WO2007079718A2 - Closure element for a surgical opening, gripping device and associated application device - Google Patents

Closure element for a surgical opening, gripping device and associated application device Download PDF

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Publication number
WO2007079718A2
WO2007079718A2 PCT/DE2007/000004 DE2007000004W WO2007079718A2 WO 2007079718 A2 WO2007079718 A2 WO 2007079718A2 DE 2007000004 W DE2007000004 W DE 2007000004W WO 2007079718 A2 WO2007079718 A2 WO 2007079718A2
Authority
WO
WIPO (PCT)
Prior art keywords
closure element
opening
gripping device
actuator
element according
Prior art date
Application number
PCT/DE2007/000004
Other languages
German (de)
French (fr)
Other versions
WO2007079718A3 (en
Inventor
Patra Charalampaki
Laszlo Kopacz
Oliver Kempski
Original Assignee
Patra Charalampaki
Laszlo Kopacz
Oliver Kempski
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 Patra Charalampaki, Laszlo Kopacz, Oliver Kempski filed Critical Patra Charalampaki
Publication of WO2007079718A2 publication Critical patent/WO2007079718A2/en
Publication of WO2007079718A3 publication Critical patent/WO2007079718A3/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
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    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A—HUMAN NECESSITIES
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
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    • A61F2/00—Filters 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
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    • A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
    • A61F2002/30016—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in hardness, e.g. Vickers, Shore, Brinell
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    • A61F2002/30069—Properties of materials and coating materials elastomeric
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    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2002/4625—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use
    • A61F2002/4628—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use with linear motion along or rotating motion about an axis transverse to the instrument axis or to the implantation direction, e.g. clamping
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2002/4635—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor using minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0008—Rounded shapes, e.g. with rounded corners elliptical or oval
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017—Angular shapes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017—Angular shapes
    • A61F2230/0019—Angular shapes rectangular
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0069—Three-dimensional shapes cylindrical
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0071—Three-dimensional shapes spherical
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0019—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in hardness, e.g. Vickers, Shore, Brinell
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body

Definitions

  • 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.
  • Skull base surgery via a transnasal transshidoidal approach is one of the minimally invasive forms of surgery in neurosurgery for the treatment of intracranial processes, in ear, nose and throat surgery for the treatment of extracranial processes in the facial cavities and in the oral cavity.
  • Maxillofacial surgery for the reconstruction of the skull base after fractures.
  • the opening of the bony structures of the skull base is always accompanied by the loss of bone in the area to be opened due to lack of space in this region. After the end of the surgical removal of the intracranial or extracranial process, the reconstruction of the bony structures of the skull is to be ensured.
  • the open area especially ere Skull base, relatively close long-term tight seal, both to prevent cerebral water flow from the intracranial space to the outside and a penetration of air and germs from the nasopharynx to the interior of the skull and thus to avoid massive neurological seizures or infections.
  • the material for sealing the skull base should be as atraumatic as possible, ie its extraction or production should not be accompanied by a renewed operation of the patient. Furthermore, the material should be easy to apply and promote coalescence of the surrounding tissue structures, so that a long-lasting sealing takes place. Of course, the material must be so compatible with the human organism that inflammation and rejection reactions do not occur.
  • the patient is retrieved from the skull base fascia, muscle and fat, which is a traumatic large wound on the abdomen or thigh of the patient is connected, and introduced together with either meningeal replacement or a titanium mesh in the skull base.
  • a lumbar drainage is applied to the patient and the nose is tamponated.
  • a multi-day bed rest is also prescribed, due to a leakage of the skull base, a loss of brain water can occur, after which the patients must be surgically restored.
  • the relatively large wounds due to removal of fascia, muscle and fat are painful for the patient and associated with surgical complications such as infection, rebleeding, post-operative pain, and so forth.
  • the materials used to reconstruct the base of the skull can act as a mass cause logical failures.
  • the nasal tamponades represent a significant problem in breathing and are only painful to remove.
  • Lumbar drainage is an invasive implantation of a foreign body, which can also cause complications such as intraspinal bleeding, infection, nerve irritation, brain water loss, nausea, and / or vomiting.
  • EP 1 091 776 B1 discloses an implantable article comprising a porous expandable material, in particular a natural or synthetic polymer, for closing 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.
  • the object with regard to the closure element is achieved in that the polymer is an elastomer and the closure element dimensioned and geometrically designed so that it seals the opening against penetration of liquids and / or bacteria under bias.
  • the elastomer has, especially in the prestressed state, a relatively dense structure, which is impermeable to bacteria and liquids, such as brain water.
  • the sealing of the opening which is introduced into a bony structure of the skull with loss of bone, for example, for a minimally invasive surgical procedure in neurosurgery, ENT surgery or oral and maxillofacial surgery, is performed by the - biased insertion of the closure element into the opening, whereby the closure element rests circumferentially sealed in the opening.
  • the opening is expediently incorporated into a bone, in particular a skull and / or a skull base.
  • the closure element is thus biased and sealingly against the bone, which represents a corresponding resistance to the expansion of the closure element.
  • the closure element preferably has the shape of a lens, a sphere, a cylinder or a cushion.
  • a lens mold has the advantage over a ball that it has a relatively large diameter at a relatively small thickness and therefore does not protrude disturbingly over the bone.
  • a non-round opening can be tightly closed with a pillow-shaped object.
  • the cushion has a rectangular or square cross-section, with all corners and edges are rounded.
  • a sufficient for sealing bias 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 these allowable deviations, it is also possible to industrially produce a variety of articles of correspondingly staggered dimensions for operations in which openings of similar size must be made.
  • the elastomer has a Shore hardness between 20 and 65.
  • the elastomer is a biocompatible, sterilizable silicone material o- 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 by no means limit the selection of possible materials, but rather have an exemplary character to the To facilitate the selection of a suitable material among the variety of commonly used materials.
  • 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.
  • 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.
  • the surface is coated with a, in particular the cell growth-promoting material.
  • the material can be both an organic and an inorganic coating material, which by Dipping, spraying, steaming, sputtering or the like is applied to the article and contributes to increase the adhesion to the bone tissue of the opening and to cell growth.
  • the surface is provided with a structure, in particular honeycomb-like depressions.
  • the structure may comprise only elevations and depressions and thus have a certain roughness.
