Multi-purpose medical device

Abstract

To provide multipurpose medical equipment and a method for executing medical treatment using the equipment.SOLUTION: Equipment of the present invention includes a handle, a body, a suction system, a sensor, and an instruction part. The body can be operably connected to the handle, and includes a hollow part extending in a length direction of the body. At least part of the body is configured to operate as a retractor during medical treatment. The suction system can include a suction passage disposed in the hollow part. The sensor can be configured to be connected to the body, and can be configured to sense saving force applied to the body during the medical treatment. The instruction part can be configured to provide feedback to a user on the basis of the sensed saving force.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] This application claims priority under 35 U.S.C. § 119 based on U.S. Provisional Patent Application No. 62 / 568,363, filed on October 5, 2017, the entire content of which is hereby incorporated by reference into this specification.

[0002] Some embodiments provided herein generally relate to multi-purpose medical devices, and more specifically, but not by way of limitation, to medical devices that provide multiple functions including, but not limited to, retraction, aspiration, force sensing, user feedback, illumination, nerve stimulation, and / or irrigation.

Background Art

[0003] For example, conventional medical devices used in complex procedures such as head, spinal cord, and peripheral nerve surgeries often exhibit significant drawbacks for medical personnel using such devices. For example, some conventional devices can be used as a platform that provides both aspiration and retraction of sensitive tissues such as brain or nerve tissue. However, such conventional aspiration devices have the drawback that they can damage the tissue when the level of retraction force applied by medical personnel exceeds the level tolerated by the sensitive tissue. For example, in neurosurgery, excessive force can cause bleeding, postoperative pain, or irreparable injury. Understanding the acceptable amount of force application requires learning through experience via case studies and hands-on training. In a hands-on training environment, the instructor can only provide subjective or qualitative feedback to the trainee. Thus, excessive force is one of the main errors committed by surgical trainees.

[0004] Furthermore, during complex procedures as described above, medical personnel may use multiple instruments such as forceps, retractors, scalpels, suction devices, etc. The exchange of instruments takes time and can lead to a decrease in concentration. An increase in instrument exchange can also lead to an increased risk of infection and confusion in the treatment room. Furthermore, in order to reduce the exchange of these tools, medical personnel often also use tools for functions other than the designated functions. For example, surgeons often use surgical instruments as retractors. This is because it is more convenient than using multiple separate retractors. In a specific example, a surgeon may use a surgical suction pipe to simultaneously retract tissue and remove liquid. However, there is no means to monitor the force generation of such surgical instruments on tissue. Thus, the lack of quantifiable feedback can result in excessive force being used, which can lead to postoperative pain or complications.

[0005] Therefore, in order to improve the work of medical personnel performing complex procedures as described above, it is necessary to develop a multi-purpose medical device that can provide multiple functions including force sensing.

Summary of the Invention

[0006] Some embodiments include a multi-purpose medical device configured to be used by a user during a medical procedure. The device can include a handle, a body, a suction system, a sensor, and an indicator. The body can be operably coupled to the handle, can have a hollow portion extending in the longitudinal direction of the body, and at least a portion of the body is configured to operate as a retractor during a medical procedure. The suction system can include a suction passage disposed within the hollow portion. The sensor can be coupled to the body and can be configured to sense a retraction force applied to the body during a medical procedure. The indicator can be configured to provide feedback to the user based on the sensed retraction force.

[0007] One embodiment provides a method of performing a medical procedure within a surgical field. The method can include providing a multi-purpose medical device, the multi-purpose medical device including a body configured to operate as a retractor, an inner surface of the body having a hollow portion, a suction system at least partially disposed within the hollow portion, and a sensing system at least partially supported by the body. The method can further include placing the device within the surgical field and using the device to retract one or more tissues within the surgical field. The method can further include sensing, using a sensor of the sensing system, a force applied to the device during retraction and providing an indication via an indicator of the sensing system when the sensed force exceeds a predetermined threshold value.

[0008] Other problems, advantages, and novel features are set forth in the following description or will become apparent to those skilled in the art upon consideration of the following detailed description and drawings.

Brief Description of the Drawings

[0009]

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Best Mode for Carrying Out the Invention

[0010] Corresponding reference numerals in the drawings indicate corresponding elements. The directions used in the drawings should not be construed as limiting the scope of the claims.

[0011] Before describing any embodiments of the present invention in detail, it should be understood that the present invention is not limited to the details of the configurations described in the following description or shown in the following drawings, nor to the arrangements of the components. The present invention can implement other embodiments and can be implemented in various ways. Also, the language and terminology used in this application are for explanatory purposes and should not be construed as limiting the present invention. When the terms "comprising", "having", or "including" and their variations are used in this application, they are meant to include the recited matters and their equivalents, as well as other matters. Unless otherwise described or limited, the terms "attach", "connect", "support", and "couple" and their variations are used in a broad sense and include both direct and indirect attachment, connection, support, and coupling. Further, "connection" and "coupling" are not limited to physical or mechanical connection or coupling. It should be understood that the present invention is not limited to the details of the configurations described in the following description or shown in the following drawings, nor to the arrangements of the components. The present invention can implement other embodiments and can be implemented in various ways. Also, the language and terminology used in this application are for explanatory purposes and should not be construed as limiting the present invention. When the terms "comprising", "having", or "including" and their variations are used in this application, they are meant to include the recited matters and their equivalents, as well as other matters. Unless otherwise described or limited, the terms "attach", "connect", "support", and "couple" and their variations are used in a broad sense and include both direct and indirect attachment, connection, support, and coupling. Further, "connection" and "coupling" are not limited to physical or mechanical connection or coupling.

[0012] The following description is provided so that those skilled in the art can produce and use embodiments of the present invention. Those skilled in the art can easily derive various improvements to the illustrated embodiments, and the general principles can be applied to other embodiments and applications without departing from the scope of the embodiments of the present invention. Therefore, the embodiments of the present invention are not intended to be limited to the illustrated embodiments, but should be considered to be the broadest scope consistent with the principles and features disclosed in this application. The following detailed description should be read in reference to the drawings, in which like elements in different drawings are labeled with like reference numerals. The drawings, which are not necessarily to scale, illustrate selected embodiments and are not intended to limit the scope of the embodiments of the present invention. A person of ordinary skill in the art will recognize that the examples provided in this application have many useful alternative embodiments and fall within the scope of the embodiments of the present invention.

[0013] As used herein, "at least one of A, B, and C" and other similar expressions mean A or B or C, or all combinations of A, B, and / or C, unless otherwise stated or limited. Thus, such expressions and other similar expressions can include singular or plural entities of A, B, and / or C, and when any of A, B, and / or C indicates a category of elements, can include singular or plural entities of any of the elements of categories A, B, and / or C.

[0014] Some embodiments of the present invention provide a multi-purpose medical device. For example, in some embodiments, the multi-purpose medical device can be configured and arranged to provide multiple functions to medical personnel such as surgeons or surgical participants (specifically, users of the device) during a medical procedure (e.g., a surgical procedure). In particular, there were also some surgical devices that could conventionally provide one or two functions, but these devices also had the drawback of imposing restrictions on medical personnel, and this drawback is solved by the embodiments of the present invention.

[0015] As a mere example, some conventional medical devices such as suction devices can provide a suction ability to medical personnel (e.g., to remove body fluids), and may be configured such that the conventional medical device can be used for medical personnel to take some measures to retract tissues within the surgical field. However, if the suction device is used for this unintended purpose, there may be an overloading of retraction or an excessive application of force to the tissues, resulting in unexpected damage to the retracted tissues. Moreover, medical personnel may need to use multiple different devices for multiple different functions during the procedure. In this case, with conventional devices, medical personnel may need to change the instruments multiple times and / or frequently, which may increase the time and complexity of the surgical procedure. One or more embodiments of the multi-purpose medical device described in the present application have the great advantage of being able to eliminate the above-mentioned drawbacks of such conventional devices.

[0016] As an example, FIG. 1 shows a multi-purpose medical device 10 of some embodiments. Generally, the multi-purpose medical device 10 can be used by medical personnel (e.g., a surgeon, etc.) to perform one or more procedures in a surgical environment, a surgical training environment, or a non-surgical environment. The multi-purpose medical device 10 can provide a plurality of functions, such as, but not limited to, one or more of retraction, aspiration, stimulation, illumination, washing, sensing, and / or user feedback.

[0017] As shown in FIG. 1, in some embodiments, the multi-purpose medical device 10 can include a main body 12 and a handle 14. For example, at least a part of the main body 12 can be configured to contact tissue during a procedure, and the handle 14 can be configured to be held by medical personnel for directing the main body 12 into a local tissue environment during a procedure and / or for controlling one or more functions. In some aspects, the main body 12 and the handle 14 can be operably coupled. For example, the main body 12 and the handle 14 can include separate elements coupled using conventional coupling techniques. In some embodiments, the handle 14 and the main body 12 can be reversibly coupled so that they can be decoupled from each other after being operably coupled. In other aspects, the main body 12 and the handle 14 can be substantially or completely integrated with each other. In certain aspects, the main body 12 and the handle 14 can be manufactured as one unit.

