Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert
Reexamination Certificate
1999-08-26
2001-07-24
Azpuru, Carlos A. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Implant or insert
C424S430000, C424S431000
Reexamination Certificate
active
06264973
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a novel apparatus for locally delivering and immediately releasing an anesthetic agent to the cervical region of a female such that the cervical region is temporarily anesthetized in anticipation of the performance of a gynecological procedure on the female.
BACKGROUND OF THE INVENTION
Many gynecological procedures, such as endometrial and cervical sampling, the Loop Electrosurgial Excision Procedure (LEEP), endometrial biopsies, hysteroscopies, dilation and curettage, and laser conization to name only a few, are being performed more frequently on an out-patient basis than in a hospital setting. Since such procedures can be painful, it is desirable that the cervical region, which includes the upper portion of the vagina and the lower portion of the uterus, be locally anesthetized prior to commencement of the procedure. Thus, methods have been developed for temporarily anesthetizing the cervical region. One such method involves an epidural injection of an anesthetic agent, or the insertion of an epidural catheter into the female. However, this method requires an injection or perforation of the epidural matter of the spine, and thus inherently inflicts pain and discomfort on the female. Moreover, it is labor intensive, time consuming, expensive, and technically difficult to perform.
Another method for locally anesthetizing the cervical region is the direct injection of an anesthetic agent into the cervical region of the female paracervical block. However, just as with an epidural injection, this method can also cause pain and discomfort to the female being anesthetized. Furthermore, this method requires the treating medical provider to possess the requisite skills to make such an injection. Also, this method can result in one or a number of recognized complications.
Still another method for anesthetizing the cervical region involves the local application of an anesthetic agent to the vaginal mucosa of the cervical region. However, this method also possesses inherent limitations. For example, the anesthetic agent can diffuse from the local point or area to be anesthetized. Thus, the amount of anesthetic agent that must be applied to the area must compensate for such diffusion. As a result, the female is exposed to a greater amount of anesthetic agent than is actually needed to anesthetize the region.
Accordingly what is needed is an apparatus that delivers an anesthetic agent locally to the cervical region of the female, and immediately releases the anesthetic agent to the cervical region. As a result, the region can be temporarily anesthetized in anticipation of the performance of a gynecological procedure.
What is also needed is an apparatus and method for locally delivering an anesthetic agent to the cervical region of a female that is easy to use, and lends itself to use in an outpatient setting, such as a doctor's office. As a result, medical providers who do not possess the requisite training to deliver anesthetic agents with methods described above can readily use such an apparatus, and thus increase the number of females that can be locally anesthetized in an out-patient setting. Also, the time, expense and risk of complications associated with alternatives described above can be reduced.
The citation of any reference herein should not be construed as an admission that such reference is available as “Prior Art” to the instant application.
SUMMARY OF THE INVENTION
There is provided, in accordance with the invention, a new and useful apparatus and method for delivering an anesthetic agent locally to the cervical region in the female to induce anesthesia temporarily of the cervical region.
Broadly, the present invention extends to an apparatus for locally delivering and immediately releasing an anesthetic agent to the cervical region of a female, wherein the apparatus comprises a ring having a surface, and at least one depression on the surface. Moreover, the ring is comprised of a pharmaceutically acceptable inert material, and has a sufficient size such that it can be inserted into the vaginal canal of the female, and be retained therein temporarily. An apparatus of the invention also comprises an anesthetic composition which is located within the at least one depression, wherein the anesthetic composition comprises the anesthetic agent and an excipient. Upon the insertion of the ring into the vaginal canal, the anesthetic agent is immediately released from the anesthetic composition, and induces temporary anesthesia in the cervical region. As a result, a gynecological procedure can be performed on the female with the ring either in place in the cervical region or removed, and the pain and discomfort associated with the procedure can be avoided.
Furthermore, the ring of an apparatus of the invention comprises numerous pharmaceutically acceptable inert materials. Particular examples of such a pharmaceutically acceptable inert material include ethylene-vinyl acetate copolymer, polyethylene, polypropylene, polyvinyl chooride, cellulose derivatives, thermoplastic rubber, thermoplastic elastomer, polyurethane, and polydimethylsiloxane, to name only a few.
Moreover, the present invention extends to an apparatus as described above, for locally delivering and immediately releasing an anesthetic agent to the cervical region of a female, wherein, an anesthetic composition comprises approximately 60% by weight the anesthetic agent and approximately 40% by weight the excipient. Numerous anesthetic agents have applications in an apparatus of the invention. Moreover, anesthetic agents having applications herein can be in a free base form or an acid addition salt form, or a mixture thereof. Particular examples of anesthetic agents having applications herein include, but are not limited to, bupivacaine, ropivacaine, dibucaine, procaine, chloroprocaine, prilocaine, mepivacaine, etidocaine, tetracaine, lidocaine, benzocaine, or a mixture thereof.
Likewise, numerous excipients have applications in an apparatus of the invention. Examples of such excipients include a saturated polyglycolyzed glyceride, a block copolymer surfactant, an emulsifier, glyceryl monolaurate, silicone, e.g. condensation cured silicone elastomer, microcrystalline cellulose, hydroxyethylcellulose, ethylcellulose, hydroxypropyl methylcellulose, polymethylmethacrylate, polyvinylpyrollidone, or a mixture thereof, to name only a few.
Furthermore, the at least one depression on the surface of a ring of an apparatus of the invention, as described above, can have numerous sizes or shapes. For example, the at least one depression can comprise at least one notch on the surface of the ring. Naturally, the at least one notch can comprise a plurality of notches on the outer surface of the ring. In a particular embodiment, the plurality of notches comprises 8 notches.
In addition, the at least one depression can comprise at least one channel on the surface of the ring. The at least one channel can be located on the upper surface, the lower surface, the inner surface or the outer surface of the ring. In an embodiment of the invention, the at least one channel comprises a channel on either the upper or lower surface of the ring. In another embodiment, the at least one channel comprises a first channel on the lower surface of the ring, and a second channel on the upper surface of the ring. In yet another embodiment, the at least one channel comprises a channel on the outer surface of the ring.
Moreover, the at least one depression on a ring of an apparatus of the invention can comprise at least one bore through the ring. In a particular embodiment, the at least one bore in the ring comprises a plurality of bores through the ring, running from the upper surface to the lower surface.
Furthermore, the present invention extends to an apparatus for locally delivering and immediately releasing an anesthetic agent to the cervical region of a female to anesthetize the cervical region, wherein the apparatus comprises (a) a ring having an inner surface, an outer surface, a lower surfa
Gooding Ann Elizabeth
Kay Martha Francine
Mahashabde Anu
Mestichelli Louis J.
Ruth Suzanne Wilford
Azpuru Carlos A.
FEI Enterprises, Ltd.
Gibbons Del Deo Dolan Griffinger & Vecchione
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