Abstract:
The invention relates to a device preferably in the form of a ceramic trimmer that is useful in treating soft tissue such as gingival tissue in an individual. The device Is capable of heat coagulating the soft tissue when the device in rotary motion is contacting the soft tissue. The device is preferably used in the area of therapy or surgery carried out on the human or animal body.

Description:
TECHNICAL FIELD OF THE INVENTION 
     The invention relates to a device preferably in the form of a ceramic trimmer that is useful in treating soft tissue such as gingival tissue in an individual. The device is capable of soft tissue modelling and heat coagulating the soft tissue when the device in rotary motion is contacting the soft tissue. The device is preferably used in the area of therapy or surgery carried out on the human or animal body. 
     BACKGROUND OF THE INVENTION 
     The prior art discloses drilling devices and dental tips for treatment of hard tissue such as bone and various non-vascular tissues such as cartilage. Such tissues essentially do not contain any body fluids and heat coagulation is therefore not an issue to be considered when treating these non-vascular tissues. The prior art neither discloses treatment of soft body tissue that results in heat coagulation of said soft tissue, nor does the prior art disclose a method of treatment that leads to an improved hemostasis by means of heat coagulation during soft tissue treatment. 
     U.S. Pat. No. 5,269,785 relates to a percutaneous tissue removal apparatus for cutting hard tissue such as for example bone, cartilage and fetal tissue. Heat coagulation of soft tissue or hemostasis of soft tissue is not disclosed and does not occur in a treatment of hard tissue in accordance with the disclosure of the patent. 
     U.S. Pat. No. 5,725,370 discloses a dental tip for use in periodental treatment such as a method of removing dental calculus. The dental tip is not for use with soft tissue, and a heat coagulating effect of soft tissue is not disclosed. 
     SUMMARY OF THE INVENTION 
     In one aspect of the present invention there is provided a device for treatment of soft tissue, said device comprising a distal end portion comprising a heat-insulating material and a proximal end portion in the form of a non-flexible drill shaft capable of being in operational contact with a power source for generating a rotary motion of said distal end portion, said rotary motion resulting in a heat coagulation of said soft tissue being contacted under practical circumstances by at least said rotating distal end comprising said heat-insulating material. 
     The device according to the invention is particularly useful in the field of dentistry and provides a means for improving various forms of treatment including gingival tissue modelling, removing mucous membranes, mucous lined tissues and hyper-plastic gingival tissue, exposing a tooth at least partly covered by a mucous membrane or mucous lined tissue, laceration of interradiculary granulation tissue, exposing an intraosseous implant or part thereof, and poche opening in connection with making a dental impression. 
     Furthermore, due to the frictional energy released when rotating the device a cutting effect is obtained in addition to the coagulation. Thus, the device is suitable for use in treatments wherein the combined cutting and coagulation of soft tissues are desired. 
     The device is capable of being fitted in any conventional dentistry apparatus useful for performing a drilling action. In particular the device is capable of being fitted into a friction grip shaft, such as shaft of a diameter of 1.6 mm. In addition to resulting in an improved heat coagulation and/or hemostasis of soft tissue being contacted by the rotating distal end comprising the heat-insulating material, the device is also useful in achieving even and well modelled surfaces of a wound as well as an improved hemostasis. The device also represents an improvement when it is desirable to produce or clean a poche opening e.g. in connection with a dental impression. 
     In one aspect the invention provides a method of heat coagulating soft tissue, said method comprising the steps of 
     i) providing a device according to the present invention, 
     ii) providing an individual in need of soft tissue treatment, 
     iii) contacting said soft tissue by at least said distal end portion of said device, and 
     iv) heat coagulating said soft tissue by means of said rotary motion of at least said distal end portion. 
     In yet another aspect there is provided a method of removing or modelling gingival tissue, said method comprising the steps of 
     i) providing a device according to the present invention, 
     ii) providing an individual in need of gingival tissue removal, 
     iii) contacting said gingival tissue by at least said distal end portion of said device, 
     iv) removing or modelling said gingival tissue by means of said rotary motion of at least said distal end portion of said device, said rotary motion further resulting in heat coagulating said gingival tissue being contacted under practical circumstances by at least said rotating distal end. 
