DE19857887B4 - Anchoring support for a heart valve prosthesis - Google Patents

Anchoring support for a heart valve prosthesis

Info

Publication number
DE19857887B4
DE19857887B4 DE1998157887 DE19857887A DE19857887B4 DE 19857887 B4 DE19857887 B4 DE 19857887B4 DE 1998157887 DE1998157887 DE 1998157887 DE 19857887 A DE19857887 A DE 19857887A DE 19857887 B4 DE19857887 B4 DE 19857887B4
Authority
DE
Germany
Prior art keywords
anchoring
characterized
heart valve
valve prosthesis
anchoring support
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
DE1998157887
Other languages
German (de)
Other versions
DE19857887A1 (en
Inventor
Christoph Dipl.-Ing. Damm
Markus Dr.med. Dr.disc.pol. Ferrari
Hans-Reiner Prof. Dr.med. Figulla
Klaus Dr.med. Lang
Carsten Dipl.-Ing. Weber
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Jenavalve Technology Inc
Original Assignee
Fraunhofer Gesellschaft zur Forderung der Angewandten Forschung eV
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fraunhofer Gesellschaft zur Forderung der Angewandten Forschung eV filed Critical Fraunhofer Gesellschaft zur Forderung der Angewandten Forschung eV
Priority to DE1998157887 priority Critical patent/DE19857887B4/en
Publication of DE19857887A1 publication Critical patent/DE19857887A1/en
Application granted granted Critical
Publication of DE19857887B4 publication Critical patent/DE19857887B4/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418Scaffolds therefor, e.g. support stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028Shapes in the form of latin or greek characters
    • A61F2230/0054V-shaped

Abstract

Anchoring support for a heart valve prosthesis, from a, at a predetermined temperature a predetermined Shape engaging shape memory metal exists and as a one-piece body consisting of rod-shaped elements (1, 2, 3, 4, 5) which at least partially represent a lattice structure, is formed, characterized in that the rod-shaped elements (4) lined up like a sawtooth are and at least one support ring (6) formed as a polygon with at least eight corners is.

