DE102012108025A1 - Surgical implant has deformable support element with support surface for surface of implant to create tissue structure of patient, where support element is connected with dimensionally stable holding unit - Google Patents

Abstract

The surgical implant (10) has a deformable support element (12) with a support surface (16) for the surface of the implant to create a tissue structure of a patient. The support element is connected with a dimensionally stable holding unit (14). The holding unit is provided for holding the drag and compressive forces. The holding unit is connected to the planar of the support element. The support element is made from physiologically acceptable plastic material, which is based on a tetrafluoroethylene polymer or copolymer, or polyurethane.

Description

The invention relates to a surgical implant with a deformable support element with a support surface for the planar application of the implant to a tissue structure of a patient for receiving tensile and / or compressive forces.

Such surgical implants are widely used as sutures for surgical sutures. When sewing fabric together, there is sometimes a risk that pressure peaks or stress peaks in the area of a seam may occur when external or internal force is applied, which can cause the fabric to tear. This can be done, for example, within a hollow body (for example an organ) by a movement of the patient or also by an external influence or also by a high natural load on the tissue.

With a closer seam or multiple seams it may be possible to partially mitigate this problem. Often, however, a greater number of sutures or the use of a more dense suture is not possible or undesirable or associated with too much time.

This problem arises in the most diverse areas of surgery, such as surgery. Orthopedics, Dentistry, Urology, Vascular Surgery, Cardiac Surgery, General Surgery etc.

Conventionally, therefore, already in the surgery soft Nahtwiderlager, for example in the form of so-called pledgets used. A typical application of the pledgets made of PTFE felt material are heart valve sutures. The PTFE felting materials are typically wicker or sprayed, for example, in the form of oriented fibers of so-called ePTFE.

The use of the felt materials prevents the thread from tearing out of the fabric when tensile forces occur.

Alternatively, sutures have been proposed for heart valve sutures of resorbable materials (eg DE 199 47 718 A1 ). Several seam abutments for the flap seam can already be factory-mounted on a surgical thread for easier handling.

The pledgets tend to be soft and conform easily to the surface of the fabric structure. For different applications, different degrees of hardness and a variety of sizes and contours are provided, even in different thicknesses. However, a pledget typically has a constant thickness.

Traditionally available pledgets have the disadvantage that, due to their high adaptability to the surface of the tissue structure on which they are applied, they can not transfer the forces exerted by the sutures held by them in a planar manner. As a result, stress peaks occur in the area of the stitches of the seam. In extreme cases, no force is transmitted to the tissue in the edge region of the pledgets.

Also, the tear strength of the pledgets is too low in some applications, so that the material of the pledgets is severed by the surgical thread with corresponding forces occurring.

The object of the invention is to propose an improved implant of the type described above.

This object is achieved by a surgical implant according to claim 1.

In the surgical implant according to the invention it is provided that, on the one hand, a sufficiently large-area contact between implant and tissue structure can be produced by the deformable support element with a contact surface for the planar application of the implant to a tissue structure of a patient, while, on the other hand, due to the dimensionally stable holding part connected to the support element, absorbs the tensile and / or compressive forces, punctual pressure or voltage peaks are avoided on the implant and thus also on the adjacent tissue structure of the patient. The forces occurring due to the seam can be transmitted uniformly to the tissue of the patient which bears against the support surface.

The dimensional stability of the holding part is already sufficient if the forces occurring selectively in the region of the suture material can be transmitted essentially uniformly to the support surface of the support element. This does not exclude that the holding part itself has a certain elasticity. Holding parts, which are substantially rigid in the forces occurring, are also preferred.

The implant according to the invention also avoids that in addition occurring tensile and / or compressive loads, the support element can tear and thus loses its effect as a suture remover.