     The above method may also pertain to removing gingival tissue in the form of hyperplastic gingival tissue. 
     Yet another aspect of the present invention pertains to a method of lacerating interradiculary granulation tissue, said method comprising the steps of 
     i) providing a device according to the present invention, 
     ii) providing an individual in need of interradiculary granulation tissue laceration, 
     iii) contacting said granulation tissue with at least said distal end portion of said device, and 
     iv) lacerating said interradiculary granulation tissue by means of said rotary motion of at least said distal end portion of said device, said rotary motion further resulting in heat coagulating said interradiculary granulation tissue being contacted under practical circumstances by at least said rotating distal end. 
     In a further aspect there is provided a method of exposing a tooth or an intraosseous implant, or part thereof, at least partly covered by a mucous membrane or mucous lined tissue, said method comprising the steps of 
     i) providing a device according to the present invention, 
     ii) providing an individual in need of exposure of a tooth at least partly covered by a mucous membrane or mucous lined tissue, 
     iii) contacting said mucous membrane or mucous lined tissue with said distal end portion of said device, 
     iv) exposing said tooth at least partly covered by a mucous membrane or mucous lined tissue by means of said rotary motion of said distal end portion of said device, said rotary motion resulting in a heat coagulation of said mucous membrane or mucous lined tissue being contacted under practical circumstances by at least said rotating distal end. 
     In a yet further aspect there is provided a method of cleaning a poche e.g. when making a dental impression, said method comprising the steps of 
     i) providing a device according to the present invention, 
     ii) providing an individual in need of poche cleaning, 
     iii) contacting said poche with said distal end portion of said device, 
     iv) cleaning said poche by means of said rotary motion of said distal end portion of said device, said rotary motion resulting in a heat coagulation of soft tissue comprised in said poche being contacted under practical circumstances by at least said rotating distal end. 
     In a further aspect there is provided the use of a ceramic drill tip in the manufacture of a device for treatment of soft tissue, said device comprising a distal end portion comprising said ceramic drill tip and a proximal end portion in the form of a non-flexible drill shaft capable of being in operational contact with a power source for generating a rotary motion of at least said distal end portion, said rotary motion resulting in a heat coagulation of said soft tissue being contacted under practical circumstances by at least said rotary distal end comprising said ceramic drill tip. 
     There is also provided the use of a ceramic drill tip in the manufacture of a device for treatment of soft tissue, said device comprising a distal end portion comprising said ceramic drill tip and a proximal end portion in the form of a non-flexible drill shaft capable of being in operational contact with a power source for generating a rotary motion of at least said distal end portion, said rotary motion resulting in hemostasis of said soft tissue being contacted under practical circumstances by at least said rotary distal end comprising said ceramic drill tip. 
    
    
     DRAWINGS 
     FIG. 1 shows a device according to the invention 
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The device according to the present invention is useful in treating soft body tissue in a human or animal. The device comprises a distal end portion comprising a heat-insulating material. The heat insulating material may also be termed heat resistant. Irrespective of which term is being used, the material is characterised by the property of being essentially unable to conduct energy in the form of heat generated for example when soft tissue is contacted by at least said distal end portion in rotary motion. As a result of the heat insulating nature of the material, the generated heat is instead directed towards the surface of the soft tissue where it results in heat coagulation and an improved hemostasis. 
     The device according to the invention also comprises a proximal end portion in the form of a non-flexible drill shaft capable of being in operational contact with a power source. The operable connection to the power source results in a rotary motion of at least said distal end portion. The rotary motion of at least said distal end portion is sufficient to generate the desired heat coagulation of the soft tissue that is contacted under practical circumstances by at least the distal end comprising the heat-insulating material. 
     One effect of achieving heat coagulation of said soft tissue is that the outflow of fluids from said soft tissue is being reduced and/or essentially eliminated during or following a treatment of said soft tissue that involves contacting said tissue with at least said distal end portion comprising said heat insulating material. It is preferred that said heat coagulation essentially eliminates the outflow of fluids from said soft tissue. 
