PHASE-SHIFTING FORMULATIONS

Abstract

The inventive composition first is highly viscous, remaining in place when administered to a patient. Then it decreases in viscosity and liquefies, facilitating easy removal, after a period of time ranging from minutes to weeks, such as after a change in temperature or other trigger; or after another component is added to cause liquefaction. Such compositions have many different medical uses, optionally with a treating agent contained in, or held in place by, the composition, such as, without limitation, prevention or reduction in scarring or adhesions after surgery involving the uterus or other body or organ cavities or other sites, by keeping raw areas of the tissue or tissue walls separated from each other during healing; delivery or retention of treating agents in body or organ cavities or other sites of administration; protection of wounds, burns, and other injuries; and holding tissue grafts in place. Even cosmetic uses are available.

Claims

1. A phase-shifting formulation for avoiding post-surgical scarring and other adhesions, comprising a suitable gel or semi-solid component in a composition that is placed on a post-surgical tissue surface before, during, or after a surgical procedure, and keeps local tissues separated while allowing healing, and then is modified to facilitate removal from the surgical site.

2. (canceled)

3. The formulation of claim 1 wherein the formulation is removed by use of a trigger that causes the formulation to lose its integrity to facilitate removal from the body cavity or tissue surface.

4. (canceled)

5. (canceled)

6. The formulation according to claim 1 wherein the formulation also delivers or maintains a treating agent or tissue regeneration stimulating agent to or on the tissue to promote healing and/or regeneration.

7. (canceled)

8. (canceled)

9. A method of preventing or minimizing post-surgical scarring or other adhesions at a site that needs to heal post surgery, comprising: preparing a viscosity-shifting composition for use during or after surgical and other medical procedures wherein the composition maintains an initial viscosity or consistency for a time sufficient to maintain the subject body tissue free from contact with other tissue or objects, and the composition subsequently reduces in viscosity or consistency over a relatively short period of time, sufficiently so as to allow the composition to be easily expelled or removed from the body tissue; conducting the surgical or other medical procedure; implacing the composition to coat or cover the site of the procedure that requires healing; allowing the composition to then, after a suitable amount of time, reduce in viscosity or consistency over the relatively short period of time; removing or allowing expulsion of the reduced viscosity or reduced consistency composition from the body tissue; and repeating the implacement of a fresh amount of the composition if and as needed until the risk of scarring or adhesions has decreased significantly.

10. The method of claim 9 wherein at least one further treating agent is applied to the site or included in the viscosity-shifting composition.

11. The method of claim 10 wherein the at least one treating agent includes at least one anti-infective agent.

12. The method of claim 10 wherein the at least one treating agent includes at least one anti-inflammatory agent.

13. A method of treating a part of a patient's body or of preventing or minimizing the development of a condition at a part of a patient's body, comprising: preparing a viscosity-shifting composition wherein the composition maintains an initial viscosity or consistency for a time sufficient to achieve the treatment for at least some time, and the composition subsequently reduces in viscosity or consistency over a relatively short period of time, sufficiently so as to allow the composition to be easily expelled or removed from the body tissue; administering the composition to coat or cover the site of the procedure that requires such prevention or treatment; allowing the composition to remain in place for a suitable amount of time, either once or with sequential administration of appropriate amounts of the formulation as needed, after each prior amount of formulation had reduced in viscosity or consistency over the relatively short period of time; removing or allowing expulsion of each quantity of the formulation at the reduced viscosity or reduced consistency composition from the body tissue; and repeating the administration of a fresh amount of the composition if and as needed until the desired treatment has substantially occurred.

14. The method of claim 13 wherein the treatment is intended to minimize or reduce development of scarring or adhesions after a medical procedure.

15. The method of claim 14 wherein the treatment is applied to one or more of a patient's uterus, fallopian tubes, colon, urethra, or bladder.

16. (canceled)

17. (canceled)

18. (canceled)

19. (canceled)

20. The method of claim 13 wherein the treatment is intended to minimize or prevent infection or inflammation.

21. The method of claim 13 wherein the treatment is intended to protect a wound from infection or from further damage pending medical attention.

