Patent Application
20090148503
The present invention relates to topical devices and methods for assisting the performance of a surgical incision. In particular, the present invention relates to topical devices and methods for reducing the risk of uncontrolled tear of a perineum following an incision.
The most common injuries to the vagina and the perineum during labor or natural childbirth delivery occur at the vaginal opening, which may tear due to excessive stretching as the baby's head passes through. The vaginal opening typically dilates to at least four inches for delivery. When dilation occurs slowly and gradually, the tissues are flexible or pliable enough to allow necessary stretching. However, when the baby descends too quickly, vaginal tissue tearing or laceration may happen. Lacerations of the vaginal opening most often occur near the midline in the posterior aspect or the part of the vagina closest to the anus, which will be referred to as perineal lacerations or lacerations of the perineum. Tears in the anterior area of the vaginal opening may also occur, but these lacerations are typically small.
Perineal lacerations are categorized from first to fourth degree in order of increasing severity. First degree lacerations, which are the most common, involve only the lining or mucosa of the vagina. Second degree lacerations involve the vaginal lining as well as deeper or submucosal tissues of the vagina. More serious lacerations involve the deeper tissues including the anal sphincter and the rectum. Third degree lacerations extend from the vaginal lining through the anal sphincter, but do not involve the rectal lining. Fourth degree tears include the vaginal lining, submucosal tissues, anal sphincter, and rectal lining.
The third and fourth degree lacerations are more challenging to repair and typically require a skilled surgeon. They are more likely to be associated with complications, including bleeding, infection, increased pain, and anal incontinence. When lacerations involve the anal sphincter, the resulted dysfunction of this muscle can cause leakage of stool or gas from the anus. Injury to the sphincter may result in long-term problems, such as fecal incontinence or the development of a recto-vaginal fistula (a small channel that connects the rectum with the vagina).
Increased risk of perineal lacerations is known to associate with women at their first vaginal delivery, delivery of a large baby, abnormal position of the baby's head, and forceps or vacuum-assisted vaginal delivery. Forceps-assisted deliveries are more likely to be complicated by vaginal wall tears and third or fourth degree vaginal lacerations.
One of the most significant risk factors that can lead to more severe lacerations is episiotomy, especially a midline or medial episiotomy. Episiotomy is an intentional incision of the vaginal opening to hasten delivery or to avoid or decrease potential tearing. Episiotomy is the most common procedure performed in obstetrics, with an estimate of one done in every three to four natural births. An episiotomy may be very beneficial in certain circumstances and may prevent the need for cesarean section or assisted vaginal delivery using forceps or a vacuum extractor. A midline or medial episiotomy is an incision of the vaginal opening along the midline, straight down toward the anus. Advantages of a midline episiotomy include lower blood loss, less pain, easy repair, and improved healing. A midline episiotomy is less likely to result in long-term tenderness or problems with pain during intercourse. However, the main disadvantage of a midline episiotomy is the likelihood for this type of incision to extend beyond the initial incision and result in a third or fourth degree tear, which involves injury or damage of the anal sphincter or the lining of the rectum.
It is believed that perineal injuries or tears may be reduced if delivery occurs in a controlled fashion, with the baby's head descending slowly and steadily through the vaginal opening. Unless there is evidence of fetal distress, letting the baby's head to rest at the vaginal opening for several minutes to allow adequate tissue stretching is thought to be beneficial. Perineum massage and warm compresses of vaginal tissues are techniques that have been tried to help the stretching process with limited success. Perineal lacerations may still occur even when good care is taken to avoid them. Although attempts have constantly been made over the years to prevent perineal trauma, there is presently no reliable method or device for preventing laceration during childbirth labor.
The pushing process by the mother during childbirth labor also results in significant forces or pressure in other tissues within or adjacent to the perineum, such as the anal sphincter muscles, the anus, the perianal tissues. As a result, the tissues can undergo excessive straining that may lead to tissue damages or trauma including strained perineal tissues, strained anal sphincter, anal tears, anal fissures, external hemorrhoid, internal hemorrhoid, prolapsed internal hemorrhoid, etc. Applied forces or pressure in the opposite direction along the sagittal plane in order to counter the pushing forces or pressure may require someone to manually push against the tissues or prevent the tissues from pushing forward along the sagittal plane with one or both hands. A device applying or resisting a compressive force or pressure along the sagittal plane against the perineum may be used to achieve the same objective, but it is not expected to help resist perineal laceration initiated at the vagina. Excessive compressive force or pressure by a device may adversely affect the tear resistance of the perineum. Furthermore, compression against the tissues in the perineum close to the vagina may adversely affect the delivery or the baby.
Limiting or preventing tissue damages including perineal laceration, especially the third or fourth degree laceration, is necessary to reduce trauma and complications associated with vaginal childbirth delivery. Previous attempts or techniques have yet proven to be effective or consistent in prevention or reduction of perineal laceration or other tissue damages. A need therefore exists for a device and a method to help reduce, limit or prevent laceration or tissue damages during natural childbirth delivery. The present invention addresses these needs.
In general, the present invention provides topical devices for assisting the performance of a surgical incision and methods of making and using the same. A topical device of the present invention comprises a flexible patch that comprises a tear-resistant support layer and an adhesive layer disposed thereon.
In one aspect, a topical device of the present invention further comprises a high tear-resistant reinforcement layer disposed on the support layer or between the adhesive layer and the support layer.
In another aspect, a topical device of the present invention is adhesively attached, affixed, bonded, or secured to a tissue, adjacent to an incision that was or will be made in the tissue, wherein at least a portion of the topical device is disposed substantially nonparallel to the incision.
In still another aspect of the invention, topical devices and related methods are provided, wherein a topical device comprises a topical patch, which comprises a support layer and an adhesive layer. The topical device is configured to be adhesively attached, affixed, bonded, or secured to, at least, a portion of the perineum without covering the anal aperture in order to reduce, limit, or prevent perineal laceration. At least a portion of the support layer is made of a tear-resistant material to provide tear-resistant support to the perineal tissues. The topical device has a shape and size that are suitable for attaching, affixing, bonding, or securing to the perineal area between the vagina and the anus without covering the anal opening. The adhesive layer provides secured attachment of the topical patch to the skin or dermal tissues of the patients, and thereby can transfer the tensile and shear stresses from the underlying dermal tissues to the support layer. The topical patch is fixedly attached to the perineum substantially parallel to a plane that is substantially tangent or parallel to the perineum and substantially transverse to the sagittal plane. In some embodiments, a release liner covering the adhesive layer and being releasable therefrom is used to protect the adhesive layer prior to use. The release liner is typically removed and discarded before the topical patch is attached to the perineum.
In still another aspect, the topical device is flexible such that, when attached to the tissue, it can be formed to follow the contour of the tissue surface.
In a further aspect, the adhesive layer comprises a biocompatible adhesive. As used herein, the term “biocompatible” means incapable of inducing an adverse reaction in a patient on whom the device is attached. Such adverse reaction can include, for example, allergic reaction, inflammatory reaction, irritation, burning sensation, or itching.
In yet another aspect of the invention, the topical device is configured to be adhesively attached, affixed, bonded, or secured to, at least, a portion of the perineum and completely or substantially surround the anus without covering the anal aperture in order to reduce, limit or prevent perineal laceration and anal tissue straining, respectively. At least a portion of the support layer comprises a tear-resistant material in order to provide tear-resistant support to the perineal tissues. At least a portion of the support layer can optionally comprise a semi-stretchable or non-stretchable material to provide stretching-resistant support to the perineal tissues. The topical device has a shape and size that are suitable for attaching, affixing, bonding, or securing to the perineal area and the perianal area between the vagina and the anus without covering the anal opening.
In yet another aspect of the invention, a topical device is configured to be adhesively attached, affixed, bonded, or secured to, at least, a portion of the perineum, completely or substantially surround the anus and cover the anal aperture in order to reduce, limit or prevent perineal laceration, anal tissue straining, and anal tissue extrusion, respectively. At least a portion of the support layer comprises a tear-resistant material in order to provide tear-resistant support to the perineal tissues. At least a portion of the support layer can optionally comprise a semi-stretchable or non-stretchable material to provide stretching-resistant support to the perineal tissues. The support layer has a shape and size that are suitable for attaching, affixing, bonding, or securing to the perineal area and the perianal area between the vagina and the anus with substantial covering the anal opening. The adhesive layer attaches, affixes, bonds, or secures the topical device to the skin or dermal tissues of the patients, and thereby can transfer the tensile and shear stresses from the underlying dermal tissues to the support layer. In certain embodiments, a release liner can be included and used, as disclosed hereinabove.
In still other aspects of the invention, topical patches of selected configurations (e.g. shape, size, thickness, materials, reinforcement, etc.) when used according to a method of the present invention can reduce, limit or prevent midline or medial laceration. Topical patches of appropriate configurations when secured at an appropriate location on the perineum according to a method of the present invention can reduce, limit or prevent medial episiotomy cut from extending further toward the anus. Topical patches of selected configurations when used according to a method of the present invention can reduce, limit or prevent third or fourth degree laceration. Topical patches of appropriate configurations when used according to a method of the present invention may also divert or deflect laceration from midline or medial direction to mediolateral direction. Topical patches of appropriate configurations when used according to a method of the present invention can bias a diverted mediolateral laceration toward a predetermined side or direction. Topical patches of appropriate configurations when used according to a method of the present invention can divert laceration to mediolateral direction and then limit such laceration from further propagation or advancement after extending to a certain length.