  • the adhesion of the closure element to the bone tissue is increased compared to a closure element having a smooth surface.
  • an actuator comprehensive handle with grippers for the closure element is operatively connected in such a way that when a loading of the actuator, the gripper either open 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 from the opening. If the grippers, in particular three, optionally provided with barbs, open when the actuator of the gripping piece designed, for example, as a pistol handle, opens, the gripping device is a so-called applicator for placing the closure element. However, if the grippers close upon actuation of the actuator, the gripper device is a so-called extractor for removing the closure element from the opening.
  • the grippers are preferably connected to the actuator via an actuating rod displaceably mounted in a tube.
  • the tube has at its free end a particular conical guide lug, which is designed for compressing mounting of the closure element.
  • the closure element is compressed when inserted into the guide lug and can be relatively easily introduced into the opening in this state.
  • the guide lug and / or the gripper are designed removable and / or sterilizable.
  • the closure element can for example be compressed inserted into the tube, the tube placed on the opening and then the actuator are acted upon, the piston with its free end, the closure element out of the tube and transported into the opening.
  • the tube expediently has a guide projection for the closure element at the end.
  • the guiding approach can be designed as already explained.
  • a medical kit may include a guiding approach for placement on a gripping device or on an application device and / or a closure element.
  • the guide projection and / or the closure element are packaged by the manufacturer together or separately and are unpacked and joined together by the surgeon immediately prior to their use and then placed on the gripping device or the application device.
  • the medical kit with the separate guide lug with a closure element received therein is prepared by the manufacturer, whereby a loading of the guide lug with the closure element is omitted during the operation. Furthermore, it is thus ensured that a guide projection adapted to the dimensions of the closure element is always used.
  • the separate guide lug is sterile packed with the closure element received therein.
  • FIG. 1 shows a side view of a closure element according to the invention in a first embodiment
  • FIG. 2 shows a side view of a closure element in a second embodiment
  • FIG. 3 shows a side view of a closure element in a third embodiment
  • FIG. 4 shows a side view of a closure element in a fourth embodiment
  • FIG. 5 shows a plan view of a closure element in a fifth embodiment
  • Figure 6 is a side view of the closure element according to Fig. 5,
  • the closure element 1 according to FIG. 1 is designed as a ball 2 and has a core 3, wherein the sheath 4 of the core 3 is made of an elastomer, namely a silicone material, and the core 3 is made of a comparatively harder polymer. Furthermore, the circumference is an annular Sealing lip 5 integrally formed on the ball 2. 2, the closure element 1 has the shape of a lens 6, which has the advantage over the ball 2 that it has a relatively small thickness at a relatively large diameter and thus less disturbing effect on the environment in the thickness expansion. According to Fig. 3, the closure element 1 is designed as a cylinder 7, the height of which substantially corresponds to the thickness of one of the cylinders 7 to be sealed with the closing occlusive bone. On the cylinder 7 shown in FIG.
  • the closure element 1 according to FIGS. 5 and 6 has the shape of a pad 8 with a rectangular cross-section, wherein all corners 9 and edges 10 of the pad 8 are provided with a radius.
  • the gripping device serves as an applicator and comprises a pistol-grip-shaped gripping piece 11, on which an actuator 12 is pivotably mounted, which cooperates with an actuating rod 14 for gripper 15 guided in a tube 13.
  • the tube 13 has at its free end a conical guide lug 16, which is designed for compressing storage of the closure element 1.
  • the actuating rod 14 is displaced in the direction of the arrow 18.
  • the closure element 1 is pushed in the form of the ball 2 from the guide lug 16 and the gripper 15 open.
  • the ball 2 passes under pretension in an opening when the guide lug 16 is attached before the opening.
  • the gripper device shown in FIG. 8, which acts as an extractor, is used, in which the actuation of the actuator 12 in the direction of the arrow 17 causes a displacement of the actuating rod 14 in the direction of the arrow 19, wherein the grippers 15 grasp the closure element 1 formed as a ball 1 in order to then be able to pull it out of the opening.
  • the application device comprises the pistol-grip-shaped grip piece 11, on which the actuator 12 is pivotally mounted, which cooperates with a piston 20 guided in the tube 13.
  • the tube 13 has at its free end on the guide lug 16 for supporting the closure element 1.

Abstract

The invention relates to a closure element for a surgical opening practised at the human body, particularly at a skull, said closure element being made of a synthetic polymer. The polymer is an elastomer and the closure element (1) is dimensioned and geometrically configured in such a manner that it seals the opening in a pre-stressed manner against the penetration of liquids and/or bacteries.

Description

Verschlusselement für eine Operationsöffnung und Greifvorrichtung sowie Applikationsvorrichtung dazu Closure element for an operation opening and gripping device and application device thereto
Beschreibungdescription
Die Erfindung bezieht sich auf ein Verschlusselement aus einem synthetischen Polymer für eine durch eine Operation bedingte Öffnung im menschlichen Körper, insbesondere in einem Schädel, und eine Greifvorrichtung sowie eine Applikationsvorrichtung dazu.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.
