Patent Grant
9259265
The present disclosure relates generally to surgical instruments suitable for sealing tissue and, more particularly, relates to surgical instruments comprising an electrode and configured to tension tissue adjacent tissue being sealed by the electrode.
In various open, endoscopic, and/or laparoscopic surgeries, for example, it may be desirable to coagulate, seal, and/or fuse tissue. One method of sealing tissue relies upon the application of energy, such as electrical energy, for example, to tissue captured or clamped within an end-effector or an end-effector assembly of a surgical instrument in order to cause thermal effects within the tissue. Various mono-polar and bi-polar radio frequency (Rf) surgical instruments and surgical techniques have been developed for such purposes. In general, the delivery of Rf energy to the captured tissue can elevate the temperature of the tissue and, as a result, the energy can at least partially denature proteins within the tissue. Such proteins, such as collagen, for example, can be denatured into a proteinaceous amalgam that intermixes and fuses, or seals, together as the proteins renature. As the treated region heals over time, this biological seal may be reabsorbed by the body's wound healing process.
In certain arrangements of a bi-polar radiofrequency (Rf) surgical instrument, the surgical instrument can comprise opposing first and second jaws, wherein each jaw can comprise an electrode. In use, the tissue can be captured between the jaws such that energy can flow between the electrodes in the opposing jaws and through the tissue positioned therebetween. Such instruments may have to seal many types of tissues, such as anatomic structures having walls with irregular or thick fibrous content, bundles of disparate anatomic structures, substantially thick anatomic structures, and/or tissues with thick fascia layers such as large diameter blood vessels, for example. With particular regard to sealing large diameter blood vessels, for example, such applications may require a high strength tissue seal immediately post-treatment.
The foregoing discussion is intended only to illustrate various aspects of the related art and should not be taken as a disavowal of claim scope.
In one non-limiting embodiment, the present disclosure, in part, is directed to an end-effector configured to be attached to a surgical instrument. The end-effector comprises a first jaw comprising an electrode and a second jaw. At least one of the first jaw and the second jaw is movable relative to the other jaw between an open position and a closed position. In the closed position, a first region of tissue positioned intermediate the first jaw and the second jaw is compressed. The first jaw comprises a first slider member movably attached to the first jaw and movable relative to the electrode. The first slider member comprises a first tissue-contacting surface configured to engage a second region of the tissue. The second jaw comprises a second slider member movably attached to the second jaw and movable relative to the electrode. The second slider member comprises a second tissue-contacting surface configured to engage the second region of the tissue. The first slider member and the second slider member are configured to apply a tensile force to tissue positioned intermediate the first region and the second region when the first slider member and the second slider member are moved relative to the electrode.
In one non-limiting embodiment, the present disclosure, in part, is directed to a surgical instrument comprising a first jaw comprising an electrode, a second jaw, and movement means for moving at least one of the first jaw and the second jaw relative to the other jaw between an open position and a closed position to compress a first region of tissue positioned intermediate the first jaw and the second jaw. The first jaw comprises a first member movably attached to the first jaw and movable relative to the electrode. The first member comprises a first tissue-contacting surface configured to grip a second region of the tissue. The second jaw comprises a second member movably attached to the second jaw and movable relative to the electrode. The second member comprises a second tissue-contacting surface configured to grip the second region of the tissue. The surgical instrument comprises biasing means for biasing at least the first member relative to the electrode to tension the tissue positioned intermediate the first region and the second region.
In one non-limiting embodiment, the present disclosure, in part, is directed to a surgical instrument, comprising an elongate shaft comprising a proximal end and a distal end, a handle portion extending from the proximal end of the elongate shaft, and an end-effector extending from the distal end of the elongate shaft. The end-effector comprises a first jaw comprising an electrode and a second jaw. At least one of the first jaw and the second jaw is movable relative to the other jaw between an open position and a closed position. In the closed position, a first region of tissue positioned intermediate the first jaw and the second jaw is compressed. The first jaw comprises a first slider member movably attached to the first jaw and movable relative to the electrode. The first slider member comprises a first tissue-contacting surface configured to engage a second region of the tissue. The second jaw comprises a second slider member movably attached to the second jaw and movable relative to the electrode. The second slider member comprises a second tissue-contacting surface configured to engage the second region of the tissue. The first slider member and the second slider member are configured to apply a tensile force to tissue positioned intermediate the first region and the second region when the first slider member and the second slider member are moved relative to the electrode.
Various features of the embodiments described herein are set forth with particularity in the appended claims. The various embodiments, however, both as to organization and methods of operation, together with the advantages thereof, may be understood in accordance with the following description taken in conjunction with the accompanying drawings as follows.
Corresponding reference characters indicate corresponding parts throughout the several views. The example embodiments set out herein illustrate various embodiments of the present disclosure, in one form, and such example embodiments are not to be construed as limiting the scope of the present disclosure in any manner.
Various embodiments are directed to apparatuses, systems, and methods for the treatment of tissue. Numerous specific details are set forth to provide a thorough understanding of the overall structure, function, manufacture, and use of the embodiments as described in the specification and illustrated in the accompanying drawings. It will be understood by those skilled in the art, however, that the embodiments may be practiced without such specific details. In other instances, well-known operations, components, and elements have not been described in detail so as not to obscure the embodiments described in the specification. Those of ordinary skill in the art will understand that the embodiments described and illustrated herein are non-limiting examples, and thus it can be appreciated that the specific structural and functional details disclosed herein may be representative and illustrative. Variations and changes thereto may be made without departing from the scope of the claims.
