WO2016150864A1

WO2016150864A1 - Surgical tissue fusion instrument

Info

Publication number: WO2016150864A1
Application number: PCT/EP2016/056003
Authority: WO
Inventors: Rainer Bargon; Bernd Blender; Stefan EICK; Nikolaus Hafner; Patrick HEIZMANN; Eugen Herner; Christian Huber; Christof Merckle; Erich Odermatt; Christoph Rothweiler
Original assignee: Aesculap Ag
Priority date: 2015-03-20
Filing date: 2016-03-18
Publication date: 2016-09-29
Also published as: DE102015205083A1

Abstract

The invention relates to a surgical tissue fusion instrument (100; 200) with two gripping structures (110;130; 210;230) which can be moved with respect to each other and which are designed for gripping and joining biological tissue sections which are to be fusioned, a heat generating means (114;134; 214; 234), which provokes tissue fusion between the biological tissue sections by heat generation, is associated with at least one gripping structure (110;130; 210;230), said heat-generating means (114; 34; 214;234) and/or at least one of the gripping structures (110;130; 210;230) comprising, at least on certain areas, a surface produced by surface treatment, promoting or supporting tissue fusion, and/or material promoting or supporting tissue fusion is contained in pores of the heat generating means (114;134; 214;234). The invention also relates to a surgical tissue fusion kit.

Description

Surgical tissue fusion instrument

Field of application and state of the art

The invention relates to a surgical tissue fusion instrument and a surgical tissue fusion kit.

For connecting body tissue, it is known, in particular in end-to-end anastomoses, to connect the tissue sections to be joined together by means of staplers by means of staples.

However, the use of staplers has the fundamental disadvantage that the staples usually remain in the body of a patient. In addition, bleeding may occur along the staple line. In the worst case, this leads to the manifestation of anastomotic insufficiency.

In order to reduce the frequency and severity of such complications, it is known that staplers are used in combination with, for example, hemostatic or wound healing enhancing adjuncts. The combined use of Klammernahtinstrument and additives, however, is perceived on the surgeon's side as very cumbersome. There is also the risk that the additives are perforated during stapling together with the body tissue to be joined, whereby the expected effects can be omitted.

It is also known to coagulate body tissue with RF current (high-frequency current), for example, by the body tissue between two RF electrodes is supplied with an RF current. A corresponding surgical tissue fusion instrument is known, for example, from DE 10 2010 020 664 A1. In order to assist and promote the connection of the body tissue, a disc of a medically acceptable material is provided, which is sandwiched between the tissue sections to be joined when the grasping structures of the tissue fusion instrument are brought together. Potentially problematic in the approach described in DE 10 2010 020 664 A1 is that the disc can dislocate during the tissue fusion process, in particular when exposed to a corresponding instrument pressure, whereby the material can no longer fulfill its desired function. Task and solution

It is therefore an object of the present invention to provide a surgical tissue fusion instrument as well as a surgical tissue fusion kit which allow for improved bonding of biological tissue sections to be joined together. In particular, the tissue fusion instrument and the tissue fusion kit should enable a secure and easier connection of body tissue.

This object is achieved by a surgical tissue fusion instrument according to independent claim 1 and by a surgical tissue fusion kit according to independent claim 22. Preferred embodiments of the tissue fusion instrument are defined in the dependent claims 2 to 21. The wording of all claims is hereby incorporated by express reference into the content of the present specification.

According to a first aspect, the invention relates to a surgical tissue fusion instrument with two relatively movable gripping structures, which are designed for gripping and joining together to be fused biological tissue sections.

At least one of the two gripping structures has a heat generating means. The gripping structure in question can therefore also be used, within the meaning of the present invention, as a carrier for the heat-generating means, i. referred to as a so-called heat generating medium carrier. If the heat generating means is, for example, an electrode, which will be discussed in more detail below, the gripping structure can be referred to as an electrode carrier.

The heat generating agent causes tissue fusion between the biological tissue sections by heat generation.

The surgical tissue fusion instrument is particularly characterized in that the heat generating means and / or at least one of the gripping structures at least partially have a tissue fusion supporting or promoting surface produced by a surface treatment. Alternatively or additionally, a tissue fusion assisting or promoting material is included in pores of the heat generating agent.

The surgical tissue fusion instrument according to the invention preferably provides a material connection between the biological tissue sections without additional mechanical connection means such as staples, threads or the like. Such a surgical beautiful tissue fusion instrument is therefore executed in particular without cleats. The compound is thus preferably based exclusively on a denaturation of tissue proteins, in particular collagen. For this purpose, the tissue sections during the fusion process by the heat generating means or preferably by several, ie at least two heat generating means, which will be discussed in more detail below, heated to temperatures above the denaturation temperature of the tissue proteins and together with the intracellular and extracellular matrix in a gelatinous state brought. After merging the tissue sections, the liquefied tissue cools to a fused mass, causing a secure connection of the tissues.

However, it can also be provided according to the invention, in addition to the heat generating means, for a tissue fusion instrument according to the invention, to provide devices for supplementary introduction of mechanical connection means, in particular staples, in order to support or reinforce the tissue fusion through a staple seam or another mechanical connection seam. Corresponding staples are preferably driven into the tissue sections in a simultaneous or previous or subsequent operation. A tissue fusion instrument according to the invention may have clamping functional areas alternately or parallel to corresponding functional surfaces of the heat generating means, to which memory or magazines for storing the staples are assigned.

Depending on the nature of the tissue fusion supporting or promoting surface or the tissue fusion promoting or promoting material, the tissue fusion performance of the surgical tissue fusion instrument may be positively enhanced in various ways. A positive influence or improvement of the tissue fusion performance, for example, on an avoidance of tissue adhesions to the gripping structures, on promoting wound healing, on increasing the strength of the tissue fusion, on an improvement of the electrical or thermal conductivity in the field of heat generation, on a thermal or electrical insulation in the area outside the heat generation, on a leveling of the tissue influence, on a reduction of the thermal tissue damage, on an improvement of the tissue contact (in particular to a sensor or a sensor arrangement of the tissue fusion instrument), on an improved energy or heat input and / or on a improved visualization of the biological tissue sections to be fused together.

The term "surface treatment" for the purposes of the present invention defines a treatment which is suitable for a tissue fusion-supporting surface or a surface to impart promotional properties or to enhance existing tissue fusion promoting or promoting properties of a surface. Suitable treatment methods will be explained in more detail below.