22. The method of claim 13 wherein the treatment is intended to maintain a skin graft in place.

23. The method of claim 13 wherein the treatment is intended to facilitate diagnosis of damage or developing lesions in or near a joint of the patient.

24. The method of claim 13 wherein the treatment is intended to be used during a cosmetic procedure.

25. The method of claim 13 wherein the treatment is intended to protect a patient's burns.

26. The method of claim 25 wherein the treatment also is intended to facilitate healing of the burns by protecting from loss of blood and bodily fluids.

27. The method of claim 26 wherein the treatment includes placing additional treating agents to help promote healing of the patient's burns either on the burn or within the viscosity-shifting composition.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0067] Surgical procedures affecting the uterine cavityperformed by endo-uterine procedures or hysteroscopy or abdominal approach (laparotomy or laparoscopy)carry the risk of causing scar tissue formationor synechia(e). These inflammatory reactions are capable of interfering with further fertility by altering uterine (or endometrial) receptivity to embryo implantation. The lying of the uterus or endometrium is constituted of distinct tissues. First there is the noble or functional tissue defined as the epithelium that carries its functional role of enabling embryo implantation and pregnancy development. Second there isas in all organsthe supportive or conjunctive tissue made essentially of fibroblast cells.

[0068] Proliferation or development of the endometrium is regulated by hormones, which exert their physiological effects in a sequential manner. First, estrogens induce full endometrial development or estrogen priming that enables its subsequent response to the second hormone, progesterone, in a 2-3 weeks time. Second, progesteronetypically produced after ovulation or administered secondarily in a hormone-priming regimen used in assisted reproductioninduces the sequences of transformation of the endometrium needed for embryo implantation.

[0069] After uterine surgery for pathologies such as the removal of polyps or fibroids, the support connective tissue and its fibroblast are stimulated to grow by the inflammatory nature of the wound created. This may lead to such a proliferation of fibroblast that scar tissue develops and join the opposing surfaces of the lining of the uterus thereby obstructing totally of partially the uterine cavity and impending the proper development of the embryo. This inflammatory process of scar tissue or siniechia(e) formationAscherman syndromemay lead to either lack of embryo implantation and infertility or repeated miscarriages.

[0070] In general, the walls of the uterine cavity will benefit from staying separated from one another in order to prevent scar formation for up to 8 weeks or so following surgery involving the uterine cavity. Two weeks are usually sufficient to allow for the development of the endometrial mucosa and its secretion which will constitute the best protection for scar formation. In certain circumstances however, clinicians may be inclined to keep the uterine walls separated for longer periods of time, as for example 6-8 weeks. It would be rare that an even longer time of separation of uterine walls will appear beneficial for preventing scar formation, but such longer time periods would be readily available with the right formulations.

[0071] Whether or not the addition of an agent to liquefy the composition to facilitate removal once the healing has taken place is needed is, again, formulation and time dependent. In most embodiments, a second agent will be instilled which will cause the composition to change into a state which is easily removed/expelled from the cavity. However, in some embodiments, the formulation is formulated with phase-shifting properties that will be triggered automatically, such as over time, and will be removed from the body without the addition of a second agent. This, too, is subject to experimentation.

[0072] Different constituents and combinations of constituents can provide the desired qualities needed for the development of products that can be used for the invention. These fall in the range of substances which form thickened, semi-solid or even solid compounds.

[0073] Ingredients useful to formulate compositions of the invention include, but are not limited to, celluloses, carbomers, starches, polxamers and colloidal clays. One of skill in the art will be able to use these or similar ingredients to make formulations which will remain on tissue surfaces and retain their structural integrity. The formulator will be able to select a trigger that will cause the composition to lose its integrity and be able to be removed from the tissue surface.

