Surgical device with multiple modes of tissue removal

Abstract

A multimodal cutting head is described having a closed configuration in which no cutting edges are present. The multimodal cutting head also has an off-center inner cutting head with two radially separated scalloped cutting edges. An opening in the outer head has two straight cutting edges positioned for interaction with the scalloped edges during rotation of the inner cutting head.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 382,045, filed November 2, 2022, the entire disclosure of which is incorporated herein by reference. Incorporation by Reference

[0002] All publications and patent applications mentioned in this specification are incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

[0002]

[0003] The present disclosure relates to a motor-driven rotary tubular cutter surgical instrument having multiple different modes of operation to create different ways to resect tissue from within a patient's body. [Background technology]

[0003]

[0004] Several rotary cutting surgical instruments are available and widely used. Despite the widespread availability of such instruments, several drawbacks remain in their performance and various techniques suitable for enhanced surgical control. Moreover, many existing devices have cutting surfaces that require the use of an additional covering delivery sheath positioned to cover the exposed cutting surface when transported into and out of the surgical field. For at least these reasons, improved rotary surgical instruments are needed to address these and other drawbacks. Summary of the Invention [Means for solving the problem]

[0004]

[0005] Described herein are embodiments of a surgical cutter head comprising a proximal end having a handle, a distal end including a cutter head with an outer cutter head having an opening and two linear cutting edges, and an inner cutter head positioned for eccentric rotation relative to the opening and in cutting relationship relative to the two linear cutting edges. In another aspect, the surgical cutter head also includes a motor control system adapted and configured to control the direction and rate of rotation of the inner cutter head. In yet a further aspect, the surgical cutter head and motor control system can be operated in a manual mode, a semi-autonomous mode, or an autonomous mode. Still further, the cutter head has a closed mode in which the cutting surface is not exposed or only the smooth outer surface of the cutter head is exposed. In some embodiments, the surgical cutter head also includes a push button, a toggle switch, a foot switch, or a voice-activated control system adapted and configured to automatically transition the cutter head to the closed mode.

[0005]

[0006] In yet a further implementation, the surgical cutting head also includes one or more sensors coupled to a portion of the cutting head and a tissue characterization and modality selection tissue cutting control system-implemented computer in electronic communication with the one or more sensors, wherein the cutting control system-implemented computer automatically adjusts or recommends the motor control system between the manual mode, the semi-autonomous mode, and the autonomous mode based at least in part on signals from the one or more sensors. Still other embodiments provide tissue characterization and the modality selection tissue cutting control system-implemented computer is configured to automatically transition the cutting head to the closed mode based on a determination of signals received from the one or more sensors.

[0006]

[0007] In still further alternatives and variations, methods of removing bone, ligaments, muscles, soft tissue, calcified tissue, scar tissue, tumors, or other target tissue using any of the devices and systems described herein are also provided.

[0007]

[0008] In yet a further implementation, a method for removing bone, ligament, muscle, soft tissue, calcified tissue, scar tissue, tumor, or other target tissue is provided, the method including the steps of advancing an apparatus including a cutting head having an outer cutting head with an opening and two straight cutting edges, and an inner cutting head positioned for eccentric rotation relative to the opening and in cutting relationship to the two straight cutting edges, toward the target tissue, selecting one or more cutting parameters based on the nature of the target tissue, and rotating the inner cutting head relative to the outer cutting head, thereby removing tissue from the target tissue.

[0008]

[0009] In a further implementation, the method further includes selecting a mode of motion of the cutting device. In yet a further implementation, selecting the mode of motion includes selecting between manual control, semi-autonomous control, or autonomous control. In a further implementation, the method includes engaging various portions of the target tissue site with the cutting head to aid in selecting an appropriate cutting mode for various portions of the target tissue site. The method can include modifying the mode of motion or cutting mode based on feedback from sensors on the cutting head. In a further implementation, rotating the inner cutting head relative to the outer cutting head can include rotating the inner cutting head back and forth approximately 2-5 times at an RPM of approximately 2000-4000 RPM, which can include cutting through soft tissue. In a further implementation, rotating the inner cutting head relative to the outer cutting head can include rotating the inner cutting head in one direction at an RPM of approximately 4000-8000 RPM, which can include cutting through cartilage and / or bone.

