Abstract:
The present invention provides a method and devices for the treatment of hemorrhoids. The method involves the combined delivery of cryotherapy and medication therapy. The devices described provide cryotherapy for immediate relief of pain, itching, reduction of swelling, reduction of existing bleeding, shrinkage of hemorrhoidal tissue, and promotes healing of affective tissues. Subsequent medication release from these devices provides sustained healing and protracted relief of symptoms. The devices may be disposable and may be used externally or internally, and may include an invasive or non-invasive applicator.

Description:
RELATED APPLICATIONS  
       [0001]     This is a continuation in part application of U.S. patent application Ser. No. 10/775362, filed Feb. 10, 2004, the contents of which, are hereby incorporated by reference. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The present invention relates to the field of devices and methods for the treatment of hemorrhoids, or the like.  
       BACKGROUND OF THE INVENTION  
       [0003]     Over ten million individuals in the United States suffer from painful hemorrhoids; a prevalence rate of more than 4%. It is therefore a significant medical problem.  
         [0004]     The term hemorrhoid is usually used by the non-medical layperson to describe the symptoms caused by hemorrhoids, since hemorrhoids exist in all healthy persons. Hemorrhoids are clusters of vascular tissue (arterioles, venules, arterio-venular connections), smooth muscle and connective tissue. Most lay-people and physicians refer to hemorrhoids when these vascular cushions cause painful symptoms. Hemorrhoids may be external or internal. Internal types do not cause cutaneous pain but may prolapse and bleed and cause severe perianal pain through spasm induction of the sphincter complex or when strangulated and/or necrosed. Internal hemorrhoids may also produce pruritus (itching). External hemorrhoids induce pain through thrombosis (by straining, diarrhea, diet change). Pain results from the rapid distention of innervated sensitive tissue caused by both clot and edema (tissue swelling).  
         [0005]     Currently accepted non-surgical medical treatments for the symptoms of hemorrhoids are directed at relieving the pain and/or pruritus (itching). Symptomatic relief should not only be directed towards the pain caused by thrombosis, prolapse and edema (swelling), however, but also to the pain resulting from spasm of the sphincter.  
         [0006]     Therapies of the prior art include the use of cold to reduce edema and numb the anal region. Separately, the prior art also describes the use of analgesics and topical anaesthetics for pain relief, topical steroids or other anti-inflammatories, topical L-arginine for the relief of sphincter spasm (a major and common precipitant of pain), and stool softeners (longer term preventative therapy). No therapy in the prior art describes a treatment in which a cryotherapy and medication treatment are combined.  
         [0007]     U.S. Pat. No. 3,939,842 issued to Harris on Feb. 24, 1976 teaches a frozen disposable insert as does this inventor&#39;s U.S. Pat. No. 4,844,073 issued to Pohler (Jul. 4, 1989). However, neither invention describes the use of medication in combination with cold or cryotherapy. The Harris device, as described in U.S. Pat. No. 4,563,182 (Jan. 17, 1986) to Stoy and Stoy, is of controversial utility given that it may produce “very low temperatures” and cause “frostbite”.  
         [0008]     Further, U.S. Pat. No. 4,563,182 issued to Stoy and Stoy (“Stoy”) teaches a rectal insert comprising a probe produced entirely of a frozen gel (with or without medication). The device may be left in place for only 1-5 minutes after which the gel, and more importantly, the functional part of the rectal insert dissolves. This limits the therapy treatment to an acute 1-5 minute treatment after which the gel dissolves, the external portion falls away and the remaining dissolved liquid either moves out the anus or moves up the colon away from the affected area. Also, because the insert is made of a gel that may dissolve, the shape of the insert may change and thus become difficult to retain within the rectum during treatment. Alternatively, the shape of the insert may change in such a fashion that it is difficult to remove the insert from the rectum once the treatment is finished.  
         [0009]     As such, in contrast to the present invention, Stoy merely provides a dissolvable device that is incapable of a protracted delivery of medication.  
         [0010]     U.S. Pat. No. 969,134 issued to Cowie (“Cowie”) on Aug. 30, 1910, teaches the use of cooling to reduce hemorrhoidal swelling and pain. The patent teaches the implementation of a hollow tube filled with ice or other cooling medium. Cowie, however, does not speak to combining the therapy with medication delivery or speak to the issue of disposability.  
         [0011]     U.S. Pat. No. 5,178,627 issued to Hudock (“Hudock”) teaches a rectal insert that delivers medicants through pores within the device. Hudock does not teach of a device that provides cryotherapy and does not teach a delay in the release of the medication as a result of the cryotherapy treatment.  