[0074] The optimal time frame during which the products used in the compositions of the invention need to remain in contact with the tissue, or in the cavity, depends on the specific circumstances of the particular patient. In fact, depending upon the specific usage the time may vary significantly. The medical practitioner will readily be able to determine the appropriate timeframe for the particular patient and situation. The formulator will readily be able to prepare a formulation with the timing characteristics specified by the medical practitioner, and including any additives to be mixed in or pre-applied. This variance may also be directly related to the formulation used. Constituents, combinations and ratios are routine in the art.

[0075] Formulations

[0076] The compositions of the invention can be made using ingredients that provide an inert, mostly impermeable formulation that will remain on tissue surfaces. This can be achieved using most gel-forming ingredients, including, but not limited to polymers (such as celluloses (including without limitation methylcellulose, ethylcellulose, hydroxyethyl cellulose, ethyl hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, and carboxymethylcellulose), carbomers, gelatin, agar, pectin, starches, high molecular weight polyethylene glycol), copolymers (such as, for example, poloxamers) and colloidal clays (such as, for example, bentonite or tragacanth).

[0077] The formulation could be made by one of skill in the art to remain intact until a trigger causes the structure to lose its integrity and dissociate from the tissues and be expelled from the body. These formulations differ from the formulations used in U.S. Pat. No. 7,727,155, which is hereby incorporated in its entirety, in that they are inherently more stable structurally and retain viscosity for days and weeks instead of minutes. In addition, the composition will have a greater tendency to remain on tissue surface in comparison to the formulations in U.S. Pat. No. 7,727,155.

[0078] Triggers that may be used with the compositions of the invention include, but are not limited to, preparations which can modify the composition's structure by changing salt concentrations (either higher or lower) to control rate and timing of when a formulation would change phase chelating certain molecules, or causing exothermic or endothermic reactions, changing the temperature of the composition directly, changing pH of the composition or the environment, physically disrupting the composition's formulation or displacing the composition's formulation from the tissues, so long as the change to the formulation results in the desired change in viscosity or liquefaction, or otherwise causing the formulation to lose viscosity and be more easily removed or expelled from the site of administration.

[0079] While the uterine cavity is the primary area in which the use of the invention is foreseen, compositions of the invention can also be used in other organs and territories. These other applications include, for example, in the Fallopian tubes or the urethra, or in the bladder.

[0080] In the Fallopian tubes, application of a composition of the invention at the end of surgery would maintain separation of the tube while the healing process takes place. A certain time later, for examples up to 2-4 weeks later, the product would liquefy, either subsequent to the nature of the formulation itself, or by instilling a second product through the uterine opening of each tube.

[0081] Allowing the walls of the Fallopian tubes to freely contact only after proper healing has taken place would likely favor better preservation of tubal functionality. Hence, the proposed product would likely decrease the risk of the complication of tubal surgery, such as infertility by tubal occlusion and/or alteration and ectopic pregnancy and the ensuing new tubal surgery. In the ureter or male urethra, the product inserted around a stent would prevent direct contact between tissue (the urinary epithelium) and the stent, and possibly allow for removal of the stent with an opening for urine flow remaining within the product itself. A liquefying second product could be administered by retrograde injection or by urinary excretion. Likewise, benefit could be obtained for surgery performed in or on any organ, body cavity, or tissue where benefit might be gained from keeping the surfaces separated after surgery, as for example in otic, nasal, orthopedic, neurosurgery or other surgical procedures.

[0082] The instant invention would be useful during various types of medical procedures, whether for observational, diagnostic, treatment, or other purpose. These include, without limitation, procedures such as x-rays, ultrasound, CT scans, MRI, HSG, or endoscopy.

[0083] The problems encountered for holding a contrast medium for imaging procedures such as MR imaging, CT-scans etc. could be handled by the time-controlled phase shifting properties of the substance. In ultrasound imaging techniques now available, constant infusion of a contrast fluidwhile cumbersomecan be performed. In other imaging techniques, infusion during the procedure is not possible, without use of a phase-shifting formulation. The phase shifting properties would make the use of intrauterine contrast substances possible while allowing for their removal afterwards through the phase shifting properties of the substance and utilizing several systems and/or methods for controlling the phase shifting.