It is advantageous if the holding part is connected flat with the support element, wherein Preferably, the holding part has a surface area that corresponds substantially to the surface area of the support element. This can ensure that the tensile and / or pressure forces exerted by the seam are always transmitted essentially to the entire support surface of the implant on the adjacent tissue structure of the patient, so that the lowest possible surface tensile and / or compressive force on the tissue of the Patient occurs.

In the case of the surgical implant according to the invention, the holding part can be connected with the support element in a force, shape and / or material fit. Particularly preferred is a non-positive or cohesive connection, since here the formation of the support element, in particular with regard to the desired deformation thereof, can take place substantially independently of other aspects.

According to a further alternative, the support element and the holding part may also be integrally formed.

Preferably, the support element of the implant according to the invention is formed from a porous material, so that in the applied state, ingrowth of the surrounding tissue is possible and thus the surgical implant is additionally and in particular permanently secured at the site selected by the surgeon.

The porous material is preferably open-pored and may be selected, for example, from non-woven materials, felt materials, foamed or sintered materials.

The support element is preferably made of a physiologically compatible plastic material, which is preferably based on a TFE polymer or copolymer or polyurethane.

For special applications, it can also be provided that the support element is made of a resorbable material, for example of lactic acid polymers and copolymers.

For the holding part of an implant according to the invention, materials such as metals or ceramics are available in addition to the physiologically compatible, optionally also resorbable plastic materials. Examples of suitable thermoplastic materials are polyamide, polyolefins, in particular polyethylenes, polycarbonates, polyaryletherketones, polyurethanes, polyesters, in particular polyolefin terephthalates, polysulfone, and also copolymers thereof and their blends. Particularly preferred are polyolefins and polyaryletherketones, for example, polyethylenes and polyetheretherketones.

Furthermore, thermosets are also suitable as plastic material for the holding parts, in particular based on polyester and polyurethane.

In addition, ceramic materials or metal, in particular steel, titanium or titanium alloys are suitable for the manufacture of the holding parts.

If resorbable support elements are used, preferably a resorbable plastic material is also used for the holding parts, for example lactic acid polymers and copolymers.

Preferably, the holding part of an implant according to the invention has two or more spaced through openings through which the surgeon can pass a needle with the surgical thread in the formation of a seam.

In a preferred embodiment, the implant according to the invention has a holding part which is equipped with a holder, by means of which the implant can be positioned by means of an application device.

The connection between the implant and the application device is preferably made detachable, so that after a positioning of the implants and their fixation on the tissue structure, for example via a seam, the application device can be detached from the implants and separated.

The above-mentioned possibility to keep the implants according to the invention on the application device solvable will be explained in more detail below with reference to some examples.

A positive connection between the implant according to the invention and the application device by means of positive locking, for example an undercut, can be carried out so that either a radial removal of the implants is possible or an axial distance, wherein the terms "radially" and "axially" on the Arrangement of the multiple implants relative to each other in their orientation on the application device.

The elasticity necessary for releasing the positive connection between implant and holding part can be realized on the one hand by the holding element and / or also by the side of the application device.

A positive connection can be realized not only at the edges of the implant, but also in principle via a positive engagement within the implant.

For producing or canceling a form fit, a switching movement can also be provided, so that a mechanical switching operation is carried out for fixing or releasing or canceling the positive connection.

Also, a form fit according to the principle of operation of the bayonet, which in turn can be solved by a double movement, is possible in the context of the positive connection of the implants according to the invention with at the application device.

A special form of positive connection is a Velcro connection, which is also suitable for holding the implants of the present invention on the application device. In this case, it can be provided that the support element, which preferably has a porous structure, in particular a non-woven structure, covers the holding element of the implant over a large area, if not substantially, so that the counterpart of a hook and loop fastener then fits into the porous structure of the support element can intervene.

Of course, adhesive compounds which can also be designed to be detachable belong to the possible cohesive connections of the implants according to the invention to the application device. A backup of the implants via an adhesive connection can be made in the axial and tangential direction, depending on the particular shape of the implant or the associated holding part. The combination with a bayonet-type connection can prevent the adhesive bond from being subjected to shear.