[0009]

[0010] All of the methods and devices described herein are contemplated herein in any combination and can be used to achieve the benefits described herein.

[0011] A better understanding of the features and advantages of the methods and apparatus described herein can be obtained by reference to the following detailed description that sets forth illustrative embodiments and the accompanying drawings. [Brief explanation of the drawings]

[0010] [Figure 1]

[0012]

[0023] Figure 1A is a perspective view of an exemplary embodiment of a rotational surgical device. Figure 1A shows the cutting head at the distal end of the device in a closed configuration in which the cutting surface is not externally exposed. Figure 1B shows the cutting head of Figure 1A with the inner cutting head partially open, exposing one wavy cutting edge and one straight edge of the outer head. Figure 1C is a view of the cutting head of Figure 1A with the inner cutting head fully open, exposing both wavy cutting edges and both straight cutting edges of the outer head (only one is visible in this view). [Figure 2]

[0013] 2A and 2B are perspective views of the outer and inner cutting heads, respectively. [Figure 3]

[0014] Figure 3A is a perspective view of the primary and secondary cutting edges with arrows indicating the direction of rotation and the resulting change in cutting surface engagement. Figure 3B is a cross-sectional view of the primary and secondary cutting edges with arrows indicating the direction of rotation and the resulting change in cutting surface engagement. [Figure 4]

[0015] Figure 4A is a cross-sectional view through the cutting head showing the interaction of the cutting edges and the resection line of the outer and inner cutting heads. Figure 4A is a closed condition; Figure 4B is an intermediate open condition; Figure 4C is a fully open condition; and Figure 4D is fully open with indication of the resection line for the outer head. [Figure 5]

[0016]

[0033] Figure 5A shows a perspective view of a prototype of an embodiment of a cutting head. Figure 5A shows the cutting head at the distal end of the device in a closed configuration where the cutting surface is not externally exposed. Figure 5B shows the cutting head of Figure 5A with the inner cutting head partially open, exposing one wavy cutting edge and one straight edge of the outer head. Figure 5C is a view of the cutting head of Figure 5A with the inner cutting head fully open, exposing both wavy cutting edges and both straight cutting edges of the outer head (only one is visible in this view). [Figure 6]

[0017] FIG. 5C is a first perspective view of a resected portion of a cadaver limb showing the effective removal of cartilage, ligaments, bone, and soft tissue by operation of the prototype cutting head of FIGS. 5A-5C. [Figure 7]

[0018] FIG. 7 is a second perspective view of the excised portion of the cadaver limb of FIG. 6, illustrating the effective removal of cartilage, ligaments, bone, and soft tissue by operation of the prototype cutting head of FIGS. 5A-5C. [Figure 8]

[0019] 1 is a flowchart detailing several different modes of operation for a cutting head surgical system. DETAILED DESCRIPTION OF THE INVENTION

[0011]

[0020] Advantageously, various embodiments of the inventive multimodal cutting head may be applied to a wide range of surgical probes utilized in various types of surgical procedures, including, but not limited to, gynecological procedures such as myomectomy and polypectomy, ENT surgery, arthroscopy, spinal surgery, tumor resection surgery, and general surgical removal, scraping, or reshaping of healthy bone, scar bone, diseased bone, ligaments, tendons, muscles, and soft tissue.

[0012]

[0021] 1A, 1B, and 1C are perspective views of an exemplary embodiment of a rotational surgical device 100. FIG. 1A shows a cutting head 102 at the distal end of the device in a closed configuration in which the cutting surface is not externally exposed. FIG. 1B shows the cutting head of FIG. 1A with the inner cutting head partially open, exposing one wavy cutting edge 104 and one straight edge 106 of the outer head. FIG. 1C is a view of the cutting head of FIG. 1A with the inner cutting head fully open, exposing both wavy cutting edges 104 and both straight cutting edges 106 of the outer head (only one is visible in this view).