For the purposes of the present invention, the singular term "tissue fusion-promoting or -promoting material" can be not only a tissue fusion-supporting or -supporting material (singular) but also a multiplicity of different tissue-fusion-supporting or -promoting materials (plural), ie at least two different tissue-fusion-promoting or -promoting materials Materials, preferably in the form of a mixture .. Suitable materials will be discussed in more detail below.

According to one embodiment, the surgical tissue fusion instrument is characterized in that the heat generating means or at least one of the gripping structures at least partially has a tissue fusion supporting or promoting surface produced by a surface treatment.

According to an alternative embodiment, the surgical tissue fusion instrument is characterized in that the heat generating means and at least one of the gripping structures at least partially comprise a tissue fusion supporting or promoting surface produced by a surface treatment.

According to a further embodiment, the heat-generating means and / or at least one of the gripping structures has only partially a tissue-fusion-supporting or -promoting surface produced by a surface treatment.

According to an alternative embodiment, the heat generating means and / or at least one of the gripping structures has a continuous, by means of a surface treatment, tissue fusion supporting or conveying surface. In other words, it is preferred according to the invention if the surface of the heat generating means and / or at least one of the gripping structures have continuous tissue fusion promoting or promoting properties, which is generated by a surface treatment of the heat generating means and / or at least one of the gripping structures.

The tissue fusion assisting or conveying surface of the heat generating means in a preferred embodiment forms part of an end face of the gripping structure. Alternatively, the tissue fusion assisting or promoting surface of the heat generating means may define an end face of the gripping structure.

In a further embodiment, the tissue fusion supporting or conveying surface of the gripping structure forms a part, in particular a heat generating means free part, of an end face of the gripping structure.

Alternatively it can be provided that the tissue fusion supporting or conveying surface of the gripping structure defines a part, in particular a heat generating means free part, of an end face of the gripping structure.

In a preferred embodiment, the tissue fusion assisting or conveying surface of the heat generating means defines an end face of the gripping structure together with the tissue fusion assisting or conveying surface of the grasping structure.

In a further embodiment, the tissue fusion supporting or conveying surface of the gripping structure is a gripping structure surface which is formed outside an end face of the gripping structure.

In a further embodiment, the tissue fusion supporting or conveying surface of the gripping structure is a part of an end face of the gripping structure and a surface outside the end face.

The end face mentioned in the previous embodiments may also be referred to as the contact surface of the gripping structure, which is preferably provided for gripping and bringing together the biological tissue sections to be fused together.

Furthermore, the end face mentioned in the previous embodiments may be (substantially) strip-shaped, (substantially) U-shaped or (substantially) circular-ring-shaped.

The mentioned in the previous embodiments end face can be flat, ie projection-free, or uneven, ie with projections or projections, be formed. For example, the end face may already have protrusions or protrusions of 0.2 mm to 1 mm as a result of heat generation. Preferably, the heat generating means is associated with the end face mentioned in the previous embodiments. The heat-applying means can be integrated in particular in the end face.

In a particularly preferred embodiment, both gripping structures each have a heat generating means, the heat generating means each cause a tissue fusion between the biological tissue sections by heat generation and each have at least partially produced by a surface treatment, tissue fusionunterstützende or -fördernde surface. The gripping structures can therefore also be used in the context of the present invention as a carrier for the heat generating means, i. be referred to as so-called heat source carrier. If the heat generating means are, for example, electrodes, which will be discussed in more detail below, the gripping structures may be referred to as electrode carriers.

According to the invention, provision can furthermore be made for the heat-generating means to each have only partially a tissue-fusion-supporting or -promoting surface produced by a surface treatment.

Alternatively, it may be provided according to the invention that the heat generating means each have a surface produced by a surface treatment, tissue fusion supporting or -fördernde surface. In other words, according to the present invention, it may be provided that the surfaces of the heat generating means each have continuous tissue fusion promoting or promoting properties generated by a surface treatment of the heat generating means.

In a preferred embodiment, the tissue fusion supporting or conveying surfaces of the heat generating means each form part of an end face of the gripping structures.

Alternatively, the tissue fusion assisting or conveying surfaces of the heat generating means may respectively define an end face of the gripping structures.

According to the invention, it can further be provided that both gripping structures each only partially have a tissue fusion supporting or conveying surface produced by a surface treatment. Alternatively, it can be provided according to the invention that both gripping structures each have a surface produced by a surface treatment, tissue fusion supporting or -fördernden surface. In other words, it may be provided according to the invention that the surfaces of the gripping structures each have continuous tissue fusion-supporting or -fördernde properties, which are generated by a surface treatment of the gripping structures.

In a further embodiment, the tissue fusion supporting or conveying surfaces of the gripping structures each form part of an end face of the gripping structures.

Alternatively, the tissue fusion assisting or conveying surfaces of the grasping structures may each define an end face of the grasping structures.

In a further embodiment, end faces of the gripping structures are respectively defined by a tissue fusion supporting or conveying surface of the heat generating means and by a tissue fusion supporting or promoting and preferably heat generating means free surface of the gripping structures.

The end surfaces mentioned in the previous embodiments may also be referred to as contact surfaces of the gripping structures, which are preferably provided for gripping and merging the biological tissue sections to be fused together.

The end surfaces mentioned in the previous embodiments are preferably facing each other. In other words, it is preferred according to the invention if the gripping structures of the surgical tissue fusion instrument have mutually facing end faces. Particularly preferably, each end face is assigned a heat generating means. Particularly preferably, a heat generating means is integrated in each end face.

The end faces mentioned in the previous embodiments can furthermore each be (substantially) strip-shaped, (substantially) U-shaped or (substantially) circular-shaped.

The end faces mentioned in the previous embodiments may be planar, ie without projections, or uneven, ie with projections or projections. For example, the end surfaces may already have heat-generating projections or protrusions of 0.2 mm to 1 mm. In a further embodiment, both gripping structures each comprise a heat generating means, wherein a tissue fusion supporting or promoting material is contained in pores of each heat generating means.

According to a particularly preferred embodiment, the tissue fusion assisting or conveying surface of the heat generating means / heat generating means is a surface of a coating of the heat generating agent (s). According to a further, particularly preferred embodiment, the tissue fusion supporting or conveying surface of the gripping structure / gripping structures is a surface of a coating of the gripping structure (s). According to the invention, it can be provided that the heat generating means / the heat generating means and / or the gripping structure / the gripping structures at least partially, in particular only partially, or completely, i. continuous or full surface, are provided with the coating.

