Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Patent
1996-02-12
1999-06-08
Stright, Ronald
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
604272, A61M 5178
Patent
active
059101334
DESCRIPTION:
BRIEF SUMMARY
DESCRIPTION
This invention relates to an arterial transintimal recanalisation device.
In middle age, over 40% of males have evidence of significant vascular impairment due to arterial fat deposits. This generalised disease, atherosclerosis, may be heralded by relatively minor, but nonetheless disabling, symptoms of lower limb peripheral vascular disease. This may range in presentation from mild intermittent claudication (limp) which may or may not limit lifestyle, to critical ischaemia with rest pain and/or ulceration or gangrene with an associated risk to life and limb. Management involves attention to the presenting clinical problem, which may be acute and necessitate immediate intervention. Surgery has been the mainstay of intervention for some three decades, however minimally invasive management by balloon angioplasty and related techniques has become of rapidly increasing importance.
In these newer procedures a guidewire is inserted percutaneously through an arterial stenosis or occlusion using x-ray control. A balloon is then passed over the guidewire and inflated in the obstructed segment. These procedures are cost effective, very low risk (about 0.4%) and are performed under a local anaesthetic; discomfort is minimal.
Technical failure occurs in about 20% of occlusions treated and is due to failed guidewire passage (due to heavy calcification, vessel perforation or, most commonly, subintimal passage of the guidewire), elastic recoil of the arterial wall, or acute occlusion due to spasm or thromboembolism. Elastic recoil and acute occlusion can be managed by alternative techniques. Where there has been subintimal guidewire passage, success may necessitate breaking through the intima into the patent, distal lumen. Whilst this can be attained in about 50% of cases in the remainder the intima resists attempts to pass a guidewire through its substance due to a combination of the strength and integrity of the intima and the necessarily atraumatic construction of the guidewires used in these procedures.
An aim of the present invention is to provide a transintimal recanalisation device which overcomes the problem of the intima resisting passage of a guidewire through its substance.
A further aim of the present invention is to provide a method of assembling a transintimal recanalisation device.
In accordance with a first aspect of the present invention there is provided a flexible transintimal recanalisation device adapted to be guided through the vasculature of a patient comprising a guide tube, a flexible needle having a bevelled end and located in said tube, wherein said needle is movable from a covered position wherein said bevelled end is within the tube to an uncovered position in which said bevelled end is exposed, and means enabling said bevelled end to adopt a desired orientation with respect to the tube.
Preferably, said tube has a bend in its length and the needle has a bend in its length which conforms with the bend of the tube, thereby orientating the bevelled end with respect to the tube.
It is preferred that said needle is hollow. Preferably, said device further comprises means for manoeuvering the needle with respect to the tube.
The means for enabling said bevelled end to adopt a desired orientation with respect to the tube may be provided by said manoeuvering means.
In a preferred embodiment of the invention said manoeuvering means comprises a first body connected to an end of the needle spaced from the bevelled end. Preferably said first body is provided with a first aperture therethrough in communication with said hollow needle.
It is preferred that said device further comprises a second body connected to an end of said tube and wherein said second body is provided with a first aperture therethrough to allow the passage of said needle.
Said first body may be provided with a second aperture extending from said first aperture to a surface of the body. Similarly, said second body may be provided with a second aperture extending from said first aperture to a surface of the body.
Said first
REFERENCES:
patent: 4013080 (1977-03-01), Froning
patent: 4511356 (1985-04-01), Froning et al.
patent: 4518383 (1985-05-01), Evans
patent: 5114402 (1992-05-01), McCoy
patent: 5152749 (1992-10-01), Giesy et al.
Nguyen A. T.
Stright Ronald
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