[0013]

[0022] In one aspect, the cutting head can remain in the closed state (FIG. 1A) as a base state for movement along an access or delivery scope or within or through a surgical site. Additionally, the user can rotate the internal cutting head to the closed state if desired. A sensor on the handle is coupled to the cutting head along with a trigger signal generator component on the rotating head element. In one aspect, the sensor can be coupled to the proximal side of the corrugated internal head that connects to the handle. In one aspect, insertion or removal of the cutting head through the surgical access scope is in the closed state. In one embodiment, there is a button on the handle that must be pressed before the insertion or removal process. A head open / head closed indicator may be used to inform the user of the actual state of the cutting head relative to the desired head movement operation.

[0014]

[0023] 2A and 2B are perspective views of an outer cutting head 200 and an inner cutting head 201, respectively. FIG. 2A shows the outer cutting head. The outer cutting head includes a smooth portion 208. The straight cutting edge 106 is also shown. The outer cutting head also includes a vacuum passage 204 and a drive shaft passage 206.

[0015]

[0024] Turning now to Figure 2B, the inner cutting head is shown. The inner cutting head comprises a scalloped cutting edge 104. The inner cutting head comprises a primary cutting edge and a secondary cutting edge, which are described in more detail in Figures 3A and 3B. The inner cutting head also comprises a drive shaft passage 212. Opposite the cutting surface is a smooth surface 214.

[0016]

[0025] During rotation, the cutting edge of the inner cutting head 201 also passes through the opening in the outer head 200, advantageously resulting in the curved cutting blade on the rotating inner sleeve matching the flat edge opening in the fixed outer sleeve.

[0017]

[0026] 3A and 3B are perspective and cross-sectional views of the primary and secondary cutting edges 302, 304, where arrow 304 indicates the direction of rotation and the resulting change in cutting surface engagement. In some embodiments, the drive shaft 308 and inner cutting head 201 are configured to rotate back and forth in the direction indicated by arrow 306.

[0018]

[0027] 4A-4D are cross-sectional views through the cutting heads showing the interaction of the cutting edges and resection line 402 of outer cutting head 200 and inner cutting head 201 in a closed condition (FIG. 4A), an intermediate open condition (FIG. 4B), a fully open condition (FIG. 4C), and fully open with indication of the resection line for the outer head (FIG. 4D). Vacuum path 404 is also visible in FIGS. 4A-4D.

[0019]

[0028] As best seen in the various views of Figures 3A-4D, the axis of rotation of the inner cutting head is off-axis from the central longitudinal axis of the overall cutting head. This is in contrast to many conventional cutting devices in which the axis of rotation of the cutting head is coaxial with the overall longitudinal axis, or in which all cutting heads in a multiple-cutting head system share a common axis of rotation. One benefit of the off-axis rotation of the inner cutting head is the resection line, shown in Figure 4D.

[0020]

[0029] In one embodiment, the user may choose between an automatic mode or a manual mode. In the manual mode, the user can manually change between two functions (soft tissue / structure target or hard tissue / structure target). In the automatic mode, the user does not need to change any system functions, and the system detects the tissue type based on torque or other detected operating characteristics to determine the appropriate cutting mode.

[0021]

[0030] In other operating variations, the cutting head may remain in the "closed" state, which is the base state. When this state is desired, the user need only press a button, and the head will rotate to the closed state. Optionally, the insertion or removal process is only possible in the closed state (to avoid damage). In some modes of operation, there is interaction with a foot switch button during operation, and the inner cutting head will stay in a different position, usually the "open" ("free") state. In the closed state, fluid circulation (cleaning) occurs through a cleaning (bypass) path, which is a hole or groove in the back of the fixed outer head.

[0022]

[0031] In yet another alternative embodiment, there is also a mechanical means for rotating the head back to a closed state, used in combination with or alone as an electronic means for closing the head. In one aspect, a mechanical head closure enforcement may be achieved, for example, by the geometry of the resector head, which urges, biases, or forces the resector head to close when the cutting head is retracted into a scope or other access device through which the resector or cutting tool is deployed.

[0023]

[0032] In another operation variation for the soft tissue function, the curved inner cutting head rotates in an oscillatory pattern. One exemplary pattern is three clockwise (CW) turns, then three counterclockwise (CCW) turns. Additionally, with each change of rotation, it will be appreciated that a different main cutting edge (i.e., straight cutting edge) on the outer head is engaged as the direction of rotation changes. For the hard tissue function, the direction of rotation does not change, so the engaged cutting edge does not change. Optionally, the user may manually select that the hard tissue function be performed with the opposite direction of rotation.

