Surgery – Endoscope – With guide means for body insertion
Reexamination Certificate
2001-10-15
2004-03-09
Robert, Eduardo C. (Department: 3732)
Surgery
Endoscope
With guide means for body insertion
C606S108000
Reexamination Certificate
active
06702735
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to devices for movement along passages.
BACKGROUND ART
Devices are generally known applicable in use for movement along passages, e.g. passages which require examination or certain treatments. In particular, devices are made which are intended for use in medical procedures, i.e., when the devices are for movement along passages of humans and animals. In this latter regard, such devices may include, for instance, a sound, a colonoscope, catheter or endoscope.
It is generally accepted that the use of any device of the above or similar medical type upon their persons, is not welcomed by patients who, while accepting that the use of such devices is necessary, face their usage with physical and emotional repulsion. Feelings of humiliation and personal degradation may also occur, particularly during the use of a colonoscope. These feelings and fears, together with the fear of diagnosis, can cause great tension and resulting spasm, which could contribute to problems during the procedure, and possibly cause pain.
However, of primary importance during the use of a colonoscope is the avoidance of injury to the patient and the completion of procedures in a safe and speedy manner, and in a predictable time. With this in mind, and in order to alleviate the above problems, many colonoscope procedures are performed under a light anaesthetic which includes an amnesiac component. This results firstly in the patient being able to report pain during the procedure, when he feels it, while ideally not feeling the pain sensations afterwards. Secondly, it warns medical staff of impending difficulties.
Many colonoscopic procedures are routinely performed without undue difficulty at present, but a certain percentage are complicated and cannot be completed with known devices. In addition, known devices may present problems in successfully negotiating twists and turns in a colon. This adds to an inordinately lengthy average procedure time, which adds to the stress of both the patient and the attendant medical staff. The lengthy procedure time results, on average, in colonoscope procedures being undesirably expensive, whether or not they are successfully completed.
In attempts to mitigate all of the above fears, various types of constructions of device have been used and suggested. In one basic type of construction of device, a flexible sheath for covering an elongate diagnostic or surgical tool is provided on its outer surface with inflatable devices sequentially positioned along the sheath. These inflatable devices, sometimes with elastic means extending between them, are inflated and deflated in predetermined order to effect movement of the sheath along the passage. Such movement is slow and intermittent and, it is believed, the continual inflation and deflation of the inflatable devices into and out of contact with the colon wall, must add to patient discomfort. Examples of this type of device are described in U.S. Pat. Nos. 4,148,307 and 4,676,228. In another basic type of construction, an elongate sheath is everted during inflation to urge a tool contained within the sheath along the passage. With this type of construction, in order to evert the sheath, the sheath must have a radially outer region inflated into contact with the passage wall, and a radially inner region which contacts the surface of the tool. However, a problem which is inherent in use of this construction is that the radially inner region of the sheath must move relative to, and upon, the surface of the tool during the eversion procedure in feeding the tool along the passage. This relative movement produces frictional resistance to movement of the device along a passage, e.g. a colon, which adds difficulty to exploratory or surgical procedures. Frictional resistance is exacerbated by inflation pressure forcing the radially inner region against the tool surface. This produces severe problems concerning freedom of movement of the device, particularly around turns and restrictions of the colon. Prior U.S. Pat. No. 5,259,364 acknowledges that the radially inner region of an eversible tube travels at twice the speed of an endoscope to move the endoscope along a colon passage. In the disclosure, it is stated that to obtain substantially no frictional forces between the tube and endoscope, fluid under pressure is directed between the radially inner region of the tube and the endoscope to space them apart.
SUMMARY OF THE INVENTION
The present invention seeks to provide a device for movement along a passage which lessens the above problems in use. When used for medical purposes, the device of the invention seeks to avoid injury to the patient while enabling completion of procedures in a safe and speedy manner and in a predictable time.
According to one aspect of the invention, there is provided a device for movement along a passage comprising:
elongate tool having a major axis, distal and proximal end regions, and a sheath abutment element at the distal end region of the tool;
an elongate inflatable sheath surrounding the tool, the sheath having an annular inflatable region disposed between the abutment element and the proximal end region of the tool, and an annular extension region for the annular inflatable region, the annular extension region having a plurality of sequentially interconnected sheath parts extending from the inflatable region, the sheath parts being relatively oriented to face each other to locate the annular extension region around the distal end region of the tool with the annular extension region movable forwardly together with the distal end region of the tool;
an annular inflation chamber defined between the inflatable region and the outer surface of the tool; and
means for introducing pressurized fluid into the chamber to inflate the inflatable region of the sheath, when inside the passage, and to cause inflationary pressure then to act against the sheath abutment element to move the tool forwardly along the passage accompanied by sequential reorientation of the sheath parts and their sequential movement into, and lengthen, the inflatable region.
When the device of the invention defined above is to be used within passages provided by inanimate matter, these passages would normally be expected to be provided with a rigid wall, e.g. in the case of metal or plastic pipes. In such a case, the radially outwards expansion of the inflatable region of the sheath would be constrained by the rigid wall and the sheath would have to expand axially, upon continued introduction of the pressurized fluid, so that the tool was moved along the passage. Where, however, the device is to be used upon living beings, particularly humans, then the sheath should have limited radial expansion, i.e., to a desired maximum. The sheath may be formed from an inelastic material, such as an inelastic polymer, e.g. polyurethane film. Alternatively, the sheath may include a plurality of longitudinally inextensible fibers which are oriented in at least one particular direction for the purpose of limiting radial expansion. Hence, the sheath should be designed so as not to apply undue pressure to the wall of the passage, e.g. a colon, but may apply sufficient pressure either merely to engage the passage wall or with a small acceptable radial enlargement of the passage. Thus the sheath will grip the passage wall and then expand progressively along its length while, simultaneously, the tool, e.g. a colonoscope, is moved forwardly by the inflationary pressure. When the device is used for medical purposes, the limit to radial expansion of the sheath thus may help to lessen any discomfort and anxiety of a patient. Sudden increases and decreases of inflationary pressure at localized regions of the passage are avoided, such as must be provided by devices having inflatable bags inflated and deflated in specified order to move a tool incrementally along the passage.
In addition to the above, and to render the device of the invention more easily useable in medical situations, and therefore to make use of the device mo
Adams Thomas
Kelly Charlotte Margaret
Robert Eduardo C.
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