WO2005016136A1

WO2005016136A1 - Speculum for colpoplasty

Info

Publication number: WO2005016136A1
Application number: PCT/US2003/024203
Authority: WO
Inventors: David L. Matlock
Original assignee: Matlock David L
Priority date: 2003-07-31
Filing date: 2003-07-31
Publication date: 2005-02-24
Also published as: AU2003274907A1

Abstract

Disclosed is a specially designed speculum for use in retraction of anatomical structures. The speculum contains an opening (1) with in a first dilatory blade. In an additional embodiment, the speculum contains a bifurcation in a first dilatory blade. Said bifurcation creating an opening (1) between a first and second arm (20). In an additional embodiment, graduations exist on a convex surface of a first dilatory blade. Also disclosed is a kit containing a speculum of the invention. Also disclosed is a method of using the speculum.

Description

SPECULUM FOR COLPOPLASTY

FIELD OF THE INVENTION [0001] The invention disclosed herein relates generally to the field of medical instruments used to gain exposure and retraction of surgical fields and other medical procedures.

BACKGROUND OF INVENTION [0002] Many devices used in medicine are designed for use in retraction of tissues to greater expose a selected area of anatomy. It is well known that certain of these devices are used for exposure in a general sense while others are used for specific purposes. For example, an army navy-type retractor is used for the retraction of large amounts of tissue exposed through incisions greater than 3 centimeters and above. The army navy-type retractor may be used for any tissue type exposed in a procedure, including tendon, bone, skin, subcuticular tissues, vessels and nerves. On the other hand, a more specific type of retractor, a Hohman retractor for example, is used primarily to retract delicate structures and would be used to retract the skin where, although the army navy retractor may work, larger retraction mechanisms are less desired. [0003] Certain other medical instruments are used for exposure wherein there is no invasive procedure contemplated in the particular area. A common example is the simple tongue depressor. It is used to depress/retract the tongue and expose the tonsils, uvula and mucosal tissues. A similarly common example of medical instrumentation used for non-invasive retraction is a speculum of the type used in obstetrics and gynecology (OBGYN) as well as gastroenterology. Like tongue depressors, speculums have remained relatively unchanged for many years. [0004] Over the course of many years, medical diagnostics and procedures may out pace advancements in medical instrumentation and the skill of the non-specially trained or unexposed physician. For example, it was decades before physicians not part of residency programs or university and research hospitals were able to familiarize themselves with Arbeitsgemeinschaft fur Osteosynthesefragen (AO) bone fixation techniques and have the competency to use it effectively. Further, although AO bone fixation techniques, diagnostic modalities and procedures were well understood by the physics involved in AO bone fixation, it was years before instrumentation was developed that simplified the process of AO fixation and a physician's ability to learn and use it. In this respect, advancement of medical science often creates a need for instrumentation to facilitate the advancement. [0005] This disclosure generally relates to the field of OBGYN, but applications in other fields of medicine are contemplated. Recently advancements in OBGYN procedures have been developed. One such procedure is colpoplasty via augmentation of the Grafenberg spot (GS) area. The procedure, as described in Matlock's U.S. Patent Application Serial No. 10/461 ,894, attorney docket no. 40031.8001. US01 , entitled "Method for Colpoplasty," filed June 13, 2003, incorporated herein by reference, involves precise localization of the GS area on the anterior wall of the vagina. Such localization is followed by either permanent or non-permanent augmentation of the GS area. Difficulties in the procedure include, but are not limited to, localization, exposure, physician skill level, problems inherent in any soft tissue surgical procedure, lighting and the ability to properly address the localized area for the procedure while using proper technique for exposure.

[0006] The GS area has been described as being on the anterior wall of the vagina along the mid-sagital line about the course of the urethra and surrounding erectile tissue. It may be located at or about the pubic symphysis, but in general, it is more properly described as being patient specific. Colpoplasty of the GS area has been used to treat anorgasmic conditions, female sexual dysfunctions including, but not limited to, hypoactive sexual desire disorder, sexual aversion disorder, hypolubrication, hypoesthesia, dysesthesia and dyserethism. Further, there has been a demand for colpoplasty of the GS area in women considered to have normal sexual physical and hormonal response. However, there are very few OBGYN physicians or other medical practitioners properly skilled in the location and colpoplasty of the GS area. Surgical instrumentation primarily designed for this procedure may help proper location and facilitation of colpoplasty of the GS area.

[0007] New procedures in OBGYN, such as the procedure disclosed in U.S.

Patent Application Serial No. 10/461 ,894, have been developed but may be hard to perfect due to the level of difficulty in the procedures for the inexperienced physician. Inexperience is as much a result of a chosen discipline, i.e., OBGYN versus urologist or OBGYN versus plastic surgeon, as it is of location. It is well known that physicians are held to the standard of the community in which they work. Such a community standard dictates that certain physicians within that community are familiar with diagnosis and procedures not required of another physician part of a distant community. For example, infectious disease specialists practicing in coastal states may be expected to be more familiar with marine acquired infections while Midwestern state infectious disease specialists may be expected to be more familiar with parasitic, fungal and moss based infections. Similarly, certain procedures are performed more in one community when compared to another. Thus, physicians in one community may enjoy the benefit of more exposure and proctoring in that certain procedure. Instrumentation that will facilitate the performance of a procedure may help to bridge the gap between the experienced and less experienced.

