Patent Grant
11065023
This invention relates to arthroscopic tissue cutting and removal devices by which anatomical tissues may be cut and removed from a joint or other site. More specifically, this invention relates to instruments configured for cutting and removing tissue with a ceramic cutting member and/or electrosurgically treating tissue with an electrode carried by the ceramic cutting member.
In several surgical procedures including subacromial decompression, anterior cruciate ligament reconstruction involving notchplasty, and arthroscopic resection of the acromioclavicular joint, there is a need for cutting and removal of bone and soft tissue. Currently, surgeons use arthroscopic shavers and burrs having rotational cutting surfaces to remove tissue for such procedures. A typical arthroscopic shaver or burr comprises a metal cutting member carried at the distal end of a metal sleeve that rotates within an open-ended metal shaft. A suction pathway for removal of bone fragments or other tissues is provided through a window proximal to the metal cutting member that communicates with a lumen in the sleeve.
When metal shavers and burrs “wear” during a procedure, which occurs very rapidly when cutting bone, the wear can be accompanied by loss of micro-particles from fracture and particle release which occurs along with dulling due to metal deformation. In such surgical applications, even very small amounts of such foreign particles that are not recovered from a treatment site can lead to detrimental effects on the patient health, with inflammation being typical. In some cases, the foreign particles can result in joint failure due to osteolysis, a term used to define inflammation due to presence of such foreign particles. A recent article describing such foreign particle induced inflammation is Pedowitz, et al. (2013) Arthroscopic surgical tools: “A source of metal particles and possible joint damage”, Arthroscopy—The Journal of Arthroscopic and Related Surgery, 29(9), 1559-1565. In addition to causing inflammation, the presence of metal particles in a joint or other treatment site can cause serious problems for future MRIs. Typically, the MRI images will be blurred by agitation of the metal particles caused by the magnetic field used in the imaging, making assessments of the treatment difficult.
Another problem with the currently available metal shavers/burrs relates to manufacturing limitations in combination with the rapid dulling of metal cutting edges. Typically, a metal cutter is manufactured by machining the cutting surfaces and flutes into a burr or abrader surface. The flute shape and geometry can be limited since it is dictated by the machining process, and burr size and shape limitations may direct usage toward more coarse bone removal applications. Further, when operated in a rotational or oscillatory mode, the cutting edges adapted for coarse bone removal may have a kickback effect as the flutes first make contact with bone, which is aggravated by rapid dulling of the machined cutting edges.
Therefore, the need exists for arthroscopic burrs and/or shavers that can operate to cut and remove bone without the release of fractured particles and micro-particles into the treatment site. Further, there is a need for burrs/cutters that do not wear rapidly and that can have cutting edges not limited by metal machining techniques.
As an alternative to such arthroscopic cutters and shavers, another class of tissue removal tools relies on radiofrequency (RF) ablation to remove the soft tissue. Tools such as those described in U.S. Pat. Nos. 6,149,620 and 7,678,069 can be highly effective in volumetric removal of soft tissue in the knee and elsewhere but are ineffective in resecting bone.
Therefore, the need exists for tools that can effectively remove both bone and soft tissue and which can combine the advantages of both cutter-based hard tissue resection and RF-based soft tissue ablation. At least some of these objectives will be met by the inventions described below.
Pedowitz, et al. (2013), Arthroscopy—The Journal of Arthroscopic and Related Surgery, 29(9), 1559-1565; U.S. Pat. Nos. 6,149,620; and 7,678,069, discussed above.
The present invention provides a variety of improved tissue removal devices and methods, including devices and methods which can remove tissue by cutting (resection) and/or by radiofrequency (RF) ablation.
In a first specific aspect of the present invention, a medical device for removing tissue includes an elongated outer sleeve has a distal opening, and a ceramic cutting member is rotatably disposed in the elongated outer sleeve. The ceramic cutting member has a proximal end and distal end disposed in the distal opening of the sleeve. A cutting window with at least one sharp cutting edge is formed in the distal end of the ceramic cutting member, where the sharp edge is configured to cut soft tissue as the cutting member is rotated or rotationally oscillated and engaged against soft tissue. At least one flute with a burr cutting edge is formed in the distal end of the ceramic cutting member, where the burr edge is configured to cut bone as the cutting member is rotated or rotationally oscillated and engaged against bone, and the burr cutting edge is circumferentially spaced-apart from the sharp cutting edge.
In specific embodiments of this medical device, an electrode may be carried on the distal end of the ceramic cutting member to provide for electrocautery or RF ablation, either as a supplement or alternative to the cutting of soft and hard tissue. The electrode and/or the cutting window are typically disposed circumferentially between a pair of flutes, and the cutting window may optionally disposed circumferentially between a pair of flutes, where the cutting window is typically diametrically opposed to the electrode and disposed circumferentially between the same pair of flutes.
