Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2002-01-29
2003-05-06
Jones, Dwayne C. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C514S449000, C514S451000, C514S450000
Reexamination Certificate
active
06559178
ABSTRACT:
BACKGROUND—SUMMARY
The current invention proposes interstitial administration of therapeutically effective doses of certain sesquiterpene epoxides (trichothecenes) to achieve ablation of non malignant cells in a selected organ or internal tissue mass.
BACKGROUND
Surgery remains the primary mode of ablation of non malignant tissue. The trend in prior art has been toward minimally invasive surgery through the use of various devices that can be inserted through small incisions or natural body orifices to reach and destroy the desired tissue. These devices employ a variety of means for ablation of tissue including cutting implements, devices for heating tissue, and devices for freezing of tissue. The destruction of tissue by these means results in cell death through necrosis.
Present invention departs from prior art in two significant respects. First, it provides a means of chemosurgery for ablation of tissue. Second, it provides a means of ablation that is accomplished by apoptosis versus prior art's necrosis. The advantages of apoptosis over necrosis will be discussed later in this application.
PRIOR ART TREATMENTS
Prior art ablation of internal tissues can broadly be divided into three categories; Conventional Surgery, Minimally Invasive Surgery, and Minimally Invasive Non Surgical Ablation.
Conventional Surgery involves making a significant incision through the skin and all underlying layers of tissue to reach a desired organ or tissue mass. All or portion of the organ or tissue mass is then cut and removed.
Minimally Invasive Surgery involves making a small incision or using an existing body orifice, insertion of a endoscope or laparoscope fitted with grasping and cutting tools or similar device, and ablation of a desired tissue mass by cutting.
Minimally Invasive Non Surgical Ablation involves insertion of devices other than grasping and cutting tools to destroy a target tissue mass.
Since applicant could not find any comparable prior art methods using chemosurgery for the more common procedures envisioned under present invention, the closest prior art comparable is Minimally Invasive Non Surgical Ablation. Consequently, a further discussion of prior art Non Surgical Ablation follows.
Non Surgical Ablation devices are generally tailored to the condition being treated or tissue mass targeted for ablation. Examples of prior art methods for treating two common conditions are presented below for illustrative purposes. Later, in the reduction to practice portion of this application, composition and methods for treating these conditions using apoptotic chemosurgery will be presented to contrast the novelty and utility of present invention's methods over prior art.
Benign Prostatic Hypertrophy (BPH)
An estimated 50% of men have histologic evidence of BPH by age 50, which increases to 75% in men older than 80 years of age. In 40-50% of these patients BPH becomes clinically significant. The prostate is a chestnut shaped body surrounding the beginning of the urethra in the male. The adult prostate weighs about 20 grams. In most men the prostate begins to enlarge further as they age. Prostatic enlargement compresses the urethra and may interfere with urination. BPH is characterized by an increased number of epithelial and stromal cells which may be the result of impaired programmed cell death (Steinbecker et. al. eMedicine Journal, Vol. 3, No. 1, Jan. 10, 2002).
Conventional surgery to remove all or part of the prostate is called a retropubic prostatectomy and involves making an incision in the abdomen and removal of prostatic tissue by hand and cauterization of bleeding vessels.
Minimally invasive surgery is called transurethral resection of the prostate (TURP). A resectoscope is passed up the urethra, a cutting edge or heated wire loop is then used to cut away as much of the prostatic tissue as possible, and a catheter is left in the urethra for several days as it heals.
Non surgical ablation methods employed under prior art include Transurethral Microwave Thermotherapy of the Prostate (TUMT), Transurethral Needle Ablation of the Prostate (TUNA), and Transurethral Laser Incision of the Prostate (TULIP).
TUMT involves insertion of a specially designed Foley-type catheter into the bladder allowing a microwave antenna to be properly positioned. TUMT uses microwaves in the 900-1100 kHz spectrum to create heat for the destruction of prostatic tissue (Rubenstein, “Transurethral Microwave Thermotherapy of the Prostate (TUMT)”, eMedicine Journal, Vol. 2, No. 6, Jun. 29, 2001).
TUNA operates at 490 kHz and uses two needles deployed from the catheter tip as electrodes. As the prostate cells resist the passage of current between the two needle electrodes, heat is produced, resulting in necrosis of the tissue (Steinbecker, “Transurethral Needle Ablation of the Prostate (TUNA)”, eMedicine Journal, Vol. 3, No. 1, Jan. 10, 2002).
TULIP is also mentioned in prior art. TULIP employs a laser. Lasers heat tissue, once again inducing necrotic cell death.
Under present invention, therapeutically effective amounts of trichothecene would be injected into the prostate to achieve a desired amount of ablation. Since compositions of present invention induce apoptosis, they would be much less traumatic than the necrotic methods employed under prior art.
Liposuction
Liposuction is the most commonly performed cosmetic procedure in the US.
Traditional liposuction involves insertion of a cannula through an incision. The cannula is a hollow tube with one or more openings for breaking down tissue and a vacuum is provided for aspiration. The cannula is moved back and forth repeatedly to rasp off and aspirate fat cells.
Internal Ultrasound Assisted Liposuction uses a cannula capable of emitting mechanical vibration energy greater than 16 kHz to enhance fat removal. The goal of using ultrasound is to achieve emulsification by microcavitation. Alternating compression and expansion cycles create microbubbles during the expansion cycle and as the bubble collapses during the compression cycle core temperatures may momentarily reach 72,000 Kelvin or higher resulting in a pulse of electromagnetic radiation termed sonoluminescence. Although Ultrasound Assisted Liposuction has the potential for less connective tissue damage than conventional liposuction, it requires continuous infusion of a wetting solution to conduct the sound waves. Additionally, short term complications include high rates of seromas and skin burn and long term issues involve concerns about DNA damage (part of the sonoluminescence is in the soft X-Ray range) and sonochemical effects such as disruption of chemical bonds resulting in the formation of free radicals and other reactive ions (Baxter, “Liposuction Techniques: Internal Ultrasound Assisted”, eMedicine Journal, Vol. 2, No. 10, Oct. 22, 2001)
Under present invention, therapeutically effective amounts of trichothecene would be injected into a given area to achieve a desired amount of ablation. Since compositions of present invention induce apoptosis, they would be much less traumatic than the necrotic methods employed under prior art. Present invention would also not harm any connective tissue as compositions of present invention function only on nucleated cells.
Because present invention operates by apoptosis versus prior art's necrosis a brief discussion of both is presented to demonstrate the significant utility of present invention's method of cell death over prior art's method of cell death.
Apoptosis Versus Necrosis
Necrotic death occurs when a cell is injured by oxygen deprivation or by a physical assault such as that from surgical procedures. Swelling and inflammation are hallmarks of necrosis. Directly damaged cells that are ruptured spill their contents into the surrounding area. Partially damaged cells that are no longer able to control their fluid and ion balance swell and rupture as charged particles such as sodium and calcium ions that are normally pumped out, now stream in. Inflammation begins as macrophages and other white blood cells of the immune system converg
Delacroix-Muirheid C.
Jones Dwayne C.
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