[0008] The importance of proper location of the GS area exists in the fact that augmentation of an area even millimeters away from the proper location will result in a markedly less successful procedure. Currently, there is no device available that is designed primarily for the purpose of accurate location of the GS area for diagnostic and medical procedures. Thus, a need exists for such instrumentation.

SUMMARY OF THE INVENTION

[0009] It is at least one object of this invention to offer instrumentation to facilitate location of the GS area. In another aspect of the invention, treatment for what is now understood as a vast array of medical and psychological conditions resulting in Female Sexual Disorder (FSD) is contemplated. Further, it is an another object of this invention to provide instrumentation to facilitate the augmentation of the GS area of normal women who do not suffer FSD.

[0010] One embodiment of the invention is directed to a speculum modified for use in colpoplasty. The speculum is modified via creation of an opening within the superior aspect a first dilatory blade. The opening may be selected from the group consisting of fenestrations, oval, circular, singular, a plurality and combinations thereof. [0011] In another aspect of the invention, the a first dilatory blade of a speculum is bifurcated from at least about one to three centimeters from its proximal aspect to and through its most distal aspect creating a left arm and a right arm.

[0012] It is contemplated that at least one embodiment of the invention is directed to use in GS area augmentation colpoplasty. It is understood that the speculum of this disclosure will have numerous other applications. Hereinafter the modified speculum will be referred to as the GS area speculum (GSS). This designation of the GSS is not meant to limit applications of the speculum disclosed herein and is only used for simplicity. For example, it is understood that the GSS is suitable for gastroenterological procedures such as the removal of polyps or other growths within the alimentary canal. [0013] In another embodiment of the invention, the GSS is one element of a kit for colpoplasty. A kit containing the GSS would also include instructions for use. [0014] Further embodiments of the invention are described and disclosed in the description and figures below.

BRIEF DESCRIPTIONS OF FIGURES [0015] Figure 1 illustrates a lateral view of a speculum [0016] Figure 2 illustrates a posterior view of a bifurcated speculum from the proximal aspect.

[0017] Figure 3 illustrates a posterior view of a speculum and represents the proximal aspect. [0018] Figure 4 illustrates superior view of a speculum.

[0019] Figure 5 illustrates a superior view of a bifurcated speculum.

DETAILED DESCRIPTION OF THE INVENTION [0020] Certain terms used in this disclosure are defined here.

[0021] The term "colpoplasty" refers to the injection of absorbable or non- absorbable materials or implantation of absorbable or non-absorbable materials deep to an identified or assumed GS area about the vaginal submucosa. Colpoplasty also refers to an augmentation of the GS area consistent with the invention disclosed herein. [0022] "Deep" is an anatomical term used to denote one structure or area as related to a more superficial area. For example, an area deep to the spine would be plural cavity. An area deep to the umbilicus would be the lower alimentary canal. Because the vagina subtends an anatomical void, an area deep to the anterior wall of the vagina would be structures that are more anterior whereas an area deep to the posterior wall would be more posterior and an area deep to the cervix would be more superior.

[0023] "Dilatory blade" is used to refer to that part of a speculum for insertion into a void to widen the void for exposure. The dilatory blade will, in most cases, comprise upper, or superoanterior, and lower, or inferoposterior, sections of a speculum wherein the superoanterior section of the dilatory blade is concave relative to an opposing dilatory blade. Further, the inferoposterior dilatory blade is commonly confluent with the handle of the speculum. [0024] "GS area" as used herein, means the area about the Grafenberg spot, including the Grafenberg spot, that is consistent with findings of erectile tissue along the course of the urethra which help complete a neural reflex loop, which may include nerve fibers from the hypogastric plexus and the pelvic nerve and in which stimulation may result in climax apart from or including clitoral stimulation. It is understood that the anatomy of the GS area will be subject specific and may occupy varying locations and sizes within a population. The "GS proper" as used herein, is the traditionally understood Grafenberg Spot. [0025] The term "removably attachable light source" refers to a light source that may be connected or attached to a speculum or used without being attached. The light source may be attached or removed without negatively disrupting colpoplastic or other vaginal procedures.