The term "coating" in the context of the present invention defines a layer which is applied to a surface, preferably to an untreated surface, of the heat-generating agent (s) and / or of the gripping structure (s) For the purposes of the present invention, in particular, they are a single layer or several, in particular cohesive, layers, in other words the coating in the sense of the present invention may be a single layer or a multi-layer structure Surface "in this context means a surface of the heat generating means / the heat generating means and / or the gripping structure / the gripping structures, which so far no surface treatment, in particular for the purpose of training or improvement of tissue fusion-supporting or -fördernden properties was raised.

The coating is preferably bonded to the heat generating means / the heat generating means and / or the gripping structure / gripping structures.

The coating may in particular be covalent, ie via atomic bonds, or not covalently, for example via Van der Waals forces, dipole-dipole interactions and / or hydrogen bonds, with the heat-generating agent (s) and / or gripping structure (s) Be connected gripping structures. The coating may furthermore have a layer thickness of 5 μm to 500 μm, in particular 10 μm to 250 μm, preferably 10 μm to 200 μm.

The coating can furthermore be porous, in particular open-pored.

The coating may, for example, pores having a mean pore diameter of 5 μηη to 1 mm, in particular 10 μηη to 0.2 mm.

In a preferred embodiment, the coating comprises a tissue-fusion-supporting or -promoting material.

The tissue-supporting or -fördernden material may in particular be an additive or an additive of the coating.

In a further embodiment, the tissue-fusion-supporting or -fördernde material, preferably as an additive or additive, contained in pores of the coating.

In another embodiment, the tissue fusion promoting or promoting material is in particulate form. The tissue-fusion-supporting or -fördernde material may for example have an average particle diameter of 10 μηη to 2 mm, in particular 50 μηη to 1 mm, preferably 100 μηη to 0.5 mm.

In a further embodiment, the coating, preferably exclusively, is formed from a tissue fusion promoting or promoting material.

The tissue fusion promoting or promoting material may be basically resorbable, partially absorbable or non-resorbable.

In a preferred embodiment, the tissue fusion promoting or promoting material is selected from the group consisting of or consisting of metal, ceramics, salt such as inorganic salt, wax, fat, fatty acid, alcohol, synthetic polymer, biopolymer (naturally occurring polymer), industrial biopolymer (industrial produced biopolymer), protein, extracellular protein, serum protein, glycoprotein, polyamino acid, polyhomoaminoic acid, polyheteroamino acid, oligopeptide, amino acid, polysaccharide, mucopolysaccharide, oligosaccharide, monosaccharide, lipid, glycolipid, drug, medicinal agent, growth factor, cyanoacrylate and mixtures from that. The metal may be selected from the group consisting of or consisting of magnesium, titanium, zirconium, tantalum, copper, silver, gold, chromium, hard chrome, and alloys thereof.

The ceramic may be selected from the group consisting of or consisting of calcium phosphate, hydroxyapatite, alumina, titanium nitride, and mixtures thereof.

The salt may be selected from the group consisting of or consisting of alkali metal halide, alkaline earth metal halide, phosphate, alkali metal phosphate, alkaline earth metal phosphate, and mixtures thereof.

In particular, the salt may be selected from the group consisting of or consisting of sodium chloride, potassium chloride, barium chloride, magnesium chloride, calcium chloride, sodium phosphate, potassium phosphate, barium phosphate, magnesium phosphate, calcium phosphate, mixed phosphates thereof, and mixtures thereof.

The synthetic polymer may in principle be a resorbable polymer or non-absorbable polymer. A preferred resorbable polymer may, for example, be selected from the group consisting of or consisting of polyglycolide, polylactide, polytrimethylene carbonate, poly-e-caprolactone, poly-3-hydroxybutyrate, poly-4-hydroxybutyrate, poly-5-hydroxybutyrate, poly-6 hydroxybutyrate and mixtures thereof. A preferred non-resorbable polymer is a fluorochemical, especially perfluorinated, polymer such as polytetrafluoroethylene.

The protein may be selected from the group consisting of or consisting of collagen, gelatin, elastin, reticuline, laminin, fibronectin, fibrillin, albumin, derivatives thereof, peptide fragments thereof, subunits thereof, and mixtures thereof.

In particular, the protein may be collagen selected from the group consisting of or consisting of Type I collagen, Type II collagen, Type III collagen, Type VI collagen, derivatives thereof, peptide fragments thereof, subunits thereof, and mixtures thereof.

The polysaccharide may be selected from the group consisting of or consisting of starch, modified starch, amylose, amylopectin, dextran, hyaluronic acid, heparin, heparan sulfate, chondroitin 4-sulfate, chondroitin 6-sulfate, dermatan sulfate, keratan sulfate, derivatives thereof and Mixtures thereof. The medicament may be selected from the group consisting of or consisting of antibiotic, cytostatic, anticonvulsant, platelet aggregation inhibitor, anticoagulant, hormone, gastrointestinal, local anesthetic, antihypertensive, antiphlogistic, analgesic, and mixtures thereof.

The medicinal or pharmaceutical active substance may be selected from the group comprising or consisting of antimicrobial, in particular antibiotic, active ingredient, haemostatic agent (hemostyptic), anti-inflammatory agent, wound healing agent, analgesic agent, growth-stimulating agent and mixtures thereof.

The antimicrobial agent may be selected from the group consisting of or consisting of silver, silver salt, antibiotic, polyhexamethylene biguanide, and mixtures thereof.

The growth factor may be selected from the group consisting of or consisting of fibroblast growth factor (FGF), transforming growth factor (TGF), platelet-derived growth factor (PDGF), epidermal growth factor (EGF) ), GMCSF (Granulocyte-Macrophage Colony Stimulating Factor), Vascular Endothelial Growth Factor (VEGF), insulin-like growth factor (IGF), hepatocyte growth factor (HGF), interleukin , Nerve Growth Factor (NGF), hematopoietic growth factor, and mixtures thereof.

In an anti-adhesive embodiment, the tissue fusion promoting or promoting material is an anti-adhesive material, i. a so-called anti-adhesion agent. The anti-adhesive material may be present as a solid and show its anti-adhesive effect only when liquefied due to heat generation by the heat generating means / the heat generating agent.