         [0012]     U.S. Pat. No. 702,789, No. 1,271,456, No. 2,653,599, and No. 3,675,642, relate to devices used to expand or hold protruding veins and a priori teach a treatment differing from that described herein.  
         [0013]     As such, while these prior art products have provided some advantages and improvement in the area of interest in the present application, it would still be desirable to provide further improvement therein.  
       SUMMARY OF THE INVENTION  
       [0014]     Accordingly, it is a principal advantage of the present invention to provide a device and a treatment method for providing a combined cyrotherapy and medication treatment wherein the medication treatment is preferably delayed until the cyrotherapy treatment has been initiated. As such, it would be desired to provide a unitary device that provides a cryotherapy effect prior to delivering a healing medium.  
         [0015]     It is a further advantage of the present invention to provide a device that first provides a controlled cryotherapy effect and then provides a healing medium to hemorrhoids, rectal tissue after surgery, or the like, that would be useful and provide a combined therapeutic advantage that was not otherwise available.  
         [0016]     It is a still further advantage of the present invention to provide a disposable device that provides a frozen medium and a healing medium, and that is both convenient and comfortable to use.  
         [0017]     The advantages set out hereinabove, as well as other objects and goals inherent thereto, are at least partially or fully provided by the cyrotherapy device of the present invention, as set out herein below.  
         [0018]     Accordingly, in one aspect, the present invention provides a combined cryotherapy and healing medium treatment device preferably for insertion into the rectum for the treatment of hemorrhoids or other such symptomatic conditions, comprising; 
        a body section which is preferably suitable for at least partial insertion into the rectum;     a wall section on at least a portion of said body section which wall section defines at least one cavity;     a healing medium located within said cavity; and     a sleeve having an open end such that said applicator can slide into said sleeve and said sleeve substantially covers said cavity so as to hold said healing medium within said cavity.        
 
         [0023]     In the present invention, the cryotherapy treatment provides pain relief within minutes and initiates the reduction of the edema. After the cryotherapy treatment, a time-delayed medicant release occurs, delivering a healing medium, such as an analgesic, aneasthetic, antipruretic and/or spincter anti-spasmotic to the affect area, so as to provide longer term relief of pain, itching, and sphincter spasm, respectively.  
         [0024]     In further aspect, the present invention also provides a method of using the device described herein.  
         [0025]     As such, in its broadest aspects, a method and device are provided herein for dual cryotherapy and medicant delivery for the treatment of hemorrhoids or other anal conditions in which pain or other discomfort is involved. The treatment method may utilize a disposable or non-disposable device for its application, and treatment can be applied internal or externally of the rectum.  
         [0026]     In its simplest embodiment the device includes a frozen active medical ingredient as a healing medium which is located within the cavity or cavities located on the wall of the device.  
         [0027]     In the preferred embodiment the active medical ingredient is formulated to provide 5 or more minutes of cooling before melting or becoming a dispersible gel. As such, unlike solid devices, the healing medium, or medication, is initially trapped in cavities within the device and then slowly released from the cavities so as to be delivered over time as the healing medium warms.  
         [0028]     The device is preferably substantially cylindrical in shape and has a substantially rounded insertion tip. The device is also preferably hollow so as to allow it to be filled with either a cryotheraputic material, and/or a healing medium, or a material which acts as both.  
         [0029]     In a further preferred embodiment the device has a substantially bulbous portion along its length so as to stop disgorgement of said device. All embodiments preferably include an enlarged external portion (which can be round, oval, trapezo, or any other imaginable shape or design) which is suitable to essentially prohibit the device from entering entirely into the anal cavity, when the device is applied into the rectum to treat internal and/or external hemorrhoids.  
         [0030]     In its more advanced embodiment the treatment method and device also allows for containment of a substance of high latent heat of fusion to be permanently sealed within the device. Such substances of high latent heat of fusion have the beneficial effect of providing cooling over an extended period of time. In this advanced embodiment, hemorrhoidal or other medication is contained primarily within external cavities of the device and released over time to the affected areas.  
