Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis – Stent structure
Reexamination Certificate
1998-07-14
2001-09-18
Milano, Michael J. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Arterial prosthesis
Stent structure
C623S017120
Reexamination Certificate
active
06290719
ABSTRACT:
FIELD OF THE INVENTION
The present invention concerns elements for anchoring implant devices in place.
The invention has been developed with particular attention to its possible application to the anchorage in place of implant devices such as electrodes for endocardial stimulation or drug delivery devices. The invention can nevertheless be used for the anchorage in place of a wide range of implant devices: some possible examples include vascular grafts, stents for angioplasty, various kinds of prosthetic cardiac valves, etc.
BACKGROUND OF THE INVENTION
Various arrangements have been proposed and utilised in order to anchor implant devices firmly in place, from suturing (consider, for example, the attachment of prosthetic cardiac valves), to retention effected by the expansion of the device in situ (one typically thinks of stents for angioplasty), to the deployment of mechanical attachment elements.
All of these above-described arrangements have greater or lesser disadvantages.
Attachment by means of suturing nearly always requires accessibility to the implant site from the outside and it is therefore practical only during surgery. Anchorage by way of expansion in situ carries the risk of the subsequent collapse of the device and is therefore practical only where particular conditions exist for the geometric coupling between the device and the associated implant site. Even mechanical attachment such as that utilised, for example, for pacemaker electrodes, often requires direct access to the implant site from the outside. Where implantation is preceded, for example, by catheterisation, the risk exists that attachment may occur before the device has reached the desired implantation site, locking the device itself in an undesirable position, when it can often be dangerous, if not impossible, to remove or reposition it.
SUMMARY OF THE INVENTION
The object of the present invention is to provide a solution which overcomes in radical manner the disadvantages described above.
According to the present invention, this object is achieved by virtue of an attachment element for implant devices having the characteristics specified in the following claims.
This invention is element for anchoring an implant device in place, comprising shape memory material so that the element is capable of passing, on reaching a transition temperature, from a substantially retracted position with respect to the associated implant device to an expanded position in which the element itself is capable of anchoring the device to an implant site. Preferably, the shape memory material reaches the transition temperature on being heated to the transition temperature. The transition temperature corresponds substantially to the temperature of the human body.
In a preferred embodiment, the element further comprises associated containment means for preventing the element itself from passing from the substantially retracted position to the expanded position on exposure of the shape memory material to the temperature of the human body during the insertion of the device towards the implant site. The element may comprise associated thermal insulation means for insulating the shape memory material from the temperature of the human body during the insertion of the device towards the implant site.
The implant device may also have an associated introduction catheter. In another preferred embodiment, associated with the element is a sheath or covering over the catheter and movable between a containment position in which the sheath or covering itself engages the element and a retracted position in which the sheath or covering disengages the element, thereby releasing it. Part of the sheath or covering capable of engaging the element preferably comprises thermal insulation material. The element may also carry an associated temperature control means. The temperature control means may be an electric resistor. The temperature control means also may extend at least partly into the element or may be generally outside the element.
Preferably, in the expanded position, the element has a general hook-like configuration and is more preferably in a general corkscrew or pig-tail-like conformation. Alternatively, the element may be in the form of a pair of corresponding anchorage elements which, in the extended position, extend from the associated implant device in a general arrow head-like configuration.
REFERENCES:
patent: 4913147 (1990-04-01), Fahlstrom et al.
patent: 5037427 (1991-08-01), Harada
patent: 5523092 (1996-06-01), Hanson et al.
patent: 5662675 (1997-09-01), Polanskyj-Stockert
patent: 5681346 (1997-10-01), Orth
patent: 657147 (1995-06-01), None
patent: 2 731 610 A1 (1996-09-01), None
patent: 2 736 257 A1 (1997-01-01), None
Milano Michael J.
Popovich & Wiles, P.A.
Sorin Biomedica Cardio S.p.A.
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