Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
  • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
  • A61B18/14—Probes or electrodes therefor
  • A61B18/1402—Probes for open surgery

Definitions

• the present invention relates generally to surgical tools, and more particularly, to surgical tools that can be used for cauterizing and cutting during a surgical operation.
• Bleeding commonly occurs during surgical procedures. Typically, the bleeding emanates from a bleeding vessel during a cutting procedure using, for example, a scalpel. The bleeding can greatly obscure surgeon's view.
• the vessel can be clamped with a surgical instrument to stop the flow of blood, and the vessel can be mended. The mending, however, tends to cause infection and improper healing.
• electrocautery systems have been used to control bleeding from a vessel.
• An electrocautery system delivers an electrical current through a cable to an electrode, which is positioned at the bleeding site.
• a heat or energy source is used to gradually increase the temperature of the electrode, which heats the tissue in order to heat the tissue surrounding the bleeding vessel. By heating the tissue, cauterization occurs at the point of bleeding.
• Known electrocautery systems are separate and distinct from the cutting tools used during surgical procedures. This means that a surgeon must constantly switch between the cutting tool and the electrocautery system during an operation. Accordingly, this increases the risk of mistakes, makes the surgery more complex, and delays the surgical procedure. Thus, a need exists for surgical tools that allow a surgeon to perform cutting and cauterizing at an application site in which the cutting and cauterizing can be performed with the same surgical tool.
• the invention is directed to an apparatus for cutting and cauterizing during a surgical procedure.
• the apparatus includes a surgical tool having a tip formed entirely from a conductive diamond material and at least one mechanical cutting edge.
• the conductive diamond material may serve as an electrical conductor for cauterizing. A surgeon can thus perform cutting and cauterizing using the same surgical tool.
• the invention is directed to a surgical tool having a tip with at least one mechanical cutting edge.
• the tip is formed entirely from a conductive diamond material.
• the invention is directed to a method for manufacturing a surgical tool that includes forming a tip entirely from a conductive diamond material and at least one mechanical cutting edge on the tip, and coupling the tip to a body.
• the invention is directed to a surgical tool that includes a tip having at least one mechanical cutting edge in which the tip is formed entirely from a conductive diamond material.
• the tip is coupled to a body, and a contact electrode is formed integral with the interior of the body which is in electrical communication with the tip.
• FIG. 1 A illustrates a bifacet tip in a first embodiment.
• FIG. IB illustrates a lance or spear tip in a first embodiment.
• FIG. 2A illustrates the bifacet tip of FIG. 1 A in a second embodiment.
• FIG. 2B illustrates the lance or spear tip of FIG. IB in a second embodiment.
• FIG. 3 illustrates the bifacet tip of FIG. 1A in a third embodiment.
• FIG. 4 illustrates a surgical tool coupled to an energy source in accordance with the present invention.
• FIG. 5 A illustrates the bifacet tip of FIG. 1A in a fourth embodiment.
• FIG. 5B illustrates the lance or spear tip of FIG. IB in a third embodiment.
• FIG. 6 illustrates the bifacet tip of FIG. 1A in a fifth embodiment.
• FIG. 7 illustrates the bifacet tip of FIG. 1A in a sixth embodiment.
• FIG. 8 illustrates the surgical tool of FIG. 4 having a push/pull device.
• FIG. 9 illustrates the surgical tool of FIG. 4 having a removable device.
• FIG. 10 illustrates a surgical tool with a tip formed from conductive diamond material in accordance with the present invention.
• the invention is directed to an apparatus for cutting and cauterizing during a surgical procedure.
• the apparatus includes a surgical tool having a tip with one or more edges for cutting, and one or more electrodes formed on at least a portion of the tip for cauterizing.
• the cutting edge preferably has a sharpness suitable for making incisions or for cutting tissue.
• the electrode can be used to pass electrocautery energy to an incision site to control bleeding.
• the invention is based on a principle different from known surgical tools for cauterizing and cutting that are used in industrial and medical applications.
• the apparatus does not use an electrode from a separate electrocautery system to cauterize an area around the incision site; rather, the apparatus includes an electrode formed on at least a portion of the tip to deliver electrocautery energy from an energy source virtually simultaneously during a cutting procedure.