     The fluids may be any serum fluid present in said tissue including fluids comprising blood. When the fluids comprise blood the heat coagulation results in an improved hemostasis by reducing and/or at least essentially eliminating the outflow of blood from said treated soft tissue. The soft tissue capable of being contacted by at least said distal end portion of the device according to the invention is any soft human or animal tissue including tissue comprising vascular tissue, such as soft tissue, comprising mucosal tissue, such as gingival tissue. In one preferred embodiment the soft tissue essentially consists of gingival tissue. 
     The heat insulating material according to the invention is preferably selected from the group consisting of a ceramic material and a cermet in the form of an alloy comprising a heat-insulating compound and a metal. The heat-insulating compound may also be referred to as a heat-resistant compound. Both the ceramic material and the cermet is characterised by being heat-insulating. Accordingly, both the ceramic material and the cermet will direct the generated heat towards the surface of the soft tissue. 
     It is preferred that the heat insulating material either comprises a ceramic material or essentially consists of a ceramic material. It is preferred that the heat insulating material consists of a ceramic material. The distal end portion comprising said heat-insulating material is sterilizable and/or disposable. 
     The distal end portion comprising said heat-insulating material preferably consisting of a ceramic material preferably has a thermal conductivity that is not substantially greater than that of a typical ceramic material, and more preferably, said distal end portion comprising said heat-insulating material is thermally non-conductive or essentially non-conductive. 
     The distal end portion comprising said heat-insulating material preferably consisting of a ceramic material preferably has a Rockwell C hardness of at least about 20, such as about 22, for example about 24, such as about 26, for example about 28, such as about 30, for example about 32, such as about 34, for example about 36, such as about 38, for example about 40, such as about 42, for example about 44, such as about 46, for example about 48, such as about 50, for example about 52, such as about 54, for example about 56, such as about 58, for example about 60, such as about 62, for example about 64, such as about 66, for example about 68, such as about 70, for example about 72, such as about 74, for example about 76, such as about 78, for example about 80, such as about 82, for example about, 84, such as about 86, for example about 88, such as about 90, for example about 95, such as about 100, for example about 105, such as about 110, for example about 115, such as about 120, for example about 130, such as about 140, for example about 150 and preferably a Rockwell C hardness of less than about 200. 
     The distal end portion comprising said heat-insulating material preferably consisting of a ceramic material is preferably electrically non-conductive. This is achieved under practical circumstances when the electrical resistivity of said heat-insulating material is preferably at least about 5×10 2  ohm/cm 2 , for example about 10 3  ohm/cm 2 , such as about 5×10 3  ohm/cm 2 , for example about 10 4 ohm/cm   2 , such as about 5×10 4  ohm/cm 2 , for example about 10 5  ohm/cm 2 , such as about 5×10 5  ohm/cm 2 , for example about 10 6  ohm/cm 2 , such as about 5×10 6  ohm/cm 2 , for example about 10 7  ohm/cm 2 , such as about 5×10 7  ohm/cm 2 . 
     In one embodiment, the ceramic material is preferably selected from the group consisting of a carbide of a transition metal of group IVa of the Periodic Table, a carbide of a transition metal of group Va of the Periodic Table, a nitride of a transition metal of group IVa of the Periodic Table, a nitride of a transition metal of group Va of the Periodic Table, a carbonitride of a transition metal of group IVa of the Periodic Table, a carbonitride of a transition metal of group Va of the Periodic Table, an oxide of a transition metal of group IVa of the Periodic Table, and an oxide of a transition metal of group Va of the Periodic Table, including any mixture thereof. 
     The transition metals of group IVa of the Periodic Table comprise Ti (Titanium), Zr (Zirconium) and Hf (Hafnium). The transition metals of group Va of the Periodic Table comprise V (Vanadium), Nb (Niobium), and Ta (Tantalum). 
     In another embodiment, the ceramic is selected from the group consisting of an aluminum ceramic, a silicon ceramic, a titanium ceramic, a vanadium ceramic, a zirconium ceramic, a niobium ceramic, a carbide ceramic, a nitride ceramic, a carbonitride ceramic, an oxide ceramic, and a dioxide ceramic, including any mixture thereof. 
