WO2014116782A1 - Device for providing sensory feedback during surgical procedures - Google Patents

Device for providing sensory feedback during surgical procedures Download PDF

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Publication number
WO2014116782A1
WO2014116782A1 PCT/US2014/012670 US2014012670W WO2014116782A1 WO 2014116782 A1 WO2014116782 A1 WO 2014116782A1 US 2014012670 W US2014012670 W US 2014012670W WO 2014116782 A1 WO2014116782 A1 WO 2014116782A1
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WO
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Patent type
Prior art keywords
grasping
instrument
sensor material
configured
tip
Prior art date
Application number
PCT/US2014/012670
Other languages
French (fr)
Inventor
Kenneth D. STEINBERG
AMANT Michael K. ST.
Jason W. CLARK
Original Assignee
Cambridge Surgical Instruments, Inc.
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/70Manipulators specially adapted for use in surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/70Manipulators specially adapted for use in surgery
    • A61B34/76Manipulators having means for providing feel, e.g. force or tactile feedback
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06Measuring instruments not otherwise provided for
    • A61B2090/064Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • A61B2090/065Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension for measuring contact or contact pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30Surgical robots

Abstract

A surgical instrument for probing, pushing, or grasping target material includes sensor material applied to a surface thereof which transmits environmental signals to a feedback system that can record or portray the sensor data in an informative manner. Embodiments provide feedback from a plurality of sensors corresponding to a plurality of environmental conditions or degrees of motion. In embodiments, the sensor material directly senses environmental, chemical, and/or structural changes occurring during a surgical procedure. In other embodiments, environmental conditions are transferred to the sensor material by a structural element of the instrument, such as a wafer in a slot, a support rib, or a living hinge. Various embodiments include complete instruments, removable instrument tips, and a method of applying sensor material to an existing instrument for use with a collection or feedback system. In embodiments, the sensing instrument tip or the sensor material can be removed and sanitized or discarded.

Description

DEVICE FOR PROVIDING SENSORY FEEDBACK DURING SURGICAL

PROCEDURES

Inventors:

Kenneth D. Steinberg

Michael K. St. Amant

Jason W. Clark

RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 61/755,584, filed January 23, 2013, which is herein incorporated by reference in its entirety for all purposes. This application also claims the benefit of U.S. Provisional Application No. 61/755,586, filed January 23, 2013, which is herein incorporated by reference in its entirety for all purposes.

FIELD OF THE INVENTION

[0002] The invention relates to surgical instruments, and more particularly, to surgical instruments that augment or act as a substitute for direct access to a surgical site and use environmental sensors as sensory, user, or algorithmic feedback.

BACKGROUND OF THE INVENTION

[0003] For more than two decades the fields of minimally invasive surgery, of robotics, and remote controlled machine systems (production equipment, gaming systems and handicapped equipment, etc.) have been advancing at a steady rate. The capabilities, intelligence, and level of control are on a constant improvement cycle that is yielding amazing results.

[0004] Similarly, cybernetic systems are advancing in almost all aspects, including dexterity, strength, cognitive thinking, and human factors. While many decades will pass before robotics systems will fully replace human functions, there is no doubt that effort and innovation in this field will continue. [0005] One of the problems surrounding man-machine interfaces is still the subject of considerable research and little success - haptics. Haptics is the ability of a remotely controlled system to provide feedback similar to what the human physiology can provide. Within days of being born, humans start to develop an enhanced level of sensory feedback, one of which being touch. The sense of touch plays out in many ways, but none more dramatic than when combined with visual feedback, leading to the development of hand-eye coordination.

[0006] Cybernetic systems currently provide very rudimentary tactile feedback, leading to a very disjointed sense of control. In many cases, the rudimentary forms of feedback currently provided are more of a detriment to working with man-machine interfaces than an enhancement. Still, robotic systems continue to work their way into many aspects of life, despite the fact that the existing gap in eye-hand, haptic coordination remains.

[0007] Many of the present day robotic system interfaces are relegated to nothing more than enhanced video gaming style controls. For example, surgeons using cybernetic interfaces to control surgical robots are confined to joystick controls and video representations of the patients they are working on. Some of the most advanced cybernetic interfaces provide control interfaces that are only marginally better then 3D television. Varying levels of vibration and the use of cumbersome resistive interfaces remain at the forefront, with little appreciable change in approach.

[0008] True interfacing with the human nervous system, which would allow for direct stimulation of the senses, is yet to be realized, as there is still considerable research to be conducted on the nervous system and how the various regions of the brain react to stimuli. Researchers are in the very early stages of understanding the human brain, let alone all of the individual permutations due to genetic diversity. The realization of actual mind-controlled systems or symbiotic nervous system interfaces is still many years in the future. [0009] Further complicating the man-machine interface issue is that of infection. Any device that penetrates the dermis provides an opportunity for disease and infection to take hold. Methicillin-Resistant Staphylococcus Aureus (MRSA) is a prime example of how a simple, small incision in the skin can create a life threatening situation. Regardless of antibiotics and instrument coatings (ex.

colloidal silver), the risk and chance of infection are still high, greatly reducing the ability to create true man-machine interfaces.

[0010] The use of robotics in surgical techniques that are performed using minimally invasive maneuvers is increasing rapidly. Such procedures prevent the surgeon from using tactile senses, and the ability to move, grasp, or probe tissue is no longer available, since these new procedures are performed using methods and access that limit visibility, space, and range of motion.

[0011] There are many surgical procedures which do not allow a surgeon to directly interact with the organs or tissue they are working with or around, either as a result of a desire to minimize patient impact or due to other complications. The surgeon might not be able to directly view the area in which he or she is working, or may not be able to manually touch the surgical site. There may be limitations on space, viewing angle, and/or patient condition that make a minimally invasive or endoscopic approach more feasible

[0012] In addition to limitations due to surgical conditions, there are also instances where a surgeon may wish to move, push, or contain tissue so that it is not impeding vision or blocking a procedure. Very frequently, a surgeon must work through and around other tissue and organs that are collocated with the tissue on which a procedure is being conducted. In such cases, the surgeon must "retain" the surrounding tissue, either by tying it back or by using another instrument to push the tissue away from the area in which he or she is working.

[0013] The process of temporarily retaining surrounding tissue can cause additional damage to the patient. This can increase the chances of complications arising, and the length of time required for the patient to recover. During minimally invasive surgery, it is not uncommon for surgeons to use sutures to tie back surrounding tissue. But the process of suturing punctures healthy tissue, leading to possible damage. If the surgeon had direct access, the retaining sutures might not be required, because the surgeon could manually move the tissue back, although even this process of tissue manipulation with an instrument can also have a detrimental effect.

[0014] In addition to the requirement to carefully retain, dissect, or move aside existing tissue and organs, there is also a need for surgeons to be able to touch tissue in order to ascertain the tissue condition. In the case of inflamed, infected, or otherwise unhealthy tissue, if a surgeon has enough room to be able to manually probe the tissue, he or she can feel the elasticity or hardness of the tissue by simply touching it. However, when space or access is limited, such as during a minimally invasive surgery, the surgeon cannot directly probe the tissue.

[0015] Tumor removal is a very common surgical procedure during which a surgeon is required to determine the edges of the tumor mass, so that only the tumor is removed and not the surrounding healthy tissue. The tumor edges are determined by probing the tissue, so that a surgical cut is made as precisely as possible. Minimally invasive surgical conditions do not allow for this direct contact.

[0016] In addition, a surgeon may wish to grip or pull tissue or other target material, such as sutures. This can be extremely problematic when dealing with soft tissue and organs. It is possible to puncture or damage tissue if it is gripped or pulled on too tightly. Conversely there are situation where a tight grip is required, such as holding a suture, which is equally impaired by the lack of tactile feedback.

[0017] Current techniques force the surgeon to use their vision as the sole means of compensating for the lack of tactile input. Various approaches employ a plurality of camera systems to give the surgeon multidimensional vision. But in the end, the surgeon is still restricted to his or her best ability to perform hand-eye coordination. Vision can be a poor replacement for a sense of touch, forcing surgeons to either develop other radical techniques or stop performing certain procedures due to risk.

[0018] What is needed, therefore, are new solutions which will allow surgeons to regain sensory feedback during robotic surgery and minimally invasive surgery.

SUMMARY OF THE INVENTION

[0019] One general aspect of the present invention, most fundamentally stated, is a surgical tool that includes a sensor near its tip, where the sensor is compatible with a monitoring or feedback system. The surgical tool and feedback system can provide input to the surgeon while using the invention, such that the feedback can serve as a substitute for the lack of direct interaction that would be available during an ordinary open surgery. The present invention can thereby be used by a surgeon performing a remote and/or minimally invasive surgical procedure to indirectly retain, manage, and probe tissue with minimal impact. In embodiments, during a minimally invasive surgical procedure, the present invention

compensates, replaces, and/or augments a surgeon's capability to access a surgical site, either manually or using a robot, via an opening that does not allow the operator to perform the procedure directly.

[0020] Embodiments of the invention allow a surgeon to retain tissue or an organ with minimal impact, and without a need to clamp or suture the tissue or organ. Other embodiments of the invention allow a surgeon to determine the edges of inflamed, infected, or otherwise unhealthy tissue, including a tumor, by providing feedback via an interface that can transmit the tissue properties, such as hardness, to the surgeon. This approach allows the surgeon to regain lost sensory feedback, so that he or she can perform the surgical procedure with maximum dexterity.

