|Publication number||US20070191713 A1|
|Application number||US 11/548,407|
|Publication date||Aug 16, 2007|
|Filing date||Oct 11, 2006|
|Priority date||Oct 14, 2005|
|Also published as||CA2625793A1, CN101511286A, CN101511286B, EP1948026A2, EP1948026A4, US20100094323, US20120078249, US20140207163, WO2007047380A2, WO2007047380A3|
|Publication number||11548407, 548407, US 2007/0191713 A1, US 2007/191713 A1, US 20070191713 A1, US 20070191713A1, US 2007191713 A1, US 2007191713A1, US-A1-20070191713, US-A1-2007191713, US2007/0191713A1, US2007/191713A1, US20070191713 A1, US20070191713A1, US2007191713 A1, US2007191713A1|
|Inventors||Stephen Eichmann, Karen Isaacs, Kenneth Kramer, Michael Lamping, Ashvani Madan, Matthew Miller, Aaron Voegele, Eitan Wiener, Joseph Young|
|Original Assignee||Eichmann Stephen E, Isaacs Karen K, Kramer Kenneth S, Lamping Michael R, Madan Ashvani K, Miller Matthew C, Voegele Aaron C, Wiener Eitan T, Young Joseph E|
|Export Citation||BiBTeX, EndNote, RefMan|
|Referenced by (52), Classifications (14), Legal Events (1)|
|External Links: USPTO, USPTO Assignment, Espacenet|
The present application claims the priority benefit of U.S. provisional patent application Ser. No. 60/726,625, filed on Oct. 14, 2005.
The present invention generally relates to ultrasonic surgical systems and, more particularly, to an ultrasonic device that is optimized to allow surgeons to perform cutting, coagulation, and fine dissection required in fine and delicate surgical procedures such as a thyroidectomy.
Ultrasonic surgical instruments are finding increasingly widespread applications in surgical procedures by virtue of the unique performance characteristics of such instruments. Depending upon specific instrument configurations and operational parameters, ultrasonic surgical instruments can provide substantially simultaneous cutting of tissue and homeostasis by coagulation, desirably minimizing patient trauma. The cutting action is typically effected by an end-effector at the distal end of the instrument, which transmits ultrasonic energy to tissue brought into contact with the end-effector. Ultrasonic instruments of this nature can be configured for open surgical use, laparoscopic or endoscopic surgical procedures including robotic-assisted procedures.
Ultrasonic surgical instruments have been developed that include a clamp mechanism to press tissue against the blade of the end-effector in order to couple ultrasonic energy to the tissue of a patient. Such an arrangement (sometimes referred to as a clamp coagulator shears or an ultrasonic transector) is disclosed in U.S. Pat. Nos. 5,322,055; 5,873,873 and 6,325,811. The surgeon activates the clamp arm to press the clamp pad against the blade by squeezing on the handgrip or handle.
Some current designs of clamp coagulator shears utilize a foot pedal to energize the surgical instrument. The surgeon operates the foot pedal while simultaneously applying pressure to the handle to press tissue between the jaw and blade to activate a generator that provides energy that is transmitted to the cutting blade for cutting and coagulating tissue. Key drawbacks with this type of instrument activation include the loss of focus on the surgical field while the surgeon searches for the foot pedal, the foot pedal getting in the way of the surgeon's movement during a procedure and surgeon leg fatigue during long cases.
Various methods have been disclosed for curved end effector balancing, which include repositioning the mass along the end effector. The drawbacks of such methods are i) high stresses in the curved region, which makes the end effector more prone to fracture if it comes in contact with metal during surgery; ii) a shorter active length, which limits the vessel size that can be operated on, (the active length is defined as the length from the distal end of the blade to where the displacement is one half of the displacement at its distal end); and/or iii) the inability to separately balance orthogonal displacements.
Some current designs of clamp coagulator shears. utilize handles that are either of a pistol or scissors grips design. The scissor grip designs may have one thumb or finger grip that is immovable and fixed to the housing and one movable thumb or finger grip. This type of grip may not be entirely familiar to surgeons who use other open-type surgical instruments, such as hemostats, where both thumb and finger grips move in opposition to one another. Current designs have scissor arms that rotate around a fixed pivot or rotation point that is perpendicular to the longitudinal axis of the working element. This approach is limited since the relative motion between the two arms is completely rotational. This feature limits the ability to control the pressure profile between the two working ends when fully closed.