In still another aspect of the invention, methods of use of the topical devices are provided. A method includes adhesively attaching or affixing a topical patch of the present invention onto the perineum before or during natural childbirth delivery, wherein an adhesive layer of said topical patch comes into contact with said perineum. The method of use may further include preparing the perineum area prior to attaching or affixing the topical patch, wherein preparing the perineum area includes shaving, waxing, washing, cleaning, disinfecting, conditioning, treating, anesthetizing, wiping, drying, or a combination thereof. The method may also include removing the release liner in multiple stages. The method may further include orienting and positioning the topical patch prior to patch placement. The method may include using additional adhesive or adhesive tape to further secure or reinforce the topical patches. The method may include removing the patch after delivery.
The method concerning the use of topical devices or topical patches may optionally include additional support by an applicator to: 1) facilitate placement and bonding of the topical patch onto the perineum prior to or during childbirth delivery; 2) improve or maintain adhesive bonding of the topical patch to the perineum during delivery; 3) prevent premature debonding or delamination of the topical patch during delivery; 4) fix, repair or reapply premature debonding or delamination of the topical patch during delivery; or 5) remove the topical patch after delivery. The method may also include direct support of the topical patch by one or both hands of a medical staff instead of using the applicator. Other features and advantages of the present invention will become apparent from the following detailed description, claims, and the appended drawings.
For the purposes of promoting an understanding of the principles of the invention, reference will now be made to preferred embodiments and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Alterations, modifications of the invention, and further applications of the principles of the invention as illustrated herein, are contemplated as would normally occur to one skilled in the art to which the invention relates.
As used herein, the term “tear-resistant” means capable of resisting significant stress and/or deformation without experiencing loss of integrity.
As used herein, the term “stretchable” means capable of being stretched or expanded in at least a dimension more than 50% of the non-stretched or non-expanded dimension without irreversible damage or loss of integrity to a device or material. The term “semi-stretchable” means capable of being stretched or expanded in at least a dimension up to 50% of the non-stretched or non-expanded dimension without irreversible damage or loss of integrity to a device or material. The term “substantially non-stretchable” means capable of being stretched or expanded in at least a dimension up to 20% of the non-stretched or non-expanded dimension without irreversible damage or loss of integrity to a device or material.
In general, the present invention provides topical devices for assisting the performance of a surgical incision and methods of making and using the same. A topical device of the present invention comprises a flexible patch that comprises a tear-resistant support layer and an adhesive layer disposed thereon.
In one aspect, a topical device of the present invention further comprises a high tear-resistant reinforcement layer or member disposed on the support layer, within the support layer, or between the adhesive layer and the support layer.
In another aspect, a topical device of the present invention is adhesively attached, affixed, bonded, or secured to a tissue, adjacent to an incision that was or will be made in the tissue, wherein at least a portion of the topical device is disposed substantially nonparallel to the incision.
In one embodiment, such reinforcement members can comprise deformable fibers, filaments, yarns, threads, wires, cables, tethers, strips, or bars that are made of polymeric, ceramic, metallic materials, or their composites.
In another embodiment, such reinforcement members can be imbedded within a matrix material, such as a polymeric material. The reinforcement members can be arranged in parallel or in the form of a mesh. Preferably, the reinforcement members are arranged in the matrix in the form of a mesh.
In still another aspect, a topical device of the present invention comprises a support layer and an adhesive layer disposed on one surface of the support layer, wherein the support layer comprises a plurality of reinforcement members disposed therein.
In still another aspect, the present invention provides topical devices and methods for adhesively attaching, affixing, bonding, or securing such devices onto the perineum of a patient undergoing vaginal childbirth delivery in order to reduce, limit or prevent perineal laceration and other tissue damages.
Reference now is made to
As shown in a closed-up perineal front view by
Also in the perineal plane view,
Referring now to
One possible support mechanism for using the topical patch discussed above may be further illustrated by
The topical devices or topical patches may have a variety of geometries or shapes which include regular geometric shapes as shown in
Although the topical device may have any shapes including those described above, examples concerning further details of the topical devices are provided below using a basic shape such as a ring shape or a round shape. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. The topical device may further be designed and manufactured such that it may have a variety of material compositions, a variety of patterns of material combination, lamination, reinforcement, etc. that are appropriate for the application described herein.
The topical device 500 may be positioned and adhesively secured to the perineal or perianal area such that the anus approximates the center of the device. The topical device 500 with substantial tear-resistance may reduce, limit or prevent laceration from approaching or reaching the anus. The topical device 500 with the reinforcing circular patch 502 may help divert, deflect or redirect a medial laceration toward a mediolateral direction, and thus, may reduce the risk of damage to the anal sphincter and the rectal mucosa. The device may also help reduce, limit or prevent other tissue damages by limiting excessive stretching. Although the topical device 500 is tear-resistant, it is preferred to be not cut-resistance. It may be necessary for the topical device to be easily cut with a pair of episiotomy scissors or a surgical scalpel in case the obstetricians or the midwives would like to perform an episiotomy or to extend an existing episiotomy in the perineal area covered by the topical device 500. Thus, the topical device 500 is preferred to be tear-resistant but not cut-resistance in order to prevent or reduce inadvertent tissue damages while not interfering with an episiotomy or the child-birth delivery process. It may be preferred that the circular reinforcing patch 502 is more cut-resistant than the oval adhesive patch 501 in order to provide more protection to the perianal area when an episiotomy incision or extension of an episiotomy incision is performed in the presence of the topical device 500. The oval adhesive patch 501 and the circular reinforcing patch 502 may be designed to have different levels of cut-resistance so that excessive or extended episiotomy may be preferably forced to go around the circular reinforcing patch 502 in order to reduce the risk of damage to the anal sphincter and the rectal mucosa.
In addition to the conventional manufacturing methods for adhesive patches, the topical devices shown in
The sizes, shapes, configurations and materials of the components shown in
Experiments were carried out to determine whether or not a topical adhesive patch, when made of a tear-resistant material, can help resist or prevent propagation of a tear. In the first experiment, a custom paper model was used to test the ability of the topical adhesive patch to stop or reduce tear propagation.
In the second experiment, a custom plastic film model was used to test the ability of a topical adhesive patch to stop or reduce tear propagation through a more ductile material. The vaginal dilation was simulated by stretching the hole in the plastic film in a radial direction in order to cause a tear to propagate toward the topical patch.
In one aspect of the invention, as shown in
The topical devices or patches described above are made of tear-resistant materials and may further be reinforced with similar or preferably better tear-resistant materials or elements in order to support underlying perineal tissues against tear or laceration. The topical patches can be made with materials or methods such that they are stretchable, semi-stretchable or substantially non-stretchable. However, it may be preferred that the topical patches are only semi-stretchable or substantially non-stretchable for more effective protection of underlying tissues. For a stretchable topical patch, it is preferred that the device has a maximum elongation of less than 100% of its original non-stretched length. In the case of a semi-stretchable topical patch, it is preferred that the device has a maximum elongation of less than 50%. A substantially non-stretchable patch is preferred to have less than 20% elongation for the scope of this invention. Depending on the purpose of the topical patches, they can be offered in a variety of configurations. Topical patches of appropriate configurations such as a convex edge facing the vagina and diverging toward the anus (
At least part of the support layer is made of a tear-resistant material to provide tear-resistant support to the perineal tissues. The tear-resistant material may also provide resistance to excessive stretching to the perineal tissues. The tear-resistant materials can be any synthetic or natural materials including polymers, metals, ceramics or their combinations. The tear resistant materials can be in any shapes or forms including solid or porous structure/construct/formation with a three dimensional shape; solid or porous planar sheet/film/membrane; fibrous, woven, non-woven, braided or knitted textile constructs; assembly, laminate, composite, combination of components or materials; etc. In the case of a textile-based or fabric support layer, an appropriate weave or knit pattern may be selected for suitable levels of tear resistance and stretchability. The support layer may be semi-stretchable with good tear resistance. Alternately, the support layer may be substantially non-stretchable with high tear resistance. However, it may be preferred that the support layer is semi-stretchable with high tear resistance. Examples of fabric adhesive tape that can be used for the support layer include Tricot fabric, knitted fabric, woven fabric, non-woven mesh, etc. Examples of the tear-resistant materials for the support layer include polyester, polyethylene, ultra-high molecular weight polyethylene, polypropylene, polyethylene terephthalate, rayon, cellulose, polyetheretherketone, polyethersulfone, polyvinylidene fluoride, polytetrafluoroethylene, silicone, polyurethane, polyimide, polyamide, or their combinations.