• the cautery and cutting can thus be performed using the same surgical tool.
• Surgical tools for mechanical cutting can be made with tips with multiple facets to form multiple types of cutting edges.
• the tip can be "bifacet" (FIG. 1A), or “lance or spear” (FIG. IB).
• FIG. 1 A shows a bifacet tip 1 with beveled edge 4 and a face 6.
• the edge 4 may be used for cutting during a surgical procedure.
• the edge 4 and the face 6 form an apex 8, which may be used for piercing.
• the edge 4 has a sharpness suitable to cut tissue or make incisions.
• a portion of the tip 1 may be covered with one or more electrodes 10.
• the electrodes 10 are formed on both sides of the tip 1 such that only the edge 4 and the face 6 are exposed.
• the electrodes 10 may be formed from current carrying metals, such as titanium, platinum, copper, nickel, tin, gold, chromium, iron, silver, or other similar conductive metals or alloys.
• the electrodes 10 may also be formed from current carrying ceramic materials, such as titanium nitride, silicon carbide, or tungsten carbide.
• the electrodes 10 may be formed on only a portion of the tip 1.
• the electrical conductors 10 may be applied to one or more surfaces of the tip 1 by painting, vapor deposition, chemical coating, adhesively bonding or other similar techniques.
• the tip 1 may be formed to include a facet 13 formed from diamond and a portion 17 formed from electrically conductive material, such as tungsten nitride, that is deposited onto the surface of the tip 1.
• the portion 17 may be used to deliver energy to the incision site.
• the tip 1, in FIG. 3, may optionally include the electrodes 10.
• the tip 1 may be formed from any combination of materials listed in Table 1 below.
• the tip 1 could be formed from a conductive steel and also include a cutting edge 4 made from, for example, diamond. In this case, the cutting edge 4 could be bonded to a conductive steel portion 17 of the tip 1 by glue.
• FIG. IB illustrates a tip 50 similar to the tip 1.
• the tip 50 includes two beveled edges 54, 56 to form a lance or spear.
• the edges 54, 56 can be used to cut, and the apex 58 can be used to pierce.
• the tip 50 may include one or more electrodes 65 formed on both sides of the tip 50 such that the edges 54, 56 are exposed (FIG. IB).
• the electrode 65 may be formed on only a portion of the tip 50 (FIG. 2B).
• the edges 4, 54, 56 may have a sharpness of about l ⁇ m - 25 nm.
• the "hardness” value can be used to determine a material's resistance to wear.
• the “strength” value can be used to determine a material's resistance to fracture or plastic deformation.
• the "flexure strength” can be used to determine how easily the material can be sharpened. If the flexure strength is not sufficient, a material may bend or break during sharpening.
• the "specific heat” can be defined as heat capacity. Combining the specific heat and “thermal conductivity” values, it can determined how quickly a material may warm during a surgical procedure.
• the thermal conductivity value can be used to determine how quickly energy can pass to, for example, a heat sink coupled to the tips 1 , 50.
• the specific heat value can be used to determine a temperature rise of the material, once a portion of the energy has passed to the heat sink.
• FIG. 4 diagrammatically illustrates an example of a cutting and cauterizing surgical tool 100.
• the surgical tool 100 includes a handle 120.
• the tip 1 is coupled to the member 101.
• the tip 50 or other similar tips can also be used.
• the tip 1 is coupled to the distal end 110 of the handle
• the contact electrode 130 Passing through the handle 120 is a contact electrode 130.
• the contact electrode 130 is configured to be in electrical contact with the electrodes 10 formed on the tip 1.
• the contact electrode 130 is formed from 300-series stainless steel that is passivated or gold plated.
• the contact electrode 130 extends substantially from the distal end 120 to the proximal end 140 of the handle 120. Attached to the proximal end 140 of the contact electrode 130 is a cable 150.
• the cable 150 is preferably connected to an energy source 170. Suitable energy sources are, for example, a Bovie generator.
• the source 170 may include a pedal 175 and a cable 180.
• the cable 180 may be coupled to a return electrode 181 situated on or under the patient's body.
• the switch 175 may be used by a surgeon to manually turn on and off the energy source 170.