[0026] The term "slidably attached" refers to the articulation between the dilatory blades of a speculum wherein two dilatory blades are attached at the inferoposterior portion of each blade in such a way that by sliding one dilatory blade relative to the other, i.e., within a track of the speculum, the dilatory blades may be separated or apposed with each other. In research performed in or about 1981 , the Grafenberg Spot was described by John Perry and Beverly Whipple and published in the Journal of Sex Research. They reported an area that formed a neural reflex loop from the female genitalia that could result in orgasm and that was independent of the previously described clitoral reflex loop. Perry and Whipple reported that they had had a physician or nurse examine more than 400 women who had volunteered to be research subjects, and a hyperesthetic, or increased sensitivity, area in the vagina was found in each of these women. They cautioned, however, that they could not state with certainty that every woman had such a sensitive area. They further reported that a second reflex pathway included the Grafenberg spot as the major source of stimulation, the pelvic nerve and hypogastric plexus as its major pathway and the musculature of the uterus, bladder, urethra, contractile elements associated with paraurethral glands and the proximal portion of the pubococcygeus muscle as its major myotonic responders. This double reflex system, the vulvar and uterine reflex systems, were accepted over time. See, <http://www.hisandherhealth.com/articles/>. [0027] The Grafenberg spot was named by John Perry and Beverly Whipple to commemorate the research of Ernst Grafenberg, a German-born obstetrician and gynecologist, who in 1944, along with Robert L. Dickinson, described a zone of heightened sensation and erogenous feeling located along the suburethral surface of the anterior vaginal wall. In 1950, Grafenberg wrote that a zone of heightened sensitivity could always be demonstrated on the anterior wall of the vagina along the course of the urethra, which seemed to be surrounded by erectile tissue, similar to the corpora cavernosa of the penis. In an anonymous questionnaire distributed to professional women in the United States and Canada, Davidson and colleagues found that 786 (66 percent) of 1 ,245 respondents perceived an especially sensitive area in their vagina that, if stimulated, produced pleasurable feelings. Whipple found that of the 800 women who completed a sexual-health questionnaire, 69 percent of the subjects reported the mid-sagital line between the neck of the bladder and the pubic symphysis was the most sensitive area. [0028] The importance of proper location and technique in surgery is critical to the outcome. With respect to colpoplasty of the GS area, augmentation of an area even millimeters away from the proper location will result in a markedly less successful procedure. Although a less successful procedure may still yield beneficial results, it is preferred to achieve the maximum results. Currently, there is no device available that is designed primarily for the purpose of accurate location of the GS area for diagnostic and medical procedures.

[0029] A speculum designed for the procedures disclosed herein would, in addition to the standard features of vaginal speculums, comprise an opening in a superior dilatory blade of the vaginal speculum. The opening may be selected from a group consisting of rectangular, square, oval, round, fenestrated, slit, multicircular and combinations thereof. It is contemplated that the openings may serve not only for proper location of the GS area but also for needle guides, wire guides, scalpel blade guides and other medical instrumentation. [0030] At least one embodiment of the invention disclosed herein provides greater ease in the field of procedures and research relating to normal female sexuality. Another area for use of the invention disclosed herein is in the field of FSD. FSD has been described and found to be age-related, progressive and highly prevalent, affecting 30-50 percent of women. Rosen RC, Taylor JF, Leiblum SR, et al: Prevalence of sexual dysfunction in women: results of a survey study of 329 women in an outpatient gynecological clinic. J. Sex. Mar. Ther. 19:171-188 (1993); Read S, King M, Watson J: Sexual dysfunction in primary medical care: prevalence, characteristics and detection by the general practitioner. J. Public Health Med. 19:387-391 (1997). In the National Health and Social Life Survey of 1 ,749 women, 43 percent experienced sexual dysfunction. Laumann E, Paik A, Rosen R., Sexual Dysfunction in the United States Prevalence and Predictors. JAMA 281 : 537-544 (1999). U.S. population census data revealed that 9.7 million American women ages 50-74 self-reported complaints of diminished vaginal lubrication, pain and discomfort with intercourse, decreased arousal, and difficulty achieving orgasm. Female sexual dysfunction is an important women's health issue that affects the quality of life of many female across the world. Id. [0031] The GS area is a hyperesthetic area identified about the anterior vaginal wall. It is usually located about halfway between the posterior aspect of the pubic bone and the cervix, along the midline course of the urethra and near the neck of the bladder. Stimulation of this area often results in rhythmic contracture of the pubococcygeous muscle, which is one of many muscles involved in the vaginally generated orgasm. While the pudendal nerve primarily innervates the clitoris, the GS area accepts nerve fibers from both the pelvic nerve and hypogastric plexus. The GS area includes tissue associated with the periurethral glands and includes the Skenes' glands and Halban's fascia; the counterpart of which in the man is the prostrate gland surrounding the proximal (male) urethra.

[0032] Upon palpation, the GS proper may be palpated and is a small area of indurated and, at the same time, spongy tissue. Stimulation causes vasodilation and swelling where an increase in diameter from the 1 to 3 cm and in some cases a 5 cm diameter GS proper will be palpable.

[0033] The GS area, then, is located on the anterior wall of the vagina approximately 3-4 cm from the distal urethra on a midline with the urethra extending just proximally to the cystourethral juncture. Clinically, upon stimulation of the GS area, a subject will usually describe a sensation of urinary urgency. This relates to the GS area's anatomical association with the paraurethral glands and urethra. [0034] In their 1981 study, Perry and Whipple hypothesized that the Grafenberg spot was probably composed of a complex network of blood vessels, the paraurethral glands and ducts, nerve endings, and the tissue surrounding the bladder neck, but they did not conduct any anatomical studies in this area.