Die Schädelbasischirurgie über einen transnasalen transsphe- noidalen Zugangsweg zählt zu den minimal invasiven Operationsformen in der Neurochirurgie zur Behandlung von intrakra- niellen Prozessen, in der Hals-Nasen-Ohren-Chirurgie zur Behandlung von extrakraniellen, in den Gesichtshöhlen befindlichen Prozessen und in der Mund-Kiefer-Gesichts-Chirurgie zur Rekonstruktion der Schädelbasis nach Frakturen. Die Eröffnung der knöchernen Strukturen der Schädelbasis geht aufgrund von Platzmangel in dieser Region stets mit dem Verlust von Knochen in dem zu öffnenden Bereich einher. Nach dem Ende der operativen Entfernung des intrakraniellen oder extrakraniellen Prozesses ist die Rekonstruktion der knöchernen Strukturen des Schädels' zu gewährleisten. Hierbei ist es insbesondere problematisch den geöffneten Bereich, insbesondere ere Schädelbasis, verhältnismäßig langfristig dicht zu verschließen, um sowohl einen Hirnwasserfluss vom intrakraniellen Raum nach außen als auch ein Eindringen von Luft und Keimen vom Nasen-Rachen-Raum in das Innere des Schädels zu verhindern und damit massive neurologische Anfälle bzw. Infektionen zu vermeiden. Das Material zur Abdichtung der Schädelbasis sollte möglichst atraumatisch sein, d.h. seine Gewinnung bzw. Herstellung sollte nicht mit einer erneuten Operation des Patienten einhergehen. Im Weiteren sollte das Material leicht applizierbar sein und ein Zusammenwachsen der umliegenden Ge- websstrukturen fördern, damit eine lang andauernde Abdichtung erfolgt. Selbstverständlich muss das Material für den menschlichen Organismus derart verträglich sein, dass Entzündungen und Abstoßungsreaktionen nicht auftreten.Skull base surgery via a transnasal transshidoidal approach is one of the minimally invasive forms of surgery in neurosurgery for the treatment of intracranial processes, in ear, nose and throat surgery for the treatment of extracranial processes in the facial cavities and in the oral cavity. Maxillofacial surgery for the reconstruction of the skull base after fractures. The opening of the bony structures of the skull base is always accompanied by the loss of bone in the area to be opened due to lack of space in this region. After the end of the surgical removal of the intracranial or extracranial process, the reconstruction of the bony structures of the skull is to be ensured. In this case, it is particularly problematic the open area, especially ere Skull base, relatively close long-term tight seal, both to prevent cerebral water flow from the intracranial space to the outside and a penetration of air and germs from the nasopharynx to the interior of the skull and thus to avoid massive neurological seizures or infections. The material for sealing the skull base should be as atraumatic as possible, ie its extraction or production should not be accompanied by a renewed operation of the patient. Furthermore, the material should be easy to apply and promote coalescence of the surrounding tissue structures, so that a long-lasting sealing takes place. Of course, the material must be so compatible with the human organism that inflammation and rejection reactions do not occur.
In der Praxis wird dem Patienten zur Rekonstruktion der Schädelbasis Faszie, Muskel und Fett entnommen, womit eine traumatisch große Wunde am Bauch oder Oberschenkel des Patienten verbunden ist, und gemeinsam entweder mit Hirnhautersatz oder einem Titangitter in die Schädelbasis eingebracht. Darüber hinaus wird dem Patienten eine lumbale Drainage angelegt und die Nase tamponiert. Obwohl zusätzlich auch eine mehrtägige Bettruhe verordnet wird, kann aufgrund einer Undichtigkeit der Schädelbasis ein Hirnwasserverlust auftreten, worauf die Patienten erneut operativ versorgt werden müssen. Ferner sind die relativ großen Wunden aufgrund der Entnahme von Faszie, Muskel und Fett für den Patienten schmerzhaft und mit Operationskomplikationen, wie Infektion, Nachblutung, Schmerzen beim Gehen nach der Operation usw., verbunden. Die zur Rekonstruktion der Schädelbasis verwendeten Materialien können beim Einbringen im Gehirn als Raumforderung wirken und neuro- logische Ausfälle hervorrufen. Darüber hinaus stellen die Na- sentamponaden ein erhebliches Problem beim Atmen dar und sind nur schmerzhaft zu entfernen. Bei der lumbalen Drainage handelt es sich um eine invasive Implantation eines Fremdkörpers, bei der ebenfalls Komplikationen, wie intraspinale Blutungen, Infektionen, Nervenirritationen, Hirnwasserverlust, Übelkeit und/oder Erbrechen, auftreten können.In practice, the patient is retrieved from the skull base fascia, muscle and fat, which is a traumatic large wound on the abdomen or thigh of the patient is connected, and introduced together with either meningeal replacement or a titanium mesh in the skull base. In addition, a lumbar drainage is applied to the patient and the nose is tamponated. Although a multi-day bed rest is also prescribed, due to a leakage of the skull base, a loss of brain water can occur, after which the patients must be surgically restored. Furthermore, the relatively large wounds due to removal of fascia, muscle and fat are painful for the patient and associated with surgical complications such as infection, rebleeding, post-operative pain, and so forth. The materials used to reconstruct the base of the skull can act as a mass cause logical failures. In addition, the nasal tamponades represent a significant problem in breathing and are only painful to remove. Lumbar drainage is an invasive implantation of a foreign body, which can also cause complications such as intraspinal bleeding, infection, nerve irritation, brain water loss, nausea, and / or vomiting.
Die EP 1 091 776 Bl offenbart einen implantierbaren Gegenstand, der ein poröses expandierbares Material, insbesondere ein natürliches oder synthetisches Polymer, umfasst und zum Verschließen einer biologischen Öffnung in situ durch Positionieren des Gegenstandes innerhalb der biologischen Öffnung und Einwachsenlassen von natürlichem Gewebe in den Gegenstand dient. Das Material des Gegenstandes besteht aus einer faserigen Matrix, ist durch Hydratisierung oder Freisetzung aus beschränkenden Mitteln expandierbar und ist eine Polyvinylal- kohol-Formulierung. Hierbei handelt es sich um eine schwammartige Struktur, die ein Einwachsen von Gewebe begünstigt. Die schwammartige Struktur des Materials, aus dem der Gegenstand gefertigt ist, kann weder gegen Flüssigkeiten noch gegen Bakterien wirksam abdichten.EP 1 091 776 B1 discloses an implantable article comprising a porous expandable material, in particular a natural or synthetic polymer, for closing 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.
Darüber hinaus ist es von Kubota et al, Surg Neurol, 1991, 36, 360-4, bekannt, zum Verschließen einer Öffnung der Schädelbasis ein Silikonplättchen zu verwenden, das entsprechend der Größe der Öffnung individuell zugeschnitten wird. Dies ist insofern nachteilig, als das Silikonplättchen nur relativ ungenau zugeschnitten werden kann, da die Öffnung der Schädelbasis mit einem Endoskop nicht genau eingesehen werden kann und auch mit dem Endoskop gekoppelte Bildwiedergabesys- teme lediglich eine verzerrte Darstellung der Öffnung liefern. Demzufolge ist aufgrund der ungenauen Anfertigung des Silikonplättchens kein abgedichtetes Einsetzen desselben in die Öffnung gewährleistet.In addition, it is known from Kubota et al, Surg Neurol, 1991, 36, 360-4, to use a silicone pad to close an opening of the skull base, which is individually tailored according to the size of the opening. This is disadvantageous in that the silicone plate can only be cut in a relatively inaccurate manner, since the opening of the skull base can not be viewed accurately with an endoscope and also image reproduction systems coupled to the endoscope can be used. only provide a distorted representation of the opening. Consequently, due to the inaccurate manufacture of the silicon wafer, no sealed insertion thereof into the opening is ensured.