Reference throughout the specification to “various embodiments,” “some embodiments,” “one embodiment,” “certain embodiments,” or “in an embodiment”, or the like, means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in various embodiments,” “in some embodiments,” “in one embodiment,” “in certain embodiments,” or “in an embodiment”, or the like, in places throughout the specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Thus, the particular features, structures, or characteristics illustrated or described in connection with one embodiment may be combined, in whole or in part, with the features structures, or characteristics of one or more other embodiments without limitation.
The entire disclosures of the following non-provisional United States patents are hereby incorporated by reference herein:
U.S. Pat. No. 7,381,209, entitled ELECTROSURGICAL INSTRUMENT;
U.S. Pat. No. 7,354,440, entitled ELECTROSURGICAL INSTRUMENT AND METHOD OF USE;
U.S. Pat. No. 7,311,709, entitled ELECTROSURGICAL INSTRUMENT AND METHOD OF USE;
U.S. Pat. No. 7,309,849, entitled POLYMER COMPOSITIONS EXHIBITING A PTC PROPERTY AND METHODS OF FABRICATION;
U.S. Pat. No. 7,220,951, entitled SURGICAL SEALING SURFACES AND METHODS OF USE;
U.S. Pat. No. 7,189,233, entitled ELECTROSURGICAL INSTRUMENT;
U.S. Pat. No. 7,186,253, entitled ELECTROSURGICAL JAW STRUCTURE FOR CONTROLLED ENERGY DELIVERY;
U.S. Pat. No. 7,169,146, entitled ELECTROSURGICAL PROBE AND METHOD OF USE;
U.S. Pat. No. 7,125,409, entitled ELECTROSURGICAL WORKING END FOR CONTROLLED ENERGY DELIVERY; and
U.S. Pat. No. 7,112,201, entitled ELECTROSURGICAL INSTRUMENT AND METHOD OF USE.
Various embodiments of systems and methods of the present disclosure relate to creating thermal “welds”, “seals” and/or “fusion” within native tissue volumes, which are indicated in the figures as “Ti”. These terms may be used interchangeably herein to describe thermal treatments of a targeted tissue volume that can result in a substantially uniform fused-together tissue mass, for example, in welding blood vessels that exhibit substantial burst strength immediately post-treatment. The strength of such welds is particularly useful for (i) permanently sealing blood vessels in vessel transection procedures; (ii) welding organ margins in resection procedures; (iii) welding other anatomic ducts wherein permanent closure is required; and also (iv) for performing vessel anastomosis, vessel closure, and/or other procedures that join together anatomic structures or portions thereof. The sealing, welding, and/or fusion of tissue as disclosed herein is to be distinguished from “coagulation”, “hemostasis” and other similar descriptive terms that generally relate to the collapse and occlusion of blood flow within small blood vessels or vascularized tissue. For example, any surface application of thermal energy can cause coagulation or hemostasis—but does not fall into the category of “sealing” as the term is used herein. Such surface coagulation may not create a seal that provides any substantial strength in the treated tissue.
At the molecular level, the phenomena of truly “sealing” tissue as disclosed herein may result from the thermally-induced denaturation of collagen and/or other protein molecules in a targeted tissue volume to create a transient liquid or gel-like proteinaceous amalgam. In various circumstances, a selected energy density can be provided in the targeted tissue to cause hydrothermal breakdown of intra- and intermolecular hydrogen crosslinks in the collagen and/or other protein molecules. The denatured amalgam can be maintained at a selected level of hydration—without desiccation—for a selected time interval which can be very brief. In various embodiments, the targeted tissue volume can be maintained under a selected high level of mechanical compression to insure that the unwound strands of the denatured proteins are in close proximity to one another to allow their re-intertwining and re-entanglement. Upon the thermal relaxation, or cooling, of the tissue, the intermixed amalgam can result in protein entanglement as re-crosslinking or renaturation occurs to thereby cause a uniform fused-together mass.
Further to the above, the thermally-induced denaturation of collagen and/or other protein molecules described above can, in various circumstances, result in permanent changes to the tissue. In certain circumstances, the tissue can be heated in a manner which allows the collagen molecules to permanently unwind and damage the tissue. In at least some such circumstances, the amount of damage done to the tissue can be measured by the amount in which the tissue shrinks as a result of the thermal energy applied thereto. For example, greatly-damaged tissue may tend to shrink more than lesser-damaged tissue. Such concepts are discussed in greater detail in Continuum thermodynamics and the clinical treatment of disease and injury, J. D. Humphrey, Appl. Mech. Rev., vol. 56, no. 2, March 2003; Heat-induced changes in the mechanics of a collagenous tissue: Isothermal isotonic-shrinkage, Chen, S. S., Wright, N. T., Humphrey, J. D., ASME Journal of Biomechanical Engineering 120, 382-388, 1998; and Kinetics of thermal damage to a collagenous membrane under biaxial isotonic loading, Harris, J. L., Humphrey J. D., IEEE Trans. Biomed. Eng. 2004 February, 51(2): 371-9, the entire disclosures of which are incorporated by reference herein.