[0084] Methods of Administration

[0085] The necessary amount of the composition, about 2-20 ml, is instilled in the uterine cavity using a syringe attached to a plastic catheter that is passed through the cervical canal. Upon instillation the composition has a gel-like consistency. The exact degree of uterine distension can be verified using ultrasound either during the process of administration of the composition or afterwards. People skilled in the art of practicing uterine surgery and uterine manipulations could determine the best degree of distension desired, possibly adjusting the parameters according to the different diagnoses.

[0086] Alternatively, the composition could be administered directly through an injecting port permanently or temporarily attached to a hysteroscope that was used during surgery and/or the layering of anti-inflammatory substances and/or layers of endometrial or stem cells. One of skill in the art would be able to manipulate the hysteroscope to apply the composition.

[0087] Some small amounts (3-5 cc) of phase-shifting formulation would be instilled in the uterine cavity at the end of surgical procedure on the uterine cavityfrom the inside (during a hysteroscopy) or the outside of the uterus (during laparotomy or laparoscopy). The phase shifting formulation would serve for slightly distending the opposing raw surfaces of the uterine cavity in order to avoid contact between the surfaces for the duration of the healing process and development of the noble tissuethe endometrium. This process typically takes 2-3 weeks. At the end of this time interval, the distending formulation would liquefyeither spontaneously by a time-set phase shifting process or through the instillation of a few CC of a second liquefying solution. Once liquefied the few CCs of formulation would be expelled naturally and easily.

[0088] The phase shifting formulation used for temporarily distending the uterine cavity could be neutral or combined with different active substances designed for preventing inflammation and/or infection development, as deemed necessary.

[0089] For the purpose of treating endometrial lesionsadhesions, area of dysfunctional disruption non-responding to hormonal treatmentwith stem cell therapy. The phase-shifting formulation will facilitate the positioning and keeping in place of stem cell preparations so that the uterine walls are kept separated during the process in order to prevent the development of inflammation. Stem cells simply applied over a raw or functionally disrupted area would otherwise require surgical removalpeelingof prior dysfunctional scarring in order to re-colonize the disrupted areas and generate a new functional tissue emanating from the population of stem cells. Taking place in an area purposely rendered raw could again generate a pathological dysfunctional scarring destroying the stem cells before they could help the physiological healing. The substance would offer the advantage of an inert covering of the area where healing is expected to take place from the stem cells layered there. Tissue protection by the substance would be required for the duration of the physiological healing, a time course that vary depending on the tissue but would generally range from 10 to 20 days.

[0090] The phase-shifting formulation also could be used in conjunction with various treating agents, such as different products exerting properties that facilitate the development of stem cells or on the contrary, prevent the growth of non-specific fibroblast that could prevent stem cell development.

[0091] Preventing Scarring Elsewhere in the Body

[0092] Example: Urology

[0093] A surgical wound in urology might benefit from a phase shifting gel that would separate the raw areas of the surgical wound from the opposite surfaces for the time of the healing for preventing scar tissue formation. For example, surgical resection of benign or cancer lesions of the prostate and other parts of the urological canal could benefit from being kept separated from the opposite surface for the time of healing, by helping to prevent adherence, undesired scarring, or accelerated scarring. And again, anti-infective agents or other treating agents may also be included in such formulations, to simultaneously provide multiple benefits.

[0094] Facilitating Healing

[0095] These formulations may provide advantages when used for facilitating healing following urological procedures. For example, after certain urological procedures, the formulation may help facilitate healing and appropriate scarring. In cases where tissue is excised, healing may be enhanced by promoting limited initial scar formation.

[0096] During the time that the formulation would serve for separating the raw surfaces or the urological procedure, a supra-pubic urinary catheter would serve for temporarily redirecting the flow of urine.