[0018] In some embodiments, the main body 12 and the handle 14 can include materials suitable for use in a sterile surgical environment. For example, the main body 12 and / or the handle 14 can include materials that can be sterilized one or more times (e.g., by radiation, heat, pressure, etc.). Specifically, the main body 12 and / or the handle 14 can include materials such as steel (e.g., stainless steel), polymer-based materials, ceramics, or any combination thereof. Also, the main body 12 and the handle 14 can include the same material or different materials.

[0019] On one side, the main body 12 and the handle 14 can be configured for single use so that the material containing the above-mentioned elements only needs to be sterilized once before the first and only use. Further, on some sides, the multi-purpose medical device 10 can also be suitable for use in a non-sterile environment. For example, as described above, the multi-purpose medical device 10 can be used in a non-surgical test environment or for display purposes with non-biological specimens. In such cases, the device 10 does not necessarily require sterilization and / or does not need to be sterilizable. However, even in such cases, the device 10 can include materials that can be sterilized for one or more non-surgical applications.

[0020] Further, in some embodiments, the main body 12 and / or the handle 14 can be provided with one or more coatings on the surface of the main body 12 and / or the handle 14. As a mere example, in some sides, the main body 12 can be provided with a Teflon (registered trademark) coating, and this Teflon (registered trademark) can reduce the light reflection from the device 10 when medical personnel observe the surgical field using a microscope or in other ways.

[0021] As shown in FIGS. 1, 2, and 4A, at least some sides of the multi-purpose medical device 10 can have a substantially circular cross-section and a generally cylindrical shape. For example, part or all of the length of the main body 12 can have a substantially circular cross-section and a generally cylindrical shape. Further, in some sides, one or more parts of the main body 12 can also have a non-circular cross-section, such as a square, pentagonal, hexagonal, or other shaped cross-section. Further, in some sides, one or more parts of the handle 14 can have a shape similar to that of the main body 12. For example, as shown in FIG. 7, the handle can have a cylindrical shape. In a plurality of other sides, the handle 14 can have a different shape from the main body 12. For example, as shown in FIG. 1, the handle can have an irregular shape that is generally ergonomically configured to be comfortably grasped by a medical personnel's hand. Regardless of the presence or absence of ergonomic considerations, the handle 14 and the main body 12 can have any shape desired by medical personnel. 、shape and / or cross-section, such as circular, cylindrical, spherical, square, pentagonal, hexagonal, and any other arbitrary type of shape desired by current or future medical personnel, etc., can be possessed.

[0022] In some embodiments, the body 12 can have a proximal end 16 and a distal end 18. For example, in some embodiments, the body 12 can be generally cylindrical in shape, and the body 12 can have a substantially linear form such that the proximal end 16 and the distal end 18 are on opposite sides of each other in a straight line. In particular, in some aspects, the proximal end 16 can be the end of the body 12 disposed substantially adjacent to the handle 14, and the distal end 18 is present at the end of the body 12 distal to the handle 14. In a plurality of other embodiments (for example, embodiments where the body 12 is non-linear or non-cylindrical), the proximal end 16 and the distal end 18 can be arranged in any other manner desired by medical personnel, and / or at least one of these elements can be omitted.

[0023] In some embodiments, the body 12 can have an inner surface 20. For example, on some sides, the inner surface 20 can define a hollow portion 22 such that most or all of the body 12 is hollow. Further, the hollow portion 22 can be configured and arranged to receive one or more multi-functional elements that can be advantageous for the multi-purpose medical device 10. Further, in some embodiments, the hollow portion 22 extends in the longitudinal direction of the body 12 to form a distal open end 18 and, in some embodiments, a proximal open end 16, and can extend from the proximal end 16 to the distal end 18 of the body 12. In some embodiments, the length that the hollow portion 22 extends can be shorter than the total length of the body 12. Further, in some embodiments, the body 12 and the handle 14 can be formed or joined together such that the hollow portion 22 communicates with and / or connects to a recess or a hollow portion (not shown) of the handle 14. With such a configuration, one or more of the multi-functional elements can be arranged to extend along the body 12 and the handle 14. In other embodiments, the body 12 can have a plurality of hollow portions 22, whereby one or more multi-functional elements of the multi-purpose medical device 10 can be respectively arranged within each hollow portion 22.

[0024] In some embodiments, the body 12 can have different size dimensions depending on the surgical procedure of the subject on which the multi-purpose medical device 10 is used. For example, in a procedure such as a spinal-related procedure, the body 12 can have an outer diameter of about 5 mm (millimeters), and in a more delicate procedure (such as a procedure related to the brain, etc.), the outer diameter can have a smaller size, such as 2 mm, etc. In a plurality of other embodiments, depending on the requirements of the medical personnel using the multi-purpose medical device 10, the outer diameter can have a size greater than 5 mm or less than 2 mm. In some embodiments, it can be made possible to replace a plurality of bodies 12 of different sizes for one handle 14, and in a plurality of other embodiments, a plurality of bodies 12 of different sizes can each have a dedicated and unique handle 14.

[0025] Similarly, the inner diameter of the main body 12 (e.g., the diameter of the hollow portion 22) can have a plurality of different sizes so as to meet the requirements of medical personnel using the multi-purpose medical device 10. For example, depending on the size of the outer diameter of the main body 12 and / or the requirements of medical personnel using the multi-purpose medical device 10, the inner diameter can have a size of 2, 3, or 4 mm. In still other embodiments, the inner diameter of the main body 12 can have a size less than 2 mm or greater than 4 mm so as to meet the requirements of medical personnel using the multi-purpose medical device 10. Further, in a plurality of embodiments including a plurality of hollow portions 22, these plurality of hollow portions 22 can have the same diameter, or can have different diameters to accommodate different multifunctional elements respectively.

[0026] Referring now to FIGS. 3A - 3C, the main body 12 can have various configurations. For example, in some embodiments, the main body 12 can have a substantially linear and straight configuration (as shown in FIG. 3A) such that the distal end 18 of the main body 12 is substantially aligned with the other portions of the length of the main body 12 and / or the handle 14. In other aspects, the main body 12 can have a configuration that is at least partially angled (as shown in FIGS. 3B and 3C) such that the distal end 18 of the main body 12 forms an angle with at least a portion of the other portions of the length of the main body 12 and / or the handle 14. For example, the angle can be fixed so that the main body 12 can be formed such that the angle does not change during the life of the main body 12. In other aspects, the main body 12 can be configured and arranged such that the distal end 18 is movable with respect to at least a portion of the other portions of the main body 12 and / or the handle 14. In this way, depending on the requirements of medical personnel using the multi-purpose medical device 10, the angle between the distal end 18 and the other portion (and / or the handle 14) of the main body 12 can be varied from about 0° (shown in FIG. 3A) to a shallow angle (shown in FIG. 3B) to a large angle (shown in FIG. 3C). Further, in some embodiments, the main body 12 can have a configuration having a combination of a linear portion and an angled portion.

[0027] As described above, the multi-purpose medical device 10 can be configured and arranged to function as an instrument used during one or more medical procedures. For example, the multi-purpose medical device 10 can be configured and arranged to be used as a surgical retractor. In particular, a medical professional (e.g., a surgeon) can grip and operate the multi-purpose medical device 10 with the handle 14. Further, the medical professional can insert and place the multi-purpose medical device 10 into the surgical field (e.g., an area within a patient where a surgical procedure is being performed or is to be performed and which is maintained in a sterile state), and use the device 10 to apply a force (e.g., a retraction force) to the tissue in the surgical field in order to retract the tissue. In this way, at least a part of the device 10, for example at least a part of the main body 12, is configured to operate as a retractor during a medical procedure. In some aspects, in order to enhance the visualization of tissues that would normally be obscured, the surgeon can use a part of the multi-purpose medical device 10 (e.g., the distal end 18 of the main body 12 or other parts along the length of the main body 12) to retract one or more types of tissues (e.g., brain tissue, nerve tissue, muscle tissue, blood vessels, etc.). In other words, the surgeon can also use the multi-purpose medical device 10 in some embodiments as a conventional retractor as one of its multiple functions.