In various circumstances, the amount in which the tissue can be damaged by the application of thermal energy thereto can be predicted. More particularly, the denaturation of the collagen within the tissue can be a function of at least two variables such as, one, the temperature to which the tissue is heated and, two, the time in which the tissue is heated, for example. Stated another way, the denaturation of the collagen within the tissue can be a function of time and temperature. It is believed by the Applicants that the degree to which the collagen is denaturized can also be a function of another variable, i.e., the mechanical force applied to the tissue. More particularly, it is believed by the Applicants that when a tensile load is applied to the tissue at the same time that the tissue is being exposed to thermal energy, excessive denaturation of the collagen can be reduced, delayed, and/or possibly prevented. It is believed that the tensioning of the tissue inhibits an undesired amount of unwinding and/or shortening of the collagen molecules. Thus, in various circumstances, the damage to tissue can be reduced and/or avoided when the tissue is stretched, for example.
Various embodiments disclosed herein provide electrosurgical jaw structures adapted for transecting captured tissue between the jaws and for contemporaneously sealing the captured tissue margins with controlled application of RF energy or other energy. The jaw structures can comprise a scoring element which can cut or score tissue independently of the tissue capturing and sealing functions of the jaw structures. The jaw structures can comprise first and second opposing jaws that carry fuses, such as positive temperature coefficient materials (“PTC” materials), for example, for modulating energy delivery to the engaged tissue.
The embodiments of the devices described herein may be introduced inside a patient using minimally invasive or open surgical techniques under direct control of a clinician or by way of indirect control of a clinician through the use of robot assistance. In some instances, it may be advantageous to introduce the devices inside the patient using a combination of minimally invasive and open surgical techniques. Minimally invasive techniques may provide more accurate and effective access to the treatment region for diagnostic and treatment procedures and include but are not limited to numerous laparoscopic approaches including the use of multiple trocars or ports distributed about the patient, multiple trocars placed at a single site, and/or a single trocar with multiple ports placed in a location such as, but not limited to, the umbilicus, for example. To reach internal treatment regions within the patient, the devices described herein may be inserted through natural openings of the body such as the mouth, anus, and/or vagina, for example. Minimally invasive procedures performed by the introduction of various medical devices into the patient through a natural opening of the patient are known as Natural Orifice, Transluminal, Endoscopic Surgery or NOTES™ procedures. Some portions of the devices may be introduced to the tissue treatment region percutaneously or through small—keyhole—incisions.
Endoscopic minimally invasive surgical and diagnostic medical procedures can be used to evaluate and treat internal organs by inserting a small tube into the body. The endoscope may have a rigid or a flexible tube. A flexible endoscope may be introduced either through a natural body opening (e.g., mouth, anus, and/or vagina) or via a trocar through a relatively small—keyhole—incision (usually 0.5-1.5 cm). The endoscope can be used to observe surface conditions of internal organs, including abnormal or diseased tissue such as lesions and other surface conditions and capture images for visual inspection and photography. The endoscope may be adapted and configured with working channels for introducing medical instruments to the treatment region for taking biopsies, retrieving foreign objects, and/or performing surgical procedures.
Certain example embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those of ordinary skill in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting example embodiments and that the scope of the various embodiments of the present disclosure is defined solely by the claims. The features illustrated or described in connection with one example embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present disclosure.
In various embodiments, referring to
In one embodiment, the surgical instrument 10 and portions of the end-effector 16 can be in communication with an energy source 11 through conductors 15 and 17 such that the jaws or other portions of the end-effector 16 can function as a pair of bi-polar electrodes, for example, wherein one electrode can have a positive polarity (+) and one electrode can have a negative polarity (−), as is discussed in greater detail herein. In one embodiment, the conductor 15 can have a positive polarity and the conductor 17 can have a negative polarity, for example. The conductors 15 and 17 can be in electrical communication with the end-effector 16 and/or other portions of the surgical instrument 10 such that energy can be supplied from the energy source 11 to the end-effector 16 or other portions of the surgical instrument 10 through the conductors 15 and 17. In one embodiment, the energy source 11 can be configured to supply energy, such as electrical energy, RF energy, ultrasonic energy, and/or thermal energy, for example, from the energy source 11 to the tissue compressed within the end-effector 16 to seal or otherwise energize the tissue. The delivery of the energy from the energy source 11, such as the magnitude, duration, wave form, and/or frequency, for example, of the energy can be sufficiently controlled or modulated by a controller 13 to provide a desired amount or type of energy to the surgical instrument 10. Although not shown, it is conceived that the energy source, controller, and/or conductors may be located on and/or within the device (e.g., within handle portion 14). Various suitable energy sources and controllers are known to those of skill in the art.