Es ist Aufgabe der Erfindung, ein Verschlusselement der eingangs genannten Art zu schaffen, mit dem die zuvor erläuterten Nachteile vermieden sind und eine einfach handhabbare Greifvorrichtung sowie eine Applikationsvorrichtung für das Verschlusselement bereitzustellen .It is an object of the invention to provide a closure element of the type mentioned, with which the disadvantages described above are avoided and to provide an easy to handle gripping device and an application device for the closure element.
Erfindungsgemäß wird die Aufgabe hinsichtlich des Verschlusselementes dadurch gelöst, dass das Polymer ein Elastomer und das Verschlusselement derart bemessen und geometrisch gestaltet ist, dass es unter Vorspannung die Öffnung gegen ein Durchdringen von Flüssigkeiten und/oder Bakterien abdichtet.According to the invention, the object with regard to the closure element is achieved in that the polymer is an elastomer and the closure element dimensioned and geometrically designed so that it seals the opening against penetration of liquids and / or bacteria under bias.
Das Elastomer weist, insbesondere im vorgespannten Zustand, ein relativ dichtes Gefüge auf, das für Bakterien und Flüssigkeiten, wie beispielsweise Hirnwasser, undurchlässig ist. Die Abdichtung der Öffnung, die z.B. für eine minimal invasive Operationsform in der Neurochirurgie, der Hals-Nasen- Ohren-Chirurgie bzw. der Mund-Kiefer-Gesichts-Chirurgie in eine knöcherne Struktur des Schädels unter Verlust von Knochen eingebracht wird, erfolgt durch das- vorgespannte Einsetzen des Verschlusselementes in die Öffnung, wodurch das Verschlusselement umfangsseitig abgedichtet in der Öffnung einliegt. Durch das derart dichte Verschließen der Öffnung, das insbesondere überall dort zur Anwendung kommt, wo die Öffnung nicht mit Haut überspannt werden kann, kann beispielsweise eine nasale Tamponade, eine lumbale Drainage oder eine zu- sätzliche Operation zur Entnahme von Faszie, Muskel und Fett entfallen.The elastomer has, especially in the prestressed state, a relatively dense structure, which is impermeable to bacteria and liquids, such as brain water. The sealing of the opening, which is introduced into a bony structure of the skull with loss of bone, for example, for a minimally invasive surgical procedure in neurosurgery, ENT surgery or oral and maxillofacial surgery, is performed by the - biased insertion of the closure element into the opening, whereby the closure element rests circumferentially sealed in the opening. By thus sealing the opening, which is used in particular wherever the opening can not be covered with skin, for example a nasal tamponade, a lumbar drainage or a additional surgery to remove fascia, muscle and fat are eliminated.
Zweckmäßigerweise ist die Öffnung in einen Knochen, insbesondere eines Schädels und/oder einer Schädelbasis, eingearbeitet. Das Verschlusselement liegt demnach vorgespannt und abdichtend an dem Knochen an, der einen entsprechenden Widerstand gegen die Ausdehnung des Verschlusselementes darstellt.The opening is expediently incorporated into a bone, in particular a skull and / or a skull base. The closure element is thus biased and sealingly against the bone, which represents a corresponding resistance to the expansion of the closure element.
Bevorzugt weist das Verschlusselement die Form einer Linse, einer Kugel, eines Zylinders oder eines Kissens auf. Eine Linsenform hat gegenüber einer Kugel den Vorteil, dass sie einen relativ großen Durchmesser bei einer verhältnismäßig geringen Dicke aufweist und demnach nicht störend über den Knochen hervorsteht. Mit einem kissenförmigen Gegenstand lässt sich insbesondere eine nicht runde Öffnung dicht verschließen. Zweckmäßigerweise weist dass Kissen einen rechteckigen oder quadratischen Querschnitt auf, wobei sämtliche Ecken und Kanten abgerundet sind.The closure element preferably has the shape of a lens, a sphere, a cylinder or a cushion. A lens mold has the advantage over a ball that it has a relatively large diameter at a relatively small thickness and therefore does not protrude disturbingly over the bone. In particular, a non-round opening can be tightly closed with a pillow-shaped object. Appropriately, the cushion has a rectangular or square cross-section, with all corners and edges are rounded.
Eine zur Abdichtung ausreichende Vorspannung kann erzielt werden, wenn vorzugsweise eine Außenkontur des Verschlusselementes 10 bis 30% größer als eine Innenkontur der Öffnung bemessen ist. Aufgrund dieser zulässigen Abweichungen ist auch möglich, für Operationen, bei denen Öffnungen ähnlicher Größe hergestellt werden müssen, eine Vielzahl von Gegenständen mit entsprechend gestaffelten Abmessungen vorrätig industriell herzustellen.A sufficient for sealing bias 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 these allowable deviations, it is also possible to industrially produce a variety of articles of correspondingly staggered dimensions for operations in which openings of similar size must be made.
Um im Anlagebereich des Verschlusselementes in der Öffnung an dem Knochen partiell einen höheren Druck bereitzustellen, ist vorteilhafterweise uitifangsseitig eine ringförmige Dichtlippe angeformt. Damit ist der radial wirksame Anpressdruck gegenüber einem Verschlusselement ohne Dichtlippe erhöht.In order partially to provide a higher pressure in the contact area of the closure element in the opening on the bone, is advantageously uitifangsseitig an annular sealing lip formed. Thus, the radially effective contact pressure is increased compared to a closure element without sealing lip.