In further specific embodiments, the window opens to a central channel in the cutting member, where the window communicates with an interior channel in the outer sleeve. The interior channel is configured to be connected to a negative pressure source to aspirate material cut by the cutting window and/or the flutes. The elongated sleeve typically extends along a longitudinal axis, and the at least one sharp cutting edge of the cutting widow and/or the at least one burr cutting edge of the flute will usually be aligned generally with the longitudinal axis. These medical devices may still further comprise a handle configured to removably attach the outer sleeve and ceramic cutting member. Such handles typically comprise a motor drive configured to couple to a proximal end of the elongated sleeve to rotate and/or rotationally oscillate the ceramic cutting member relative to the elongated sleeve.
In a second aspect of the present invention, a system for removing tissue in a patient includes any of the medical device described above and elsewhere herein in combination with a controller configured to energize the electrode and to power and control the motor drive to rotate, rotationally oscillate, and position the ceramic cutting member relative to the elongated sleeve. The controller may be further configured to rotate the ceramic cutting member in a first direction to cut soft tissue and in a second direction to cut hard tissue. Alternatively or additionally, the controller may be configured to rotationally oscillate the ceramic cutting member to cut soft tissue and/or to cut hard tissue. Alternatively or additionally, the controller may be configured to simultaneously rotate or rotationally oscillate the ceramic cutting member and to deliver RF energy to the electrode to cut soft tissue and/or to cut hard tissue. Alternatively or additionally, the ceramic cutter may carry position sensors and the controller may be configured to sense rotational position of the ceramic cutter relative to the elongated sleeve. Alternatively or additionally, the controller may be configured to sense when the ceramic cutter is rotationally misaligned and to stop rotation and/or provide an alarm when such misalignment is sensed. Alternatively or additionally, the controller may be configured to automatically center the electrode within the opening in elongated sleeve. Alternatively or additionally, the controller may be configured to determine a size of the cutting window and to determine an oscillation range for the ceramic cutting member based on the size of the widow.
In a third aspect of the present invention, methods for selectively cutting hard tissue or soft tissue may utilize any of the medical devices and systems described previously or elsewhere herein. Such methods comprise engaging the distal end of the ceramic cutting member against hard tissue and rotating or rotationally oscillating the flutes against the hard tissue to abrade the hard tissue. The methods will usually further comprise selectively engaging the distal end of the ceramic cutting member against soft tissue and rotating or rotationally oscillating the cutting window against the soft tissue to cut the hard tissue. The methods may further or alternatively comprise simultaneously delivering RF energy with the electrode while rotating or rotationally oscillating the ceramic cutting member. The methods may still further or alternatively comprise sensing when the ceramic cutter is rotationally misaligned and stopping rotation and/or providing an alarm when such misalignment is sensed.
In other aspects of this invention, a medical device for removing tissue includes an elongated sleeve having a longitudinal axis, a proximal end, and a distal end. A ceramic cutting member with at least one cutting edge extends distally from the distal end of the elongated sleeve, and an electrode is carried by the cutting member. A motor drive is configured to couple to the proximal end of elongated sleeve to rotate the cutting member. In some embodiments, the elongated sleeve is an inner sleeve and is coaxially and rotatably disposed in an outer sleeve, where the outer sleeve may have a cut-out to expose the ceramic cutting member and the electrode.
The cutting edge of medical device for removing tissue will have a radially outward rotational periphery which is at least as great as an outward rotational periphery of the electrode, and the dielectric material typically comprises a wear-resistant ceramic material, usually consisting exclusively of the wear-resistant ceramic material. Exemplary wear-resistant ceramic materials are selected from the group consisting of yttria-stabilized zirconia, magnesia-stabilized zirconia, ceria-stabilized zirconia, zirconia toughened alumina and silicon nitride. The medical device will typically further comprise an RF source connected to the electrode and a controller operatively connectable to the motor drive, the RF source, and a negative pressure source.
The cutting member of the medical device will often have at least one window in a side thereof which communicates with an interior channel of the elongated (inner) sleeve which is configured to be connected to a negative pressure source. The window is typically adjacent to the electrode so that material released by resection and/or ablation can be aspirated through said window. The window optionally can be used for fluid infusion for use in electrosurgery. In some instances, the window is proximal to the electrode and/or proximal to the cutting edges, an/or at least partly intermediate the cutting edges. The cutting member may have from 1 to 100 cutting edges, a diameter ranging between 2 mm and 10 mm, and may extend over an axial length ranging between 1 mm and 10 mm. The cutting edges may be arranged in a pattern selected from at least one of helical, angled and straight relative to said axis.
In a second specific aspect of the present invention, a medical system for removing tissue includes an elongated rotatable shaft with a distal tip comprising (or composed of) a ceramic material. A motor drive is configured to rotate the shaft and the distal tip, and an electrode is carried by the distal tip. The electrode is coupled to an RF source, and a controller is operatively connected to the motor drive and to the RF source. The controller is configured to stop rotation of the shaft in a selected position, such as a position that will expose the electrode in a position that allows it to be used for ablative or other tissue treatment.