It may also be preferred that, at least, a portion of the support layer is further reinforced with reinforcement members or reinforcement layers for even more tear resistance. Such reinforcements may be achieved by embedded into or laminated onto the support layer with one or more high tear-resistant materials, which include polymers, metals, ceramics and their combinations. Examples of high tear-resistant materials include but not limited to polymeric materials with improved inherent toughness, polymeric materials oriented axially or bi-axially, textile-based or fabric materials, composite polymeric materials, composites of polymers and metals, composites of polymers and ceramics, composite of metals and ceramics, composites of polymers, metals and ceramics, etc. Examples of textile-based materials include fibers, filaments, threads, tethers, tapes, strips, knitted fabric, woven fabrics, non-woven meshes, braided constructs, sheets, films, bars, rods, which can be made of one or more materials selected from polymers, metals, ceramics or their composites. These textile-based materials may be embedded, coated, laminated, bonded, attached or secured to one or more materials (e.g. polymeric matrix materials, polymer films, polymer adhesive tapes, polymer foam layers, absorbent materials, other textile-based materials, polymeric adhesives, or their combinations) to form the support layer, the reinforcement layer or the topical device. In the case of a textile-based or fabric reinforcement layer, an appropriate weave or knit pattern may be selected for suitable levels of tear resistance and stretchability. The reinforcement layer may be semi-stretchable with good tear resistance. Alternately, the reinforcement layer may be substantially non-stretchable with high tear resistance. However, it may be preferred that the reinforcement layer is semi-stretchable with high tear resistance. Examples of fabric adhesive tape that can be used for the reinforcement layer include Tricot fabric, knitted fabric, woven fabric, non-woven mesh, reinforced fabric, etc. Examples of the tear-resistant materials used for the reinforcement layer or reinforcement member include polyester, polyethylene, ultra-high molecular weight polyethylene, polypropylene, polyethylene terephthalate, rayon, cellulose, polyetheretherketone, polyethersulfone, polyvinylidene fluoride, polytetrafluoroethylene, silicone, polyurethane, polyimide, polyamide, or their combinations.
The support layer may have other beneficial features such as peeling tabs or strips not coated with adhesive, water resistance, water-permeability, air-permeability, drug-eluting capability, drug reservoirs, electrical stimulators, micro-needles for transdermal drug delivery, etc. A variety of additives may be incorporated into the support layer or its surfaces for different purposes. Additives can also be incorporated into the adhesive layer or between the support layer and the adhesive layer. Micro-needles may also be included for transdermal delivery of additives. Examples of additives include chemical, pharmacological or biological agents or substances for enhancing the patch performance or providing therapeutic treatment. Examples of pharmaceutical additives include analgesic drugs, anesthetic drugs, anti-inflammatory drugs, antibiotic drugs, etc. Examples of chemical additives include various types of oils, solvents, alcohols, ethanol, glycerol, dimethyl sulfoxide, silver, silver compounds, micro-particles or nano-particles of silver, anti-microbial metals, anti-microbial compounds, anti-microbial solvents, anti-fouling agents, etc.
The adhesive layer bonds or secures the support outer layer to the skin of the patients, and thereby may transfer the tensile and shear stresses from the underlying dermal tissues to the support outer layer. The tensile and shear stresses occurring in the underlying dermal tissues and the topical patches may be substantially parallel to the perineum plane, which is tangent or parallel to the perineum and substantially transverse to the sagittal plane. The adhesive layer preferably has adequate bonding strength to the skin or stress-resisting capability for sufficient resistance to unintended loosening, peeling, loss of adhesion, detaching or delamination due to stresses imposed by underlying dermal tissues. On the other hand, the adhesive layer is preferably easy to be removed or peeled off at the end of its use. Any type of hypoallergenic or biocompatible adhesive materials may be used. It is preferred that the adhesives and their components are non-sensitizing, non-irritating, non-cytotoxic, and biocompatible. Pressure sensitive adhesives are preferred as these pre-coats are easy to use and convenient for the users. However, other types of adhesive are also contemplated, which include self-curing single-component adhesives, self-curing multiple-components adhesives, solvent-evaporation-activated adhesives, air-activated adhesives, moisture-activated adhesives, heat-activated adhesives, light-activated adhesives, uv-activated adhesives, infrared-activated adhesives, radiation-activated adhesives, radio-frequency activated adhesives, etc. Examples of pressure sensitive adhesives include acrylic adhesives, modified-acrylic adhesives, acrylate-based adhesives, silicone adhesives, rubber-based adhesives, etc.
The adhesive layer may partially or totally cover the outer support layer. There may be a variety of adhesive coating patterns on the outer support layer. Examples of adhesive coating patterns include at or around the perimeter, at or around the center, on one or more sides or corners, uniform and complete coating, non-uniform and incomplete coating, random non-continuous coating, complete coating except the peeling tabs, etc. The adhesive layer may have other beneficial features such as water proof, body fluid resistance, water permeability, gas permeability, drug-eluting, drug reservoirs, electrical stimulation, etc. A variety of additives may be incorporated into the adhesive layer or its surface for different purposes. Examples of additives include chemical, pharmacological or biological agents or substances for enhancing the patch performance or providing therapeutic treatment. Examples of pharmaceutical additives include analgesic drugs, anesthetic drugs, anti-inflammatory drugs, antibiotic drugs, etc. Examples of chemical additives include various types of oils, solvents, alcohols, ethanol, glycerol, dimethyl sulfoxide, silver, silver compounds, micro-particles or nano-particles of silver, anti-microbial metals, anti-microbial compounds, anti-microbial solvents, anti-fouling agents, etc.
The release liner is used to protect the adhesive layer prior to use. The release liner is typically removed and discarded right before the topical patch is applied to the perineum. The release liner can be made of a variety of suitable materials and has any suitable size or shape to protect the adhesive layer during manufacturing, packaging, storage, shipping, handling, and application. Examples of the release liner include polymer sheets or films, polymer-coated papers, laminates of paper and polymeric materials, etc. Additional examples of release liners include polyethylene terephthalate (PET) films, densified kraft paper, polycoated kraft, and polyethylene or polypropylene films. Examples of materials used to coat or make release liners include silicone, polyester, polyethylene, polyethylene terephthalate, etc. Materials, designs, and methods of use of release liners are well known to people with skills in the art.
In another aspect of the invention, as shown in
In yet another aspect of the invention, as shown in
In other aspects of the invention, topical devices or topical patches of appropriate configurations (including shape, size, thickness, materials, reinforcements, etc.) may reduce, limit or prevent perineal lacerations, which include midline or medial laceration and mediolateral laceration, when bonded, adhered or adhesively secured to appropriate locations on the perineum. Topical patches with a shape, size and thickness that are suitable for adhering to, at least, part of the perineum between the vagina and the anus may be used. Examples of such topical devices or patches are shown in
It is preferred that the patches have a shape or configuration with the vagina-facing edge (or the edge's tangent line) forming an angle of less than 180 degrees, preferably less than 165 degrees, more preferably less than 135 degrees from the midline connecting the vagina and the anus as shown in
Topical patches of appropriate configurations as discussed above when affixed, adhered or adhesively secured to appropriate locations on the perineum may reduce, limit or prevent a medial or mediolateral episiotomy cut from extending further toward the anus. Topical patches with a shape, size and thickness that are suitable for adhering to, at least, part of the perineum between the vagina and the anus may be used. Examples of such topical devices or patches are shown in
Topical patches of appropriate configurations as discussed above when bonded, adhered or adhesively secured to appropriate locations on the perineum may reduce, limit or prevent the third or fourth degree laceration. Topical patches with a shape, size and thickness that are suitable for adhering to, at least, part of the perineum between the vagina and the anus may be used. Examples of such topical devices or patches are shown in
Topical patches of appropriate configurations as discussed above when bonded, adhered or adhesively secured to appropriate locations on the perineum may also divert, deflect, steer or bias laceration from a medial direction to a mediolateral direction. Topical patches with a shape, size and thickness that are suitable for adhering to, at least, part of the perineum between the vagina and the anus may be used. Examples of such topical devices or patches are shown in
Topical patches of appropriate configurations as discussed above when bonded, adhered or adhesively secured to appropriate locations on the perineum may divert, deflect, steer or bias a laceration toward a pre-determined mediolateral direction. Topical patches with a shape, size and thickness that are suitable for attaching, affixing, or adhering to, at least, part of the perineum between the vagina and the anus may be used. Examples of such topical devices or patches are shown in
Topical patches of appropriate configurations as discussed above when bonded, adhered or adhesively secured to appropriate locations on the perineum may divert, deflect, steer or bias laceration to a mediolateral or lateral direction and then limit it from further propagation after its extension to a certain length. Topical patches with a shape, size and thickness that are suitable for adhering to, at least, part of the perineum between the vagina and the anus may be used. Examples of such topical devices or patches may be shown in
In other aspects of the invention, methods are contemplated for using topical patches of appropriate configurations including those discussed above in order to reduce, limit or prevent perineal laceration, which include midline or medial laceration and mediolateral laceration. The methods include providing at least one topical patch with appropriate configurations, adhering or adhesively securing the topical patch to an appropriate location on the perineum, and maintaining the patch during, at least, part of the childbirth labor process in order to reduce, limit or prevent perineal laceration. Topical patches with a shape, size and thickness that are suitable for adhering, attaching, affixing, bonding, or adhesively securing to, at least, part of the perineum between the vagina and the anus may be used according to the described methods. Examples of such topical devices or patches are shown in
Methods for using topical patches of appropriate configuration to reduce, limit or prevent medial or mediolateral episiotomy cut from extending further toward the anus are also contemplated. The methods include providing at least one topical patch with appropriate configurations, adhering or adhesively securing the topical patch to an appropriate location on the perineum, and maintaining the patch during, at least, part of the childbirth labor process in order to reduce, limit or prevent a medial or mediolateral episiotomy cut from extending further toward the anus. Topical patches with a shape, size and thickness that are suitable for adhering to, at least, part of the perineum between the vagina and the anus may be used according to the described methods. Examples of such topical devices or patches are shown in