[0021] This ability to transmit the sense of touch through a tool removes the need in some cases for an assistant to provide a touch plate against which they can feel the surgeons probe. Without direct feedback, a surgeon performing minimally invasive surgery may require the temporary implantation of a backing instrument against which the surgeon can press. This pressure is felt by the assistant holding the backing instrument. The assistant then provides verbal feedback to the surgeon when different feedback is felt. Using the invention, there may be cases where this backing instrument and the associated verbal queues are not required.

[0022] There are also cases where a backing instrument cannot be inserted or positioned, such as surface brain tumor removal. The use of the present invention, coupled with a feedback system, allows the surgeon to receive feedback while still performing the procedure in the most minimalistic fashion.

[0023] In embodiments, the use of feedback interfaces coupled to the present invention lends itself to telepresence applications, where a surgeon is removed from the surgical instrument and patient by distance. A common scenario includes surgical procedures conducted ship-to-shore or across continental borders. By providing a means for feedback, the invention can be the critical element in scenarios that include even a minor time delay between the surgeon and the surgical instruments.

[0024] A wide variety of sensors known in the art are used in various

embodiments of the present invention. Some of these sensors are essentially rigid, while others are flexible, and can be conformed and adhered to a suitable location at or near the distal end of a surgical instrument. For example, flexible capacitive tactile sensors are commercially available, which are formed by sandwiching a flexible dielectric between two layers of conductive cloth. Some of these flexible dielectric sensors provide only one output signal, which corresponds to an overall measurement of pressure by the sensor. For other flexible dielectric sensors, the top and bottom electrodes are divided into orthogonal strips, so that a distinct capacitor is formed at each point where the electrodes overlap. By selectively scanning a single row and column, the capacitance at the overlapping location, and thus the local pressure at that location, can be measured. [0025] Another general aspect of the present invention is a surgical instrument that encompasses commonly used sensor implementations such as a pulse oximeter circuit, a chemical analysis sensors, or tissue analysis sensors using energy transmission media.

[0026] Yet another general aspect of the present invention is a surgical instrument for grasping tissue that includes sensor material configured to provide feedback to a person performing robotic surgery, such as a minimally invasive surgical procedure. The sensor material can be applied to one or more grasping arms of the instrument.

[0027] In embodiments, sensor material is affixed to a rear surface of a grasping arm and a pressure, temperature, or other environmental condition is conveyed to the sensor material by a wafer slidably installed in a slot that penetrates from the grasping surface to the sensor material. A support rib can be used to provide rigidity to the sensor material by positioning the rib underneath, along, or on both sides of the sensor material.

[0028] In other embodiments, the sensor material is inserted in a slot that is parallel to the grasping surface and extends to three sides, so that the grasping surface is supported by a living hinge and presses on the sensor material when gripping tissue.

[0029] In still other embodiments, sensor material is attached to the grasping surface, and directly presses on grasped tissue.

[0030] Minimally invasive techniques are often limited in the number of egresses through which surgical and support tools (cameras, lights etc) can be inserted. In such cases, it can be advantageous to augment existing instruments with sensory capabilities.

[0031] In addition to the requirement to carefully retain, dissect, or move aside existing tissue and organs, there is also a need for surgeons to be able to virtually "touch" or "prove" tissue in order to ascertain the tissue condition. In the case of inflamed, infected, or otherwise unhealthy tissue, if a surgeon has enough room to be able to manually probe the tissue, the surgeon can feel the elasticity or hardness of the tissue by simply touching it. When space or access is limited, however, such as in the case of minimally invasive surgery, the surgeon cannot directly probe the tissue. Providing a sense of touch or other sensory feedback via a surgical probe, as described in this invention can replace direct contact.

[0032] Tumor removal is a very common surgical procedure during which a surgeon is required to determine the edges of a tumor mass so that only the tumor is removed, and not surrounding healthy tissue. The edges of the tumor are determined by probing the tissue, so that a surgical cut is made as precisely as possible. Minimally invasive surgical conditions do not allow for this direct contact. However, the present invention, connected to a feedback apparatus, can transmit the tissue properties, such as hardness, to a surgeon, so that the surgeon can obtain sensory feedback that is similar to what would be available if direct physical contact were possible. This allows the surgeon to determine the edges of the tumor, and to perform surgical procedures with maximum dexterity.

[0033] A first general aspect of the present invention is an environment-sensing surgical instrument that includes a surgical instrument, sensor material applied proximal to a distal end of the surgical instrument, the sensor material being configured to emit electrical signals in response to exposure of the distal end to environmental conditions, and electrical leads configured to convey the electrical signals to a signal monitoring system.

[0034] In embodiments, the instrument is configured to make incisions. In some embodiments, the instrument is configured to hold tissue away from a surgical site. In other embodiments, the instrument is configured to probe tissue and provide information regarding physical features thereof.

[0035] In various embodiments the sensor material is applied to the instrument in a plurality of sections, the sections being configured to provide a plurality of electrical signals that correspond to a plurality of environmental conditions sensed at the distal end of the instrument.

[0036] And in certain embodiments, the sensor material is removable from the surgical instrument.

[0037] A second general aspect of the present invention is a removable sensing tip for a surgical instrument that includes an instrument tip that can be removably installed on a distal end of a surgical instrument, sensor material applied to the instrument tip, the sensor material being configured to emit electrical signals in response to exposure of the instrument tip to environmental conditions, electrical tip leads, and electrical instrument leads configured to electrically connect with the electrical tip leads when the tip is installed on the surgical instrument, and to convey the electrical signals from the tip to an electronic feedback system.

[0038] In embodiments, the tip is configured to make incisions. In some embodiments, the tip is configured to hold tissue away from a surgical site. In other embodiments the tip is configured to probe tissue and to provide information regarding physical features thereof.

[0039] In certain embodiments, the sensor material is applied in a plurality of sections, the sections being configured to provide a plurality of signals that indicate a plurality of environmental conditions sensed at the tip.

[0040] In various embodiments, the sensor material is removable from the tip. And in some embodiments the sensing material is incorporated into a juncture between the tip and the surgical instrument, so that exposure of the tip to the environmental conditions results in actuation of at least a portion of the sensing material.

[0041] A third general aspect of the present invention is a method for adapting a surgical instrument for use with a feedback system. The method includes attaching sensing material proximal to a distal end of the surgical instrument, the sensing material being applied in a configuration that will emit electrical signals in response to exposure of the distal end to environmental conditions, and attaching electrical leads to the surgical instrument in a configuration that will not interfere with surgical use of the instrument, the electrical leads being configured to convey the electrical signals to a feedback system.

[0042] In embodiments, the instrument is configured to make incisions. In some embodiments, the instrument is configured to hold tissue away from a surgical site. In other embodiments, the instrument is configured to probe tissue and provide information regarding physical features thereof.

[0043] In various embodiments the sensor material is applied in a plurality of sections, the sections being configured to provide a plurality of signals that indicate exposure of the distal end of the instrument to a plurality of

environmental conditions. And in certain embodiments the sensor material is removable from the surgical instrument.

[0044] A fourth general aspect of the present invention is an environment- sensing surgical grasping instrument that includes a grasping instrument, including a first grasping arm and a second grasping arm, the first grasping arm including a first grasping surface and an opposing first rear surface, the second grasping arm including a second grasping surface and an opposing second rear surface, the grasping arms being configured to close together and grasp target material between the grasping surfaces, and to separate and release the material, a first slot extending from the grasping surface to the rear surface of the first grasping arm, first sensor material applied to the rear surface of the first grasping arm and configured to cover at least a portion of the first slot, a first wafer inserted within the first slot in contact with the first sensor material and

protruding from the first grasping surface, the first wafer being configured to convey environmental conditions from the first grasping surface to the first sensor material in proportion to exposure of the first grasping surface to the

environmental conditions when the target material is grasped between the grasping arms, and first electrical connections configured to convey an electrical signal generated by the first sensor material in response to the environmental conditions conveyed to it by the first wafer.

[0045] Embodiments further include a second slot extending from the second grasping surface to the second rear surface, second sensor material applied to the second rear surface and configured to cover at least a portion of the second slot, a second wafer inserted within the second slot in contact with the second sensor material and protruding from the second grasping surface, the second wafer being configured to convey environmental conditions to the sensor material in

proportion to exposure of the second grasping surface to the environmental conditions when the target material is grasped between the grasping arms and second electrical connections configured to convey an electrical signal generated by the second sensor material in response to the environmental conditions conveyed to it by the second wafer.

[0046] In certain embodiments, the grasping arms are connected to each other by a pivot joint, so that the grasping arms close together and separate by pivoting about the pivot joint.

[0047] In various embodiments the wafer and first sensor material are removable from the first grasping arm. In some of these embodiments, the first wafer and first sensor material are attachable to the first grasping arm by at least one clip.

[0048] In some embodiments n the instrument is one of forceps, needle drivers, sheers, and retractors.

