as a first pattern and a second pattern joined together with an attachment mechanism <NUM>, e.g., suture, adhesive, staples, heat bonding and combinations of the same or the like.

According to the claimed invention, the device <NUM> includes RO imaging markers as described herein. The device <NUM> can be used with any surgical procedures described herein.

<FIG> illustrates an exemplary perspective view of a medical device according to an implementation of the present disclosure.

Referring <FIG>, the medical device is generally depicted with reference to <NUM>. The device <NUM> includes a foam material <NUM> non-releasably attached to the substrate <NUM>. The substrate <NUM> may be any material e.g., plastic, thermoplastic, paper, cardboard, combination of the same or the like or any rigidity, e.g., stiff, flexible, etc. In this embodiment, the substrate <NUM> includes a rigid thermoplastic material adhered to the <NUM> with one or more of heat, adhesive, suture, staple, and the like. The foam material <NUM> may be any material described herein. The substrate is configured to increase the rigidity of the foam material <NUM>.

The device <NUM> can be used with any surgical procedures described herein.

Referring <FIG>, the foam medical device is generally depicted with reference to <NUM>. The device <NUM> is configured as a foam material <NUM> has described herein. In this embodiment, the device is a square geometric configuration with a length <NUM>, width <NUM> and thickness (not shown) into the substrate. The thickness (not shown) may be in a range from about <NUM>/<NUM> inch or greater, e.g., <NUM>/<NUM> inch to about <NUM> inch or greater, the length by about <NUM>/<NUM> inch to about <NUM> inch or greater, and the width in a range from about <NUM>/<NUM> inch to about <NUM> inch or greater. Hereby <NUM> inch equals <NUM>.

The device <NUM> has radiopaque imaging markers printed onto a surface of the foam, as described herein. The device <NUM> can be used with any surgical procedures described herein.

Referring to <FIG>, the device <NUM> is configured as a sheet of foam material having top <NUM>, a bottom <NUM>, a first side <NUM> and a second side <NUM>. Perforations are arranged through a thickness of the foam. The perforations are arranged as a vertical line of perforations <NUM>, <NUM>, and <NUM> and perforations are arranged in horizontal lines of perforations <NUM>, <NUM>, <NUM>. The perforations are configured through or partially through the foam material and are configured to separate the material into medical devices <NUM> of predetermined sizes. The perforations can be in any pattern or orientation to create medical devices of different geometries, e.g., circle pattern, square pattern, triangle pattern, rectangle pattern and the like. The perforations are further configured through the material to allow for easy separation into a predetermined sections <NUM>. The device <NUM> has radiopaque ink markers printed onto a surface of the foam, as described herein.

<FIG> illustrates an exemplary method of using a medical device according to another implementation of the present disclosure. Such a method does not form part of the claimed invention.

A method for performing a medical procedure with a reusable multi-use surgical medical device is generally described with reference to number <NUM>. In step <NUM> the user provides the reusable multi-use surgical medical device as described in any of the embodiments or examples herein. In step <NUM> the user applies a solution to the reusable multi-use surgical medical device to condition for use by arranging the medical device in a bowl containing the solution. The solution can be any solution described herein, e.g., saline or water. In step <NUM> the user removes the reusable multi-use surgical medical device from the solution and releases residual solution by manual wringing, e.g., with hands. In step <NUM> the user uses the conditioned reusable multi-use surgical medical device during a surgical procedure. The surgical procedure can be any surgical procedure described herein. In step <NUM> the user returns the now-used reusable multi-use surgical medical device to the bowl containing the solution to clean and rinse it. Optionally, in step <NUM>, the user can repeat any of the steps <NUM>, <NUM>, <NUM>, <NUM> and <NUM>, as necessary.

<FIG> illustrates an exemplary method of using a medical device according to another implementation of the present disclosure, which does not form part of the claimed invention.

A method for performing a medical procedure with a reusable multi-use surgical medical device is generally described with reference to number <NUM>. In step <NUM> the user provides the reusable multi-use surgical medical device as described in any of the embodiments or examples herein. In step <NUM> the user applies a solution to the reusable multi-use surgical medical device to condition for use by arranging the medical device in a bowl containing the solution. The solution can be any solution described herein, e.g., saline or water. The reusable multi-use surgical medical device is completely hydrated in the bowl. In step <NUM> the user removes the reusable multi-use surgical medical device from the solution and releases residual solution by manual wringing, e.g., with hands. In step <NUM> the user manipulates the device by arranging it into a proximal end of a trocar. In step <NUM> a blunt grasping instrument is used to push the conditioned multi-use surgical medical device through a lumen of the trocar into a bowl, e.g., a catch basin. In step <NUM> after the reusable multi-use surgical medical device is used the conditioned reusable multi-use surgical medical device returns to its normal shape. Optionally, in step <NUM> the user returns the now-used reusable multi-use surgical medical device to the bowl containing the solution to clean and rinse it. Optionally, in step <NUM> the user can with the blunt grasping instrument push the used and reconditioned multi-use surgical medical device through a lumen of the trocar into a bowl, e.g., a catch basin. Any of these steps may be repeated as desired.