• the source 170 may be activated automatically, for example, in predetermined time intervals.
• the source 170 then delivers an electrical current to the contact electrode 130 via the cable 150.
• the electrical current may be increased by, for example, repeatedly pressing the switch 175.
• the current then passes to the electrodes 10 on the tip 1.
• the current then passes through the patient's body to the cable 180 via the return electrode 181.
• This configuration thus forms a complete electrical circuit.
• the surgeon can use the non-cutting edges of the tip 1 to cauterize at the incision site.
• a surgeon can also perform cutting procedures using the tip edge 4 and apex 8. The surgeon can thus use the same surgical tool to perform both cutting and cauterizing, without having to switch between separate surgical tools, as in known systems.
• electromagnetic radiation for example, from a laser, may be delivered through the handle 120.
• the radiation may be delivered using a waveguide (not shown) or other similar device.
• the radiation may be emitted through the edge 4 and the face 6.
• the radiation may be emitted through the edges 54, 56.
• FIG. 5A illustrates the tip 1 in a fourth embodiment.
• a conductor 200 slides parallel to the face 6, and across a surface 7 of the tip 1.
• the electrodes 10, in this embodiment may be optional.
• FIG. 5B shows the tip 50 in a third embodiment. In FIG. 5B, the conductor 200 slides across a surface 55 of the tip 50.
• the tip 50 may optionally include the electrodes 65.
• FIG. 8 shows an example of a push/pull device 204 for sliding the conductor.
• FIG. 8 shows the tip 1 coupled to the handle 120 with the integrated push/pull device 204.
• the tip 1 could be replaced with the tip 50 and also be used with the device 204.
• the device 204 includes a body 206 and a projection 208.
• the conductor 200 is coupled to a distal end 209 of the body 206.
• the contact electrode 130 is coupled to a proximal end 211 of the body 206. In this configuration, the contact electrode 130 and the electrode 200 are electrically coupled together inside the body 206, such that electrocautery energy can be delivered to the electrode 200.
• a surgeon can move the electrode 200 to and from the application site using the projection 208.
• a surgeon can manually push the projection 208 toward the tip 1. This causes the electrode 200 to travel toward the application site across the surface 7.
• the surgeon can retract the electrode 200 by sliding the projection 208 in a direction away from the application site.
• FIG. 6 illustrates an electrode 300 bonded parallel to the face 6 on the surface 7.
• the electrode 300 may have a diameter of about 0.6 mm or less.
• the electrode 300 may be formed from materials similar to the electrodes 10.
• the electrode 300 forms an electrical contact with the contact electrode 130 similar to the electrodes 10. In this configuration, the electrodes 10 may be optional.
• the electrode 300 may be a wire electrode.
• FIG. 7 illustrates an electrode 400 formed integral with the tip 1.
• the electrode 400 is embedded in a cavity 16 of the tip 1.
• the electrode may be about 0.25 mm or less.
• An insulation layer 18 may cover at least a portion of the electrode 400.
• the electrode 400 may be a wire electrode. Similar to the electrode 300, the electrode 400 forms an electrical contact with the contact electrode 130.
• the cavity 16 may also be filled with suitable bonding or filling material to secure the electrode 400 inside the cavity 16.
• the surgical tool 100 may include a removable device
• the device 500 includes the tip 1 rigidly attached to a plug 506.
• the plug 506 includes a locking clip 507 to secure the tip 1, and a pin 504 coupled to the locking clip 507 with a mount 509.
• the pin 504 is coupled to the tip 1 via the plug 506, such that the pin 504 is in electrical communication with the electrodes 10 on the tip 1.
• the pin 504 is configured to frictionally engage the handle 120 through an opening 510. When the pin 504 frictionally engages the handle 120, the pin 504 can electrically communicate with the electrode 130. As a result, electrical current from the source 170 can be delivered to the electrodes 10 via the electrode 130 and the pin 504.
• the surgical tool 100 also includes a button 503 formed integral with the handle 120.
• the button 503 is configured to allow a surgeon to deliver electrical current to the tip 1 via the electrode 130 by pressing the button 503. In this way, the surgeon can immediately and simply deliver electrical current to the application site to cauterize without having to use a separate electrocautery system.
