Arthroscopic devices and methods
11419670 · 2022-08-23
Assignee
Inventors
- Aaron Germain (San Jose, CA, US)
- Kyle Klein (San Jose, CA, US)
- Michael D. Walker (San Francisco, CA, US)
Cpc classification
A61B18/148
HUMAN NECESSITIES
A61B17/1615
HUMAN NECESSITIES
A61B2018/142
HUMAN NECESSITIES
A61B17/1637
HUMAN NECESSITIES
A61B2017/00039
HUMAN NECESSITIES
A61B17/1633
HUMAN NECESSITIES
International classification
Abstract
A medical device 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 rotate the cutting member. The cutter is engaged against bone and rotated to cut bone tissue without leaving any foreign particles in the site.
Claims
1. A cutting device for cutting tissue in a joint of a patient, the cutting device comprising: an inner sleeve having a proximal end, a distal end, and an axial extraction channel therein that extends through the inner sleeve for connecting to a negative pressure source; a ceramic cutting member disposed at the distal end of the inner sleeve for rotation with the inner sleeve, the ceramic cutting member including a proximal ceramic portion with a window formed therein that communicates with the axial extraction channel when the ceramic cutting member is disposed at the distal end of the inner sleeve, the ceramic cutting member also including a distal ceramic portion with at least a first burr cutting edge and a second burr cutting edge formed thereon for cutting tissue when rotated or oscillated against tissue, the first burr cutting edge and the second burr cutting edge each including a proximal end that is located distally of a distal end of the window along the ceramic cutting member, the distal ceramic portion additionally including at least a first opening formed therein that is separate from the window along an outer surface of the ceramic cutting member and which communicates with the axial extraction channel when the ceramic cutting member is disposed at the distal end of the inner sleeve, wherein the first opening is situated between the first burr cutting edge and the second burr cutting edge, and wherein the entirety of the first opening is located distally of the distal end of the window along the ceramic cutting member; and a motor drive operatively connected to the proximal end of the inner sleeve for rotating the inner sleeve at a speed of at least 3,000 rpm.
2. The cutting device of claim 1, wherein the ceramic cutting member is fabricated from a ceramic material having a hardness of at least 8 Gpa (kg/mm2).
3. The cutting device of claim 1, wherein the ceramic cutting member is fabricated from a ceramic material having a fracture toughness of at least 2 MPam.sup.1/2.
4. The cutting device of claim 1, wherein the ceramic cutting member is fabricated from a ceramic material having a coefficient of thermal expansion of less than 10 (1×10.sup.6/° C.
5. The cutting device of claim 1, wherein the ceramic cutting member is fabricated from a ceramic material selected from the group of yttria-stabilized zirconia, magnesia-stabilized zirconia, cerin-stabilized zirconia, zirconia toughened alumina and silicon nitride.
6. The cutting device of claim 1 further comprising an outer sleeve in which the inner sleeve is rotatably received.
7. The cutting device of claim 6, wherein the respective proximal ends of the first burr cutting edge and the second burr cutting edge are located distally of a distal-most surface of the outer sleeve when the inner sleeve is rotatably received in the outer sleeve.
8. The cutting device of claim 6, wherein the outer sleeve is formed with metal.
9. The cutting device of claim 6, wherein the outer sleeve includes a distal cut-out portion.
10. The cutting device of claim 9, wherein the respective proximal ends of the first burr cutting edge and the second burr cutting edge are located distally of the distal cut-out portion when the inner sleeve is rotatably received in the outer sleeve.
11. The cutting device of claim 9, wherein the window is rotatable in the distal cut-out portion of the outer sleeve.
12. The cutting device of claim 1, wherein the distal ceramic portion also includes a second opening formed therein that is separate from the first opening and the window along the outer surface of the ceramic cutting member, the second opening communicating with the axial extraction channel when the ceramic cutting member is disposed at the distal end of the inner sleeve, the entirety of the second opening located distally of the distal end of the window along the ceramic cutting member.
13. The cutting device of claim 1, wherein, in a lateral direction around the ceramic cutting member, the first opening is at least partially aligned with the window on a first side of the ceramic cutting member.
14. A cutting device for cutting tissue in a joint of a patient, the cutting device comprising: an inner sleeve having a proximal end, a distal end, and an axial extraction channel therein that extends through the inner sleeve for connecting to a negative pressure source; a ceramic cutting member disposed at the distal end of the inner sleeve for rotation with the inner sleeve, the ceramic cutting member including a proximal ceramic portion with a window formed therein that communicates with the axial extraction channel when the ceramic cutting member is disposed at the distal end of the inner sleeve, the ceramic cutting member also including a distal ceramic portion with at least a first burr cutting edge and a second burr cutting edge formed thereon for cutting tissue when rotated or oscillated against tissue, the first burr cutting edge and the second burr cutting edge each including a proximal end that is located distally of a distal end of the window along the ceramic cutting member, the distal ceramic portion additionally including at least a first opening formed therein that is separate from the window along the outer surface of the ceramic cutting member and which communicates with the axial extraction channel when the ceramic cutting member is disposed at the distal end of the inner sleeve, wherein, in a longitudinal direction along the ceramic cutting member, the first opening is located distally of the distal end of the window, and wherein, in a lateral direction around the ceramic cutting member, the first opening is at least partially aligned with the window on a first side of the ceramic cutting member; and a motor drive operatively connected to the proximal end of the inner sleeve for rotating the inner sleeve at a speed of at least 3,000 rpm.