[0035] Despite the evidence that specific anatomical structures correspond to the area defined as the Grafenberg spot, its exact anatomical identity remains inconclusive. This may be due to expected anatomical differences in size, innervation and location among women in general. A recent study by O' Connell in Australia posited that the clitoris was an organ of much the same dimensions and anatomical divisions as the male penis. The study investigated the anatomical relationship between the urethra and the surrounding erectile tissue, and reviewed the appropriateness of the current nomenclature used to describe this anatomy. A detailed dissection was performed on 2 fresh and 8 fixed human female adult cadavers (age range 22 to 88 years). The relationship of the urethra to the surrounding erectile tissue was ascertained in each specimen, and the erectile tissue arrangement were determined and compared to standard anatomical descriptions. Nerves supplying the erectile tissue were carefully preserved and their relationship to the soft tissues and bony pelvis were noted. The study concluded that the female urethra, distal vaginal wall and erectile tissue were packed into the perineum caudal (superficial and inferior) to the pubic arch, which is bounded laterally by the ischiopubic rami, and superficially by the labia minora and majora. This complex was reported not as flat against the rami, as is commonly depicted, but projected from the bony landmarks for 3 to 6 cm. The perineal urethra was noted to be embedded in the anterior vaginal wall and surrounded by erectile tissue in all directions. Although the study attempts to associate its findings with redefining the anatomical clitoris, it is apparent that the findings are consistent with the work of Grafenberg, Whipple, Davidson, Ladas and Perry.

[0036] Although the exact anatomical location of the GS area and GS proper vary, the GS area and GS proper are confidently defined by association with the paraurethral and Skenes glands, pubic symphysis, urethra, bladder and vestibule all or which, or combinations of which, serve as appropriate anatomical landmarks for augmentation consistent with the invention described herein. In light of the difficulty in perfecting the exact location of the GS area in a given subject, a specialized speculum or GSS is disclosed. [0037] One preferred embodiment of a GSS is directed to a speculum that has been modified for use in colpoplasty. It is understood that the GSS will have many other applications.

[0038] The GSS is a speculum comprised of a superoanterior dilatory blade hereon referred to as a first blade and an inferoposterior dilatory blade referred hereon as a second dilatory blade. [0039] Referring to Figure 1 , a lateral view of a GSS may be appreciated.

Generally, a first dilatory blade 2 is shown in contact with a second dilatory blade 3. The same second dilatory blade 3 is confluent with the handle 3a of the GSS. Each dilatory blade is shaped in a substantially L shaped or substantially right angular configuration. A superoanterior portion the first blade 2 is concave relative to a second dilatory blade that opposes the first dilatory blade. In other words, the convex outer surface of the first dilatory blade and second dilatory blade is in contact with an anatomical structure being retracted. [0040] Preferably, the GSS comprises of two dilatory blades 2, 3 wherein the dilatory blades 2, 3 are slidably attached or otherwise attached to each other and wherein the second dilatory blade is considered fixed relative to the first dilatory blade which is slidable or may be pivoted about the first dilatory blade 2, preferably at the apex of the angle subtended between the anterior and posterior portions of the blade. The second dilatory blade 3 slides along a tract that exists within the inferoposterior portion of the second dilatory blade 3. Each portion of the dilatory blades 2, 3 then, maintains a proximal and a distal portion.

[0041] Figure 1 further illustrates an opening 1 in the first dilatory blade 2. Said opening is meant for the delivery of an anatomical structure of focus in a given procedure. For example, in a colpoplastic augmentation of the GS area, the GS area will be presented within the opening 1 of the GSS upon proper placement of the first dilatory blade. The second dilatory blade then, upon inferior distraction will place force upon internal structures to expose the contents of the GSS. As an opening 1 exists within the first dilatory blade 2, the structures within the opening 1 will be delivered through the opening 1. That structure, whether the GS area, another structure within the vaginal canal or other structure such as a polyp within the alimentary canal. [0042] In one aspect of the invention, the opening 1 is located within the first dilatory blade 2, wherein the opening 1 is at least about 1-3 cm distal to the proximal most aspect 2a of the first dilatory blade and in another embodiment is 2 cm distal to the proximal most aspect 2a of the first dilatory blade. The proximal most aspect of the first dilatory blade 2a may be generally illustrated, as in Figure 1 , by an artificial line of demarcation 4 between the first dilatory blade 2 and a handle 4a confluent with the first dilatory blade. In one embodiment, an opening 1 is at least about 1-7 cm long. In another embodiment, an opening is preferably at least about 2-5 cm long. In another embodiment, an opening is preferably at least about 3-4 cm long. The width of the opening 1 , in one embodiment, is at least about 0.5-3 cm wide. In another embodiment, the opening is preferably at least about 1-2 cm wide. In another embodiment, the opening is preferably at least about 1.5 cm. The shape of the opening 1 may be selected from the group consisting of circular, oblong, oval, multiple circular openings side by side, square, triangular, hourglass and fusiform.