Methods for using topical patches of appropriate configurations to reduce, limit or prevent the third or fourth degree laceration are also contemplated. The methods include providing at least one topical patch with appropriate configurations, adhering or adhesively securing the topical patch to an appropriate location on the perineum, and maintaining the patch during, at least, part of the childbirth labor process in order to reduce, limit or prevent the third or fourth degree laceration. Topical patches with a shape, size and thickness that are suitable for adhering to, at least, part of the perineum between the vagina and the anus may be used according to the described methods. Examples of such topical devices or patches are shown in
Methods for using topical patches of appropriate configurations as discussed above to divert, deflect, steer, redirect or bias laceration from a medial direction to a mediolateral direction. The methods include providing at least one topical patch with appropriate configurations, adhering or adhesively securing the topical patch to an appropriate location on the perineum, and maintaining the patch during, at least, part of the childbirth labor process in order to divert, deflect, steer, redirect or bias laceration from a medial direction to a mediolateral direction. Topical patches with a shape, size and thickness that are suitable for adhering to, at least, part of the perineum between the vagina and the anus may be used according to the described methods. Examples of such topical devices or patches are shown in
Methods for using topical patches of appropriate configurations as discussed above to divert, deflect, steer, redirect or bias a laceration toward a pre-determined mediolateral direction. The methods include providing at least one topical patch with appropriate configurations, adhering or adhesively securing the topical patch to an appropriate location on the perineum, and maintaining the patch during, at least, part of the childbirth labor process in order to divert, deflect, steer, redirect or bias a laceration toward a pre-determined mediolateral direction. Topical patches with a shape, size and thickness that are suitable for adhering to, at least, part of the perineum between the vagina and the anus may be used according to the described methods. Examples of such topical devices or patches may be shown in
Methods for using topical patches of appropriate configurations as discussed above to divert, deflect, steer, redirect or bias laceration to a mediolateral or lateral direction and then limit it from further propagation after its extension to a certain length. The methods include providing at least one topical patch with appropriate configurations, adhering or adhesively securing the topical patch to an appropriate location on the perineum, and maintaining the patch during, at least, part of the childbirth labor process in order to divert, deflect, steer, redirect or bias laceration to a mediolateral direction and then limit it from further propagation after its extension to a certain length. Topical patches with a shape, size and thickness that are suitable for adhering to, at least, part of the perineum between the vagina and the anus may be used according to the described methods. Examples of such topical devices or patches may be shown in
In still another aspect of the invention, additional methods concerning the use of topical devices or topical patches are provided. A method includes providing a topical patch, exposing the adhesive and then placing the topical patch onto at least part of the perineum, which includes the perivaginal area, perianal area or the area between the vagina and the anus, before or during childbirth delivery. A similar method may also be used to support or treat part of the perineum after childbirth delivery using a topical device or patch that contains an additive as described herein. The method may include removing the release liner to expose the adhesive. If other types of adhesive are used instead of a pressure sensitive adhesive, the adhesive coating on the support layer may be activated using a suitable method which includes exposure to environment, a fluid, light, or other sources of energy. The topical patch comprising a support outer layer, an adhesive layer or an adhesive material, and other components may be provided as a kit and may be assembled prior to use. The method may further include preparing the perineum area to receive the topical patch, wherein preparing the perineum area includes shaving, waxing, washing, cleaning, disinfecting, conditioning, treating, anesthetizing, wiping, drying, or combinations thereof. The method may also include removing the release liner in multiple stages or steps during the application of the topical patch. The method may include orienting and positioning the topical patch prior to its placement. The method may include placement of the topical patch on the lower or posterior side of the perineal area, which is closer to the anus than the vagina, in order to reduce potential interference with vaginal dilation. The method may include using additional adhesive or adhesive tapes to further secure or reinforce the topical patch. The method may include support of the topical patch by a hand or by an applicator pushing onto the device during, at least, part of the childbirth delivery process. The method may include removing the patch after childbirth delivery. The method may include dressing or supporting the patient's compromised perineum with the topical patch after childbirth delivery. The method may include dressing or treating the patient's compromised perineum with the topical patch after childbirth delivery, wherein the patch contains one or more additives or active agents described elsewhere in the document. The method may include treating sensitive or painful perineum after childbirth delivery using a topical patch that contains a solvent, a chemical agent, a pharmaceutical agent, and/or a biological agent. The method may include treating sensitive or painful perineum after childbirth delivery using a topical patch that contains one or more analgesic or anesthetic agents or drugs.
It may be preferred that the patch is not placed immediately adjacent to the edge of the dilated vagina as the perineal tissues closest to the vagina should be allowed to stretch as naturally as possible in order to facilitate dilation. The closest edge of the patch to the vagina is preferred to be positioned at an appropriate distance away from the edge of the dilated vagina. Such an appropriate distance depends on the perineal length of the patient, which is the linear measurement between the closest edges of the vagina and the anus. It is preferred that the distance between the closest edges of the patch and the vagina is larger than 20% of the patient's perineal length, preferably larger than 35%, more preferably larger than 50%. The preferred distance may be determined by an obstetrician or a midwife in order to achieve optimal balance between allowance of natural perineal stretching and reduced risks of laceration, unintended extension of an episiotomy cut, third or fourth degree of laceration, etc.
Tears in the anterior area of the vaginal opening may also occur during childbirth delivery, but these lacerations are typically small. The topical devices described above such as those of
The method concerning the use of topical devices or topical patches may optionally include additional support by an applicator to: 1) facilitate placement and bonding of the topical patch onto the perineum prior to or during childbirth delivery; 2) improve or maintain adhesive bonding of the topical patch to the perineum during delivery; 3) prevent premature, loosening, peeling, loss of adhesion, detaching or delamination of the topical patch during delivery; 4) fix, repair or reapply prematurely detached or delaminated topical patch during delivery; or 5) remove the topical patch after delivery. The applicator may optionally be used to support the topical patch against perineal dermal tissues in order enhance the effectiveness of the pressure-sensitive adhesive layer or other types of adhesive layer. The applicator may be held by hand or some how secured to the patient. In one embodiment, the applicator has an elongated shape with the distal end configured to contact or engage the outer surface of the topical patch on the perineum and the proximal end configured for holding with one or both hands. In another embodiment, the applicator has a body with the distal surface configured to contact or engage the topical patch on the perineum and the proximal surface configured to be secured to the patient by a fastening means including belts, straps, tethers, cords, adhesive tapes, hook-and-loop tapes, etc. The applicator, the topical patch and other components may be provided in a single or multiple kits to the medical staff. It is preferred that these components of the product kits are supplied in sterile single-use packaging. The applicator may be provided separately as a single-use or a reusable instrument. Depending on whether the applicator is for single-use or reusable, the instrument is preferred to be made of one or more materials that can withstand at least one type of sterilization methods such as steam, autoclaving, heat, chemical, ethylene gas, gamma radiation, electron-beam radiation. Examples of suitable materials for the applicator include polycarbonate, polyvinyl chloride, acrylics, polyimide, polyamide, polyesters, polyethylene, ultra-high molecular weight polyethylene, polypropylene, polyaryletherketone, polyethersulfone, polyvinylidene fluoride, polytetrafluoroethylene, silicone, polyurethane, stainless steel, titanium alloys, cobalt-chrome alloys, or their combinations.
The topical patch and the applicator may have complementary designs with appropriate configurations and features for achieving one or more of the functions or purposes mentioned above. The outer surface of the topical patch may have features for releasable engagement or securing to the distal end or distal surface of the applicator. Examples of the features include: 1) an adhesive layer on the outer surface of the patch for attaching, affixing, bonding, or adhering to the surface of the applicator, 2) a non-adhesive outer surface of the patch for attaching, affixing, bonding, or adhering to an adhesive surface of the applicator, 3) a patch surface with loops for engaging the surface with hooks on the applicator, 4) a patch surface with hooks for engaging the surface with loops on the applicator, 5) a patch surface with high friction such as textured surface, serrated surface, porous surface, rubbery surface, silicone surface or the alike for friction engagement with a high friction surface on the applicator. The topical patch may be placed on the perineum and subsequently engaged with the applicator for bonding support. The topical patch may be placed on the distal end or distal surface of the applicator before adhesively attaching, affixing, bonding, or securing to the perineum. The method of use may also include direct hand support of the topical patch by a medical staff instead of using the applicator. The support of the topical patch prior or during delivery may be done using one or both hands.
The topical devices or topical patches used in the methods described above comprise a support layer, an adhesive layer, and a release liner. Topical patches of appropriate configurations when adhesively bonded or secured onto the perineum between the vagina and the anus may reduce or limit perineal laceration, especially midline or medial laceration, and other tissue damages. Appropriate patch configurations include appropriate geometry, size, thickness, flexibility, mechanical properties, support layer material, reinforcement materials of the support layer, reinforcement patterns of the support layer, adhesive layer materials, reinforcement materials for the adhesive layer, overall physical and mechanical behaviors of the patches, releasable additives in the patches, etc.