Description

  • The The invention relates to an anchoring support (stent) for a heart valve prosthesis, in which a shape memory metal, also called memory metal, is used to make a heart valve prosthesis to implant without major surgery, with complete opening of the Perform thorax to have to.
  • So it is, among other things, for example, from the DE 195 46 692 A1 It is known to introduce a self-expanding prosthetic heart valve with an anchorage support via a cardiac catheterization system without opening the thorax on the opened in the groin of a human aorta and position on reaching the desired location, near the heart, preferably in the region of the original heart valve and this through there to permanently install a self-expansion.
  • It However, it has been shown that the there indicated solution principle previously not practicable implemented. It has been so far no way can be demonstrated with which an anchoring support for a heart valve prosthesis once in a state so small could be folded together that they are common with a catheter through the aorta and especially through the Aortic arch led to the heart could be. However, such an anchoring support must also be able to a size and shape to a second state with which it is ensured that the heart valve function over a sufficiently long period can be secured again.
  • As also not practicable has the DE 43 16 971 A1 removable proposal proved. There, a memory material is to be used, which should be rollable or expandable at the site. The designated there as a heart valve anchor ring support for an artificial heart valve in the rolled state, as already mentioned, guided by means of a catheter to the heart and there invest in warming due to the winding of the anchoring ring to the aortic inner wall, with additional anchorage to the anchoring ring for anchoring outwardly, are present.
  • Also this solution could not be implemented so far practicable, since the spirally wound up body in its diameter is still too large to pass through an aorta easily led to the heart to be able to. Furthermore must have a corresponding Furnishings if you are near the Heart should be leveled, extremely accurate be positioned because the openings the coronary vessels in none May be closed manner.
  • Problematic might in addition also the solution proposed there in terms of the increase of one Danger of thrombosis.
  • Also the use of balloon catheters, for the intended application, so far has not shown satisfactory results and so could the system described in WO 91/17720 A1 not yet in practice be used. It is a composed of several metal wires and uses curved element on which a heart valve prosthesis can be attached and that with the present on the catheter Balloon is mechanically clamped. However, the size required for this is sufficient actually to disposal standing spatial conditions in the aorta not, and so it has not been successful, one perform appropriate surgical intervention with success can.
  • Next to it is in DE 195 32 846 A1 a so-called valve device described there, which can be used in particular as a replacement for a heart valve. In this solution, tensioning and expanding brackets are used, on which a sail, which is to take over the function of a heart valve prosthesis, is sewn like a bag.
  • A so-called "stent", which can be used for the dilation of simple blood vessels, is in US 5,540,712 described. This "stent" is formed by a wire-shaped lattice structure, which consists of a shape memory metal, wherein after introduction of this "stent" and appropriate temperature, the shape memory metal causes a widening of this "stent", so that it rests against the vessel inner wall. For an improved fixation in the blood vessel, it is proposed to form barbs which become entangled in the vessel wall or which are intended to improve the fit by correspondingly impressing different diameters on different blood vessel inner diameters.
  • It is therefore an object of the invention, an anchoring support for a heart valve prosthesis to disposal To put, which is easy to produce and with which you in the location is offset, this together with a heart valve prosthesis through to guide the aorta to the immediate vicinity of the heart and implant there with success.
  • According to the invention this object is achieved with the features of claim 1 for the anchoring support. Advantageous embodiments and developments of the invention will become apparent by the features mentioned in the subordinate claims.
  • there goes the solution of the invention of the well-known idea of using a memory material and it is therefore proposed, an anchoring support a shape memory metal to use that is capable of achieving a certain predeterminable critical temperature take an impressed shape and size, a secure fit, tightness of the heart valve prosthesis, low Risk of thrombosis and observance of the freedom of the coronary vessel openings allows. The anchoring support according to the invention for a heart valve prosthesis is therefore as a one-piece body formed, which is formed of individual rod-shaped elements, the at least partially represent a lattice structure.
  • there becomes the thickness of the rod-shaped Elements as small as possible selected once to ensure sufficient strength and stability and on the other hand, the risk of thrombosis correspondingly small too hold. Consequently, the strength of the rod-shaped Elements in the range between 0.3 to a maximum of 1 mm.
  • Thereby can be assured that the from a semifinished product consisting of a shape memory metal body on the other hand can be very small compressed or folded and in the positioning of the compressed or folded body not to be crossed by the aorta free cross-section of about 7 mm can be safely met.
  • According to the invention anchor post from a shape memory metal Semi-finished manufactured in which the actual structure with the rod-shaped elements cut out or punched out. When cutting has become particularly advantageous a laser cutting process that puts you in the position is offset, very accurately and exactly the desired structures in the relative small wall thicknesses train.
  • After this the desired Structure is formed, the anchorage post is in the desired Shape and size for the implanted Condition brought and at the same time during a heat treatment, taking into account the temperature to be set, which is advantageous in the area of about 37 ° C lie should, imprinted.
  • When Semifinished may be a correspondingly formed plate-shaped element, but preferably a tubular Semi-finished products are used. For the case that one disc-shaped Element is used, this must for the inculcate the desired shape and size not only expanded, but also accordingly, at least approximately in to be bent into a circular shape.
  • To the impressing the shape and size of the anchoring support according to the invention can her heart valve prosthesis attached. The heart valve prosthesis can from the outside slipped over from one side onto the anchoring support and optionally additionally sewn on, this part of the anchoring support being shaped and dimensioned is that the Commissures of a biological heart valve prosthesis, e.g. from can be taken from a pig heart and provided in a prepared form is taken into account becomes. But such a prosthetic heart valve can also be guided by the anchoring support and from the inside of the appropriately formed grid structure or arcuate Elementes are attached. In similar But it can also be an artificial one Heart valve prosthesis from this suitable materials are used.
  • When Shape memory metal For example, a nickel-titanium alloy, e.g. commercially available under the name "Nitinol", be used. After the formation of the structure and memorizing the desired Shape and size in the implanted Condition, can be the anchorage post by means of known surface treatment methods, such as. be polished and smoothed on the surface of the electropolishing, so that too As a result, the risk of thrombosis can be counteracted.
  • at the anchoring support according to the invention is formed a grid structure formed in the rod-shaped elements partly meandering are and form in their orientation at least one support ring, as such in the implanted state on the aortic inner wall can create. On the one but also on several such with the rod-shaped Elements formed supporting rings can Anchoring hook be formed, which also from the used Shape memory metal consist. However, this anchoring hook is when impressing a radially outward set upright position so that they are implanted in the Hook the condition in the inner wall of the aorta and adjust the anchoring support accordingly can be safely held and the entanglement in addition to Clamping force of the expanded anchorage support can act.
  • It is advantageous if the anchoring hooks are stamped with different erection directions, which are each in opposite directions with respect to the longitudinal axis of the anchoring support at an angle not equal to 90 °, so that a secure anchoring in both possible movement Rich tions an anchor support can be achieved. The anchoring hooks should have a length of at least 1 and a maximum of 5 mm, so that a complete transection of the Aortenwandung can be avoided.
  • Becomes an anchorage post with more than one support ring used, can These support rings by means Connecting webs between adjacent meanders, through the rod-shaped elements the support rings are formed can be achieved.
  • The Heart valve prosthesis can be located on a frontally arranged closed Ring or a ring formed from a polygon abut.
  • It but it is also possible on this end face of the anchoring support three arcuate elements for the Forming fixation of the heart valve prosthesis. These are arcuate Elements in the implanted state on the aortic inner wall. With the arcuate Elements can, in contrast to a closed ring, have a higher elasticity in the Self - expansion and at the same time an adaptation to the shape of the Commissures of a prosthetic heart valve can be achieved.
  • Next a tubular shape Can the United anchoring support according to the invention also be formed in the form of a polygon, but this at least over eight Corners have should. The latter form has an increased Selbstarretiereffekt, because the corner edges and the for the connection of several support rings used rod-shaped Elements not parallel to the longitudinal axis the anchorage post can be aligned. Therefore, a heightened Positive locking for the safe Hold the anchorage post be reached in the aorta.
  • To the attachment of the heart valve prosthesis to the anchoring support according to the invention both compressed together or folded and in a bag attached to a catheter is to be accommodated. Here is the bag with a cooling system connected, is passed through the appropriately cooled saline, so that the anchor post is kept below the transition temperature.
  • The Catheter can then be placed in a known manner, on a wire through the aorta to the immediate vicinity of the heart become. After reaching the desired position and checking the Situation regarding the coronary vessel openings can the protective one Cap removed or destroyed and upon reaching the transition temperature arises as a result of self-expansion the for the implantation desired Shape and size of the anchor support, at the same time raise the anchoring hooks and in clamp the aortic inner wall.
  • in the Connection to this can Guidewire and Catheters are removed again and the prosthetic heart valve, the Function of the natural Take the heart valve.
  • following If the invention is to be explained in more detail by way of example with reference to exemplary embodiments.
  • there demonstrate:
  • 1 an example of an anchoring support according to the invention with a heart valve prosthesis in implanted form and size and
  • 2 a lattice structure of an example of an anchoring support in a settlement.
  • At the in 1 As shown in the example, the anchoring support has two saw-tooth-shaped row-shaped elements 4 formed support rings 6 , with connecting bridges 3 connected to each other. There is also a sealing and fastening ring 1 for the heart valve prosthesis 2 , which has a circular ring shape here and other rod-shaped elements are present, the connection to the support rings 6 and take into account the shape and size of the commissures of prosthetic heart valves.
  • In addition, on the support rings 6 additional anchoring hook 5 present, which, as already mentioned in the general part of the description, rise radially outwards when the critical temperature given by embossing is exceeded.
  • At the in 2 shown example of an anchoring support according to the invention, the form of presentation of a settlement was chosen in order to recognize the formed in the shape memory metal structure more clearly. In this example again two support rings 6 , by sawtooth formation of rod-shaped elements 4 , which in turn anchor hooks 5 are present, selected. The two support rings 6 are also again with connecting bridges 3 connected, which are partially looped for an optionally required length compensation.
  • In the area of the anchor support to which the heart valve prosthesis is to be positioned and fixed, in this example three arcuate elements 7 trained, where the heart valve prosthesis can rest and is attached. The shape of the arched elements 7 takes into account the shape and size of the commissures of a biological heart valve prosthesis.