The medical device may further include a sensor configured to sense a rotational position of the shaft and to send signals to the controller indicating said rotational position. The controller may be configured to stop rotation of the shaft in the selected or other position, for example when a portion of distal tip such as the electrode or cutter element is properly oriented to perform a desired ablation, resection, or other treatment. The sensor is usually a Hall sensor. The controller may be further configured to control delivery of RF energy to the electrode when the shaft in said selected position. The distal tip of the rotatable shaft may have at least one window in a side thereof that opens to an interior channel in the shaft where the channel is configured to communicate with a negative pressure source. The window may be adjacent the electrode and/or may be at least partly proximal to the electrode. The distal tip may comprise or consist entirely of a wear-resistant ceramic material, such as those listed elsewhere herein.
In a third specific aspect of the present invention, a medical device for removing tissue includes an elongated shaft with a distal tip having a ceramic member. A window in the ceramic member connects to an interior channel in the shaft, and an electrode in the ceramic member is positioned adjacent to the window. The interior channel is configured to be coupled to a negative pressure source.
The electrode is usually disposed distally of the window, and the electrode may have a width equal to at least 50% of a width of the window, sometimes being at least 80% of the width of the window, and sometimes being at least 100% of the width of the window, or greater. At least one side of the window may have a sharp edge, and the electrode may at least partly encircle the distal end of the window. The ceramic member may have at least one sharp edge for cutting tissue, and a radially outward surface of the ceramic member usually defines a cylindrical periphery with an outward surface of the electrode being within said cylindrical periphery. The ceramic member will usually have at least one and more usually a plurality of sharp edges for cutting tissue.
In a fourth specific aspect of the present invention, a method for electrosurgical tissue ablation comprises providing an elongated shaft with a working end including an active electrode carried adjacent to a window that opens to an interior channel in the shaft. The channel is connected to a negative pressure source, and the active electrode and window are positioned in contact with target tissue in a fluid-filled space. The negative pressure source may be activated to suction the target tissue into the window, and the active electrode is activated (typically to deliver RF energy) to ablate tissue while translating the working end relative to the targeted tissue.
In specific aspects of the methods, a motor drive rotates the shaft and the distal tip (typically at at least 3,000 rpm), and a controller operatively connects the interior channel to the negative pressure source and an RF source to the electrode. The ceramic member is a wear-resistant material, typically as noted previously herein. Tissue debris is aspirated through the interior channel, and the working end is translated to remove a surface portion of the targeted tissue and/or to undercut the targeted tissue to thereby remove chips of tissue.
In still further aspects, the present invention provides a high-speed rotating cutter or burr that is fabricated entirely of a ceramic material. In one variation, the ceramic is a molded monolith with sharp cutting edges and is adapted to be motor driven at speeds ranging from 3,000 rpm to 20,000 rpm. The ceramic cutting member is coupled to an elongate inner sleeve that is configured to rotate within a metal, ceramic or composite outer sleeve. The ceramic material is exceptionally hard and durable and will not fracture and thus not leave foreign particles in a treatment site. In one aspect, the ceramic has a hardness of at least 8 GPa (kg/mm2) and a fracture toughness of at least 2 MPam1/2. The “hardness” value is measured on a Vickers scale and “fracture toughness” is measured in MPam1/2. Fracture toughness refers to a property which describes the ability of a material containing a flaw to resist further fracture and expresses a material's resistance to such fracture. In another aspect, it has been found that materials suitable for the cutting member of the invention have a certain hardness-to-fracture toughness ratio, which is a ratio of at least 0.5 to 1.
While the cutting assembly and ceramic cutting member of the invention have been designed for arthroscopic procedures, such devices can be fabricated in various cross-sections and lengths and can be use in other procedures for cutting bone, cartilage and soft tissue such as in ENT procedures, spine and disc procedures and plastic surgeries.
In another aspect, the present invention provides a medical device that includes an elongated sleeve having a longitudinal axis, a proximal end and a distal end. A cutting member extends distally from the distal end of the elongated sleeve, and has sharp cutting edges. The cutting head is formed from a wear-resistant ceramic material, and a motor coupled to the proximal end of elongated sleeve rotates the cutting member. The cutter may be engaged against bone and rotated to cut bone tissue without leaving any foreign particles in the site.
The wear-resistant ceramic material may comprise any one or combination of (1) zirconia, (2) a material selected from the group of yttria-stabilized zirconia, magnesia-stabilized zirconia and zirconia toughened alumina, or (3) silicon nitride. The cutting member typically has from 2 to 100 cutting edges, a cylindrical periphery, and is usually rounded in the distal direction. The cutting member will typically have diameter ranging from 2 mm to 10 mm, and the cutting edges will typically extend over an axial length ranging between 1 mm and 10 mm. The cutting edges may be any one of helical, angled or straight relative to said axis, and flutes between the cutting edges usually have a depth ranging from 0.10 mm to 2.5 mm. An aspiration tube may be configured to connect to a negative pressure source, where the cutting member has at least one window in a side thereof which opens to a hollow interior. In these embodiments, the hollow interior is open to a central passage of the elongated member which is connected to the aspiration tube.
In a further aspect, the present invention provides a medical device for treating bone including an elongated shaft having a longitudinal axis, a proximal end, and a distal end. A monolithic cutting member fabricated of a material having a hardness of at least 8 GPa (kg/mm2) is coupled to the distal end of the elongated shaft, and a motor is operatively connected to the proximal end of the shaft, said motor being configured to rotate the shaft at at least 3,000 rpm.