[0028] The body 12 alone can be suitable for a healthcare provider to perform a desired tissue retraction. However, in some embodiments, the multi-purpose medical device 10 can further include an inflatable member (not shown). For example, the inflatable member can generally be configured as an inflatable balloon containing a sterilizable and inflatable / shrinkable medical-grade material in response to the requirements of the healthcare provider using the multi-purpose medical device 10. In some embodiments, the inflatable member can be supported by and / or coupled to the body 12. Further, the inflatable member can be coupled to the distal end 18 or a portion of the body 12 adjacent to the distal end 18 and placed in a controllable fluid communication state with a fluid source (e.g., via a hollow portion 22 of the body 12 or other conduits). A surgeon using the multi-purpose medical device 10 can operate this fluid source to inflate the inflatable member to a desired pressure by flowing a fluid such as air, liquid, etc. into the inflatable member. In this way, when the inflatable member is disposed at or near the distal end 18, the inflatable member can impart a retraction ability to the multi-purpose medical device 10 without causing traumatic effects. In other words, the inflatable member can be used to assist with the above-described retraction ability. Further, the inflatable member can reduce the force applied to the tissue to be retracted and provide the above-described retraction assistance, thereby allowing the surgeon to reduce iatrogenic trauma during the medical procedure. Specifically, in some embodiments, the inflatable member can be used as the sole site of the retraction force during the procedure, and in other aspects, the inflatable member can be used to increase the retraction force exerted on the tissue within the surgical field by the surgeon using the body 12.

[0029] Referring to FIGS. 2 and 7, the body 12 supports and / or couples to one or more other functional systems of the multi-purpose medical device 10 This is achievable. For example, the multi-purpose medical device 10 can include a suction system 24, a stimulation system 26, a cleaning system 28, an illumination system 29, and / or a sensing system 30. The multi-purpose medical device 10 shown in FIGS. 2 and 7 includes all of these functional systems. However, it should be noted that some embodiments can alternatively include various combinations of one or more of the above functional systems.

[0030] In some embodiments, the suction system 24, the stimulation system 26, the cleaning system 28, the illumination system 29, and the sensing system 30 can be at least partially supported by the main body 12. For example, in some embodiments, at least a part of the suction system 24, the stimulation system 26, the cleaning system 28, the illumination system 29, and / or the sensing system 30 can be disposed at least partially within the hollow portion 22. Further, in some embodiments, at least a part of the sensing system 30 can be coupled to a part of the main body 12, such as the outer surface of the main body 12 and / or the handle 14. Further referring to FIG. 7, in some aspects, a part of the suction system 24, the stimulation system 26, the cleaning system 28, the illumination system 29, and / or the sensing system 30 extends through a part or all of the handle 14 and can be connected to other devices necessary for the operation and monitoring of the multi-functional medical device 10. In a plurality of other embodiments, at least any one of the suction system 24, the stimulation system 26, the cleaning system 28, the illumination system, and / or the sensing system 30 can communicate wirelessly at least in part with other devices necessary for the operation and monitoring of the multi-functional medical device 10. Such other devices can include, but are not limited to, a suction source, a waste container, a current source, a fluid source, a power source, an illumination light source, and / or a computer system 45 (shown in FIG. 7).

[0031] Referring to FIGS. 2, 4A, 5, 7 and 10, at least a portion of the suction system 24 can be supported by the body 12 and can include a suction passage 32. Generally, the suction passage 32 can be disposed within the hollow portion 22 and can extend from the distal end 18 through the proximal end 16 and, in some aspects, further through the handle to a suction source (not shown).

[0032] For example, the suction passage 32 can be disposed within at least a portion of the hollow portion 22 or, in some embodiments, within at least one of a plurality of hollow portions. In some embodiments where the suction passage 32 is disposed within a portion of the hollow portion 22, the suction passage 32 can have a separate element (such as a conduit) that can be disposed within (e.g., routed through) a portion of the hollow portion 22. In other embodiments, the suction passage 32 can encompass the entire hollow portion 22. Specifically, by having the suction passage 32 be a hollow portion disposed within the body 12 and within the handle 14, the suction passage 32 can encompass the hollow portion 22. In some embodiments having a plurality of hollow portions, the suction passage 32 can be substantially or completely integral with at least one of the plurality of hollow portions or can be a separate element disposed within one of the plurality of hollow portions. Further, the suction passage 32 can be connected to a tube (e.g., adjacent to the handle 14) that can generate a suction flow from a suction source (such as a vacuum source) to the suction passage 32.

[0033] In some embodiments, the suction source can be controlled by one or more of the medical personnel participating in the medical procedure. For example, the suction source can be operated by an on-off switch, a foot pedal, a hand switch, or any other means for controlling the activation and deactivation of the suction source. Further, in some embodiments, the suction source can be activated for part or all of the procedure. Further, the suction supplied through the suction passage 32 can be selectively controlled by the surgeon. For example, in some aspects, the handle 14 can form a suction control aperture 34 (as shown in FIG. 1) that is operably in fluid communication with the suction passage 32. Thus, the suction control aperture 34 can pass through at least a portion of the handle 14 so as to be in fluid communication with the suction passage 32. In this way, when the surgeon desires to supply suction to a particular location within the surgical field, the surgeon need only block all or part of the suction control aperture 34 (e.g., with his or her finger or thumb, or by another element), whereby suction is supplied through the suction passage 32 to remove liquid and debris from the surgical field through the distal end 18 of the body 12. When the surgeon desires to reduce the suction or remove all of the suction, the surgeon need only move his or her finger or thumb or another element away from all or part of the suction control aperture 34, whereby the suction level can be reduced to zero. In other words, the suction control aperture 34 can be used to control the level of suction supplied to the surgical field. In this way, the suction system 24 can be used to supply suction to remove undesired fluids and tissue during a surgical procedure. Further, in combination with the retraction ability described above, the multi-purpose medical device 10 can provide a combination of retraction and suction within the surgical field simultaneously or substantially simultaneously. Further, the suction passage 32 can be in fluid communication with one or more waste containers (not shown). The one or more waste containers can be the final destination of the fluid and tissue removed from the surgical field through the suction system 24 (i.e., the destination after flowing through the suction passage 32).

[0034]

[0035] ​Referring now to FIGS. 2, 4A, 5, 7, and 8, at least a portion of the stimulation system 26 can be supported by the body 12. For example, the stimulation system 26 can include a stimulation path 36, which can be disposed within at least a portion of the cavity 22, or in some embodiments, within at least one of a plurality of cavities. For example, in some embodiments, the stimulation path 36 can be substantially or completely integral with the cavity 22 (or at least one of a plurality of cavities). In other embodiments, the stimulation path 36 can be disposed within a portion of the cavity 22. For example, the stimulation path 36 can have a separate element (e.g., wiring, etc.) and can be disposed within a portion of the cavity 22 (or within a portion of one of a plurality of cavities).

[0036] Referring particularly to FIG. 8, in some embodiments, generally the stimulation system 26, and specifically the stimulation path 36, can be configured and arranged to transmit current from a current source, such as a battery or other power source (not shown), to the stimulation tip 38. More specifically, the stimulation path 36 can be configured and arranged as a substantially insulated electrical wire (e.g., including a conductive material such as copper) to conduct current from the current source to the stimulation tip 38. In some embodiments, the operation of the stimulation system 26 can be controlled by one or more medical personnel performing the operation using any conventional control technique, such as an on-off switch, a foot pedal, a hand switch, etc.

[0037] In some embodiments, the stimulation tip 38 can generally be disposed at or near the distal end 18 of the body 12. For example, if a surgeon (or other medical professional) wishes to evaluate the proximity from the multi-purpose medical device 10 to one or more nerves in adjacent tissue within the surgical environment, the surgeon can activate the stimulation system 26 so that current can flow from the current source through the stimulation path 36 to the stimulation tip 38, and the stimulation tip 38 can be positioned. In this way, when the stimulation tip 38 supplies current to the tissue, if the stimulation tip 38 is generally adjacent to one or more nerves, the patient's body will react to the electrical stimulation (e.g., by small involuntary movements). If the surgeon determines that the device 10 is overly close to one or more nerves, the surgeon can change the position of the nerve or adjust his own position within the surgical field.

[0038] In some embodiments, the stimulation tip 38 can be configured and arranged to move depending on the operating state of the stimulation system 26. For example, in some embodiments, the stimulation tip 38 can be made movable or biasable (e.g., retractable) depending on the operating state of the stimulation sys tem 26. As a mere example, when the stimulation system 26 is in either the non-operating state or the operating state but the surgeon does not want to supply current to the local tissue to evaluate the proximity to one or more nerves, the stimulation tip 38 can be in a generally retracted position (not shown). Then, when the surgeon wishes to evaluate the proximity to one or more nerves, the surgeon can move the stimulation tip 38 from the retracted position to the extended position (as shown in FIG. 8). In this extended position, the stimulation tip 38 can extend from the distal end 18 so that current can be supplied to the local tissue to evaluate the proximity to one or more nerves. In some aspects, one or more biasable members (such as a spring, etc.) (not shown) or other retraction mechanisms can be used to move the stimulation tip 38.