The anti-adhesive material is preferably selected from the group comprising fluorine-containing, in particular perfluorinated, polymer and release agent. The anti-adhesive material may be, for example, polytetrafluoroethylene or, alternatively, a release agent, preferably a lubricant, especially a silicone-containing or fluoropolymer-containing lubricant. A suitable fluoropolymer-containing lubricant is commercially available, for example under the name Electrolube ^®. In an embodiment which is advantageous in terms of tissue fusion strength and / or tissue fusion sealing, the tissue fusion promoting or promoting material is a surgical tissue adhesive. The surgical tissue adhesive can be present as a solid and show its adhesive effect only when liquefied due to heat generation by the heat generating means / the heat generating means. The surgical tissue adhesive may be selected from the group consisting of or consisting of cyanoacrylate adhesive, fibrin glue, and mixtures thereof. Preferably, the surgical adhesive is N-butyl cyanoacrylate or a N-butyl cyanoacrylate-containing tissue adhesive.

In a further embodiment, the tissue fusion promoting or promoting material is a heat-generating and / or tissue-inflating material preferably selected from the group consisting of collagen, gelatin, elastin, reticulin, laminin, fibronectin, fibrillin, Albumin, derivatives thereof, peptide fragments thereof, subunits thereof, and mixtures thereof. The collagen may be selected from the group consisting of or consisting of Type I collagen, Type II collagen, Type III collagen, Type VI collagen, derivatives thereof, peptide fragments thereof, subunits thereof, and mixtures thereof.

In an embodiment which is advantageous in terms of conductivity, the tissue-fusion-promoting or promoting material is a salt, preferably an inorganic salt. For example, the tissue fusion assisting or promoting material may be selected from the group consisting of or consisting of alkali metal halide, alkaline earth metal halide, phosphate, alkali metal phosphate, alkaline earth metal phosphate, and mixtures thereof. In particular, the tissue fusion promoting or promoting material may be selected from the group consisting of or consisting of sodium chloride, potassium chloride, barium chloride, magnesium chloride, calcium chloride, sodium phosphate, potassium phosphate, barium phosphate, magnesium phosphate, calcium phosphate, mixed phosphates thereof, and mixtures thereof.

In another embodiment, the tissue fusion promoting or promoting material is a tissue contact enhancing material. In particular, the tissue fusion assisting or promoting material may be a material configured to enhance tissue contact with a sensor or sensor assembly of the surgical tissue fusion instrument. In particular, such a material may be an immersion medium such as glycerine, hydrogels or oils having a defined refractive index. In a further embodiment, the tissue fusion supporting or promoting material is a material which is designed to improve an imaging evaluation of the biological tissue sections to be fused together or of biological tissue sections already fused together. A suitable material may in particular be designed as a contact material for better coupling of, for example, ultrasound for imaging evaluation. Suitable materials are, for example, hydrogels of carbomers or derivatives thereof, vegetable lipogels (oleogels), synthetic lipogels (oleogels), mineral lipogels (oleogels), hyaluronic acid or biological gels such as aloe vera.

In a further embodiment, the material that supports or promotes tissue fusion is a material which is designed to improve an energy input and thus a heat input into the biological tissue sections to be fused together. A suitable material represents, for example, glycerol, biological oils, synthetic oils, mineral oils, hydrogels or lipogels (oleogels).

In another embodiment, the tissue fusion promoting or promoting material is an energy converting or absorbing material configured to effectuate a positioned transformation from an energy form, such as light energy, to thermal energy. A suitable material may be, for example, metallic or metallized particles such as silver particles, carbon particles or other absorbent materials or nanostructures. The material can be applied in particular in the form of particles, emulsions, melts or in dissolved form.

In another embodiment, the tissue fusion assisting or promoting material is an energy coupling material which is particularly adapted to effect the introduction of inductive energy. Such a material may be, for example, ferromagnetic particles, graphite or carbonaceous materials.

In a further embodiment, the tissue fusion promoting or promoting material is a tissue structure marking material which is adapted to cause a marking of the biological tissue sections to be fused together or of biological tissue sections already fused together. A suitable material is, for example, a fluorescent dye. The use of fluorescent dyes in particular has the advantage that the structure of the tissue sections coincides. can detect a contained in the surgical tissue fusion instrument optical sensor assembly.

In a further embodiment, the tissue fusion promoting or promoting material is a tissue density marking material capable of marking the density of the biological tissue sections to be fused together or of biological tissue sections already fused together, for example, by ultrasound. A suitable material is, for example, gas-filled microbubbles ("microbubbles").

In another embodiment, the tissue fusion promoting or promoting material is an X-ray contrast agent, such as barium sulfate or an iodine-containing contrast agent. As a result, an imaging evaluation of the biological tissue sections to be fused together or biological tissue sections already fused together is particularly advantageously possible.

In a further embodiment, the above-mentioned coating is a solid coating, in particular a powder or plasma coating.

In a further embodiment, the coating is a spray coating.

In a further embodiment, the coating is a gel-like, in particular hydrogel-shaped, coating. Alternatively, the coating may be a solid material which can be converted into a gel-like, in particular hydrogel-shaped, coating by rinsing with an aqueous liquid or, on contact with a bodily tissue fluid, in particular blood. Such a coating is particularly suitable as a contact medium for better coupling of, for example, ultrasound for imaging evaluation or to an improved energy or heat input. For a suitable solid material, reference will be made to the materials mentioned in connection with the tissue fusion promoting or promoting material.

In a further embodiment, the coating is in lyophilized or freeze-dried form.

In a further embodiment, the coating is a protein coating (ie a coating consisting of a protein or protein mixture) or proteinaceous coating. With regard to suitable proteins, reference is made to the previous description.

In another embodiment, the coating is a polysaccharide coating (i.e., a coating consisting of a polysaccharide or polysaccharide mixture) or a polysaccharide-containing coating. With regard to suitable polysaccharides, reference is made to the previous description.

In another embodiment, the coating is a polymer coating (i.e., a coating composed of a polymer or polymer blend) or a polymer-containing coating. The coating is preferably a polytetrafluoroethylene coating or polytetrafluoroethylene-containing coating.

