1. Field of the Invention
The present invention relates to medical stabilizer methods and devices and, more particularly, devices that can be utilized to stabilize surgical instruments that would otherwise be hand held for maintaining exposure to a surgical site or otherwise.
2. Description of the Background
During surgery, whether open or laparoscopic, there is a need for a device that can be utilized to stabilize surgical instruments for various functions, most commonly for stabilizing instruments that would otherwise be handheld, in order to achieve desired tissue tension or to maintain exposure to the surgical site. Many such apparatuses already exist. For example, Cooper Surgical has recently released a hydraulically-controlled table mounted uterine manipulator stabilizer.
For example, United States Patent Application 20070129634 to Hickey et al. published Jun. 7, 2007 shows a biomedical positioning and stabilization system that allows the adjustable, yet rigid placement of a probe or other medical instrument against a region of interest/treatment on a patient. The system employs a flexible goose-neck armature attached to a rigid stand.
U.S. Pat. No. 5,170,790 to Lacoste et al. issued Dec. 15, 1992 shows a stabilizer system with a rigid arm hinged to a support stand at one end and to a ball-and-socket joint, a second arm reaching to an adjustable probe bracket.
U.S. Pat. No. 6,248,101 issued to Whitmore et al. (Barzell Whitmore Maroon Bells, Inc) on Jun. 19, 2001 shows an omni-directional precision instrument platform connected to stationary objects such as a portable floor stand and/or operating table.
U.S. Pat. No. 4,963,903 to Cane issued Oct. 16, 1990 shows a surgical camera positioning system that employs a flexible gooseneck.
U.S. Pat. No. 7,189,246 to Otsuka et al. (Olympus) issued Mar. 13, 2007 shows a medical instrument holding device with a tensor-lamp configuration leading to a ball-and-socket joint.
U.S. Pat. No. 6,514,239 to Shimmura et al. (Olympus) issued Feb. 4, 2003 shows a medical instrument holding apparatus likewise with a tensor-lamp configuration leading to a yoke-mounted support arm.
John R. Bookwalter has various patent for the various configurations and components of his retractor system, including U.S. Pat. Nos. 4,424,724 (expired); 4,254,763 (expired); 5,375,481 (active); and 5,520,608 (active). This system is made and marketed by Codman and employs a set of steel bars mounted to an operating table and used to suspend a steel ring above and around the surgical incision. The ring in turn serves as a docking site for instruments used to retract the wound edges.
There are variations within the Codman accessory line such as the Magrina vaginal retractor that can be used for similar surgical exposure during vaginal surgery. Other table mounted systems are available for similar functions, used to stabilize other devices such as the Martin's Arm (LTL Medical, LLC) that can be used to retain a camera in a fixed position during laparoscopy.
U.S. Pat. No. 6,958,038 to Feng et al. (Allegiance Corporation) issued Oct. 25, 2005 shows a multipositional ratchet-type stabilizer.
However, all of the foregoing systems require two free hands or one foot and one hand to change position of the stabilizing components, requiring the surgeon to basically put down whatever surgical instruments he or she may be using, adjusting the stabilizer and/or stabilized instruments, and then returning to the task at hand. This need for two hands or one foot and one hand to perform adjustments renders the existing devices inefficient and less amenable to frequent repositioning to suit the surgeon's needs. Additionally, the space required to use two hands for adjustments limits the application of these systems in situations where space is constrained, such as robotically assisted laparoscopic surgery.
As a specific example, during laparoscopic or robotically assisted sacral colpopexy, a vaginal probe is generally used to place the vagina on tension during dissection of anatomic spaces and subsequently during attachment of suspending graft to the vaginal muscularis. The probe is typically held in place by a surgical assistant because of the frequent need for repositioning of the probe to achieve the desired tissue tension. However, holding the probe in position is ergonomically awkward for an assistant standing at the bedside, particularly in the case of robotically assisted sacral colpopexy in which the surgical robot occupies the space between the patient's legs. The ideal solution would be to use a table mounted stabilizer that can hold the vaginal probe in the desired position, and yet allow repositioning of the vaginal probe quickly and easily enough to allow frequent repositioning by the surgeon or surgical assistant. For the sake of efficiency as well as to account for space constraints, the ideal table mounted stabilizer would be able to be repositioned with one hand (or voice activated).
A table-mounted stabilizer with these qualities would be useful for other operations that use hand held vaginal or rectal instruments such as uterine manipulators or vaginal retractors used during gynecologic surgery or rectal probes used during urologic and colorectal operations. Moreover, such systems could be used to stabilize the camera during laparoscopic surgery, or to maintain tissue positioning. Thus, it would be greatly advantageous to provide a device that can be utilized to stabilize surgical instruments for maintaining exposure to a surgical site or otherwise, which device can be adjusted and repositioned with one hand or by voice command.