         [0031]     Whereas the prior art therapies provide either immediate, but brief, pain and/or pruritus relief (cryotherapy), or delayed pain and/or pruritus relief (medication), the method of the present invention provides the advantage that it provides both immediate and long-term symptom relief due to the combined cryotherapy treatment and subsequent treatment with the healing medium.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0032]     The above-mentioned, and other, features and advantages of this invention, and the manner of attaining them, will become apparent and be better understood by reference to the following description of the embodiments of the invention in conjunction with the accompanying drawings, wherein:  
         [0033]      FIG. 1 . is a plan view of the cryotherapy device of the present invention;  
         [0034]      FIG. 2  is an exploded view of the device of  FIG. 1 ;  
         [0035]      FIG. 3  is a cross-sectional view of the device of  FIG. 1 ;  
         [0036]      FIG. 4  is a second plan view of the device of  FIG. 1 ;  
         [0037]      FIG. 5  is a partial cross-sectional view of the device of  FIG. 1 ;  
         [0038]      FIG. 6   a  is a perspective view of a second embodiment of the cryotherapy device of the present invention;  
         [0039]      FIGS. 6   b ,  6   c  and  6   d  are a partial perspective view of a portion of the cryotherapy device of  FIG. 6   a , and a cross-sectional views thereof;  
         [0040]      FIGS. 7   a  to  7   d  are plan and perspective views of a third embodiment of the cryotherapy device of the present invention; and  
         [0041]      FIG. 8   a  and  8   b  display an example of the packaging for a device as described in  FIG. 1 . 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0042]     The novel features which are believed to be characteristic of the present invention, as to its structure, organization, use and method of operation, together with further objectives and advantages thereof, will be better understood from the following drawings in which presently preferred embodiments of the invention will now be illustrated by way of example only. In the drawings, like reference numerals depict like elements.  
         [0043]     It is expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the invention.  
         [0044]     An example of a disposable cryotherapy device in accordance with the present invention, which is primarily intended for the treatment of hemorrhoids, rectal tissue after surgery, or the like, is shown in  FIGS. 1 and 2 . The cryotherapy device  10  includes a rectal insert  12  and a sleeve  14 .  
         [0045]     The rectal insert  12  includes a body  20  and a cap  22 . In this example, the body  20  includes an external wall having cavities, or openings, in the forms of slots  24 , a rounded tip  26 , and a cap receiving portion  28 . Body  20  encloses a chamber  30  which is shown in more detail in  FIG. 3 . The body  20  has a rounded tip  26 , and a cylindrical shape for comfortable insertion into a rectum. The chamber  30  contains a frozen “active hemorrhoidal ingredient” (hereinafter “AHI”) which acts as a healing medium. The frozen AHI can be comprised of, for example, water, or a substance such as aloe vera gel mixed with purified water, glycerine, a carbomer and a sodium hydroxide solution. Alternatively, any existing hemorrhoid product such as, but not limited to licodaine, hydrocortisone, an appropriate analgesic, hamamelis water L-arginine or any other effective haemorrhoid medication when used either alone or mixed with water or a substance such as aloe vera gel mixed with purified water, or glycerine, or a carbomer and sodium hydroxide, might be used. It is to be understood, however, that AHI formulations with high heat capacity and high latent heats of fusion are preferred since they will provide superior cooling. It is also to be further understood that the construction -material and thickness of the device wall, and the selection of the AHI, are designed so that the conduction of heat away from the anus is limited and does not cause tissue freezing and necrosis.  
         [0046]     To further maximize the cryotherapy treatment effect, the frozen AHI is preferably formulated such that it remains substantially “solid”, or frozen, for at least 1 minute, more preferably at least 2 minutes, and even more preferably at least 5 minutes after the cyrotherapy device is applied to the rectal tissue.  
         [0047]     It is to be noted that the term “frozen” or “freezing” will be used hereinafter for brevity. However, it is to be clearly understood that these terms are to include any solidification, or any other suitable increase in viscosity, as a result of cooling, that permits the operation of the present invention.  
         [0048]     It is preferred that the pH of the AHI be in a physiologically suitable range, and that the materials used are suitable for their intended application.  
         [0049]     The cap  22  is configured for engaging the cap receiving portion  28  ( FIG. 2 ) of the body  20 . More particularly, the cap  22  is configured to snap onto the cap receiving portion  28  of the body  20  in a sealing manner as shown in  FIG. 1  and  FIG. 3 . The cap  22  and the cap receiving portion  28  preferably include multiple complementary sealing structures  32  to retain the AHI within the chamber  30 . Alternatively, cap  22  and cap receiving portion  28  may include complimentary threads to seal off the open end of the body  20 .  