Zweckmäßigerweise weist das Elastomer eine Shore-Härte zwischen 20 und 65 auf. Nach einer Weiterbildung ist das Elastomer ein biokompatibler, sterilisierbarer Silikonwerkstoff o- der ein einen Silikonwerkstoff umfassender Verbundwerkstoff. Der Silikonwerkstoff kann beispielsweise eine Shore-Härte von 28, eine Reißfestigkeit von 6,5 NN/mm2 und eine Reißdehnung von 700% aufweisen, wobei diese Werte keinesfalls eine Beschränkung der Auswahl möglicher Werkstoffe darstellen, sondern vielmehr einen beispielhaften Charakter haben, um dem Fachmann die Auswahl eines geeigneten Werkstoffes unter der Vielzahl allgemein üblicher Werkstoffe zu erleichtern. Bei der Verwendung eines Silikonwerkstoffes wird die Dichtwirkung aufgrund der glatten und anschmiegsamen Oberfläche gesteigert. Das Verschlusselement ist sonach verhältnismäßig leicht mittels einer Pinzette oder wie nachfolgend erläutert applizierbar. Zweckmäßigerweise verfügt das Verschlusselement über einen Kern, der aus einem gegenüber dem Elastomer festeren Werkstoff gefertigt ist. Der insbesondere eine Shore-Härte zwischen 50 und 60 aufweisende Kern kann beispielsweise aus einem hartelastischen Polymer gefertigt und mit einem Silikonwerkstoff ummantelt sein. Selbstverständlich ist es möglich, den Kern aus einem beliebigen Werkstoff zu fertigen.Conveniently, the elastomer has a Shore hardness between 20 and 65. According to a development, the elastomer is a biocompatible, sterilizable silicone material o- 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 by no means limit the selection of possible materials, but rather have an exemplary character to the 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 Ausgestaltung ist die Oberfläche mit einem, insbesondere das Zellwachstum fördernden Werkstoff beschichtet . Bei dem Werkstoff kann es sich sowohl um einen organischen als auch einen anorganischen Beschichtungswerkstoff handeln, der durch Tauchen, Besprühen, Bedampfen, Sputtern oder dergleichen auf den Gegenstand aufgebracht wird und zur Erhöhung der Haftung an dem Knochengewebe der Öffnung sowie zum Zellwachstum beiträgt.In an embodiment, the surface is coated with a, in particular the cell growth-promoting material. The material can be both an organic and an inorganic coating material, which by Dipping, spraying, steaming, sputtering or the like is applied to the article and contributes to increase the adhesion to the bone tissue of the opening and to cell growth.
Bevorzugt ist die Oberfläche mit einer Struktur, insbesondere mit wabenartigen Vertiefungen, versehen. In einer verhältnismäßig einfachen Ausgestaltung kann die Struktur lediglich Erhöhungen und Vertiefungen umfassen und somit eine bestimmte Rauhigkeit aufweisen. Hierdurch ist die Haftung des Verschlusselementes am Knochengewebe gegenüber einem Verschlusselement mit einer glatten Oberfläche erhöht.Preferably, the surface is provided with a structure, in particular honeycomb-like depressions. In a relatively simple embodiment, the structure may comprise only elevations and depressions and thus have a certain roughness. As a result, the adhesion of the closure element to the bone tissue is increased compared to a closure element having a smooth surface.
Die Aufgabe wird erfindungsgemäß hinsichtlich der Greifvorrichtung für das zuvor erläuterte Verschlusselement dadurch gelöst, dass ein einen Betätiger umfassendes Griffstück mit Greifern für das Verschlusselement derart in Wirkverbindung steht, dass sich bei einer Beaufschlagung des Betätigers die Greifer entweder öffnen oder schließen.The object is achieved according to the invention with respect to the gripping device for the previously described closure element in that an actuator comprehensive handle with grippers for the closure element is operatively connected in such a way that when a loading of the actuator, the gripper either open or close.
Die Greifvorrichtung erleichtert die Handhabung des Verschlusselementes und dessen Einsetzen in die gegebenenfalls schwer zugängliche Öffnung oder das Entfernen des Verschlusselementes aus der Öffnung. Öffnen sich die insbesondere drei, gegebenenfalls mit Widerhaken versehene Greifer bei einer Beaufschlagung des Betätigers des beispielsweise als pistolen- griffförmig gestalteten GriffStückes, handelt es sich bei der Greifvorrichtung um einen so genannten Applikator zum Platzieren des Verschlusselementes . Falls sich die Greifer jedoch bei der Beaufschlagung des Betätigers schließen, handelt es sich bei der Greifvorrichtung um einen so genannten Extraktor zum Entfernen des Verschlusselementes aus der Öffnung.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 from the opening. If the grippers, in particular three, optionally provided with barbs, open when the actuator of the gripping piece designed, for example, as a pistol handle, opens, the gripping device is a so-called applicator for placing the closure element. However, if the grippers close upon actuation of the actuator, the gripper device is a so-called extractor for removing the closure element from the opening.
Zur besseren Erreichbarkeit der Öffnung sowie zur Verwendung der Greifvorrichtung bei minimal invasiven Eingriffen stehen bevorzugt die Greifer über eine in einem Rohr verschiebbar gelagerte Betätigungsstange mit dem Betätiger in Verbindung.For better accessibility of the opening as well as for the use of the gripping device in minimally invasive procedures, the grippers are preferably connected to the actuator via an actuating rod displaceably mounted in a tube.
In weiterer Ausgestaltung weist das Rohr an seinem freien Ende einen insbesondere konischen Führungsansatz auf, der zur komprimierenden Lagerung des Verschlusselementes ausgebildet ist. Das Verschlusselement wird beim Einsetzen in den Führungsansatz verdichtet und lässt sich in diesem Zustand verhältnismäßig einfach in die Öffnung einbringen.In a further embodiment, the tube has at its free end a particular conical guide lug, which is designed for compressing mounting of the closure element. The closure element is compressed when inserted into the guide lug and can be relatively easily introduced into the opening in this state.
Zur leichten Reinigung sowie zur Auswechselbarkeit und Verwendung im Zusammenhang mit Verschlusselementen unterschiedlicher Abmessungen sind vorzugsweise der Führungsansatz und/oder die Greifer abnehmbar und/oder sterilisierbar ausgebildet.For ease of cleaning and interchangeability and use in connection with closure elements of different dimensions preferably the guide lug and / or the gripper are designed removable and / or sterilizable.
Die Aufgabe wird erfindungsgemäß hinsichtlich der Applikationsvorrichtung für das zuvor erläuterte Verschlusselement dadurch gelöst, dass ein Betätiger eines Griffstückes mit einem in einem Rohr verschiebbar gelagerten Kolben zur Verlagerung des Verschlusselementes in Wirkverbindung steht.The object is achieved according to the invention with respect to the application device for the above-described closure element in that an actuator of a handle is operatively connected to a displaceably mounted in a tube piston for displacement of the closure element.