[0039] With the above configuration, the stimulation system 26 can be used to supply nerve stimulation or other stimulation during a surgical procedure. Further, in combination with the above-described retraction ability, the multi-purpose medical device 10 can provide a combination of retraction and stimulation in the surgical field simultaneously or substantially simultaneously.

[0040] Referring now to FIGS. 2, 4A, 5, 7 and 9, at least a portion of the cleaning system 28 can be supported by the body 12 and can have a cleaning flow path 40. Generally, the cleaning flow path 40 is disposed within the cavity 22 and can extend from the distal end 18 through the proximal end 16 and, in some aspects, further through the handle 14 to a cleaning source (not shown).

[0041] For example, the cleaning flow path 40 can be disposed within at least a portion of the cavity 22 or, in some embodiments, within at least one of a plurality of cavities. Further, in some aspects, the cleaning system 28 can be disposed within the body 12 of a particular embodiment, such as within a body 12 having a relatively large outer diameter (e.g., 5 mm or greater). In other aspects, the cleaning system 28 can be configured and arranged to be disposed within a body 12 of any size or shape. In some embodiments where the cleaning flow path 40 is disposed within a portion of the cavity 22, the cleaning flow path 40 can have a separate element (e.g., a conduit) that can be disposed within a portion of the cavity 22. In other embodiments, the cleaning flow path 40 can encompass the entire cavity 22. Specifically, by the cleaning flow path 40 being a cavity disposed within the body 12 and within the handle 14, the cleaning flow path 40 can encompass the cavity 22. In some embodiments having a plurality of cavities, the cleaning flow path 40 can be substantially or completely integral with at least one of the plurality of cavities or can be a separate element disposed within one of the plurality of cavities. Further, the cleaning flow path 40 can be connected to a tube (e.g., adjacent to the handle 14) that can flow fluid from a fluid source or cleaning source to the cleaning flow path 40.

[0042] Regardless of the configuration, the cleaning flow path 40 can penetrate the main body 12 from the proximal end 16 to the distal end 18 so that fluid can flow from the fluid source into the multi-purpose medical device 10 and flow out from the distal end 18. For example, in some embodiments, the operation of the cleaning system 28 can be controlled by one or more medical personnel performing the operation using any conventional control technique such as an on-off switch, a foot pedal, a hand switch, etc. In this way, when a medical personnel desires to clean at least a part of the surgical field, the cleaning system 28 can be activated to transport fluid (e.g., saline or other salt-containing or carbohydrate-containing solution) from the fluid source through the cleaning flow path 40 to the said part of the local surgical field.

[0043] Thus, by using the cleaning system 28, medical personnel can help remove (i.e., clean) local unwanted tissue or body fluid by supplying fluid through the cleaning flow path 40. Further, in combination with the above-described retraction ability, the multi-purpose medical device 10 can provide a combination of retraction and cleaning within the surgical field simultaneously or substantially simultaneously.

[0044] Referring to FIGS. 2, 4A, 5 and 7, at least a part of the lighting system 29 can be supported by the main body 12. For example, the lighting system 29 can have an optical channel 31, and the optical channel 31 can be disposed inside at least a part of the hollow portion 22, or in at least one of a plurality of hollow portions according to an embodiment. For example, in some embodiments, the optical channel 31 can be substantially or completely integrated with the hollow portion 22 (or at least one of a plurality of hollow portions). In other embodiments, the optical channel 31 can be disposed inside a part of the hollow portion 22. For example, the optical channel 31 can comprise a separate element (e.g., wiring or an optical fiber cable) and can be disposed inside a part of the hollow portion 22 (or inside a part of one of a plurality of hollow portions). Further, in order to connect a power source or a light source (not shown) to the optical channel 31, the optical channel 31 can be connected to external wiring (e.g., adjacent to the handle 14).

[0045] In some embodiments, generally the lighting system 29, specifically the light channel 31, can be configured and arranged to emit light from the distal end 18 of the body 12. In some embodiments, the operation of the lighting system 29 can be controlled by one or more medical personnel performing the operation using any conventional control technique such as an on-off switch, a foot pedal, a hand switch, etc. In this way, the surgeon can activate the lighting system 29 to assist in observing the surgical field near the distal end 18.

[0046] Thus, the lighting system 29 can be used to provide additional illumination to the local tissue environment during a surgical procedure. Further, in combination with the above-described retraction ability, the multi-purpose medical device 10 can provide a combination of retraction and illumination within the surgical field simultaneously or substantially simultaneously.

[0047] Referring to FIGS. 2, 4A, 5, 7 and 11, at least a part of the sensing system 30 can be supported by the main body 12. For example, the sensing system 30 can include at least one sensor 42 coupled to or otherwise disposed along the main body 12, and at least one indicating unit 43 (as shown in FIGS. 7 and 11). In some embodiments, the sensor 42 can be configured and arranged to sense or detect the amount of force or pressure applied in the local environment. For example, the sensor 42 can be one or more pressure sensors provided on the main body 12 and configured to detect the pressure applied to the local tissue in the surgical field by the device 10. In some aspects, for example, when the multi-purpose medical device 10 is used as a retractor to move one or more local tissues (such as brain tissue) or apply force to the local tissue, the sensor 42 can be used to detect a specific force or pressure (such as a retraction force) applied to the main body 12. The indicating unit 43 can be configured to provide feedback to the surgeon (such as the user of the device 10) based on the sensed retraction force. More specifically, by sensing this retraction force, the force data collected by the sensor 42 can be transmitted to at least one indicating unit 43, thereby providing feedback to the surgeon performing the procedure. This feedback can guide the surgeon to reduce the risk of applying excessive force to the local tissue.

[0048] Thus, in some embodiments, the sensor 42 can communicate with at least one indicating unit 43. For example, the sensor 42 can communicate with at least one indicating unit 43 by wired communication (see FIG. 11 for example) or wireless communication. The indicating unit 43 can include one or more of the following forms of indicating units: a visual indicating unit (such as an LED that can blink or change color), a tactile indicating unit (such as a vibration tactile signal generating mechanism such as a small vibration motor), and an auditory indication An indication unit (for example, a device capable of emitting one or more noises, such as a buzzer, a beeping device, or other noise generating devices, etc.). Further, in some embodiments, the indication unit 43 can also be disposed outside or inside the main body 12 or the handle 14. For example, in FIGS. 7 and 11, the indication unit 43 is shown to be at the proximal end of the handle 14, but it can be disposed at any position along the main body 12 or the handle 14. Further, in some embodiments, the indication unit 43 can be disposed at another location remote from the main body 12 and the handle 14, and close enough to the surgeon and the surgical field to provide distinguishable feedback. For example, the indication unit 43 can be a remote visual or auditory indication unit for providing feedback to the surgeon, or a remote tactile indication unit that contacts the surgeon.

[0049] Furthermore, in some embodiments, the indicating unit 43 can provide feedback when the sensed evacuation force exceeds a predetermined threshold. In a plurality of other embodiments, the indicating unit 43 can provide different feedback based on the level of the evacuation force sensed by the sensor 42. For example, a plurality of different types of indicating units 43 can indicate different levels of the force data acquired by the sensor 42, or one indicating unit 43 can have a plurality of different types of feedback based on a plurality of different levels of the force data. For example, the visual indicating unit 43 can emit different colors of light based on the force data, such as green light when the force data indicates an acceptable force below a threshold (e.g., the above-mentioned predetermined threshold), and red light when the force data indicates an excessive force exceeding the threshold. Alternatively, the visual indicating unit 43 can have a color other than red and green, or can have additional colors corresponding to an increase in the number of feedback levels. For example, green light can be emitted when the force data indicates an acceptable force below a first threshold, yellow light can be emitted when the force data indicates an intermediate force exceeding the first threshold and below a second threshold, and red light can be displayed when the force data indicates an excessive force exceeding the second threshold. Here, the above-mentioned intermediate force can be a force that is still acceptable but approaching excess. In another example, a plurality of different types or volumes of auditory feedback can be used based on the level of the feedback. In yet another example, a plurality of different types or levels of tactile feedback (e.g., a plurality of different types or intensities of vibration) can be used based on the level of the feedback.

[0050] In some embodiments, the indicating unit 43 can be provided as part of a computer system 45 that communicates with the multifunctional medical device 10 (as shown in FIG. 7). In other words, the computer system 45 can function as a remote indicating unit 43. For example, the multifunctional medical device 10 can communicate with the computer system 45 by wire or wirelessly such that force data acquired by the sensor 42 is transmitted to the computer system 45 (e.g., via a wired connection 57 as shown in FIG. 7). The computer system 45 can be configured to receive force data from the sensor 42, and can also analyze the force data in real time and provide feedback (visual, auditory, tactile, etc.) to the surgeon based on this force data (e.g., based on a force measurement value calculated or derived from the force data). The computer system 45 can also store the force data, for example, for later review after a procedure or training session, or for other record-keeping purposes. The computer system 45 can also receive, analyze, and / or store other data related to other functions of the multifunctional medical device 10. This will be described in detail below.