         [0050]     The sleeve  14  fits and locks over the rectal insert  12  such that sleeve  14  completely cover the slots  24  as shown in  FIGS. 3 and 5 . In preparation for use, the user ensures that the body  20  of the rectal insert is fully inserted into the sleeve  14 . The selected AHI is placed into the chamber  30  via the cap receiving portion  28 , as indicated by the arrows shown in  FIG. 4 . The chamber  30  is preferably not completely filled to allow expansion of the AHI during changes in temperature. The cap  22  is then attached to the cap receiving portion  28 . With this configuration, sleeve  14  allows the AHI to be placed into chamber  30  prior to being frozen by precluding the AHI from leaking out of slots  24  to any significant extent. Device  10  is then frozen.  
         [0051]     After freezing, the device  10  may be used entirely externally wherein it is held between the buttocks, and as such, is non-invasive. Alternately, it may be inserted into the rectum and thus treat internal and external hemorrhoids. For some applications, such as pregnant and some post-operative patients, the device  10  can also be used with the sleeve  14  on by placing it between the buttocks, and thereby introduce cryotherapy treatment without medication.  
         [0052]     In order to treat hemorrhoids or rectal tissue after surgery with medication, however, the packaged, frozen cryotherapy device  10  is removed from the freezer and then separated from any packaging. The empty packaging, as shown in  FIG. 8 , is discarded. The rectal insert  12  is then removed from the sleeve  14  ( FIG. 2 ). Again, as previously noted, the AHI does not leak through the slots  24  because it is now frozen. The rectal insert  12  is inserted into the rectum with the rounded end  26  first. The enlarged cap receiving  28  and cap  22  prevent the rectal insert  12  from being inserted so far into the rectum that it is difficult to remove.  
         [0053]     Additionally, a string may be attached to the cap  22  to aid in the removal of the rectal insert  12  from the rectum.  
         [0054]     During its use, the frozen AHI (and insert  12 ) first treats the tissue by cooling. Further, after several minutes, the frozen AHI begins to melt, and thus the AHI is delivered to the tissue providing a second phase of treatment which extends out over the time period of the AHI treatment. After treatment, the remaining rectal insert  12  is removed and it, sleeve  14 , and the empty packaging are all discarded.  
         [0055]     In a second embodiment, a non-invasive disposable or non-disposable cryotherapy device is shown. Also, in this embodiment, the device is configured so as to reduce the amount of medication required to fill the device which thereby reduces its cost and improving its utility. Such a device  110  is shown in  FIG. 6   a . In this embodiment the medication is placed in grooves  124  ( FIG. 6   a  ) and there is no medication in the interior cavity of body  112 . This reduces the amount of, and the cost of, medication required, as compared to device  10 . The cryotherapy device  10  is configured to be applied externally to hemorrhoids and tissue and may be additionally used after surgery and includes a substantially cylindrical surface  112  having cavities in the form of slots  124  and a sleeve/cover  114 . AHI is placed in the cavities  124  of the cryotherapy device and then frozen.  
         [0056]     After freezing, the sleeve/cover  114  is removed and the substantially cylindrical surface  112  is positioned to contact either the external hemorrhoidal tissue. As such, a cryotherapy treatment is thus initially delivered, and as the AHI melts, prolonged relief is provided as the melted AHI exerts its effect on the tissue.  
         [0057]     It should be noted that the configuration of the cryotherapy device  110  shown in  FIG. 6   a  has four slots  124 , however any number of slots or any other configuration of cavity or cavities may be used such as but not limited to concave dimples, holes, helical depressions, or grooves may be used to communicate the frozen AHI to the tissue and it is understood that many acceptable shapes may be imagined.  
         [0058]     It is also to be understood that the device body  112  in  FIG. 6   a  may be either solid or hollow.  
         [0059]     In  FIGS. 6   b  to  6   d , a body section  130  is shown (in a perspective view ( 6   c , and partial vertical ( 6   d ) and horizontal ( 6   b ) cross-sectional views) having a number of grooves  132  for receiving the AHI. It is further understood that if the body is hollow, as shown in  FIG. 6   c , the body  130  may contain any additional substance with the correct properties so as to improve the cryotherapy effect of the device.  
         [0060]     In a third embodiment of the invention, device  70  of  FIG. 7  is designed so that an alternative method for placing the AHI into the device is proved. In  FIG. 7   a , the rectal insert portion  71  of body  72  of the device  70 , which rectal insert portion  70  is hollow, is filled with a cryotherapy media through its opening  73 , as indicated by the arrows, and as previously described, and then sealed with cap  76 .  
         [0061]     Unfrozen AHI  78  is dispensed into a sleeve  74  ( FIG. 7   b ). The assembled insert  72 , shown in  FIG. 7   c , is then inserted into sleeve  74  so as to push the AHI up the sides of body  72  and into the spiral cavity, or groove,  80  as shown in  FIG. 7   d . The completed device  70  is then frozen prior to use.  