The following examples are intended to be illustrative only and are not intended to limit the scope of the invention to only the constructions described by these examples. These examples are to be considered as reference-examples.

A medical device having a hydrophobic foam material was tested having a length of about <NUM> inches, thickness of about <NUM> inches and width dimension of about <NUM> inches. Hereby <NUM> inch equals <NUM>. The device was first submerged in <NUM> of a low particulate water (LPW) that is filtered with a twin <NUM> micron filter system and then squeezed to remove saline and this step was repeated three times. Next, the device was placed in a testing solution of LPW and tested for particulates. This device was tested by Nelson Laboratories for particulate matter as set forth in Appendix A. Particulate matter is defined in the USP as extraneous, mobile, undissolved substances, other than gas bubbles, unintentionally present in a solution (or in/on a device). All test method acceptance criteria were met. Testing was performed in compliance with US FDA good manufacturing practice (GMP) regulations <NUM> CFR Parts <NUM>, <NUM> and <NUM>.

Light Obscuration was done with testing performed using the HIAC Royco Liquid Particle Counting System (LPC), Model #<NUM>. The counter detects and sizes particles using a light-obscuration sensor. The LPC's sensor was calibrated by the manufacturer using polystyrene latex particles from <NUM> to <NUM>. Testing was conducted to ensure compliance with the applicable standard listed in the interpretation of results section.

Results are shown as values rounded to the nearest whole number. If present, results reported as "<NUM>" do not necessarily indicate that zero particles were detected.

Test Method Acceptance Criteria: Light Obscuration (LO): The environment control must have no more than a total of <NUM> particles ≥ <NUM> when adding the counts of all five aliquots (<NUM> total). The positive control must exceed the USP <<NUM>> large volume criteria.

Interpretation of Results: Light Obscuration: USP <<NUM>> and EP <NUM>. <NUM> Requirements: There are no USP or EP specifications for particulate matter found in/on medical devices. The results are shown in Tables <NUM>, <NUM>, and <NUM>.

Medical devices having an open-celled foam material described herein having a length of <NUM> inches, a thickness of <NUM> inches and a width dimension of <NUM> inches and a medical device having a length of <NUM> inches, a length of <NUM> inches and a thickness of <NUM> inches were tested for endotoxicity levels. Hereby <NUM> inch equals <NUM>.

Each of the devices were tested by a lab. The Bacterial Endotoxins Test (BET), or Limulus Amebocyte Lysate (LAL) test, is an invitro assay to detect and quantify bacterial endotoxin, a component of the cell wall of Gram negative bacteria. Standard controls and a positive product control (PPC) demonstrate a compliant assay. A PPC recovery within the <NUM>%-<NUM>% range indicates that the test solution is free of interfering factors given the specific conditions of the test. If applicable, dilutions are calculated into the reported endotoxin level. All test method acceptance criteria were met. The testing was conducted in accordance with the following regulatory documents: ANSI/AAMI ST72:<NUM>/(R)<NUM>, USP <<NUM>>, USP <<NUM>>, EP <NUM>. <NUM>, and JP <NUM>. Testing was performed in compliance with US FDA good manufacturing practice (GMP) regulations <NUM> CFR Parts <NUM>, <NUM> and <NUM>. The results are shown in Table <NUM>.

As shown from above, the device is usable for various medical applications including cerebrospinal fluid contact situations. The standard for finished medical devices is an endotoxin limit not more than <NUM> EU/device. In addition, the endotoxin limit for medical devices in contact with cerebrospinal fluid is not more than <NUM> EU/device and the endotoxin limit for medical devices in contact with intraocular ophthalmic devices is not more than <NUM> EU/device.

A total of eight medical device specimens were tested as shown in Table <NUM> for abrasion resistance. The Martindale Abrasion Test under the ASTM International (formerly the American Society for Testing and Materials) D49 <NUM>-Standard Test Method for Abrasion Resistance of Textile Fabrics (Martindale Abrasion Tester Method) was used to test a medical device's resistance to abrasion. The medical device's ability to resists abrasion, tears and punctures is particularly important to avoid contamination to the patient from the medical device.