[0043] In another aspect of the invention, as illustrated in Figure 5, the first dilatory blade 20 is bifurcated and comprises a right arm 50 and a left arm 60. The opening 10 between the arms is at least about 0.5-3 cm, 1-2 cm. In another embodiment the opening 10 between the arms is preferably at least about 1.5 cm wide. The length of the right arm 60 and left arm 50 is at least about 7-9. In another embodiment the length of the left arm 50 and the right arm 60 is preferably at least about 4-5 cm and in another embodiment is preferably 8 cm long. The bifurcation is at least about 1-3 cm distal to the proximal most aspect 20a of the first dilatory blade and in another embodiment is preferably 2 cm distal to the proximal most aspect 40 of the first dilatory blade. The proximal most aspect of the first dilatory blade may be generally illustrated, as in Figure 5, by an artificial line of demarcation 40 between the first dilatory blade 20 and a handle 40a confluent with the first dilatory blade 20. [0044] In another embodiment of the invention a first dilatory blade comprises graduations preferably on the concave side of the blade. The graduations may be in the metric system, e.g., in millimeters, and centimeters, or in the British system of measurement, e.g. inches and parts of fractions of inches thereof, combinations of the above. Graduations on the concave or underside of the first dilatory blade allow the medical practitioner to adjust the path of the needle or make other adjustments without relocating the GSS. Graduations on the convex side are also contemplated. [0045] The GSS may be made of plastics, metals, ceramics and combinations thereof. Preferably, the GSS is made of a disposable plastic. It is contemplated that the GSS will contain a removably attachable light source. The first dilatory blade and the second dilatory blade may be either slidably attached, attached via a hinge or via an angular locking mechanism well known in the art. [0046] In another embodiment of the invention, a kit is contemplated wherein a

GSS is provided with instructions for use. The GSS of the kit can either be of the embodiment wherein an opening exists in a first dilatory blade or wherein an opening is created between a left arm and a right arm as the result of a bifurcation in the first dilatory blade. The kit may further comprise a plurality of povodone iodine or other antiseptic swabs, lubricating jelly, underpads, a plurality of syringes of differing volume being 1 ml to 10 ml, a plurality of needles of differing gauge being 14 to 30 guage, a plurality of operating room towels, a beaver blade and No. 15 blade, a surgical skin marker, a measuring device, a surgical measuring device, absorbable suture material and gauze. In place of the gauze, a tampon may be used. A preferred kit includes a GSS with either an opening or a bifurcated first dilatory blade, a 3 ml syringe, a 5 ml syringe, a 25 gauge needle, lubricating jelly, an underpad, a surgical skin marker, two operating room towels and three povodone iodine swabs. [0047] In a first step of a method of using the GSS, the GS area of an adult female subject should be clinically identified and localized via superficial anatomical landmarks and direct guidance by the subject. In the lithotomy position, the GS area may be located along the midline of the anterior vagina from the front of the inferior aspect of the pubic symphysis to the midpoint of the GS area corresponding to location 3-4 cm distal to the cervix on the anterior wall of the vagina. The linear distance from the distal urethra or vestibule to the midpoint of the GS area should be measured with a non-flexible or mildly flexible measuring device. Measuring devices are well known in the art and certain modifications, discussed below, may assist the surgeon in locating and marking the GS area. The medical practitioner may also use digital measuring techniques known in the art and practiced in gynecological procedures.

[0048] Thus, the method for finding the G-Spot in vivo is consultation and self examination by the patient to locate the G-Spot. The clinician digitally palpates the area located by the patient at or about the anterior vagina. The clinician may then palpate the surface anatomy of the patient at or about the mons pubis or symphysis pubis by proprioception of the digit used for GS area identification and the thumb opposed against the anteroinferior surface of the pubic symphysis against the digit used for GS area identification. Opposing digital "contact" is maintained and the GS area identification digit is withdrawn from the GS area and vestibule. At this point, a measurement may be taken of the location of the thumb at or about the pubic symphysis or mons pubis. A surgical marking pen is then use to mark the point of the thumb "contact" to the previous placement of the GS area identification digit and then the measuring ruler is placed at this point and the distal measurement taken. This is the distance from the anterior surface of the pubic symphysis and the GS area. The GSS is then placed in the vaginal canal and GSS is marked where it aligns with the anterior pubic bone. The GSS is then removed and the measuring device is placed at the mark at the heel of the GSS and the prior distance recorded is marked at the distal area at the opening of the GSS. In that version of the GSS containing graduations on the convex side of the first dilatory blade, the medical practitioner may avoid the use of an additional measuring device.

[0049] The GSS is then reinserted and caution is used to make sure that the mark previously placed on the GSS is consistent with the anterior pubic symphysis. By doing so the mark at the opening of the GSS indicates the position of the GS area. [0050] In either method, the distance identified with the measuring device should be recorded. Confirmation of this measurement may be accomplished by asking the subject to again locate the GS area and confirming that the distance measured clinically and measured manually by the subject are substantially the same. If a subject is unable to identify the GS area, the surgeon may still be confident in his/her clinical evaluation of the anatomical GS area location.

[0051] The material to be used for injection/augmentation may be pre-loaded into a syringe for delivery of the material. In the alternative, certain materials may be loaded into syringe for delivery intra-operatively. In the alternative, permanent materials may be used, some of which are not suited for delivery via a syringe. These materials are discussed in more detail below.