[0049] Other embodiments further include a first central support rib attached to the first grasping arm, the first central support rib having a flat support surface located in contact with a rear surface of the first sensor material, the first sensor material being sandwiched between the flat support surface and the first rear surface, the flat support surface being configured to compress the first sensor material between the flat support surface and the first wafer when the target material is grasped between the grasping arms.

[0050] Various embodiments further include a first cover configured to protect the first electrical connections. Certain embodiments further include g a passage extending through the first wafer through, the first electrical connections being routed from the first sensor material through the passage, and thereby through the first slot to the rear surface of the first grasping arm.

[0051] In some embodiments the first sensor material is attached to the rear surface of the first grasping arm by an adhesive. In other embodiments the first sensor material is magnetically attached to the rear surface of the first grasping arm. And in various embodiments the first sensor material is further applied to a distal end of the first grasping arm and configured to provide a signal that is proportionate to pressure applied to tissue by the distal end of the grasping arm.

[0052] A fifth general aspect of the present invention is an environment- sensing surgical grasping instrument that includes a grasping instrument having a first grasping arm and a second grasping arm, the first grasping arm having a first grasping surface and the second grasping arm having a second grasping surface, the grasping arms being configured to close together and grasp target material between the grasping surfaces, and to separate and release the material, a first slot extending parallel to and below the first grasping surface and extending to a distal end and to both sides of the first grasping arm, so that the first grasping surface is supported by a proximal living hinge, first sensor material inserted within the first slot and configured so that environmental conditions are conveyed from the first grasping surface to the first sensor material, and first electrical connections configured to convey an electrical signal generated by the first sensor material in response to exposure of the first grasping surface to the environmental conditions.

[0053] Embodiments further include a second slot extending parallel to and below the second grasping surface and extending to a distal end and to both sides of the second grasping arm, so that the second grasping surface is supported by a proximal living hinge, second sensor material inserted within the second slot, and configured so that environmental conditions are conveyed from the second grasping surface to the second sensor material, and second electrical connections configured to convey an electrical signal generated by the second sensor material in response to exposure of the second grasping material to the environmental conditions.

[0054] In various embodiments, the first sensor material can be inserted into the first slot and removed from the first slot. And some of these embodiments further include a clip that maintains the first sensor material within the first slot, the clip being configured to cover the slot where it extends to the distal end and at least one side of the first grasping arm.

[0055] A sixth general aspect of the present invention is an environment- sensing surgical grasping instrument that includes a grasping instrument having a first grasping arm and a second grasping arm, the first grasping arm having a first grasping surface, the second grasping arm having a second grasping surface, the grasping arms being configured to close together and grasp target material between the grasping surfaces, and to separate and release the target material, first sensor material attached to the first grasping surface, and configured so that environmental conditions of the target material are applied to the first sensor material when the target material is grasped between the grasping surfaces, and first electrical connections configured to convey an electrical signal generated by the first sensor material in response to the environmental conditions of the target material.

[0056] Embodiments further include second sensor material attached to the second grasping surface, and configured so that environmental conditions of the target material are applied to the second sensor material by target material grasped between the grasping surfaces, and second electrical connections configured to convey an electrical signal generated by the second sensor material in response to the environmental conditions of the target material. [0057] In various embodiments, the first sensor material is adhered to the first grasping surface by an adhesive. In some embodiments, the first sensor material includes a surface pattern that enhances frictional retention of tissue grasped between the grasping surfaces. Other embodiments further include a marking pad affixed thereto, the marking pad being loaded with non-toxic ink, the marking pad being usable to mark selected tissue during a surgical procedure.

[0058] And in various embodiments at least one of the first and second sensor materials can be replaced by sensor material of a different type, so as to change the environmental condition being sensed thereby.

[0059] The features and advantages described herein are not all-inclusive and, in particular, many additional features and advantages will be apparent to one of ordinary skill in the art in view of the drawings, specification, and claims.

Moreover, it should be noted that the language used in the specification has been principally selected for readability and instructional purposes, and not to limit the scope of the inventive subject matter.

BRIEF DESCRIPTION OF THE DRAWINGS

[0060] Figure 1A illustrates the basic concept of physical touch by a human hand and physical feedback via the nervous system to the brain;

[0061] Figure I B illustrates an analogous system that uses a robotic hand and user feedback;

[0062] Figure 2A illustrates the concept of minimally invasive surgical techniques;

[0063] Figure 2B illustrates the use of an instrument to retain and/or move tissue during a procedure;

[0064] Figure 2C illustrates the use of an instrument to probe tissue properties; [0065] Figure 3A shows a surgical instrument wrapped with sensor material; [0066] Figure 3B details the components of an adhesive-affixed sensor pad on an instrument;

[0067] Figure 4A shows a surgical instrument with a tip designed to retain tissue while providing sensor feedback;

[0068] Figure 4B is an exploded view of Figure 4A that details the components of a removable surgical retention tip;

[0069] Figure 4C is an exploded view that details the components of the coaxial connector of a removable surgical retention tip;

[0070] Figure 4D depicts the coaxial connection of Figure 4C in an engaged state.

[0071] Figure 5A depicts a multidimensional surgical instrument tip;

[0072] Figure 5B is an exploded view that details the components of a removable multidimensional instrument tip;

[0073] Figure 5C illustrates sensor compression due to lateral forces applied to a multidimensional tip;

[0074] Figure 5D details the inner components of a multidimensional tip;

[0075] Figure 5E details the surface mate properties between the

multidimensional tip and the sleeve;

[0076] Figure 6A depicts a single dimension removable instrument tip;

[0077] Figure 6B is an exploded view that depicts the components of a single dimension removable instrument tip;

[0078] Figure 6C illustrates the components of a single dimension removable tip in an engaged state; [0079] Figure 6D illustrates the inner wiring of a single dimension removable tip;

[0080] Figure 6E depicts a surgical instrument fitted with a removable pressurize probe tip;

[0081] Figure 6F is a three dimensional cut-away view of the components of the removable pressurized probe tip of Figure 6E;

[0082] Figure 6G is an exploded view of the removable pressurized probe tip of Figure 6E;

[0083] Figure 6H is a three dimensional cut-away of a removable fluid- pressurized fluid tip;

[0084] Figure 61 is an exploded view of the components of a removable fluid- pressurized fluid tip;

[0085] Figure 6J is an orthogonal view of a removable pressure-sensitive dissection tip;

[0086] Figure 6K is an exploded view of a removable pressure-sensitive dissection tip;

[0087] Figure 6L is a three dimensional cut-away view of a removable pressure-sensitive dissection tip;

[0088] Figure 7A is a right side rear, top down perspective view of a forcep having a clip-on sensor apparatus;

[0089] Figure 7B is a right side front, top down perspective view of the forcep of Figure 7A;

[0090] Figure 7C is a left side front, top down perspective view of the forcep of Figure 7A; [0091] Figure 7D is a right side perspective view of a removable sensor clip in position;

[0092] Figure 7E is a bottom perspective view of the removable sensor clip of Figure 7D attached to a forcep;

[0093] Figure 8A is a rear top perspective view of a protruding sensor of an embodiment of the present invention attached to a grasping arm of a mechanical forceps with a pressure-transmitting wafer installed in a central slot down the middle of its elongated axis;

[0094] Figure 8B is a top perspective view of the protruding sensor and grasping arm of Figure 8A;

[0095] Figure 8C is an inverted side perspective view of the forceps of Figure 8B;

[0096] Figure 9A is a front, upward perspective view of a removable sensor clip attached to a forcep in an embodiment of the present invention;

[0097] Figure 9B is an orthogonal perspective view of a removable sensor clip attached to a forcep in an embodiment of the present invention;

[0098] Figure 9C is a side, downward perspective view of a removable sensor clip attached to a forcep in an embodiment of the present invention;

[0099] Figure 10A is a perspective view of the underside of a tip-covering sensor attached to a set of forceps in an embodiment of the present invention;

[00100] Figure 10B is a top right side perspective view of the embodiment of Figure 10A;

[00101] Figure I OC is a top left side perspective view of the embodiment of Figure 10A; [00102] Figure 1 1 A is a component perspective view of an embodiment of the present invention, shown from the right side;

[00103] Figure 1 I B is a component perspective view of the embodiment of Figure 1 1 A shown from the left side;

[00104] Figure 12A is a left side upwards perspective view of forceps in an embodiment of the present invention with sensor material installed in a slot that is below and parallel to the grasping surface;

[00105] Figure 12B depicts a right side upwards perspective view of an embodiment similar to Figure 12 A, but including a sensor clip that covers the exposed edges of the sensor material;

[00106] Figure 13A illustrates inner detail of the embodiment of Figure 12B;

[00107] Figure 13B illustrates details of the sensor clip of Figure 12B without the forceps;

[00108] Figure 14A is an orthogonal perspective view of a grasper fitted with a removable sensor tip;

[00109] Figure 14B is a right side upwards perspective view of a grasper fitted with a removable sensor tip;

[00110] Figure 14C is an exploded view of a grasper fitted with a removable sensor tip;

[00111] Figure 14D is a right side downward exploded view of the grasper of Figure 14C;

[00112] Figure 14E depicts the partial placement of a removable sensor tip over a square forcep post;

[00113] Figure 14F illustrates alternate placement of sensors on a removable sensor tip; [00114] Figure 15A depicts an exploded view of a removable sensor tip employing a round forcep post configuration;

[00115] Figure 15B is a cut-away view of a removable sensor tip employing a round forcep post configuration;

[00116] Figure 16A is an orthogonal perspective view of a grasper fitted with a removable button sensor tip;

[00117] Figure 16B is a left side downward exploded view of a forcep with a removable button sensor tip; and

[00118] Figure 16C is a left side upward exploded view of a forcep with a removable button sensor tip.