In this Example, the testing was performed on a Martindale tester manufactured by James H. Ltd and results are in Table <NUM>. A total of <NUM> specimens were tested and details can be found in the following table. The specimens were loaded per the tester instructions and each specimen had a pressure of <NUM> kpa and #<NUM> duck cloth for the abradant. No testing anomalies were noted. Foam samples showed no visible wear during the test. A small amount of fibers from the duck cloth were seen in the pores of the foam samples at <NUM>,<NUM> cycles. At no time did any of the foam transfer to the abradant. Gauze samples transferred fibers to the abradant at <NUM>,<NUM> cycles. At <NUM>,<NUM> cycles, the gauze disintegrated, and the testing of this sample was terminated at <NUM>,<NUM> cycles. Lap sponge samples began shedding minor fibers at <NUM>,<NUM> cycles. At <NUM>,<NUM> cycles, an excessive amount of white powder was observed on the abradant and abradant holder. At <NUM>,<NUM> cycles, pilling began to occur. Testing was stopped at <NUM>,<NUM> cycles.

A number of laundered medical devices were tested for particulates with results shown in Table <NUM>. Each device was laundered in an aqueous solution of low particulate water (LPW) to reduce manufacturing particulates. Liquid Particle Counting (LPC) system and processing was used to determine a particulate count.

Medical device specimens were tested for cytotoxicity as shown in Table <NUM>. A cytotoxicity test using the MEM elution method was utilized. The specimens were open-celled foam each having a blue thread sewn into across each sample. The blue thread included radio opaque (RO) material. The test method was ISO <NUM>-<NUM> biological evaluation of method medical device-Part <NUM>: Test for in vitro cytotoxicity Test on Extracts. The reagent control was 1X MEM composition: <NUM>% Gibco MEM Earle's salts, <NUM>% fetal bovine serum, <NUM>% antibiotics (<NUM>,<NUM> units/mL, Penicillin G sodium and <NUM>,<NUM> ug/mL Streptomycin sulfate in <NUM>%), Sodium pyruvate <NUM>% (<NUM>) and <NUM>% (<NUM>) L-glutamine. The negative control was high density polyethylene (HDPE). The positive control was <NUM>% ZDEC polyurethane film (RM-A). The tissue code L929, (Mouse fibroblast cells, ATCC CCL-<NUM>, NCTC <NUM>).

The test preparation was based on USP ratio of <NUM><NUM>:<NUM>. The reagent control preparation used a medium test specimen as reagent control. The negative control preparation, was high density polyethylene (HDPE), was used as a negative control material that was tested in accordance with ISO <NUM>-<NUM>:<NUM>(E). The positive control preparation, was <NUM>% ZDEC polyurethane film (RM-A), was used as a positive control in accordance with ISO <NUM>-<NUM>:<NUM>(E). based on the SP ration of <NUM><NUM>:<NUM>.

The method utilized was cell suspension of <NUM> × <NUM> cells/mL L929 in MEM completed medium was feed into the <NUM> well plate each <NUM> per well. It was incubated at <NUM>, <NUM> % CO2 to obtain confluent monolayer prior to testing. The MEM completed medium was replaced with the extracts of test sample, negative control, and positive control. After incubation, the cells were examined microscopically for cytotoxic response. Observation for the test extract and negative control were conducted at <NUM> hours, <NUM> hours, and <NUM> hours of incubation. The positive control well was observed at <NUM> hours of incubation. To determine any change in cell morphology clearly, scoring for cytotoxicity was based on the criteria. Table <NUM> shows the results.

As shown in Table <NUM> the medical devices were non-toxic and did not have cytotoxicity. A value of <NUM> was no reactivity and conditions of all cultures was discrete intracytoplasmic granules, no cells lysis, no reduction of cell growth. A value of <NUM> is severe reactivity and conditions of all cultures was nearly complete or complete destruction of the cell layers.

In this Example <NUM>, the number of particles associated with medical devices as identified in Table <NUM> were tested with a testing lab. Each of the medical devices identified as having hydrophilic foam material were laundered in an aqueous solution to remove manufacturing particulates prior to testing. The number of particles were measured with Light Obscuration (LO) system and techniques as known in the art and as described with reference to Example <NUM>.

Claim 1:
A reusable multi-use surgical medical device,
comprising:
a laundered hydrophilic polyurethane foam material comprises reticulated foam that is a cellulose free, latex free, a bisphenol A (BPA free) and a di(<NUM>-ethylhexyl)phthalate (DEHP) free having an ultra-low number of particles before use,
wherein the laundered hydrophilic polyurethane foam material comprises a reticulated foam material that was laundered in aqueous solution of low particulate water (LPW) to reduce manufacturing particulates,
wherein the laundered hydrophilic polyurethane foam material is configured to absorb bodily fluids and configured to be reused repetitively during the procedure;
a plurality of scratch resistant radiopaque (RO) ink markers printed onto a surface of the laundered hydrophilic foam material, wherein the scratch resistant radio opaque (RO) printed ink markers are configured to be visible under an imaging device at various orientations,
wherein the laundered hydrophilic polyurethane foam material has bacterial endotoxin level below at least <NUM> EU/medical device, and
wherein the laundered hydrophilic polyurethane foam material does not contain a surfactant or any other coatings.