MXPA06008267A - Needle counter device - Google Patents

Needle counter device

Info

Publication number
MXPA06008267A
MXPA06008267A MXPA/A/2006/008267A MXPA06008267A MXPA06008267A MX PA06008267 A MXPA06008267 A MX PA06008267A MX PA06008267 A MXPA06008267 A MX PA06008267A MX PA06008267 A MXPA06008267 A MX PA06008267A
Authority
MX
Mexico
Prior art keywords
needle
retention device
base
adhesive
cohesive material
Prior art date
Application number
MXPA/A/2006/008267A
Other languages
Spanish (es)
Inventor
W Kanner Rowland
Lee Young Larry
Original Assignee
Atrion Medical Products Inc*
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Atrion Medical Products Inc* filed Critical Atrion Medical Products Inc*
Publication of MXPA06008267A publication Critical patent/MXPA06008267A/en

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Abstract

A needle counter device which includes a latch mechanism for securing the device in a closed condition. The latch mechanism preferably consists of a latch member which is integrated into the edge of a lid of the device and which is configured to be received in a corresponding hole or aperture in a base of the device, as this arrangement simplifies manufacturing, as well as increases resistance to deflection and spreads the opening load (i.e., the load used to unlatch the latch mechanism) into a whole side of the part instead of having the load be concentrated at a narrowportion. This latch mechanism can be implemented in connection with a needle counter device as described above, wherein the needle counter device utilizes an adhesive disposed in one or more troughs. Alternatively, the latch mechanism can be implemented in connection with a more conventional needle counter device, such as one which does not include an adhesive disposed in one or more troughs.

Description

NEEDLE COUNTER DEVICE DESCRIPTION OF THE INVENTION The present invention relates generally to needle counter devices used in surgery, and more specifically refers to a needle counter device that includes an adhesive disposed to one or more grooves, to receive and retain elements. cutting (ie, needles, blades, etc.) during surgery. It is important to justify and safely retain all suture needles used in a surgical procedure for removal. Since the number of needles used for any given surgical procedure can vary widely, it may be necessary for several needles to be justified and each need to be justified to ensure that none remain on the patient or on surgical fabrics, bed sheets or are lost in somewhere. This protects the patient, the surgical and nursing staff as well as the cleaning and laundry staff. The scalpels can also be removed or changed during the procedure and thus become a risk unless they are also justified. The possibilities of presence of pathogens originating in the blood on these contaminated cutting objects makes their custody essential so that they can be eliminated at the minimum risk. There are already numerous concepts of needle counting devices. Methods used to retain the cutting elements include the use of soft penetrable foam strips, magnetic sheets, thin film adhesive, foam coated film adhesive, "piggy" type receiving groove and various combinations of these elements. Many of these devices date back more than 30 years. Many of the devices are contained within a variation of an articulated plastic box shape that opens and closes like a book. Several methods have been employed to hook or secure the closed box. Frequently, the section that receives the cutting elements between the needle counter is divided into numbered sections for the placement of needles in order to facilitate the counting process. From the user's point of view, improved means to ensure and facilitate the accurate counting of these needles and prevent accidental eviction has become more important, especially when the average age and the general shortage of nursing equipment means that the decadent quality from the point of view of the users and their need to be more efficient conflict. Some examples of prior art devices can be found in U.S. Patent Nos. 3,944,069 (Foam cushion coated with pressure sensitive adhesive); 4,008,802 (Elastic cushion with ridges raised to receive needles); 4,013,109 (Articulated container with magnetic surface to contain needles); 4,243,140 (Articulated container with slotted foam flanges on one side and a thin adhesive layer on • the other to contain cutting elements); and 4,596,329 (Combinations of foam and magnetic media for retaining cutting elements). Needle counters are very much an element of comfort in the field of health care and as such should be economically manufactured and sold economically in order to compete. Emphasis and legislation of recent OSHA directed towards methods and systems of safe handling for contaminated cutting elements to avoid transfer of diseases by pathogens originating from blood, has directed more attention on user friendliness and ease of use of these devices . Soft foam cushions require that frequently curved suture needles be impaled on or through them. Some foam cushions are slotted to receive needles into their slots. Magnetic sheets are sometimes used to hold needles. Some hybrid concessions have thin adhesive film applied to a foam cushion where the cushion can prevent impaling with the needle or the needle or cutting element can be retained by the adhesive in contact. All these devices do their job with varying degrees of success: 1) The foam device generally provides very little grip and often does not hold the needles against very low eviction force unless they are formed from an elastomeric foam and then require a force a . rather high insertion force to be able to give a high release force. 2) Magnets keep low carbon stainless steel needles with some degree of success, but the needles typically separate very easily and can move and become disorganized or finish loose even slightly messy. Occasionally, the cutting elements may be magnetized in contact with the magnetic sheet, thereby allowing them to move from their assigned location and stacking which makes counting difficult, especially when very fine needles are involved. Some surgeons complain that the magnetized needles tend to attract the needle holder pliers and become difficult to handle. The magnetic sheets are also expensive and are generally dark in color so that they do not provide good visual contrast to observe the shiny metallic needles. 