[0024]

[0033] As best seen in the view of FIG. 4D, the eccentric shaft feature is required for better "comminuted" (hard tissue cutting) performance. The smooth back surface of the cutting element results from the eccentric design. The eccentric device feature has the advantage of being highly versatile, and in a first case, it may be used for hysteroscopic resection of hard / calcified uterine tissue (and soft uterine tissue). In yet further possible modes of operation, the cutting head may be used for other types of operations, including as a bone scraper (e.g., orthopedic), a soft tissue resector, or both, selected as required based on the clinical environment.

[0025]

[0034] 5A-5C are perspective views of prototypes of embodiments of the cutting head. FIG. 5A shows the cutting head at the distal end of the device in a closed configuration, with no cutting surface exposed to the outside. FIG. 5B shows the cutting head of FIG. 5A with the inner cutting head partially open, exposing one wavy cutting edge and one straight edge of the outer head. FIG. 5C is a view of the cutting head of FIG. 5A with the inner cutting head fully open, exposing both wavy cutting edges and both straight cutting edges of the outer head (only one is visible in this view).

[0026]

[0035] FIG. 6 is a first perspective view of a resected portion 602 of a cadaver limb showing the effective removal of cartilage 604, ligaments 606, bone 608, and soft tissue 610 by operation of the prototype cutting head of FIGS. 5A-5C.

[0027]

[0036] Figure 7 is a second perspective view of the excised portion of the cadaver limb of Figure 6, showing the effective removal of cartilage, ligaments, bone, and soft tissue by operation of the prototype cutting head of Figures 5A-5C. Figures 6 and 7 are exemplary demonstrations of how a multi-modality cutting head is suitable for cutting a variety of soft tissues, as well as hard or calcified tissues, unlike conventional surgical cutters that are optimized or configured for only one cutting technique. In embodiments of the inventive cutting head, different cutting modes may be selected and switched between operation with easy user control, semi-autonomous, or autonomous modes of operation. Optionally, the user may also manually set the RPM within a preselected operating range or oscillation mode of the rotating head.

[0028]

[0037] 8 is a flowchart detailing several different modes of operation for the cutting head surgical system. It will be appreciated that in some embodiments, the cutting surgical system is adapted and configured to sense what type of tissue or structure the cutting surface is contacting or engaged with, either initially prior to cutting or intermittently during the cutting operation. In still further aspects, cutting parameters may be adjusted for different modes of operation, including, but not limited to, 1) user request 802 or 2) semi-autonomous 804 in response to a request sensed by the system, or 3) autonomous 806.

[0029]

[0038] User manual mode control can allow selection of alternative modes by preference, including guided fly-by-wire or haptic feedback. Semi-autonomous modes can include using sensor input or feedback for operation. Autonomous modes can be based on feedback of demands on the cutting head.

[0030]

[0039] The number and type of cutting capabilities are also available to the user via a suitable user interface, a control system interface at the proximal end of the device in the handle, or part of the control interface. Additionally or optionally, the system may be used in a test and detect mode 808, in which various portions of the surgical site are engaged and a tissue engagement index is examined to assist the user in the appropriate cutting mode for each area tested, as an aid in surgical planning. In one aspect, use of this feature will improve safety by ensuring that the lowest power cutting mode is selected for the most effective removal of target tissue, while maintaining safety for surrounding tissue that may be harmed if a more aggressive cutting mode is used in situations where tissue is easier to cut.

[0031]

[0040] In the exemplary cutting mode 810, the user can receive feedback in response to the cutting engagement, including tactile, audible, and audio feedback.

[0041] One exemplary cutting style control allows the user to enhance tissue removal performance by changing settings through the device's user interface.

[0032]

[0042] In another exemplary cutting style control, the system can adjust some parameters autonomously, while others remain under direct user control. For example, the system can reduce the rpm when it senses lower resistance. This could be a safety feature. Another example is to increase the rpm when it senses higher resistance. This is an improved performance measure.