     Particularly preferred ceramic materials are selected from from the group consisting of aluminum oxide, aluminium silicate, niobium carbide, silicon carbide, silicon nitride, tantalum carbide, titanium carbide, titanium nitride, titanium carbonitride, zirconium oxide, zirconium dioxide, and a mixed oxide of zirconium dioxide and aluminum oxide, including any mixture thereof. 
     A more preferred ceramic material comprises aluminium oxide, and most preferred, the ceramic material essentially consists of aluminium oxide. 
     When the heat insulating material comprises a cermet in the form of an alloy comprising a heat-resistant compound and a metal, said heat-resistant compound is preferably selected from the group consisting of a carbide of a transition metal of group IVa of the Periodic Table, a carbide of a transition metal of group Va of the Periodic Table, a nitride of a transition metal of group IVa of the Periodic Table, a nitride of a transition metal of group Va of the Periodic Table, a carbonitride of a transition metal of group IVa of the Periodic Table, and a carbonitride of a transition metal of group Va of the Periodic Table, including any mixture of some or all of the aforementioned compounds. 
     Any metal may in principle be used in the cermet, and the metal component of the cermet is preferably selected from the group consisting of iron, nickel and cobalt, including any mixture thereof. 
     The rotary motion of said distal end portion must be sufficient to achieve the result of heat coagulating the soft tissue being contacted by at least said distal end portion in said rotary motion. The rotary motion of said distal end portion is preferably at least about 150,000 rounds per minute and preferably less than about 800,000 rounds per minute, such as at least about 170,000 rounds per minute and preferably less than about 775,000 rounds per minute, for example at least about 190,000 rounds per minute and preferably less than about 750,000 rounds per minute, such as at least about 210,000 rounds per minute and preferably less than about 725,000 rounds per minute, for example at least about 230,000 rounds per minute and preferably less than about 700,000 rounds per minute, such as at least about 250,000 rounds per minute and preferably less than about 700,000 rounds per minute, such as at least about 270,000 rounds per minute and preferably less than about 700,000 rounds per minute, for example at least about 290,000 rounds per minute and preferably less than about 700,000 rounds per minute, such as at least about 310,000 rounds per minute and preferably less than about 700,000 rounds per minute, for example at least about 330,000 rounds per minute and preferably less than about 680,000 rounds per minute, such as at least about 340,000 rounds per minute and preferably less than about 660,000 rounds per minute, for example at least about 350,000 rounds per minute and preferably less than about 640,000 rounds per minut, such as at least about 360,000 rounds per minute and preferably less than about 630,000 rounds per minut, for example at least about 370,000 rounds per minute and preferably less than about 620,000 rounds per minut, such as at least about 380,000 rounds per minute and preferably less than about 610,000 rounds per minut, for example at least about 390,000 rounds per minute and preferably less than about 600,000 rounds per minut, such as at least about 400,000 rounds per minute and preferably less than about 590,000 rounds per minut, for example at least about 410,000 rounds per minute and preferably less than about 580,000 rounds per minut, such as at least about 420,000 rounds per minute and preferably less than about 570,000 rounds per minut, for example at least about 430,000 rounds per minute and preferably less than about 560,000 rounds per minut, such as at least about 440,000 rounds per minute and preferably less than about 550,000 rounds per minut, for example at least about 450,000 rounds per minute and preferably less than about 540,000 rounds per minut, such as at least about 460,000 rounds per minute and preferably less than about 530,000 rounds per minut, for example at least about 470,000 rounds per minute and preferably less than about 520,000 rounds per minut, such as at least about 480,000 rounds per minute and preferably less than about  510 , 000  rounds per minut, for example about 500,000 rounds per minut. 
     The distal end portion comprising said heat insulating material is preferably pointed and may form a tip. In particular, when a cutting effect is desired it is preferred that the distal end portion tapers to form a tip. 
     The device may in one preferred embodiment further comprise a linker portion connecting said distal and proximal ends. The linker portion preferably comprises a cavity for harbouring said distal end portion, and said linker portion may further comprise fixation means for maintaining said distal end portion in a fixed position in said cavity. 