3) Thin film adhesive surfaces are not very condescending and therefore are limited in effectiveness by the amount of surface area of the cutting elements to which they can be attached. Coating the thin film adhesives by a foam cushion aids in the use of the adhesive but moves away from an ideal solution since the membrane of the film also tends to inhibit the insertion of the needles into the foam. Many devices have also used an adhesive on their bottom to be able to secure the device on a work surface and prevent movement during use. An object of one embodiment of the present invention is to provide a needle counter device which is configured to contain a needle held with minimal insertion force or simple in incidental contact to be able to ensure that the needle remains in the location that was assigned by a needle. health worker. Another object of an embodiment of the present invention is to provide a needle counter device that facilitates good illumination of the placed needles to ensure their easy visibility for placement and counting at the end of the procedure. Still another object of an embodiment of the present invention is to provide a needle counter device which is configured so that the needles remain vertical where they are placed and are not prevented from being observed by the background color of the retaining means. Yet another object of one embodiment of the present invention is to provide a needle counter device that has easy-to-read numeric indicia. Still another object of an embodiment of the present invention is to provide a needle counter device which is: very inexpensive to manufacture, constructed of very few parts, capable of being assembled in a few stages, and designed in a manner that facilitates automated process. Briefly, and in accordance with at least one of the above objects, one embodiment of the present invention provides a needle counter device using an adhesive disposed in one or more grooves. Although the grooves may be provided in many different cross-sectional shapes, the grooves are preferably V-shaped to preserve the amount of adhesive that must be provided to fill the grooves. The adhesive provides strong instant grip with the contact, but also provides very low resistance to penetration of the needle. In other words, it is easy to sink a needle into the adhesive, but it is difficult to remove the needle from the adhesive. The adhesive can be a "hot melt" adhesive of synthetic polymer which quickly conforms to the surface of the needle and due to its low durometer, displays remarkable adhesion to still very fine needles distributed with a force equal to no more than own weight of the needle. Preferably the properties of the adhesive are such that pulling an applied needle tends to cause the adhesive to elongate at the junction or "legs of attraction" in such a way that the needle, when released, is resiliently pulled back toward the surface of the adhesive. adhesive. Preferably the adhesive is thicker than that of the common film type, and is injected into the grooves, so that the aspect ratio of the applied adhesive is more like that of an account than that of a film. The adhesive material can be applied in such a way that it rises visibly on the housing surface to present a very thick lens for inserting the needle or simply placing it against the sticky surface. Out of economic need, preferably the device is designed for ease of manufacture and assembly in order to facilitate automated construction. Preferably, the device includes a latch mechanism for securing the device in a closed condition. The latching mechanism preferably consists of a latching member which is integrated into the edge of a lid of the device which is configured to be received: a corresponding hole or opening in a base of the device, since this arrangement simplifies the manufacture, as well as increases the deflection resistance and propagates the opening load (i.e., the load used to disengage the latch mechanism) throughout the side of the part instead of having the load concentrated in a narrow portion. This latching mechanism can be implemented in conjunction with a needle counter device as described above, wherein the needle counter device uses an adhesive disposed in one plus furrows. Alternatively, the latching mechanism may be implemented in conjunction with a more conventional needle counter device such as that which does not include an adhesive disposed in one or more grooves. BRIEF DESCRIPTION OF THE DRAWINGS The organization and form of the structure and operation of the invention, together with several objects and advantages thereof, can be better understood by reference to the following description, taken where together with the attached drawings, wherein: Figure 1 is a top perspective view of a needle counter device which according to a preferred embodiment of the present invention is showing the device partially open; Figure 2 is a bottom perspective view of the needle counter device shown in Figure 1, showing the device partially open; Figure 3 is a view similar to Figure 1, but showing the device in cross section; Figure 4 is a view similar to that of Figure 1, but showing a longitudinal base of the device; Figure 5 is a view similar to Figure 1, but showing a device cover in longitudinal section; Figure 6 is a close-up view of the needle counter device, showing a needle inserted in location 1 and a needle reclined in location 11; Figures 7 and 8 illustrate a series of types of needles offered by a vendor in the market; Figure 9 illustrates a needle counter device which is in accordance with an alternative embodiment of the present invention, wherein a large foam cushion with orifice is provided on the inner surface of the cap; Figure 10 is a top perspective view of a needle counter device (in an open condition) which is in accordance with yet another embodiment of the present invention, wherein the device includes "an improved latching mechanism; is a view of the needle counter device of Figure 10, showing the device in a closed condition; Figure 12 is a close-up view of the hook mechanism of the needle counter device shown in Figures 10 and 11; 13 is a cross-sectional view, taken along line 13-13 of Figure 11, of the needle counter device shown in Figures 10 and eleven; Figure 14 is a view very similar to Figure 12, but at an angle so that the interior of the device can be observed; Figure 15 is a cross-sectional view of one of the joints of any of the needle counter devices shown in the previous Figures. Although the invention may be susceptible to modalities in different