The topical devices or topical patches used in the methods described above may have any geometries or shapes. The topical patches may be two or three-dimensional objects. The edges or surfaces of the topical patches may be flat, linear, curved, angular, twisted, folded, rolled-up, supported or combinations of these characteristics. The edges or surfaces of the topical patches may be concave, convex, wavy, porous, semi-porous, perforated, partially perforated, or combinations of these characteristics. For example, the topical patches may be a substantially planar or two-dimensional device with a width and length (or a diameter if relatively circular) and a thickness substantially small compared to the other dimensions. In another example, the topical patches may be a three-dimensional device with a depth or height (or a relatively large thickness) in addition to a width and length (or a diameter). The upper and lower surfaces of the topical patches may be substantially planar and parallel with each other. However; if the topical patches are flexible, pliable or conformable, their substantially planar shape may change and conform to the shape or topography of the underlying tissue surface to which they adhere. If the topical patches are only partially flexible, pliable or conformable, only the flexible or pliable portion of the topical patches is expected to change and conform to the shape or topography of the underlying tissue surface to which they adhere. The upper or lower surfaces of the topical patches may be three-dimensional and substantially unparallel with each other. The three-dimensional topical patches may be partially or entirely flexible or pliable. As shown in
The topical devices or topical patches used in the methods described above may have any suitable size for adhesively bonding, adhering or securing onto the perineum. The topical patches should be sized appropriately so that it provides sufficient coverage of the perineum between the vagina and the anus, around the anus, and/or above the anus for protection against laceration and other tissue damages. However, the size of the topical patches should not be excessively large that it would cover too much of the perineum in order to minimize potential interference to the stretching of the perineum for delivery. In the areas that do not significantly interfere with the perineal stretching for delivery, the topical patches may have a larger surface coverage for increased bonding area to the underlying tissues. This is expected to help enhance overall bonding, adhesion or fixation of the topical patches. It is preferred that the largest dimension of the patches does not exceed 400 mm, more preferably less than 300 mm, and more preferably less than 200 mm. In the case of the two-dimensional topical patches, the largest thickness (measured substantially along the sagittal plane) of the patches is preferred to be 10 mm, more preferably less than 5 mm, and more preferably less than 3 mm. The patch thickness may be uniform or variable through out the patch surface. In the case of three-dimensional topical patches, the depth, height or thickness of the topical patches, which may be measured along the sagittal plane, is preferably less than 35 mm, more preferably less than 25 mm, and most preferably less than 15 mm.
The topical devices or topical patches used in the methods described above may be pliable or flexible, semi-flexible, semi-rigid, or rigid. The topical patches may be partially or completely flexible. In the case of partially flexible patches, the flexible portions may be positioned anywhere within the patches. For example, the flexible portions may be at or around the edges, at or around the center of the patches, at one side or one corner of the patches, uniformly or randomly located within the patches, etc. The patches may be inelastic, semi-elastic, elastic or combinations of these characteristics. For examples, the patches may be inelastic where they must resist stretching and may be semi-elastic or elastic where they must allow certain stretching. Unlike transdermal drug-delivery topical patches currently on the market, the topical patches disclosed in this invention must have adequate mechanical properties and tear resistance in order to support the perineal tissues against laceration and other tissue damages. The patches may also have appropriate tensile properties to help support the underlying dermal tissue against excessive tensile stresses or stretching. It may be preferred that, at least, certain parts of the topical patches are further reinforced for high tear resistance and/or high stretching resistance. The reinforcement for the topical patches may be achieved via reinforcement of the support layer and/or the adhesive layer. In one embodiment, the topical patches are resistant to tears caused by perineal tissue laceration or cuts made by surgical instruments such as scalpels or episiotomy scissors. In a different embodiment, the topical patches are resistant to tears caused by perineal tissue laceration but not cuts that are made by surgical instruments such as scalpels or episiotomy scissors. This may be beneficial in the case that the initial episiotomy cut must be extended partially or completely through the topical patches in order to facilitate safe or fast delivery.
A flexible topical device or patch with a large size or large surface area may benefit from a less flexible or more rigid support frame or support element positioned around and/or within the device or its surface. Such a support frame or support element is expected to provide increased rigidity to the flexible topical device, which may be useful for its handling and placement. In one embodiment, the support frame or support element is designed such that it reduces the overall flexibility of the flexible topical patch. In another embodiment, the support frame or support element is designed such that the flexible topical patch does not fold over itself or experiences excessive deformation under its own weight during handling or placement, especially after the release liner is removed. The support frame may have any shapes or configurations, which include elongated shape, ring shape, cross shape, X shape, H shape, I shape, N shape, C shape, U shape, Y shape, W shape, or their combinations. The support frame may be placed at any locations on or within the topical device such as along the periphery, along the diameter, near or across the center, on top of the reinforcement layer, on top and across the reinforcement layer, on top of the support layer, on top of the support layer and around the reinforcement layer, embedded between the reinforcement layer and the support layer, embedded between the support layer and the adhesive layer, between the adhesive layer and the release liner, etc. The support frame may be a permanent or removable component of the topical device. In one embodiment, the support frame may be removed during or after placement of the patch. In another embodiment, the support frame is a non-removable or permanent integral part of the topical patch.
Examples of the support frame include: 1) a X-shaped layer of a pliable foam sheet that is less flexible than the support layer, 2) a H-shaped layer of a pliable polymer sheet that is less flexible than the support layer, 3) a ring-shaped layer of a pliable fabric sheet that is less flexible that the support layer, 4) a strip of a pliable foam layer disposed along the support layer's periphery, 5) a U-shaped layer of a pliable polymer sheet placed along the adhesive layer's periphery and embedded between the adhesive layer and the release liner, 6) at least one polymer or metal strip that is less flexible than the support layer positioned along the length of the topical patch, 6) a pliable foam sheet that is less flexible than the support layer but of the same size and/or shape as the support layer, 7) a combination of example #1 and example #4, 8) a combination of example #4 and example #6. The thickness of the support frame may be in the range from 0.1 mm to 10 mm, preferably from 0.2 mm to 5 mm, more preferably from 0.3 mm to 3 mm. The materials used for the support frame may be a polymer, a metal, a ceramic or their combinations. Examples of polymeric materials include polymer foam sheet, solid polymer sheet, perforated polymer sheet, polymer mesh, woven fabric, knitted fabric, non-woven mesh, or combinations thereof. The support frame can be embedded, attached, affixed, bonded, or laminated to the support layer, the reinforcement layer, and/or the adhesive layer by any appropriate means known in the art including adhesive bonding, thermal fusion, compression molding, ultrasonic welding, sewing, etc.
The support frame may be designed and fabricated such that it can also be used as the tear-resistant reinforcement layer. Similarly, the tear-resistant reinforcement layer may be designed and constructed such that it can also be used as the support frame. Thus, the tear-resistant reinforcement layer with appropriate designs, materials, constructs, positioning within the topical device, etc. may function as a reinforcement member against tear as well as a structural support element for increased rigidity and support of the flexible topical device during handling, especially after the release liner is removed.
Examples of the support frame described above are shown in
The topical devices or patches described above with tear-resistant capability may also be used to support, protect or treat tissues outside of the perineal or perianal areas. The topical devices may be used to reinforce weakened tissues, support compromised tissues, protect injured tissues, dress sensitive tissues, or treat painful tissues anywhere on an animal or a human subject. The topical devices may be applied or affixed onto any dermal tissues to prevent or limit an initiation or propagation of a stress- or strain-induced tear in a tissue resulting from an incision made therein when the topical devices are disposed on the tissue adjacent to the incision. The incision may be made at the dermal tissues located beneath the topical patches by cutting through the patches or cutting within the opening of the patch.
A variety of additives may be incorporated into the topical patches or their surfaces for different purposes. Examples of additives include chemical, pharmacological or biological agents and substances for enhancing the patch performance or providing therapeutic treatment. Examples of pharmaceutical additives include analgesic drugs, anesthetic drugs, anti-inflammatory drugs, antibiotic drugs, etc. Examples of chemical additives include various types of oils, solvents, alcohols, ethanol, glycerol, dimethyl sulfoxide, etc. The topical patches may have other beneficial features or characteristics such as peeling tabs without adhesive coating, water resistance, body fluid resistance, gas permeability through micro-porosity, gas permeability through macro-porous openings or channels, heating or cooling capability to sooth pain or facilitate healing, etc. The topical patches may be transparent, translucent, opaque or combinations of these optical characteristics. The topical patches may have useful printings on the surface such as dimensional references, linear or angular orientation guiding features, reference position marking features, instructions of use, warnings, and other helpful texts or images. The topical patches may have overhung tabs or strips that are not coated with adhesive in order to help facilitate patch peeling or removal after or during delivery. The topical patches may be further secured to the perineum with additional means including manual pushing, hand pressing, device supporting, adhesive tapes, tethers, straps, belts, hooks-and-loops components, or any other means known by people with skills in the art. The topical patches comprising a support layer, an adhesive layer or an adhesive material, and other optional components mentioned above may be provided as a kit and assembled prior to use.
At least part of the support layer is made of a material with adequate tear resistance, preferably with good to high tear resistance, in order to provide support against tear or laceration to underlying dermal tissues in the perineum. The tear-resistant materials may be any synthetic or natural materials including polymers, metals, ceramics or their combinations. The tear-resistant materials may be in any shapes or forms including solid or porous sheet, film or membrane; fibrous, woven, non-woven, braided or knitted textile constructs; assembly, laminate, composite, combination of components or materials; etc. Examples of the tear-resistant materials for the outer layer include polyesters, polyethylene, ultra-high molecular weight polyethylene, polypropylene, polyetheretherketone, polyethersulfone, polyvinylidene fluoride, polytetrafluoroethylene, silicone, polyurethane, polyimide, polyamide, or their combinations. At least 2%, preferably 10%, and more preferably 25% of the support layer is made of tear-resistant materials. The remaining material of the support layer may be made of any materials suitable for mixing, blending, bonding, joining, laminating, or otherwise contacting the tear-resistant materials. The combinations of the tear-resistant materials and the remaining materials within the support layer can be of any arrangements, patterns, orientations, distributions, or degrees of homogeneity that are suitable for effective support against tear or laceration of underlying dermal tissues in the perineum. For example, tear-resistant materials such as fibers, filaments or fabric may be preferred to be arranged in a substantially perpendicular fashion such as an approximate 90-degrees angle when compared to the medial line between the vagina and the anus as the topical patch is secured to the perineum. Certain combinations of materials within the support layer may be intended to divert tear or laceration toward a different direction such as mediolateral direction from an otherwise medial direction. For example, tear-resistant materials such as polymeric fibers, filaments or fabric can be arranged in a substantially angular fashion such as a 45-degrees angle when compared to the medial line between the vagina and the anus as the topical patch is secured to the perineum. In another example, an approximate 45-degrees angle between fabric filaments and the medial line between the vagina and the anus may be preferred if a certain level of patch stretching is desired. The support layer preferably has a shape, size, thickness, and flexibility or rigidity that are suitable for bonding to dermal tissues in the perineum and adjacent areas.