In one embodiment, the handle portion 14 can comprise a grip 22 including a gripping surface 23, a trigger 24, and an actuation button 26 optionally positioned on and/or extending from the trigger 24. In various embodiments, the actuation button 26 can be configured as a separate trigger. In other various embodiments, the actuation button can be positioned on the handle portion 14, instead of the trigger 24, for example. In use, as described in greater detail below, the trigger 24 can be moved or pivoted proximally toward the grip 22 to actuate and/or close the end-effector 16 of the surgical instrument 10. In one embodiment, the handle portion 14 can comprise a rotatable knob 28 operably engaged with and/or attached to the proximal end 18 of the elongate shaft 12. In at least one such embodiment, the elongate shaft 12 can form a longitudinal axis extending between the proximal end 18 and the distal end 20 of the shaft 12 wherein the rotatable knob 28 can allow a surgeon to rotate the end-effector 16 about the longitudinal axis in the direction indicated by arrow “R” (
In one embodiment, referring to
In one embodiment, referring to
In one embodiment, referring to
In various embodiments, further to the above, the first slider member 50 and the third slider member 66 can be slidably attached to the base 42 of the first jaw 30. In at least one embodiment, the biasing member 56 can connect the distal end of the first slider member 50 and the distal end of the third slider member 66 to the distal end of the base 42. In at least one such embodiment, the biasing member 56 can comprise a base portion which is embedded within and/or otherwise attached to the base 42 and, in addition, two ends extending therefrom wherein one of the ends can be engaged with the first slider member 50 and the other end can be engaged with the second slider member 66. In various embodiments, the biasing member 56 can be configured to resiliently bias the first and third slider members 50 and 66 inwardly toward a longitudinal axis, or center, of the end-effector 16. In order to move the first and third slider members 50 and 66 outwardly, as described in greater detail below, the movable member 36 can engage the first and third slider members 50 and 66 and displace them outwardly. In at least one such embodiment, the cams 40 extending from the movable member 36 can engage the proximal ends of the first and third slider members 50 and 66 to displace the slider members 50 and 66 outwardly away from the longitudinal axis when the movable member 36 is advanced into the end effector 16. In use, the fins 37 of the movable member 36 can engage the second jaw 32 and pivot the second jaw 32 into a closed position prior to the cams 40 contacting the slider members 50 and 66. In at least one such embodiment, as a result, the slider members 50 and 66 would be moved outwardly after the second jaw 32 has been closed. In such embodiments, at least a portion of the fins 37 can lead, or be positioned distally, with respect to the cams 40. In certain embodiments, the fins 37 can engage the jaw 32 at the same time that the cams 40 contact the slider members 50 and 66. In at least one such embodiment, as a result, the slider members 50 and 66 would be moved outwardly at the same time that the second jaw 32 is closed. In either event, the first and third slider members 50 and 66 can be configured to be moved relative to and/or away from the electrode 44, relative to and/or away from a longitudinal axis of the end-effector 16, and/or relative to and/or away from the base 42.
In various embodiments, the base 42 of the first jaw 30 can comprise at least one first guide rail configured to guide the first slider member 50 along a predetermined path. In at least one such embodiment, the first slider member 50 can comprise at least one first channel or guide slot configured to slidably receive the first guide rail therein. In use, the first guide rail and the first guide slot can co-operate to limit the movement of the first slider member 50 such that the first slider member 50 moves laterally when it is displaced. Further to the above, the base 42 of the first jaw 30 can further comprise at least one third guide rail configured to guide the third slider member 66 along a predetermined path. In at least one such embodiment, the third slider member 66 can comprise at least one first channel or guide slot configured to slidably receive the first guide rail therein. In use, the third guide rail and the third guide slot can co-operate to limit the movement of the third slider member 66 such that the third slider member 66 moves laterally when it is displaced.
In various embodiments, as described above, the movable member 36 can comprise a cutting member, or knife edge, 38, for example, which can transect the tissue captured between the first jaw 30 and the second jaw 32 as the movable member 36 is advanced through the end-effector 16. In certain embodiments, further to the above, the knife edge 38 can lag the front, or leading, edge of the fins 37 such that the knife edge 38 may not contact the tissue until the second jaw 32 is in its closed position. In at least one such embodiment, the knife edge 38 may also lag the cams 40 such that the knife edge 38 may not contact the tissue until the slider members 50 and 66 have been displaced laterally. In certain embodiments, a surgical instrument can comprise a cutting member which is movable independently of the movable member 36. In at least one such embodiment, the movable member 36 can comprise fins 37 and cams 40, for example, which can close the second jaw 32 and displace the slider members 50 and 66, respectively, wherein a separate cutting member can be advanced distally at any suitable point during the operation of the instrument. In various embodiments, the surgical instrument can comprise a lock which can be configured to prevent the distal motion of the cutting member until the slider members 50 and 66 have been displaced laterally, for example. Regardless of when the cutting member is advanced to transect the tissue, in various embodiments, the first jaw 30 can also comprise a cutting member slot 60 configured to receive a portion of the cutting member 38 therein.
In one embodiment, referring now to
In various embodiments, the support portion 57 of the second jaw 32 can comprise at least one second guide rail configured to guide the second slider member 52 along a predetermined path. In at least one such embodiment, the second slider member 52 can comprise at least one second channel or guide slot configured to slidably receive the second guide rail therein. In use, the second guide rail and the second guide slot can co-operate to limit the movement of the second slider member 52 such that the second slider member 52 moves laterally when it is displaced. Further to the above, the support portion 57 of the second jaw 32 can further comprise at least one fourth guide rail configured to guide the fourth slider member 68 along a predetermined path. In at least one such embodiment, the fourth slider member 68 can comprise at least one fourth channel or guide slot configured to slidably receive the fourth guide rail therein. In use, the fourth guide rail and the fourth guide slot can co-operate to limit the movement of the fourth slider member 68 such that the fourth slider member 68 moves laterally when it is displaced.