In another embodiment, the coating is a metal coating (i.e., a coating consisting of a metal or metal combination, especially alloy) or metal-containing coating. For example, the coating may be selected from the group consisting of or consisting of titanium coating (ie titanium coating), titanium-containing coating, hard chrome coating (ie, a hard chrome plated coating), hard chrome-containing coating, gold coating (ie, a gold-based coating). and gold-containing coating.

In a further embodiment, the tissue fusion supporting or promoting material is contained in pores of a metal coating, in particular a titanium coating, preferably a microporous titanium coating.

The surface treatment in a further embodiment is selected from the group consisting of or consisting of wetting, spraying, dipping, pressing, embossing, rolling, and brushing.

In an alternative embodiment, the surface treatment is a chemical vapor deposition. The chemical vapor deposition is preferably selected from the group consisting of plasma enhanced chemical vapor deposition, hot wire activated vapor deposition, chemical vapor deposition at low pressure, chemical vapor deposition at atmospheric pressure and metalorganic chemical vapor deposition. In an alternative embodiment, the surface treatment is a physical vapor deposition. The physical vapor deposition is preferably selected from the group consisting of or consisting of thermal evaporation, electron beam evaporation, laser beam evaporation, arc evaporation, molecular beam epitaxy, sputtering, ion beam assisted deposition, ion plating, and ion-assisted physical vapor deposition.

The heat generating means / heat generating means is / are preferably formed as a heat introducing means.

The heat generating means / heat generating means may basically be an electrode or electrode arrangement / electrodes or electrode arrangements, in particular high-frequency electrode (HF electrode) or high-frequency electrode arrangement (HF electrode arrangement) / high-frequency electrodes (HF electrodes) or high-frequency electrodes. Electrode arrangements (RF electrode arrangements) or radio-frequency electrode (RF electrode) or radio-frequency electrode arrangement (RF)

Electrode arrangement) / radio-frequency electrodes (RF electrodes) or radio-frequency electrode arrangements (RF electrode arrangements), a laser or a laser arrangement / laser or laser arrangements, a sonotrode or sonotrode arrangement / sonotrodes or sonotrode arrangements, a microwave generator / microwave generators, a plasma generator / plasma generators, a resistance heating element / resistance heating elements such as chewing or a combination of two or more of said heat generating means act.

It is particularly preferable according to the invention for the heat generating means / the heat generating means to be designed as an electrode or electrode arrangement / electrodes or electrode arrangements. The electrode (s) may be configured as strip-shaped electrode (s), horseshoe-shaped electrode (s), or ring electrode (s). The electrode (s) can in particular be subdivided into electrode segments, in particular into strip-shaped, horseshoe-shaped or ring-shaped electrode segments. The electrode (s) is preferably an HF electrode / HF electrodes.

The surgical tissue fusion instrument is designed in a further embodiment as a linear tissue fusion instrument. The tissue fusion instrument preferably has two forceps-like gripping structures, which bring about a linear clamping of the corresponding biological tissue sections as soon as the tissue fusion instrument has been brought together by menführen the gripping structures is closed. Between the gripping structures, the biological tissue sections in this embodiment are connected together along a linear junction.

In an alternative embodiment, the surgical tissue fusion instrument is configured as a circular tissue fusion instrument. Such a tissue fusion instrument is intended to connect biological tissue sections in the form of hollow organ sections, i. to merge. The tissue fusion instrument preferably has a gripping structure in the form of a base part and a gripping structure in the form of an anvil part, which effect a circular clamping of the hollow organ sections as soon as the tissue fusion instrument is closed by merging the gripping structures. Between the gripping structures, the biological tissue sections in this embodiment are connected together along a circular junction.

In a further embodiment, the surgical tissue fusion instrument comprises a sensor or a sensor arrangement. The sensor or the sensor arrangement may be an electronic sensor or an electronic sensor arrangement, temperature sensor or temperature sensor arrangement or an optical sensor, in particular a spectroscopic sensor, or an optical sensor arrangement, in particular a spectroscopic sensor arrangement. Preferably, the sensor or the sensor arrangement is integrated in a handle of the surgical tissue fusion instrument.

In a further embodiment, the surgical tissue fusion instrument has an energy source, in particular a current generator, preferably a high-frequency current generator, a radio-frequency generator, an ultrasonic wave generator, a microwave generator or a light source, in particular a laser. Preferably, the energy source is integrated in a handle of the surgical tissue fusion instrument.

In a further embodiment, the surgical tissue fusion instrument has a power transmission element, which is designed to effect a transfer of energy from an energy source of the surgical tissue fusion instrument to at least one of the two gripping structures, in particular to both gripping structures, preferably to the heat generating means / the heat generating means. The energy transmission element can be, for example, electrical lines or optical fibers, ie transparent components such as fibers, tubes or rods, which can transport light over short or long distances. In a further embodiment, the surgical tissue fusion instrument has an accumulator (rechargeable battery). The accumulator is designed to supply the tissue fusion instrument, in particular a power source contained therein, with electricity. The accumulator may in principle be an accumulator cell (battery cell) or a battery pack. The accumulator is also preferably integrated in a handle of the surgical tissue fusion instrument.

In a second aspect, the invention relates to a surgical tissue fusion kit.

The surgical tissue fusion kit includes a surgical tissue fusion instrument having two relatively movable gripping structures configured to grip and merge biological tissue sections to be fused together, and a tissue fusion assisting or promotional material that is in a sprayable form.

At least one of the two gripping structures has a heat generating means, which causes a fusion between the biological tissue sections by heat generation.

The fabric-fusion-supporting or -fördernde material is intended to be sprayed on the heat generating means and / or at least one of the two gripping structures, in particular an end face of one of the two gripping structures.

In a preferred embodiment, the gripping structures each have a heat generating means. The heat generating means are preferably assigned to mutually facing end faces of the gripping structures. In particular, the heat generating means may be integrated in mutually facing end faces of the gripping structures. In this embodiment, the fabric-fusion-supporting or -fördernde material may be provided in particular to be sprayed on both heat generating means and / or both gripping structures, in particular on facing end faces of the gripping structures.

The tissue fusion promoting or promoting material is preferably an anti-adhesive material, ie, an anti-adhesion agent. The anti-adhesion agent may in particular be a fluorine-containing, in particular perfluorinated, polymer, such as, for example, polytetrafluoroethylene, or a release agent or lubricant, in particular a silicone-containing or fluoropolymer-containing release agent or lubricant. A suitable fluoropolymer-containing lubricant is commercially available, for example under the name Electrolu- be ^®. Alternatively, the tissue fusion promoting or promoting material may be a tissue contact enhancing material, such as an immersion medium, in particular, immersion oil. By such a material, an improvement of the tissue contact to a sensor or a sensor arrangement of the surgical tissue fusion instrument can be achieved with particular advantage.