It may also be preferred that, at least, part of the support layer is further reinforced for high tear resistance. Such reinforcements may be achieved by introducing into the support layer one or more high tear-resistant materials, which include polymers, metals, ceramics and their combinations. Examples of high tear-resistant materials include but not limited to polymeric materials with improved inherent toughness, polymeric materials oriented axially or bi-axially, textile-based materials, composite polymeric materials, composites of polymers and metals, composites of polymers and ceramics, composite of metals and ceramics, composites of polymers, metals and ceramics, etc. Examples of textile-based materials include fibers, filaments, woven fabrics, non-woven meshes, braided constructs, which can be made of one or more materials of polymers, metals or ceramics. The support layer may have a thickness of less than 8 mm, preferably less than 4 mm, more preferably less than 2 mm. It may be transparent, translucent or opaque. It may have any colors, patterns, images or text printed on the outer surface. It may be smooth or textured. It may have uniform or variable thickness. It may have uniform or variable density. It may have elastic, semi-elastic, inelastic characteristics or various combinations of these behaviors.
The adhesive layer bonds or secures the support outer layer to the skin of the patients, and thereby may transfer the tensile and shear stresses from the underlying dermal tissues to the support outer layer. The tensile and shear stresses occurring in the underlying dermal tissues and the topical patches may be substantially parallel to the perineum plane, which is tangent or parallel to the perineum and substantially transverse to the sagittal plane. The adhesive layer preferably has adequate bonding strength to the skin or stress-resisting capability for sufficient resistance to unintended loosening, peeling, loss of adhesion, detaching or delamination due to stresses imposed by underlying dermal tissues. On the other hand, the adhesive layer is preferably easy to be removed or peeled off at the end of its use. Any type of hypoallergenic adhesive materials may be used. It is preferred that the adhesives and their components are non-sensitizing, non-irritating, non-cytotoxic, and biocompatible. Pressure sensitive adhesives are preferred as these pre-coats are easy to use and convenient for the users. However, other types of adhesive are also contemplated, which include self-curing single-component adhesives, self-curing multiple-components adhesives, solvent-evaporation-activated adhesives, air-activated adhesives, moisture-activated adhesives, heat-activated adhesives, light-activated adhesives, uv-activated adhesives, infrared-activated adhesives, radiation-activated adhesives, radio-frequency activated adhesives, etc. Examples of pressure sensitive adhesives include acrylic adhesives, modified-acrylic adhesives, acrylate-based adhesives, silicone adhesives, rubber-based adhesives, etc.
The adhesive layer may partially or totally cover the outer support layer. There may be a variety of adhesive coating patterns on the outer support layer. Examples of adhesive coating patterns include at or around the perimeter, at or around the center, on one or more sides or corners, uniform and complete coating, non-uniform and incomplete coating, random non-continuous coating, complete coating except the peeling tabs, etc. The adhesive layer may have other beneficial features such as water proof, body fluid resistance, water permeability, gas permeability, drug-eluting, drug reservoirs, electrical stimulation, etc. A variety of additives may be incorporated into the adhesive layer or its surface for different purposes. A layer of absorbent material may be placed on the adhesive side of the topical patch for a variety of purposes including absorbing moisture, absorbing some anal discharge, holding and delivery of sprayed analgesics, containing and delivery of other additives for therapeutic treatments, etc. The topical patches with an absorbent layer can be used by a medical staff to deliver various sprayed-on formulations of analgesic drugs, local anesthetic drugs, or other additives. Examples of additives include chemical, pharmacological or biological agents or substances for enhancing the patch performance or providing therapeutic treatment. Examples of pharmaceutical additives include analgesic drugs, anesthetic drugs, anti-inflammatory drugs, anti-infective drugs, anti-allergic drugs, antibiotic drugs, etc. Examples of chemical additives include various types of oils, solvents, alcohols, ethanol, glycerol, dimethyl sulfoxide, silver, silver compounds, micro-particles or nano-particles of silver, anti-microbial metals, anti-microbial compounds, anti-microbial solvents, anti-fouling agents, etc.
The release liner is used to protect the adhesive layer prior to use. The release liner is typically removed and discarded right before the topical patch is applied to the perineum. The release liner can be made of a variety of suitable materials and has any suitable size or shape to protect the adhesive layer during manufacturing, packaging, storage, shipping, handling, and application. Examples of the release liner include polymer sheets or films, polymer-coated papers, laminates of paper and polymeric materials, etc. Additional examples of release liners include polyethylene terephthalate (PET) films, densified kraft paper, polycoated kraft, and polyethylene or polypropylene films. Examples of materials used to coat or make release liners include silicone, polyester, polyethylene, polyethylene terephthalate, etc. Materials, designs, and methods of use of release liners are well known to people with skills in the art.
The adhesive layer and/or the support layer may contain one or more additives selected from the group comprising a solvent, a chemical agent, a pharmaceutical agent, a biological agent, or combinations thereof. Pharmacological agents include analgesic drugs, anesthetic drugs, anti-inflammatory drugs, antibiotic drugs, etc. Analgesic drugs include topical analgesics, opioid analgesics, narcotic analgesics, etc. Examples of topical analgesics include rubefacients, nonsteroidal anti-inflammatory drugs (NSAIDs), local anesthetics, and others. Examples of Rubefacients include traditional formulations based on salicylate and nicotinate esters, capsaicin and capsicum extracts and derivatives. Further examples of Rubefacients include benzocaine, benzyl nicotinate, methyl salicylate, diethylamine salicylate, trolamine salicylate, salicylamide, camphor, menthol, dimethyl sulfoxide, etc. Examples of NSAIDs include diclofenac, felbinac, ibuprofen, ketoprofen, piroxicam, naproxen, flurbiprofen and other NSAIDs. Examples of local anaesthetics include lidocaine, lignocaine and benzocaine. Examples of other topical analgesics include benzydamine, mucopolysaccharide polysulphate, salicylamide and cooling spray formulae.
Various non-limiting aspects of the present invention are enumerated, as follows.
1. A method for support of perineal tissues, the method comprising the steps of:
providing a topical device having a support layer on a first side and an adhesive layer on a second side, said topical device configured for adhesive attachment to at least a portion of the perineal area of a human body;
positioning said topical device approximate at least a portion of the perineal area; and
adhesively secure said topical device to at least a portion of the perineal area.
2. The method of aspect 1, further comprising the step of preparing said portion of the perineal area before adhesively securing said topical device.
3. The method of aspect 2, wherein the step of preparing said portion of the perineal area includes shaving, waxing, washing, cleaning, disinfecting, conditioning, treating, anesthetizing, wiping, drying, or combination thereof.
4. The method of aspect 1, wherein said topical device further comprising a release liner for protecting said adhesive layer before application.
5. The method of aspect 4, further comprising the step of removing said release liner prior to adhesively securing said topical device.
6. The method of aspect 1, wherein at least a portion of said topical device is substantially flexible.
7. The method of aspect 1, wherein at least a portion of said topical device is semi-stretchable or substantially non-stretchable.
8. The method of aspect 1, wherein said topical device has a concave edge
9. The method of aspect 8, wherein said concave edge of said topical device faces the vagina.
10. The method of aspect 1, wherein at least a portion of said topical device is substantially tear-resistant.
11. The method of aspect 1, wherein said topical device is substantially tear-resistant, but not cut-resistant.
12. The method of aspect 1, wherein said support layer is made of a polymeric material, a metallic material, a ceramic material, or combination thereof.
13. The method of aspect 12, wherein said polymeric material includes polyesters, polyethylene, ultra-high molecular weight polyethylene, polypropylene, polyetheretherketone, polyethersulfone, polyvinylidene fluoride, polytetrafluoroethylene, silicone, polyurethane, polyimide, polyamide, or their combinations.
14. The method of aspect 1, wherein at least a portion of said support layer is reinforced with a high-tear resistant material.
15. The method of aspect 1, wherein at least a portion of said adhesive layer is a pressure sensitive adhesive.
16. The method of aspect 15, wherein said pressure sensitive adhesive includes acrylic adhesives, modified-acrylic adhesives, silicone adhesives, rubber-based adhesives, or combinations thereof.
17. The method of aspect 1, wherein at least a portion of said release line is made of PET films, densified kraft paper, polycoated kraft, and polyethylene films.
18. The method of aspect 1, wherein said portion of the perineal area includes at least a portion of one of the perivaginal area, the perianal area and the area between the vagina and the anus.
19. The method of aspect 1, further comprising the step of supporting said topical device with an applicator device that comprises an elongated body with a distal end and a proximal end, wherein the distal end is configured for releasably engagement to the outer surface of said topical patch and the proximal end is configured for hand-holding or securing to the patient.
20. The method of aspect 1, further comprising the step of supporting said topical device by one or both hands of a medical staff.