forms, specific embodiments of the invention will be described in detail in the drawings, and will be described in detail herein. The present description will be considered as an example of the principles of the invention and is not intended to limit the invention to what is illustrated and described herein. Figures 1-6 illustrate a needle counter device 10 which is in accordance with a preferred embodiment of the present invention. The needle counter device provides a mechanism containing a needle held with minimal insertion force or simple incidental contact to be able to ensure that the needle remains in its location that was assigned by a health worker. The needle counter device also facilitates good illumination of the placed needles to ensure easy visibility for placement and counting at the end of the procedure. Furthermore, the needle counter device stipulates that the needles remain vertically where they are placed and that the visualization thereof is not obscured by the background color of the retaining means. The device is very economical to manufacture, it is constructed of very few parts, it is capable of being assembled in a few stages, and it is designed to facilitate an automated process. Along with the description of the needle counter devices, terms such as needles, blade, cutting elements, etc., are used with the understanding that the needle counter device is meant to be used in conjunction with a surgical device, such as a surgical device. that has a sharp edge or tip, which the healthcare provider may wish to be aware of during the surgery. As shown in Figures 1-5, the device The needle counter includes a base 12 and a cover 14 which is pivotally connected to the base 12, so that the device 10 can be opened and closed very similar to a book. The base 12 and the lid 14 can be of a two-piece construction having a joint snap assembly, thereby forming one or more joints 16. Alternatively, the device could be constructed in a one-piece molded form, connected by medium of an integrally molded movable joint. Independently, preferably the device 10 is very economical to manufacture, build or very few parts, capable of assembling in a few stages, and designed to facilitate an automated process. Preferably, the lid 14 provides a generally planar body portion 18, and a wall 20 which is disposed on the periphery of the portion 18 of the main body. The latching structure 22 is preferably provided in the lid 14 and a corresponding orifice 24 or other corresponding structure is provided in the base 12, so that the device 10 can be closed, and tends to remain closed unless it is intentionally opened. The step 14 is preferably about two thirds of the overall height of the device 10 when the device 10 is closed. This provides sufficient space under the lid 14 to close and contain captured suture needles retained by the base 12. As shown in FIGURE 2, a layer 17 of adhesive with a release cover 19 can be provided on the outer surface 21 of the lid 14, where in use, a user can peel off the cover 19, thereby exposing the adhesive layer 17, the adhesive layer 17 can be pressed onto a surface, thereby securely, though removably, mounting the needle counter device. on the surface. As shown in FIGURE 1, a thin layer of the adhesive 26 can be provided on the interior 28 of the lid 14, to retain the used surgical blades. Alternatively, layer 26 may be a magnetic surface. Additionally a piece of elastic foam 29 can be provided on the interior 28 of the lid 14, where the foam can be used to temporarily "park" a suture needle, if desired. Needles that have joined suture and are still in use can "park" in the foam until the end of using the suture. As will be more fully described in the following in conjunction with FIGURE 9, foam 29 can be provided as having an arrangement of holes to facilitate the removal of parked needles and scalpels. The base 12 is preferably generally planar, but includes one or a plurality of grooves 30 that are filled with a cutting element retention means, the sticky adhesive elastomer 32 (due to the need to illustrate detail of the grooves themselves in the Figures). 1, 4 and 5, the adhesive is only shown in Figures' 3 and 6). Preferably the upper surface 37 of the adhesive 32 is under the upper part 39 of each groove 30, since this takes up less material, as well as preventing the counters of needles and other instruments, sutures, surgical garments and the like from inadvertently coming into contact with the sticky adhesive The grooves 30 can be formed in a variety of shapes in cross section. Figures 1, 3, 4 and 5 illustrate the grooves 30 as having a V-shaped cross section and such a form is preferred. The V-shaped groove is configured to provide the depth needed to bury the tip of the needles and sufficiently wide to provide a reasonable target for users to guess. However, other shapes, such as rectangular cross-section grooves, are entirely possible. Although it is possible to provide grooves having a rectangular cross-section, those grooves formed in the V-shaped configuration will considerably save an adhesive use compared to a rectangular groove design of the same width. Not only in the preferably V-shaped grooves but also preferably each groove 30 is relatively narrow having a width (dimension 31 in Figure 3) of, for example, 0.381 centimeter (0.150 inches). The depth (dimension 33 in Figure 3) of each groove 30 may be 0.483 cm (0.190 inches), although the depth of the adhesive may be, for example, 0.305 centimeters (0.120 inches). The adhesive can be provided by being much more superficial, as superficial as 0.152 centimeters (0.060 inches in height). Not only do they have a lower cost to manufacture the narrow grooves 30 filled to a low level with adhesive 32, but also the narrow grooves 30 tend to provide that the needles inserted in the adhesive 32 are retained in a vertical position by the side walls 35. (see FIGURE 3) which defines each groove 30. If the grooves are provided as being too wide, the needles inserted in the grooves may stop, making them more difficult to count. As a result of stipulating that the grooves are narrow and that the side walls 35 are closer together, the inserted needles are arranged in a much more vertical and orderly fashion for faster recognition and counting. This benefits the user a lot. Additionally, because the grooves 30 are narrow, the needles will tend to be inserted longitudinally instead of transversely in the grooves 30. Thus the needle guidance is assisted by the side walls.