With regard to further features and advantages of the kit according to the invention, in particular of the heat generating means and of the tissue fusion supporting or conveying material, reference is made to avoid repetition to the statements made in the context of the first aspect of the invention.

According to a third aspect, the invention relates to a method for producing a tissue fusion instrument with a tissue fusion supporting or promoting surface, the tissue fusion instrument having two relatively movable gripping structures, which are designed for gripping and joining together to be fused biological tissue sections, wherein at least one gripping structure a heat generating means which causes tissue fusion between the biological tissue sections by heat generation.

The method is particularly characterized in that the heat generating means and / or at least one of the gripping structures are provided by a surface treatment with a tissue fusion supporting or -fördernden surface. Alternatively or additionally, the method is particularly characterized in that a tissue fusion-supporting or -förderndes material is introduced into pores of the heat generating means.

In a preferred embodiment, the heat generating means and / or at least one of the gripping structures are coated with a tissue fusion promoting or promoting material or provided with a coating containing a tissue fusion promoting or promoting material.

With regard to further features and advantages of the method according to the invention, in particular the surgical tissue fusion instrument, the gripping structures, the heat generating means, the surface treatment, the tissue fusion supporting or promoting material and the coating, reference is made to avoid repetition to the statements made within the scope of the present invention aspects , Further advantages and features of the invention will become apparent from the claims and from the following description of preferred embodiments of the invention, which are illustrated by the drawings.

The figures show schematically the following:

1 shows an embodiment of a surgical tissue fusion instrument according to the invention in linear design,

2 is an enlarged plan view of an end face of the lower gripping structure of the tissue fusion instrument according to FIG. 1, FIG.

3 is an enlarged plan view of an end face of the lower gripping structure of the tissue fusion instrument according to FIG. 1 with a segmented electrode, FIG.

4 shows an embodiment of a surgical tissue fusion instrument according to the invention in a circular design

5 shows an enlarged view of a head region of the tissue fusion instrument

Fig. 4 in the open position and

6 shows an enlarged plan view of an end face of the lower gripping structure of the tissue fusion instrument according to FIGS. 4 and 5 with a segmented electrode.

A surgical tissue fusion instrument 100 according to FIG. 1 is intended to connect, ie fuse, biological tissue sections, preferably without additional mechanical connection means, by means of merging, clamping and heat generation. The surgical tissue fusion instrument 100 according to FIG. 1 is designed as a linear tissue fusion instrument. The linear tissue fusion instrument 100 has two gripping structures 110, 130 movable relative to one another, of which a lower gripping structure 110 is held stationary, ie stationary, relative to a base part 15 of the tissue fusion instrument 100. The upper gripping structure 130 shown in FIG. 1 is arranged on a top part 135 which can be lifted relative to the base part 15, so that the two gripping structures 1 10, 130 can be linearly moved toward one another or away from one another in the vertical direction relative to one another. The gripping structures 1 10, 130 therefore cause a linear clamping of the corresponding biological tissue sections as soon as the tissue fusion instrument 100 is closed by merging the gripping structures 1 10, 130. Between the gripping structures 1 10, 130 are biological tissue sections are interconnected along a linear junction. The upper part 135 has a grip area 137 and the base part 15 has a grip area 17. Both gripping areas are each manually engageable for operation of the tissue fusion instrument 100. The tissue fusion instrument 100 is powered by a power cable indicated at 104. Alternatively, tissue fusion instrument 100 may be powered by a rechargeable battery. The use of a rechargeable battery particularly advantageously allows the installation of an energy source, in particular a high-frequency current generator, into the surgical tissue fusion instrument 100. In this case, the energy source and the rechargeable battery are preferably arranged in the upper part 135 or the base part 15.

The gripping structures 1 10, 130 each have an end face 1 1 1, 131 and an electrode 1 14, 134. The end faces 1 1 1, 131 are facing each other and form contact surfaces for gripping and merging biological tissue sections to be joined together. The electrodes 1 14, 134 are identical and (substantially) U-shaped. The electrode surfaces each form a part of the end faces 1 1 1, 131.

The electrodes 1 14, 134 are electrically energized to generate heat in the biological tissue sections in the region of the connection point, in particular in order to introduce a heat input into the biological tissue sections in the region of the connection point. The heat generation via the electrodes 1 14, 134 causes the desired tissue fusion. The electrodes 1 14, 134 are preferably designed as HF electrodes (high-frequency electrodes).

To avoid tissue adhesion, the electrode surfaces are provided with an anti-adhesive coating, for example made of polytetrafluoroethylene. Such a coating is provided with the reference numeral 140 in FIG. The surface 142 of the coating 140 defines a tissue fusion assisting or conveying surface in the sense of the present invention. Additionally or alternatively, electrode-free regions 1, 18, 138 of the end faces 1 1 1, 131 may be provided with such a coating (not shown).

The electrodes 1 14, 134 may in particular be subdivided into electrode segments. A corresponding structure of the electrodes 1 14, 134 will be described in more detail below by way of example in conjunction with FIG. 3 on the basis of the electrode 14. For example, the electrode 1 14 may have a total of 30 electrode segments 120, with 15 electrode segments offset from each other in two rows of electrodes 122, 124 arranged parallel to each other along each electrode section 126 and electrically insulated from each other. The electrode segments 120 are rectilinear and strip-shaped. The electrode segments 120 form an electrode surface 1 16. The electrode segments 120 define therebetween an electrode center line 127, which is also U-shaped in accordance with the shape of the electrode 1 14. In the area of the electrode section 128, two further electrode segments 121 are arranged, each of which completes the electrode rows 122 and 124 of the electrode sections 126. The electrode segments 120 and 121 are thus arranged offset from one another in a direction defined by the electrode center line 127.

In order to be able to apply a current to the electrode segments 120, 121, these are each arranged in an electrically conductive manner with a corresponding current connection in proximal end regions of the gripping structures 110, 130. The power connections can be connected to a power generator using appropriate connection cables or cables.