Some current designs of clamp coagulator shears are not specifically designed for delicate procedures where precise dissection, cutting and coagulation are required. An exemplary procedure is a thyroidectomy where precise dissection, cutting and coagulation is required to avoid critical blood vessels and nerve bundles.
It would be desirable to provide an ultrasonic surgical instrument that overcomes some of the deficiencies of current instruments. The ultrasonic surgical instrument described herein overcomes those deficiencies.
An ultrasonic clamp coagulator assembly embodying the principles of the present invention is configured to permit selective dissection, cutting, coagulation and clamping of tissue during surgical procedures.
A first expression of a first embodiment of the invention is for an ultrasonic waveguide including an ultrasonically actuated blade attached to the distal end of the waveguide; a tissue pad having a tissue engaging surface having a first width and a second width less than the first width; and a clamp member defining a distal portion and a proximal portion and moveable with respect to the blade and having an open position in which at least a portion of the clamp member is spaced from the blade and a closed position in which the clamp member is adjacent to the blade for clamping tissue between the tissue pad and the blade.
A second expression of a first embodiment includes a clamp member defining a first dimension and a second dimension in a first plane and the first dimension is greater than the second dimension and further defining a first dimension and a second dimension in a second plane and the first dimension is greater than the second dimension.
A first expression of a third embodiment includes a method of assembling a sterilized ultrasonic clamp coagulator apparatus including the steps of providing an ultrasonic waveguide having a proximal end and a distal end and an ultrasonically actuated blade attached to the distal end of the waveguide; a tissue pad having a flange and a tissue engaging surface having a first width and a second width less than the first width; a clamp member moveable with respect to said end-effector and having an open position in which at least a portion of the clamp member is spaced from the blade and a closed position in which the clamp member is adjacent to the blade for clamping tissue between the tissue pad and the blade, and where the clamp member includes a slot for slidably receiving the flange and slidably engaging the flange within the slot and then sterilizing the clamp coagulator apparatus.
A first expression of a fourth embodiment of an ultrasonic surgical instrument is for a housing configured to accept a transducer and further defining a longitudinal axis; a first switch positioned on the housing for actuation by one or more fingers of a user in a direction parallel to the longitudinal axis and further electrically connected to a generator for providing an electrical signal to the generator for controlling a first level of ultrasonic energy delivered by the transducer.
A second expression of a fourth embodiment of an ultrasonic surgical instrument is for a second switch positioned on the housing for actuation by one or more fingers of a user in a direction parallel to the longitudinal axis and further electrically connected to a generator for providing an electrical signal to the generator for controlling a second level of ultrasonic energy delivered by the transducer.
A first expression of a fifth embodiment of an ultrasonic surgical instrument is for an ultrasonic waveguide defining a longitudinal axis, having a proximal end, a most distal node and a distal end and an ultrasonically actuated blade positioned at the distal end of the waveguide and which defines a functional asymmetry within a first plane, a first balance asymmetry distal to the most distal node and proximal to the blade; and a second balance asymmetry proximal to the most distal node.
A first expression of a sixth embodiment of an ultrasonic surgical instrument is for a housing, an outer shroud having a proximal end joined to the housing, an ultrasonic waveguide positioned within the outer tube, an ultrasonically actuated blade positioned at the distal end of the waveguide, and an actuating lever for operating a clamp arm located at the distal end of the lever. The actuating lever has camming members, which operatively engage the outer tube such that movement of the actuating lever positions the clamp arm between open and clamped positions relative to the blade.
A second expression of a sixth embodiment of an ultrasonic instrument is for stationary finger ring that defines an opening having a length L and the housing and a transducer are sized to position a center of gravity of the surgical instrument at the housing within the dimension of length L.
A first expression of a first embodiment of a torque wrench for use with an ultrasonic clamp coagulator apparatus is for a hand wrench body, a cantilever arm movably attached to said wrench body, at least one tooth located at the cantilever arm's distal end, and an adaptor rotatably attached to the hand wrench and comprising a cam for operatively engaging the tooth.
The novel features of the invention are set forth with particularity in the appended claims. The invention itself, however, both as to organization and methods of operation, may best be understood by reference to the following description, taken in conjunction with the accompanying drawings in which:
Before explaining the present invention in detail, it should be noted that the invention is not limited in its application or use to the details of construction and arrangement of parts illustrated in the accompanying drawings and description. The illustrative embodiments of the invention may be implemented or incorporated in other embodiments, variations and modifications, and may be practiced or carried out in various ways. Further, unless otherwise indicated, the terms and expressions employed herein have been chosen for the purpose of describing the illustrative embodiments of the present invention for the convenience of the reader and are not for the purpose of limiting the invention.
