Apparatus for providing transcutaneous access to an internal...

Surgery – Instruments

Reexamination Certificate

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Details

C606S108000, C600S114000, C604S513000

Reexamination Certificate

active

06540738

ABSTRACT:

BACKGROUND OF THE INVENTION
The invention relates to an apparatus for providing transcutaneous access to an internal hollow organ, in particular to the stomach, comprising a tubular flexible probe disposable transcutaneously in the hollow organ of a living body, and a rigid sleeve attachable to a section of the probe extending from the body, such that the sleeve engages around this section.
Such an apparatus is disclosed in the German patent DE 195 43 011. In the known apparatus, a tubular flexible probe is introduced into the stomach and passed outwardly through the stomach wall and the abdominal wall. A retention ring at the opposite end of the probe prevents the probe from being extracted from the stomach. A reinforcing sleeve is applied to the section of the probe extending from the body, namely over its outer surface. As little relative shifting as possible should take place between the probe and the applied reinforcement sleeve, which probably results from frictional connection, although the document does not mention this.
The assembly comprising the probe section extending from the body and the reinforcement sleeve provides a transcutaneous access to an interior hollow organ, in this case the stomach. Instruments for example can be introduced into the body through this access. A valve element is provided at the outer end of the reinforcement sleeve to avoid release of the contents of the stomach or intestines or insufflation gas from the hollow organ.
A drawback of this apparatus is that relative motion between the probe section extending from the body and the applied sleeve cannot be excluded. Even if one provides a relatively good frictional connection between the outer surface of the flexible probe and the inner surface of the applied sleeve, it cannot be excluded that a relative movement takes place, for example when coughing which is undesirable.
This fixed frictional connection also greatly impairs the handling when applying the reinforcement sleeve to the probe. The reinforcement sleeve must be slid over the section extending from the body. With high friction, this is difficult and requires irregular sudden movements, so that it is difficult to subsequently correct the seating.
It is therefore an object of the present invention to provide an apparatus by which transcutaneous access can be accomplished in simple manner and with as little trauma as possible to the patient, in particular to ensure a reliable seating of the sleeve attached to the probe.
SUMMARY OF THE INVENTION
According to the present invention, this object is achieved in that a clamping device is provided for releasably, but securely connecting the probe to the sleeve, which comprises moveable clamping elements being moveable between a clamping and a non-clamping position.
The sleeve can be slid onto the probe section extending from the body without resistance and can be properly positioned, because the moveable clamping elements can be brought into a non-clamping position. A proper positioning is accomplished in that the probe is slightly drawn out so that its inner ring pushes the stomach wall onto the abdominal wall. After adjusting the proper and desired relative position between the probe and the applied sleeve, the clamping device is actuated and the moveable clamping elements are brought into the clamping position. The clamping effect can be selected such that no relative shifting takes place, even with sudden movements of the patient, for example when coughing.
A releasable, but fixed connection between the outer rigid sleeve and the probe section arranged therein is acheived through the clamping means, so that no relative movement between these two components is possible in clamped condition. The probe need only be cut off to the length of the apparatus, so that the instruments can be introduced via a sleeve-like element, as physicians are accustomed to with trocars. After removing the apparatus from the probe, a sufficiently long section remains extended from the body through which corresponding connections can be made for intragastral feeding or also other connecting elements. If necessary, the apparatus can again be attached to this section.
The probe is exactly aligned, because the sleeve engages around and guides the probe, such that it sits precisely concentrically in the rigid sleeve. The proximal, end face of the probe is also exactly circular, so that no danger exists that instruments can catch on the end edges during insertion, which could be the case if these were deformed to become oval or have another form. This represents a substantial contribution to the reliability of the apparatus.
In a further embodiment of the present invention, a base portion is provided for application of the apparatus to a body surface. The feature has the advantage that an exactly aligned seating of the apparatus is ensured on the body.
In a further embodiment, a valve assembly is provided through which the access produced by the probe is sealingly closed. The feature has the advantage that the apparatus itself comprises this valve assembly, so that no complicated connections need be made on the probe itself, rather the apparatus only needs to be placed upon or slid onto the probe.
In a further embodiment of the present invention, the clamping device comprises moveable clamping elements, which can be applied onto the outer side of the probe. The feature has the advantage that after slipping the apparatus onto the probe, the clamping elements can be applied to the outer side of the probe and a clamping between the apparatus and the probe can be accomplished.
In a further embodiment of the present invention, the moveable clamping elements can be applied over the surface of the outer side of the probe. The feature has the advantage that with the larger surface, a frictional connection is achieved even with a relatively small pressure, where the apparatus is clamped to the probe so as not to be shiftable in axial direction. The clamping device is non-distructive, without damaging the material structure, the form or the outside of the probe. This friction connection can then be enhanced by corresponding surface treatments or by the roughness of the clamping elements.
In a further embodiment of the present invention, the clamping elements include projections, which penetrate into the flexible probe when the clamp is closed, however without altering the lumen in the probe. The feature has the advantage that the projections ensure that the apparatus cannot release from the probe even by unskilled handling or with inadvertent catching of the apparatus on other instruments. With a corresponding flexible material, the projections can penetrate from the outside into the probe without altering the lumen in the probe, so that the entire inner cross-section is also available in the clamped condition as an instrument channel.
In a further embodiment of the present invention, the base portion is formed as a separate component. The feature has the advantage that the application of the apparatus is simplified in that the base is first slid onto the probe extending from the body and the base is then positioned and aligned at a suitable location on the body.
In a further embodiment of the present invention, the base comprises a clamping device. The feature has the advantage, especially combined with the above-mentioned features, that the base can be clamped after its alignment with the probe. Corrections can still be made, which are then easier for the operator to carry out than if the complete apparatus were attached.
In a further embodiment of the present invention, the clamping device comprises two approximately half-shell clamping elements. The feature has the advantage that these clamping elements can be arranged to save space, can engage around a large surface area of the probe and then encompass the probe in clamped condition to be aligned, sealed and supported.
In a further embodiment of the present invention, the clamping device comprises a cam shaft rotatable by an external lever, whose cam engages with at lea

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