After merging the gripping structures 1 10, 130 are due to the identical design of the electrodes 1 14, 134 equal or substantially equal-sized electrode segments 120 and 121 opposite each other and face each other. They form a whole pair of electrode segments. Overall, the tissue fusion instrument in this embodiment thus comprises 32 electrode segment pairs.

The electrode segments 120, 121 form part of the end face 1 1 1. Preferably, the electrode segments 120, 121 are integrated into the end face 1 1 1.

In order to avoid tissue adhesions, in this embodiment the surfaces of the electrode segments 120, 121 are provided with an anti-adhesive coating 140, for example made of polytetrafluoroethylene. The surface 142 of the coating 140 defines a tissue-promoting or promoting surface within the meaning of the present invention. Such a coating is likewise provided with the reference numeral 140 in FIG. Additionally or alternatively, electrode-free regions 1 18 of the end face 1 1 1 may be provided with such a coating (not shown).

It is understood that the surfaces of the electrodes 1 14, 134 and / or the electrode-free regions 1 18, 138 also with another tissue fusion-supporting or -feördernden Material can be coated. In that regard, reference is made to the statements made in the general description.

A tissue fusion surgical instrument 200 according to Figure 4, like the tissue fusion instrument 100 described above, is intended to connect biological tissue sections, preferably without additional mechanical connection means, by mating, clamping and heat generation, i. to merge. The surgical tissue fusion instrument 200 of FIG. 4 is designed as a circular tissue fusion instrument that can interconnect biological tissue sections in the form of hollow organs.

The surgical tissue fusion instrument 200 is preferably for performing end-to-end anastomoses. The tissue fusion instrument 200 has a handle portion 203 which is hand-operable for operation of the tissue fusion instrument 200. The handle region 203 is associated with an actuating handle 205, which enables activation and control of the tissue fusion instrument 200. The tissue fusion instrument 200 is powered by a power cable indicated by reference numeral 204. Alternatively, tissue fusion instrument 200 may be powered by a rechargeable battery. The use of a rechargeable battery particularly advantageously enables the incorporation of an energy source, in particular a high-frequency current generator, into the surgical tissue fusion instrument 200. In this case, the energy source and the rechargeable battery are preferably arranged in the gripping region 203 of the surgical tissue fusion instrument 200. A head region of the tissue fusion instrument 200, which has a gripping structure 210 in the form of a base part and a gripping structure 230 in the form of an anvil part, projects from the grip region 203 over an elongated neck. The anvil member 230 is longitudinally slidably mounted in the base member 210 by means of an anvil shaft 236 coaxial with a central longitudinal axis M of the neck of the head portion. By means of a drive system, not shown, the anvil member 230 along the central longitudinal axis M between an open position shown in FIG. 5 and a closed position shown in FIG. 4 relative to the base member 210 movable.

The base part 210 and the anvil part 230 each have an end face 21 1, 231 and an electrode 214, 234. The end faces 21 1, 231 face each other and form contact surfaces for gripping and merging biological tissue sections to be joined together. The electrodes 214, 234 are identical and (substantially) annular. The surfaces of the electrodes 214, 234 each form part of the end faces 21 1, 231. The electrodes 214, 234 serve to be acted upon electrically and thus to generate heat in the biological tissue sections in the region of the connection point by means of current, in particular to introduce a heat input onto the biological tissue sections to be connected to one another. The defined between the end faces 21 1, 231 in the closed position contact area is referred to as a connection area or as a connection point for the tissue sections. The electrodes 214, 234 allow focused and directed heat generation within the joint region, in particular a focused and directed heat input into the tissue sections to be joined together, thereby effecting the desired tissue fusion between the tissue sections.

The electrodes 214, 234 are preferably designed as HF electrodes (high-frequency electrodes).

Furthermore, the electrodes 214, 234 are preferably subdivided into electrode segments. The structure of the electrodes 214, 234 will be described in more detail below by way of example in conjunction with FIG. 6 with reference to the electrode 214.

For example, the electrode 214 may be divided into four electrode segments 220, which are electrically isolated from each other. The electrode segments 220 are strip-shaped or substantially strip-shaped. The four electrode segments 220 define two electrode rows 222, 224. Each electrode row in each case comprises a part of the four electrode segments 220. In this case, each electrode segment 220 has a first electrode segment section 223, which forms part of the first electrode row 222, and a second electrode segment section 225, which forms a part of the second electrode row 224. The two electrode rows 222, 224 are curved overall, wherein the electrode segment sections 223, 225 each define electrically conductive circular ring sections. Overall, the two electrode rows 222, 224, which are defined by four electrode segment sections 223 and 225, respectively, are formed in a closed annular manner. In order to be able to contact the electrode segments 220 in the desired manner, each electrode segment 220 is electrically conductively connected to a connection contact 226, which is arranged in a connection region between the electrode segment sections 223, 225.

The electrode segments 220 form part of the end face 21 1 of the gripping structure 210. The electrode segments 220 are preferably integrated into the end face 21 1. In order to reduce the heat generation and to equalize the tissue influence, the electrode segments 220 are provided with a heat-generating and tissue-influencing coating 240, for example of collagen. The surface 242 of the coating 240 defines a tissue fusion supporting or promoting surface in the sense of the present invention. Additionally or alternatively, electrode-free regions 218 of the end face 21 1 may be provided with such a coating (not shown).

It is understood that the surfaces of the electrodes 214, 234 and / or electrode-free regions of the end faces 21 1, 231 can also be coated with another tissue fusion-promoting or -fördernden material. In that regard, reference is made to the statements made in the general description.

Claims

claims

1 . A surgical tissue fusion instrument (100; 200) having two relatively movable gripping structures (1 10; 130; 210; 230) which are designed to grip and merge biological tissue sections to be fused together, at least one gripping structure (1 10; 210, 230) comprises a heat generating means (1 14; 134; 214; 234) which effects tissue fusion between the biological tissue sections by heat generation, characterized in that the heat generating means (1 14; 134; 214; 234) and / or at least one the gripping structures (1 10; 130; 210; 230) have at least partially a surface-treated, tissue fusion supporting or promoting surface, and / or a tissue diffusion promoting or promoting material in pores of the heat generating means (1 14; 134; 214; 234) is included.

A surgical tissue fusion instrument (100; 200) according to claim 1, characterized in that said tissue fusion assisting or conveying surface of said heat generating means (1 14; 134; 214; 234) forms part of an end face (1 1 1; 131; 21 1; 231 ) of the gripping structure (1 10; 130; 210; 230).

