Patent ID: 12209704

DETAILED DESCRIPTION OF THE INVENTION

While the making and using of various embodiments of the present invention are discussed in detail below, it should be appreciated that the present invention provides many applicable inventive concepts which can be embodied in a wide variety of specific contexts. The specific embodiments discussed herein are merely illustrative of specific ways to make and use the invention, and do not delimit the scope of the present invention.

Referring initially toFIG.1throughFIG.6, therein is depicted one embodiment of a base station assembly10to support a surgical head holder14and various surgical accessories being utilized during surgical operations on the skull and brain of patient P. The base station assembly10, the surgical head holder14with multiple low-pressure cranial pins for cranial stabilization, and the operating table12being the basic important components of a group of surgical tools required to provide stability of the patient's head for microsurgical operations as well as for utilization of image guidance technology on patients of nearly all sizes and ages.

Until recently, skeletal pin fixation could not be safely used with children under five (5) years of age with traditional neurosurgical headrests utilizing three (3) or four (4) pins at high pressures such as 70 lbs (or 45 lbs for so-called “pediatric” pins), because of the risks and incidence of serious complications. The skulls of this young children are simply too thin and flexible. The pins may fracture or deform the skull; they may penetrate and injure the brain or cause hemorrhage; the child may fall from the headrest during microsurgery. Now, there is a surgical headrest that can support the weight of a small child's head with a gel pad or gel pad assembly supraposed to the dorsal surface of the headrest, while cranial movement can be eliminated with multiple low pressure (finger-tightened) pins, because these latter pins are not supporting any of the weight of the head. To achieve cranial stability, this novel headrest may require 4 to 6 pins for an adult or teenager, 6 to 8 pins for a child, 8-10 pins for a newborn or small infant, and 10-12 pins, or more, for a premature infant.

That cranial stabilization with multiple low-pressure pins is no longer beyond the limitations of reasonable safety measures, microneurosurgery and image guidance technology can be done on nearly all patients of diverse ages and sizes, including premature infants. This surgical approach is not only applicable to neurosurgical operations but also be appropriate for use in some otolaryngological and orthopedic procedures as well.

The operating room table12provides the surgical equipment necessary on which a patient P lies during the surgical operation. As shown, the operating room table12includes an operating room table pad18supraposed to an operating room tabletop20including a support block22connected to a support block24by a horizontal support member26. Vertical support members28,30extend ventrally from the support block24with the vertical support member28having a support block32and the vertical support member30having a support block34. The support blocks22,24,32,34may each be selectively adjustable with knobs (not shown) to assist the surgical staff with proper alignment and placement of the components of the base station assembly10, the surgical head holder14, and various surgical accessories on the operating room table12. By way of example, the support blocks32,34provide for alignment and placement in the dorsal-ventral direction as well as the caudal-cephalic direction. As shown, a surgical drape36is positioned over the entire operating room table12as well as the head of the patient P. The surgical drape36has a surgical field opening38providing access to the head or other body part of the patient P. It should be appreciated that although one embodiment of the operating room table12is illustrated and described, the teachings presented herein are applicable to other operating room table configurations and designs.

The surgical head holder14includes a headrest40, which may be a universal headrest, that generally functions in a plane approximately parallel to the top of the operating room table12; although, the headrest40may be tilted in any direction as necessary. The headrest40with appropriate gel pads carries the weight of the head of the patient P. The surgical head holder14includes a skull pin holder assembly42having skull pin holders44,46,48,50,52,53, or more, depending on the thinness of the patient's skull. Utilizing multiple low-pressure (finger-tightened) pins, the skull pin holder assembly42contributes to preventing any movement of the head of the patient P, thereby allowing safe microsurgery and enabling accurate employment of image guidance technology. As shown, the headrest40is supported by a support block54having a vertical support member56extending therefrom that connects to the base station assembly10with the use of a support block58. The support blocks54,58may each be selectively adjustable with knobs (not shown) to assist the surgical staff with proper alignment and placement of the components of the surgical head holder14. It should be appreciated that although one embodiment of the surgical head holder14is illustrated and described, the teachings presented herein are applicable to other operating room table configurations and designs.