It is an object of the present invention to provide a table mounted stabilizer system capable of holding an instrument (camera, vaginal probe, etc.) or plurality of instruments in any desired position, which allows repositioning of the instrument(s) quickly and easily by single-handed or voice activated manipulation by a surgeon or surgical assistant, and which may also deliver a vacuum through the stabilized instrument to maintain tissue positioning.
It is another object to provide a table mounted stabilizer system as above that provides full adjustability of the location of the desired instrument up and down along a vertical axis, forward and back, i.e, toward or away from the patient, and rotationally. It is another object to provide a table mounted stabilizer system as above with a minimum load carrying capability of 2 ft-lbs torsionally, 25 pounds axially and 10 pounds laterally for rigid, reliable and secure support of any device.
It is still another object to provide a table mounted stabilizer system with the adjustability as above and yet which can be selectively locked into position for rigid, reliable and secure support of an instrument.
Other objects, features, and advantages of the present invention will become more apparent from the following detailed description of the preferred embodiments and certain modifications thereof. The stabilizer system serves to securely hold virtually any instrument during any procedure, for example, during laparoscopic sacral colpopexy which requires an absolutely stable probe during suturing of mesh to the vagina. The system utilizes currently available opposing horizontal side-rails mounted to opposing sides of a surgical table. A plurality of struts and adjustment mechanisms are then employed to create a plurality of separate adjustment points. Specifically, global lengthwise positioning is accomplished with a first component translationally attached to the side rails. Global unidirectional positioning is achieved with a flexible arm connected to an instrument-supporting hand piece. The instrument-supporting hand piece is pivotally mounted for angular orientation of the instrument supported thereby. In addition, some surgical tools that may be stabilized with this device require the use of vacuum through the tool and as such, this device provides for a vacuum feature. Thus, the present device allows easy single handed (or voice activated) repositioning in multiple directions (any direction, rotation or angle) when in an “unlocked” condition, a secure fixed position when in a “locked” condition, and with variable user-adjustable resistance there between, coupled with same hand (or voice activated)-control over the rigidity of the flexible arm combined with the delivery of vacuum when applicable.
Other objects, features, and advantages of the present invention will become more apparent from the following detailed description of the preferred embodiment and certain modifications thereof, in which
As described above, the present invention is a system for stabilizing surgical instruments that would otherwise be handheld, or to maintain desired tissue tension or position or to maintain exposure to a surgical site or otherwise.
The collar 50 carries an articulating boom including an actuator 64 that extends an actuator housing 54 to a flexible arm 22 mounted there atop. The actuator housing 54 is adjustably mounted in the collar 50 and can be extended upward or retracted downward therein, and clamped in place. Specifically, the actuator 64 housing is slidably held within the yoke of the collar 50, and the yoke may be loosened if desired to extend or retract the actuator housing 54. A set screw with handle 52 (see
An alternative scheme (described below) allows for fixation of the collar 50 and associated components described above directly to one of the existing horizontal side rails 12, without the use of the U-shaped frame 40.
The flexible arm 22 comprises a plurality of mating ball and socket links 230 optionally covered with a thin walled elastomeric sheath (not shown). The sheath is intended to prevent pinching of the patient or user between the flexible links 230, improves contamination control, improves sterilization capabilities and improves the aesthetics but otherwise performs no structural or operational function. A tensioning cable 240 (described below) runs throughout the arm 22 and actuator housing 54 and connects to actuator 64, the actuator 64 controlling the tension load on the cable 240. As the cable 240 tension is increased, the links 230 endure a corresponding increase in compressive load between each mating ball and socket. This loading system creates normal force loads between the ball and socket links 230, which in turn generates friction loads. The amount of friction is a function of a number of variables including the geometry of the links 230 (e.g., the size of the links 230), the materials of the links 230, the mating surface finishes, and the magnitude of the normal force on each link, all of which can be varied within the scope of the present invention. For any given design, the load between the links 230 (and the corresponding friction load) is controlled via the tension in the cable 240. As loads on each link are increased (with higher tension in the cable 240), each link imposes higher friction forces, which collectively alters the overall flexibility of the arm 22. Thus, at higher cable 240 tension, the arm 22 will endure external loads such as a surgeon pressing on a given tool that is being supported by the system. Therefore, greater tension in the cable 240 allows the arm 22 to support higher loads at the end of the arm 22 that supports a given tool, due to the increased friction between the links 230. At low cable 240 tension, there is little or no friction between the links 230 and the arm 22 can be manually moved and positioned by the operator with little or no resistance.