15. The cutting device of claim 14, wherein the distal ceramic portion also includes a second opening formed therein that is separate from the first opening and the window along the outer surface of the ceramic cutting member, the second opening communicating with the axial extraction channel when the ceramic cutting member is disposed at the distal end of the inner sleeve, the entirety of the second opening located distally of the distal end of the window along the ceramic cutting member.
16. A cutting device for cutting tissue in a joint of a patient, the cutting device comprising: an inner sleeve having a proximal end, a distal end, and an axial extraction channel therein that extends through the inner sleeve for connecting to a negative pressure source; a ceramic cutting member disposed at the distal end of the inner sleeve for rotation with the inner sleeve, the ceramic cutting member including a proximal ceramic portion with a window formed therein that communicates with the axial extraction channel when the ceramic cutting member is disposed at the distal end of the inner sleeve, the ceramic cutting member also including a distal ceramic portion with at least a first burr cutting edge and a second burr cutting edge formed thereon for cutting tissue when rotated or oscillated against tissue, the first burr cutting edge and the second burr cutting edge each including a proximal end that is located distally of a distal end of the window along the ceramic cutting member, the distal ceramic portion additionally including at least a first opening formed therein that is separate from the window along the outer surface of the ceramic cutting member and which communicates with the axial extraction channel when the ceramic cutting member is disposed at the distal end of the inner sleeve, wherein the entirety of the first opening is located distally of the distal end of the window along the ceramic cutting member, wherein the distal ceramic portion also includes a second opening formed therein that is separate from the first opening and the window along the outer surface of the ceramic cutting member, the second opening communicating with the axial extraction channel when the ceramic cutting member is disposed at the distal end of the inner sleeve, the entirety of the second opening located distally of the distal end of the window along the ceramic cutting member; and a motor drive operatively connected to the proximal end of the inner sleeve for rotating the inner sleeve at a speed of at least 3,000 rpm.
17. The cutting device of claim 16 further comprising an outer sleeve in the inner sleeve is rotatably received.
18. The cutting device of claim 17, wherein the respective proximal ends of the first burr cutting edge and the second burr cutting edge are located distally of a distal-most surface of the outer sleeve when the inner sleeve is rotatably received in the outer sleeve.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) 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.
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DETAILED DESCRIPTION OF THE INVENTION
(17) 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.
(18) 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.
(19) In one variation shown in
(20) 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 (
(21) Referring to
(22) In
(23) Now referring to
(24) 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.
(25) TABLE-US-00001 CHART A Fracture Ratio Hardness Hardness Toughness to Fracture (GPa) (MPam.sup.1/2) Toughness Cortical bone 0.8 12 .07:1 Stainless steel 304 2.1 228 .01:1 Yttria-stabilized zirconia (YTZP) YTZP 2000 (Superior 12.5 10 1.25:1 Technical Ceramics) YTZP 4000 (Superior 12.5 10 1.25:1 Technical Ceramics) YTZP (CoorsTek) 13.0 13 1.00:1 Magnesia stabilized zirconia (MSZ) Dura-Z ® (Superior 12.0 11 1.09:1 Technical Ceramics) MSZ 200 (CoorsTek) 11.7 12 0.98:1 Zirconia toughened alumina (ZTA) YTA-14 (Superior 14.0 5 2.80:1 Technical Ceramics) ZTA (CoorsTek) 14.8 6 2.47:1 Ceria stabilized zirconia CSZ (Superior Technical 11.7 12 0.98:1 Ceramics) Silicon Nitride SiN (Superior Technical 15.0 6 2.50:1 Ceramics)
(26) 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.
(27) 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).
(28) 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 may bne selected from the group consisting 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/mm.sup.2). In another aspect of the invention, the ceramic cutting member 125 has a fracture toughness of at least 24 MPam.sup.1/2.
(29) 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
(30) In
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(36) 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/mm.sup.2) and/or a fracture toughness of at least 2 MPam.sup.1/2 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.
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(43) In another embodiment (not shown) a cutting member can be fabricated of corundum. Corundum is a crystalline form of aluminum oxide which may have various colors, and which generally is referred to as sapphire. The terms “corundum” and “sapphire” may be used interchangeably herein to refer to the crystalline form of aluminum oxide. A monolithic, monocrystal cutting member could be made from a sapphire and falls within the scope of the invention, and would be most suitable for simple cutting elements as fabrication costs would be high for any complex shapes. Similarly, silica and silica borate and other forms of glass fall within the scope of the invention.
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(45) In one variation, the joystick 158 can be used to actuate the motor drive and also to control its speed and direction of rotation. In a variation, the joystick 158 is adapted for movement in four directions and also can be depressed downwardly to actuate a function. In one variation, the joystick 158 can be pushed downward to activate the motor drive and released to de-activate the motor drive. The joystick 158 can be moved forward and backward relative to the axis of handle 104 to either increase or decrease the speed of the motor. In such a variation, movement of joystick 158 to the left or to the right can increase or decrease fluid inflow/outflow rates from a fluid management system associated with an arthroscopic procedure.
(46) The control panel 260 further includes push buttons 156a, 156b and 156c that can be used to select various operational modes, such as selection of forward (clockwise) rotating mode, selection of backward (counter-clockwise) rotating mode, selection of intermittent forward or backward rotating mode, selection of oscillating mode, selection of level of aspiration through an extraction channel of the device, selection of inflows such as a flush mode and the like.
(47) In another embodiment, a cutting system as shown in
(48) A number of embodiments of the invention have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the invention.