Um das Verschlusselement in die Öffnung einzusetzen, kann das Verschlusselement beispielsweise komprimiert in das Rohr eingesetzt, das Rohr auf die Öffnung aufgesetzt und anschließend der Betätiger beaufschlagt werden, wobei der Kolben mit seinem freien Ende das Verschlusselement aus dem Rohr heraus und in die Öffnung befördert.In order to insert the closure element in the opening, the closure element can for example be compressed inserted into the tube, the tube placed on the opening and then the actuator are acted upon, the piston with its free end, the closure element out of the tube and transported into the opening.
Zweckmäßigerweise weist das Rohr endseitig einen Führungsansatz für das Verschlusselement auf. Der Führungsansatz kann wie bereits erläutert ausgebildet sein.The tube expediently has a guide projection for the closure element at the end. The guiding approach can be designed as already explained.
Ein medizinisches Set kann einen Führungsansatz zum Aufsetzen auf eine Greifvorrichtung oder auf eine Applikationsvorrichtung und/oder ein Verschlusselement umfassen. Der Führungsansatz und/oder das Verschlusselement sind herstellerseitig gemeinsam oder getrennt verpackt und werden vom Chirurg unmittelbar vor ihrer Verwendung ausgepackt und zusammengefügt sowie anschließend auf die GreifVorrichtung bzw. die Applikationsvorrichtung aufgesetzt.A medical kit may include a guiding approach for placement on a gripping device or on an application device and / or a closure element. The guide projection and / or the closure element are packaged by the manufacturer together or separately and are unpacked and joined together by the surgeon immediately prior to their use and then placed on the gripping device or the application device.
Das medizinische Set mit dem separaten Führungsansatz mit einem darin aufgenommenen Verschlusselement wird herstellerseitig vorbereitet, wodurch während der Operation ein Bestücken des Führungsansatzes mit dem Verschlusselement entfällt. Im Weiteren ist somit gewährleistet, dass stets ein auf die Abmessungen des Verschlusselementes angepasster Führungsansatz verwendet wird. Bevorzugt ist der separate Führungsansatz mit dem darin aufgenommenen Verschlusselement steril verpackt.The medical kit with the separate guide lug with a closure element received therein is prepared by the manufacturer, whereby a loading of the guide lug with the closure element is omitted during the operation. Furthermore, it is thus ensured that a guide projection adapted to the dimensions of the closure element is always used. Preferably, the separate guide lug is sterile packed with the closure element received therein.
Es versteht sich, dass die vorstehend genannten und nachstehend n.och zu erläuternden Merkmale nicht nur in der jeweils angegebenen Kombination, sondern auch in anderen Kombinationen verwendbar sind. Der Rahmen der Erfindung ist nur durch die Ansprüche definiert.It is understood that the features mentioned above and hereinafter n.och be used not only in the combination specified, but also in other combinations. The scope of the invention is defined only by the claims.
Die Erfindung wird im Folgenden anhand mehrerer Ausführungs- beispiele unter Bezugnahme auf die zugehörigen Zeichnungen näher erläutert. Es zeigt:The invention will be described below with reference to several embodiments. Examples with reference to the accompanying drawings explained in more detail. It shows:
Fig.l eine Seitenansicht eines erfindungsgemäßen Ver- schlusselementes in einer ersten Ausführungsform,FIG. 1 shows a side view of a closure element according to the invention in a first embodiment, FIG.
Fig.2 eine Seitenansicht eines Verschlusselementes in einer zweiten Ausführungsform,2 shows a side view of a closure element in a second embodiment,
Fig.3 eine Seitenansicht eines Verschlusselementes in einer dritten Ausführungsform,3 shows a side view of a closure element in a third embodiment,
Fig.4 eine Seitenansicht eines Verschlusselementes in einer vierten Ausführungsform,4 shows a side view of a closure element in a fourth embodiment,
Fig.5 eine Draufsicht auf ein Verschlusselement in einer fünften Ausführungsform,5 shows a plan view of a closure element in a fifth embodiment,
Fig.6 • eine Seitenansicht des Verschlusselementes nach Fig. 5, • Figure 6 is a side view of the closure element according to Fig. 5,
Fig.7 eine als Applikator ausgebildete Greifvorrichtung für das Verschlusselement,7 a gripping device designed as an applicator for the closure element,
Fig.8 eine als Extraktor ausgebildete GreifVorrichtung für das Verschlusselement und8 is designed as an extractor gripping device for the closure element and
Fig.9 eine Applikationsvorrichtung für das Verschlusselement .9 shows an application device for the closure element.
Das Verschlusselement 1 nach Fig. 1 ist als Kugel 2 ausgebildet und weist einen Kern 3 auf, wobei die Umhüllung 4 des Kerns 3 aus einem Elastomer, nämlich einem Silikonwerkstoff, und der Kern 3 aus einem demgegenüber härteren Polymer gefertigt ist. Im Weiteren ist umfangsseitig eine ringförmige Dichtlippe 5 an der Kugel 2 angeformt. Gemäß Fig. 2 weist das Verschlusselement 1 die Form einer Linse 6 auf, die gegenüber der Kugel 2 den Vorteil hat, dass sie bei einem relativ großen Durchmesser eine verhältnismäßig geringe Dicke besitzt und sich demnach in der Dickenausdehnung weniger störend auf die Umgebung auswirkt. Nach Fig. 3 ist das Verschlusselement 1 als -Zylinder 7 gestaltet, dessen Höhe im Wesentlichen der Dicke eines die mit den Zylinder 7 abzudichtend verschließende Öffnung aufweisenden Knochens entspricht. An dem in Fig 4 dargestellten Zylinder 7 ist umfangsseitig die ringförmige Dichtlippe 5 vorgesehen, die selbstverständlich einstückig mit dem Zylinder 7 ausgebildet ist. Das Verschlusselement 1 nach den Fig. 5 und 6 weist die Form eines Kissens 8 mit einem rechteckförmigen Querschnitt auf, wobei sämtliche Ecken 9 und Kanten 10 des Kissens 8 mit einem Radius versehen sind.The closure element 1 according to FIG. 1 is designed as a ball 2 and has a core 3, wherein the sheath 4 of the core 3 is made of an elastomer, namely a silicone material, and the core 3 is made of a comparatively harder polymer. Furthermore, the circumference is an annular Sealing lip 5 integrally formed on the ball 2. 2, the closure element 1 has the shape of a lens 6, which has the advantage over the ball 2 that it has a relatively small thickness at a relatively large diameter and thus less disturbing effect on the environment in the thickness expansion. According to Fig. 3, the closure element 1 is designed as a cylinder 7, the height of which substantially corresponds to the thickness of one of the cylinders 7 to be sealed with the closing occlusive bone. On the cylinder 7 shown in FIG. 4, the annular sealing lip 5 is peripherally provided, which of course is formed integrally with the cylinder 7. The closure element 1 according to FIGS. 5 and 6 has the shape of a pad 8 with a rectangular cross-section, wherein all corners 9 and edges 10 of the pad 8 are provided with a radius.
