Surgery – Instruments – Cutting – puncturing or piercing
Reexamination Certificate
2000-02-28
2002-07-16
Truong, Kevin T. (Department: 3731)
Surgery
Instruments
Cutting, puncturing or piercing
C606S028000
Reexamination Certificate
active
06419683
ABSTRACT:
The present invention relates to an instrument for resectioning hemorrhoids for the minimal invasive subanodermal removal of hemorrhoidal tissue.
Hemorrhoidal ailments account for the most frequent rectal disease found in the Western civilized world; the disease frequency is said to be 50% among the population over 50 years. Hemorrhoids are vessel convolutes covered with mucous membrane, which are noticed by bleeding, pressure sensation or protrusion. Starting from a hemorrhoidal enlargement of the third and fourth degree, a surgical intervention in which tissue is removed manually is required for providing relief.
As a rule, hemorrhoidal tissue is formed below the anoderm, i.e. below the transitional skin which is located at the end of the anal canal between the mucous membrane of the rectum and the external skin of the buttock. The anoderm has an extremely high nerve density which ensures sensory continence, i.e. the ability to distinguish gas, liquid or feces and to retain the same.
The methods which have so far been known are concerned with segmental excisions, e.g. according to Milligan-Morgan, in which large incisions are required in the highly sensitive anoderm. This may impair the sensory system of the anoderm and is relatively painful for the patient in the subsequent wound healing process.
U.S. Pat. No. 4,428,748 describes an ophthalmic surgical instrument for treating cataracts of the crystalline lens. The operative attachment of the instrument is needle-shaped and is provided in the area of the tip with a milling opening for removing tissue parts in the area of the crystalline lens. The outer part of the needle can be driven in an ultrasonic surgical manner. For the selective removal of portions of the crystalline lens the needle-like lens is required for selectively treating the parts to be removed within the millimeter range. The instrument is not suited for treating inhomogeneous tissue structures.
EP 0 591 619 A1 discloses a resectioning instrument for the operative removal of tumors, or the like, for instance in the field of gallbladders. An ultrasonic unit is used for reducing the size of the tumor employing an endoscope. The size-reduced tumor particles are removed with the help of a flushing device.
U.S. Pat. No. 4,931,047 suggests an ultrasonic unit for the fragmentation of tumor tissue on the digestive organ. The tissue is fragmented by way of ultrasound to eliminate the tumor.
(Continued on page 2 of the original description)
U.S. Pat. No. 3,945,375 and U.S. Pat. No. 3,937,222 disclose surgical milling units for the removal of tissue. Each milling unit comprises at least one rotating knife which is rotating in the area of an opening of a sleeve, so that tissue within the area of the opening can be removed by the milling device.
It is the object of the present invention to provide an instrument permitting a simple and gentle surgical removal of hemorrhoidal tissue in accordance with anatomical conditions.
This object is achieved according to the invention by a resectioning instrument for the minimal invasive, subanodermal, submucous removal of hemorrhoidal tissue, with a narrow, elongated carrier device being provided, comprising a vibrating surgical tissue size-reducing device and at least one tissue-removing milling unit.
Only a small incision in the skin is required for the surgical application of said instrument. The incision is preferably made at the base of a hemorrhoidal node on the anal edge region. The anoderm ends in this region or passes into the skin of the buttock. The anoderm is here not incised or only incised to a very slight degree.
Thanks to the small incision, the narrow, elongated carrier device can be introduced below the anoderm. In the subanodermal region the removal of the hemorrhoidal plexus may be started on the front end portion of the instrument.
With the tissue size-reducing device, the hemorrhoidal tissue can be prepared and fragmented in a vibrating surgical manner. It can be isolated from the inner sphincter at the one side and from the anoderm at the other side. The anoderm remains intact and the Musculus internus undamaged.
An ultrasonic surgical tool may e.g. be used as the vibrating surgical device which is e.g. operated within the range of 20,000 to 40,000 Hz. The hemorrhoidal tissue can thus be prepared and fragmented in a very selective manner and without any damage to the healthy tissue.
The prepared tissue can then be reduced in size and removed with the tissue-removing milling unit, so that it is removable piece by piece from the area between the sphincter and the anoderm.
This instrument allows for a very easy operation which does not require any assistance and only needs about a third of the time of conventional surgical methods.
The highly sensitive anoderm remains intact and can subsequently be repositioned into the anal canal in accordance with the anatomy. This means for the patient that less healthy tissue is destroyed, resulting in a faster wound healing process. Because of the maintained anoderm the postoperative wound pain is considerably reduced.
Preferably, when viewed in the longitudinal direction of the carrier device, the tissue size-reducing device can be arranged closer to the tip of the carrier device than the milling unit. As a result, when the instrument is advanced into the hemorrhoidal tissue, the tissue sizereducing device will first get into active contact with the tissue. Preparation and fragmentation will be performed in the advance direction before the milling unit becomes operative.
The tissue size-reducing device can be arranged in a particularly advantageous manner directly at the foremost tip of the carrier device. Thus the preparation can be performed at the foremost end of the carrier device, so that the preparation can be carried out during the selective advance movement of the instrument.
Advantageously, the milling device can be arranged in spaced-apart relationship with the tip of the carrier device in the lateral circumferential area of the carrier device. As a consequence, the milling unit can be operated laterally and, when viewed in the advance direction, will only become active after the hemorrhoidal tissue has been prepared.
Specifically, at least two spaced-apart milling openings of the milling unit may be provided in the lateral circumferential area of the carrier device. Tissue can there by be removed at two sides, so that the hemorrhoidal tissue can be removed relatively rapidly and in different spatial directions.
When viewed in a direction perpendicular to the longitudinal direction, the milling openings should be arranged approximately on the same circumferential line. This ensures that during the advance movement of the instrument the milling action will only begin from a specific circumferential line onwards.
In a preferred embodiment the front end portion may comprise an inclined surface extending at an angle relative to the longitudinal axis of the carrier device, resulting in the formation of a front end portion having an approximately wedge-shaped or beak-shaped cross-section. Such a shape facilitates the advance movement of the instrument in the tissue.
In a particularly advantageous manner, the angle of inclination of the inclined surface may be about 40° to 50°, preferably 45°, relative to the longitudinal axis of the carrier device. With such an angle, the front end portion is still sufficiently stable and can be advanced relatively easily into the hemorrhoidal tissue.
In a variant of the invention an active surface of the tissue size-reducing device may be integrated at least in part into the inclined surface. As a result, the tissue size-reducing operation can be performed in a direction arranged at a slight angle relative to the advance direction, so that a slightly lateral preparation is also possible.
A light providing device which emits diaphanoscopically usable light is possibly provided on the front end portion. Diaphanoscopy means the transillumination of body parts to detect the structure or contours of tissue by way of shadows. During use of t
Donohue Michael J.
Seed IP Law Group PLLC
Truong Kevin T.
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