The material usually has a fracture toughness of at least 2 MPam1/2, and further usually has a coefficient of thermal expansion of less than 10 (1×106/° C.). The material typically comprises a ceramic selected from the group of yttria-stabilized zirconia, magnesia-stabilized zirconia, ceria-stabilized zirconia, zirconia toughened alumina and silicon nitride, and the cutting member typically has a cylindrical periphery and an at least partly rounded periphery in an axial direction.
In a still further aspect, the present invention provides a medical device for treating bone comprising a monolithic cutting member fabricated of a material having a hardness-to-fracture toughness ratio of at least 0.5:1, usually at least 0.8:1, and often at least 1:1.
In yet another aspect, the present invention provides a medical device for cutting tissue including a motor-driven shaft having a longitudinal axis, a proximal end, a distal end, and a lumen extending therebetween. A rotatable cutting member is fabricated entirely of a ceramic material and is operatively coupled to the distal end of the motor-driven shaft. At least one window in the cutting member communicates with the lumen in the shaft, and a negative pressure source is in communication with the lumen to remove cut tissue from an operative site.
The ceramic material typically has a hardness of at least 8 GPa (kg/mm2) and a fracture toughness of at least 2 MPam1/2. Additionally, the ceramic material will usually have a coefficient of thermal expansion of less than 10 (1×106/° C.). Exemplary ceramic materials are selected from the group consisting of yttria-stabilized zirconia, magnesia-stabilized zirconia, ceria-stabilized zirconia, zirconia toughened alumina and silicon nitride, and the cutting member usually has cutting edges where the at least one window is proximate to the cutting edges, and the at least one window is in at least one flute between the cutting edges.
In another aspect, the present invention provides a method for preventing foreign particle induced inflammation at a bone treatment site. A rotatable cutter fabricated of a ceramic material having a hardness of at least 8 GPa (kg/mm2) and a fracture toughness of at least 2 MPam1/2 is engaged against bone and rotated to cut bone tissue without leaving any foreign particles in the site.
The ceramic material is usually selected from the group consisting of yttria-stabilized zirconia, magnesia-stabilized zirconia, ceria-stabilized zirconia, zirconia toughened alumina and silicon nitride, and the cutter is typically rotated at 10,000 rpm or greater. Cut bone tissue is removed from the bone treatment site through a channel in the cutter, typically by aspirating the cut bone tissue through the channel.
In a first specific aspect of the present invention, a device for removing tissue in a patient comprises a shaft having a longitudinal axis. The shaft includes (1) an outer sleeve having a distal region with an outer window and an axial bore therethrough and (2) an inner sleeve axis rotationally disposed in the axial bore of the outer sleeve. A dielectric cutting member having a longitudinal axis is carried at a distal end of the inner sleeve, and the dielectric cutting member has an inner window with at least one sharp cutting edge. An electrode is disposed on an exterior surface of the cutting member so that the inner sleeve can be rotated by a motor or otherwise relative to the outer sleeve to expose the electrode through the outer window of the outer sleeve.
The cutting member is usually cylindrical, and the inner window typically has two circumferentially spaced-apart edges wherein at least one of said edges carries or defines the sharp cutting edge. Often, each of the two circumferentially spaced-apart window edges defines or carries a sharp cutting edge. In many embodiments, the electrode is an elongate electrode aligned longitudinally with the axis of the cutting member. The elongate electrode is typically circumferentially spaced-apart from the at least one sharp cutting edge of the inner window.
Such medical device usually will include a motor drive configured to be detachably coupled to the shaft to rotate the inner sleeve and the cutting member relative to the outer sleeve. The motor drive usually includes a controller configured automatically stopping rotation of the inner sleeve and cutting member relative to the outer sleeve to position the electrode within said outer window.
A rotational position sensor that senses the relative rotational positions of the inner sleeve and the outer sleeve may be employed to deliver the positional information to the controller, and the controller may use the positional information to position the inner sleeve and cutting member relative to the outer sleeve to position the electrode within said outer window.
In specific embodiment, the cutter member may comprise an electrically insulating ceramic material, and the inner and outer sleeves of the shaft may comprise an electrically conductive metal. In such designs, an electrically insulating layer will be disposed between an interior surface of the axial bore of the outer sleeve and an exterior surface of the inner sleeve. An electrically conductive inner sleeve allows the electrode to be electrically coupled to to the controller and associated electrosurgical power supply via the inner sleeve.
In a second specific aspect of the present invention, a method for removing tissue in a patient comprises positioning a distal end of a shaft at a tissue target site so that an outer window of an outer sleeve of the shaft is engaged against a target tissue. An inner window of a ceramic cutting member carried by an inner sleeve of the shaft is counter-rotated relative to the outer window of the outer sleeve of the shaft to shear target tissue which penetrates through the windows. Rotation of the inner and outer sleeves may be stopped to expose an electrode on the ceramic cutting member in the outer window. The exposed electrode may then be engaged against target tissue, and electrical current delivered through the electrode to the target tissue engaged by the electrode.