         [0062]     Alternatively, body  72  may be frozen prior to insertion into sleeve  74  in order to assist in freezing the AHI material.  
         [0063]     The production method of  FIG. 7  has the improved utility of allowing rapid manufacture of this device in terms of the step in which AHI is applied to the device, and in terms of the amount of AHI used. Further utility is gained by its use of generally transverse running grooves, such as, for example, spiral grooves, or by the use of other transverse running cavities, that assist in preventing the inadvertent release of the AHI when the patient removes the body section from the protective sleeve. Also, it is noted that the space between sleeve  74  and body  72  permits an increased amount of AHI to be attached to the exterior of body  72 .  
         [0064]     In its intended use the device is assembled, packaged and given to the patient as in the configuration of  FIG. 7   d . The patient then freezes this and once frozen, removes it from the packaging, removes the exterior sleeve ( FIG. 7   b ) and inserts the body  72  so as to contact the hemorrhoidal tissue.  
         [0065]     In a preferred embodiment, cap  76  and body  72  ( FIG. 7 ) are manufactured so as to allow snap-together assembly as shown in  FIG. 7   a . Body  72  also preferably is provided so as to allow snap-together assembly with sleeve  74 . This has the utility in that the additional frozen, or unfrozen AHI  78  (shown between the sleeve and probe) is sealed within the device.  
         [0066]     The AHI used in this third embodiment could be as simple as water, or a substance such as aloe vera gel mixed with purified water, glycerine, a carbomer and a sodium hydroxide solution. Alternatively, an existing hemorrhoid product such as but not limited to licodaine, hydrocortisone, an appropriate analgesic, hamamelis water L-arginine or any other effective hemorrhoid medication is used either alone or mixed with water, or a substance such as aloe vera gel mixed with purified water, or glycerine, or a carbomer and a sodium hydroxide. Also, the AHI might be a commercial product such as Preparation H (tm), anusol, paceonia, or any other know suitable substance or natural healing media.  
         [0067]     The packaged cryotherapy devices containing the AHI, as described in the present invention, are preferably placed in a freezer for at least at one hour to thereby freeze the AHI. The time required for freezing may, however, vary according to the formulation and the amount of the frozen AHI.  
         [0068]     In use, the frozen AHI aids in assisting the treatment of the tissue by cooling the tissue. Further, after several minutes, the frozen AHI melts, and as such, the AHI is delivered to the tissue providing the second phase of the treatment, which extends out over the desired AHI treatment time period. After treatment, the rectal insert is removed from the rectum, and the insert, the sleeve, and the empty package are all discarded.  
         [0069]     The cryotherapy device is preferably individually packaged as shown in  FIGS. 8   a  and  8   b . The packages may be sealable plastic bags or a series of blow moulded compartments sealed by conventional packaging methods that allows the compartments to open individually. Alternatively, the cryotherapy device may be packaged in a bubble wrap or any other packing method that keeps the device substantially sterile while in storage or during the freezing process.  
         [0070]     While the invention has been described with reference to preferred embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the scope of the invention.  
         [0071]     Therefore, it is intended that the invention not be limited to the particular embodiments disclosed as the best mode contemplated for carrying out this invention, but that the invention will include all embodiments falling within the scope and spirit of the appended claims.  
         [0072]     Thus, it is apparent that there has been provided, in accordance with the present invention, a combined cryotherapy and healing medium treatment device which fully satisfies the goals, objects, and advantages set forth hereinbefore. Therefore, having described specific embodiments of the present invention, it will be understood that alternatives, modifications and variations thereof may be suggested to those skilled in the art, and that it is intended that the present specification embrace all such alternatives, modifications and variations as fall within the scope of the appended claims.  
         [0073]     Additionally, for clarity and unless otherwise stated, the word “comprise” and variations of the word such as “comprising” and “comprises”, when used in the description and claims of the present specification, is not intended to exclude other additives, components, integers or steps.  
         [0074]     Moreover, the words “substantially” or “essentially”, when used with an adjective or adverb is intended to enhance the scope of the particular characteristic; e.g., substantially planar is intended to mean planar, nearly planar and/or exhibiting characteristics associated with a planar element.  
         [0075]     Further, use of the terms “he”, “him”, or “his”, is not intended to be specifically directed to persons of the masculine gender, and could easily be read as “she”, “her”, or “hers”, respectively.  
         [0076]     Also, while this discussion has addressed prior art known to the inventor, it is not an admission that all art discussed is citable against the present application.