As described above, the cams 40 extending from the movable member 36 can displace the first slider member 50, the second slider member 52, the third slider member 66, and the fourth slider member 68 laterally, or outwardly, away from the longitudinal center of the first jaw 30 and the second jaw 32. In various embodiments, the cams 40 can engage the slider members 50, 52, 66, and 68 simultaneously, or at least substantially simultaneously, and displace the slider members 50, 52, 66, and 68 at the same time. In such embodiments, further to the below, the first slider member 50 and the second slider member 52 can comprise a first pair of slider members which can tension tissue in a first direction and the third slider member 66 and the fourth slider member 68 can comprise a second pair of slider members which can tension tissue in a second direction, which can be opposite the first direction, for example. In at least one such embodiment, the first pair of slider members 50 and 52 and the second pair of slider members 66 and 68 can pull in the tissue in different directions at the same time. In various other embodiments, the slider members 50, 52, 66, and/or 68 can be displaced sequentially. In at least one such embodiment, the first pair of slider members 50 and 52 can be displaced laterally before the second pair of slider members 66 and 68 are displaced laterally, for example. In certain embodiments, the cams 40 can be positioned on the movable member such that the cams 40 that engage the third slider member 66 and the fourth slider member 68 are staggered proximally behind the cams 40 that engage the first slider member 50 and the second slider member 52.
In at least one embodiment, referring to
In one embodiment, again referring to
In one embodiment, temperature measuring devices or sensors, such as thermocouples, RTD's (resistive thermal devices), thermistors, and/or other suitable devices can be embedded at strategic locations within the end-effector 16 to sense the temperature of the tissue positioned within the end-effector 16. In certain embodiments, the delivery of energy to at least one of the electrodes can be controlled in response to feedback from these devices, for example.
In one embodiment, the energy source 11 can deliver energy to the conductive element 46, the electrode 44, the electrode 45, and/or a return conductive element. In various embodiments, the actuation button 26 can be operably engaged with a switch to allow the energy to pass from the energy source 11 to the conductive element 46 and thereby to the electrode 44 when the actuation button 26 is actuated or depressed. In certain embodiments, energy can flow to the electrode 44 until the button 26 is released. In at least one embodiment, the actuation button 26 can allow energy to flow to the electrode 44 for a predetermined suitable period of time regardless of how long the actuation button 26 is depressed by the surgeon. Such a feature can ensure that adequate energy is supplied to the tissue to create a suitable seal in the tissue. In one embodiment, the predetermined suitable period of time can be based on the thickness of the tissue clamped within the end-effector 16.
In one embodiment, the path of the energy can be from the energy source 11, to the conductor 15, through the switch, to the conductive element 46, to the electrode 44, through the tissue clamped within the end-effector 16 (i.e., through the first region of the tissue), through the fuse 33, to the return electrode 45 (e.g., portions of the second jaw 32), through a return conductor, through the conductor 17 and back to the energy source 11, thereby completing the circuit of the energy source 11 with the end-effector 16.
In one embodiment, heat can be generated in the end-effector 16 when electrical energy is provided to the end-effector 16 during the tissue-sealing process. More particularly, owing to the impedance, or resistance, of the tissue positioned intermediate the electrodes 44 and 45 of the end effector 16, heat can be generated within the tissue as the current is flowing therethrough. As discussed above, such heat can denature the collagen within the tissue positioned intermediate the electrodes 44 and 45. In various circumstances, however, the heat can spread from the regions of the tissue being sealed between the electrodes 44 and 45 (i.e., the sealing region) into the tissue surrounding or adjacent to the region of the tissue being sealed (i.e., the surrounding region). Such thermal spreading into the surrounding region may not be desirable in certain circumstances in that the heat can over-denaturate the collagen in, and/or otherwise damage, the surrounding tissue. As a result, in some instances, it may be desirable to tension the surrounding tissue in order to reduce the denaturation thereof. Further to the above, tensioning, or applying tensile stresses or loads to, the tissue in the surrounding region of tissue can decrease, or possibly exponentially decrease, the rate at which the thermal damage to the surrounding tissue can occur. More specifically, tensioning the surrounding tissue can decrease, or possibly exponentially decrease, the amount in which the surrounding tissue shrinks during the sealing process. As such, it may be desirable to tension or apply a mechanical stress or load to the surrounding tissue to reduce the rate at which thermal damage occurs in the surrounding tissue.
In view of the above, referring to
In one embodiment, referring to
In various embodiments, referring to
In one embodiment, further to the above, the movable member 36 can be a cutting member configured to cut the tissue within the first region of the tissue 72. The cutting member can be configured to engage the first jaw 30 and the second jaw 32 when the cutting member is advanced distally within the end-effector 16 to compress and cut or score the first region of the tissue 72. The cutting member can be configured to act against and/or bias the various slider members to move the various slider members relative to, away from, and/or toward the electrode 44. In such an embodiment, the cutting member can comprise cams, similar to cams 40, described above. Other details of the cutting member's engagement with the various slider members can be the same as or similar to the engagement of the movable member 36 with the various slider members described herein.
In one embodiment, referring to
When energy is supplied by the energy source 11 to the electrode 44 on the first jaw 30, the energy can pass through the first region of the tissue 72 and then flow through the fuse 33 to the electrode 45 on the second jaw 32. This passage of energy through the first region of tissue 72 can generate heat within the first region of the tissue 72 which heat can extend toward, to, or beyond the second region of tissue 74 and/or the third region of tissue 76. As such, the heat can also extend into the first non-engaged portion of the tissue 78 and the second non-engaged portion of the tissue 80, for example, and then outwardly therefrom. Tensioning of the first and second non-engaged portions of the tissue 78 and 80 can reduce the spread of thermal damage from the first region of tissue 72 as the rate of thermal damage at a given temperature is reduced in the presence of increased tensile stresses within the tissue. In one embodiment, the tensioning of the first and second non-engaged portions of the tissue 78 and 80 can reduce the spread of thermal damage beyond the second and third regions of tissue 74 and 76, for example.