The electrical current is usually a radiofrequency current, and the electrical current may be delivered to cauterize or ablate tissue. As a particular advantage, the electrical current may be delivered to cauterize tissue at a location where tissue had been sheared by the counter-rotating windows.
In a still further aspect of the present invention, a medical shaver device for removing tissue comprising inner and outer concentric sleeves extending to a working end with a distal tissue cutting member. A light emitter carried by the working end. The light emitter may be carried by the inner sleeve, may be carried by the outer sleeve, or in some instances could be carried by or span both the inner and outer sleeves The light emitter is typically a light emitting diode.
In yet another aspect of the present invention, a method for removing tissue comprising providing a tissue cutter having a light-emitting source at an end adjacent to a tissue cutting member. A target tissue is exposed to light emitted from the light-emitting source on the tissue cutter so that light passes through the target tissue. Tissue characteristics can be determined based upon the observed light which passes through the tissue, and the tissue can be cut with the tissue cutter based upon the observed tissue characteristics. Salient tissue characteristics may be assessed based upon the observed tissue translucence and include any one of a thickness of an anatomic structures, a cutting depth, and a location of adjacent anatomic structures, and the like.
In alternative embodiments of the device, a single elongated sleeve may be provided and used to remove tissue. The single elongated sleeve may be used without a second sleeve and carries a dielectric cutting member extending distally from a distal end of the sleeve. A window with at least one sharp cutting edge is disposed in or on the cutting member, and an electrode is also carried by the cutting member, typically being circumferentially spaced-apart from the window. The device typically further includes a motor drive configured to couple to a proximal end of the elongated sleeve to rotate the cutting member.
In other aspects of the present invention, the electrodes may have a plurality of micropores or microchannels therein configured to communicate with a negative pressure source, typically via a central channel in ceramic body and/or a bore through an associated sleeve. During use of a working end in a saline-submerged working space, typically when the electrode is energized to coagulate or ablate tissue, the negative pressure source can be actuated to draw fluid through the microchannels of the electrode to inhibit or eliminate bubble formation about the electrode surface which can significantly improve endoscopic viewing of the targeted treatment site.
In yet another aspect of the present invention, a robust and economical connection between the ceramic body the associated metal sleeve can be made without on adhesive bonds, brazing or the like. A metal collar, typically having a thin wall, has openings or slots for receiving projecting features formed on a reduced diameter proximal region of the ceramic body. Each receiving opening typically has a first longitudinal surface and a second longitudinal surface that interface with longitudinal surfaces of the projecting features. The collar can have an axial discontinuity or break to allow it to circumferentially open or flex apart to be placed over the projecting features on the proximal region of the ceramic body. The outer diameter of the metal collar is typically dimensioned to fit into a bore of the inner sleeve. After assembly, the metal sleeve can be permanently welded to the metal collar, e.g. by laser welding from the exterior of metal sleeve.
Various embodiments of the present invention will now be discussed with reference to the appended drawings. It should be appreciated that the drawings depict only typical embodiments of the invention and are therefore not to be considered limiting in scope.
The present invention relates to bone cutting and removal devices and related methods of use. Several variations of the invention will now be described to provide an overall understanding of the principles of the form, function and methods of use of the devices disclosed herein. In general, the present disclosure provides for an arthroscopic cutter or burr assembly for cutting or abrading bone that is disposable and is configured for detachable coupling to a non-disposable handle and motor drive component. This description of the general principles of this invention is not meant to limit the inventive concepts in the appended claims.
In general, the present invention provides a high-speed rotating ceramic cutter or burr that is configured for use in many arthroscopic surgical applications, including but not limited to treating bone in shoulders, knees, hips, wrists, ankles and the spine. More in particular, the device includes a cutting member that is fabricated entirely of a ceramic material that is extremely hard and durable, as described in detail below. A motor drive is operatively coupled to the ceramic cutter to rotate the burr edges at speeds ranging from 3,000 rpm to 20,000 rpm.
In one variation shown in
The cutter assembly 100 has a shaft 110 extending along longitudinal axis 115 that comprises an outer sleeve 120 and an inner sleeve 122 rotatably disposed therein with the inner sleeve 122 carrying a distal ceramic cutting member 125. The shaft 110 extends from a proximal hub assembly 128 wherein the outer sleeve 120 is coupled in a fixed manner to an outer hub 140A which can be an injection molded plastic, for example, with the outer sleeve 120 insert molded therein. The inner sleeve 122 is coupled to an inner hub 140B (phantom view) that is configured for coupling to the motor drive unit 105 (
Referring to
In
Now referring to
The authors evaluated technical ceramic materials and tested prototypes to determine which ceramics are best suited for the non-metal cutting member 125. When comparing the material hardness of the ceramic cutters of the invention to prior art metal cutters, it can easily be understood why typical stainless steel bone burrs are not optimal. Types 304 and 316 stainless steel have hardness ratings of 1.7 and 2.1, respectively, which is low and a fracture toughness ratings of 228 and 278, respectively, which is very high. Human bone has a hardness rating of 0.8, so a stainless steel cutter is only about 2.5 times harder than bone. The high fracture toughness of stainless steel provides ductile behavior which results in rapid cleaving and wear on sharp edges of a stainless steel cutting member. In contrast, technical ceramic materials have a hardness ranging from approximately 10 to 15, which is five to six times greater than stainless steel and which is 10 to 15 times harder than cortical bone. As a result, the sharp cutting edges of a ceramic remain sharp and will not become dull when cutting bone. The fracture toughness of suitable ceramics ranges from about 5 to 13 which is sufficient to prevent any fracturing or chipping of the ceramic cutting edges. The authors determined that a hardness-to-fracture toughness ratio (“hardness-toughness ratio”) is a useful term for characterizing ceramic materials that are suitable for the invention as can be understood form the Chart A below, which lists hardness and fracture toughness of cortical bone, a 304 stainless steel, and several technical ceramic materials.