. In addition, the needles, if desired, can be pressed deep into the adhesive 32 instead of spreading on it. This makes the needle distribution process very easy. Regardless of the shape of the grooves 30 ',' preferably the sides 34 of each groove 30 are aligned with an interrupted flange under a series of separate pickets 36 which serve to prevent an accidentally placed surgical instrument from making unintentional contact with the adhesive. 32. Preferably, numerical indices 38 are provided along each groove 30 to provide rapid visual assistance for the count process at the end of the procedure. For simplicity, the indices 38 are shown only in Figure 6. Although the grooves 30 are shown to be vertical with respect to the indices 38, they can in fact be provided as being horizontal. An example of the function of the ridges 36 and the numerical index 38 is illustrated in Figure 6, where one needle 40 will be inserted into adhesive 32 at location 1, and another needle 42 has been placed on the adhesive on location 11. Ideally, base 12 is one color, such as red, which facilitates good illumination of the needles placed to ensure easy visibility for placement and counting at the end of the procedure. Additionally, preferably the adhesive 32 is translucent and is provided in a color, such as a honey color, which does not impede the full view of the needles. Preferably the adhesive 32 which is retained in the grooves 30 is a sensitive elastomeric adhesive - the pressure, of a single part, too viscous and is such that it can be distributed towards the hot groove (s), where it settles rapidly as cool Preferably, the adhesive 32 is clear and does not require curing, solvents or smoke handling, and is therefore stable and ideal for use in a simple automated online assembly system. This type of adhesive is well suited for the dense application required by the groove design. Preferably, the adhesive is homogeneous. Many different adhesives can be used in conjunction with the present invention. The adhesive can be as described in the North American Patent No; 5, 869,562 (see specifically Example 2). U.S. Patent No. 5,869,562 is incorporated herein by reference in its entirety. Main benefits of adhesive-filled groove procedures include: 1) The provision of a deep concentration of adhesive in which the tip of a needle can be inserted for capture by means of eny-ace; 2) The provision of a sufficient adhesive volume to allow large elastic extensions to be maintained and resist the removal of any needle to which the adhesive has been attached; 3) Too much initial viscosity lowered conditions of minimum needle contact pressure. The adhesive-filled groove process is designed to exploit the benefits of manufacturing and performance of pressure-sensitive adhesive (PSA), elastomeric, fast-setting, smoke-free and solvent-free materials with a 100% solids content. they can be applied quickly in deep grooves inside the needle counter. The strength of an adhesive bond is generally understood to be proportional to the contact area, in this way more contact area translates directly into a stronger connection. The thickness of the adhesive has a significant effect on the resistance to detachment of a bond as well. This is due to the viscoelastic nature of the adhesive. With elastomeric adhesives, thicker bond lines will generally result in greater peel strength. Viscoelastic adhesives also perform better when loaded in a shear stress commission than in a peel condition. The nature of the needle counter design provides a much larger surface area for needle to contact, moisten and hold by the adhesive. This is because the tip of the needle can go deep into a groove full of adhesive, where the adhesive is not only viscous on its surface, but also internally. In all the buried surface of the tip of the needle therefore is in full contact co ?. the viscous adhesive. In comparison, a thin film adhesive applied to the foam, paper or paper substrate of prior art needle counters provides the minimum bond line thickness. In some configurations of the needle counter of the prior art, the contact area of the adhesive against the piercing needle is little more than the circumference of the needle multiplied by the thickness of the adhesive film.
The design also allows the visco-elastic properties of the adhesive to be fully exploited with the part of the retention mechanism by minimizing the restrictions against elongation of the adhesive, which retains a needle. The elongation for these adhesives can run from 500% to 5000%. This freedom to stretch or stretch in response to the load resists the release of the needle by keeping the adhesive in shear for a longer time, extending the nucleation phase and delaying the onset of link failure due to detachment. Conversely, the paper or foam substrate of the prior art examples serve to stiffen the adhesive film layer. For the. thus, the amount of adhesive available to feed or stretch elastically by itself under load is less, since this property depends on the thickness of the adhesive. As a consequence, nucleation. it is reached before, accelerating the start of the link failure. Under conditions of use, with thin stiffened adhesive films, very little travel distance is allowed per substrate before elongation and the limits of detachment are reached. Stiffened adhesive films occur much sooner because of their inability to retard detachment by stretching themselves elastically. The negative consequence of the strength provided by the rigid substrate is that the adhesive is released from the shear stress and enters a release condition sooner. A further advantage of the design described above, which utilizes "the deep groove of adhesive in place of a conventional thin film adhesive, is the minimization of the adverse performance that results from any degradation of the surface viscosity due to storage or environmental conditions. Preferred adhesives for the needle counter device should also be suitable for: the penetration of any type of needle used by medical procedure.Since the variety of needles available is virtually unlimited, the adhesive used in this application must be receptive to needles 'very pointed, ranging from 0.23 cm (.009") diameter needles to half the size of a flange, blunt-tip security needles with a diameter of 0.157 cm (.d2") (see, for example, Figures 7 and 8 illustrating types: of a vendor's needles) -All types of needles must be accommodated and the insertion force to penetrate the adhesive It must not be excessive. The penetration requirements for these needles mean that the adhesive used in a needle counter device should be soft and stable and not be so hard that insertion of the needle is difficult. Prior art device substrate coating materials also tend to reinforce and harden the immediate underlying surface against penetration of the needle. In very small and blunt-tip safety needles they are particularly difficult to insert through this reinforced underlying placement. The design of the needle counter device described herein provides a deep homogeneous body of adhesive to receive the needle that is free from any adjacent surface placement of hard reinforcement and therefore highly receptive