[0052] In one preferred embodiment of the invention, collagen is pre-loaded into a syringe. One preferred collagen source may be human allograft material of the fascia lata of the Idwer extremity collected from human cadaver donors. Donor suitability should be determined by the appropriate tissue bank according to the standards of the American Association of tissue Banks (MTB) and the FDA. Donor serum should be negative by FDA-licensed tests for human immunodeficiency virus antibody (anti-HIV 1- 2), Hepatitis B surface antigen (HBsAG), Hepatitis B core antibody (HBcAB), Hepatitis C antibody (anti HCV), human T-lymphotropic virus type I antibody (anti HTLV-1 ), and rapid plasma reagin (RPR) for syphilis. In this embodiment of the invention, as well as the embodiment of the invention discussed as a kit for colpoplasty, the material should be freeze-dhed, irradiated, particulated, and vacuum-sealed. [0053] Certain collagen sources may or may not require subject pre-testing for allergic reaction. Collagen banks, or other tissue banks, may be used for collagen or other tissues used for colpoplastic implantation. For example, tissue for implantation may be obtained from LifeLink Tissue Bank, Tampa, FL., USA, <http://www.lifelinkfound.org/bank.html>; PathServe Autopsy and Human Tissue Bank San Francisco, CA, USA, <http://www.tissuebank.com/>; and Peterborough Hospital Human Research Tissue Bank which is based in Peterborough District Hospital,

Cambridgeshire, UK, <http://www.tissuebank.co.uk/>, as well as many other suppliers of tissue. Implantation may also be performed by autograft of a subjects own tissue; tissue from liposuction, for example. [0054] The amount used for the augmentation of the GS area may range from at least about 50 mg to 300 mg, 100 mg to 275 mg, 150 to 250 mg and 200 to 230 mg. Further ranges include but are not limited to at least about 140 to 220 mg, 160 to 250 mg, and is preferably at least about 240 mg when using collagen as opposed to other absorbable substances such as poly galactic acid. The collagen may be between 0.5 to 4 mm, 1 to 3 mm and preferably 1-2 mm particulate size. These formulations will deliver easily through a 3 cc to 10 cc leur lock syringe. The collagen may be re- hydrated by attaching it to another 3 cc to 10 cc leur lock syringe via a patent double edge leur lock connector containing 2 cc of local anesthetic containing epinephrine. For example, 1% lidocaine with epinephrine or 0.5% bupivocaine with epinephrine may be used. The mixture should be agitated back and forth numerous times until the collagen is completely re-hydrated. With collagen, this should be performed at lease ten minutes prior to the GS area colpoplasty. [0055] It is preferred that subjects be pre-operatively medicated with of a broad spectrum antibiotic, 100 mg of doxycycline for example, orally or parenterally at least one hour prior to GS area colpoplasty. The antibiotic should be continued a minimum of three days post GS area colpoplasty.

[0056] The vaginal canal should be prepped with plurality and preferably three separate passes of three separate povodone iodine swabs. Specially designed L- shaped metric rulers are available and may be preset with the subjects GS area measurements in preparation for marking the GS area proper. GS area access can be obtained with a sterile speculum. A traditional speculum is adequate. [0057] In one preferred embodiment of the method a temporary colpoplasty may be performed. Said temporary colpoplasty should be performed with the subject in the lithotomy position. A GSS should be used for visualization of the anatomy of the vagina. Lubricant, as with most gynecological procedures, is indicated here. Attention should be directed to exposing the anterior vaginal wall and inferior aspect of the pubic symphysis as described above. The vertical limb of the preset L-shaped measuring device may then be placed against the anterior surface of the pubic symphysis and the horizontal limb introduced into the vagina along the midline of the anterior wall. In the alternative, the graduated GSS may be used. The intra-vaginal distal end of the measuring device represents the midpoint of the subject's GS area along the midline of the anterior vagina. The GS area or GS proper should then be marked with either a standard surgical marker or a marker specially designed for the procedure. [0058] Infiltration of 1-3 cc of an anesthetic with epinephrine should be injected just deep to the previously marked GS area through the opening of the GSS. Anesthetics appropriate for use are those that result in the appropriate local anesthesia via infiltration of 5 cc or less of anesthetic. For example, 1 or 2 % lidocaine, 0.5 or 0.75 % bupivocaine may be delivered to the area at a volume less than 5 cc and create the appropriate local blockade or anesthesia. Certain anesthetics, such as cocaine hydrochloride, may be used without epinephrine, as the anesthetic is a hemostatic agent in and of itself. Any anesthetic, either amide based or ester based, may be used. However, due to the longer acting capabilities of the amide anesthetics, amide anesthetics are preferred. [0059] At this point in the procedure, anesthetic, it is noted, is used not only for neural blockade but for submucosal hydrodissection, or fluid adhesiotomy, depending on the condition of the soft tissue. For this purpose a 5 cc leur lock syringe with a 3->2 spinal needle may be used. A minimal gauge needle, such as a 30 gauge, 27 gauge and no more than a 25 gauge needle should be used for neural blockade and submucosal hydrodissection. Care should be taken to insert the needle just deep to the submucosa fascial line in the frontal plane. This action is facilitated by the GSS. The surgeon should remember to aspirate the syringe just prior to injection to insure against vascular infiltration. [0060] The absorbable material, collagen in this description, may be re-hydrated by connecting one syringe containing a hydrating liquid to another syringe containing the collagen. A syringe connector is usually supplied with the collagen and comprises two leur lock ends on a small cylinder. The connector is used for aseptic transfer or the hydrating liquid to the syringe containing the collagen. Once the liquid has been transferred, the collagen will rehydrate.

