Fixing device, in particular for fixing to vascular wall tissue

Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Heart valve

Reexamination Certificate

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C623S001240, C623S002360, C623S002380, C606S153000

Reexamination Certificate

active

06790229

ABSTRACT:

The present application is subdivided into 16 sections, i.e.: Sections X.Y, where X=1,2,3 or 4 and Y=1,2,3 or 4.
The sections where X=1 are sections relating to the preamble to the description; the sections where X=2 are sections relating to listing of the figures; the sections where X=3 are sections relating to the description of the figures; and the sections where X=4 are sections relating to the claims.
The sections where Y=1, i.e. Sections 1.1, 2.1, 3.1 and 4.1 and associated
FIGS. 1-14
have been taken as a whole from NL-A 1 012 150 with date of filing May 25, 1999. Section 1.1 is the preamble to the description of NL-A 1 012 150, Section 2.1 is the list of figures in NL-A 1 012 150; Section 3.1 is the description of the figures in NL-A 1 012 150 and Section 1.4 contains the claims of NL-A 1 012 150. It should be clear that Sections 1.1, 2.1, 3.1, 4.1 and the associated
FIGS. 1-14
can in the future be split off in isolation from the present application as an individual application without any problem. It is not precluded that these sections will be supplemented from other sections when they are split off, as will be clear from the remainder of the application.
The sections where Y=2, i.e. Sections 1.2, 2.2, 3.2 and 4.2 and associated
FIGS. 15-25
have been taken as a whole from NL-A 1 013 933 with date of filing Dec. 23, 1999. However, the figure numbers and reference numerals have been adjusted to prevent duplication with
FIGS. 1-14
from NL-A 1 012 150. It should once again be clear that Sections 1.2, 2.2, 3.2, 4.2 and the associated
FIGS. 15-25
can in the future be split off from the present application as an individual, isolated application, without any problem. It should also be clear from the remainder of this application that material from other sections of this application could be added hereto.
Sections 1.3, 2.3, 3.3, 4.3 and the associated
FIGS. 25-32
relate to a particular embodiment disclosed in NL 1 012 150 (that as such is identical to the content of Sections 1.1, 2.1, 3.1, 4.1 and associated
FIGS. 1-14
) and further developments thereof. It should once again be clear that Sections 1.3, 2.3, 3.3 and 4.3 and the associated
FIGS. 26-32
can in the future be split off from the present application as an individual, isolated application without any problem and that this could also be done in combination with the material from Sections 1.1, 2.1, 3.1, 4.1 and associated
FIGS. 1-14
. It should also be clear from the remainder of this application that material from other sections of this application could be added hereto.
Sections 1.4, 2.4, 3.4 and 4.4 relate to a number of inventions, such as, inter alia, more detailed embodiments or particular embodiments of the subjects of Sections 1.1 , 2.1, 3.1, 4.1 and 1.2, 2.2, 3.2 and 4.2. Various aspects from Sections 1.4, 2.4, 3.4 and 4.4 and associated figures, on their own or in combination with material from other sections and figures, could also lead to split-off applications in the future.
Where reference is made below to Section X.1, this is intended to be a reference to Sections 1.1, 2.1, 3.1 and 4.1 and the associated figures. Where reference is made below to Section X.2, this is intended to be a reference to Sections 1.2, 2.2, 3.2, 4.2 and the associated figures. Where reference is made below to Section X.3, this is intended to be a reference to Sections 1.3, 2.3, 3.3, 4.3 and the associated figures. Where reference is made below to Section X.4, this is intended to be a reference to Sections 1.4, 2.4, 3.4, 4.4 and the associated figures.
Where the term “first, second, third embodiment and/or first, second, third, etc. aspect” or “invention” is used in a Section X.1, X.2, X.3 or X.4 in the present application, this must be read as relating to the relevant Section X.1, X.2, X.3 or X.4. It is thus possible, for example, for mention to be made of a first embodiment in Section 3.3 and for this to be a different embodiment from a first embodiment mentioned in Section 3.4.
BACKGROUND OF THE INVENTION
In all sections of this application a portal fixing device is understood to be a device which is fixed to a vascular wall provided with a passage and is positioned around said passage in order to feed through said passage, for example, a cannula or other surgical or medical instrument or vascular fixing device or implant, such as valve or ring fixing device, or the obturator prosthesis fixing device to be mentioned below. The opening delimited by the tubular element of such a portal fixing device can be (temporarily) fully open, but can also be occluded by a (temporary) membrane, sphincter or valve mechanism. Such a portal fixing device can also serve as a coupling piece for a cannula or a working conduit, which may or may not be provided with said membranes, sphincters or valves. In the case of the last-mentioned applications, the portal fixing device can first be joined to the vascular tissue or element, after which the portal fixing device is joined to the cannula or the working conduit. It is also possible for the portal fixing device already to be integrated with the cannula or working conduit, so that only the join to the tissue has to take place. After removal of the cannula, medical or surgical instrument, implant, working conduit, etc. via or from the portal fixing device, the portal can be closed off by means of a cap. Such a cap can be made of or covered by anticoagulant material, such as carbon, carbon coating, urethane, urethane coating, heparin, heparin-like materials, but also by vascular tissue or pericardium, which may or may not be from the patient him/herself, or vascular prosthesis materials such as, for example, Dacron or Teflon. That side of the cap which can come into contact with the blood can also consist of a network structure, which is optionally coated with absorbable material such as, for example, PDS, to promote the growth of endothelial cells.
In all sections of this application an obturator prosthesis fixing device is understood to be a device for fixing an obturator prosthesis, optionally the entire obturator prosthesis itself, which can be used to close one or more holes or cavities in blood vessels or organs, such as, for example, in the case of an atrium or ventricle septum defect, rupture of the ventricle septum or aorta, true or false aneurysms, fistulas, etc. It is optionally conceivable with this arrangement for the tubular element already to be closed on the inside from the start and, for example, to assume the form of a closed disc. The materials which can be used for this will consist of the same materials or coatings as mentioned above for the cap for closing off the portal fixing device, in any event on the side or sides which can come into contact with blood.
Where STS anastomosis is mentioned in any section of this application, this refers to a so-called side-to-side anastomosis.
Where ETS anastomosis is mentioned in any section of this application, this refers to a so-called end-to-side anastomosis.
Where ETE anastomosis is mentioned in any section of this application, this refers to a so-called end-to-end anastomosis.
Wherever tube-like or tubular is mentioned in any section of this application it will be clear that this can also be understood to mean tube-like or tubular elements which are short in the axial direction, or ring-like or annular elements.
It is pointed out that where reference is made in any section to inner flange, outer flange, bottom flange, top flange, flange segments, etc. said flanges can always be either flanges which extend uninterrupted or flanges which extend with interruptions (which then are thus made up of flange sections with gaps between them).
SECTION 1.1
The present invention relates to a cardiac prosthesis fixing device comprising a tubular element which can be accommodated within a valve annulus of a heart and is provided with a bottom flange and a top flange, the bottom and top flanges extending in the peripheral direction of the tubular element, and the bottom and top flange

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