[0033]

[0043] In yet another exemplary cut style control embodiment, the system can autonomously control across all performance parameters. An example would be an automatic shutdown, also a safety feature.

[0034]

[0044] In yet other exemplary cutting style control embodiments, parameters that can be adjusted in such a manner are rpm, direction of rotation, different types of alternating directions including applied vacuum action and degree of suction, and fluid flow into the surgical site. In yet another aspect, cutting speed sensors or other measurement sensors, such as ultrasound to measure distance or accelerometers to measure movement, may be used to provide inputs to the system. These or other sensor inputs can vary depending on the surgical scenario, surgical preference settings, or overall safety settings to increase the safety margin for system operation, along with different sampling rates and combinations and considerations of different input or system performance parameters.

[0035]

[0045] These and other parameters that can be sensed by the system to adjust performance advantageously include tissue resistance measurements detected at the motor level or directly measured by ultrasound or optical systems, heat output, motion parameter detection, tissue removal rate detection, and other such sensors used to determine parameters related to the surgical field, tissue, or tool operation. Furthermore, one overall benefit of autonomous operation is improved safety associated with reduced length of surgery. Also, surgeons no longer need to use multiple tools because the tools can handle all tissue densities and calcification levels. This further reduces time (no replacements), cost (one device instead of many), and safety (one device to study instead of many).

[0036]

[0046] In one embodiment, the cutting head effectively functions as a hybrid head, combining the capabilities of a resector and a bone scraper. For example, if a user wishes to cut soft tissue and ligaments, the inner wavy head rotates (360 degrees), typically three times backward (CW) and three times forward (CCW), at 2000-4000 RPM to achieve resector-like operating characteristics. Furthermore, if a user wishes to cut cartilage and bone, the inner wavy head rotates only in one direction (e.g., CW) at 4000-8000 RPM to achieve scraper or pulverizer-like operating characteristics. The outer head, with its straight cutting edge, remains stationary at all times. While straight cutting edges are more robust than wavy edges, the wavy shape on the inner head also provides scraping functionality to the target tissue. The secondary cutting edge must cut tissue, which becomes lodged in the vacuum pathway inlet (see, e.g., Figures 4A-4D). The rotation axis of the corrugated inner head and the central axis of the outer head are eccentric. The cut line is out of shape of the outer head, but the head can be closed, for example, when needed to go through a seal. A back opening (groove) on the outer head allows a bypass path for fluid circulation when the head is closed.

[0037]

[0047] In one specific implementation of the surgical cutter of the invention, the same design is used for resection of soft tissue, ligaments, cartilage, and bone. The diameter can be 3-8 mm in the closed position. The current OD is 5.33 mm. The cutting window can be 3-15 mm. One prototype design includes an 8.2 mm cutting window. The resection line is radially offset from the closed head OD. The RPM with vibration for soft tissue and ligaments is 2000-4000 rpm. The RPM without vibration for cartilage and bone is 4000-8000 rpm. The cutting edges can be of different shapes, waves, and angles (scissor effect, different cutting edge profile angles, various numbers of clamps on the inner head, clamps on the outer head, various numbers of clamps on the outer head). Various numbers and sizes of bypass grooves can also be provided on the heads. Additionally or optionally, the vacuum pathways can be defined by various sizes and shapes.

[0038]

[0048] It should be understood that all combinations of the foregoing concepts and additional concepts discussed in more detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein and may be used to achieve the benefits described herein.

[0039]

[0049] The process parameters and order of steps described and / or illustrated herein are provided by way of example only and can be varied as desired. For example, although the steps illustrated and / or described herein may be shown or discussed in a particular order, these steps do not necessarily have to be performed in the order illustrated or discussed. The various example methods described and / or illustrated herein may also omit one or more of the steps described or illustrated herein or include additional steps in addition to those disclosed.

[0040]

[0050] As a further example, the surgical head described herein would be included as part of a system with a resection motor, a fluid system (with a pump), a specimen trap, a controller, and a hysteroscope. In additional aspects, there may also be a mix of reusable and disposable parts in the system. In one exemplary embodiment, the reusable components of the system may include the resection motor, the pump (without fluid lines), the controller, and an access scope such as a hysteroscope. The disposable parts may include, for example, the resection head, the fluid lines, and the specimen trap. Alternative divisions between disposable and reusable are possible.

