Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-03-15
2004-06-22
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S514000
Reexamination Certificate
active
06752799
ABSTRACT:
FIELD OF THE INVENTION
Background
The invention relates to a method of endoscopically injecting at least one fluid and an apparatus with which to implement the method.
During endoscopic operations a great variety of manipulations are undertaken in natural or artificial cavities in the body, in the course of which it repeatedly becomes necessary to remove tissues and/or stop bleeding. Among the techniques used here are forms of injection. For example, a polyp on a sufficiently long stalk can be removed relatively simply (by catching it in a noose), but this is not possible in the case of so-called sessile polyps, which are merely small elevations in the tissue. In such cases it is necessary to raise the polyps, by injecting fluid, in particular physiological saline, into the underlying tissue by means of an injection needle. A sessile polyp raised in this way can then be removed with the known techniques.
A different occasion for the injection of fluids arises when bleeding must be stanched. One way to stop bleeding is to inject physiological saline so as to form a depot around a blood vessel and thereby close it mechanically. Alternatively, a corresponding effect can be achieved by the injection of medications, in particular vasoconstrictive substances. Another means of stopping bleeding is the injection of fibrin adhesives.
Finally, yet another application of injections should be mentioned, namely the marking of operation or treatment sites. Often after a treatment such as the removal of a growth in the intestine, the affected site must be inspected at regular intervals in order to monitor the result of the treatment or the healing process. In particular when the operation site covers a small area and healing is progressing well, it is very difficult to find the treated site again. For this purpose it is useful to stain the treated site or to place marking dots in its vicinity.
The object of the invention is to disclose a method and an apparatus by means of which fluids can be injected during endoscopic operations.
To solve the problem cited above a method is disclosed for the endoscopic injection of at least one fluid, in particular a solution, a suspension or an emulsion or a mixture of several solutions, into a tissue in a hollow organ, a body cavity or an artificial cavity in a human or animal body. In this process a specified amount of fluid is expelled from the end of a tube or from a nozzle with specifiably adjustable hydraulic parameters such as pressure, rate of rise of pressure, duration and velocity of fluid flow, and with energy such that after an essentially free flight across a distance separating the tube end or nozzle from the tissue, the fluid penetrates into the tissue. That is, in the method in accordance with the invention (or in the apparatus in accordance with the invention) no injection needle is used, which would have to be inserted into the tissue to which the liquid is to be applied. This property makes the method in accordance with the invention especially suitable for the application of fluids during endoscopic operations. In particular, the hydraulic parameters can be adjusted so as to ensure that the fluid penetrates the tissue down to a specified depth, at which the fluid can then exert the desired effect. As a result, it also becomes considerably more certain that undesirable effects will be avoided. For instance, when a site in the intestine is to be marked, it is extremely dangerous to operate with an injection needle, because it is very easy to pierce through the intestinal wall. When the method in accordance with the invention is used, this danger is considerably less.
The preferred procedure is not to apply the entire amount of fluid to be injected in a single “portion”. Instead, the desired amount of fluid is injected as a plurality of minimal amounts, all of substantially the same size. The result is to ensure that essentially any desired total amount of fluid can be injected, while nevertheless keeping constant the hydraulic parameters, i.e. the parameters that determine the depth of injection, the diameter of the opening formed in the tissue, and so on; the outcome of the injection process is therefore optimal.
The fluid is preferably not injected perpendicularly into the tissue (i.e., perpendicular to its surface), but rather at an angle. This angle is preferably 30° to 60° with respect to the tissue. Surprisingly, this range has been found to give the best injection results.
Where possible, the fluid is injected in such a thin stream that the hole formed in the tissue during injection closes immediately thereafter, so that practically none of the injected fluid is then released. This can readily be achieved, because when a correspondingly large number of single (individually small) portions is injected, the amount of fluid can be made as large as desired even though the stream of fluid is very thin.
When two different fluids that can react with one another are to be applied, such as the above-mentioned fibrin adhesive or the like, the fluids are preferably not mixed until just before they injected together, or they are injected separately in rapid succession (in small portions as described above) at the same site, in such a way that they become mixed at the injection site. Especially in the case of fluid mixtures, the individual components of which react with one another very rapidly, and in particular solidify or adhere together, this method of successive injection of fluids is an excellent means of preventing a reaction from taking place in the injection apparatus itself (nozzle or end of tube) and hence destroying the apparatus.
A certain problem can be presented by the unintended emergence of fluid from the end of the tube. This is of no importance when the fluid is a physiological saline solution to be injected underneath a polyp. However, if it is a marking fluid such as tattooing ink, accidental leakage from the end of the tube has fatal consequences, because a place is marked that should not be marked at all. It would be equally fatal if medications were to leak out accidentally. However, some leakage cannot be avoided, if only because a tube filled to its distal end and positioned in the working channel of the endoscope changes its volume—although only slightly—as the endoscope moves, so that some liquid emerges. It is now proposed to suck away fluid that emerges unintentionally from the end of the tube. This action is made particularly simple by generating a continuous suction current, such that the volume it withdraws per unit time is smaller than the volume injected per unit time during the injection process. By this means, it is ensured that the slowly, unintentionally emerging fluid is completely sucked away, whereas the amount of fluid emerging at high velocity, with a relatively high volume flow per unit time, is practically not reduced.
SUMMARY OF THE INVENTION
The endoscopic injection apparatus in accordance with the invention, designed to inject at least one fluid, in particular a solution, a suspension or an emulsion or a mixture thereof into a tissue in a hollow organ, a body cavity or an artificial cavity in a human or animal body, comprises a tube with a distal and a proximal end, which can be so inserted through a working channel of an endoscope, or is so incorporated into an endoscope, that the distal end of the tube projects out of a distal end of the endoscope or ends substantially at the end of the endoscope. A pump mechanism is provided that is in sealed connection with the proximal end of the tube and is so constructed that in response to a control signal it expels from the distal end of the tube a specified amount of fluid, with hydraulic parameters such as pressure, rate of pressure increase, duration and/or velocity that can be set to specified values, and with sufficient energy that the fluid penetrates into the tissue.
The distal end of the tube in this arrangement is preferably so shaped, or provided with a nozzle in such a way, that the hole formed in the tissue during injection closes of its own
Farin Günter
Grund Karl Ernst
Özmen Dogan
Casler Brian L.
Erbe Elektromedizin GmbH
Sirmons Kevin C.
St. Onge Steward Johnston & Reens LLC
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