[0051] Thus, in some embodiments, the sensing system 30 can be used to provide the surgeon with guidance useful for avoiding complications associated with excessive retraction of tissue within the surgical field. In addition to performing the above measurements, the sensor 42 can process the sensed amount of force, strain, or pressure and provide an indication to the indicating unit 43 to provide feedback to the surgeon if it detects that the sensed force exceeds a predetermined threshold. Alternatively, the sensor 42 can transmit the measurement data to the indicating unit 43 (and / or the computer system 45) and process the sensed amount of force , strain, or pressure to provide appropriate feedback.

[0052] In some embodiments, the predetermined threshold can include a detected force from about 0.3 N (Newton) to about 1.5 N. In some aspects, this detected force can be less than 0.3 N (e.g., 0.1 N or less, etc.) or greater than 1.5 N (e.g., 1.84 N or more). For example, in some applications such as procedures targeting relatively sensitive areas of the brain, a low force of about 0.01 N to 0.1 N can be detected. Further, as described above, the predetermined threshold can include a plurality of values so that the surgeon can receive a plurality of signals from the indicator unit 43. For example, when a predetermined threshold of 0.3 N, 0.7 N, 1.0 N, and 1.5 N is reached, the surgeon can receive a unique feedback. In this way, when the device 10 is used as a retractor, the surgeon can rely on the sensor 42 and the indicator unit 43 to receive guidance on the amount of force applied. Further, in some aspects, a plurality of types of indicator units can each indicate a different force level (e.g., auditory feedback for 1.5 N, visual feedback for 1.0 N, and tactile feedback for 0.3 N). After receiving such feedback, the surgeon can make any necessary changes to the retraction force applied to the local tissue within the surgical field.

[0053] In some aspects, the sensor 42 can be configured and arranged as a pressure-sensitive device, for example, as a pressure-sensitive film 42 that can be coupled to the outer surface 44 of the body 12 (as shown in FIGS. 2, 4A, 4B, 4C, and 6 - 11). In some aspects, the sensor 42 can be configured as any other arbitrary technique that can detect force, strain, and / or pressure and does not necessarily have to be coupled to the outer surface 44 (e.g., FIG. 5 shows an embodiment that operates without a sensor 42 provided on the outer surface 44). Further, in some aspects, by disposing at least a portion of the sensing system 30 at a distance (e.g., 5 mm) from the distal end 18, the sensing system 30 can be prevented from interfering with the operation of the stimulation system 26 or other functional systems. In a plurality of other aspects, a portion of the sensing system 30 can be disposed at the distal end 18.

[0054] In some conventional devices, attempts have been made to measure force based on the pushing away of water or the deformation of silicone, for example, by attaching a silicone-based retraction member or the like to the pipe of a suction device. Although it is practical due to its accuracy, disposability, and ease of sterilization, this method may not be optimal because it makes it difficult to penetrate deep tissues by imposing size constraints, thereby changing the shape of the device. Also, by changing the physical properties of the device, its handling and the resulting tissue interaction may change. This method also requires the use of a camera and other tools to reliably suppress tissue damage, which can clutter the operating table. Thus, the above-described conventional attempts have not achieved a device practical for medical treatment.

[0055] The multifunctional medical device 10 of some embodiments achieves an improvement over the above-described conventional methods by using the sensor 42 as one or more strain gauges. For example, a strain gauge can detect deformation (e.g., surface deformation) in response to a load (e.g., retraction or other movement of tissue within the surgical field). Specifically, a strain gauge consists of an electrical grid attached to a support base. For example, by joining a strain gauge to the surface of the main body 12 or the like, deformation occurs in the grid of the strain gauge due to the deformation of this surface, and a strain measurement value along the axis of the gauge is obtained based on the change in the electrical resistance of the grid. This strain measurement value is a dimensionless number because it is the ratio of the change in the length of the surface to the original length. The direction of the force can be known from the direction of the strain along that location, and it can also be known whether tension, compression, shear strain, torsion, etc. is applied to the surface.

[0056] With the above configuration, by performing calibration tests and calculations using strain information, the nature and / or type of the applied load can be generally, substantially, or accurately estimated. Further, in some aspects, the relative position of the load can also be determined using strain information. In some aspects, this can be considered an indirect force measurement mode.

[0057] In some embodiments, a strain gauge or other sensor 42 can be supported by passing a fastening element, screw, or other coupling structure through the body 12 or the handle 14. For example, a through-hole or a blind hole can be drilled, or provided in other ways (e.g., along the central axis / long axis of the screw) by a screw or other structure, so that the sensor 42 gauge can be disposed within the screw and / or supported by the screw.

[0058] Referring to FIGS. 12A and 12B, in some embodiments, the sensing system 30 can include a support member 46 and a strain gauge 48. For example, one or more of the support members 46 can be coupled to at least a portion of the body 12 (e.g., the outer surface 44 of the body 12) or supported by at least a portion of the body 12 in other ways. In some aspects, as shown in FIG. 12A, some or all of the support members 46 can extend along a part or all of the length of the body 12. In other embodiments, the support member 46 can have any other suitable length. In some aspects, the support member 46 can have a round, flat, regular polygon, or irregular shape according to the requirements of the end user (as an example, FIG. 12B shows a cross-sectional form in which a plurality of support members 46 are substantially T-shaped on a flat outer surface). In some embodiments, some or all of the support members 46 can be coupled to the outer surface 44 at a known distance from the distal end 18.

[0059] In some further embodiments, one or more strain gauges 48 can be coupled to the plurality of support members 46 (e.g., uniaxially). With such a configuration, when pressure is applied to the surrounding tissue by the surgeon orienting the device 10 (as shown, for example, in FIG. 12A), the support members 46 can bend slightly, thereby enabling the strain gauge 48 to detect tension (when the strain gauge 48 is attached to the outer surface of the support member 46) or compression (when the strain gauge is attached to the inner surface of the support member 46). Further, by calibrating the plurality of strain gauges 48 prior to use, a particular combination of strain patterns can be made to correspond to a particular magnitude of compressive force applied to the surrounding tissue. In this way, force or strain can be sensed based on sensor readings. In some aspects, this calibration can be performed using machine learning (e.g., using a neural network).

[0060] FIGS. 13 - 18 show other embodiments of the multi-functional medical device 10 with the sensing system 30, which sensing system 30 includes one or more pressure sensors 42.

[0061] For example, FIG. 13 shows the multi-functional medical device 10 with the sensing system 30 of some embodiments. The multi-functional medical device 10 of FIG. 13 can include retraction, aspiration, and sensing functions. Specifically, the medical device 10 can include a body 12, a handle 14, an aspiration system 24, and a sensing system 30.

[0062] The body 12 and the handle 14 can have similar features as those described above with reference to FIGS. 1 - 12A. For example, the handle 14 can have a substantially cylindrical shape, be coupled to the body 12, or be integral with the body 12. The body 12 can include a proximal end 16 adjacent to the handle 14, a distal end 18 distal from the handle 14, and a hollow portion 22 extending through the body 12 (e.g., functioning as the aspiration passage 32 of the aspiration system 24) It can be provided with (...). The main body 12 can also be provided with a tapered or rounded portion 50 at the proximal end, a linear portion 52 adjacent to the proximal end 16 (e.g., aligned with the handle 14), and an angled portion 52 extending from the linear portion 52 (e.g., forming an angle with the handle 14). In one embodiment, the handle 14 can include stainless steel 321, and the main body 12 can include stainless steel 304 (however, in some embodiments, other materials are also possible). Further, in one embodiment, the main body 12 can also have an outer diameter of about 4 mm. However, in some embodiments, the outer diameter of the main body can be in the range of about 2 mm to about 5 mm as described above.

[0063] The suction system 24 can have features similar to those described above with reference to FIGS. 1 - 12A. Thus, at least a part of the suction system 24 can be supported by the main body 12 and can have a suction passage 32. Specifically, the hollow portion 22 can function as the suction passage 32 inside the main body 12, and the suction passage 32 can further extend into the handle 14. The suction passage 32 can be connected to a pipeline from the handle 14, and this pipeline is further connected to a suction source. The handle 14 can also have a suction control opening 56 communicating with the suction passage 32, whereby a medical staff member can selectively control the suction from the distal end 18 as described above.