Referring now toFIG.1throughFIG.8, in some embodiments, the base station assembly10includes a base station70having a selectively moveable clamp72attached thereto. The selectively moveable clamp72has a vertical support arm74extending therefrom. The vertical support arm74may include a short, tight “S” curve S to assist in positioning of the vertical support arm74and a surgical accessory76attached thereto. That is, the vertical support arm74extends from the selectively moveable clamp72to provide selective attachment of the surgical accessory76such as a retractor arm, a surgical armrest, or an image guidance frame, for example. In one implementation, the base station70includes a horizontal support member80having ends82,84with a midpoint86therebetween. A horizontal support member88has ends90,92. The end90of the horizontal support member88is coupled to the midpoint86of the horizontal support member80such that the horizontal support member88is perpendicular to the horizontal support member80and secured to the horizontal support member80at a position offset from a center T. A horizontal support member94includes ends96,98with the end98being connected to the horizontal support member80between the end82and the midpoint86. As shown, the horizontal support member94extends caudally from the horizontal support member80such that the horizontal support member94is perpendicular to the horizontal support member80. Similarly, a horizontal support member100includes ends102,104with the end104being connected to the horizontal support member80between the end84and the midpoint86. As shown, the horizontal support member100extends caudally from the horizontal support member80such that the horizontal support member100is perpendicular to the horizontal support member80. The horizontal support members94,100of the base station70join the base station assembly10to the operating room table12. More particularly, in one embodiment, the horizontal support member80is joined to the vertical support member28at the support block32and the horizontal support member100is joined to the vertical support member30at the support block34.

An arcuate rail member106, which may be an upright bar in cross-section, includes a radius r1, as measured from the center T, and ends107,108. The end107is coupled to the end82of the horizontal support member80and the end108is coupled to the end84of the horizontal support member80. The vertical support member56is secured to the horizontal support member88, which is off center with respect to the center T, such that the vertical support member56is positioned at the center T. In turn, the surgical head holder14and the headrest40are positioned at the center T with various surgical accessories positionable and repositionable, at the surgeon's discretion, via the base station assembly10around the center T.

A second arcuate rail member110, which may also be an upright bar in cross-section, includes a radius r2, as measured from the center T, and ends111,112. The end111is coupled to the end82of the horizontal support member80at a ventral tab114and the end112is coupled to the end84at a ventral tab116of the horizontal support member80. The use of the ventral tab114and the ventral tab116permit the arcuate rail member106and the arcuate rail member110to be vertically offset. For example, placement of the selectively moveable clamp72specialized as necessary to fit on ventral tab114or ventral tab116may, one or the other, provide an ideal location to attach the reference frame required for image guidance as depicted inFIG.17. Importantly, as shown, a passage125is located between the horizontal support member88and the arcuate rail member106to provide for the movement of the selectively moveable clamp72around the orbit of the arcuate rail member106.

In one implementation, the arcuate rail member106and the second arcuate rail member110are concentric. Further, the radius r2of the arcuate rail member110is greater than the radius r1of the arcuate rail member106. In one embodiment of the base station70, the arcuate rail member106may have an arc of about 190 degrees to about 200 degrees. In one particular embodiment of the base station70, the arcuate rail member106may have an arc of about 195 degrees. In one embodiment of the base station70, the arcuate rail member110may have an arc of about 205 degrees to about 215 degrees. In one particular embodiment of the base station70, the arcuate rail member110may have an arc of about 210 degrees. As will be discussed in additional detail hereinbelow, it should be appreciated that, depending on the embodiment selected by the surgeon, the base station70may have one arcuate rail member, i.e., arcuate rail member106or arcuate rail member110, or the base station70may have two arcuate rail members, i.e., arcuate rail members106,110.