Further, it is understood that any one or more of the following-described embodiments, expressions of embodiments, examples, etc. can be combined with any one or more of the other following-described embodiments, expressions of embodiments, examples, etc.
The present invention is particularly directed to an improved ultrasonic surgical clamp coagulator apparatus which is configured for effecting tissue cutting, coagulation, and/or clamping during surgical procedures, including delicate surgical procedures, such as a thyroidectomy. The present apparatus is configured for use in open surgical procedures. Versatile use is facilitated by selective use of ultrasonic energy. When ultrasonic components of the apparatus are inactive, tissue can be readily gripped and manipulated, as desired, without tissue cutting or damage. When the ultrasonic components are activated, the apparatus permits tissue to be gripped for coupling with the ultrasonic energy to effect tissue coagulation, with application of increased pressure efficiently effecting tissue cutting and coagulation. If desired, ultrasonic energy can be applied to tissue without use of the clamping mechanism of the apparatus by appropriate manipulation of the ultrasonic blade.
As will become apparent from the following description, the present clamp coagulator apparatus is particularly configured for disposable use by virtue of its straightforward construction. As such, it is contemplated that the apparatus be used in association with an ultrasonic generator unit of a surgical system, whereby ultrasonic energy from the generator unit provides the desired ultrasonic actuation for the present clamp coagulator apparatus. It will be appreciated that a clamp coagulator apparatus embodying the principles of the present invention can be configured for non-disposable or multiple use, and non-detachably integrated with an associated ultrasonic generator unit. However, detachable connection of the present clamp coagulator apparatus with an associated ultrasonic generator u nit is presently preferred for single-patient use of the apparatus.
With specific reference now to
Ultrasonic transducer 50, and an ultrasonic waveguide 80 together provide an acoustic assembly of the present surgical system 19, with the acoustic assembly providing ultrasonic energy for surgical procedures when powered by generator 30. The acoustic assembly of surgical instrument 100 generally includes a first acoustic portion and a second acoustic portion. In the present embodiment, the first acoustic portion comprises the ultrasonically active portions of ultrasonic transducer 50, and the second acoustic portion comprises the ultrasonically active portions of transmission assembly 71. Further, in the present embodiment, the distal end of the first acoustic portion is operatively coupled to the proximal end of the second acoustic portion by, for example, a threaded connection.
The ultrasonic surgical instrument 100 includes a multi-piece handle assembly 68 adapted to isolate the operator from the vibrations of the acoustic assembly contained within transducer 50. The handle assembly 68 can be shaped to be held by a user in a conventional mariner, but it is contemplated that the present ultrasonic surgical instrument 100 principally be grasped and manipulated in a scissor-like arrangement provided by a handle assembly of the instrument, as will be described. While multi-piece handle assembly 68 is illustrated, the handle assembly 68 may comprise a single or unitary component. The proximal end of the ultrasonic surgical instrument 100 receives and is fitted to the distal end of the ultrasonic transducer 50 by insertion of the transducer into the handle assembly 68. The ultrasonic surgical instrument 100 may be attached to and removed from the ultrasonic transducer 50 as a unit. The ultrasonic surgical instrument 100 may include a handle assembly 68, comprising mating housing portions 69 and 70 and an ultrasonic transmission assembly 71. The elongated transmission assembly 71 of the ultrasonic surgical instrument 100 extends orthogonally from the instrument handle assembly 68.
The handle assembly 68 may be constructed from a durable plastic, such as polycarbonate or a liquid crystal polymer. It is also contemplated that the handle assembly 68 may alternatively be made from a variety of materials including other plastics, ceramics or metals. Traditional unfilled thermoplastics, however, have a thermal conductivity of only about 0.20 W/m° K. (Watt/meter-° Kelvin). In order to improve heat dissipation from the instrument, the handle assembly may be constructed from heat conducting thermoplastics, such as high heat resistant resins liquid crystal polymer (LCP), Polyphenylene Sulfide (PPS), Polyetheretherketone (PEEK) and Polysulfone having thermal conductivity in the range of 20-100 W/m° K. PEEK resin is a thermoplastics filled with aluminum nitride or boron nitride, which are not electrically conductive. The thermally conductive resin helps to manage the heat within smaller instruments.