Finally, a cohesive connection can also be realized as a one-piece design of holding parts of the application device on the one hand and of the holding element of the implant on the other hand, in which case a separation between the implant and the application device can be achieved, for example via a predetermined breaking point.

For non-positive connections in addition to clamp connections and threaded connections can be mentioned. In addition, the implants according to the invention can be held by magnetic forces.

Another alternative of a positive connection can be achieved via a vacuum, wherein suction cups can be used for the passive or active generation of a vacuum. When the vacuum is actively generated, the fluid line required in this case can also support the dissolution by generating an overpressure.

In addition, of course, combinations of positive, positive and cohesive connection are conceivable.

Furthermore, a connection between an implant according to the invention and the holding element can be imagined via a seam, which can then be separated to remove the application device.

In a preferred embodiment of the invention, the surgical implant has a holding part, which on its side facing away from the support element has a receptacle into which a flexible Applizierelement, in particular in the form of a rope, a wire, a thread or a belt, is engageable.

This receptacle can be provided in addition to or as an alternative to the above-described two through openings for creating a seam fixing the implant to the tissue structure, so that additionally or alternatively to a seam connection between implant and tissue structure, fixation of the implants by means of the flexible applicator element can be performed.

The receptacle on the holding part of the surgical implant according to the invention is preferably designed such that the flexible Applizierelement does not protrude beyond the surface of the holding part.

Also, the receptacle can be designed so that it can accommodate more than one flexible Applizierelement, for example, two or three of these Applizierelemente, in particular in a parallel arrangement to each other.

The receptacle is furthermore preferably designed as an abutment for the flexible applicator element, so that the tensile and / or compressive forces exerted on the flexible applicator element can have the largest possible effect on the support element and thus on the tissue of the patient abutting the implant.

Often the support element and possibly also the holding part is made of a sheet material. This can be done simply by punching, for example, from a continuous material, blanks for the support elements or holding parts. Alternatively, in particular, the holding part can also be produced as an injection-molded or sintered part.

Preferably, the support element has a polygonal, in particular a rectangular or a substantially round to elliptical shape.

Furthermore, the implant and / or support element can be formed flat or contoured on its support side. Depending on the application, the bearing surface may be formed arched in one or two orthogonal directions, so that from the outset a certain adjustment of the support surface is given to the contour of the tissue structure on which the implant is to be applied.

These and other advantageous embodiments of the invention are explained in more detail below with reference to the drawing. They show in detail:

1 Four implants according to the invention according to a first embodiment in a schematic application position;

2 : four implants according to the invention according to a second embodiment, secured with a flexible application element in a schematic application position;

3 : four implants according to the invention of a third embodiment, detachably held on an application device;

4 four implants according to the invention on an alternative application device; and

5 A further alternative application device with an implant according to the invention.

1 shows four with the reference numeral 10 provided implants according to the invention having a substantially rectangular basic structure, consisting of a support element 12 and a holding part 14 are formed. The implants 10 are shown in pairs arranged opposite one another, as would be the case, for example, during a reshaping or a remodeling of the myocardium following a myocardial infarction with the aid of the implants according to the invention. The implants 10 would be arranged around the heart muscle whose tip is approximately coaxial with the axis of symmetry of the arrangement of the four implants 10 would be lost.

In an alternative, likewise preferred embodiment, the implants have an elliptical basic structure.

The support elements 12 are made of a PTFE felt material having an open-pored, deformable structure (not shown in detail). The support elements 12 have a bearing surface 16 on which in the longitudinal direction of the implant 10 slightly concave arched is designed. In the transverse direction, the support surfaces have slightly inclined recessed edges 18 . 19 on, between which a middle strip 20 is formed concave.

In the end areas of the middle strip 20 are two through holes 22 . 23 designed for the simplified performing a surgical suture (not shown).