[0097] Delivery of Treating Agents Within Body or Organ Cavities or Elsewhere

[0098] The usefulness of a phase-shifting media to deliver treating agents to various sites within the body becomes apparent when taking into account the ability to adjust the time the media remains in one phase prior to shifting to another. For example, a treating agent can be maintained in a cavity or on a body surface (without physically attaching to, or causing or allowing any solid material to contact, any tissue within the cavity or to on the surface) for a period long enough to impart the desired effect in the cavity or to the surface, then be eliminated from the cavity or off the surface via its phase-shifting properties. One or more treating agents could be delivered within such cavities during a medical procedure by adding the treating agent to the formulation used during the procedure, or they could be separately or again delivered, after a procedure or otherwise, in a similar formulation that could be designed to remain in place for a longer period of timeup to weeks or more, as appropriate.

[0099] Non-Medical Uses

[0100] For example, such formulations may prove useful in cosmetic procedures such as protecting the scalp or facial skin during hair bleaching and coloring procedures; providing protection during tanning in the sun or tanning booths; promoting healing of the site of a fresh tattoo on the body; use with agents such as insect repellants, to provide lasting protection that is easily removed when desired; and maintaining contact with skin or hair for an extended period of time, such as with moisturizing or regenerative agents overnight. For certain uses, such as potentially with insect repellants, the formulation could be designed to help protect the user from the insect repellant, while maintaining the repellant's efficacy, by forming a barrier between the skin of the user and the repellant.

[0101] Suitable Treating Agents

[0102] Active ingredients suitable for use in or with the present invention include, but are by no means limited to: (1) glycoproteins, such as follicle-stimulating hormone (FSH), luteinizing hormone (LH), human chorionic gonadotropin (HCG), thyroid-stimulating hormone (TSH), and the like; (2) proteins, such as GnRH (agonist and antagonist), desmopressin, oxytocin analogs, insulin analogs, TRH analogs, somatostatin analogs, tissue plaminogen activator (TPA), growth hormone releasing hormone (GHRH), corticotropin-releasing hormone analogs (CRH analogs), and the like; (3) sex hormones, such as estradiol, testosterone, progesterone, other estrogenic and progestogenic compounds, and the like; (4) anti-hormones and selective estrogen and progestin receptor modulators, such as tamoxifen, mifepristone, raloxifene, and the like; (5) nitrates, such as nitroglycerin, isosorbide, erythrityl tetranitrate, pentaerythritol tetranitrate, and the like; (6) beta-agonists, such as terbutaline, albuterol, pirbuterol, bitolterol, ritodrine, and the like; (7) beta-antagonists, such as propranolol, metoprolol, nadolol, atenolol, timolol, esmolol, pindolol, acebutolol, labetalol, and the like; (8) opioids, such as morphine, hydromorphone, oxymorphone, codeine, hydrocodone, oxycodone, levorphanol, levallorphan, buprenorphine, fentanyl, nalbuphine, butorphanol, pentazocine, and the like; (9) opioids-antagonists, such as naloxone, nalmefene, and the like; (10) antidepressants, such as amitriptyline, amoxapine, desipramine, doxepin, imipramine, maprotilen, nortriptyline, protripyline, trimipramine, fluoxetine, trazodone, and the like; (11) HMG CoA reductase inhibitors, such as lovastatin, mevastatin, simvastatin, pravastatin, atorvastatin, and the like; (12) antihistamines, such as loratadine, chlorpheniramine maleate, brompheniramine maleate, diphenhydramine, dimenhydrinate, carbinoxamine, promethazine, tripelannamine, and the like; (13) ACE inhibitors, such as captopril, enalapril, lisinopril, and the like; (14) prostaglandins, are a class of naturally occurring chemically related, long-chain hydroxy fatty acids, such as prostaglandin E.sub.2 (PGE.sub.2), PGE.sub.1, PGA.sub.1, PGB.sub.1, PGF.sub.1, 19-hydroxy-PGA.sub.1, 19-hydroxy-PGB.sub.1, PGA.sub.2, PGB.sub.2, 19-hydroxy-PGA.sub.2, 19-hydroxy-PGB.sub.2, PGE.sub.3, PGF.sub.3; semisynthetic or synthetic derivatives of natural prostaglandins, including mioprostol, carboprost tromethamine, dinoprost tromethamine, dinoprostone, lipoprost, gemeprost, metenoprost, sulprostone and tiaprost; analogues thereof and the like; (15) non-steroidal anti-inflammatory drugs (NSAIDS), such as diclofenac, etodolac, fenoprofen, lurbiprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, meclofenamate, fenamic acid, meloxicam, nabumetone, naproxin, oxaprozin, piroxicam, sulindac, tolmetin, and the like; (16) anti-infectives; (17) anesthetics, such as lidocaine, cocaine, chloroprocaine, tetracaine, prilocaine, mepivacaine, buipivacaine, levobupivacaine, articaine, ropivacaine, phenol, benzocaine, pramoxine, dyclonine, etidocaine, procaine, proparacaine, dibucaine, and pramoxine; (18) immune system modifiers such as imiquimod and the like; (19) muscarinic agonists and antagonists such as bethanecol and oxybutinyn and the like; (20) anti-neoplastic agents including alkylating agents such as melphalan, antimetabolites such as fluorouracil, and natural products such as vinca alkaloids and bleomycin as well as agents such as cisplatin and the like; (21) vitamin K; (22) ondansetron; (23) levocarnitine; (24) anti-fungals; (25) carbamide peroxide; (26) dopamine antagonists (bromocriptine); (27) bisphosphonates: (28) nicotine; (29) anti-virals (acyclovir); (30) anti-diabetagenics (metformin); (31) peptides (octreatide, desmopressin, GNRH, other proteins); (32) insulin; (33) anti-Parkinson agents (levadopa); (34) low molecular weight heparins; (35) antimicrobials such as metronidazole and the like; (36) anti-cancer agents, such as tumor specific agents or other agents; and (37) anti-infective compounds such as heavy metals, salts, and radio-active substances. Accordingly, one of ordinary skill in the art will appreciate that formulations according to the invention may be used with a wide variety of active ingredients to treat a wide variety of conditions, and that the ingredients could be placed separately, before the gel formulation, or they could be included within the gel formulation itself.