The movement of the cable 240 in the actuator 64 (and hence the tension in the cable 240) may be controlled in various ways. For example, the tension in the cable can be controlled by a button 222 mounted on an instrument-supporting hand piece 60, which button 222 may be connected to actuator 64 via a hard wired connection, optical, infrared, RF, Bluetooth (or other wireless communication). When used with a hard wired or optical connection, a slip ring or rotating connector is preferably incorporated in the hand piece 60 to allow the wires or optical fibers to slip relative to the mating link 230 and therefore prevent damage to the wires or fibers that could occur when the hand piece 60 is over rotated by the operator relative to the actuator 64. Alternatively, button 222 may be replaced with a foot pedal controller in communication with the actuator 64. Alternatively, button 222 may be replaced with a voice activated control system in communication with the actuator 64. A suitable voice activated control system includes a microphone coupled to an audio amplifier in turn coupled to a processor capable of running voice recognition software, such as Dragon Naturally Speaking™ software commercially available from Nuance™, or Fonix FAAST™ software commercially available from Fonix Corporation, 1225 Eagle Gate Tower, 60 East South Temple, Salt Lake City, Utah. The processor may be the actuator 64 control system. Button 222 (or foot pedal or voice control) provides for convenient same hand (or voice)-operated control over the amount of flex imparted to the arm 22. Pressing the button 222 (and holding it in this orientation), causes the cable 240 in the actuator 64 to extend or grow in length which reduces the amount of tension in the cable 240 by a predetermined amount and thereby reducing the friction load between the links 230 such that the flexible arm 22 can move in a more relaxed manner as chosen by the operator. Releasing the button 222 causes the cable 240 in the actuator 64 to retract in overall length which increases the amount of tension in the cable 240 by a predetermined amount, thereby increasing the friction load between the links 230 such that the flexible arm 22 has increased rigidity to a selectable degree chosen by the operator. At maximum tension the arm 22 becomes fully rigid in that the links 230 will not rotate relative to each other unless the maximum loading of the arm 22 is exceeded. In the case of voice activation, the operator will be able to control the movement and location of the flexible arm 22 through oral messages interpreted by an on-board processor such as the actuator 64 control system.
An ergonomic instrument-supporting hand piece 60 is mounted to the distal end of the flexible arm 22, and the hand piece 60 accepts a variety of probe-adapter inserts 220 each of which serves as a conforming receptacle for insertion of a probe. In the illustrated embodiment a vaginal probe 70 is mounted in the adapter 220 on the instrument-supporting hand piece 60 (although most any instrument or imaging device may be so mounted with a conforming probe-adapter insert 220).
The primary goals of the present device are to: 1) allow easy single handed repositioning of the arm 22 in multiple directions (any direction, rotation or angle) when in an unloaded or “unlocked” condition; 2) to provide a secure fixed position when in a “locked” condition; and 3) to provide the user with variable user-adjustable resistance there between, coupled with single-hand or voice activated-control over the rigidity of the flexible arm 22. This would be well-suited for situations requiring frequent repositioning, such as for stabilization of a laparoscopic camera, and would be equally suited for stabilizing a rectal probe, uterine manipulator, vaginal probe 70 or similar surgical tools. The need for adjustable resistance arises from the different types of instruments requiring stabilization. For instance, a table mounted stabilizer used to hold a laparoscopic camera in a fixed position requires only minimal resistance because it need only resist the weight of the camera itself. In contrast, a stabilizer used to hold a vaginal probe used during laparoscopic sacral colpopexy or a uterine manipulator during laparoscopic hysterectomy would require substantially greater resistance in order to keep the probe stable during suturing of mesh to the vagina. The present invention accomplishes this by including the ability to adjust the overall tension in the cable 240.
The invention provides multiple features to adjust the location and operating range of the flexible arm 22 via five separate adjustments settings A thru E as described below:
At point A, the instrument-supporting hand piece 60 is pivotally mounted to the distal end of the flexible arm 22 for angular orientation of the instrument supported thereby.
Point B is an adjustable-tension unidirectional adjustment point for local positioning implemented by the flexible arm 22 (controlled by button 222 or voice) with internal tensioning cable 240 (allowing multi-axis positioning by the plurality of ball and socket links 230).
Point C allows transverse global positioning of both the flexible arm 22 and instrument-supporting hand piece 60. This is accomplished by the collar 50 which is translatable lengthwise along support arm 46.