The transmission assembly 71 includes a waveguide 80 and a blade 79. It will be noted that, in some applications, the transmission assembly is sometimes referred to as a “blade assembly”. The waveguide 80, which is adapted to transmit ultrasonic energy from transducer 50 to the tip of blade 79 may be flexible, semi-flexible or rigid. The waveguide 80 may also be configured to amplify the mechanical vibrations transmitted through the waveguide 80 to the blade 79 as is well known in the art. The waveguide 80 may further have features to control the gain of the longitudinal vibration along the waveguide 80 and features to tune the waveguide 80 to the resonant frequency of the system. In particular, waveguide 80 may have any suitable cross-sectional dimension. For example, the waveguide 80 may have a substantially uniform cross-section or the waveguide 80 may be tapered at various sections or may be tapered along its entire length.
Ultrasonic waveguide 80 may, for example, have a length substantially equal to an integral number of one-half system wavelengths (nλ/2). The ultrasonic waveguide 80 and blade 79 may be preferably fabricated from a solid core shaft constructed out of material, which propagates ultrasonic energy efficiently, such as titanium alloy (i.e., Ti-6Al-4V), aluminum alloys, sapphire, stainless steel or any other acoustically compatible material.
Ultrasonic waveguide 80 may further include at least one radial hole or aperture 66 extending therethrough, substantially perpendicular to the longitudinal axis of the waveguide 80. The aperture 66, which may be positioned at a node, is configured to receive a connector pin 27, discussed below, which connects the waveguide 80, to the handle assembly 70.
Blade 79 may be integral with the waveguide 80 and formed as a single unit. In an alternate expression of the current embodiment, blade 79 may be connected by a threaded connection, a welded joint, or other coupling mechanisms. The distal end of the blade 79 is disposed near an anti-node 85 in order to tune the acoustic assembly to a preferred resonant frequency fo when the acoustic assembly is not loaded by tissue. When ultrasonic transducer 50 is energized, the distal end of blade 79 or blade tip 79 a is configured to move substantially longitudinally (along the x axis) in the range of, for example, approximately 10 to 500 microns peak-to-peak, and preferably in the range of about 20 to about 200 microns at a predetermined vibrational frequency fo of, for example, 55,500 Hz. Blade tip 79 a also preferably vibrates in the y axis at about 1 to about 10 percent of the motion in the x axis.
The blade tip 79 a provides a functional asymmetry or curved portion for improved visibility at the blade tip so that a surgeon can verify that the blade 79 extends across the structure being cut or coagulated. This is especially important in verifying margins for large blood vessels. The geometry also provides for improved tissue access by more closely replicating the curvature of biological structures. Blade 79 provides a multitude of edges and surfaces, designed to provide a multitude of tissue effects: clamped coagulation, clamped cutting, grasping, back-cutting, dissection, spot coagulation, tip penetration and tip scoring.
Blade tip 79 a is commonly referred to as a functional asymmetry. That is, the blade (functionally, the blade provides a multitude of tissue effects) lies outside the longitudinal axis of waveguide 80 (that is, asymmetrical with the longitudinal axis), and accordingly creates an imbalance in the ultrasonic waveguide. If the imbalance is not corrected, then undesirable heat, noise, and compromised tissue effect occur.
It is possible to minimize unwanted tip excursion in the y and z axes, and therefore maximize efficiency with improved tissue effect, by providing one or more balance asymmetries or balancing features proximal to the blade functional asymmetry.
Referring now to FIGS. 3A-G, transmission assembly 71 includes one or more balancing features placed at blade 79, at a position proximal and/or distal to the distal most node 84. In addition, the balancing features at the waveguide 80 are shaped to balance the two orthogonal modes in the y and z axes, separately. The size and shape and location of the balance features allow flexibility to reduce stress at the blade 79, make the active length longer and separately balance the two orthogonal modes.
FIGS. 3A-B show a single balance cut 82 at the waveguide 80 distal to node 84. In this embodiment balance cut 82 has side walls perpendicular to the longitudinal axis of waveguide 80 and the bottom cut is parallel to the longitudinal axis of waveguide 80. In this embodiment the high stresses experienced during operation are localized at the balancing cut 82, which is away from the more sensitive curved region at the blade 79.