[0103] Burns, Wounds

[0104] Blood and other bodily secretions ooze or flow from wounds, including serious burns. The formulation typically will prevent the oozing of such fluids from the wound and/or raw area by not mixing with the fluid, and thus retaining critical protein exudate in the wound. This property could be used for diminishing inflammation, accelerate healing and provide a nicer less destructive and/or disharmonious scar. The retention property is lost as soon as the viscosity decreases and the formulation liquefies. The formulation could be applied on the raw surface and/or open wound as it is in an inert sterile form or combined with active substances such as anti-inflammatory and/or antibiotics and/or other substances capable of ameliorate the healing process. Similarly, the active substance could be, for example, sprayed on the wound, or otherwise administered before the phase-shifting formulation is put in place.

[0105] Thus the phase-shifting formulation provides potential use for protecting such injuries without the normal detrimental effects of using fabric bandages. Instead, the formulation enables preparation of a new skin bandage with no material touching the skin for extended wounds like burns, or for sensitive areas, like the face.

[0106] For example, there currently is no real way to cover a wound without any material touching the surface of the wound, or while at least preventing the oozing of fluid and blood to attach to the covering. Removing or changing such coverings without disturbing the wound is nearly impossible, and inevitably causes significant pain, too, as well as delaying the healing process.

[0107] Use of these formulations may provide a bandage or covering without direct contact with the healing wound by the covering fabric. Using the formulation to separate the bandage from the underlying wound would greatly enhance the healing process, reducing discomfort for the patient. Further, with certain injuries such as extensive serious burns, the formulation may help prevent fluid losses and maintain crucial factors such as coagulation factors in the patient's bodily fluids.