DETAILED DESCRIPTION

[00119] Figure 1A illustrates the physiological concept of human touch sensation, and Figure I B illustrates the robotic analogy. As an example, Figure 1A shows a human hand 10 squeezing on an egg 1 1 . This sensation 12 is transmitted to the brain 14 in the form of signals 13 from the nerve endings in the fingertips and hand muscles. This feedback allows the human brain to control the muscles as they contract, avoiding crushing the egg while still allowing a human to hold it. In addition, if the intent was to crush the egg, the brain would continue to apply pressure, via muscle contraction, until the release of pressure was felt, aka the egg being crushed.

[00120] With reference to Figure IB, in modern robotics a similar scenario can be problematic. A robotic hand 15 may try to hold an egg 16 without crushing it. The operator of the robotic hand has only pressure transducer output 17 which is depicted as an electronic signal 18 on a display. There is no direct means of providing an interface with the human brain 14 that allows for the same delicate level of muscle control in the robotic hand 15. As a result the egg 16 might be dropped or crushed. The operator must use other senses, such as sight, to control the robot.

[00121] Holding an egg 16 is a very simple example which might be achievable in a lab environment after the operator has had sufficient time to practice.

However, some applications of robotic equipment do not provide the operator with the full use of other senses to compensate for the loss of touch. A surgeon performing an operation via robotic assistance, while still provided with visual input via a camera, may be working with tissue, arteries, or sutures which do not have a level of tolerance to pressure that an eggshell would. Similarly, the operator of a bomb squad robot may require very delicate control and feedback that pure visual input cannot provide. Trigger switches and wires may be pressure intolerant, resulting in catastrophic outcomes. Finding some means to provide a proportional sense of touch to an operator without encumbering the operator's motions is therefore critical.

[00122] Figure 2A illustrates the concept of minimally invasive surgery using instruments 201 and cameras 202 injected into a body cavity 203 through ports in the surrounding tissues 207 as a means to perform a procedure on internal tissue 208. This technique allows surgeons to perform complex medical procedures while minimizing the impact on the patient, because the access to the surgical site 208 is gained through a series of small ports as opposed to opening up the cavity 203. This reduces the potential for infection and the time required for the patient to recover. The drawback is the surgical team is now required to perform the procedure in an enclosed space, without direct access to the surgical site 208. The use of instruments 201 and cameras 202 causes the surgeon to lose the dexterity and tactile feedback that comes with direct access to the surgical site 208.

[00123] Figure 2B illustrates the use of an instrument 204 to retain tissue 205 with minimal damage. Often, surrounding or dissected tissue must be held out of the way in order for a surgical procedure to be performed. This is typically accomplished by using forceps to hold the tissue, or sutures to tie the tissue back. Both of these methods damage surrounding tissue, potentially creating complications and increasing patient recovery time.

[00124] Figure 2C illustrates the use of an instrument as a means of probing tissue 206. Probing tissue allows a surgeon to examine the tissue for various symptoms, such as hardness, elasticity, blood flow, and many more. The use of surgical instruments as a surrogate for direct tactile feedback requires that the surgeon use only his or her sense of sight, whereas a pressure sensitive instrument would provide further feedback and would augment the surgeon's visual information.

[00125] Figure 3A depicts an embodiment of the present invention that uses an adhesive-backed flexible sensor material 301 wrapped around the arm of a surgical instrument 300 to provide electrical signals to a user feedback system. In embodiments, the sensor is a flexible capacitive tactile sensor that is commercially available.

[00126] In Figure 3A, the specific instrument attached at the end of the arm 302 varies based upon the instrument design, and has no impact on the wrapped sensor 301. The wrapped sensor 301 and user feedback system provide to the surgeon an ability to use the instrument arm 300 as an additional means of obtaining tactile feedback without having to use an additional device or assistant.

[00127] Figure 3B illustrates how the sensor material 301 can be affixed to the instrument arm 300 with an adhesive backing 303, and the electrical connections 304 can be affixed to the outside of the instrument arm 300 in order to provide electrical connectivity. The electrical cabling 304 can be constructed using coated, flat ribbon cabling which will fit through the space between the port and the instrument arm 300. When the procedure is complete, the sensor pad 301 and connections 304 can be peeled off of the instrument arm 300 and disposed of. The instrument can then be disinfected using any standard technique. The sensor pad 301 can also be split into multiple sectors, thereby allowing for directional feedback. For example, the top and bottom electrodes of the flexible tactile sensor can be divided into orthogonal strips, so that a distinct capacitor is formed at each point where the electrodes overlap. By selectively scanning a single row and column, the capacitance at the overlapping location, and thus the local pressure at that location, can be measured.

[00128] Figure 4A depicts a removable tip 400 that attaches to the distal end of an instrument 401. The tip 400 is designed to be used to retain tissue without damage by providing a smooth radial surface covered with pressure sensor material 406 that can provide a feedback signal to the surgeon via a set of coaxial connections 403, 404. The bottom 407of the tip has a slight lip that helps to retain tissue as the sides of the tip 400 are used to retain or move tissue. The finished edge of the tip 400 also has a rounded shape, so as not to cause damage to any tissue it may move along or brush against.

[00129] Figure 4B is an exploded view that shows in further detail the subcomponents of an embodiment of the invention. The embodiment includes sensor material 406 which is wrapped around a tip 405 that connects to the instrument arm 401 using a set of nibs 402. Within the tip 405 is a lower coaxial connector 404 which mates with the upper coaxial connector 403, allowing the tip to be removed for sanitizing purposes.

[00130] Figure 4C is an exploded view that depicts the inner connectors of the coaxial disconnect system of Figure 4B. Each coaxial connector includes two connection points, which are respectively attached to an inner and outer core and separated by insulating material. In the lower coaxial connector there is a center pole 408 connected to one lead of the sensor material and to another outer connector 41 1 , which is used to connect to the other lead of the sensor material, allowing for the creation of a complete circuit. The inner pole 408 mates with the inner core of the upper coaxial connector 409, while the outer connector of the lower coaxial connector interfaces with the outer pole of the upper coaxial connector 410. Connectivity to circuitry outside of the instrument can then be made though the center of the instrument arm by connecting to connectors 409 and 410 in the upper coaxial connector. These coaxial connectors can be pressed, glued, secured, or heat sealed into the tip and instrument arm according to manufacturing requirements. If the instrument arm is made of conductive material, an outer insulation layer can be wrapped around each coaxial connector to creation electrical isolation. These figures assume that the tip and instrument arm are made of non-conductive material. The tip locks into the instrument arm by using a set of nibs 412 onto which the tip twists and locks using the channels 419 cut into the side of the tip.

[00131] Figure 4D provides a cut-away view of the sub-components of Figure 4C. The upper coaxial connector 414 sits within the instrument arm 416, where it interfaces with the lower coaxial connector 415 which is fit into the tip 417. Each coaxial connector has connection tabs for electrical wiring to the control or sensor material respectively. The tip overlaps 413 the instrument tip in order to provide a seal, increase stability when lateral pressure is applied to the tip, and as a set for the twist-lock channels. The sensor material connectors 418 protrude through the inner portion of the tip 417, so that these leads can be connected to the two poles in the lower coaxial connector 415. The sensor material is wrapped around the tip 417 and held in place using a standard adhesive backing or clips. The sensor material can be affixed during production, or attached on-site using a peel-away adhesive backing or any other retention technique known in the art.

[00132] Figure 5A shows an instrument tip 500 configured with a concave surface 501 that is used to retain, probe, or manipulate tissue. The tip 500 sits in a pocket 502, which is placed within the tip of an instrument arm 503.

[00133] Figure 5B shows the sub-components of the embodiment of Figure 5A, including the tip 504, which slides into an inner pocket 505. The inner pocket 505 has a foam sleeve 506 which fits inside of it, flush to the top of the inner pocket 505, held in place by an adhesive. At the bottom of the inner pocket 505 is a magnet 508 which sits under a layer of sensor material 507. The magnet 508, along with the friction of the inner sleeve 506, holds the tip 500 in place. The tip 500 can be made from magnetic material, or can have a small amount of magnetic material affixed to its bottom or included as a core. There are grooves in the side of the inner pocket 505 which allow the connectors from the sensor material to travel up the inner core of the instrument arm 509 for connectivity to electrical systems.

[00134] Figure 5C illustrates the principle behind the embodiment of Figures 5A and 5B. The tip 525 rests on a pad of sensor material that responds to changes in pressure. When the tip experiences lateral pressure 510, 512, the tip compresses one side of the sensor material 5 1 1 , 513, causing a signal to be generated or modified. When the tip experiences pressure on its end, similar compression happens across the complete surface of the sensor material, causing similar signal generation or modification. Because the tip is resting on the sensor material, any pressure applied to the tip results in a signal. To add degrees of motion sensing, the sensor material can be divided into independent regions or sectors, each of which can provide additional or complimentary signals back to the electrical interface.