FIGS. 3E-F show two balancing features 82 and 82 d, distal and proximal to the node 84. The side walls of balance feature 82 d are angled with respect to each other in the x-z plane and provide for individual balancing of the bending mode in the y direction. The angled side walls define an, included angle ? of between 1° and about 90°, preferably between about 15° and about 25°, and more preferably between about 19° and about 21°. The weight removed at each balance feature is a function of multiple parameters including the radius of curvature at blade tip 79 a and the desired level of removal of the overlapping bending modes in the y and z direction. In an illustrative example, the balance cut 82 represents a weight reduction of about 0.003 to about 0.004 oz., and most preferably about 0.0034 oz. The balance cut 82 d represents a weight reduction of about 0.004 to about 0.005 oz., and most preferably about 0.0043 oz.
As would be apparent to one skilled in the art, any combination of balance cuts 82 through 82 e are possible to provide balancing of a waveguide and curved blade.
Referring back to
Referring now to FIGS. 6A-D and 7A-B, blade 79 is curved along with the associated clamp member 56. This is illustrative only, and blade 79 and a corresponding clamp member 56 may be of any shape as is known to the skilled artisan. One benefit of the invention, however, is the ability to perform finer, more delicate surgical procedures. It is also multifunctional and able to dissect tissue as well as coagulate and transect.
The ability to finely dissect is enabled primarily by the tapering of the end effector 81. The end effector is tapered in two planes, which mimics typical hemostats. This allows the user to create windows in the tissue and then spread the tissue apart more easily. The blade 79 and clamp member 56 are tapered in both the x and z directions from the proximal end to the distal end. The pad 58 is only tapered in the Z direction. That is, the clamp pad 58 has a constant thickness, but the width of the clamp pad 58 at the distal end is less than the width at the proximal end. Accordingly, the surface area of section A is greater than the surface area of section B.
In addition to the taper, the radius at the distal end of the blade 79 and clamp member 56 also promotes fine dissection. The radius at the tip of the clamp member 56 is approximately 0.040 inches, and the blade radius is approximately 0.045 inches.
With specific reference to
In a third expression of blade 79,
Referring back to
Referring now to
Referring to FIGS. 10A-C, in a first expression of an alternate embodiment, clamp pad 58 consists of a first tissue pad 58 b and a second pad portion 58 a, which may be an insert within pad 58 b. Tissue pad 58 b may comprise a tissue engaging surface having saw tooth-like teeth and proximal portion 58 a may have a smoother surface relative to pad 58 b. The advantage of two separate components 58 a and 58 b is that each pad may be constructed from different materials. For example, having a two-piece tissue pad allows the use of a very lubricious material at the distal end that is not particularly resistant to high temperatures compared to a very high temperature material at the proximal end that is not particularly lubricious because the proximal end is an area of lower amplitude. Such a configuration matches the tissue pad materials to the amplitude of the blade 79.
In a second expression of an alternate embodiment of the present invention, clamp pad 58 b is formed from TEFLONŽ or any other suitable low-friction material. Clamp pad 58 a is formed from a base material and at least one filler material, which is a different material from the base material. The surface of proximal clamp pad 58 a may be smoother than distal clamp pad 58 b, or proximal clamp pad 58 a may also have a similar type saw-tooth configuration.
Several benefits and advantages are obtained from one or more of the expressions of the invention. Having a tissue pad with a base material and at-least-one filler material allows the base material and the at-least-one filler material to be chosen with a different hardness, stiffness, lubricity, dynamic coefficient of friction, heat transfer coefficient, abradability, heat deflection temperature, glass transition temperature and/or melt temperature to improve the wearability of the tissue pad, which is important when high clamping forces are employed because tissue pads wear faster at higher clamping forces than at lower clamping forces. In experiments, a 15% graphite-filled polytetrafluoroethylene tissue pad showed substantially the same wear with a 7 pound clamping force as a 100% polytetrafluoroethylene tissue pad showed with a 1.5 pound clamping force. Having a flexible clamping arm and/or a flexible tissue pad should also improve the wearability of the tissue pad due to the ability of the flexible member to more evenly distribute the load across the entire surface of the tissue pad. Further benefits and expressions of this embodiment are disclosed in U.S. provisional patent application, Ser. No. 60/548,301, filed on Feb. 27, 2004 and commonly assigned to the assignee of the present application.
