DE102006001952A1 - Closure element for an operation opening and gripping device and application device thereto - Google Patents

Abstract

A closure element for an opening in the human body, in particular in a skull, caused by an operation is made of a synthetic polymer. The polymer is an elastomer and the closure element (1) is dimensioned and geometrically designed in such a way that it pre-tensions the opening against the penetration of liquids and / or bacteria.

Description

The The invention relates to a closure element made of a synthetic Polymer for an operation-related opening in the human body, in particular in a skull, and a gripping device and an application device thereto.

The Skull base surgery over one transnasal transsphenoidal access path is one of the minimally invasive Types of surgery in neurosurgery for the treatment of intracranial Processes in the treatment of ear, nose and throat surgery extracranial processes in the facial cavities and in the oral and maxillofacial surgery for the reconstruction of the Skull base after Fractures. The opening the bony Structures of the skull base due to lack of space in this region always goes with the loss of bones in the open one Area associated. After the end of the surgical removal of the intracranial or extracranial process is the reconstruction of the bony Structures of the skull to ensure. In this case, it is particularly problematic the open area, especially skull base, relatively long term close tightly, to both a cerebral water flow from the intracranial space to the outside than also penetration of air and germs from the nasopharynx in the inside of the skull to prevent and thus massive neurological seizures or To avoid infections. The material for sealing the skull base should be possible be atraumatic, i. its production or production should not associated with a reoperation of the patient. in the Furthermore, the material should be easy to apply and grow together promote the surrounding tissue structures, thus a long-lasting Sealing done. Of course must the material for be so compatible with the human organism that inflammation and rejection reactions do not occur.

In The practice will help the patient to reconstruct the skull base Fascia, muscle and fat taken, causing a traumatic large wound on the Abdominal or thigh of the patient is connected, and together either with meningeal replacement or a titanium mesh in the skull base brought in. About that In addition, the patient is a lumbar drainage created and the Nose tampon. Although in addition also a multi-day Bed rest is prescribed, may be due to a leak in the skull base brain water loss occurs, causing the patients to undergo surgery again need to be supplied. Furthermore, the relatively large Wounds due to the removal of fascia, muscle and fat for the patient painful and with surgical complications, such as infection, rebleeding, Pain when walking after surgery, etc., connected. The to Reconstruction of the skull base used materials can when introduced in the brain act as a mass and neuro logical losses cause. About that In addition, the nasal tamponade a significant problem in Breathe and are only painful to remove. At the lumbar Drainage is an invasive implantation of a foreign body complications, such as intraspinal bleeding, infections, Nerve irritation, brain water loss, nausea and / or vomiting, may occur.

The EP 1 091 776 B1 discloses an implantable article comprising a porous expandable material, particularly a natural or synthetic polymer, and for occluding a biological opening in situ by positioning the article within the biological opening and allowing natural tissue to grow into the article. The material of the article consists of a fibrous matrix, is expandable by hydration or release from restricing agents, and is a polyvinyl alcohol formulation. This is a sponge-like structure that promotes tissue ingrowth. The sponge-like structure of the material from which the article is made can not effectively seal against liquids or bacteria.

Furthermore it is known from Kubota et al, Surg Neurol, 1991, 36, 360-4, for closing an opening of Skull base a silicone plate too use that individually tailored according to the size of the opening becomes. This is disadvantageous, as the silicone plate only can be cut relatively inaccurate, since the opening of the skull base with an endoscope can not be viewed accurately and also with coupled to the endoscope Bildwiedergabesys systems only a distorted Presentation of the opening deliver. Consequently, due to the inaccurate manufacture of the silicone plate ensures no sealed insertion of the same in the opening.

It Object of the invention, a closure element of the aforementioned To create kind, with which the disadvantages explained above are avoided and an easy to handle gripping device and an application device for the To provide closure element.

According to the invention Task with regard to the closure element solved by the Polymer an elastomer and the closure element sized and geometrically designed that it is biased against the opening a penetration of liquids and / or bacteria seals.