[0108] For example, a large bandage with a valve system could allow changing or refreshing the formulation by first liquefying the portion already covering the wound, and then gently removing it or allowing it to seep away while a fresh portion of formulation is administered. Such periodic refreshing of the formulation would allow removal of cell debris and/or delivering new dosing of an active substanceany desirable active agents could be included in or along with the formulation, for any or all of the administrations.

[0109] One possible embodiment would provide a constant or pulsatile flow of formulation periodically, allowing periodic phase changes while applying only slight pressure through two valves opening into the bandage system. Such gentle treatment of the wound, combined with preserving more of the patient's natural fluids and agents, should provide a significant advantage in treating certain injuries, especially burns, and most especially large burns.

[0110] Another use would be as an emergency application to a burn or wound in the field, pending full medical treatment. Promptly coating and protecting the wounded tissue until full medical attention is available would help to minimize infection, further damage, and fluid loss. The easy removal of the formulation after liquefaction facilitates prompt full medical attention as soon as it is available.

[0111] This could be particularly important for covering large burns from which large amounts of fluid rich in protein and other blood constituents are lost daily to the point of making the compensation difficult.

[0112] For example, the formulation could be used in combination with a bandage of different size and shape adhering at the periphery under which a suitable formulation would be injected through a valve system opening until sufficient material is present for a) avoiding contact between the damaged surface and the covering, and b) helping retain the blood and fluid and preventing the constant effusion that characterizes large burns.

[0113] The formulation could either be neutral or contain any type product deemed helpful for facilitating healing and/or preventing complications such as infections.

[0114] The principle described above for offering a formulation coverage or protective layer could apply not only on skin wound as described above but also to protect and help treatment of wounds and/or post traumatic scar tissue of internal organs such as possibly encountered in gynecology (intra-uterine or tubes), urology or ENT (ear, nose and throat) practices.

Other Medical Uses

[0115] Skin Grafts

[0116] The formulation virtual barrier could also serve for holding in place fragments of graft tissue and/or stem cell preparations and/or any growth factor and/or anti rejection substance in case of grafting.

[0117] Joints

[0118] Diagnosis of damages or developing lesions (degenerative or linked or inflammation or cancer process) could be facilitated by the temporary distension of the joint, and delivering formulation, with or without treating agents, to the joint space.

[0119] Urology

[0120] Certain diagnostic processes (ultrasound, MRI, etc.) looking for urological lesions could be facilitated by generating contrast interphases in between surfaces that are normally collapsed on themselves. Such formulations also could be used in combination with treating agents.

[0121] Dental Use

[0122] There are potential uses for the formulation during and after dental procedures, too. The formulation could be used to maintain active agents, such as antibiotics, in place, such as after or during an extraction, or a root canal procedure. Use during or after gum surgery similarly could help maintain an appropriate treating agent, like an antibiotic, in place for an extended period of time. Alternatively, the composition could be used to protect soft tissue during use of bleaching agents for whitening teeth, or for administering fluoride treatment to the teeth, or to coat the gums to protect them from sticking to cement or adhesive used during procedures.

[0123] Non-Medical Uses

[0124] For example, such formulations may prove useful in cosmetic procedures such as protecting the scalp or facial skin during hair bleaching and coloring procedures; providing protection during tanning in the sun or tanning booths; promoting healing of the site of a fresh tattoo on the body; and maintaining contact with skin or hair for an extended period of time, such as with moisturizing or regenerative agents overnight.

[0125] Any and all publications and patent applications mentioned in this specification are (1) indicative of the level of skill of those skilled in the art to which this invention pertains, and (2) hereby incorporated by reference to the same extent as if each individual publication or application was specifically and individually incorporated by reference.

[0126] It is to be understood that the invention is not to be limited to the exact configuration as illustrated and described herein. Accordingly, all expedient modifications readily attainable by one of ordinary skill in the art from the disclosure set forth herein, or by routine experimentation therefrom, are deemed to be within the spirit and scope of the invention as defined by the appended claims.