[00135] Figure 5D shows a cut-away view of an embodiment in which the tip 514 is sitting within the inner pocket 5 16, and the inner pocket contains an inner foam sleeve 515, a sensor pad 517, and a magnet 518, all of which fit within the instrument arm 520. The connectors to the sensor pad 517 protrude from a groove in the side of the inner pocket 516 in order to facilitate electrical connectivity. Due to the space between the sleeve 515 and the bottom of the pocket 516, as well as the compressibility of the sensor pad 517 material, the tip 514 is allowed to rotate about the point 521 , which provides a pivot point for detecting lateral pressure.

[00136] Figure 5E is a close-up view of the inner pocket, highlighting the slight curvature of the upper lip 522 and the gap 523 that exist between the pocket 522 and the tip 524. This allows the tip 524 to tilt as pressure is applied laterally. Without the curved lip 522 and the gap 523 it creates, the tip 524 would not tilt, and therefore would not exert pressure on the outer edges of the sensor material at the bottom of the pocket.

[00137] Figure 6A displays an instrument tip configured to be used as a probe in one degree of motion. The tip 601 is fitted with a sensor cap 602 which can be attached to an instrument arm 600, so that the operator can use the invention to probe tissue for certain characteristics, such as hardness, elasticity, and blood flow.

[00138] Figure 6B shows the sub-components of the instrument of Figure 6A, including a sensor pad 606 fitted into the end of tip 605, which fits into an instrument arm 603. The tip 605 is hollow, and contains wiring from the sensor pad 606 to nibs 608 in either side of the tip 605. These nibs 608 fit into slots in the instrument arm 603 as a means of retention and electrical connectivity. A spring 604 is provided to keep tension on the tip, and to keep it from dislodging.

[00139] Figure 6C shows a view of the tip 610 engaged with the instrument arm 608. In order to make the electrical connection between the leads 612 on the sensor pad 61 1 and the traces 609 going up the instrument arm 608, wires are run from the leads 612 to the nibs 621 , which provide an electrical contact by interfacing with the traces 609 at the top of the twist-lock channel 622. The spring at the base provides pressure, ensuring that the flat side of the nibs 621 is always in full contact with the flat side of the traces 609 that are built into the edges of the twist-lock channels 622 that are embedded in the instrument arm 608.

[00140] Figure 6D further illustrates the internal configuration of the instrument tip of Figure 6A. The figure provides a cut-away view, which show the sensor tip 620 connected to the nibs 617 via a pair of wires 619 which run through the hollow internal structure of the tip 618. The tip 618 fits into the instrument arm 615 through a pair of "J" shaped twist-lock grooves 616 carved into the side of the instrument tip 618. The wires 619 connect to the nibs 617 in the side of the tip 618, allowing the flat side of the nib 617 to come in contact with electrical traces which are embedded in the instrument arm 615 and wrap around the twist-lock grooves 616, so that an electrical connection can be made. There is a spring 623 located within the instrument arm which provides pressure against the base of the tip 618, so that the nibs 617 are in full contact with the twist-lock grooves 616.

[00141] Figure 6E depicts a surgical instrument 625 which has a removable sensor tip 624 affixed to one end that uses changes in air pressure and movement to detect pressure applied to the tip 624. The pressure is maintained and monitored through a supply line 626 which runs along the inside of the instrument 625.

[00142] Figure 6F provides further detail about the inner configuration and components that comprise the removable tip 624 of Figure 6E. A sharp, needlelike cut is made in the end of the pressurization tube 632, which allows it to puncture the underside of the pressure bubble tip. The supply tube 632 is fitted through a foam-like plug 633, which helps to maintain an airtight seal around the tube 633 and keep the tip pressurized. The location of the tube 632 is maintained by the insertion of spacers 634 within the instrument 625. The spacers 634 can be designed to accommodate and place a single supply tube or a plurality of supply tubes.

[00143] Figure 6G highlights how the components fit within the instrument arm 625. The pressurize tip 627 is manufactured to fit over the tip base 629, which is inserted into the instrument arm 625. The tip is constructed of a material that allows a gas to be used to inflate the tip and set the desired pressurization.

Pressure exerted against the tip 627 is then translated down the pressurization tube 633, allowing circuitry to detect the change in pressure and provide the operator with the necessary feedback. A foam-like plug 630 is inserted within the tip base 629, which allows the pressurization tube to puncture the tip 627 without allowing gas to leak back up the instrument arm 625. One or more spacers 631 are placed in the instrument arm 625 to provide structural and positional support to the pressurization tube. The spacers in Figure 6G have material removed from the outer circumference of the space in order to reduce friction during the insertion of the spacers 631 into the instrument arm 625.

[00144] This embodiment allows the pressurized tip 627, the tip base 629, and the plug 630 to be manufactured as a whole, and supplied to the surgeon during a procedure. A new tip can be added to the instrument arm 625, pressurized, and used in situ until no longer needed. The tip assembly (627, 629, 630) can then be removed from the instrument arm and disposed of. The instrument arm and its related componentry can then be sterilized and reused.

[00145] Figure 6H illustrates an embodiment of the pressurize sensor tip similar to the embodiment of Figures 6E, 6F and 6G. In this embodiment, the tip 635 is pressurized with a fluid that is fed through an inlet 636 and measured through an outlet 639. The tip 635 is a flexible material which is manufactured to seal around a base 637. The base fits into a mating plug 638 which is fitted into the instrument arm. The feed and return tubes are fitted down the inside of the instrument arm and inserted into the bottom of the plug 638, creating a sealed system. Once the tip 635 is pressurize by the fluid, pressure applied to the tip, for example when used to probe tissue, will be concentrated and reflected back up the outlet tube, allowing measurement devices to translate the pressure change into feedback to the surgeon.

[00146] Figure 61 illustrates further details of the components of the

embodiment of Figures 6G and 6H. The tip 640 is fitted to and around the outside of the base 641 , ensuring that some of the tip material wraps around the underside of the base 641. A retaining ring 642 is then placed over the underside of the base

641 and retained via a clip or glue. This provides additional pressure to the material of the tip 640, ensuring that it seals around the tip base 641. This ring

642 also acts as a friction interface, helping to retain the tip assembly in the instrument arm. The fittings in the bottom of the base 641 insert into holes in the spacer fitting 643, creating a fluid-tight seal between the tip assembly (640, 641 , 642) and the fluid feeds inside the instrument arm. This allows the fluid tip assembly to be removed and replaced as required by the surgeon, similar to the gas pressurized tip discussed above.

[00147] Figure 6J depicts another embodiment of a removable sensor surgical instrument tip. The tip 645, in this illustration, is fitted with one sensor 646 which is mounted radially. The tip 645 is retained by a toothed clip 647, which latches into a notch in the instrument arm. The tip 645 can be removed by applying pressure to the clip 647 and pulling on the tip 645. The tip 645 depicted in Figure 6J is designed to allow the surgeon to use the sensor in the tip to manipulate or interact with any feature of the anatomy being probed. As an example, a pressure sensitive pad affixed to the tip 645 might be used to help a surgeon dissect or move tissue while minimizing damage due to resistance. A pressure sensation would allow the surgeon to detect the resistance being asserted by tissue and thereby detect potential issues.

[00148] Figure 6K illustrates the internal components of the embodiment of Figure 6J. The tip 645 is fitted with a bottom cap 653 which seals the internal wiring 652 from the sensor 646 traced through an ingress 651. The sensor wiring 652 is connected to contact points on the outside of the bottom cap 653 so that they will come in contact with mating tabs 656, allowing the sensor to

electronically interface with components at the top of the instrument arm. The mating tabs are fitted into a spacer 655, which is inserted into the instrument arm at a distance that allows for a pressure mating between the contact points on the bottom cap 653 and the mating tabs 656. This allows the sensor tip to be removed and replaced as required, and allows the tip assembly (651 , 645, 653, 652) to be manufactured as a single component, and thereby easily replaced or disposed of in surgically sterile environments.

[00149] Figure 6L illustrates the internal structure of an embodiment of the invention once all of the components are in place. The tip 645 has an internal chase 648 that allows the wires to run from the sensor to the base 653 while keeping all electrical contacts free from fluids that would introduce electrical signal disruption. The tip is graduated, and fixed with clips that allow it to be inserted into the instrument arm via the use of a spacer 650, and removed when required. The embodiment of Figure 6L uses a clip retention system. Similar embodiments employ other solutions, such as threaded attachment, pressure fitting, or clipping with clips. The gating factor is that the electrical conductivity must be maintained and the tip must not inadvertently work loose during use. In further embodiments of the invention, several sensors can be affixed radially around the axis of the tip to allow for multiple sensing components.

[00150] Figure 7A is a top view of a set of forcep arms 708, 713 which work together to form surgical forceps. The grasping surface of each arm has a set of teeth 714 that enhance the grip. An embodiment of the invention 100 is clipped over one of the forcep arms 715, which has a central slot cut in the elongated face of the forcep penetrating from the grasping surface to a rear surface. A pressure- transmitting wafer 71 1 protrudes through this slot in order to transmit to the sensor material pressure applied to tissue being held between the forcep arms 713 708.