The Elastomer has, in particular in the prestressed state, a relative dense structure on that for Bacteria and liquids, as brain water, impermeable. The sealing of the opening, the e.g. For a minimally invasive surgical procedure in neurosurgery, the Ear, nose and throat surgery or oral and maxillofacial surgery in a bony structure of the skull is introduced by loss of bone, carried by the prestressed Inserting the closure element in the opening, whereby the closure element sealed circumferentially in the opening rests. By the such a tight seal the opening, especially everywhere used where the opening does not span with skin can be, for example, a nasal tamponade, a lumbar Drainage or an additional Surgery to remove fascia, muscle and fat are eliminated.

Conveniently, is the opening into a bone, in particular a skull and / or a skull base, incorporated. The closure element is therefore biased and sealing to the bone, which has a corresponding resistance represents against the expansion of the closure element.

Prefers the closure element is in the form of a lens, a sphere, a Cylinder or a pillow. A lens shape has opposite one Ball the advantage that they have a relatively large diameter at a relatively low Has thickness and therefore does not interfere with the bone protrudes. With a pillow-shaped Object in particular, close a non-round opening tight. Appropriately, points that pillows have a rectangular or square cross section, where all Corners and edges are rounded.

A sufficient preload for sealing can be achieved if preferably an outer contour of the closure element 10 to 30% greater than an inner contour of the opening is dimensioned. Because of this allowed Deviations are also possible for operations, where openings are more similar Size made Need to become, a variety of items in stock with corresponding staggered dimensions in industrial production.

Around partially in the abutment region of the closure element in the opening on the bone a higher one To provide pressure is advantageously circumferentially one annular Sealing lip molded. This is the radially effective contact pressure across from a closure element without sealing lip increases.

Conveniently, the elastomer has a Shore hardness between 20 and 65. According to a development, the elastomer is a biocompatible, sterilizable silicone material or a composite material comprising a silicone material. The silicone material may, for example, have a Shore hardness of 28, a tensile strength of 6.5 NN / mm ² and an elongation at break of 700, these values in no way limiting the choice of possible materials but rather having an exemplary character to those skilled in the art to facilitate the selection of a suitable material among the variety of commonly used materials. When using a silicone material, the sealing effect is increased due to the smooth and supple surface. The closure element is thus relatively easy to apply by means of tweezers or as explained below. Conveniently, the closure element has a core, which is made of a material that is firmer with respect to the elastomer. The core, in particular having a Shore hardness between 50 and 60, can for example be made of a hard-elastic polymer and coated with a silicone material. Of course, it is possible to manufacture the core of any material.

In Design is the surface coated with a, in particular cell growth promoting material. The material can be both organic and act an inorganic coating material by dipping, Spray, Steaming, sputtering or the like is applied to the article and to increase the adhesion to the osseous tissue of the opening and to cell growth contributes.

Prefers is the surface provided with a structure, in particular honeycomb-like depressions. In a relatively simple Embodiment, the structure may include only elevations and depressions and thus have a certain roughness. This is the Adhesion of the closure element on the bone tissue against a Increases closure element with a smooth surface.

The The object is achieved according to the invention the gripping device for the previously explained Closure element solved by that one an actuator comprehensive handle with grippers for the closure element is operatively connected in such a way that upon actuation of the actuator either open the grippers or close.

The gripping device facilitates the handling of the closure element and its insertion into the possibly difficult to access opening or the removal of the closure element out of the opening. Open the particular three, optionally barbed gripper in an actuation of the actuator, for example, designed as pistol grip-shaped handle, it is in the gripping device to a so-called applicator for placing the closure element. However, if the grippers close upon actuation of the actuator, the gripping device is a so-called extractor for removing the closure element from the opening.

to better accessibility of the opening and the use of the gripping device in minimally invasive Intervene are preferably the gripper slidable over a pipe mounted operating rod with the actuator in connection.