Die GreifVorrichtung nach Fig. 7 dient als Applikator und um- fasst ein pistolengriffförmiges Griffstück 11, an dem ein Betätiger 12 schwenkbar gelagert ist, der mit einer in einem Rohr 13 geführten Betätigungsstange 14 für Greifer 15 zusammenwirkt. Das Rohr 13 weist an seinem freien Ende einen konischen Führungsansatz 16 auf, der zur komprimierenden Lagerung des Verschlusselementes 1 ausgebildet ist. Bei einer Beaufschlagung des Betätigers 12 in Richtung des Pfeils 17 wird die Betätigungsstange 14 in Richtung des Pfeils 18 verlagert. Hierbei wird das Verschlusselement 1 in Form der Kugel 2 aus dem Führungsansatz 16 geschoben und die Greifer 15 öffnen sich. Bei dieser Bewegungsfolge gelangt die Kugel 2 unter Vorspannung in eine Öffnung, wenn der Führungsansatz 16 vor der Öffnung angesetzt ist. Falls das Verschlusselement 1 aus der Öffnung entfernt werden soll, kommt die in Fig. 8 dargestellte, als Extraktor dienende Greifvorrichtung zum Einsatz, bei der die Beaufschlagung des Betätigers 12 in Richtung des Pfeils 17 eine Verlagerung der Betätigungsstange 14 in Richtung des Pfeils 19 bewirkt, wobei die Greifer 15 das als Kugel 1 ausgebildete Verschlusselement 1 fassen, um es dann aus der Öffnung ziehen zu können .The gripping device according to FIG. 7 serves as an applicator and comprises a pistol-grip-shaped gripping piece 11, on which an actuator 12 is pivotably mounted, which cooperates with an actuating rod 14 for gripper 15 guided in a tube 13. The tube 13 has at its free end a conical guide lug 16, which is designed for compressing storage of the closure element 1. Upon actuation of the actuator 12 in the direction of the arrow 17, the actuating rod 14 is displaced in the direction of the arrow 18. Here, the closure element 1 is pushed in the form of the ball 2 from the guide lug 16 and the gripper 15 open. In this sequence of movements, the ball 2 passes under pretension in an opening when the guide lug 16 is attached before the opening. If the closure element 1 is to be removed from the opening, the gripper device shown in FIG. 8, which acts as an extractor, is used, in which the actuation of the actuator 12 in the direction of the arrow 17 causes a displacement of the actuating rod 14 in the direction of the arrow 19, wherein the grippers 15 grasp the closure element 1 formed as a ball 1 in order to then be able to pull it out of the opening.
Die Applikationsvorrichtung nach Fig. 9 umfasst das pistolen- griffförmige Griffstück 11, an dem der Betätiger 12 schwenkbar gelagert ist, der mit einem in dem Rohr 13 geführten Kolben 20 zusammenwirkt. Das Rohr 13 weist an seinem freien Ende den Führungsansatz 16 zur Lagerung des Verschlusselementes 1 auf. Bei einer Beaufschlagung des Betätigers 12 in Richtung des Pfeils 17 wird der Kolben 20 in Richtung des Pfeils 18 verlagert und das Verschlusselement 1 in Form der Kugel 2 aus dem Führungsansatz 16 geschoben. Bei dieser Bewegungsfolge gelangt die Kugel 2 unter Vorspannung in eine Öffnung, wenn der Führungsansatz 16 vor der Öffnung angesetzt ist. The application device according to FIG. 9 comprises the pistol-grip-shaped grip piece 11, on which the actuator 12 is pivotally mounted, which cooperates with a piston 20 guided in the tube 13. The tube 13 has at its free end on the guide lug 16 for supporting the closure element 1. When the actuator 12 is acted upon in the direction of the arrow 17, the piston 20 is displaced in the direction of the arrow 18 and the closure element 1 in the form of the ball 2 is pushed out of the guide projection 16. In this sequence of movements, the ball 2 passes under pretension in an opening when the guide lug 16 is attached before the opening.

Claims

Patentansprüche claims
1. Verschlusselement aus einem synthetischen Polymer für eine durch eine Operation bedingte Öffnung im menschlichen Körper, insbesondere in einem Schädel, dadurch gekennzeichnet, dass das Polymer ein Elastomer und das Verschlusselement (1) derart bemessen und geometrisch gestaltet ist, dass es unter Vorspannung die Öffnung gegen ein Durchdringen von Flüssigkeiten und/oder Bakterien abdichtet.A 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 is an elastomer and the closure element (1) sized and geometrically designed to bias the opening seals against penetration of liquids and / or bacteria.
2. Verschlusselement nach Anspruch 1, dadurch gekennzeichnet, dass die Öffnung in einen Knochen, insbesondere eines Schädels und/oder einer Schädelbasis, eingearbeitet ist.2. Closure element according to claim 1, characterized in that the opening in a bone, in particular a skull and / or a skull base, is incorporated.
3. Verschlusselement nach Anspruch 1, gekennzeichnet durch die Form einer Linse (6), einer Kugel (2), eines Zylinders (7) oder eines Kissens (8).3. Closure element according to claim 1, characterized by the shape of a lens (6), a ball (2), a cylinder (7) or a pad (8).
4. Verschlusselement nach Anspruch 3, dadurch gekennzeichnet, dass das Kissen (8) einen rechteckigen oder quadratischen Querschnitt aufweist, wobei sämtliche Ecken (9) und Kanten (10) abgerundet sind.4. Closure element according to claim 3, characterized in that the cushion (8) has a rectangular or square cross section, wherein all corners (9) and edges (10) are rounded.