As described above, referring to
Further to the above, the various slider members of the end-effector 16 can be in their first, unexpanded position prior to the end-effector 16 being closed. When the trigger 24 is retracted to advance the movable member 36 distally within the end-effector 16, the cams 40 can engage and move along the channels 94 and contact the first camming surfaces 90 and the second camming surfaces 92. Through contact with the camming surfaces and the distal movement of the movable member 36, the various slider members can be moved relative to and/or away from the electrodes 44 and 45, relative to and/or away from the longitudinal axis of the end-effector 16, and/or relative to and/or away from the cutting member slots 60 and 60′. Such movement can cause the various slider members to tension the first and second non-engaged portions of the tissue 78 and 80 and reduce the spread of thermal damage outside of the first and second non-engaged portions of tissue 78 and 80. As the cams 40 progress distally within the end-effector 16, they can engage the cam tracks 96 to maintain the various slider members in the second, expanded position (i.e., the tensioned position). In various circumstances, the biasing members 56 and 56′ can limit the displacement of the slider members to assure that the slider members are not over-extended, or moved too far away from the first region of tissue 72, as the over tensioning of the tissue could possibly tear the first and second non-engaged portions of the tissue 78 and 80, for example.
In at least one embodiment, after the movable member 36 has been sufficiently advanced and the first region of tissue 72 has been sufficient sealed and incised, a release button (not illustrated) on the handle portion 22 can be depressed to allow the movable member 36 to move proximally with respect to the end-effector 16. While the movable member 36 is being moved proximally, the cams 40 can move proximally along the cam tracks 96 of the various slider members until the cams 40 are sufficiently disengaged from the first camming surfaces 90 and the second camming surfaces 92. Thereafter, the biasing member 56 of the first jaw 30 can pull the first slider member 50 and the third slider member 66 inwardly toward one another and, similarly, the biasing member 56′ of the second jaw 32 can pull the second slider member 52 and the fourth slider member 68 inwardly toward one another. In such circumstances, the various slider members can move relative to and/or toward the electrodes 44 and 45 and/or relative to and/or toward the longitudinal axis of the end-effector 16 and return the slider members to their first, or unexpanded, position (see e.g.,
In certain alternative embodiments, further to the above, only the first and second slider members 50 and 52 may be movable relative to and/or away from the electrode 44 such that only the first non-engaged portion 78 is tensioned upon the distal movement of the movable member 36 within the end-effector 16. In such an embodiment, the end-effector may not comprise the third and fourth slider members 66 and 68, but instead, the end-effector may comprise third and fourth fixed members. In other embodiments, the cams 40 may not be provided on one side of the movable member 36 such that the third and fourth slider members 66 and 68 are not moved into their second, expanded position upon distal movement of the movable member 36 within the end-effector 16. In other embodiments, only the third and fourth slider members 66 and 68 may be movable relative to, away from, and/or toward the electrode 44 to tension the second non-engaged portion of tissue 80.
In one embodiment, referring to
In one embodiment, although not illustrated, the end-effector 16 can be configured to deploy staples and/or other permanent fasteners, for example, into the first region of the tissue 72 and/or any other suitable region of tissue. It is also conceived that these fasteners may be made of an absorbable or dissolvable material such as Vicryl and/or iron, for example. Other materials could include PDS, PLA, and/or any other suitable polymer and/or magnesium and/or any other suitable metal, for example. In various embodiments, the movable member 36 can comprise a staple driver on a distal end or portion thereof, for example. The first jaw 30 can be configured to receive a staple cartridge comprising one or more staples or rows of staples and the second jaw 32 can comprise one or more anvil pockets or rows of anvil pockets configured to receive the legs of one or more staples therein to deform the staples as they are deployed. The anvil pockets can be aligned with staple cavities in the staple cartridge such that the staple legs can be deformed when the staples are deployed from the staple cartridge. In one embodiment, the staples can be fired or deployed from the staple cartridge using the staple driver. In various embodiments, the staple driver can be energized by the energy source 11, or another energy source such that, when the staple driver contacts the one or more staples, the staples can be energized to form a seal in the tissue where the staple legs puncture the tissue. In such an embodiment, the staples and the staple driver can comprise electrically conductive materials. In various embodiments, the electrode 45 on the second jaw 32 can act as the return electrode such that energy can flow from the staples, through the fuse 33, to the electrode 45 and then be returned to the energy source 11.
In various embodiments, the cutting member 38 and/or portions of the movable member 36 can be energized by the energy source 11, for example, such that as the cutting member 36 cuts the first region of tissue 72, as described above, a seal can be created at the edges of the cut line. Here, the energy from the cutting member 38 can pass through the tissue, to the fuse 33, to the electrode 45, and back to the energy source 11. In various embodiments, as described above, the flow of current through the tissue can be controlled by the actuator button 26 which can be actuated before, during, and/or after the tissue is tensioned as described herein.