[0041]

[0051] When a feature or element is referred to herein as being "on" another feature or element, it can be directly on the other feature or element, or intervening features and / or elements may be present. In contrast, when a feature or element is referred to herein as being "directly on" another feature or element, there are no intervening features or elements present. Also, when a feature or element is referred to as being "connected," "attached," or "coupled" to another feature or element, it will be understood that it can be directly connected, attached, or coupled to the other feature or element, or there may be intervening features or elements present. In contrast, when a feature or element is referred to as being "directly connected," "directly attached," or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or illustrated with respect to one embodiment, features and elements so described or illustrated may be applicable to other embodiments. Those skilled in the art will also understand that a reference to a structure or feature being disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.

[0042]

[0052] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms "a," "an," and "the," are intended to include the plural forms as well, unless the context clearly dictates otherwise. Furthermore, it will be understood that the term "comprising," when used herein, specifies the presence of stated features, steps, operations, elements, and / or components, but does not exclude the presence and addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ."

[0043]

[0053] Spatial relative terms such as "below," "belower," "lower," "above," and "upper" may be used herein for ease of description to describe the relationship of one element or feature shown in the figures to another element or feature. It will be understood that the spatial relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation shown in the figures. For example, if the device in the figures were inverted, elements described as being "below" or "directly below" the other element or feature would then be oriented "above" the other element or feature. Thus, the exemplary term "below" can encompass both an above and below orientation. The device may be otherwise oriented (rotated 90 degrees or at other orientations), and the spatial relative descriptors used herein will be interpreted accordingly. Similarly, terms such as "upward," "downward," "vertical," and "parallel" are used herein for descriptive purposes only, unless specifically indicated otherwise.

[0044]

[0054] Although the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements should not be limited to these terms unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another. Thus, a first feature / element discussed below may be referred to as a second feature / element, and similarly, a second feature / element discussed below may be referred to as a first feature / element, without departing from the teachings of the present invention.

[0045]

[0055] Throughout this specification and the claims that follow, unless the context requires otherwise, the word "comprises" and variations thereof mean that various components may be employed in conjunction with one another in methods and articles (e.g., apparatus and composites that include methods). For example, it will be understood that the term "comprises" implies the inclusion of any stated elements or steps, but not the exclusion of any other elements or steps.

[0046]

[0056] Generally, the apparatus and methods described herein should be understood to be inclusive, although all or a subset of the components and / or steps may alternatively be exclusive and may be expressed as "consisting of" or "consisting essentially of" various components, steps, subcomponents, or substeps.

[0047]

[0057] As used herein in the specification and claims, including in the examples, unless expressly specified otherwise, all numbers may be read as if they are preceded by the term "about" or "approximately," even if the word "about" or "approximately" does not explicitly appear. The phrase "about" or "approximately" may be used when describing a size and / or location to indicate that the stated value and / or location is within a reasonably expected range of values ​​and / or locations. For example, a numerical value may have a value that is ±0.1% of the stated value (or range of values), ±1% of the stated value (or range of values), ±2% of the stated value (or range of values), ±5% of the stated value (or range of values), ±10% of the stated value (or range of values), etc. Additionally, any numerical value given herein should be understood to include about or approximately that value unless the context dictates otherwise. For example, if the value "10" is disclosed, "about 10" is also disclosed. Any numerical ranges set forth herein are intended to include all subranges incorporated therein. Also, as will be appreciated by those skilled in the art, when a value is disclosed, it is understood that "less than or equal to that value," "greater than or equal to that value," and possible ranges between values ​​are also disclosed. For example, if a value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" (e.g., X is a numerical value) are also disclosed. It is also understood that throughout this application, data is provided in several different formats, and this data represents endpoints and starting points, and ranges for any combination of data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it is understood to mean greater than 10 and 15, greater than or equal to 10 and 15, less than or equal to 10 and 15, equal to 10 and 15, and between 10 and 15. It is also understood that each unit between two specified units is also disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13, and 14 are also disclosed.