As can be seen in Chart A, the hardness-toughness ratio for the listed ceramic materials ranges from 98× to 250× greater than the hardness-toughness ratio for stainless steel 304. In one aspect of the invention, a ceramic cutter for cutting hard tissue is provided that has a hardness-toughness ratio of at least 0.5:1, 0.8:1 or 1:1.
In one variation, the ceramic cutting member 125 is a form of zirconia. Zirconia-based ceramics have been widely used in dentistry and such materials were derived from structural ceramics used in aerospace and military armor. Such ceramics were modified to meet the additional requirements of biocompatibility and are doped with stabilizers to achieve high strength and fracture toughness. The types of ceramics used in the current invention have been used in dental implants, and technical details of such zirconia-based ceramics can be found in Volpato, et al., “Application of Zirconia in Dentistry: Biological, Mechanical and Optical Considerations”, Chapter 17 in Advances in Ceramics—Electric and Magnetic Ceramics, Bioceramics, Ceramics and Environment (2011).
In one variation, the ceramic cutting member 125 is fabricated of an yttria-stabilized zirconia as is known in the field of technical ceramics, and can be provided by CoorsTek Inc., 16000 Table Mountain Pkwy., Golden, Colo. 80403 or Superior Technical Ceramics Corp., 600 Industrial Park Rd., St. Albans City, Vt. 05478. Other technical ceramics that may be used consist of magnesia-stabilized zirconia, ceria-stabilized zirconia, zirconia toughened alumina and silicon nitride. In general, in one aspect of the invention, the monolithic ceramic cutting member 125 has a hardness rating of at least 8 GPa (kg/mm2). In another aspect of the invention, the ceramic cutting member 125 has a fracture toughness of at least 2 MPam1/2.
The fabrication of such ceramics or monoblock components are known in the art of technical ceramics, but have not been used in the field of arthroscopic or endoscopic cutting or resecting devices. Ceramic part fabrication includes molding, sintering and then heating the molded part at high temperatures over precise time intervals to transform a compressed ceramic powder into a ceramic monoblock which can provide the hardness range and fracture toughness range as described above. In one variation, the molded ceramic member part can have additional strengthening through hot isostatic pressing of the part. Following the ceramic fabrication process, a subsequent grinding process optionally may be used to sharpen the cutting edges 175 of the burr (see
In
Referring to
It can be understood that the ceramic cutting members can eliminate the possibility of leaving metal particles in a treatment site. In one aspect of the invention, a method of preventing foreign particle induced inflammation in a bone treatment site comprises providing a rotatable cutter fabricated of a ceramic material having a hardness of at least 8 GPa (kg/mm2) and/or a fracture toughness of at least 2 MPam1/2 and rotating the cutter to cut bone without leaving any foreign particles in the treatment site. The method includes removing the cut bone tissue from the treatment site through an aspiration channel in a cutting assembly.
In the variation illustrated in
The active electrode arrangement 425 can consist of a single conductive metal element or a plurality of metal elements as shown in
As can be seen in
Another aspect of the invention is illustrated in
In general, the tissue resecting system comprises an elongated shaft with a distal tip comprising a ceramic member, a window in the ceramic member connected to an interior channel in the shaft and an electrode arrangement in the ceramic member positioned distal to the window and having a width that is at least 50% of the width W of the window, usually at least 80% of the width W of the window, and often at least 100% of the width W of the window, or greater. Further, the system includes a negative pressure source 160 in communication with the interior channel 420.
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Under endoscopic vision, referring to
In general, a method corresponding to the invention includes providing an elongated shaft with a working end 400 comprising an active electrode 425 carried adjacent to a window 415 that opens to an interior channel in the shaft which is connected to a negative pressure source, positioning the active electrode and window in contact with targeted tissue in a fluid-filled space, activating the negative pressure source to thereby suction targeted tissue into the window and delivering RF energy to the active electrode to ablate tissue while translating the working end across the targeted tissue. The method further comprises aspirating tissue debris through the interior channel 420. In a method, the working end 400 is translated to remove a surface portion of the targeted tissue. In a variation of the method, the working end 400 is translated to undercut the targeted tissue to thereby remove chips 488 of tissue.