In a third expression of an alternate embodiment, a tissue pad with a base material and at least two filler materials allows the base material and the at-least-two filler materials to be chosen with a different hardness, stiffness, lubricity, dynamic coefficient of friction, heat transfer coefficient, abradability, heat deflection temperature, and/or melt temperature to improve the wearability of the tissue pad, which is important when high clamping forces are employed because tissue pads wear faster at higher clamping forces than at lower clamping forces. In experiments, a 15% graphite-filled, 30% PTFE-filled polyimide tissue pad showed substantially the same or better wear with a 4.5 pound clamping force as a 100% polytetrafluoroethylene tissue pad showed with a 1.5 pound clamping force. The advantage of a 15% graphite-filled, 30% PTFE-filled polyimide tissue pad is increased heat resistance, which improves the overall wear resistance of the tissue pad. This polyimide-composite clamp pad has a useful heat resistance up about 800° F. to about 1200° F., as compared to a useful heat resistance up to about 660° F. of a PTFE clamp pad. Alternatively, Other materials are also useful for a portion of the tissue pad, such as ceramics, metals, glasses and graphite.
FIGS. 10A-C disclose a first expression of an embodiment of attaching a two part clamp pad 58 a-b to a clamp member 56. In
FIGS. 11A-E illustrate a second expression of attaching a clamp pad 58 c to a clamp arm 56 c. Clamp pad 58 c comprises one or more protrusions 62 for insertion into one or more corresponding apertures 63 in clamp arm 56 c. If a second or more clamp pad(s) 58 d is also used in accordance with the previous discussion, then clamp pad 58 c further comprises corresponding aperture 61 for accepting one or more clamp pad(s) 58 d. Clamp arm 56 c has corresponding aperture(s) 63 for accepting protrusions 62, as well as a corresponding cavity 64 for accepting the one or more clamp pad 58 d.
FIGS. 12A-C illustrate a third expression of attaching a clamp pad 58 d to a clamp arm 56 d. In addition to a T-shaped flange 55, clamp pad 58 d further comprises a hook-like protrusion or clip 65 for attaching to a corresponding opening 66 at the distal tip of clamp arm 56 d. In this expression, the distal tip of clamp arm 56 d is open and the clamp pad 58 d is inserted from the distal to proximal direction until the hook clip engages opening 66. Hook clip 65 may be biased closed so when clip 65 engages opening 66, clip 65 applies compressive forces against opening 66.
A first expression for a method for inserting a clamp pad on a clamp arm includes a) inserting a first clamp pad having a first width dimension greater than a second width dimension and having a first-shaped flange into a clamp arm having a slot that accepts the first-shaped flange; and b) engaging a pad stop to secure the clamp pad within the clamp arm. In a second expression of the method, the clamp pad consists of a second clamp pad fabricated from a base material and at least one filler material, which is a different material from the base material. The second clamp pad may have a second-shaped flange for engaging a second-shaped slot on the clamp arm. The tissue surfaces of the clamp pads may be smooth or have tissue gripping features, such as a saw-tooth configuration.
A first expression for a method for replacing clamp pads would include the steps of: a) disengaging a pad stop; b) removing a first clamp pad from the clamp arm; c) removing a second clamp pad from the clamp arm, wherein at least one of the first or second clamp pads has a first width dimension greater than a second width dimension; d) inserting third and fourth clamp pads into the clamp arm wherein at least one of the third or fourth clamp pads has a first width dimension greater than a second width dimension; and e) engaging a pad stop to secure the third and fourth clamp pads within the clamp arm. In a second expression of this method one of the third and fourth clamp pads may be fabricated from a polymeric material such as TEFLON, and the other clamp pad may be fabricated from a base material and at least one filler material, which is a different material from the base material. The tissue surfaces of the clamp pads may be smooth or have tissue gripping features, such as a saw-tooth configuration.
A first expression of clamp arm 60 comprises jaw-carrying member 60 a and mating member 60 b. Jaw-carrying member 60 a includes two camming members 94 a and 94 b for mating with two corresponding camming slots 95 a and 95 b located outer shroud 72. Mating member 60 b includes two camming members 96 a and 96 b for mating with two corresponding camming slots 97 a and 97 b located outer shroud 72. Corresponding camming members 94 a/94 b and 96 a/96 b (and corresponding camming slots 95 a/95 b and 97 a/97 b) may align along common axes perpendicular to the longitudinal axis of waveguide 80 or camming members may be offset to facilitate the assembly process. Members 60 a and 60 b fixedly attach to each other as shown in
In a second expression of clamp arm 60, the camming members may be replaced with spherical elements that interface with cam slots. Alternatively camming members may be replaced with spherical depressions for receiving ball bearings that interface with the cam slots. Other camming mechanism would be useful as is well known to the skilled artisian.
