Surgery – Body inserted urinary or colonic incontinent device or...
Reexamination Certificate
1999-06-23
2002-07-30
Lacyk, John P. (Department: 3736)
Surgery
Body inserted urinary or colonic incontinent device or...
Reexamination Certificate
active
06425853
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to treating body tissue, particularly to treating body tissue by altering the shape or volume of that body tissue using energy or substances deployed from an interstitial location in the body.
2. Related Art
Human beings and other animals are subject to a number of medical disorders, including those in which a body structure is subject to unwanted features or is otherwise dysfunctional. For example, the body structure can include muscular tissue, mucosal tissue, gastro-intestinal tissue, lumen walls, stenotic locations in lumens or interstitial locations, or tumors or other cancerous or precancerous conditions. The unwanted features can for example include being distended or engorged, being unduly large or small, being misshapen, having cysts or tumors, or having undesirable growths. Other dysfunctions can include aneurysms, diverticuli, fissures, hemorrhoids, tumors, or simply an inability for the body structure to perform its proper function.
Medical disorders of these kinds can be particularly critical when they involve important areas of the body, including the cardiovascular system, the gastro-intestinal tract, the genito-urinary system, the pulmonary system, the locomotor system, the vascular system, or other body systems. For a first example, disorders involving body structures in the gastro-intestinal tract can lead (at a first end thereof) to inadequate operation of the esophageal sphincter, to gastro-intestinal reflux, or to Barrett's esophagus. For a second example, disorders involving body structures in the gastro-intestinal tract can lead (at a second end thereof) to fecal or urinary incontinence.
Surgical treatment of such disorders can be relatively invasive and labor-intensive. This has the drawbacks of incurring relatively high expense, of incurring relatively high risk (in some cases) of damage to important nerves, and of producing iatrogenic effects that are relatively hazardous to the patient.
The use of radio frequency (RF) to ablate tissue in the body (such as heart muscle tissue) is known in the art of cardiac treatment. However, known systems using RF energy are still subject to several drawbacks. One known problem is that it can be difficult to block the flow of bodily fluids and gases into an area of the body where tissue ablation is taking place. Bodily fluids can dissipate and detrimentally absorb the energy to be applied to the tissue to be ablated. Dissipation of bodily fluids detracts from the goal of treatment of diseased tissue.
A second problem in the known art involves directing and positioning the electrodes in the body cavity or orifice. Difficulties in accurately positioning the electrodes in the target orifice detract from treatment. Frequently, unhealthy tissue remains untreated while healthy tissue is compromised. Difficulties in directing and positioning the electrodes are particularly problematic because one of the goals of treatment is to minimize collateral damage to healthy tissue and to completely treat diseased tissue.
A third problem in the known art involves providing a cooling element that does not detract from the goal of successful treatment. Some known systems rely upon infusion of a cooling liquid into the targeted area for treatment. While such infusion of liquid can minimize thermal injury to the patient, it is not always applicable in all parts of the body. For example, infusion of cooling liquids into an internal body cavity such as a bladder, uterus, or stomach can rupture the targeted organ or cause osmotic imbalance within the tissue.
A fourth problem in the known art involves difficulty in the simultaneous use of complimentary technology. Known systems do not provide for optimal, simultaneous use of auxiliary tools for visualization, feedback technology and drug administration.
A fifth problem in the known art involves protection and stimulation of nerve bodies in the tissue. Known systems do not provide for protection of sensitive nerves during treatment or allow nerves to be identified and stimulated. This is particularly problematic because many tissue disorders arise because afferent and efferent nerves are either under-stimulated or over-stimulated.
Accordingly, it would be advantageous to provide a method and apparatus for treatment for body structures, especially internal body structures involving unwanted features or other disorders, that does not require relatively invasive surgery, and is not subject to other drawbacks noted of the known art. This advantage is achieved in an embodiment of the invention in which a relatively minimally invasive catheter is inserted into the body, treatment of the body structures is applied using electrodes that extend through a cooling element, so the unwanted features or disorders are ameliorated using the applied treatments. Unlike known devices, positioning of the electrodes and cooling element can be achieved without disturbing the entire length of the catheter because the electrodes and cooling element are mounted on a section of the catheter that is disposed to extend or retract. The applied treatments can include application of energy or substances, including application of energy (such as of radio frequency energy, microwave energy, laser or other electromagnetic energy, or ultrasound or other wave energy) or substances (such as collagen or other bulking, plumping, or shaping agents; saline or other energy-receiving electrolytes; astringents or other debulking, reducing, or shaping agents; or antibiotics or other bioactive, chemoactive, or radioactive compounds). Rupture, osmotic damage and other dangers associated with infusion of cooling liquids are avoided because the electrodes that apply such energy are embedded in a contained cooling element. The catheter also includes probes disposed to identify specific nerves for subsequent stimulation or protection. More than one applied treatment can be performed, either in conjunction, in parallel, or seriatim, so as to achieve a combined effect more substantial than any one applied treatment by itself.
SUMMARY OF THE INVENTION
The invention provides a method and system for treatment for body structures, especially internal body structures involving unwanted features or other disorders, that does not require relatively invasive surgery, and is not subject to other drawbacks of the known art. A relatively minimally invasive catheter including a contained cooling element is inserted into the body. The distal and proximal end of the catheter are extended or retracted or some combinations thereof so as to achieve optimal delivery of treatment. Treatment of the body structures is applied using the electrodes and the cooling element, so the unwanted features or disorders are ameliorated using the applied treatments.
In a preferred embodiment, the applied treatments can include application of energy or substances, including application of energy (such as of radio frequency energy, microwave energy, laser or other electromagnetic energy, or ultrasound or other wave energy) or substances (such as collagen or other bulking, plumping, or shaping agents; saline or other energy-receiving electrolytes; astringents or other debulking, reducing, or shaping agents; or antibiotics or other bioactive, chemoactive, or radioactive compounds).
In a preferred embodiment, more than one applied treatment can be performed, either in conjunction, in parallel, or seriatim, so as to achieve a combined effect more substantial than any one individual such applied treatment.
In preferred embodiments, the unwanted features or other disorders include one or more of the following:
Barrett's disease, other growths on the esophageal lining or near the esophageal sphincter, or otherwise relatively near an ingestive end of the gastro-intestinal system;
fecal incontinence or other failures of the musculature or sphincters relatively near an excretory end of the gastro-intestinal system;
menorrhagia, fibroids, cysts or other failures of the musculature of the female reproduc
Edwards Stuart D.
Glenn Michael A.
Lacyk John P.
Peil Christopher
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