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With further reference to
In order to provide the desired electrosurgical function, the active electrode 750 and return electrode 755 must be electrically isolated one another during operation (or the power circuit would short out). To avoid shorting, the active electrode 750 can only be powered (activated) when said active electrode 750 is exposed in window 716 of the outer sleeve 710 and thus out of contact with all portions of outer sleeve 710. Typically, the inner sleeve 712 and cutting member 720 are maintained in a stopped position where the active electrode 750 is exposed in the window 720 so that said active electrode is available to treat tissue (through window 712 in the outer sleeve 710) and remains out of contact with the return electrode 755. As can be understood from
To position the active electrode 750 and enable the electrosurgical mode, the controller 155 may be programmed or otherwise adapted to automatically stop rotation of the inner sleeve 712 and ceramic cutting member 720 in a pre-selected “stopped” rotational position around axis 705 as shown in
In another variation, the controller 155 can be programmed or adapted to provide a plurality of “stopped” positions which can provide for open gaps having different widths to control suction through the partly aligned windows 716 and 725, or the windows may be moved completely out of alignment (closed) to stop suction and prevent any loss of material which had been previously aspirated. Further, the controller 155 can be adapted to modulate, pulse, or terminate fluid outflows through partly aligned windows 716 and 725 while operating in the electrosurgical mode to optimize RF coagulation or RF ablation parameters.
In specific examples, the controller 155 and motor drive unit 105 are configured with a sensor or other mechanism to automatically stop rotation of the inner sleeve 712 within the outer sleeve 710 with the electrode 750 exposed generally in the center of window 716. A number of mechanisms can be used for stopping rotation of the inner sleeve 712 in a known location. For example, Hall sensors or micro-switches in the inner and outer hubs (see
In another aspect of the invention,
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As can be seen from
In the variation of
Now turning to
Of particular interest, the electrode 950 is microporous and in one variation has a plurality of micropores or microchannels 970 therein that communicate with the central channel 960 in ceramic body 905 and bore 956 of inner sleeve 910 which is connected to a negative pressure source 965. During use of the working end 900 in a saline-submerged working space at the time the electrode 950 is energized to coagulate or ablate tissue, the negative pressure source 965 can be actuated to draw fluid through the microchannels 970 of the electrode 950 which can eliminate bubble formation about the electrode surface which is very important for endoscopic viewing of the targeted treatment site. The controller further can provide different levels of negative pressure for each of the coagulation mode of operation and the ablation mode of operation, with the coagulation mode using a lower level of negative pressure and fluid outflow through the microchannels 970 and the ablation mode using a higher level of negative pressure and fluid outflows through the microchannels.
In general, the electrode 950 typically has a surface area ranging from 1 mm2 to 10 mm2, and more often the electrode surface area range from 2 mm2 to 5 mm2. In a typical variation, the micropores comprise channels having a diameter ranging between 10 micrometers and 100 micrometers, and more often the micropores have a diameter ranging between 20 micrometers and 50 micrometers.
Turning to
Now referring again to
As can be understood from
It has been found that a plurality of projecting features 995 and receiving opening slots 1008 is desired to distribute loads over the ceramic body which can be subject to substantial torque, such as when operating in an oscillating mode and the ceramic body engages bone or other hard tissue. The number of projecting features 995 and slots 1008 typically ranging from 2 to 100 and more often from 4 to 10. The projecting features and slots also may take the form of a spline connection. Typically, the connection provides a minimum length LL of the longitudinal surfaces 1010a, 1010b, 1015a and 1015b that is at least 1 mm and often 2 mm or more. In general, the connection between the ceramic body 905 and the metal inner sleeve 910 includes from 4 to 100 interfacing longitudinal surfaces each having a length of at least 1 mm or at least 2 mm, wherein such surfaces are distributed around the circumference of the ceramic body and sleeve.
It has been found that configuring the ceramic cutter 1105 with a plurality of flutes or grooves 1106 each having at least one sharp edge 1108 will allow the physician to cut bone with the sharp burr edges 1108 while not interfering with the sharp edges 1112 around the cutting window 1115 that are adapted for soft tissue cutting. The number of grooves or flutes 1106 can range between 1 and 10 or more and can have a depth ranging from 0.5 mm to 2 mm or more. The length of such flutes 1106 will typically range from 2 mm to 12 mm, typically being from 4 mm to 8 mm. In other respects, the dimensions of ceramic cutter 1105 will be generally the same as those described for other embodiments described previously, and the cutter body 1105 may optionally carry an electrode 1140, as described previously.
Still referring to
Referring to
Still referring to
In another aspect of the invention, it has been found that rapid rotational oscillation of the ceramic cutter 1105 or 1105′ while activating the electrode 1140 can be particularly effective for performing an RF ablation treatment. Thus, a controller can be configured to rotationally oscillate the ceramic cutter body 1105 or 1105′ from 5° to 30° in one direction from the start position and then from 5° to 30° from the start position in the other direction while contemporaneously activating an RF source.
In order to oscillate the ceramic cutter body 1105 or 1105′ and electrode 1140 as just described, the controller can operate the motor to initially position the electrode 1140 in the center of the cutting window 1115, e.g. by using the Hall sensors to stop or move the cutter body rotationally to the start position (e.g. a center of cutting window 1115). The controller can then drive the motor in one direction until a first Hall sensor interrupt occurs. The controller then causes the cutter to rotate in the opposite direction until a second Hall sensor interrupt occurs, and the oscillatory drive pattern continued until for as long as the treatment requires. During at least a portion of such rotational oscillation, the controller will also activate an RF source to effect the ablation.