• the removable device 500 allows a surgeon to easily replace the tip 1 with a sharper or different tip.
• the preferred configurations for the surgical tool 100 and the tips 1, 50 are inexpensive, simple, robust, and efficient. A surgeon can cut and cauterize using the same tool. Thus, separate surgical tools are not required, as in known systems. Further, the preferred surgical tools can be used for monopolar and bipolar electrocautery applications. This can be done by operating the electrodes 10, 65, 200, 300, and 400 at different potentials from the contact electrode 130. Additionally, the preferred surgical tool 100 is versatile. Depending on the application, the electrodes can optionally be formed on the tip, brazed to an edge of the tip, embedded in the tip, or retracted to and from the tip. Alternatively, the tip can be formed from a conductive member with a cutting edge bonded thereto.
• the electrodes can be removed and replaced, by, for example, acid etching, such that the same tip can be used for multiple applications.
• a cooling mechanism may be coupled to the surgical tool to cool the tip during cutting or cauterizing.
• the tip may be formed from a conductive diamond material.
• the conductive diamond material may be formed from a wafer of synthetic diamond material that is fabricated by chemical vapor deposition ("CVD"). As the wafer is deposited, boron may be used to dope the diamond. The boron creates depletion areas in the crystal lattice of the synthetic diamond wafer, which causes the diamond material to be electrically conductive, and thus, act as an electrical conductor.
• FIG. 10 illustrates a surgical tool 700 with a tip 701 formed from a conductive diamond material 750.
• the tip 701 may have a shape similar to the tips 1, 50 described above.
• the tip 701 is rigidly attached to a proximal end 703 of the surgical tool 700 using, for example, glue.
• the surgical tool 700 may be a surgical scalpel that is formed from an insulator that can withstand the temperatures and pressures of known autoclave sterilization.
• Suitable insulating materials include polycarbonate, polysulfone, or other suitable engineering plastic.
• the surgical tool 700 may be used to cut and cauterize tissue similar to the surgical tool 100 described above.
• a contact electrode 710 similar to the contact electrode 130 described above may pass through the body 720 of the surgical tool 700.
• a distal end 740 of the contact electrode 710 may be connected to the energy source 170 via the cable 150, as described above.
• An electrical current may be delivered from the energy source 170 to the tip of 701 via the proximal end of 707 of the contact electrode 710, similar to the operations of the contact electrode described above.
• no additional electrodes for example electrodes 10, 65, 200, 300, and 400, are required using the conductive diamond tip 701. This is because the synthetic diamond material, doped with boron using a CVD process, generates an electrical conductor, which is suitable for cauterizing tissue.
• the preferred surgical tool 700 is thus formed using principles different from known surgical tools for cutting or cauterizing.
• the tip 701 is not formed by depositing or adding a conductive material, such as ceramic, directly to a pre-existing blade or tip; rather the tip 701 itself is formed entirely from a synthetic conductive diamond material, which does not require the addition of a conductive material.
• the surgical tool 700 can be used for both cutting and cauterizing during a surgical procedure without requiring additional electrodes to be formed on the tip.
• the preferred tip 701 can include a cutting edge that is substantially sharper than edges formed using known material, such as steel. This is because the conductive diamond material has a hardness value which is much higher than other known materials, as described above.
• a non-stick coating may be placed on at least a portion of the electrodes to minimize or prevent tissue from sticking to the tip.
• Suitable coatings include fluoropolymers, such as TeflonTM, ceramic titanium alloys, and ceramics including transition metals, such as titanium nitride.
• the electrodes 10, 65, 200, 300, and 400 may be removed from the tips 1, 50 by acid etching and can be coated with a friction reducing compound, such as Teflon , Parylene , or other compounds, which can prevent the adhesion of cauterized tissue to the cutting edges.

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• 2001
  • 2001-01-11 EP EP01942291A patent/EP1248576A2/de not_active Withdrawn
  • 2001-01-11 WO PCT/US2001/001063 patent/WO2001050964A2/en not_active Application Discontinuation
  • 2001-01-11 AU AU2001229405A patent/AU2001229405A1/en not_active Abandoned

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