to "all types of needles. for this application has a sufficiently low durometer and resistance to penetration on its surface under conditions of use to facilitate the insertion of the needle.Experience has shown that adhesives that has a durometer that varies from 10 to 24 Shore "A", preferably in the range of 12 to 20 Shore "A", they work well in this application PRESSURE SENSITIVE ADHESIVES (PSA) PSAs are generally defined as being permanently sticky that do not require activation by water, solvent or heat They are inherently soft materials formulated to provide a balance of adhesive properties and cohesive strength. This balance depends on. the viscoelastic nature of the adhesive as well as the additives used in its formulation. The primary bonding mode for a pressure-sensitive adhesive is not chemical or mechanical but rather a polar attraction of the adhesive to the substrate. Pressure is required to provide sufficient moisture on the surface of the substrate to provide adequate adhesion. The cohesion or internal resistance of the adhesive must be high enough to withstand stresses due to plastic deformation and shear stress in the end use application. With PSA, the surface energy of the intended substrate can dictate the type of base polymer that is used. Polar polymers such as acrylic adhesives have a tendency to adhere better to high surface energy substrates (eg, metals, glasses, etc.) by virtue of their dipole-dipole interaction and / or hydrogen bonding. Non-polar adhesives tend to adhere to other substrates of high and low surface energy (eg plastics and EPDM rubber). Hot melt adhesives are composed mainly of thermoplastics or materials that appear to be thermoplastic. Elastomer-based PSAs typically have a synthetic rubber as the base polymer. Styrene block copolymers or styrene butadiene rubbers are commonly used as the synthetic resin in these formulations.The styrenic block copolymer (SBC) is synthesized by anionic polymerization such as styrene-isoprene (SIS) or styrene-butadiene. Styrene (SBS). 'SBCs offer high cohesive strength similar to that of chemically vulcanized rubbers, because the crosslinks in these polymers are still physical rather than chemical, they are reversible allowing the liquid type flow when heated over the Vitreous transition temperature (Tg) of polystyrene molecular end blocks Some polyamide polymers are also formulated for high performance hot melt PSAs Ethylene vinyl acetate (EVA) based adhesives are the type of fusion in hot, usually more common purpose, but suffers from poor adhesion to low energy substrate. Hot melt power bases are used but are probably also not suitable for the needs of the needle counter device described herein as SEC and polyamides. Since a low melt melt viscosity is required, most of the polymers used as the base for hot melt adhesives are semi-crystalline in character. SBCs are well known for their low temperature flexibility combined with heat resistance and most types are used for pressure sensitive applications. Most block copolymers can be attached after the adhesive has cooled. Polyamides are high-performance hot melts that are used when bonds need to withstand high temperatures (176,667 ° C (350 ° F)) as well as fuels or solvents. They are among the strongest hot melt adhesives and can be formulated to be soft and viscous or hard and rigid depending on the polymer and resin used. Typical performance characteristics for SBC and polyamides are: 1. High heat resistance. 2. Excellent resistance to cohesion. 3. Excellent resistance to detachment. 4. High viscosity-Excellent fast adhesion. '5. Low volatile emissions. 6. Low shrinkage after application. See your solvent-based adhesives. 7. Achieves high viscosity very fast after application. 8. High solids content facilitates extremely thick applications. 9. The non-polar nature provides adhesion to both non-polar substrates of low surface energy and polar substrates of high surface energy. The hot fusions of Tg. They are characterized by their vitreous transition temperature (Tg) which is currently a composite of several physical attributes. It reflects the behavior of the adhesive and is a way to understand the molecular movement that occurs in a polymer system which is a fundamental concern when considering the adhesion, cohesion and other properties of polymers. At low temperatures, a polymer exists as a solid in which the molecular segments vibrate smoothly or independently. When the temperature increases, a point is reached at which the molecule suddenly becomes more flexible and mobile. This increased flexibility occurs when the molecular vibrations become strong enough to shake the segments of adjacent chains and allows the molecules to slide freely within themselves. The temperature required for this to occur is known as the glass transition temperature, Tg. It is a transition of the polymer from a vitreous to a gummy state where, when the temperature rises further, the distance between the molecular segments increases. This can be seen as a different increase in the inclination of the polymer volume as a function of temperature. The transition reverses with cooling. Tg and COHESIVE PROPERTIES. The strength of an articulated adhesive at elevated temperatures is indicated much more by its Tg. The Tg must be above the top usage temperature of adhesive for good bond strength and resistance to chattering. The peel strength, however, will be low when the Tg is noticeably above the upper use temperature and the low temperature performance of a relatively high Tg adhesive is limited due to brittleness. In general, a bond strength of the adhesive increases and is maximized near the Tg. Tg and its PRESSURE-SENSITIVE PROPERTIES. Two requirements for PSA are that they must experience plastic flow in contact and that the surface of the substrate must moisten. Polymeric materials can only be pressure sensitive (flowable under light pressure) on their Tg. In this way, most PSA materials have one, Tg near or below room temperature. Having a Tg below room temperature does not mean that these adhesives will achieve high cohesive strength since in this gummy state the molecules are also mobile enough to flow under load until the bond fails. The ideal Tg therefore is a compromise based on the performance needs and therefore it is preferred that it be around4 from -29 to -5 ° C. It can be adjusted through the formulation, although generally, low Tg values ensure very high viscosity, and the Tg medium gives the optimum resistance to loosening and acceptable cohesiveness. Plasticizers and flexibilizers can be added to lower the Tg of adhesive polymer by inserting a cohesively weak region of material between the base polymer molecules. ADHERENT RESINS. Adhesive resins can also be grouped to improve the "fast grip" of the adhesive by reducing the viscosity of the polymer to give a faster, more complete wetting of substrate and to raise the Tg of the adhesive (plasticizers achieve the first objective but not the second ). Reducing the viscosity makes bond formation easier and raising the Tg makes bond failure more difficult. Wetting is improved when the adhesive polymer is fluid and is in a molecularly mobile state in which molecular movement allows the adhesive to compete with contaminants for binding to the surface sites. VISCOSITY MECHANISMS. Viscosity is defined as the property that allows an adhesive to form a bond of edible resistance with the surface of another material with brief contact and at low pressure. It is implicit that the adhesive separates cleanly from the surface, without any macroscopic residue. Viscosity consists of two processes. The first is a bonding process that results from the adhesive deformation and the flow in contact by the substrate to allow a union through the polar attraction, after which, the second phase, a deformation or process of outcome may occur in which the adhesive is separated by detachment from the surface. The viscosity or resistance to the separation of the substrate depends on: 1. Ease of deformation, or in our application, penetration of the adhesive during the bonding stage (this determines the amount of interfacial contact area on which the forces of attraction can develop polar). 