As discussed above, a surgical instrument can comprise an end effector which can be configured to clamp and compress tissue captured within the end effector and then spread or stretch the tissue laterally in order to create tension within the tissue outside the desired region to be sealed. As also discussed above, creating tension within the tissue can reduce the rate at which thermal damage occurs, for example, through the tensioned tissue and, as a result, the spread of thermal tissue damage can be controlled. In various embodiments, a surgical instrument can comprise an end effector configured to stretch the tissue captured therein in any suitable direction. Referring now to
Referring now to
Further to the above, the surgical instrument can be operated through a series of stages between an open, unfired configuration (
Referring again to
In various embodiments, further to the above, portions of the first jaw 100 and the second jaw 102 can extend from the shaft frame 110 and, thus, when the shaft frame 110 is moved distally, such portions of the first jaw 100 and the second jaw 102 can be moved distally as well. Correspondingly, when the shaft frame 110 is not advanced distally, such portions of the first jaw 100 and the second jaw 102 can be held in position. Comparing
Referring to
Further to the above, referring to
Once the detent lock holding the shaft frame 110 to the handle frame 126 has been depressed, or deactivated, in various circumstances, the firing member 130, the movable member 136, and the shaft frame 110 can be advanced distally together, as illustrated in
Similar to the above, the second jaw 102 can comprise a portion thereof which is mounted to the shaft frame 110 and advanced distally when the shaft frame 110 is advanced distally. In various embodiments, referring again to
As discussed above, the longitudinal displacement of various portions of the first jaw 100 and the second jaw 102 can create tension within the tissue. To create such tension, in various circumstances, a portion of the jaws 100 and 102 can compress and hold a portion of the tissue in a stationary, or at least substantially stationary, position while, at the same time, a different portion of the jaws 100 and 102 can compress and pull another portion of the tissue distally, for example. In various embodiments, referring to
As described above, the longitudinal stretching of the tissue can occur as the drive member 130, the movable member 136, and the shaft frame 110 are displaced distally together. As the reader will note when comparing
In order to permit the firing member 130 and the movable member 136 to be advanced distally relative to the shaft frame 110, as described above, the detent member 132 can abut the distal end 117 of the slot 113 and, in response to the longitudinal force applied the firing member 130 by the firing trigger 124, the detent member 132 can be depressed inwardly into the guide slot 133 defined in the firing member 130. In such circumstances, the detent member 132 can slide out of the longitudinal detent slot 113 and slide relative to the shaft frame 110. In at least one such embodiment, the detent member 132 can comprise an inclined, conical, and/or curved surface, for example, which can be configured to bias the detent member 132 into the guide slot 133 when the detent member 132 abuts the distal end 117 of the longitudinal slot 133. As the detent member 132 is biased inwardly, the detent member 132 can compress the spring 131 positioned intermediate the detent member 132 and a base of the guide slot 133. Once the detent has been deactivated, the firing trigger 124 can be moved toward the handle portion 122 until the firing trigger 124 has reached its fully-retracted, fully-fired position. The reader will note from the above that the longitudinal force applied to the firing member by the trigger 124 can deactivate detent 128 and 132. Thus, springs 121 and 131, respectively, must be carefully selected such that detent 128 is deactivated before detent 132. In at least one such embodiment, the spring 131 can comprise a higher spring stiffness than the spring 121, for example. This order of release may also be accomplished by adjusting the amount of interference within each detent.
The full retraction of the firing member can advance the movable member 136 distally until the distal end of the movable member 136 has reached the distal end of the slots 160 and 160′ defined in the jaws 100 and 102, as illustrated in
When the firing trigger 124 is released, further to the above, the firing trigger 124 can be rotated forward, or away from the handle portion 122. In such circumstances, the top portion of the firing trigger 124 can be rotated proximally and, owing to the operative engagement between the top portion of the firing trigger 124 and the firing member 130, the firing member 130 can be retracted proximally as well. The retraction motion applied to the firing member 130 can be transmitted to the movable member 136 such that the firing member 130 and the movable member 136 can be retracted together. As movable member 136 is retracted, the fins 37 of the movable member can be disengaged from the first jaw 100 and the second jaw 102 which can allow the second jaw 102 to be re-opened to release the tissue. In at least one such embodiment, a jaw spring can be configured to bias the second jaw 102 into an open configuration. At some point during the retraction of firing member 130, the detent member 132 can be realigned with the longitudinal detent slot 113 defined in the shaft frame 110. In such circumstances, the detent spring 131 can bias the detent member 132 into the detent slot 113 wherein further retraction of the firing member 130 can position the detent member 132 against the proximal wall 115 of the detent slot 113. Similar to the above, the detent member 132 can transmit a longitudinal force between the firing member 130 and the shaft frame 110 such that the firing member 130 can drive the shaft frame 110 proximally as the firing member 130 is retracted. When the shaft frame 110 is moved proximally, the first jaw frame 150 and the second jaw frame 151 can be retracted proximally to their unextended positions and, at some point during the retraction of shaft frame 110, the detent member 128 can be realigned with the lock notch 123 defined in the handle frame 126. In such circumstances, the detent spring 121 can bias the detent member 128 into the lock notch 123 and complete the resetting process of the surgical instrument.
Referring again to
Referring now to
Once the tissue region has been compressed between the electrodes 244 and 245 and the tissue regions 274 and 276 have been compressed between the clamping portions 290 and 292 and the clamping portions 296 and 298, respectively, the electrodes 244 and 245 can be moved distally with respect to the first jaw frame 250 and the second jaw frame 251, as illustrated in
In various embodiments, referring now to
While the present disclosure has been illustrated by description of several example embodiments and while the example embodiments have been described in considerable detail, it is not the intention of the applicants to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications may be readily apparent to those of skill in the art. Furthermore, although the example embodiments disclosed herein have been described in connection with a surgical instrument, other embodiments are envisioned in connection with any suitable medical device. While this disclosure has been described as having exemplary designs, the disclosure may be further modified within the spirit and scope of the disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the disclosure using its general principles. Further, this disclosure is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this disclosure pertains.