5. Verschlusselement nach einem der Ansprüche 1 bis 4, dadurch gekennzeichnet, dass eine Außenkontur des Verschlusselementes 10 bis 30% größer als eine Innenkontur der Öffnung bemessen ist.5. Closure element according to one of claims 1 to 4, characterized in that an outer contour of the closure element 10 to 30% greater than an inner contour of the opening is dimensioned.
6. Verschlusselement nach einem der Ansprüche 1 bis 5, dadurch gekennzeichnet, dass umfangsseitig eine ringförmi- ge Dichtlippe (5) angeformt ist.6. Closure element according to one of claims 1 to 5, characterized in that circumferentially a ringförmi- ge sealing lip (5) is formed.
7. Verschlusselement nach Anspruch 1, dadurch gekennzeichnet, dass das Elastomer eine Shore-Härte zwischen 20 und 65 aufweist.7. Closure element according to claim 1, characterized in that the elastomer has a Shore hardness between 20 and 65.
8. Verschlusselement einem der Ansprüche 1 bis 7, dadurch gekennzeichnet, dass das Elastomer ein biokompatibler, sterilisierbarer Silikonwerkstoff oder ein einen Silikonwerkstoff umfassender Verbundwerkstoff ist.8. Closure element according to one of claims 1 to 7, characterized in that the elastomer is a biocompatible, sterilizable silicone material or a composite material comprising a silicone material.
9. Verschlusselement nach einem der Ansprüche 1 bis 8, dadurch gekennzeichnet, dass ein aus einem gegenüber dem Elastomer festeren Werkstoff gefertigter Kern (3) vorgesehen ist.9. Closure element according to one of claims 1 to 8, characterized in that a made of a respect to the elastomeric material made of solid core (3) is provided.
10. Verschlusselement nach einem der Ansprüche 1 bis 9, dadurch gekennzeichnet, dass die Oberfläche mit einem, insbesondere das Zellwachstum fördernden Werkstoff beschichtet ist.10. Closure element according to one of claims 1 to 9, characterized in that the surface is coated with a, in particular the cell growth promoting material.
11. Verschlusselement nach einem der Ansprüche 1 bis 10, dadurch gekennzeichnet, dass die Oberfläche mit einer Struktur, insbesondere mit wabenartigen Vertiefungen, versehen ist.11. Closure element according to one of claims 1 to 10, characterized in that the surface is provided with a structure, in particular with honeycomb-like depressions.
12. GreifVorrichtung für ein Verschlusselement (1) nach einem der Ansprüche 1 bis 8, dadurch gekennzeichnet, dass ein einen Betätiger (12) umfassendes Griffstück (11) mit Greifern (15) für das Verschlusselement (1) derart in Wirkverbindung steht, dass sich bei einer Beaufschlagung des Betätigers (12) die Greifer (15) entweder öffnen o- der schließen. 12. 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 in operative connection, that upon actuation of the actuator (12), either open or close the grippers (15).
13. GreifVorrichtung nach Anspruch 9, dadurch gekennzeichnet, dass die Greifer (15) über eine in einem Rohr (13) verschiebbar gelagerte Betätigungsstange (14) mit dem Betätiger (12) in Verbindung stehen.13. Gripping device according to claim 9, characterized in that the grippers (15) via a in a tube (13) slidably mounted actuating rod (14) with the actuator (12) are in communication.
14. Greifvorrichtung nach Anspruch 9 oder 10, dadurch gekennzeichnet, dass das Rohr (13) an seinem freien Ende einen insbesondere konischen Führungsansatz (16) aufweist, der zur komprimierenden Lagerung des Verschlusselementes (1) ausgebildet ist.14. Gripping device according to claim 9 or 10, characterized in that the tube (13) has at its free end a particular conical guide lug (16) which is designed for compressing mounting of the closure element (1).
15. Greifvorrichtung nach Anspruch 9 oder 10, dadurch gekennzeichnet, dass der Führungsansatz (16) und/oder die Greifer (15) abnehmbar und/oder sterilisierbar ausgebildet sind.15. Gripping device according to claim 9 or 10, characterized in that the guide projection (16) and / or the gripper (15) are designed to be removable and / or sterilizable.
16. Applikationsvorrichtung für ein Verschlusselement (1) nach einem der Ansprüche 1 bis 8, dadurch gekennzeichnet, dass ein Betätiger (12) eines Griffstückes (11) mit einem in einem Rohr (13) verschiebbar gelagerten Kolben (20) zur Verlagerung des Verschlusselementes (1) in16, 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 a in a tube (13) slidably mounted piston (20) for displacing the closure element ( 1) in
Wirkverbindung steht .Active compound is.
17. Applikationsvorrichtung nach Anspruch 16, dadurch gekennzeichnet, dass das Rohr endseitig einen Führungsansatz für das Verschlusselement (1) aufweist.17. Application device according to claim 16, characterized in that the tube end has a guide projection for the closure element (1).
18. Medizinisches Set umfassend einen Führungsansatz zum Aufsetzen auf eine Greifvorrichtung nach einem der Ansprüche 12 bis 15 oder auf eine Applikationsvorrichtung nach Anspruch 16 oder 17 und/oder ein Verschlusselement18. A medical set comprising a guide projection for placement on a gripping device according to one of claims 12 to 15 or to an application device according to claim 16 or 17 and / or a closure element
(1) nach einem der Ansprüche 1 bis 11.(1) according to any one of claims 1 to 11.
19. Set nach Anspruch 18, dadurch gekennzeichnet, dass das Verschlusselement (1) in dem Führungsansatz aufgenommen ist.19. Set according to claim 18, characterized in that the Closure element (1) is accommodated in the guide lug.
20. Set nach Anspruch 18 oder 19, gekennzeichnet durch eine sterile Verpackung. 20. Set according to claim 18 or 19, characterized by a sterile packaging.
PCT/DE2007/000004 2006-01-16 2007-01-05 Closure element for a surgical opening, gripping device and associated application device WO2007079718A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102006001952A DE102006001952A1 (en) 2006-01-16 2006-01-16 Closure element for an operation opening and gripping device and application device thereto
DE102006001952.0 2006-01-16

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WO2007079718A2 true WO2007079718A2 (en) 2007-07-19
WO2007079718A3 WO2007079718A3 (en) 2007-09-27

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WO2007079718A3 (en) 2007-09-27

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