In Another embodiment, the tube at its free end a in particular conical guiding approach on, which is designed for compressing storage of the closure element is. The closure element is inserted into the guide approach compacted and leaves relatively easy in this state in the opening contribute.

to easy cleaning as well as exchangeability and use in the Connection with closure elements of different dimensions are preferably the guiding approach and / or the gripper designed to be removable and / or sterilizable.

The The object is achieved according to the invention the application device for the previously explained Closure element solved by that an actuator a grip with a displaceably mounted in a tube piston for displacement the closure element is in operative connection.

Around insert the closure element into the opening, For example, the closure element may be compressed into the tube inserted, the pipe on the opening put on and then the actuator be acted upon, the piston with its free end the Closing element out of the tube and into the opening.

Conveniently, the tube has an end guide approach for the Closing element on. The leadership approach can be formed as already explained be.

One Medical kit can be a leadership approach for placement on a gripping device or on an application device and / or comprise a closure element. The guide lug and / or the closure element are packaged by the manufacturer together or separately Unpacked and assembled by the surgeon immediately before use subsequently placed on the gripping device or the application device.

The medical set with the separate leadership approach with one inside recorded closure element is prepared by the manufacturer, which while the operation a loading of the leadership approach deleted with the closure element. Furthermore, it is thus ensured that always one adapted to the dimensions of the closure element leadership approach is used. Preferably, the separate guide lug is with the recorded therein Closure element packed sterile.

It It is understood that the above and below to be explained features not only in the specified combination, but also in other combinations are usable. The scope of the invention is only through the claims Are defined.

The Invention will be described below with reference to several embodiment examples with reference to the associated Drawings closer explained. It shows:

1 a side view of a closure element according to the invention in a first embodiment,

2 a side view of a closure element in a second embodiment,

3 a side view of a closure element in a third embodiment,

4 a side view of a closure element in a fourth embodiment,

5 a top view of a closure element in a fifth embodiment,

6 a side view of the closure element according to 5 .

7 a gripping device designed as an applicator for the closure element,

8th a trained as an extractor gripping device for the closure element and

9 an application device for the closure element.

The closure element 1 to 1 is as a ball 2 formed and has a core 3 on, with the wrapping 4 of the core 3 made of an elastomer, namely a silicone material, and the core 3 made of a contrast harder polymer. Furthermore, the circumference is an annular sealing lip 5 at the ball 2 formed. According to 2 has the closure element 1 the shape of a lens 6 on, facing the ball 2 has the advantage that it has a relatively small diameter with a relatively large diameter and thus less disturbing effect on the environment in the thickness expansion. To 3 is the closure element 1 as a cylinder 7 designed whose height is substantially the thickness of one with the cylinder 7 to be sealed occlusive opening having bone corresponds. At the in 4 illustrated cylinder 7 is circumferentially the annular sealing lip 5 provided, of course, in one piece with the cylinder 7 is trained. The closure element 1 after the 5 and 6 has the shape of a pillow 8th with a rectangular cross-section, with all corners 9 and edges 10 of the pillow 8th are provided with a radius.

The gripping device after 7 serves as an applicator and includes a pistol grip handle 11 on which an actuator 12 is pivotally mounted, with one in a tube 13 guided operating rod 14 for grapples 15 interacts. The pipe 13 has a conical guiding approach at its free end 16 on, for the compressing storage of the closure element 1 is trained. When the actuator is acted upon 12 in the direction of the arrow 17 becomes the operating rod 14 in the direction of the arrow 18 relocated. This is the closure element 1 in the form of the ball 2 from the leadership approach 16 pushed and the grapple 15 open up. In this sequence of movements, the ball passes 2 under bias in an opening when the guiding approach 16 before the opening is attached.