     In the aspect of the invention pertaining to a method of heat coagulating soft tissue, and comprising the steps of i)providing a device according to the present invention, ii) providing an individual in need of soft tissue treatment, iii) contacting said soft tissue by at least said distal end portion of said device, and iv) heat coagulating said soft tissue by means of said rotary motion of said distal end portion, said heat coagulation in one embodiment effectively reduces the outflow of fluids including fluids comprising blood from said soft tissue. In another preferred embodiment, the heat coagulation essentially eliminates the outflow of fluids including fluids comprising blood from said soft tissue. 
     The method of heat coagulating soft tissue according to the invention aims to achieve hemostasis and/or results in the achievement of an improved hemostasis. The improved hemostasis is attained for soft tissue comprising vascular tissue, and in particular soft tissue comprising gingival tissue. It is most preferred that the soft tissue essentially consists of gingival tissue. 
     Furthermore, the invention Comprises a method of obtaining a cutting effect with the device. The cutting effect may be obtained by performing brush stroke movements with the distal end of the device against the soft tissue to be treated. When obtaining the cutting effect the device is not forced against the tissue. When obtaining a cutting effect by the device according to the invention a combination of simultaneous cutting and coagulation is obtained decreasing bleeding and secretion of body fluids from the wound. 
     The method of heat coagulating soft tissue may further comprise an additional step of cutting or penetrating said soft tissue by using e.g. a conventional cutting instrument such as a scalpel. In a yet further step there is provided a step of eliminating said soft tissue. 
     In another aspect of the invention, the method of removing gingival tissue by means of treatment and comprising the steps of i) providing a device according to the present invention, ii) providing an individual in need of gingival tissue removal, iii) contacting said gingival tissue by at least said distal end portion of said device, and iv) removing said contacted gingival tissue by means of said rotary motion of said distal end portion of said device, results in a heat coagulation of said soft tissue being contacted under practical circumstances by at least said rotating distal end. The heat coagulation results in an improved hemostasis by at least reducing and/or essentially eliminating the outflow of fluids including blood from said gingival tissue. 
     In yet another aspect the method of lacerating interradiculary granulation tissue and comprising the steps of i) providing a device according to the present invention, ii) providing an individual in need of interradiculary granulation tissue laceration, iii) contacting said granulation tissue with said distal end portion of said device, and iv) lacerating said interradiculary granulation tissue by means of said rotary motion of said distal end portion of said device, results in a heat coagulation of said interradiculary granulation tissue being contacted under practical circumstances by at least said rotating distal end. The heat coagulation results in an improved hemostasis by at least reducing and/or essentially eliminating the outflow of fluids including blood from said interradiculary granulation tissue. 
     In one particularly interesting aspect of the invention, there is provided a device according to the present invention for use in one or more of i) a method of heat coagulating soft tissue as described herein above, ii) a method of removing gingival tissue as described herein above, and iii) a method of lacerating interradiculary granulation tissue as described herein above. 
     One embodiment of the invention pertains to the use of a ceramic drill tip in the manufacture of a device for treatment of soft tissue, wherein said device comprises a distal end portion comprising said ceramic drill tip and a proximal end portion in the form of a non-flexible drill shaft capable of being in operational contact with a power source for generating a rotary motion of said distal end portion, and wherein said rotary motion results in a heat coagulation of said soft tissue being contacted under practical circumstances by at least said rotary distal end comprising said ceramic drill tip. 
     In yet another embodiment there is provided the use of a ceramic drill tip in the manufacture of a device for treatment of soft tissue, wherein said device comprises a distal end portion comprising said ceramic drill tip and a proximal end portion in the form of a non-flexible drill shaft capable of being in operational contact with a power source for generating a rotary motion of said distal end portion, and wherein said rotary motion results in hemostasis of said soft tissue being contacted under practical circumstances by at least said rotary distal end comprising said ceramic drill tip. 
     The device according to the invention is described in greater detail in the relation to the drawings. 
     In FIG. 1, a device  1  according to the invention is shown wherein the distal end portion  2  comprises the heat-insulating material. The distal end portion  2  is preferably provided with a tip  3  of same material. The distal end portion  2  is harboured and fixed in a linker portion  5  connecting the distal end portion  2  to the proximal end portion  4 . The length of the device  1  is preferably below 5 cm, such as from 1.5-3.0 cm. The distal end portion  2  preferably constitutes from ¼-½ of the total length of the device  1 .