[0061] The now re-hydrated collagen should be agitated multiple times, both initially and a few more times prior to injection. The leur lock syringe containing the re- hydrated collagen should then be removed from the connector and attached to a needle extender at the end of which a luer lock needle at least about 14 gauge 13.5 cm needle is attached The needle may be at least about 10 to 18 gauge and from at least about 8 cm to 15 cm. The gauge of the needle will depend upon the selection of augmentation material to be used; a 14 gauge needle is adequate for delivery of collagen. The extender and needle should be primed with collagen and then directed to the previously marked GS area. Care should be taken to insert the needle parallel to the frontal plane and perpendicular to the transverse plane. Attention should be directed to the submucosa of the GS area along a midsagital line. Again, syringe aspiration should be performed prior to injection of the collagen. The collagen should be injected in a slow and deliberate manner. At least about 240 mg of 1 mm particle size re-hydrated collagen in 2 cc of 1 % lidocaine (said lidocaine used as a hydrating liquid) will create an augmented GS area of at least or about 15 to 20 mm in diameter with an anterior vaginal height of at least or about 5-10 mm. The injection site may or may not need a temporary gauze pressure dressing to control bleeding. The procedure is complete after removal of all instrumentation and after all bleeding has subsided. The subject will usually be able to verify correct collagen placement upon normalized esthesia following diminished anesthesia.

[0062] In the above description, collagen is used as a material of choice for colpoplasty. However, other materials that may be used for temporary colpoplasty can be selected from the group consisting of fibril, adipose, alloderm, cymetra, and fascian. These materials may form a part of a kit for colpoplasty disclosed herein. [0063] In another embodiment of the invention, the colpoplsty may be permanent.

In this case, a non-absorbable material is used in the injection. Non-absorbable materials may be selected from the group consisting of silicon, silastic beads, e-PTFE, polyacylamide gel, and calcium hydroxiapatite. Other permanent materials include, but are not limited to, ceramics, surgical and stainless steals, glass, polymethyl- methacrylate and other plastics. It is contemplated that these permanent materials may be selected and used in anatomically compatible shapes such as oblong, round, oval, linear, cuboidal and the like. Permanent implants may be sized by displaceable volume, i.e., a space filling implant. Volumes may be used that range from at least about 1 cc to 10 cc; and in another embodiment 2-9 cc; and in another embodiment 3 to 7 cc; and in another embodiment 4 to 6 cc. A volume of at least about 3 to 5 cc is preferred or that volume that creates an augmented GS area of at least about 15-20 mm in diameter and 5-10 mm in height. Said materials may also form part of a kit for colpoplasty disclosed herein.

[0064] In embodiments of the invention not suitable for injection the permanent implants disclosed herein may be placed in the GS area using other surgical technique. Following the same preparation of the subject, identification and marking of the GS area and local anesthesia, this procedure would further involve a small, between 2 and 15 mm, incision in an area just caudal to the GS area. The GS area location should be pre-measured and marked as described above. For this incision, a No. 15 blade or Beaver-type blade may be used. All techniques and protocols for minimal incision surgery, as is known in the art, should be followed. The incision should be deepened no more than that necessary to accommodate the chosen implant. Soft tissue dissection technique should be used to create a pocket for nesting of the implant. Once the pocket is created, the implant may be nested. The implant may be selected from the group consisting of glass, silicone, stainless steel, surgical plastics e-PTFE, ceramics and other inert materials designed for implantation in humans. Once placement of the implant is perfected, the area should be copiously flushed with an antibiotic solution. Absorbable suture, such as poly galactic acid suture, should be used to close the surgical site. A short-term pressure dressing over the surgical area may be used but may not be required.

EXAMPLE I: Colpoplasty in an Anorgasmic Subject. [0065] A patient presented with a complaint of long term inability to achieve orgasm. Further, patient complained of hypolubrication and low sexual desire and arousal. A history and physical examination revealed a well nourished female above the age of consent and in no acute distress. Allergies and significant past medical history were denied and reported as negative for complications. The medical practitioner advised a colpoplasty via augmentation of the Grafenberg spot area using collagen obtained from an appropriate tissue bank. Colpoplasty was performed as follows.

[0066] 240 mg of collagen was chosen to create a 15-20 mm diameter and 5-10 mm high augmentation of the Grafenberg spot area. The collagen was of a 1 mm particulate size. Collagen was re-hydrated by attaching the collagen-containing syringe to another leur lock syringe of similar volume capacity via a patent double edge leur lock connector containing 2 cc of 1% lidocaine with epinephrine. The mixture was agitated back and forth numerous times until the collagen was completely re-hydrated. Agitation and re-hydration occurred at lease ten minutes prior to the colpoplasty. [0067] The patient was pre-operatively medicated with an oral dose of 100 mg of doxycycline, one hour prior to colpoplasty.

[0068] With the patient in the lithotomy position, the vaginal canal was prepped with three povodone iodine swabs. Specially designed L-shaped metric rulers were selected to be preset with the patient's GS area measurements in preparation for marking the GS area. GS area access was obtained with a sterile GSS with removably attachable light source. Lubrication was used as necessary throughout the colpoplasty. [0069] Attention was then directed to exposing the anterior vaginal wall and the palpable inferior aspect of the pubic symphysis. The vertical limb of the preset L- shaped measuring device was then placed against the anterior surface of the pubic symphysis and the horizontal limb introduced into the vagina along the midline of the anterior wall. The intra-vaginal distal end of the measuring device represented the midpoint of the patient's GS area along the midline of the anterior vagina. The GS area was then marked with a standard surgical marker. The GSS was prepared for insertion into the vagina using an appropriate lubricant.