[0048]

[0058] While various exemplary embodiments have been described above, any of several modifications may be made to the various embodiments without departing from the scope of the invention as set forth in the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be skipped entirely. Optional features of various apparatus and system embodiments may be included in some embodiments and not in others. Accordingly, the foregoing description has been provided primarily for illustrative purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

[0049]

[0059] The examples and figures included herein illustrate, by way of illustration, not limitation, specific embodiments in which the subject matter may be practiced. As stated, other embodiments may be utilized and derived therefrom, and thus structural and logical substitutions or changes may be made without departing from the scope of the present disclosure. Such embodiments of the inventive subject matter may be individually or collectively referred to herein under the term "invention" for convenience only, when in fact more than one is disclosed, and without any intention to independently limit the scope of this application to any single invention or inventive concept. Thus, while specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiment illustrated. The present disclosure is intended to cover any and all adaptations or variations of the various embodiments. Upon reviewing the above description, combinations of the above embodiments, as well as other embodiments not specifically described herein, will be apparent to those skilled in the art.

Claims

1. a proximal end having a handle; a distal end including a cutting head having an outer cutting head having an opening and two straight cutting edges, and an inner cutting head positioned for eccentric rotation relative to the opening and in cutting relationship to the two straight cutting edges; A surgical cutting head comprising:

2. a motor control system adapted and configured to control the direction and rate of rotation of the internal cutting head; 10. The surgical cutting head of claim 1.

3. The motor control system can be operated in a manual, semi-autonomous, or autonomous mode.

3. The surgical cutting head of claim 2.

4. The cutting head has a closed design, with no cutting surface exposed or only the smooth outer surface of the cutting head being exposed. A surgical cutting head according to claims 1 to 3.

5. further comprising a push button, toggle switch, foot switch, or voice activated control system adapted and configured to automatically transition the cutting head to the closed configuration; 5. The surgical cutting head of claim 4.

6. one or more sensors coupled to a portion of the cutting head; a computer having a tissue characterization and modality selective tissue cutting control system implemented therein, in electronic communication with the one or more sensors; Furthermore, and based at least in part on signals from the one or more sensors, the computer-implemented cutting control system automatically adjusts or recommends the motor control system between the manual mode, the semi-autonomous mode, and the autonomous mode.

4. The surgical cutting head of claim 3.

7. The computer-implemented tissue characterization and modality selection tissue cutting control system is configured to automatically transition the cutting head to the closed modality of claim 4 based on a determination of signals received from the one or more sensors.

7. The surgical cutting head of claim 6.

8. 8. A method of removing bone, ligament, muscle, soft tissue, calcified tissue, scar tissue, tumor, or other target tissue using any of the devices of any one of claims 1 to 7.

9. 1. A method for removing bone, ligament, muscle, soft tissue, calcified tissue, scar tissue, tumor, or other target tissue, comprising: advancing an instrument to a target tissue, the instrument comprising a cutting head having an outer cutting head having an opening and two straight cutting edges, and an inner cutting head positioned for eccentric rotation relative to the opening and in cutting relationship to the two straight cutting edges; selecting one or more cutting parameters based on the properties of the target tissue; rotating the inner cutting head relative to the outer cutting head, thereby removing tissue from the target tissue; A method comprising:

10. further comprising the step of selecting a mode of operation of the cutting device.

10. The method of claim 9.

11. selecting the mode of operation includes selecting between manual control, semi-autonomous control, or autonomous control; The method of claim 10.

12. further comprising engaging various portions of the target tissue site with the cutting head to assist in selecting an appropriate cutting mode for the various portions of the target tissue site.

10. The method of claim 9.

13. further comprising modifying the mode of motion or mode of cutting based on feedback from sensors on the cutting head.

10. The method of claim 9.

14. rotating the inner cutting head relative to the outer cutting head includes rotating the inner cutting head back and forth approximately 2-5 times at an RPM of approximately 2000-4000 RPM; 10. The method of claim 9.

15. further comprising cutting through soft tissue.

15. The method of claim 14.

16. rotating the inner cutting head relative to the outer cutting head includes rotating the inner cutting head in one direction at an RPM of about 4000-8000 RPM; 10. The method of claim 9.

17. further comprising cutting through cartilage and / or bone; 16. The method of claim 15.

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