[0064] With the above configuration, the multifunctional medical device 10 in FIG. 13 can provide three functions: suction, retraction, and sensing / feedback. Further, although not shown in FIG. 13, in some embodiments, the multifunctional medical device 10 can also be provided with other functional systems such as a stimulation system, a cleaning system, and / or an illumination system.

[0065] Regarding the sensing system 30, the multifunctional medical device 10 can be provided with one or more sensors. Specifically, it can be provided with one or more strain gauges 48 coupled to the outer surface 44 of the main body 12. By joining the strain gauge 48 to the outer surface 44, even if size constraints are imposed on the device 10 by the thin grid of the strain gauge 48, they can be minimized. Further, in some embodiments, a coating and / or adhesive can be applied to the strain gauge 48 to enable sterilization of the multifunctional medical device 10 without affecting the function of the strain gauge.

[0066] For example, as shown in FIG. 13, three strain gauges 48 can be arranged at approximately 90° intervals around the circumferential surface of the main body 12 (e.g., around the circumferential surface of the angled portion 54 of the main body 12). However, in some embodiments, the number of strain gauges 48 used can be increased or decreased depending on, for example, restrictions due to the circumferential surface of the main body 12. Further, as shown in FIG. 13, the strain gauge 48 can also be arranged at a distance away from the distal end 18. In one embodiment, the strain gauge 48 can be arranged at a position approximately 6.8 cm from the distal end 18 (however, other lengths are possible in other embodiments). Further, in some embodiments, as shown in FIG. 14, the strain gauge 48 can include, for example, an external wired connection portion 57, which can be connected to a computer system 45 or other data acquisition system. In a plurality of other embodiments, the strain gauge 48 can be coupled to internal wiring (not shown) wired within the hollow portion 22 and within the handle 14.

[0067] In some embodiments, the strain gauge 48 can be a uniaxial strain gauge (i.e., a strain gauge capable of measuring strain in one direction) or a rosette gauge (i.e., a device in which two or more gauges are arranged at angular intervals from each other and can measure strain in two or more directions). In some embodiments, multiple rosette gauges can be spaced apart or overlapped. It should be noted that a stacked rosette gauge can have a smaller required surface area than spaced-apart rosette gauges, and since all the grids overlap at one point, measurements from all the grids can be made on the same plane. Thus, the multifunctional medical device 10 of some embodiments can include any number and type of gauge configurations.

[0068] For example, the plurality of strain gauges 48 shown in FIG. 13 can be uniaxial strain gauges or rosette gauges and can be oriented to detect the bending force of the body 12. Specifically, the orientation of the uniaxial strain gauge 48 can be in the longitudinal direction along the body 12 (e.g., in the direction along the longitudinal axis of the body 12), and / or the rosette gauge 48 can include one gauge in the longitudinal direction along the body 12. As a result, the strain gauge 48 can sense the bending force of the body 12. Specifically, for example, when a force is applied to the body 12, such as when a point adjacent to the distal end 18 is pressed against tissue to displace the tissue, the body 12 will deform slightly, and one or more of the strain gauges 48 can sense this bending strain. Further, the strain gauge 48 can sense the force even when the force is applied to the curved surface of the body 12 (i.e., not applied to a traditional flat plane).

[0069] For example, as shown in FIG. 15, when a force F is applied to the main body 12, the main body 12 deforms downward (based on the direction shown in FIG. 15), the upper surface of the main body 12 expands, and the gauge 48A detects this tension. At the same time, the lower surface of the main body 12 is compressed, and the gauge 48B detects this compressive force. The other gauge 48C generally does not detect a bending force or shows a minimum response to bending in the direction shown in FIG. 15. This is because the bending strain is zero at the geometric centroid of the cross-sectional shape. Specifically, since the hollow portion of the main body 12 is symmetric and the cross-section is circular, its geometric centroid lies on a horizontal line passing through the center of the circle. This other gauge 48C is on this stress / strain-free line, and this line is called the "neutral axis". Also, when a force F is applied at a point between the two strain gauges 48, all three strain gauges 48 can detect any component of the applied force. The computer system 45 can combine the measurement results from the plurality of strain gauges 48 around the main body 12 to obtain the resultant applied force. For example, the multifunctional medical device 10 can be calibrated to determine the relationship between the strain measurement results and different angles of vertical force application. By using such a relationship as a calibration standard, an unknown force and application angle can be predicted. Therefore, by arranging and using a plurality of strain gauges 48 around the circumferential surface of the main body 12, the force applied at any location around the main body 12 can be detected and calculated.

[0070] Furthermore, any change in the strain measurement results caused by the fluid flow within the hollow portion 22 (e.g., suction of a conventional vacuum pressure for medical treatment, etc.) can be considered by the computer system 45 and filtered out from the final force measurement value. For example, although studies have shown that a bias may occur in the strain readings due to the start and end of the fluid flow, it has been shown that this bias can be taken into account even though the change in the flow pressure after the flow starts or ends has a minimal effect on the strain measurement results. Thus, in some embodiments, the computer system 45 can also receive an input regarding the operation of the cleaning system 28.

[0071] Therefore, the force measurement value can be obtained by measuring the bending strain of the main body 12. However, in order to obtain the actual force measurement value based on the bending strain, the moment arm must be known. That is, the distance from which the force is applied from the strain gauge 48 must be known. Therefore, if the multifunctional medical device 10 is configured such that the force is applied only at a known distance from the strain gauge (for example, the distance of the first 2 cm from the distal end 18), the force measurement value can be obtained using the bending strain. On the other hand, when the multifunctional medical device 10 is configured such that the force can be applied at any distance along the length of the main body 12, the bending force alone may be insufficient to accurately calculate the force. Specifically, since the contact area is unknown, the dependence on the moment arm may make it difficult to determine the force. Therefore , additional strain measurements may be required in some embodiments.

[0072] For example, in addition to measuring the bending strain, a rosette gauge can measure the shear strain (i.e., the shear strain can be measured by providing a plurality of gauges in a plurality of directions), and this shear strain does not depend on the location where the force is applied. Specifically, a laminated rosette gauge such as a 3-axis rosette gauge disposed on the circumferential surface of the main body 12 can perform measurements in three directions, and a more comprehensive strain measurement can be achieved around (compared to a single uniaxial gauge alone), and both the shear strain and the bending strain can be calculated, and the calibration results can be compared using both parameters. For example, the shear strain can be calculated using established strain theory principles and the three uniaxial strains of each gauge in the stack of the rosette gauge 48. Further, the multifunctional medical device 10 can also be calibrated so that both the shear strain and the bending strain can be used to predict an unknown force, an unknown application angle, and an unknown distance from the gauge 48. Also, in some embodiments, the rosette gauge can further determine the maximum principal strain and the minimum principal strain, and the angles of these principal strains.

[0073] As an example, FIGS. 16A and 16B show a technique for calculating force and contact angle using calibration results obtained from the circumferential rosette gauges 48 when the moment arm is known and an incremental angle experiment. Each circumferential rosette gauge 48 is arranged such that one of the three uniaxial gauges of each rosette gauge 48 is positioned along the long axis of the hollow portion (i.e., the long axis of the body 12), or alternatively, the uniaxial gauges can be used alone with this technique. When the strain measurement values from the grid along the length of the body 12 of each rosette gauge 48 (or each uniaxial gauge) are determined based on the applied force assuming a known moment arm (step 62), the angle can be approximated using the polarities and relative magnitudes of the three strain readings (step 64). The calibration result of strain versus angle shows a sinusoidal trend as shown in FIG. 16A. In this way, the angle can be estimated using the polarity of each reading (e.g., to find the region including all curves with the correct polarity), the relative magnitude (e.g., if one reading is larger than another, narrowing the original region to a small region where the curve of the gauge is above the curve of another gauge), and the equivalence of the magnitude intersection (e.g., if the magnitudes of two measurement results are close and neither measurement result is near the x-axis, further narrowing the above-mentioned small region to the point where the curves intersect away from the x-axis). By using such a technique, in some embodiments, the above curve can be used as a guideline for estimating an angle within ±25°. Thereafter, these strain measurement values are divided by the cosine of the approximated angle described above to obtain uniaxial strain, i.e., strain at 0° (step 66). Thereafter, linear rosette calibration (performed when the force is applied at the above angle) can be applied to the normalized strain measurement values. More specifically, a linear calibration can be used for each individual rosette and its grid to determine the force based on a given moment arm (step 68).

[0074] Thus, in some embodiments, the multifunctional medical device 10 of FIG. 15 can include a plurality of rosette gauges 48 around the circumferential surface of the main body 12 and can be configured to measure both strain and bending force. However, in some embodiments, if the distance that the rosette gauge 48 wraps around the main body 12 is excessively long, it will cause the shear strain measurement value not to be independent (for example, the measurement value includes loads other than shear), so the circumferential surface of the main body 12 can be made smaller so that the distance does not become excessively long. Thus, in some embodiments, as shown in FIG. 17, the multifunctional medical device 10 can include a sensing system 30 and a main body in a geometric form improved in consideration of the above-described inhibiting factors for independent shear strain measurement.