[0070] Insertion of the GSS lead to physical delivery of the GS area into the opening within the first dilatory blade. Infiltration of 3 cc of an anesthetic with epinephrine was injected just deep to the previously marked GS area. The injection was notably facilitated by the delivery of the GS area into the opening in the first dilatory blade of the GSS. Neural blockade and submucosal hydrodissection was accomplished through the opening in the first dilatory blade. For this purpose a 5-cc leur lock syringe with a 3->2 spinal needle (27 gauge) was used. Care was taken to insert the needle just deep to the submucosal fascial line in the frontal plane. Again, this injection was facilitated by the GSS.

[0071] Care was taken to insert a needle from a syringe containing collagen parallel to the frontal plane and perpendicular to the transverse plane. This alignment is consistent with the opening in the first dilatory blade of the GSS. Attention was directed to the submucosa of the GS area along a midsagital line. The collagen was injected in a slow and deliberate manner. 240 mg of 1 mm particle size re-hydrated collagen in 3 cc of 1% lidocaine created an augmented GS area of at least or about 20 mm in diameter with an anterior vaginal height at least or about 10 mm. The procedure was complete after removal of all instrumentation and after all bleeding had subsided. The patient was easily able to verify correct collagen placement once anesthesia had subsided. The GSS was disposed upon removal of the removably attachable light source. [0072] The foregoing descriptions of embodiments of the invention and examples are intended to be illustrative of the embodiments of at least one aspect of the invention, and are not intended to limit the invention in any way. Although the invention has been described with respect to specific modifications, the details thereof are not to be construed as limitations, for it will be apparent that various equivalents, changes and modifications may be resorted to without departing from the spirit and scope thereof and it is understood that such equivalent embodiments are to be included herein. All publications and patent applications are incorporated by reference as if fully set forth herein. At least one aspect of the invention is further illustrated by the following examples, which are not intended to limit the effective scope of the claims. [0073] All references cited herein are incorporated by reference in their entirety. The descriptions in the present invention are provided only as examples and should not be understood to be limiting on the claims.

Claims

1. A speculum comprising: a first dilatory blade; a second dilatory blade; and an opening in the first dilatory blade.

2. The speculum of claim 1 wherein a proximal aspect of the opening in the first dilatory blade is 1-3 distal to a proximal most aspect of the dilatory blade.

3. The speculum of claim 1 wherein the proximal aspect of the opening is 2 cm distal to the proximal most aspect of the first dilatory blade.

4. The speculum of claim 1 wherein the opening is at least about 1-7 cm long.

5. The speculum of claim 4 wherein the opening is at least about 2.5 cm long.

6. The speculum of claim 5 wherein the opening is at least about 3-4 cm long.

7. The speculum of claim 6 wherein the opening is at least about 3.5 cm long.

8. The speculum of claim 1 wherein the opening is at least about 0.5-3 cm wide.

9. The speculum of claim 8 wherein the opening is at least about 1-2 cm wide.

10 The speculum of claim 9 wherein the opening is at least about 1.5 cm wide.

11 A speculum comprising: a first dilatory blade; a second dilatory blade; and a bifurcation in the first dilatory blade.

12. The speculum of claim 11 wherein the bifurcation in the first dilatory blade creates a left arm and a right arm.

13. The speculum of claim 11 wherein bifurcation creates an opening.

14. The speculum of claim 13 wherein the bifurcation creates the opening between the left arm and the right arm.

15. The speculum of claim 13 wherein the opening is at least about 0.5-3 cm wide.

16. The speculum of claim 12 wherein the left arm and the right arm are at least about 7-9 cm long..

17. The speculum of claim 16 wherein the opening is at least about 1.5 cm wide.

18. A speculum comprising: a first dilatory blade with an opening; graduations on a surface of the first dilatory blade; and a second dilatory blade.

19. The speculum of claim 18 wherein the graduations are on a concave or a convex side the surface of the first dilatory blade.

20. The of speculum of claim 18 wherein the opening is at least about 1-7 cm long.

21. The speculum of claim 18 wherein the opening is at least about 0.5-3 cm wide.

22. A kit comprising: a speculum of claim 1 and instructions for use.

23. The kit of claim 22 further comprising a measuring device.

24. The kit of claim 22 further comprising a light source wherein said light source is removably attachable to the speculum.

25. The kit of claim 22 further comprising a syringe.

26. The kit of claim 22 further comprising absorbable suture material.

27. The kit of claim 22 further comprising a gauze.

28. The kit of claim 22 further comprising a surgical marking device.

29. The kit of claim 22 further comprising a multiple of povodone iodine swabs

30. The kit of claim 22 further comprising a beaver blade and a No. 15 blade.

31. A kit comprising a speculum of claim 11 and instructions for use.

32. A kit comprising a speculum of claim 1 , a 3 ml syringe, a 5 ml syringe, a 25 gauge needle, lubricating jelly, an underpad, a surgical skin marker, two operating room towels and three povodone iodine swabs.

33. A kit comprising a speculum of claim 11 , a 3 ml syringe, a 5 ml syringe, a 25 gauge needle, lubricating jelly, an underpad, a surgical skin marker, two operating room towels and three povodone iodine swabs.