21. A method for limiting perineal laceration during childbirth delivery, the method comprising the steps of:
providing a topical device having a support layer on a first side and an adhesive layer on a second side, said topical device configured for adhesive attachment to at least a portion of the perineal area of a patient;
positioning said topical device approximate at least a portion of the perineal area; and
adhesively secure said topical device to at least a portion of the perineal area.
22. A method for limiting perineal laceration during childbirth delivery, the method comprising the steps of:
providing a topical device having a support layer on a first side and an adhesive layer on a second side, said topical device configured for adhesive attachment to at least a portion of the perineal area between the vagina and the anus of a patient;
positioning said topical device approximate at least a portion of the perineal area between the vagina and the anus; and
adhesively secure said topical device to at least a portion of the perineal area between the vagina and the anus.
23. A method for limiting perineal laceration during childbirth delivery, the method comprising the steps of:
providing a topical device having a support layer on a first side and an adhesive layer on a second side, said topical device configured for adhesive attachment to at least a portion of the perineal area between the vagina and the anus of a patient;
preparing the perineal area to receive said topical device;
positioning said topical device approximate at least a portion of the perineal area between the vagina and the anus; and
adhesively secure said topical device to at least a portion of the perineal area between the vagina and the anus.
24. A method for limiting perineal laceration during childbirth delivery, the method comprising the steps of:
providing a topical device having a support layer on a first side, an adhesive layer on a second side, and a release liner covering the adhesive layer, said topical device configured for adhesive attachment to at least a portion of the perineal area between the vagina and the anus of a patient;
preparing the perineal area to receive said topical device;
removing at least part of said release liner to expose said adhesive layer;
positioning said topical device approximate at least a portion of the perineal area between the vagina and the anus; and
adhesively secure said topical device to at least a portion of the perineal area between the vagina and the anus.
25. A method for limiting perineal laceration and other tissue damages during childbirth delivery, the method comprising the steps of:
providing a topical device having a support layer on a first side and an adhesive layer on a second side, said topical device configured for adhesive attachment to at least a portion of the perineal area between the vagina and the anus and the perineal area around the anus of a patient;
positioning said topical device approximate at least a portion of the perineal area between the vagina and the anus and the perineal area around the anus; and
adhesively secure said topical device to at least a portion of the perineal area between the vagina and the anus and the perineal area around the anus.
26. A method for limiting perineal laceration, tissue straining, and tissue extrusion during childbirth delivery, the method comprising the steps of:
providing a topical device having a support layer on a first side and an adhesive layer on a second side, said topical device configured for adhesive attachment to at least a portion of the perineal area between the vagina and the anus, the perineal area around the anus, and the anus of a patient;
positioning said topical device approximate at least a portion of the perineal area between the vagina and the anus, the perineal area around the anus, and the anus; and
adhesively secure said topical device to at least a portion of the perineal area between the vagina and the anus, the perineal area around the anus, and the anus.
27. A method for limiting episiotomy cut from advancing toward the anus during childbirth delivery, the method comprising the steps of:
providing a topical device having a support layer on a first side and an adhesive layer on a second side, said topical device configured for adhesive attachment to at least a portion of the perineal area between the vagina and the anus of a patient;
positioning said topical device approximate at least a portion of the perineal area between the vagina and the anus; and
adhesively secure said topical device to at least a portion of the perineal area between the vagina and the anus.
28. A method for reducing third and fourth degree perineal laceration during childbirth delivery, the method comprising the steps of:
providing a topical device having a support layer on a first side and an adhesive layer on a second side, said topical device configured for adhesive attachment to at least a portion of the perineal area between the vagina and the anus of a patient;
positioning said topical device approximate at least a portion of the perineal area between the vagina and the anus; and
adhesively secure said topical device to at least a portion of the perineal area between the vagina and the anus.
29. A method for reducing medial laceration of perineal tissues during childbirth delivery, the method comprising the steps of:
providing a topical device having a support layer on a first side and an adhesive layer on a second side, said topical device configured for adhesive attachment to at least a portion of the perineal area between the vagina and the anus of a patient;
positioning said topical device approximate at least a portion of the perineal area between the vagina and the anus; and
adhesively secure said topical device to at least a portion of the perineal area between the vagina and the anus.
30. A method for diverting medial laceration of perineal tissues during childbirth delivery, the method comprising the steps of:
providing a topical device having a support layer on a first side and an adhesive layer on a second side, said topical device configured for adhesive attachment to at least a portion of the perineal area between the vagina and the anus of a patient;
positioning said topical device approximate at least a portion of the perineal area between the vagina and the anus; and
adhesively secure said topical device to at least a portion of the perineal area between the vagina and the anus.
31. A topical device for support of perineal tissues comprising a support layer on a first side and an adhesive layer on a second side, said topical device configured for adhesive engagement to at least a portion of the perineal area of a human body.
32. The device of aspect 31, further comprising a release liner for protecting said adhesive layer before application to said portion of the perineal area.
33. The device of aspect 31, wherein the shape of said topical device can be one of those shown in
34. The device of aspect 31, wherein at least a portion of said topical device is substantially flexible.
35. The device of aspect 31, wherein at least a portion of said topical device is semi-stretchable or substantially non-stretchable.
36. The device of aspect 31, wherein said topical device has a concave edge
37. The device of aspect 36, wherein said concave edge of said topical device faces the vagina
38. The device of aspect 31, wherein at least a portion of said topical device is substantially tear-resistant.
39. The device of aspect 31, wherein said topical device is substantially tear-resistant.
40. The device of aspect 31, wherein said topical device is substantially planar.
41. The device of aspect 31, wherein said topical device is a topical adhesive patch.
42. The device of aspect 31, wherein said support layer is made of a polymeric material, a metallic material, a ceramic material, or combination thereof.
43. The device of aspect 42, wherein said polymeric material includes polyesters, polyethylene, ultra-high molecular weight polyethylene, polypropylene, polyethylene terephthalate, rayon, cellulose, polyetheretherketone, polyethersulfone, polyvinylidene fluoride, polytetrafluoroethylene, silicone, polyurethane, polyimide, polyamide, or their combinations.
44. The device of aspect 31, wherein said support layer is polymeric film, sheet or membrane of a solid or a porous configuration.
45. The device of aspect 31, wherein said support layer is a textile fabric, mesh or sheet of woven, non-woven, braided or knitted configuration.
46. The device of aspect 31, wherein said support layer is a laminate or composite of a textile layer and a polymeric layer, wherein the textile layer and the polymeric layer can be separated or intermingled.
47. The device of aspect 31, wherein at least a portion of said support layer is reinforced or laminated with a high-tear resistant material including high tenacity fibers, high modulus fibers, oriented polymeric films, high-tear resistant polymers in elongated configurations, fabric layers, mesh layers, or combination thereof.
48. The device of aspect 31, wherein at least a portion of said adhesive layer is a hypoallergenic adhesive.
49. The device of aspect 31, wherein at least a portion of said adhesive layer is a pressure sensitive adhesive.
50. The device of aspect 49, wherein said pressure sensitive adhesive includes acrylic adhesives, modified-acrylic adhesives, silicone adhesives, rubber-based adhesives, or combinations thereof.
51. The device of aspect 31, wherein at least a portion of said adhesive layer is reinforced or laminated with a high-tear resistant material including high tenacity fibers, high modulus fibers, oriented polymeric films, high-tear resistant polymers in elongated configurations, fabric layers, mesh layers, or combination thereof.
52. The device of aspect 31, wherein at least a portion of said adhesive layer contains an additive selected from the group comprising a solvent, a chemical agent, a pharmaceutical agent, a biological agent, or combination thereof.
53. The device of aspect 31, wherein at least a portion of said release line is made of PET films, densified kraft paper, polycoated kraft, and polyethylene films.
54. The device of aspect 31, further comprising an applicator device for supplemental support of the topical device against the perineal tissues.
55. The device of aspect 54, wherein the applicator device has an elongated body with a distal end configured to engage the outer surface of the topical device and a proximal end configured for applying a force to the topical device.
56. The device of aspect 55, wherein applying a force comprises pushing onto said applicator device by hands.
57. The device of aspect 55, wherein applying a force comprises fastening said applicator device onto the patient.
58. A method for reducing potential contact of a patient's anal discharge with perineal tissues and the baby during childbirth delivery, the method comprising the steps of:
providing a topical device having a support layer on a first side and an adhesive layer on a second side, said topical device configured for adhesive attachment to at least a portion of the perineal or perianal area of a human body;
positioning said topical device approximate above the anus; and
adhesively secure said topical device to at least a portion of the perineal or perianal area.
59. The method of aspect 58, further comprising a method for limiting perineal laceration during childbirth delivery.
60. The method of aspect 58, further comprising a method for limiting perineal laceration, tissue straining, and tissue extrusion during childbirth delivery.
61. The method of aspect 58, further comprising a method for limiting episiotomy cut from advancing toward the anus during childbirth delivery.
62. The method of aspect 58, further comprising a method for reducing third and fourth degree perineal laceration during childbirth delivery.
63. The method of aspect 58, further comprising a method for reducing medial laceration of perineal tissues during childbirth delivery.
64. The method of aspect 58, further comprising a method for diverting medial laceration of perineal tissues during childbirth delivery.
65. A topical device for reducing potential contact of a patient's anal discharge with perineal tissues and the baby during childbirth delivery comprising a support layer on a first side and an adhesive layer on a second side, said topical device configured for locating above the anus and for adhesive engagement to at least a portion of the perineal or perianal area of a human body.