The holding parts 14 embrace the support elements 12 and are connected to them cohesively, in particular glued or welded. The holding parts 14 are made of a dimensionally stable plastic material, such as PEEK.

On its side facing away from the support elements have the holding parts 14 one parallel to the longitudinal direction of the implants 10 running groove 24 on, which in each case in the region of the passage openings arranged below 22 respectively. 23 the support elements ends.

2 shows four implants 40 in an alternative embodiment, but in a similar arrangement as in 1 ,

The implants 40 in turn are made of a deformable support element 42 and a dimensionally stable holding part 44 formed and have a similar basic shape.

The support elements 42 of the implants 40 have a design like the support elements 12 of the implants 10 of the 1 so that reference can be made to the details of their description.

The support elements 42 have a bearing surface 46 on which in the longitudinal direction of the implant 40 slightly concave arched is designed. In the transverse direction to have the bearing surfaces 46 slightly inclined recessed edges 48 . 49 on, between which a middle strip 50 is formed concave.

In the end areas of the middle strip 50 are two through holes 52 . 53 designed for the simplified performing a surgical suture (not shown).

The holding parts 44 embrace the support elements 42 and are connected to them cohesively.

On her of the support elements 42 facing away from the holding parts 44 one parallel to the longitudinal direction of the implants 40 running groove 54 on, which in each case in the region of the passage openings arranged below 52 respectively. 53 the support elements 42 ends.

Unlike the implants 10 have the implants 40 on the holding parts on the support elements 42 remote surface extending over the entire longitudinal direction of the implants recesses 56 on, which as a receptacle for a flexible Applizierelement, such as a plastic tape 55 (dash-dotted representation), can serve, so that the surgeon can optionally or additionally make a fixation of the implants in their final position on the tissue structure with the plastic band. The return 56 preferably takes the Applizierelement completely so that it does not over the surface of the holding part 44 also available.

In some applications, the fixation of the implants 40 sufficient on the fabric structure by means of the flexible Applizierelements, so that can be dispensed with the additional fixing by means of a seam.

3 finally shows an example of a device 68 for applying four implants according to the invention 70 ,

The device 68 has a holding device 72 with four retaining elements 74 on which the implants 70 are kept detachable. The holding device 72 is on an annular positioning device 76 arranged.

With the positioning device 76 let the retaining elements 74 the holding device 72 from a first position, in which the pairs of opposing held implants 70 have a large distance from each other, in the in 3 in a substantially synchronous manner, in which the implants lie against the tissue structure and, if desired, bring it into a predetermined new shape, as would be the case, for example, in the remodeling of the myocardium.

The positioning device 76 has a lever mechanism for this purpose 78 preferably detachable on the positioning device 76 is held. The lever mechanism is preferably configured such that when a force is applied to the positioning device 76 for positioning the implants 70 no torsional forces on those of the implants 70 enclosed heart muscle.

Are the implants 70 positioned, the lever mechanism 78 the heart is returned to its normal position and cardiac function, for example, checked echocardiographically. If necessary, the lever mechanism 78 again at the positioning device 76 docked and the position of the implants 70 be changed again.

Is the optimal position of the implants 70 This can either be secured by piercing the myocardium by means of surgical sutures or, alternatively or additionally, secured by means of a flexible applicator element, as described in connection with the description of FIG 1 and 2 has already been carried out in detail.

After that, next to the lever mechanism 78 also the positioning device 68 as a whole of the implants 70 separated and removed, leaving the implants 70 in a situation like in the 1 and 2 for the implants 10 respectively. 40 shown schematically, remain on the fabric structure.

In the 4 is another application device 150 shown, in contrast to the previously discussed inventive application device a flexible instead of a dimensionally stable holding device 152 having. Also in this device are implants according to the invention 154 . 155 . 156 . 157 aligned in pairs on one of several bands 164 . 166 . 168 existing bracket 152 arranged.