2. Resistance to separation of contact areas. 3. The degree of deformation of the adhesive and, therefore, the amount of energy dissipated as friction heating during the process of denouement. Obviously, quantifying the viscosity property is mostly influenced by the experimental method and the parameters. Not only depends on the nature of PSA and adhesion, but also on the pressure and contact time. In addition, because the response is a viscoelastic response, the temperature and the release rate play an important role in the measured resistance. In other words, viscosity is defined as the test used to measure it. In this way it is important to know what kind of tests are used, what kind of information is given and its limits. Related standards are published by national groups, such as ASTM, and by professional associations. Standardized tests are well defined and require equipment that is readily available. They are a bridge between laboratories, users, distributors, etc. in the industry. Example of standard viscosity test include rolling ball viscosity test, loop viscosity test, peel viscosity test and viscosity test with probe. Standard test descriptions can easily be found in the industry and specifically on the Internet. Specifically, the descriptions can now be found, for example, at www. specialchem4adhesives. com. The equipment for performing these standard viscosity tests can also be easily found in the industry (ie, rolling ball viscosity testers, loop viscosity testers, viscosity testers with probe, etc., are readily available in the market). FAILURE OF LINK UNDER LOAD. The phenomenon observed during the separation of an adhered body and a viscous adhesive follows a pattern in which: a) Initially, when the adhered body is removed, the tension increases linearly with the displacement of the body. b) Then, the voltage begins to increase in a non-linear proportion due to nucleation (the appearance of cavities in the interconnection). c) The force reaches a maximum when the nucleation is stopped. d) Then a decrease in tension occurs when the cavities, perpendicular to the interconnection begin to grow. e) The outcome then begins to occur when 1) the cavities grow until coalescence occurs and the tension decreases to zero (adhesion fails), or 2) the cavities grow to a critical size, fibrillation appears and the fibrils lead to a failure of adhesion or a cohesive failure within the adhesive. VISCOSITY MEASUREMENT. Viscosity is defined by the test used to measure it. A brief explanation of the common measurement methods relevant to the present application is discussed in the following: 1. ROLLING BALL VISCOSITY TEST (RBT). FThis simple, frequently used test is one of the oldest. Gives a brief idea of adhesive behavior and is easily understood. It provides a quick comparison of high viscosity adhesive. The distance a ball travels on a ramp is inversely proportional to the viscosity; the greater the distance, the lower the viscosity of the adhesive. In the procedure, a rolling object (typically a steel ball) is placed on top of an inclined sliding guide followed by a horizontal adhesive face up. The ball is allowed to roll towards the sliding guide and the relevant measure is the distance the ball travels along the surface of the adhesive. The test method is represented in ASTM-D3121. 2. PROOF OF VISCOSITY WITH PROBE. Analogous to pressing a thumb on the adhesive and removing it, this test allows more accurate and reproducible results. Mechanical testers viscosity probe put a probe into contact (ball or cylinder of various materials) in a controlled and pressure ratio, and wait a given measures necessary to take a specific proportion delay force. The test method is based on ASTM-D 2979-00, based on the Viscosity Test with Poliken Probe. Other tests commonly associated with hot melt PSAs include: VISCOSITY, to determine the melt viscosity of the hot melt adhesive at a specific temperature. ASTM-D 3236-88 RING AND SPHERE SOFTENING POINT (RBSP), to determine the softening point of the hot melt adhesive. ASTM-E 28-67 TEMPERATURE OF EFFORT ADHESION FAILURE CUTTER (SAFT), to test the heat resistance of hot melt adhesives in the shear mode under a predetermined load and a constantly rising temperature. ASTM-D 4498-85. 180 DEGREES, to test the adhesion of pressure sensitive adhesives to stainless steel panels or high density polyethylene (HDPE) panels. ASTM-D 3330. MOMENT OF FAILURE OF STATIC CUTTING EFFORT, to test the plastic deformation resistance of hot melt adhesives in the shear stress mode. ASTM-D 2294 and PSTC-7. FUSION FLOW INDEX (MFI), to determine the relative viscosity of thermoplastic polymers (related to the molecular weight and structure of a polymer). ASTM-D1238-9. Desirable physical properties of the adhesive used in conjunction with the needle counter device shown in Figures 1-6 and described above are: 1. Type: Hot Melt PSA, high viscosity. 2. Ingredients: Approved under Reg. Fed. 21 CFR 175.105 3. Ring and Ball SP: 82 ° C (180 ° F) at 100 ° C (212 ° F) 4. Support Sterilization: ETO, Gamma, Beam of electrons 5. Color: Luminous for needle display 6. SAFT F Degrees: 151F +/- 2F (Static Adhesion Failure Test) 7. Detach at 180 degrees Ibs / inch = / > 3.2 8. Ozone loop viscosity. / inch = / > 86 7. Polymer Polar Nature: It is preferred non-polar, polar possible. 