66. The device of aspect 65, further comprising an adhesive-free area on the patient-contacting side.
67. The adhesive-free area of aspect 66, further comprising an adhesive-free area approximately above the anus on the patient-contacting side.
68. The adhesive-free area of aspect 66, further comprising an elongated adhesive-free channel running approximately along the midline from the anus toward the coccyx on the patient-contacting side.
69. The device of aspect 65, further comprising a cap located approximately above the anus.
70. The device of aspect 69, wherein said cap is rigid, semi-rigid or flexible.
71. The device of aspect 69, wherein said cap is planar or non-planar relative to the device prior to application onto a patient.
72. The device of aspect 69, wherein said cap is either concave or convex relative to the patient-contacting side of the topical device.
73. The device of aspect 69, wherein said cap is a drainage reservoir cap with increased space between the anus and the device for temporary collection of anal discharge or secretion.
74. The drainage reservoir cap of aspect 69, further comprising a flexible pouch.
75. The drainage reservoir cap of aspect 69, further comprising an expandable membrane.
76. The drainage reservoir cap of aspect 69, further comprising a dome-shape object.
77. The device of aspect 65, further comprising drainage tubing.
78. The device of aspect 77, further comprising a drainage container connected to the drainage tubing.
79. The device of aspect 65, further comprising a drainage reservoir cap located approximately above the anus, connected drainage tubing, and a connected drainage container.
80. The device of aspect 65, wherein at least a portion of said topical device is substantially tear-resistant.
81. The device of aspect 65, wherein said topical device is substantially tear-resistant, but not cut-resistant.
82. The device of aspect 65, further comprising a release liner for protecting said adhesive layer before application to said portion of the perineal or perianal area.
83. The device of aspect 65, wherein the shape of said topical device can be one of those shown in
84. The device of aspect 65, wherein the shape of said topical device can be one of those shown in
85. The device of aspect 65, wherein at least a portion of said topical device is substantially flexible.
86. The device of aspect 65, wherein said topical device is substantially flexible.
87. The device of aspect 65, wherein at least a portion of said topical device is substantially non-stretchable.
88. The device of aspect 65, wherein said topical device is substantially non-stretchable.
89. The device of aspect 65, wherein said topical device is substantially planar.
90. The device of aspect 65, wherein said topical device is a topical adhesive patch.
91. The device of aspect 65, wherein said support layer is made of a polymeric material, a metallic material, a ceramic material, or combination thereof.
92. The device of aspect 65, wherein said polymeric material includes polyesters, polyethylene, ultra-high molecular weight polyethylene, polypropylene, polyetheretherketone, polyethersulfone, polyvinylidene fluoride, polytetrafluoroethylene, silicone, polyurethane, polyimide, polyamide, or their combinations.
93. The device of aspect 65, wherein said support layer is polymeric film, sheet or membrane of a solid or a porous configuration.
94. The device of aspect 65, wherein said support layer is a textile fabric, mesh or sheet of woven, non-woven, braided or knitted configuration.
95. The device of aspect 65, wherein said support layer is a laminate or composite of a textile layer and a polymeric layer, wherein the textile layer and the polymeric layer can be separated or intermingled.
96. The device of aspect 65, wherein at least a portion of said support layer is reinforced with a high-tear resistant material including high tenacity fibers, high modulus fibers, oriented polymeric films, high-tear resistant polymers, or combination thereof.
97. The device of aspect 65, wherein at least a portion of said adhesive layer is a hypoallergenic adhesive.
98. The device of aspect 65, wherein at least a portion of said adhesive layer is a pressure sensitive adhesive.
99. The device of aspect 65, wherein said pressure sensitive adhesive includes acrylic adhesives, modified-acrylic adhesives, silicone adhesives, rubber-based adhesives, or combinations thereof.
100. The device of aspect 65, wherein at least a portion of said adhesive layer is reinforced with a high-tear resistant material.
101. The device of aspect 65, wherein at least a portion of said adhesive layer contains an additive selected from the group comprising a solvent, a chemical agent, a pharmaceutical agent, a biological agent, or combination thereof.
102. The device of aspect 65, wherein at least a portion of said release line is made of PET films, densified kraft paper, polycoated kraft, and polyethylene films.
103. The device of aspect 65, further comprising an applicator device for supplemental support of the topical device against the perineal or perianal tissues.
104. The device of aspect 65, wherein the applicator device has an elongated body with a distal end configured to engage the outer surface of the topical device and a proximal end configured for applying a force to the topical device.
105. The device of aspect 65, wherein applying a force comprises pushing onto said applicator device by hands.
106. The device of aspect 65, wherein applying a force comprises fastening said applicator device onto the patient.
107. The device of aspect 31, wherein the shape of said topical device can be one of those shown in
108. The device of aspect 31, wherein the shape of said topical device can be one of those shown in
109. The device of aspect 65, wherein the shape of said topical device can be one of those shown in
110. A method for supporting compromised or injured tissues in the perineal or perianal areas before, during or after childbirth delivery, the method comprising the steps of
providing a topical device having a support layer on a first side and an adhesive layer on a second side, said topical device configured for adhesive attachment to at least a portion of the perineal or perianal area of a human body;
positioning said topical device approximate at least a portion of the compromised or injured perineal or perianal area; and
adhesively secure said topical device to at least a portion of the compromised or injured perineal or perianal area.
111. The device of aspect 110, further comprising a release liner for protecting said adhesive layer before application to said portion of the perineal or perianal area.
112. The device of aspect 110, wherein the shape of said topical device can be one of those shown in
113. A method for treating compromised or injured tissues in the perineal or perianal areas before, during or after childbirth delivery, the method comprising the steps of
providing a topical device having a support layer on a first side and an adhesive layer on a second side, wherein at least a portion of said adhesive layer or said support layer contains an additive selected from the group comprising a solvent, a chemical agent, a pharmaceutical agent, a biological agent, or combination thereof, said topical device configured for adhesive attachment to at least a portion of the perineal or perianal area of a human body;
positioning said topical device approximate at least a portion of the compromised or injured perineal or perianal area; and
adhesively secure said topical device to at least a portion of the compromised or injured perineal or perianal area.
114. The device of aspect 113, further comprising a release liner for protecting said adhesive layer before application to said portion of the perineal or perianal area.
115. The device of aspect 113, wherein the shape of said topical device can be one of those shown in
116. The device of aspect 113, wherein said pharmaceutical agent can be selected from the group comprising analgesic drugs, anesthetic drugs, anti-inflammatory drugs, anti-infective drugs, anti-allergic drugs, antibiotic drugs.
117. The device of aspect 113, wherein said chemical agent can be selected from the group comprising oils, solvents, alcohols, ethanol, glycerol, dimethyl sulfoxide, elemental silver, silver compounds, particulate silver, anti-microbial metals, anti-microbial compounds, and anti-microbial solvents.
118. A method for treating sensitive or painful tissues in the perineal or perianal areas before, during or after childbirth delivery, the method comprising the steps of
providing a topical device having a support layer on a first side and an adhesive layer on a second side, wherein at least a portion of said adhesive layer or said support layer contains an additive selected from the group comprising a solvent, a chemical agent, a pharmaceutical agent, a biological agent, or combination thereof, said topical device configured for adhesive attachment to at least a portion of the perineal or perianal area of a human body;
positioning said topical device approximate at least a portion of the sensitive or painful perineal or perianal area; and
adhesively secure said topical device to at least a portion of the sensitive or painful perineal or perianal area.
119. The device of aspect 118, further comprising a release liner for protecting said adhesive layer before application to said portion of the perineal or perianal area.
120. The device of aspect 118, wherein the shape of said topical device can be one of those shown in
121. The device of aspect 118, wherein said pharmaceutical agent can be selected from the group comprising analgesic drugs, anesthetic drugs, anti-inflammatory drugs, anti-infective drugs, anti-allergic drugs, and antibiotic drugs.
122. The device of aspect 121, wherein said analgesic drugs can be selected from the group comprising topical analgesics, opioid analgesics, narcotic analgesics, rubefacients, nonsteroidal anti-inflammatory drugs, local anesthetics, lidocane, benzocaine benzydamine, mucopolysaccharide polysulphate, and salicylamide.
123. The device of aspect 31, wherein at least a portion of said support layer is reinforced or laminated with at least one reinforcement member comprising deformable fiber, filament, yarn, thread, wire, cable, tether, strip, or bar that is made of polymeric, ceramic, metallic materials, or their composites.
124. The device of aspect 123, wherein said reinforcement member also functions as a support frame or support element.
125. The device of aspect 31, wherein at least a portion of said support layer is reinforced or laminated with at least one reinforcement layer comprising tape, strip, film, sheet, knitted fabric, woven fabric, non-woven mesh, braided construct, or combinations thereof.
126. The device of aspect 125, wherein said reinforcement layer functions as a support frame or element.
127. The device of aspect 123 or 125, wherein at least a portion of said device is further supported with at least one support frame or support element.
128. The device of aspect 127, wherein said support frame or support element is less flexible than one of said support layer, said reinforcement members, or said reinforcement layers.
129. The device of aspect 31, wherein at least a portion of said support layer is supported with at least one support frame or support element.
130. The device of aspect 129, wherein said support frame or support element is less flexible than said support layer.
This present application claims the priority and benefit of U.S. Provisional Patent Application Nos. 60/998,587 filed on Oct. 12, 2007 and 61/133,744 filed on Jul. 2, 2008, which are incorporated by reference herein in their entirety.
| Number | Date | Country | |
|---|---|---|---|
| 60998587 | Oct 2007 | US | |
| 61133744 | Jul 2008 | US |