[0075] Specifically, the multifunctional medical device 10 of FIG. 17 can include a main body 12, a handle 14, a suction system 24, and a sensing system 30. Thus, the multifunctional medical device 1 0 can have retraction, suction, and sensing functions. The suction system 24 in the figure can have the same characteristics as those described above with reference to FIGS. 1 to 15. For example, FIG. 17 shows a suction tube 61, and the suction tube 61 is coupled to the handle 14 (for example, communicating with a suction passage 32 extending within the handle 14 and the main body 12). Further, although not shown in FIG. 17, in some embodiments, the multifunctional medical device 10 can further include additional functional systems such as a stimulation system, a cleaning system, and / or an illumination system.

[0076] In some embodiments, the body 12 and the handle 14 can generally have similar features as those described above with reference to FIGS. 1-15. For example, the handle 14 can be substantially cylindrical in shape. The body 12 can include a proximal end 16 adjacent to the handle 14, a distal end 18 distal from the handle 14, and a hollow portion 22 (e.g., functioning as the suction passage 32 of the suction system 24) extending through the body 12. In one embodiment, the handle 14 can include stainless steel 321, and the body 12 can include stainless steel 304 (however, in some embodiments other materials are also possible). Further, in one embodiment, the body 12 can also have an outer diameter of about 4 mm. However, in some embodiments, the outer diameter of the body can be in the range of about 2 mm to about 5 mm as described above.

[0077] The body 12 can also include a tapered or rounded portion 50 adjacent to the proximal end, a linear portion 52 adjacent to the tapered portion 50 (e.g., aligned with the handle 14), and an angled portion 52 extending from the linear portion 52 (e.g., angled with respect to the handle 14). The body 12 can further have, for example, an intermediate portion 58 at or near the proximal end 16 adjacent to the handle 14 (or at other positions along the length of the body 12). As shown in FIG. 17, the intermediate portion 58 has one or more flat surfaces 60. For example, the intermediate portion 58 can have a cross-section that is square, pentagonal, hexagonal, heptagonal, octagonal, or other shapes having one or more flat surfaces.

[0078] Regarding the sensing system 30 of FIG. 17, the multifunctional medical device 10 can be provided with one or more sensors. More specifically, it can be provided with one or more strain gauges 48 coupled to the flat surface 60 of the intermediate portion 58. As an example, FIG. 17 shows one strain gauge 48 (e.g., a biaxial or triaxial rosette gauge) joined to one of the flat surfaces 60, but additional strain gauges 48 can also be joined to each flat surface 60 (or to a smaller number of flat surfaces 60 than all of the flat surfaces 60). For example, in one embodiment, the multifunctional medical device 10 is provided with four strain gauges 48, and each strain gauge 48 is attached to each corresponding flat surface 60. In another embodiment, the multifunctional medical device 10 is provided with eight strain gauges 48, and each strain gauge 48 is attached to each corresponding flat surface 60. In some embodiments, the strain gauge 48 can include, for example, an external wired connection portion (not shown), which can be connected to a computer system 45 or other data acquisition system. In a plurality of other embodiments, the strain gauge 48 can be coupled to internal wiring (not shown) routed within the hollow portion 22 and within the handle 14.

[0079] By being affixed to the flat surface 60, each strain gauge 48 can enable more accurate and more independent shear strain measurements. As described above, using the shear load measurement value, the applied force can be determined without depending on the moment arm (i.e., without depending on the location of the applied force). In this way, based on the measurement results from the strain gauge 48, the computer system 45 calculates the force applied to the tissue by the multifunctional medical device 10 and provides feedback to the surgeon operating the device 10 (either via the computer system 45 or via a separately connected indicator 43). This can be done.

[0080] As described above, the device 10 can include a plurality of strain gauges 48 to obtain shear strain measurement values. In some embodiments, with a plurality of different device designs and strain gauge 48 positionings, the device 10 (or a part thereof) can be made to act like a shear beam type load cell. In a first example, the strain gauges 48 are disposed directly on the body 12 and are oriented to detect shear strain to the maximum extent as described above. In another example, the body 12 can have one or more recessed positions (not shown). Each recessed position (formed in the body 12, for example, by machining) can form a shear web, and strain gauges 48, such as biaxial rosette gauges, are disposed on both sides of this shear web to generate an output proportional to the shear force applied to the body 12 (in one component direction, for example). In some aspects, by connecting opposing strain gauges to form a full bridge circuit, the output can be made less susceptible to off-axis load components or lateral loads.

[0081] In still other embodiments, the device 10 can have additional structures with strain gauges 48 for sensing shear strain. In one example, the strain gauge 48 is disposed along the flat surface 60 of the intermediate portion 58 as described above. In another example, the body 12 or the intermediate portion 58 can have one or more elastic beam elements (not shown), such as, for example, two or three parallel elastic beam elements (e.g., arranged to be parallelogram elastic elements connected by rigid flanges). And the uniaxial tensile / compressive strain gauge 48 can be coupled to one or more of the above-described beam elements to sense the applied shear force (e.g., the gauge 48 near the applied force senses compression, while the gauge 48 at a position away from the force senses tension). In yet another example, a plurality of orthogonal small parallelogram or shear beam elements having different sensing directions can be assembled in series to attach the strain gauge 48. On one side, the intermediate portion 58 can comprise two orthogonal parallelogram elements for measuring force components in both the vertical and horizontal directions. In this aspect, the body 12 can be continuous through the intermediate portion 58 (e.g., a flexible conduit) to the handle 14, but the load is transmitted to the intermediate portion 58 rather than the handle 14. In this way, the handle 14 and the body 12 can be structurally coupled via the intermediate portion 58, and the intermediate portion 58 generally acts as a "spring" element for detecting force. Generally, it should be noted that within the scope of the present disclosure, other configurations not specifically described in the present application can also be implemented to provide a device 10 having one or more strain gauges 48 coupled to the body 12 and / or one or more other structures for determining shear load.

[0082] Further, FIG. 18 shows a multi-functional medical device 10 of some embodiments, which can include a sensing system 30 configured to perform force measurement and calculation without prior knowledge of the force application point.

[0083] Specifically, the multifunctional medical device 10 in FIG. 18 can include a main body 12, a handle 14, a suction system 24, and a sensing system 30. Thus, the multifunctional medical device 10 can have retraction, suction, and sensing functions. The suction system 24 in the same figure can have features similar to those described above with reference to FIGS. 1 to 15 and 17. Further, although not shown in FIG. 18, in some embodiments, the multifunctional medical device 10 can also include other functional systems such as a stimulation system, a cleaning system, and / or an illumination system.

[0084] In some embodiments, the main body 12 and the handle 14 can generally have features similar to those described above with reference to FIGS. 1 to 15. For example, the handle 14 can be substantially cylindrical in shape. The main body 12 can include a proximal end 16 adjacent to the handle 14, a distal end 18 distal from the handle 14, and a hollow portion 22 (e.g., functioning as a suction passage 32 of the suction system 24) extending through the main body 12. The main body 12 can also include a linear portion 52 adjacent to the proximal end 16 (e.g., aligned with the handle 14), an angled portion 54 extending from the linear portion 52 (e.g., forming an angle with the handle 14), and (optionally further, a tapered or rounded portion 50 adjacent to the proximal end 16). In one embodiment, the handle 14 can include stainless steel 321, and the main body 12 can include stainless steel 304 (however, in some embodiments, other materials are also possible). Further, in one embodiment, the main body 12 can also have an outer diameter of about 4 mm. However, in some embodiments, the outer diameter of the main body can be in the range of about 2 mm to about 5 mm as described above.

[0085] Regarding the sensing system 30 of FIG. 18, the multifunctional medical device 10 can include two or more sensors arranged in a straight line. More specifically, the body 12 can be coupled with (e.g., at the angled portion 54) two or more strain gauges 48 arranged in a straight line, and the two or more strain gauges 48 can be arranged at different distances from the distal end 18 and in a straight line. As an example, FIG. 18 shows a first strain gauge 48 (e.g., a uniaxial or biaxial or triaxial rosette gauge) joined to the body 12 at a first distance D1 from the distal end 18, and a second strain gauge 48 (e.g., a uniaxial or biaxial or triaxial rosette gauge) joined to the body 12 along the same axis as the first strain gauge 48 and at a second distance D2 from the distal end 18 that is farther from the distal end 18. In some embodiments, the multifunctional medical device 10 has a plurality of pairs of the above-described strain gauges 48 arranged around the circumferential surface of the body 12. Further, in some embodiments, the strain gauge 48 can include, for example, an external wired connection portion (not shown), which can be connected to a computer system 45 or other data acquisition system. In other embodiments, the strain gauge 48 can be coupled to internal wiring (not shown) wired within the hollow portion 22 and within the handle 14.