This remains in a transfer of the implants of the invention 154 . 155 . 156 . 157 the implant 154 stationary while the two implants 155 . 157 both are moved synchronously against each other.

The implant 156 is compared with twice the path increment per unit of time compared to the implants 155 . 157 moves, so that again a synchronous, even approach of the implants 154 . 156 results.

On the holding device 152 is a roll-up mechanism for this purpose 160 with a knob 162 provided in which the bands via corresponding hubs 170 be wound up with the required different lengths per time increment.

On their back side, the implants of the invention 154 . 155 . 156 . 157 Means for holding for the bands 164 . 166 . 168 and 168 ' the application device 150 on.

The means for holding and guiding the bands can, for example, as webs 170 . 172 at the ends of the implant 154 be formed, which has a through hole 174 . 176 limit, through which a band can be led. The bridges 170 . 172 themselves can serve to hold band ends.

On the implant 156 is an end to the band 168 at the footbridge 172 fixed. The ribbon 168 is through openings 174 . 176 of the implant 155 sliding guided and runs through the opening 174 of the implant 154 to the reeling mechanism 160 ,

At the jetty 172 of the implant 155 Furthermore, a band 166 is fixed with one of its ends, which also to the retractor mechanism 160 runs.

In a mirror-image arrangement is at the jetty 170 of the implant 156 a band 168 ' fixed, which slidingly guided through openings 174 . 176 of the implant 157 towards the reeling mechanism 160 runs. The ribbon 168 ' is before entering the reeling mechanism 160 still around the jetty 172 of the implant 154 diverted.

Another band 164 is with one end on the dock 170 of the implant 157 fixed and runs parallel spaced from the tape 168 ' to the reeling mechanism 160 ,

About a corresponding embodiment of the reeling mechanism 160 will be the winding up of the tapes 164 . 166 on the one hand and the bands 168 . 168 ' on the other hand controlled so that the kinetics of the implants described above 154 . 155 . 156 and 157 with the different Weginkrementen per unit time results.

For better handling of the application device 150 This can be initially provided in the original state with a silicone ring or silicone segments (not shown), the or the individual implants 154 . 155 . 156 . 157 stabilized in a correct Applizieranordnung or stabilize. In particular, this helps to prevent the ligament from twisting while it is being applied to the heart muscle.

In this embodiment of the application device as well, it is possible to check the achieved shaping of the heart echocardiographically before the implants are definitively fixed-whether via suture material with corresponding ventricular stings or via a fixation of the ligaments in their final form.

Instead of the bands, other flexible transport media may also be used in the previously described application device, such as e.g. Chains, wires, ropes, threads etc.

If wires, ropes or threads are used, preferably two juxtaposed parallel threads, wires or ropes are used as Torsionssicherung.

In addition, in this device it is conceivable that the application device as a whole is spent with the implants according to the invention via a minimally invasive procedure in the interior of the body of a patient and then applied there.

In the case that the introduction of the application device 150 A further lateral access or a further access can take place via a higher-lying intercostal space, with which then the application device according to the invention 150 prepositioned on the epicard. If necessary, also tubular shaft instruments can be used to help.

An additional advantage of the flexible holding devices 152 the application device described above 150 is that the coronary arteries or the epicardium are spared because direct contact with the epicardium can be largely or completely avoided by the support points of the bands. This has the particular advantage that during the rolling of the bands, ie when transferring the implants from a first arrangement into the second arrangement, in which the implants occupy a smaller distance from each other, no friction between the bands and the epicardium occurs. A possible risk of injury is thereby minimized or eliminated.

Another application device for the implants according to the invention is in 5 in the form of an application device 250 shown with a holding device 252 which essentially consists of four web-like holding elements 254 . 255 . 256 . 257 is formed, which are connected together at one of its ends and at its other, each free end a holding part 260 . 261 . 262 . 263 for an implant according to the invention 266 wear (in 5 is just one of the implants 266 shown).