The various embodiments of the present disclosure have been described above in connection with cutting-type surgical instruments. It should be noted, however, that in other embodiments, the surgical instruments disclosed herein need not be a cutting-type surgical instrument. For example, it could be a non-cutting endoscopic instrument, a grasper, a stapler, a clip applier, an access device, a drug/gene therapy delivery device, an energy device using ultrasound, RF, laser, etc. In certain embodiments, an ultrasonic instrument can be utilized in accordance with the embodiments disclosed herein. In one such embodiment, an ultrasonic instrument can comprise a first portion comprising a handle portion and/or end effector, for example, and a second portion comprising radiation-sensitive electronics. Various ultrasonic instruments are disclosed in U.S. Pat. No. 6,063,098, entitled ARTICULATABLE ULTRASONIC SURGICAL APPARATUS, which issued on May 16, 2000, the entire disclosure of which is hereby incorporated by reference in its entirety. Although the present disclosure has been described herein in connection with certain disclosed embodiments, many modifications and variations to those embodiments may be implemented. For example, different types of end effectors may be employed. Also, where materials are disclosed for certain components, other materials may be used. The foregoing description and following claims are intended to cover all such modification and variations.
The disclosures of the following references are also incorporated by reference herein in their entireties:
Heat-induced changes in the mechanics of a collagenous tissue: Isothermal free-shrinkage. Chen, S. S., Wright, N. T., Humphrey, J. D., 1997. ASME Journal of Biomechanical Engineering 119, 372-378.
Heat-induced changes in the mechanics of a collagenous tissue: Pseudoelastic behavior at 37° C. Chen, S. S., Humphrey, J. D., 1998. Journal of Biomechanics 31, 211-216.
Phenomenological evolution equations for heat-induced shrinkage of a collagenous tissue. Chen, S. S., Wright, N. T., Humphrey, J. D., 1998b. IEEE Transactions on Biomedical Engineering 45, 1234-1240.
Time-Temperature Equivalence of Heat-Induced Changes in Cells and Proteins. Wright, N. T., Chen, S. S., Humphrey, J. D., 1998. ASME Journal of Biomechanical Engineering 120, 22-26.
Altered mechanical behavior of epicardium under isothermal biaxial loading. Wells P. B., Harris J. L., Humphrey J. D. J Biomech. Eng. 2004 August; 126(4):492-7.
Altered mechanical behavior of epicardium due to isothermal heating under biaxial isotonic loads. Harris J. L., Wells P. B., Humphrey J. D. Biomech. Eng. 2003 June; 125(3):381-8.
Rate of shrinkage of tendon collagen—heat, entropy and free energy of activation of the shrinkage of untreated tendon. Effect of acid salt, pickle, and tannage on the activation of tendon collagen. Weir, C. E., 1949. Journal of the American Leather Chemists Association 44, 108-140.
Reversible and irreversible denaturation of collagen fibers. Hormann, H., Schlebusch, H., 1971. Biochemistry 10, 932-937.
Studies in thermal injury V. The predictability and the significance of thermally induced rate processes leading to irreversible epidermal injury. Henriques, F. C., 1947. Archives of Pathology 43, 489-502.
Thermal modification of collagen. Wall, M. S.; Deng, X. H.; Torzilli, P. A.; Doty, S. B.; O'Brien, S. J.; Warren, R. F.; 1999. J. Shoulder Elbow Surg. 1999; 8:339-344.
Thermally induced shrinkage of joint capsule. Moran, K.; Anderson, P.; Hutcheson, J.; Flock, S.; 2000. Clinical Orthopaedics and Related Research; 381:248-255.
A multi-sample denaturation temperature tester for collagenous biomaterials. Lee, J. M., Pereira, C. A., Abdulla, D., Naimark, W. A., Crawford, I., 1995. Med. Eng. Phys. 1995; 17:115-121.
The effect of thermal heating on the length and histologic properties of the glenohumeral joint capsule. Hayashi, K., Thabit, III, G., Massa, K. L., Bogdanske, J. J., Cooley, A. J., Orwin, J. F., Markel, M. D., 1997. American Journal of Sports Medicine Vol. 25; 1:107-112.
Thermal modification of connective tissues: Basic science considerations and clinical implications. Arnoczky, S. P., Aksan, A., 2000. Journal of the American Academy of Orthopaedic Surgeons 2000; 8:305-313.
The surgical instruments disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the surgical instruments can be reconditioned for reuse after at least one use. Reconditioning can comprise any combination of the steps of disassembly of the surgical instruments, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the surgical instruments can be disassembled, and any number of the particular pieces or parts of the surgical instruments can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the surgical instruments can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a surgical instrument can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned surgical instrument, are all within the scope of the present disclosure.
Although the various embodiments of the devices have been described herein in connection with certain disclosed embodiments, many modifications and variations to those embodiments may be implemented. For example, different types of end effectors may be employed. Also, where materials are disclosed for certain components, other materials may be used. Furthermore, according to various embodiments, a single component may be replaced by multiple components, and multiple components may be replaced by a single component, to perform a given function or functions. The foregoing description and following claims are intended to cover all such modification and variations.
Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated materials does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
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