Claims (8)

  1. An anchoring support for a heart valve prosthesis, which consists of a shape-memory metal occupying a predetermined shape at a predeterminable temperature and which as a one-piece body consists of rod-shaped elements ( 1 . 2 . 3 . 4 . 5 ), which at least partially constitute a lattice structure, is formed, characterized in that the rod-shaped elements ( 4 ) are lined up in a sawtooth manner and at least one support ring ( 6 ) formed as a polygon with at least eight corners.
  2. Anchoring support according to claim 1, characterized in that anchoring hooks ( 5 ), which rise radially outward upon reaching the transition temperature of the shape memory metal, on / on the support ring (s) ( 6 ) available.
  3. Anchoring support according to claim 2, characterized in that the anchoring hooks ( 5 ) have a length of at least 1 mm.
  4. Anchoring support according to one of claims 2 or 3, characterized in that anchoring hooks ( 5 ), which are erected in opposite directions at an angle other than 90 ° radially outward with respect to the longitudinal axis of the anchorage post.
  5. Anchoring support according to one of claims 1 to 4, characterized in that the support rings ( 6 ) by means of connecting webs ( 3 ) are connected.
  6. Anchoring support according to one of claims 1 to 5, characterized in that on the side on which the heart valve prosthesis is fixed, three arcuate elements ( 7 ) for fixing the heart valve prosthesis ( 2 ) are formed, which bear against the aortic inner wall.
  7. Anchoring support according to one of claims 1 to 6, characterized in that all rod-shaped elements ( 1 . 3 . 4 . 5 ) have a width / diameter of a maximum of 1 mm.
  8. anchor post according to one of the claims 1 to 7, characterized in that the grid structure, the size and location the coronary vessel openings Taking into account, are formed.
DE1998157887 1998-12-15 1998-12-15 Anchoring support for a heart valve prosthesis Expired - Lifetime DE19857887B4 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
DE1998157887 DE19857887B4 (en) 1998-12-15 1998-12-15 Anchoring support for a heart valve prosthesis

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE1998157887 DE19857887B4 (en) 1998-12-15 1998-12-15 Anchoring support for a heart valve prosthesis

Publications (2)

Publication Number Publication Date
DE19857887A1 DE19857887A1 (en) 2000-07-06
DE19857887B4 true DE19857887B4 (en) 2005-05-04

Family

ID=7891182

Family Applications (1)

Application Number Title Priority Date Filing Date
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Country Status (1)

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Cited By (113)

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US7846203B2 (en) 1996-12-31 2010-12-07 Edwards Lifesciences Pvt, Inc. Implanting a stent valve prosthesis at the native aortic valve
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