[0086] The strain gauges 48 can each independently measure the bending force (and thus, each strain gauge 48 can be a uniaxial gauge or a rosette gauge). For each pair of strain gauges arranged in a line, since the distance between D1 and D2 can be made known, the readings of both strain gauges 48 can be calibrated using a known load at the offset distance from both strain gauges 48. Using these known loads and readings, a calibration curve (for example, a calibration curve of strain versus applied moment) can be created. Thereby, for each strain gauge 48, the slope of the calibration curve can be determined for the strain output per unit Nm (Newton - meter) of applied bending. It should be noted here that these curves are different for each strain gauge arranged in a line. The reason is that the distance from the applied load to each strain gauge is different. After calibration, for any unknown force applied to the main body 12 offset from the strain gauge 48 thereafter, even though the location was initially unknown, both the magnitude of the force (in units of N) and the location of the net force can be mathematically determined using the new gauge reading and the calibrated slope.

[0087] As an example, when an unknown force F is applied to the main body 12 at unknown distances (for example, an unknown distance x1 from the first strain gauge 48 and an unknown distance x2 from the second strain gauge 48) from a plurality of strain gauges 48 arranged in a line, by using the gauge readings together with the above - mentioned calibration curves, the bending moments M1, M2 at each strain gauge 48 can be obtained. Thus, the bending moments can be defined as M1 = x1F and M2 = x2F. The force can be calculated as F=(M1 - M2) / d, and the distance from point d to the force application point can be calculated as x1 = M1d / (M2 - M1), where d=(x2 - x1) is the known distance between the strain gauges 48. Therefore, by using the calibration curve to obtain the moments M1, M2 and since the distance between the strain gauges 48 is known, the distance from the strain gauge to the force application point can be calculated.

[0088] In some further embodiments, in order to determine the horizontal and vertical components of the applied force, a plurality of strain gauges 48 arranged in a line can be disposed around the circumferential surface of the main body 12. For example, in the example shown in FIG. 15, a plurality of strain gauges 48 arranged in a line can be disposed at points A and B, whereby a first component (e.g., the vertical component) of the force acting on the main body 12 is obtained. Also, in the example shown in FIG. 15, a plurality of strain gauges 48 arranged in a line can be disposed at point C and at a point on the opposite side of point C, whereby a second component (e.g., the horizontal component) of the force acting on the main body 12 is obtained. By obtaining strain measurement values in both component directions, the magnitude of the resultant force in the radial direction can be determined.

[0089] Thus, the computer system 45 can acquire readings from a plurality of strain gauges 48 arranged in a line and, based on the measurement values from these strain gauges 48, calculate the force applied to the tissue by the multifunctional medical device 10 (regardless of the location where the force is applied), and based on the calculated force, provide feedback to the surgeon operating the device 10 (either via the computer system 45 or via a separately connected instruction unit 43).

[0090] Furthermore, generally, the multi-purpose medical device 10 of any of the above embodiments can communicate with one or more computer systems 45. For example, the device 10 can communicate with the plurality of computer systems 45 by wired or wireless communication. In some embodiments, the computer system 45 can include elements such as, for example, a medical image storage and communication system (PACS system) or one or more electronic medical records. Further, although the sensing system 30 is described as being configured to communicate with the computer system 45, in some embodiments, one or more of the other functional systems of the multi-purpose medical device 10 can also communicate with the computer system 45. For example, in some embodiments, the suction system 24, the sensing system 30, the cleaning system 28, and / or any other functional system can communicate with the computer system 45. With such a configuration, data can be collected from the operation of the above systems in order to perform long-term record storage in one or more computer systems 45, for example, from the input to the computer system 45. This collected data can be used to provide feedback for seeking force application as described above, and can also be used to understand the actions taken during patient care and / or during a procedure by a surgeon. In some embodiments, the data can also be used to assist in clinical and forensic issues that may arise as a result of a surgical procedure.

[0091] In summary, the multiple different systems of the multi-purpose medical device 10 can offer significant advantages over conventional devices. For example, by providing one device equipped with a suction system 24, a stimulation system 26, a cleaning system 28, an illumination system 29, and / or a sensing system 30, the device 10 provides a combination of multiple functions that can be used by a surgeon to perform a surgical procedure (such as a spinal surgery like a head surgery, a minimally invasive spinal surgery, a peripheral nerve surgery, or other medical procedures) effectively and efficiently. Specifically, by combining one or more of the above advantages in one device, the time required to change instruments during the procedure can be reduced, thereby also reducing the total amount of time for the procedure. The above-mentioned reduction in instrument change and total procedure time can improve patient safety (for example, by at least improving the surgeon's concentration, minimizing confusion, and / or minimizing the risk of infection). Furthermore, by providing a sensing system 30 with at least one sensor 42 and a retraction function, the multi-functional medical device 10 can quantify and monitor the tool-tissue interaction in real time and provide visual, auditory, and / or tactile feedback to medical personnel. As a result, the risk of overloading during retraction and the risk of unexpected brain and nerve damage caused by retraction can be reduced. Furthermore, the above-mentioned feedback mechanism can be used to train interns and surgeons to apply an appropriate amount of retraction force during the procedure, thereby reducing the learning curve and improving patient safety.

[0092] While the present invention has been described with reference to specific embodiments and examples above, it is not necessarily limited thereto, and it will be apparent to those skilled in the art that numerous other embodiments, examples, uses, and modifications and derivatives of the above embodiments, examples, and uses are also intended to be included within the scope of the appended claims. The disclosures of each patent and each publication cited in this application are hereby incorporated by reference in their entirety into this application and are treated in the same manner as if each such patent or each such publication were individually incorporated by reference into this application. The various configurations and advantages of the present invention are set forth in the following claims.

Claims

1. A multipurpose medical device configured to be used by a user to retract tissue during a medical procedure, a cylindrical or prismatic body having a hollow portion extending in the longitudinal direction of the body, a suction system having a suction passage disposed within the hollow portion, a sensing system coupled to the body and configured to sense a force applied to the body during the medical procedure regardless of the location where the force is applied, an indicating unit configured to provide feedback to the user based on the sensed force, in the multipurpose medical device comprising: the sensing system includes a plurality of pairs of gauges disposed around the circumferential surface of the body, each of the plurality of pairs of gauges is a gauge arranged linearly in the axial direction of the body, the gauges arranged linearly in the axial direction are coupled to a first location and a second location of the body such that a known distance is provided between the gauges arranged linearly in the axial direction, the multipurpose medical device is configured to determine a distance between the location where the force is applied and the first location and a distance between the location where the force is applied and the second location A multipurpose medical device characterized by the above.

2. The indicating unit includes at least one of a visual indicating unit, a tactile indicating unit, and an auditory indicating unit, The device according to claim 1.

3. The body further includes a handle operably coupled thereto, the suction system further has a suction control opening provided to penetrate at least a portion of the handle, the suction control opening is operably in fluid communication with the suction passage and is configured to control the suction supplied through the suction passage, The device according to claim 1 or 2.

4. The indicating unit is configured to provide different feedback to the user based on the level of the force sensed by the sensing system, The device according to any one of claims 1 to 3.

5. The indicating unit is configured to provide feedback to the user when the force of 0.3 N to 1.5 N is detected, The device according to any one of claims 1 to 4.

6. The gauges arranged linearly in the axial direction are pressure sensors coupled to the body, The device according to any one of claims 1 to 5.

7. The pressure sensor is a uniaxial strain gauge configured to sense a bending force along the body. The device according to claim 6.

8. The pressure sensor is a rosette gauge configured to sense a bending force and a shear force along the body. The device according to claim 6.

9. Each pair of the plurality of pressure sensors is a pair of strain gauges arranged in a line and arranged at different distances from the distal end of the body. The device according to claim 6.

10. The device further includes a handle operably coupled to the body, The body has one of a linear form and a form that forms an angle at least in part with respect to the handle. The device according to claim 1.

11. The device further includes a computer system that communicates with the sensing system, The computer system is configured to receive data regarding the sensed force from the sensing system. The device according to any one of claims 1 to 10.

12. The body further supports at least a part of any one of a stimulation system, an illumination system, and a cleaning system. The device according to any one of claims 1 to 11.

13. The stimulation system includes a stimulation channel at least partially disposed within the hollow portion and a stimulation tip disposed at the distal end of the body, The stimulation tip is configured to supply an electric current to tissue during the medical treatment. The device according to claim 12.

14. The body is cylindrical, The body has an outer diameter of 2 mm to 5 mm. The device according to any one of claims 1 to 13.

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