8. Viscosity: (Brookfield RVT) 149 ° C (300 ° F) 10,000 (cP) -16,000 (cP) 177 ° C (350 ° F) 3,600 (cP) -6,600 (cP) 9. Tg: -29 ° C (~ 20 ° F) at -5 ° C (23 ° F) 10. Hardness Margin: 12 to 20 Shore "A" 11. Viscosity with Rolling Ball: NA 12. Viscosity with Probe: N.A. 13. Application Temperature: < 177 ° C (375 ° F) Several types of surgical blades are often used during a surgical procedure. The blades are of different styles, they can be interchanged periodically in the handle of the escarpment, the removed blade is available in later reuse. In these cases, the layer 26 of thin adhesive within the cover 14 of the needle counter must be suitable for temporary parking. The layer 26 can be provided as being a magnetic sheet. However, although the magnetic force tends to retain the blades well enough, thin blades can be difficult to take on a magnetic surface. As mentioned in the above, the foam cushion 29 that is provided on the interior 28 of the lid 14, can be provided as having holes. FIGURE 9 illustrates the situation where the foam cushion 29a covers at least half of the surface of the lid and includes a plurality of through holes 52 accommodated in a grid design. Specifically, the cushion 29a can be approximately 4.76 mm. (3/16") thick and has through holes of 6.36 mm (1/4 inch) accommodated in a grid pattern of 1.27 cm x 1.27 cm (0.5 inch x 0.5 inch) (where the center of each hole It is about 1.27 cm (0.500 inch) apart over the entire area of the cushion.The surface of the cushion, which is softer than a magnet, prevents damage to the brittle cutting edges of the scarps and provides sufficient grip to avoid "The blades slide. The blades placed on the perforated surface of the cushion will inevitably open one or more holes. The location of the bridge provides a place to place the tip of the forceps under the blade to retrieve it for reinstallation of a scarf handle when required. If a hole is not convenient, the adhesion of the foam cushion allows the understanding by the tips of the forceps to slide under a blade. When a foam cushion like this is used, the retention of the blades for removal is achieved either by sinking the tip of the scarp into the adhesive filled through or by distributing it to a portion of the lid not covered by the foam and having a light coating of a sticky adhesive material 26 in place. This foam could provide double work, functioning as a needle placement station, as well as a scalpel placement. Figures 10-14 illustrate a needle counter device 10 which is in accordance with an alternative embodiment of the present invention. The needle counter device 10a used in Figures 10-14 is very similar to the needle counter device 10 shown in Figures 1-6 and 9, but by the latch mechanism 15a. For example, very similar to the needle counter device 10 described in detail in the foregoing, the needle counter device 10 preferably has grooves 30a filled with adhesives with indications of the associated needle counter (indicated with points 38a in Figure 10, but see Figure 6 and associated description for details regarding the indicia) at its base 12a, and a thin layer of adhesive or a thin magnetic surface 26a may be provided on the interior 28a of the cap 14a, to retain the surgical blades used. The cover 14a and the base 12a are preferably connected by an articulation 16a; however, it can be an integral part of each other and have a mobile articulation between them. In addition very similar to the 10th needle counter device, the needle counter device 10 can have a piece of elastic foam 29 on the inside 28 of the lid 14a, where the foam can be used to temporarily "park" a suture needle if desired . The foam 29b may or may not have through holes, as shown in Figure 9 (see foam 29a in Figure 9). Also, a layer 17a of adhesive with a release cover 19a can be provided on the outer surface 21a of the cover 14a. All this is described in detail in the foregoing together with the device 10 needle counter. As shown in Figure 10, the base 12a includes an embossed edge 102. As shown in Figures 11, 13 and 14, when the lid 14a closes and engages, a rim 104 of the lid 14a sits against a surface plane 106 formed on the base 12a. The base 12a is preferably flat, and the raised flange 102 extends upwardly from the flat surface 106 of the base 12a and serves to: 1) locate the lid 14a when the lid 14a is closed, as shown in Figure 11; 2) provides structural support for the thin lid 14a against dislodging by transferring that load to the base 12a when the device 10a receives an impact, "such as if it fell; 3) provides a tortuous path against the escape of a needle or element. contaminated shear contained within the closed structure; 4) avoids damage in relation to movement between the retaining device 15a and the articulation 16a due to lateral impact when resolving the impact loads within the structures of the lid 14a and the base 12a With respect to the retention mechanisms 15a, as shown in Figures 10-14, the retention mechanism 15a consists of a retention member 22a and a corresponding hole 24a in the base 12a and the retention member 22a is integrated at the edge 23a of the lid 14a As shown in Figure 10, the side 25a of the lid 14a includes a surface 27a, and the retaining member 22a extends from, and is integrated into with the surface 27a and has a hook portion 129a at its end 31a. In other words, the latching mechanism 15a comprises an integral projection 22a which directly depends on the wall 27a of the cover 14a and penetrates the hole 24a in the base 2a, thereby securing the device 10a in a closed condition. The retention member 22a can be inserted and removed in the hole 24a so that the device 10a can be secured in the closed condition, as shown in Figures 11-14 and tends to remain closed unless it is intentionally opened. More specifically the base 12a constitutes a flat surface 106 having a hole 24a on the flat surface for receiving the retaining member 22a. The retention mechanism 15a is configured to stipulate that the retention member 22a need not go inside or require a support ring to match. Compared to the retention mechanism (i.e., retention member 22 and orifice 24) of the needle counter device 10 shown in Figures 1-6 and 9, the retention mechanism I5a of the needle counter device 10a shown in FIGS. Figures 10-14, because the retaining member 22a which is integrated in the edge 23a of the lid 14a, simplifies the manufacture, as well as increasing the deflection resistance and propagating the opening load (i.e., the load used to open the retention member 22a of the hole 24a) on an entire side 25a of the device 10a instead of having the load concentrated in a narrow portion. As described above, the retention mechanism 15a shown in Figures 10-14 can be implemented together with a needle counter device using a device arranged in one or more grooves (see Figures 1-6 and 9 and associated description). previous). Alternatively, the retention mechanisms 15a can be implemented together with a more conventional needle counter device, such as one which does not include adhesive disposed in one or more grooves. The articulation mechanism 16, 16a (with respect to the device 10, 10a needle counter) preferably consists of a plurality of articulations (such as a pair as shown in Figures 1, 2, 4, 5 and 10), of Each one is identical and can be provided as shown in Figure 15. As shown in Figure 15, each can constitute a "U" shaped joint finger 110 providing the base 12, 12a and having a jaw 112 that effectively engages and retains a complementary hinge pin 114 which is provided in the lid 14, 14a, disposed between two panels 116, thereby retaining the shape of the hinge. Alternatively, some other suitable articulation structure may be used in conjunction with the needle counter devices 10, 10a. Although the embodiments of the present invention are shown and described, it is envisioned that those skilled in the art can visualize various modifications of the present invention without departing from the spirit and scope of the present disclosure.