With solid camming members and corresponding slots, the force delivered between the clamp pad 58 and blade 79 is directly related to the force that the user applies at the thumb ring 35 and finger ring 36. In a third expression of clamp arm 60, a force limiting element 98, such as an elastomer or coil or leaf spring, may be inserted within one or more cam slots and provide a force limit to the coaptation force seen at the end effector 81. Preferably, the spring constant of an elastomer or spring ranges from 10-500 lb./in.
Outer shroud 72, distal shroud 76 and clamp arm 60 may be constructed from any number of biocompatible materials, such as titanium, stainless steel or plastics. Preferably, however, these elements are constructed of either 7075 or 6061 T6 aluminum. The aluminum provides a large benefit in terms of heat dissipation. Devices of the prior art have sheaths and clamp arms made of stainless steel. Typical values for thermal conductivity for aluminum are around 250 W/m K. The values for stainless steel are around 16 W/m K. Thus, aluminum has approximately 15 times greater capability to transmit heat through the same amount of volume.
The inventors have found through testing of similar inputs (clamp force and blade displacement), the present invention operates approximately 150° F. lower in temperature than instruments of the prior art. The aluminum components more effectively draw the heat away from the pad and the blade, thus keeping the end effector cooler than other prior art instruments.
Referring now to
In one expression of the current embodiment, the distal end of transducer 50 threadedly attaches to the proximal end of transmission rod 80. The distal end of transducer 50 also interfaces with switch assembly 300 to provide the surgeon with finger-activated controls on surgical instrument 19.
Transducer 50 includes a first conductive ring 400 and a second conductive ring 410 which are securely disposed within the transducer body 50 as is described in co-pending application Ser. No. ______ (Attorney docket no. END5747USNP2).
Switch assembly 300 comprises a pushbutton assembly 310, a flex circuit assembly 330, a switch housing 350, a first pin conductor 360 and a second pin conductor 370. Switch housing 350 is saddle-shaped and is supported within handle assembly 68 by way of corresponding supporting mounts on switch housing 350 and housing portions 69 and 70. Housing 350 defines a first receiving area 353 for a dome switch, and a second receiving area 351 for a dome switch.
With particular reference now to
In a second expression of switch assembly 300 elastomeric connectors having copper traces etched onto the elastomer press fit into switch housing 350 to provide the electrical interconnect between transducer 50 and flex circuit 330. One end of the elastomer connectors electrically engage dome switches 332 and 334 via conductors 337 and 335. The other end of the elastomer connectors slidably interface with conductors 400 and 410 of transducer 50. Compression of the elastomer connectors allow a working travel of up to 20% of the total height of the elastomer connectors to allow for manufacturing tolerances associated with the stackup of the assembled parts.
A flex circuit 330 provides for the electromechanical interface between pushbuttons 321 and 322 and the generator 30 via transducer 50. Flex circuit comprises two dome switches 332 and 334 that are mechanically actuated by depressing pushbuttons 321 or 322 axially in the x direction. Dome switches 332 and 334 are electrical contact switches, that when depressed provide an electrical signal to generator 30 as shown by the electrical wiring schematic of
Flex circuit 330 generally sits within a channel 352 of switch assembly 350 so that dome switches 332 and 334 interface with the corresponding backing surfaces 351 and 353. Backing surfaces provide a firm support for the dome switches during operation, discussed below. Dome switches 332 and 334 may be fixedly attached to backing surfaces 351 and 353 by any convenient method, such as, an adhesive.
As is readily apparent, by depressing pushbuttons 321 and 322 the corresponding contact surfaces 323 and 324 depress against corresponding dome switches 332 and 334 to activate the circuit illustrated in
Referring now to FIGS. 17A-B, the pushbutton axial actuation reduces stress on the surgeon's fingers and allows the fingers to actuate force in a more ergonomic position preventing stresses at the hands and wrists. The switch movement also allows comfortable button activation in less than optimal hand positions, which surgeons often encounter throughout a typical procedure.
At the proximal end of each access ring 35 and 36 are protrusions 37 and 38, respectively, that allow the surgeon to rest his or her pinky finger for added control and comfort. This also allows the surgeon to use the pinky when clamping on tissue, thereby reducing the force on the other fingers. Each access ring 35 and 36 includes a soft-touch surface on the interior and exterior surfaces whether by inserting fingers into the access rings or palming the access rings. This feature allows a greater number of hand sizes to comfortably use the device.