Point D allows global vertical positioning of the combined actuator 64, flexible arm 22 and instrument-supporting hand piece 60 by virtue of the actuator 64 which may be slidably repositioned within the collar 50
Finally, Point E allows global lengthwise positioning of both the flexible arm 22, instrument-supporting hand piece 60, actuator 64, support arm 46, collar 50 and U-shaped frame 40 along the surgical table by virtue of the quick-release bracket 30, which is movably mounted to the side-rail 12. The friction of the quick-release bracket 30 may be adjusted by knobs 31.
The foregoing configuration facilitates easy single-handed (or voice activated) local and global multi-directional repositioning of the supported instrument and variable resistance-setting. The range of motion is significantly increased. Surgical instruments can be supported in any location and any orientation within a 60 centimeter diameter spherical range of the point of origin of the instrument-supporting hand piece 60.
Moreover, selection of the material for the flexible elements 230 (high modulus of elasticity), combined with manufacturing requirements for controlled and uniform surface finish (injection molding) as well as the design of the optimum geometry of the flexible elements 230 has enabled the load carrying capacity of the foregoing configuration to be substantially greater than prior art stabilizers.
The downwardly protruding angle arms 42 are joined directly to the opposing collars 30 and (in
The collar 50 carries the actuator 64 (by its protruding housing 54), and so the collar 50 also allows the actuator housing 54 to be extended upward or retracted downward therein, and clamped in place.
The actuator 64 can be a variety of different types. For example, the actuator 64 may be an electronic motor that selectively winds/unwinds a tensioning cable onto a pulley. Alternatively, the actuator 64 may be a linear actuator, or pneumatic cylinder (e.g., air cylinder), hydraulic cylinder, or any other suitable actuator capable of tightening/loosening a cable. The actuator 64 provides the motive force and incorporates control circuitry to selectively tighten/loosen the internal tensioning cable 240 which extends through actuator housing 54 to the flexible arm 22 mounted there atop. Preferably, actuator 64 includes an internal actuator control system constructed according to the type of actuation, and generically including one or more position sensors, a PLC controller, and hydraulic/pneumatic valves as necessary. By way of example, Duff-Norton™ sells a TracMaster™ line of linear actuators in a variety of stroke lengths, along with accessory control packages and digital position indicators that will suffice.
The flexible arm 22 comprises a plurality of links 230, optionally covered with a thin walled elastomeric sheath.
The combination of the high modulus of elasticity material used for the links 230, high coefficient of friction between the mating links 230 (increased by controlled and uniform injection-molded surface finish, as well as the above-described optimum geometry of the links 230, has enabled the load carrying capacity of the above-described configuration to be substantially greater than prior art stabilizers. Specifically, once the arm 22 is locked the table mounted stabilizer system has a minimum load carrying capability of 2 ft-lbs torsionally, 25 pounds axially and 10 pounds laterally for rigid, reliable and secure support of any device.
Each link 230 is defined by an axial passage 234 for passing the cable 240, and a control wire to the button 222, and (optionally) for the delivery of negative air pressure (vacuum) for suction instruments. The end adapter 210 includes a square insert 212 backed by a flange 212 at one end for insertion into the square tubular actuator housing 54. Another ball-and-socket link identical to 230 protrudes integrally from the other side of flange 212.
The hand piece 60 allows 360 degree rotation of the instrument wielded thereby. The ergonomic hand piece 60 is a contoured member having the arm control button 222 mounted there atop. The throw of actuator 64 is controlled by the button 222 on the instrument-supporting hand piece 60. The hand piece 60 includes an open-ended receptacle for insertion of an adapter 220 that will interface with and support a variety of desired surgical tools. The adapter 220 preferably allows snap-fit insertion of a vaginal probe 70 or other device.
One skilled in the art should now understand that the foregoing allows full adjustability of the location of the desired instrument up and down along a vertical axis, forward and back, i.e, toward or away from the patient, and rotationally so that the desired instrument can be angled up or down and side to side. Once locked the table mounted stabilizer system has a minimum load carrying capability of 2 ft-lbs torsionally, 25 pounds axially and 10 pounds laterally for rigid, reliable and secure support of any device. Moreover, the hand piece allows single-handed release control of all degrees of freedom.
Having now fully set forth the preferred embodiment and certain modifications of the concept underlying the present invention, various other embodiments as well as certain variations and modifications of the embodiments herein shown and described will obviously occur to those skilled in the art upon becoming familiar with said underlying concept. It is to be understood, therefore, that the invention may be practiced otherwise than as specifically set forth in the appended claims.
The present application is a continuation-in-part of PCT Application No. PCT/U.S.08/13661, which derives priority from U.S. provisional patent application No. 61/005,746 filed 14 Dec. 2007.
Number | Date | Country | |
---|---|---|---|
Parent | PCT/US08/13661 | Dec 2008 | US |
Child | 12584366 | US |