Claims (29)

  1. CLAIMS 1. A needle retainer device characterized in that it comprises: a lid; an integral base with or connected to the lid and configured to retain needles, wherein an edge of the lid has an integral retention mechanism therewith, wherein the retention mechanism can be received in a corresponding hole in the base, which With this, it fixes the needle retainer in a closed condition. The needle retention device according to claim 1, characterized in that the cap includes a flange and the base includes a flat surface, where the flange of the cap sits against the flat surface of the base when the retention device of needles is closed, where there is at least one groove provided to the flat surface of the base; and a cohesive material disposed in the groove, where the cohesive material is configured to join a needle and thereafter resist the removal of the needle. The needle retainer according to claim 1, characterized in that the hole is provided on a flat surface of the base, and where there is at least one groove provided on the flat surface of the base; and a cohesive material disposed in the groove, where the cohesive material is configured to join a needle and thereafter resist removal of the needle. The needle retainer according to claim 1, characterized in that the base includes an embossed rim extending from a flat surface of the base, the raised rim configured to serve at least one of the following functions : locating the lid when the needle retainer closes; providing structural support for the lid against dislodging by transferring the load to the base when the needle retainer closes and receives an impact; providing a tortuous path against the escape of a needle or contaminated cutting element contained within the needle-holding device when the needle-holding device is closed; and avoiding damage in relation to movement between the retention mechanism and a joint of the needle retainer due to a lateral impact when resolving the impact loads within the cap and base. The needle retention device according to claim 1, characterized in that the lid and the base are two pieces of different size and shape that are configured to perform different functions. The needle retention device according to claim 1, characterized in that the base includes a surface, at least one groove provided on the surface;, and a cohesive material disposed in the groove, where the cohesive material, is set to join a needle and after-this will resist removal of the needle. The needle retention device according to claim 6, characterized in that the cohesive material is configured in a way that the needle is easier to place on the cohesive material than it is to remove the needle from the cohesive material. The needle retainer according to claim 6, characterized in that the needle retainer includes a plurality of grooves provided on the surface. The needle retention device according to claim 6, characterized in that the groove is V-shaped. The needle retention device according to claim 6, characterized in that the groove includes side walls that accommodate at an included angle between the opposite faces. 11. The needle retention device according to claim 10, characterized in that the side walls which define the groove generally prevent the needle from falling. 12. The needle retention device according to claim 6, characterized in that the cohesive material comprises a cohesive hot melt material. The needle retention device according to claim 6, characterized in that the lid is at least connected and integral to the base, the lid can be pivoted relative to the base, where the needle retention device It can be opened and closed. The needle retention device according to claim 13, characterized in that the needle retention device is configured such that once the device is closed, the device tends to remain closed unless it is intentionally opened. 15. The needle retention device according to claim 14, further characterized in that it comprises a retention structure that is configured to secure the cap and the base relative to each other. The needle retainer according to claim 13, further characterized in that it comprises a layer of cohesive material disposed on an inner surface of the lid. 17. The needle retention device according to claim 13, further characterized in that it comprises a piece of elastic foam disposed on an inner surface of the cap. The needle retainer according to claim 13, further characterized in that it comprises a layer of cohesive material disposed on an inner surface of the lid, and a piece of elastic foam disposed on the inner surface of the lid, close to the layer of cohesive material. 19. The needle retention device according to claim 13, further characterized in that it comprises a magnetic surface disposed on an inner surface of the lid. 20. The needle retention device according to claim 6, characterized. because the sides of the groove are covered with structure which are configured to prevent an accidentally placed needle from making unintentional contact with the cohesive material. 21. The needle retention device according to claim 20, characterized in that the structure which is configured to prevent an accidentally placed needle from making unintentional contact with the cohesive material comprises pickets. 22. The needle retention device according to claim 6, further characterized by comprising numerical indicia arranged on the surface, next to the groove, the numerical indicia configured to provide a visual counting aid of needles retained by the cohesive material. 23. The needle retention device according to claim 6, characterized in that the cohesive material comprises an adhesive. 24. The needle retention device according to claim 6, characterized in that the cohesive material is translucent. 25. The needle retention device according to claim 6, characterized in that the cohesive material is homogeneous. 26. The needle retention device according to claim 23, characterized in that the adhesive is at least 0.152 centimeters (0.060 inches deep). 27. The needle retention device according to claim 13, further characterized in that it comprises an articulation mechanism configured to stipulate that the cap is pivotable relative to the base wherein the articulation mechanism comprises the articulation member in the form of of "U" having a jaw configured to retain a complementary hinge pin. 28. The needle retention device according to claim 27, characterized in that the "U" shaped articulation member is provided to the base, and the complementary articulation pin is provided in the cap. 29. The needle retention device according to claim 1, characterized in that the retention mechanism comprises an integral projection that directly depends on a wall of the cap and enters the orifice in the base, thereby securing the device in a closed condition.
MXPA/A/2006/008267A 2005-08-09 2006-07-20 Needle counter device MXPA06008267A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US11199696 2005-08-09

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MXPA06008267A true MXPA06008267A (en) 2008-09-02

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