A surgical tissue fusion instrument (100; 200) according to claim 1 or 2, characterized in that the tissue fusion assisting or conveying surface of the gripping structure (1 10; 130; 210; 230) comprises a part of an end face (1 1 1, 131, 21 1 231) of the gripping structure (1 10; 130; 210; 230).

4. A surgical tissue fusion instrument (100; 200) according to any one of the preceding claims, characterized in that in the tissue fusion supporting or conveying surface of the gripping structure (1 10; 130; 210; 230) about a surface outside an end face (1 1 1 ; 131; 21 1; 231) of the gripping structure (1 10; 130; 210; 230).

5. Surgical tissue fusion instrument (100; 200) according to any one of the preceding claims, characterized in that both gripping structures (1 10; 130; 210; 230) each have a heat generating means (1 14; 134; 214; 234) which by heat generation a Tissue fusion between the tissue biological sections causes, wherein the heat generating means (1 14; 134; 214; 234) each at least partially a Having a surface treatment treated, tissue fusion supporting or promoting surface.

6. Surgical tissue fusion instrument (100; 200) according to one of the preceding claims, characterized in that both gripping structures (1 10; 130; 210; 230) each have at least partially a tissue fusion supporting or promoting surface produced by a surface treatment.

7. A surgical tissue fusion instrument (100; 200) according to any one of the preceding claims, characterized in that the two gripping structures (1 10; 130; 210; 230) each have a heat generating means (1 14; 134; 214; 234), wherein a tissue-supporting supporting or promoting material is contained in pores of each heat generating means (1 14; 134; 214; 234).

A surgical tissue fusion instrument (100; 200) according to any one of the preceding claims, characterized in that the tissue fusion assisting or promoting surface is the surface of a coating (140; 240) of the heat generating means (1 14; 134; 214; 234). / the heat generating means (1 14; 134; 214; 234) and / or the gripping structure (1 10; 130; 210; 230) / gripping structures (1 10; 130; 210; 230).

The surgical tissue fusion instrument (100; 200) of claim 8, characterized in that the coating (140; 240) comprises a tissue fusion promoting or promoting material.

A surgical tissue fusion instrument (100; 200) according to claim 9, characterized in that said tissue fusion promoting or promoting material is an additive of said coating (140; 240), which preferably in pores of said coating Coating (140, 240) is included.

1 1. A surgical tissue fusion instrument (100; 200) according to any one of claims 8 to 10, characterized in that the tissue fusion assisting or promoting material is selected from the group consisting of metal, ceramic, salt such as inorganic salt, wax, fat, fatty acid, alcohol, synthetic polymer , Biopolymer, technical biopolymer, protein, extracellular protein, serum protein, glycoprotein, polyamino acid, polyhomoamino acid, polyheteroamino acid, oligopeptide, amino acid, polysaccharide, mucopolysaccharide, oligosaccharide, monosaccharide, lipid, glycolipid, medicament, medicinal cellular or pharmaceutical active ingredient, growth factor cyanoacrylate and mixtures thereof.

12. A surgical tissue fusion instrument (100; 200) according to any one of claims 8 to 1 1, characterized in that the tissue fusion supporting or - promoting material to an anti-adhesive, preferably polytetrafluoroethylene or a lubricant, in particular silicone or fluoropolymer-containing lubricant , acts.

A surgical tissue fusion instrument (100; 200) according to any one of claims 8 to 12, characterized in that the tissue fusion promoting or promoting material is a surgical tissue adhesive, preferably N-butyl cyanoacrylate.

14. A surgical tissue fusion instrument (100; 200) according to any one of claims 8 to 13, characterized in that the tissue fusion supporting or promoting material is a heat-generating and / or tissue-inflating material which is preferably selected from the group comprising Collagen, gelatin, elastin, reticulin, laminin, fibronectin, fibrillin, albumin, derivatives thereof, peptide fragments thereof, subunits thereof, and mixtures thereof.

The surgical tissue fusion instrument (100; 200) according to any one of claims 8 to 14, characterized in that said tissue fusion promoting or promoting material is a salt selected, in particular, from the group comprising alkali metal halide, alkaline earth metal halide, phosphate, alkali metal phosphate , Alkaline earth metal phosphate and mixtures thereof.

16. Surgical tissue fusion instrument (100; 200) according to one of claims 8 to 15, characterized in that the coating is a solid coating, in particular a powder or plasma coating.

17. The surgical tissue fusion instrument (100; 200) according to claim 8, wherein the coating is selected from the group comprising polytetrafluoroethylene coating, titanium coating, hard chrome coating and gold coating.

18. A surgical tissue fusion instrument (100; 200) according to any one of the preceding claims, characterized in that the surface treatment is selected from the group comprising wetting, spraying, dipping, pressing, embossing, rolling and brushing.

A surgical tissue fusion instrument (100; 200) according to any one of the preceding claims, characterized in that the surface treatment is a chemical vapor deposition, which is preferably selected from the group comprising plasma enhanced chemical vapor deposition, hot wire activated vapor deposition, chemical vapor deposition Low pressure, chemical vapor deposition at atmospheric pressure and organometallic chemical vapor deposition.

20. A surgical tissue fusion instrument (100; 200) according to any one of claims 1 to 17, characterized in that the surface treatment is a physical vapor deposition, which is preferably selected from the group comprising thermal evaporation, electron beam evaporation, laser beam evaporation, arc evaporation, molecular beam epitaxy Sputtering, ion beam assisted deposition, ion plating, and ion-assisted physical vapor deposition.

21. A surgical tissue fusion instrument (100; 200) according to any one of the preceding claims, characterized in that the heat generating means (1 14; 134; 214; 234) / the heat generating means (1 14; 134; 214; 234) are electrodes / electrodes, preferably HF Electrode / RF electrodes, is configured / are.

22. A surgical tissue fusion kit, comprising a surgical tissue fusion instrument (100, 200) with two relatively movable gripping structures (1 10, 130, 210, 230), which are designed for gripping and merging together to be fused biological tissue sections, wherein at least one gripping structure (1 10; 130; 210; 230) comprises heat generating means (1 14; 134; 214; 234) for causing tissue fusion between the biological tissue sections by heat generation and a tissue fusion promoting or promoting material which is in sprayable form is present.