[00151] Figure 7B shows the pressure-transmitting wafer in the embodiment of Figure 8B protruding through the slot in one of a set of forcep arms forceps 71 1 , where the forcep arms rotate around a center axis 712. This allows the sensor material to detect pressure applied to the tissue without significantly reducing the grip of the forcep. This configuration also supports the full range of forcep use, whether closed or fully open.

[00152] Figure 7C is a view of the opposite side of the forceps of Figure 7B, detailing how the embodiment is attached to the forcep arm by sliding it from the tip to the hinge. The rear clip 709 aligns with the notch at the rear, while the tip clips 710 stick through the notch and attach at the tip. The embodiment can be removed from the forcep arm by squeezing the tip clips 710 together and pulling the invention up and out of the slot, while pulling back on the rear clip 709. [00153] In further embodiments, sensor material can be attached to both forcep grasping arms in order to transmit signals from both sides of the gripped tissue. The depiction of sensor material being attached to only one forcep arm in the drawings is merely to illustrate one potential configuration.

[00154] In yet other embodiments, the invention can be fit into instruments that have different slot configurations, such as needle drivers, sheers, retractors, and graspers. The configuration of the notch(s) though which the wafer(s) protrude(s) does not affect the function of the invention. The sensor material, wafer, and retaining clip can be formed to fit any size or shape notch according to the embodiment.

[00155] In additional embodiments, the rear clip can be added to both sides of the embodiment to increase the holding power and stability of the embodiment while it is in use.

[00156] Figure 7D provides additional detail of the embodiment of Figure 7c by illustrating the invention as it is attached to one arm of the forceps 702. The invention contains a central support rib 701 on which the sensor material 704 is attached. The length of the rib 701 and the thickness of the sensor material 704 are determined by the thickness of the instrument through which the invention protrudes and the type of sensor material 704 used. The support rib 701 provides a firm surface to which the sensor material 704 can be attached, and against which the sensor material 704 can be compressed. This allows for repeated use of the embodiment without the sensor material 704 becoming deformed. Without a sufficient support, the sensor material 704 could buckle and bend after a few uses, and could even require replacement during a procedure. The central support rib 701 serves to reduce this problem, and allows the invention to be used throughout a procedure without replacement. The sensor material 704 can be attached to the central support rib using an adhesive, or by any other method of attachment known in the art. The central support rib is held in place by a combination of a rear clip 703 and a set of tip clips. The rear clip 703 maintains a low profile and slips into the notch at the rear of the forcep arm. The clip can be removed by pulling the clip arm 703 away from the notch and pulling it perpendicular to the grasping arm.

[00157] Figure 7E provides further detail about the manner in which the embodiment of Figure 7D is attached to the forcep arm and electrically connected. At the front of the central support rib are a set of clip tips 707 which clip over the surface of the forcep arm, to keep the front end of the wafer from slipping out of the notch. This clip also ensures that the embodiment remains stable when pressure is applied to the front edge of the pressure material. A cover 706 on the top of the grasping arm protects the electrical connections 705 to the sensor material in the embodiment. The cover 706 is designed to have a minimal, shaped profile, so as not to interfere with any action which relies on the tip of any instrument to part or penetrate tissue. This cover 706 can be affixed with clips or adhesives, since it is not intended to be removed or reused.

[00158] Figure 8A is a view of the embodiment of Figure 7E when removed from the grasping arm. The sensor material 801 is attached to the central support rib 802 of the embodiment, which has a hole or notch 803 in it which allows the electrical connectors from sensor material to connect outside of the surgical site. The connector and through-hole are protected from catching or clogging by the cover 706 shown in Figure 7A.

[00159] Figure 8B provides an enhanced view of the distal end of the central support rib 807 of Figure 8A, showing the front tip clips 706. There are two clip arms separated by a gap, so that when the invention is pushed into the forcep notch the tip arms are pushed together, allowing them to slip through the notch. When the tips protrude from the notch they will spread apart and clip over the surface of the forcep face. This will create a retention surface for the invention and allow the invention to be removed by squeezing the tips together and pulling in a direction perpendicular to the griping surface of the grasping arm.

[00160] Figure 8C details the specifics of the rear clip 804 of the embodiment of Figure 8A, as well as the channel 805 for the electrical connectors from the sensor material. The indentation of the wiring is optional, but does reduce the possibility of the wiring getting caught on any internal tissue or sinew. The wiring can be held in place by an adhesive, clips built across the channel, or the cover plate described above. The rear clip 804 is angled so as to catch on the countersunk notch in the back of the grasping arm. The notch width, length, and thickness are a function of the overall design of the instrument to which the invention is attached and the space provided thereby.

[00161] Further embodiments of the invention include a clip which can be broken off when the invention is being removed.

[00162] Additional embodiments of the invention use an adhesive or a magnetic clasp to hold the invention in place and thereby eliminate the need for the rear clip 804.

[00163] Further embodiments employ a set of rear notch clips similar to the tip clips 806 to hold the invention in place, and thereby eliminate the need for the rear clip 804. Various embodiments include combinations of all or any of the attachment mechanisms described above, and/or other mechanisms known in the art.

[00164] Figure 9 A shows the underside view of another embodiment of the invention 901 clipped over the grasping arm of a forcep 903. In this embodiment, the invention does not protrude from a notch or opening in the grasping surface 902 of the forceps 903, but instead clips over the tip of the forceps 903, thereby providing a low profile surface onto which sensor material 901 is affixed.

[00165] Figure 9B shows the right side of the forceps of Figure 10A detailing the manner in which the embodiment is attached to the forceps. The rear clip 907 clips into the rear forceps notch 908. The front of the invention fits over the front of the instrument and provides a surface 906 on which the sensor material and electrical connections can be affixed. [00166] Figure 9C presents a view of the embodiment of Figure 10A from the opposite side of the forceps. This depiction details the use of an electrical cover plate 905 which protects the sensor wiring 904. The cover plate can be affixed in any manner known in the art, such as by an adhesive and/or by attachment clips. The wiring 904 protrudes out of the rear face of the cover plate so as to be away from the surfaces in use.

[00167] In further embodiments, the sensor connection is run under the tip, along the front edge of the forceps, or through a hole in the instrument. Electrical connections can also be run along the side face of the forceps and up the rear clip 907 of the invention.

[00168] In yet other embodiments of the invention, the clip can cover all or additional portions of the grasping arm. The embodiment shown in Figure 9C is representative of one aspect of the invention. Additional surfaces can be added to the invention to allow for sensor material to be placed anywhere along any surface of the invention. Sensor material can even be affixed to edges of the clip for use in other procedures such as tissue retention.

[00169] Figure 10A shows the right side view of the components of the embodiment of the invention depicted in Figure 9A. The invention is primarily composed of three core components, the clip 1007, the sensor material and connections 1004, and the cover plate 1001. The cover plate 1001 is a hollow structure that protects the electrical wiring 1004. The clip 1007 has corner guides 1008 placed on its surface to aid in alignment of the cover plate 1001. These corner guides 1008 can be aligned to fit inside or outside of the cover plate 1001. Alternately pins or clips can be used to align and retain the cover plate 1001.

[00170] Figure 10B provides additional detail concerning the components of the invention portrayed in Figure 9A. In this view the notches can be seen in the cover plate that allow electrical connection to run through the back 1002 and side 1003 of the cover plate. The sensor material 1005 can be affixed to the grip-side face of the clip, so that it will come in contact with the tissue being gripped by the instrument. The clip based embodiment slips over the instrument by allowing the tip of the instrument to fit into a cavity 1006 in the clip tip.

[00171] In further embodiments the cover plate notches 1002 and 1003 are not used, but instead the electrical wiring is recessed into the clip material.

[00172] Figure 1 1 A illustrates the concept of undercutting forceps so that sensor material 1 102 can be placed under the griping surface of a grasping arm of forceps 1 108 and therefore will not interfere with the use of the forceps. The undercut 1 101 is a slot that is beneath and parallel to the grasping surface and penetrates to three sides of the grasping arm, so that the grasping surface is suspended by a living hinge. Sensor material 1 102 can be inserted into the slot so that pressure applied to the grasping surface is translated from the forceps 1 108 to the sensor material 1 102 as result of the living hinge effect of the forcep material bending under pressure. While the movement of the grasping surface is slight, the sensor material 1 102 will be compressed proportionally when any force is exerted on the tripping surface of the forceps 1 108.

[00173] Figure 1 1B shows the clip side of the embodiment of Figure 1 1 A. The clip 1 106 provides a base into which the sensor material is seated. The clip 1 106 also covers 1 105 the leads 1 104 from the sensor material, and protects the sensor material from foreign matter becoming lodged in the tip of the undercut forceps by providing a faceplate 1 107. The faceplate 1 107 also has a vertical protrusion which provides stability and protects against any angular motion of the undercut forcep surface.