In specific examples, the controller may drive the motor to fully rotate the cutter and/or rotationally oscillate the cutter. Rotational oscillation may span a range from ±5% to ±25°, often from ±10° to ±20°, typically being about ±15°, i.e. the cutter oscillates 7.5° back and forth from a center or start position. The controller will usually also control the motor drive speed to in turn control rotation and/or rotational oscillation of the cutter, typically using a PID or other control algorithm. For full rotation, the motor speed will typically be controlled to rotate the cutter at a rate in the range from 100 RPM to 1000 RPM, usually from 250 RPM to 750 RPM, typically about 500 RPM. For rotational oscillation, the controller will drive the motor to oscillate the cutter in a range from 20 Hz to 2000 Hz, usually from 100 Hz to 500 HZ, and typically about 200 Hz.
In another aspect of the invention, the rotational position of the ceramic cutter body 1105 or 1105′ and electrode 1140 is monitored while oscillating during both coagulation and ablation modes of operation. The controller monitors the rotational position of the cutter by tracking the strength of the Hall magnet of the inner sleeve in real time. The strength of the Hall magnet will decrease as the electrode 1140 moves away from the center of the window. If the Hall magnet signal drops below a specified amount from a previously determined peak value when the cutter is centered, the controller can immediately turn off the RF power and alert the user via an on-screen error or other alarm. In this way, the electrode 1140 is prevented from travelling outside its expected oscillatory range which can cause arcing to the outer sleeve 1116 (
Optionally, the controller may be further configured to correct rotational misalignment of the electrode 1140 by driving the motor to re-center the electrode 1140 in the window 1115 when the cutter rotational position falls outside of a specified range. For example, the controller may determine in which direction the electrode 1140 had been rotating based on the tracked Hall sensor output and then drive the motor in the reverse direction until the Hall strength is back to its peak value indicating that the electrode 1140 is re-centered in the cutting window 1115 (
The controller can be further configured to specify an acceptable range or tolerance for each unique disposable cutter and thus software can adapted to independently control at what point such a safety shutdown (or repositioning of the cutter and electrode) occurs based on the physical properties of the disposable. In one example, when a disposable cutter with a larger window is identified, the controller can allow the electrode 1140 to move further away from the center of the window before the controller terminates RF delivery or warns the user via the screen or other signal. The controller can determine a cutter window size using a look-up table or data encoded on the individual cutter body or assembly. Alternatively, the controller can measure the window size based on placement of the Hall sensor, electrodes, other sensors, and/or other features.
Although particular embodiments of the present invention have been described above in detail, it will be understood that this description is merely for purposes of illustration and the above description of the invention is not exhaustive. Specific features of the invention are shown in some drawings and not in others, and this is for convenience only and any feature may be combined with another in accordance with the invention. A number of variations and alternatives will be apparent to one having ordinary skills in the art. Such alternatives and variations are intended to be included within the scope of the claims. Particular features that are presented in dependent claims can be combined and fall within the scope of the invention. The invention also encompasses embodiments as if dependent claims were alternatively written in a multiple dependent claim format with reference to other independent claims.
Although particular embodiments of the present invention have been described above in detail, it will be understood that this description is merely for purposes of illustration and the above description of the invention is not exhaustive. Specific features of the invention are shown in some drawings and not in others, and this is for convenience only and any feature may be combined with another in accordance with the invention. A number of variations and alternatives will be apparent to one having ordinary skills in the art. Such alternatives and variations are intended to be included within the scope of the claims. Particular features that are presented in dependent claims can be combined and fall within the scope of the invention. The invention also encompasses embodiments as if dependent claims were alternatively written in a multiple dependent claim format with reference to other independent claims.
The use of the terms “a” and “an” and “the” and similar referents in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The terms “comprising,” “having,” “including,” and “containing” are to be construed as open-ended terms (i.e., meaning “including, but not limited to,”) unless otherwise noted. The term “connected” is to be construed as partly or wholly contained within, attached to, or joined together, even if there is something intervening. Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein, is intended merely to better illuminate embodiments of the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should.
Preferred embodiments of this invention are described herein, including the best mode known to the inventors for carrying out the invention. Variations of those preferred embodiments may become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventors expect skilled artisans to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than as specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.
All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.
Other variations are within the spirit of the present invention. Thus, while the invention is susceptible to various modifications and alternative constructions, certain illustrated embodiments thereof are shown in the drawings and have been described above in detail. It should be understood, however, that there is no intention to limit the invention to the specific form or forms disclosed, but on the contrary, the intention is to cover all modifications, alternative constructions, and equivalents falling within the spirit and scope of the invention, as defined in the appended claims.
The present application claims the benefit of Provisional Application 62/473,189, filed on Mar. 17, 2017, the full disclosure of which is incorporated herein by reference.
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| Number | Date | Country | |
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