Referring now to
Adaptor 550 has a longitudinal shaft 552 with cantilevered tabs 554 at its distal end. At the proximal end of shaft 552 are spline gears 556 projecting in a perpendicular fashion along the outer circumference of shaft 552. Spline gears 556 include cam ramps 556 a disposed at an angle from about 23° to about 28° with respect to the perpendicular angle between the outer circumference of shaft 552 and spline gears 556. Shaft 552 further defines a lateral opening (not shown) proximal to spline gears 556 for accepting curved blade 79, discussed below. Adaptor further includes an interface 560 rigidly connected to shaft 552 and defining an opening for rigidly engaging the distal end of instrument 19. Optionally, a skirt 558 surrounds spline gears 556 to prevent glove snags due to moving parts and forms a cavity 559.
In assembly, torque wrench opening 502 is aligned with shaft 552 and guided along substantially the entire length of shaft 552 until the tabs 554 flex inward and capture shoulder 505 (not shown) at the distal end of hand wrench 500. Hand wrench lip 503 engages the distal end of optional skirt 558 allowing cantilever teeth 501 a to slidably engage spline gears 556. Cam ramp 501 b slidably engages retainer cam ramps 29 b. The torque wrench assembly 450 slidably engages the distal end of instrument 19 and is held rigidly in place. Flat surfaces 560 b and 560 a of interface 560 mate with flat surfaces 565 b (
Clockwise annular motion or torque is imparted to hand wrench 500 through paddles 504. The torque is transmitted through arms 501 and teeth 501 a to gears 556, which in turn transmit the torque to the waveguide 80 via clamp arm assembly 60 via outer shroud 72 via insulated pin 27. When a user imparts 5-12 lbs. of torque, the ramps 501 b and 556 cause the arms 501 to move or flex away from the centerline of wrench 500 ensuring that the user does not over-tighten the waveguide 80 onto transducer 50. When a counter-clockwise torque is applied to wrench 500 via paddles 504, the perpendicular flat sides of teeth 501 a and 556 abut allowing a user to impart a torque to the interface between the waveguide 80 and transducer 50 in proportion to the force applied to the paddles facilitating removal of the instrument 100 from the transducer 50. The torque wrench 450 may be constructed from a durable plastic, such as polycarbonate or a liquid crystal polymer. It is also contemplated that the wrench 450 may alternatively be made from a variety of materials including other plastics, ceramics or metals.
In another embodiment (not shown), the paddles and cantilever arm assembly may be separate components attached by mechanical means or chemical means such as adhesives or glue.
Preferably, the ultrasonic clamp coagulator apparatus 19 described above will be processed before surgery. First, a new or used ultrasonic clamp coagulator apparatus is obtained and if necessary cleaned. The ultrasonic clamp coagulator apparatus can then be sterilized. In one sterilization technique the ultrasonic clamp coagulator apparatus is placed in a closed and sealed container, such as a plastic or TYVEK bag. Optionally, the ultrasonic clamp coagulator apparatus can be bundled in the container as a kit with other components, including a torque wrench 450. The container and ultrasonic clamp coagulator apparatus, as well as any other components, are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation kills bacteria on the ultrasonic clamp coagulator apparatus and in the container. The sterilized ultrasonic clamp coagulator apparatus can then be stored in the sterile container. The sealed container keeps the ultrasonic clamp coagulator apparatus sterile until it is opened in the medical facility.
While the present invention has been illustrated by description of several embodiments, it is not the intention of the applicant to restrict or limit the spirit and scope of the appended claims to such detail. Numerous variations, changes, and substitutions will occur to those skilled in the art without departing from the scope of the invention. Moreover, the structure of each element associated with the present invention can be alternatively described as a means for providing the function performed by the element. Accordingly, it is intended that the invention be limited only by the spirit and scope of the appended claims.
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|Cooperative Classification||A61B17/162, A61B2017/320072, A61B17/1606, A61B17/320092, A61B2017/00424, A61B17/2841, A61B2017/2825, A61B2017/00477, A61B17/8875|
|European Classification||A61B17/32U8, A61B17/16C2, A61B17/28D8|
|May 14, 2007||AS||Assignment|
Owner name: ETHICON ENDO-SURGERY, INC., OHIO
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:EICHMANN, STEPHEN E.;ISAACS, KAREN K.;KRAMER, KENNETH S.;AND OTHERS;REEL/FRAME:019289/0272;SIGNING DATES FROM 20070412 TO 20070514