[00174] Figure 12A illustrates in further detail the manner in which the sensor material is used with the embodiment of Figure 1 1A. The sensor material is fitted into the slot which is beneath and parallel to the grasping surface, allowing enough room for an appropriately sized pad of sensor material to fit exactly therein. The sensor material does not protrude from either side of the forceps in order to prevent entanglement with tissue or organs. In this embodiment, the sensor material is attached to a one-sided clip which can be slid onto the forceps from the side. There is a front plate 1201 which covers the tip and provides stability. The front plate is designed not to extend into the opening of the forceps, so as not to interfere with use. At the back of the clip is a rising which has an inner channel in which the electrical connections to the sensor pad can be made. This keeps the wires from catching on any foreign material.

[00175] In further embodiments, the invention is designed to provide clip support from both sides of the forceps or none at all. The use of clip material is designed to keep the sensor material from being deformed when inserted into the undercut slot. The slot should be cut so as to exactly fit the width of the sensor material, thus minimizing any pressure on the pad when the forceps are not in use. Depending on the cut, angle, depth, and type of sensor material used, supporting material may or may not be required. It is feasible to provide backing material to the pad of sensor material, adding rigidity that precludes the need for support clips.

[00176] In yet other embodiments of the invention, the rising for the electrical connections is replace with an adhesive-backed ribbon cable or a chase-way cut into the side face of the grasping arm. The need for a rising or chase-way is a function of the sensor connections footprint and likelihood of catching on foreign material.

[00177] Figure 12B shows the embodiment of Figure 12A without the forceps. This figure further illustrates the internal form and function of the embodiment. The vertical key 1207 fitted into the back of the face plate is designed to snap into a notch cut into the front edge of the forceps. This key provides two functions: one is to keep the sensor pad 1206 in place, and the other is to keep the surface of the forceps from moving side-to-side when in use. Also depicted in the figure is the rear clip 1205 which helps keep the sensor pad 1206 from moving, and the side chase-way and wire 1204 which provide connectivity to the sensor page 1206.

[00178] Figure 13A provides an exploded view of the various components of an embodiment of the invention. The outer clip 1301 has an inner cut channel into which the side of the pad of sensor material is fitted and affixed, as well as a chase-way 1302 for the wiring 1303. The clip 1301 and sensor pad are attached to the forceps by sliding the invention in from the side and locking the invention in place through the use of a rear clip which fit into a depression 1304 in the forceps, and the front retaining notch 1308 which holds the key in the tip of the clip 1301.

[00179] Figure 13B is an exploded view of the embodiment of Figure 14A shown from the underside, revealing how the sensor pad 1306 slides into the inner notch in the clip and slips into the undercut notch in the forceps 1305. The front key 13012 locks the face plate in place and enhances material stability.

[00180] Figure 14A details a grasper comprising a fixed forcep 1404 and a removable, replaceable forcep 1403. The replaceable forcep 1403 is held in place by a clip 1402, which is secured to the base of the replaceable forcep and controlled by a linkage 1401. This embodiment allows for replaceable sensor clips 1403 to be attached to one (or both) forceps 1404, 1403, such that the mechanical componentry of the complete grasper can be sterilized and reused while the replaceable forcep 1403 can be removed and replaced with a new, sterile sensor, or a different type of sensor, as the surgeon requires.

[00181] Figure 14B is an underside view of the grasper depicted in Figure 14A, exposing the underside of the replacable forcep 1403, which has a gripping surface 1405 and sensor material 1406 affixed to its inside. The grasper's forceps are controlled by a scissor-like action, with the base of the replacable forcep 1403 designed to fit between the outer finger of the fixed forcep 1404, so as to allow room for electrical wiring to attach to the removable forcep base without interfering with any of the mechanical componentry. Critical to the proper implementation of a removable sensor is the support for sterilization, structural integrity, and the protection of the sensor wiring during use.

[00182] Figure 14C depicts components of a replaceable forcep 1409 having a recess 1410 in one side that allows a sensor 141 1 to be fixed in place for contact with the electrical mating points 1412 on the forcep paddle 1408. The replaceable forcep 1409 has a slot cut into one end which allows the sensor 1049 to slide over the forcep paddle 1408 and mate firmly in place. The sensor 1409 can be affixed with a gasket material on the edge that mates between the sensor slot face and the forcep base, creating a water-tight seal.

[00183] Figure 14D further illustrates how the replaceable sensor 1409 of Figure 14C attaches to the forcep paddle 1408, allowing for the electrical connections on the top of the sensor to protrude through slots in the recess of the replaceable sensor 1409 and to come in contact with the mating connectors 1412 on the paddle 1408. The replaceable sensor 1409 has as clip having a small underside

protuberance which fits into a retention depression 1414 on the forcep base. The wires 1413 for the connections mounted in the forcep paddle 1408 protrude out the rear of the forcep base, allowing them to be routed up the internal structure of the instrument arm. This significantly reduces the damage to the wiring as a result of other instrumentation and use.

[00184] Figure 14E provides additional detail on how the replaceable sensor 1416 slides over the forcep paddle 1418, allowing the two components to mate in a manner that provides the same capabilities and integrity as a fixed forcep. The replaceable sensor is removed by using a small tool or fingernail to lift the end of the retaining clip by accessing the shallow cutout 1417 in the end of the clip. Affixing the replaceable sensor 1416 can also be achieved through the use of any commonly known clip appliance, friction surface, pin or adhesive, or any other attachment mechanism known in the art.

[00185] Figure 14F depicts a further embodiment of the invention in which sensors are attached to additional faces of the replaceable clip. Shown are a top- attached sensor 1419 and a nose-attached sensorl418. The replaceable sensor can be designed to contain one or more of these sensors on any face. The internal connections on the force paddle can be multiplied to provide numerous electrical connections for one or more sensor embedded in the replaceable clip body. [00186] Figure 15A depicts an alternative embodiment of the invention where the replaceable sensor clip mates with a round conductor 1501 , approximating the electrical connectivity capabilities 1502 of a phono-plug, with the electrical contact points embedded as bands down the axis of the round conductor 1501. The round conductor 1501 protrudes from a square base 1503 which, in the case of only one round conductor being employed, keeps the clip from rotating when in use. The sensor, being affixed to a face of the clip, has tabs with circular contact points 1504, which allow the round conductor 1501 to slide through and connect with the senor. The number of contact points is determined by the number and type of sensors in the clip.

[00187] Figure 15B is a cut-away diagram that illustrates how the round conductor 1505 of Figure 15A mates with the sensor tabs 1506 when the clip is in place.

[00188] In further embodiments of the invention, more than one conductor pole or a supporting pin is used to prevent rotation of the clip, so that the use of a square base 1503 is eliminated. The use of more than one conductor pole in these embodiments also facilitates the use of more complex sensors or a multiplicity of sensors employed in one clip, because more conductor poles facilitate more electrical connection as well as structural integrity.

[00189] Figure 16A depicts a fenestrated grasper with a removable sensor affixed to the upper forcep 1601. In this embodiment, both the lower forcep 1603 and the upper forcep 1601 are permanently installed in the instrument arm 1602. The upper forcep 1601 has one or more fenestrations (holes), which are cut through from the underside to the top. A button which is in contact with a sensor embedded in the cover is inserted through one of the fenestration holes.

[00190] Figure 16B is an exploded view that illustrates how the components of the sensor button assembly (1605, 1606, 1604) are inserted into the fenestration in the forcep of Figure 16A. The button 1606 is place in the fenestration such that it will come into contact with anything hitting the gripping face of the forcep. The top of the button 1606 has a slight lip, which retains the button in the fenestration. The top of the button 1606 is in contact with a sensor attached to the bottom surface of the sensor cover 1605. When pressure is applied to the button 1606 as a result of using the grasper or forcep, the pressure is translated to the sensor affixed to the cover 1605, which converts it to electrical signals that are

transmitted up the instrument arm via an electrical circuit 1604.

[00191] Figure 16C further illustrates the embodiment of the fenestrated sensor button of Figures 16A and 16B by depicting the mating surface of the button 1608 and how the top of the button mates with the sensor on the bottom side of the cover 1609. The sensor has electrical connection pads 1610 which mechanically mate with the electrical circuit 161 1 , which travels up and out of the instrument arm. The button is inserted in the fenestration 1612 such that when no pressure is applied, the signals from the sensor approximate a calibrated "zero" state. The complete assembly can be held in place by any number of mechanical or adhesive means known in the art, or any combination thereof.

[00192] In further embodiments of the invention, sensor material is simply affixed to the grasping surface of a surgical instrument by any means known in the art, such as by using an adhesive backing for retention of the material and wiring. These embodiments do not rely on supporting material, and simply stick the sensor material to the grasping surface of the instrument.

[00193] In additional embodiments, the sensor material includes gripping patterns that enhance friction for those surfaces covered in sensor material. Sensor material may cover critical etchings in the surface of the instrument and create a lower coefficient of friction. Stamping patterns into the sensor material or coating it with a non-slip material will overcome this loss.

[00194] In yet further embodiments of this invention, marking pads, loaded with non-toxic ink, can be affixed to the invention, allowing the surgeon to use the instrument to probe the tissue and make marks to indicate certain procedural areas, such as cutting edges. [00195] In additional embodiments, sensors used in the invention can be comprised of numerous or multiple sensors providing a wide range of feedback signals such as, but not limited to, pressure, temperature, tissue density, viscosity, chemical composition, and shear.

[00196] The foregoing description of the embodiments of the invention has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Many modifications and variations are possible in light of this disclosure. It is intended that the scope of the invention be limited not by this detailed description, but rather by the claims appended hereto.