If the closure element 1 should be removed from the opening, comes in 8th shown, serving as an extractor gripping device for use, in which the application of the actuator 12 in the direction of the arrow 17 a displacement of the actuating rod 14 in the direction of the arrow 19 causes the grippers 15 that as a ball 1 trained closure element 1 to pull it out of the opening.

The application device according to 9 includes the pistol grip-shaped handle 11 at which the actuator 12 is pivotally mounted, with one in the tube 13 guided piston 20 interacts. The pipe 13 has at its free end the leadership approach 16 for storage of the closure element 1 on. When the actuator is acted upon 12 in the direction of the arrow 17 becomes the piston 20 in the direction of the arrow 18 shifted and the closure element 1 in the form of the ball 2 from the leadership approach 16 pushed. In this sequence of movements, the ball passes 2 under bias in an opening when the guiding approach 16 before the opening is attached.

Claims (20)

Closure element made of a synthetic polymer for an operation-related opening in the human body, in particular in a skull, characterized in that the polymer comprises an elastomer and the closure element ( 1 ) is sized and geometrically designed so that it seals the opening against penetration of liquids and / or bacteria under bias. Closure element according to claim 1, characterized in that that the opening into a bone, in particular a skull and / or a skull base, is incorporated. Closure element according to claim 1, characterized by the shape of a lens ( 6 ), a ball ( 2 ), a cylinder ( 7 ) or a pillow ( 8th ). Closure element according to claim 3, characterized in that the cushion ( 8th ) has a rectangular or square cross section, wherein all corners ( 9 ) and edges ( 10 ) are rounded. Closure element according to one of claims 1 to 4, characterized in that an outer contour of the closure element 10 to 30% larger than an inner contour of the opening is measured. Closure element according to one of claims 1 to 5, characterized in that the circumference of a ringförmi ge sealing lip ( 5 ) is formed. Closure element according to claim 1, characterized in that that the elastomer has a Shore hardness between 20 and 65. Closure element according to one of claims 1 to 7, characterized that the elastomer is a biocompatible, sterilizable silicone material or a composite comprising a silicone material. Closure element according to one of Claims 1 to 8, characterized in that a core made of a material that is firmer with respect to the elastomer ( 3 ) is provided. Closure element according to one of claims 1 to 9, characterized in that the surface with a, in particular promoting cell growth Material is coated. Closure element according to one of the claims che 1 to 10, characterized in that the surface is provided with a structure, in particular honeycomb-like depressions. Gripping device for a closure element ( 1 ) according to one of claims 1 to 8, characterized in that an actuator ( 12 ) comprehensive handle ( 11 ) with grippers ( 15 ) for the closure element ( 1 ) is operatively connected in such a way that upon actuation of the actuator ( 12 ) the grippers ( 15 ) either open or close. Gripping device according to claim 9, characterized in that the grippers ( 15 ) over one in a pipe ( 13 ) displaceably mounted actuating rod ( 14 ) with the actuator ( 12 ) keep in touch. Gripping device according to claim 9 or 10, characterized in that the tube ( 13 ) at its free end a particular conical leadership approach ( 16 ), which for compressing the storage of the closure element ( 1 ) is trained. Gripping device according to claim 9 or 10, characterized in that the guiding approach ( 16 ) and / or the grippers ( 15 ) are designed to be removable and / or sterilizable. Application device for a closure element ( 1 ) according to one of claims 1 to 8, characterized in that an actuator ( 12 ) of a handle ( 11 ) with one in a tube ( 13 ) displaceably mounted pistons ( 20 ) for displacing the closure element ( 1 ) is in operative connection. Applikationsvorrichtung according to claim 16, characterized in that the tube end a guide extension for the closure element ( 1 ) having. Medical set comprising a guide projection for placing on a gripping device according to one of claims 12 to 15 or on an application device according to claim 16 or 17 and / or a closure element ( 1 ) according to one of claims 1 to 11. Set according to claim 18, characterized in that the closure element ( 1 ) is included in the guidance approach. Set according to claim 18 or 19, characterized by a sterile packaging.