Surgery – Instruments – Sutureless closure
Reexamination Certificate
1999-05-26
2001-03-20
Thaler, Michael H. (Department: 3731)
Surgery
Instruments
Sutureless closure
Reexamination Certificate
active
06203563
ABSTRACT:
The main object for this invention is a healing device applied to wounds, fistulas, pancreatis, varicose ulcers and other medical or veterinary pathologies requiring compacting into said wound an aerated material by means of atmospheric depression, and it has as its secondary object the method for applying said device.
BACKGROUND AND PRIOR ART OF THIS INVENTION
It is well know to professionals skilled in the art of healing, that a wound at any part of the human body can be provoked either by a pathological agent, as well through a traumatic agent. In either cases, the final result is a wound which segregates fluids, accumulates detritus and creates a bacteria breeding site, which in direct function of the nature and size of the wound, may impede its healing. On the other hand, a fistula is an orifice open from within an organ or limb in the human body, with an outlet.
A healing process implies cleansing the wound, drying same of noxious fluids, and since a wound may be considered as an infectious cavity within the body, a fistula is a wound defining a passage or opening communicating one of more internal organs with the outer environment. The healing process for these medical pathologies are successful when the wound is clean and dry, ceasing in its emission of humorous fluids and detritus. Most of these are provoked by the activity of bacteria and pathogenic agents, which according to their nature must have a sufficient threshold of oxygen pressure in order to live and multiply, or in the case of gangrene, the absence of oxygen is required for same to infest the body.
The necessary oxygen pressure for these bacteria, or the like, to thrive is attained at sea level at atmospheric pressure (760 mm Hg.), and in the case of gangrenes it has been found that a reasonable acceptable means of oxygenating the base of the gangrenous wound is to induce an increase of blood irrigation in its area. As a rule an infected wound produces an interface between the external environment and the base of the wound. It is also known that atmospheric air at a pressure of 760 mm Hg. has an average of 20% in oxygen. This means the oxygen present in air is responsible for 150 mm Hg. as measured in the pressure column. It is further common knowledge that any living organism needs an average column of 100 mm Hg. in oxygen in order to allow the oxygen exchange through its cell membrane, while under this oxygen pressure it is not possible to sustain life due to lack of the vital oxygen exchange.
In the following exposition, it will be only be made mention to a fistula in the abdominal region, which has interested a portion of intestine, short-circuiting the digestive tract, without this sole mention being capable to construe any limitation to the actual scope of this instant invention, which can be applied to any wound as above said, and specifically to fistulas in any part of the body, being this scope delimited by the first claim of this patent.
As known to the skilled in the art, a fistula implies some serious inconveniences, such as:
undernourishment, if said fistula is an intestinal fistula, with an elevated flow of humorous fluids;
loss of body fluids and electrolytes (such as blood, etc.)
a degradation process of the tissue in the area surrounding said fistula, since the body humours exiting from said wound acts as a ferment.
This means a fistula acts, like a true communication opening through which, (as in this chosen non limiting example) one or more portions of intestine are thus in direct communication with the external environment, short-circuiting the lower digestive tract.
Considering always the abdominal fistulas, it is believed post-chirurgic entero-cutaneous fistulas appears between 0.5 to 2% of all patients with abdominal operations. Depending on the treated pathology, and also considering if we are dealing with emergency surgery or programmed interventions, when and if a fistula papers, it aggravates the prognosis for the patient. The flow rate of the intestinal contents, its proteolitic activity, its anatomical placing, the peritoneal infection, the difficulty in the distal transit and the base illness, are causes whose combination averages a mortality rate between 20 to 40% of all patients thus affected.
Professionals skilled in the art knows that when a fistulae appears, they have two choices:
medical treatment, or
chirurgic treatment.
As a rule, considering the inherent complications attached to a chirurgic treatment of fistulas, there is a tendency to try to obtain its obturation through medical treatment.
Chirurgy is not always practicable since the orifices segregates a high flow rate of intestinal liquids (an average of 1500 cc/ day), and the aggression of these liquids at its full final digestive process literally “digests” or “eats” the new tissue intended to precisely close the orifice. There exists an important relative pressure within the intestine, which pumps the liquids in a natural way towards the end of the digestive tract, helping same to exit with any contention through said fistula. In the operated cases the recidivate reaches around 20%.
Of the several procedures tried out in the past for the closing of fistula openings, no one gave the expected mortality reductions rate results.
Beginning by surgery, it has been already explained why same cannot prosper. It is known to have been tried to obturate the orifices with adhesives, including instant adhesivation, but it was not possible to maintain dry the wound area.
In order to reduce a secretion rate, traditionally it has been used a continues aspiration, applied to the wound, along with the prescription of antiexocrine medication, and this forces the patient to lay in bed, tending to create the necessary conditions for a pulmonary emboli, pulmonary hipostasia with risks of pulmonary infection.
It is also necessary to replace intravenously into the patient the lost electrolytes due to the secretion flow rate, and a long term parental feeding which produces a high mortality rate of due to these causes.
The last consideration given to fistulas treated with the known traditional methods is time: in effect, it has been known cases in which the patent has been subjected to post-surgery terms of several months, sometimes even almost an year, with being able to walk, and acute nutritional problems.
OBJECTS OF THIS INVENTION
It is a main object of this invention a device which allows at the same time to dry the wound, or fistula, or the excreted fluids, humors and detritus, while at the same time is capable of denying the necessary oxygen pressure at the interface (wound surface/ secreted fluid), and lastly, it allows the blood irrigation increase at the base of said interface, oxygenating same while it avoids the humidity from the secretions, which is the determinant factor of the bacterial growth. To this end it is important to remember that the secretions are a bacterial growing broth.
It is a further main object of this invention a device for treating wounds, fistulas, pancreatitis, varicose ulcers and other medical or veterinarian pathologies requiring atmospheric depression, compacting an aerated material in direct contact with said wound or fistula, stopping the secretion of fluid from the body to the exterior environment, and establishing the conditions allowing the patient to regenerate its own tissues, with the given time, closing the opening of the wound of fistula.
It is another object of this invention a device, which in the specific case of fistulas, allows to stop the drainage of internal fluids proper of the affected organ (such as the intestine) thus detaining its dysfunction, such as for example an aggravated undernourishment, or grave hemorrhage, such as in the case of varicose wounds.
It is a further object of the invention a device capable of creating a vacuum chamber (negative pressure) capable of compacting the aerated fibrous material, against the portion of the body against which this chamber is applied, determining a malleable structure of selective rigidity particularly apt for treating bone fractur
Bui Vy Q.
Thaler Michael H.
Walker Alfred M.
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