Claims

What is claimed is: 1. An environment-sensing surgical instrument, comprising:
a surgical instrument;
sensor material applied proximal to a distal end of the surgical instrument, the sensor material being configured to emit electrical signals in response to exposure of the distal end to environmental conditions; and
electrical leads configured to convey the electrical signals to a signal monitoring system. 2. The surgical instrument of claim 1 , wherein the instrument is configured to make incisions. 3. The surgical instrument of claim 1 , wherein the instrument is configured to hold tissue away from a surgical site. 4. The surgical instrument of claim 1 , wherein the instrument is configured to probe tissue and provide information regarding physical features thereof. 5. The surgical instrument of claim 1 , wherein the sensor material is applied to the instrument in a plurality of sections, the sections being configured to provide a plurality of electrical signals that correspond to a plurality of environmental conditions sensed at the distal end of the instrument. 6. The surgical instrument of claim 1 , wherein the sensor material is removable from the surgical instrument. 7. A removable sensing tip for a surgical instrument, comprising:
an instrument tip that can be removably installed on a distal end of a surgical instrument;
sensor material applied to the instrument tip, the sensor material being configured to emit electrical signals in response to exposure of the instrument tip to environmental conditions; electrical tip leads; and
electrical instrument leads configured to electrically connect with the electrical tip leads when the tip is installed on the surgical instrument, and to convey the electrical signals from the tip to an electronic feedback system. 8. The sensing tip of claim 7, wherein the tip is configured to make incisions. 9. The sensing tip of claim 7, wherein the tip is configured to hold tissue away from a surgical site. 10. The sensing tip of claim 7, wherein the tip is configured to probe tissue and to provide information regarding physical features thereof. 1 1. The sensing tip of claim 7, wherein the sensor material is applied in a plurality of sections, the sections being configured to provide a plurality of signals that indicate a plurality of environmental conditions sensed at the tip. 12. The sensing tip of claim 7, wherein the sensor material is removable from the tip. 13. The sensing tip of claim 7, wherein the sensing material is incorporated into a juncture between the tip and the surgical instrument, so that exposure of the tip to the environmental conditions results in actuation of at least a portion of the sensing material. 14. A method for adapting a surgical instrument for use with a feedback system, the method comprising:
attaching sensing material proximal to a distal end of the surgical instrument, the sensing material being applied in a configuration that will emit electrical signals in response to exposure of the distal end to environmental conditions; and
attaching electrical leads to the surgical instrument in a configuration that will not interfere with surgical use of the instrument, the electrical leads being configured to convey the electrical signals to a feedback system.
15. The method of claim 14, wherein the instrument is configured to make incisions. 16. The method of claim 14, wherein the instrument is configured to hold tissue away from a surgical site. 17. The method of claim 14, wherein the instrument is configured to probe tissue and provide information regarding physical features thereof. 18. The method of claim 14, wherein the sensor material is applied in a plurality of sections, the sections being configured to provide a plurality of signals that indicate exposure of the distal end of the instrument to a plurality of environmental conditions. 19. The method of claim 14, wherein the sensor material is removable from the surgical instrument. 20. An environment-sensing surgical grasping instrument, comprising:
a grasping instrument, including a first grasping arm and a second grasping arm, the first grasping arm including a first grasping surface and an opposing first rear surface, the second grasping arm including a second grasping surface and an opposing second rear surface, the grasping arms being configured to close together and grasp target material between the grasping surfaces, and to separate and release the material;
a first slot extending from the grasping surface to the rear surface of the first grasping arm;
first sensor material applied to the rear surface of the first grasping arm and configured to cover at least a portion of the first slot;
a first wafer inserted within the first slot in contact with the first sensor material and protruding from the first grasping surface, the first wafer being configured to convey environmental conditions from the first grasping surface to the first sensor material in proportion to exposure of the first grasping surface to the environmental conditions when the target material is grasped between the grasping arms; and
first electrical connections configured to convey an electrical signal generated by the first sensor material in response to the environmental conditions conveyed to it by the first wafer. 21. The surgical instrument of claim 20, further comprising:
a second slot extending from the second grasping surface to the second rear surface;
second sensor material applied to the second rear surface and configured to cover at least a portion of the second slot;
a second wafer inserted within the second slot in contact with the second sensor material and protruding from the second grasping surface, the second wafer being configured to convey environmental conditions to the sensor material in proportion to exposure of the second grasping surface to the environmental conditions when the target material is grasped between the grasping arms; and second electrical connections configured to convey an electrical signal generated by the second sensor material in response to the environmental conditions conveyed to it by the second wafer. 22. The surgical instrument of claim 20, wherein the grasping arms are connected to each other by a pivot joint, so that the grasping arms close together and separate by pivoting about the pivot joint. 23. The surgical instrument of claim 20, wherein the first wafer and first sensor material are removable from the first grasping arm. 24. The surgical instrument of claim 23, wherein the first wafer and first sensor material are attachable to the first grasping arm by at least one clip. 25. The surgical instrument of claim 20, wherein the instrument is one of forceps, needle drivers, sheers, and retractors.
26. The surgical instrument of claim 20, further comprising a first central support rib attached to the first grasping arm, the first central support rib having a flat support surface located in contact with a rear surface of the first sensor material, the first sensor material being sandwiched between the flat support surface and the first rear surface, the flat support surface being configured to compress the first sensor material between the flat support surface and the first wafer when the target material is grasped between the grasping arms. 27. The surgical instrument of claim 26, wherein the first sensor material is attached to the flat support surface. 28. The surgical instrument of claim 20, further comprising a first cover configured to protect the first electrical connections. 29. The surgical instrument of claim 20, further comprising a first passage extending through the first wafer, the first electrical connections being routed from the first sensor material through the first passage, and thereby through the first slot to the first rear surface. 30. The surgical instrument of claim 20, wherein the first sensor material is attached to the first rear surface by an adhesive. 31. The surgical instrument of claim 20, wherein the first sensor material is magnetically attached to the first rear surface. 32. The surgical instrument of claim 20, wherein the first sensor material is further applied to a distal end of the first grasping arm and configured to provide a signal that is proportionate to environmental conditions sensed at the distal end of the grasping arm. 33. An environment-sensing surgical grasping instrument, comprising:
a grasping instrument having a first grasping arm and a second grasping arm, the first grasping arm having a first grasping surface and the second grasping arm having a second grasping surface, the grasping arms being configured to close together and grasp target material between the grasping surfaces, and to separate and release the material;
a first slot extending parallel to and below the first grasping surface and extending to a distal end and to both sides of the first grasping arm, so that the first grasping surface is supported by a proximal living hinge;
first sensor material inserted within the first slot and configured so that environmental conditions are conveyed from the first grasping surface to the first sensor material; and
first electrical connections configured to convey an electrical signal generated by the first sensor material in response to exposure of the first grasping surface to the environmental conditions. 34. The surgical instrument of claim 33, further comprising:
a second slot extending parallel to and below the second grasping surface and extending to a distal end and to both sides of the second grasping arm, so that the second grasping surface is supported by a proximal living hinge;
second sensor material inserted within the second slot, and configured so that environmental conditions are conveyed from the second grasping surface to the second sensor material; and
second electrical connections configured to convey an electrical signal generated by the second sensor material in response to exposure of the second grasping material to the environmental conditions. 35. The surgical instrument of claim 33, wherein the first sensor material can be inserted into the first slot and removed from the first slot. 36. The surgical instrument of claim 35, further comprising a clip that maintains the first sensor material within the first slot, the clip being configured to cover the first slot and to extend to the distal end and to at least one side of the first grasping arm.
An environment-sensing surgical grasping instrument, comprising a grasping instrument having a first grasping arm and a second grasping arm, the first grasping arm having a first grasping surface, the second grasping arm having a second grasping surface, the grasping arms being configured to close together and grasp target material between the grasping surfaces, and to separate and release the target material;
first sensor material attached to the first grasping surface, and configured so that environmental conditions of the target material are applied to the first sensor material when the target material is grasped between the grasping surfaces; and
first electrical connections configured to convey an electrical signal generated by the first sensor material in response to the environmental conditions of the target material. 38. The surgical instrument of claim 37, further comprising:
second sensor material attached to the second grasping surface, and configured so that environmental conditions of the target material are applied to the second sensor material by target material grasped between the grasping surfaces; and
second electrical connections configured to convey an electrical signal generated by the second sensor material in response to the environmental conditions of the target material. 39. The surgical instrument of claim 37, wherein the first sensor material is adhered to the first grasping surface by an adhesive. 40. The surgical instrument of claim 37, wherein the first sensor material includes a surface pattern that enhances frictional retention of target material grasped between the grasping surfaces. 41. The surgical instrument of claim 37, further comprising a marking pad affixed thereto, the marking pad being loaded with non-toxic ink, the marking pad being usable to mark selected target material during a surgical procedure.
42. The surgical instrument of claim 37, wherein at least one of the first and second sensor materials can be replaced by sensor material of a different type, so as to change the environmental condition being sensed thereby.
PCT/US2014/012670 2013-01-23 2014-01-23 Device for providing sensory feedback during surgical procedures WO2014116782A1 (en)

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