The implants 266 are again aligned in pairs and lying opposite each other on the fixture 252 prepositioned and can by means of a flexible support medium (not shown), in particular a band or the like., Via a Aufrollmechanik (not shown), which at one of the webs (here web 256 ), wound up, approximated to each other.

The roll-up mechanism together with the flexible support medium in this embodiment forms the positioning device.

To the implants of the invention 266 at the application device 250 or their holding parts 260 . 261 . 262 and 263 To be able to determine releasably, have them on opposite side surfaces 270 groove 272 on, in the forked prongs 274 . 276 the holding parts can be slidably inserted. For fixing the implants according to the invention 266 Show the holding parts 260 . 261 . 262 . 263 a resilient locking element 278 on, which with an implant-side locking projection 280 in a corresponding recess on the implant surface opposite the bearing surface 282 intervenes.

The operating principle of the application device 250 differs from the functional principle of the previously discussed application devices in that here - depending on the resistance of the heart wall and the restoring force of the typically designed as a spring element webs 254 . 255 . 256 . 257 - Different path increments of the implants 260 per unit time.

The bridges 254 . 255 . 256 . 257 can be made of metal or a plastic. For different heart sizes are different lengths of the bars 254 . 255 . 256 . 257 needed.

After fixation of the implants 266 on the myocardium can the holding device 252 be removed, as well as the Aufrollmechanik with the tape (not shown).

In the occurring forces, it may well happen that not only an elastic deformation of the webs 254 . 255 . 256 . 257 but also a partial plastic deformation, but with regard to the fixation of the implants 266 is unproblematic about a band.

Again, a fixation of the implants 266 via a ventricular puncture and an echocardiographic examination must be carried out beforehand.

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• DE 19947718 A1 [0007]

Claims (16)

Surgical implant comprising a deformable support element with a support surface for the planar application of the implant to a tissue structure of a patient and a support member connected to the dimensionally stable holding member for receiving tensile and / or compressive forces. Implant according to claim 1, characterized in that the holding part is connected flat with the support element. Implant according to claim 1 or 2, characterized in that the holding part with the support element is positively, positively and / or materially connected. Implant according to claim 1, characterized in that the support element and the holding part are integrally formed. Implant according to one of claims 1 to 4, characterized in that the support element is formed of a porous material. An implant according to claim 5, characterized in that the porous material is selected from non-woven materials, felt materials, open cell foamed or sintered materials. Implant according to one of claims 1 to 6, characterized in that the support element is made of a physiologically compatible plastic material, which is preferably based on a TFE polymer or copolymer or polyurethane. Implant according to one of claims 1 to 7, characterized in that the holding element is made of a physiologically compatible plastic material, metal or ceramic. Implant according to one of claims 1 to 8, characterized in that the holding part has two spaced passage openings. Implant according to one of claims 1 to 9, characterized in that the holding part has a holder, by means of which the implant can be connected to a positioning device. Implant according to claim 10, characterized in that the holder is designed so that the implant with the positioning device is detachably connectable. Implant according to one of claims 1 to 11, characterized in that the holding part on its side facing away from the support element has a receptacle into which one or more flexible Applizierelemente, in particular in the form of a band, a wire, a rope or a thread, are engageable , Implant according to claim 12, characterized in that the receptacle of the holding part is designed as an abutment for the flexible Applizierelement or the flexible Applizierelemente. Implant according to one of claims 1 to 13, characterized in that the support element and / or the holding part contains a pharmaceutical active substance, which is preferably dosed releasable in the implanted state. Implant according to one of claims 1 to 14, characterized in that the support element and optionally the holding part is made of a sheet material. Implant according to one of claims 1 to 15, characterized in that the support element has a polygonal, in particular rectangular, or a substantially round to elliptical shape.

Images