As shown, the bottoms of the surgical drape36that fall naturally from the draping of the head of the patient are gathered and tucked inside a drape holder120having an arcuate space122defined by rostral retaining members124,126, and caudal retaining member130. The drape holder120is adjustably secured to the vertical support member56by a support member128. In one embodiment, the radius r3of the drape holder120is less than the radius r1of the rail member106and the radius r2of the rail member110. This permits the surgical drape36to be gathered and groomed so as not to interfere with the surgical procedure or use of the base station assembly10.

Referring now toFIG.9throughFIG.13, in some embodiments, the selectively moveable clamp72includes a body130having an upper end132and a lower end134. The body130includes a rail frame136and a rail frame138. Rollers140,142are secured to the rail frame136and configured to be placed on the arcuate rail member106or in a different implementation, the arcuate rail member110. Similarly, rollers144,146are secured to the rail frame138and configured to be placed on the arcuate rail member106or in a different implementation, the arcuate rail member110. As shown, the roller140may appose the roller144and the roller142may appose the roller146. The body130has a distance d between the rollers140,144and the rollers142,146, which is set to accommodate a width of a rail in the form of the arcuate rail member106of the base station70or, alternatively, the arcuate rail member110of the base station.

A finger lock150is coupled to the body130for pivoting movement in a mandibular motion relative to the rail frame136about an axis A1parallel to a tangent of the arcuate rail member106. The axis A1may be parallel to the floor of the operating room. The finger lock150is configured to be placed in a braking relationship with the arcuate rail member106to prevent movement of the selectively moveable clamp72on the arcuate rail member106. In some embodiments, the braking relationship is achieved exerting enough pressure and friction between the finger lock150of the selectively moveable clamp72on the arcuate rail member106or the arcuate rail member110when the finger lock150is in the closed position, thereby preventing movement of the selectively moveable clamp72. When the finger lock150is released from the arcuate rail member106, movement of the selectively moveable clamp72is facilitated by rollers140,142,144,146thereon the arcuate rail member106. A receiving member152, which may be in the form of a lock screw, for example, intersects the body130at the upper end132and the receiving member152retains a clamp pin154. As shown, the clamp pin154is located suprajacent the finger lock150with axial movement about an axis A2perpendicular to the axis A1. The clamp pin154is configured to actuate the finger lock150between an open position O and a closed position C. In the open position O, as shown inFIGS.10A and11A, the clamp pin154is disengaged with the finger lock150and, in the closed position C, as shown inFIGS.10B and11B, the clamp pin154is engaged with the finger lock150. Further, in the open position, the finger lock150does not make strong contact with the arcuate rail member106and the rollers140,142,144,146are permitted to move along the arcuate rail member106. On the other hand, in the closed position C, the finger lock150is forced into the braking relationship with the arcuate rail member106, and the rollers140,142,144,146are inhibited from moving along the arcuate rail member106. Similarly, the selectively moveable clamp or clamps72positioned on the arcuate rail member110show analogous braking and release features as discussed.

The rail frames136,138may define a chamber156and the finger lock150is coupled to the body130for pivoting movement by a pivot pin158which extends from the body130into the chamber156. In this configuration, the clamp pin154may extend into the chamber156to engage the finger lock150in the closed position C. In operation, in the open position O, the rollers140,142,144,146facilitate movement of the selectively moveable clamp72along the rail, which may have an arcuate form with a rectangular cross-section, for example, and, as illustrated includes the arcuate rail member110. It should be appreciated, however, that the rail may take the form of the arcuate rail member106as well.

Referring now toFIG.3,FIG.4,FIG.5,FIG.9,FIG.10A,FIG.10B, andFIG.14, in some embodiments, the vertical support arm74includes an elongated member170having ends172,174with a channel176therethrough. A ball bearing train178is located in the channel176from proximate the end172to proximate the end174. The ball bearing train178has an upper end180proximate the end172and a lower end182proximate the end174. As shown, the ball bearing train178includes multiple ball bearings184-a,184-b,184-c,184-d,184-e,184-f,184-g,184-h,184-i,184-j,184-k,184-l,184-m,184-n,184-o,184-p,184-q,184-r,184-s,184-t,184-u,184-v,184-w,184-x,184-y,184-z,184-aa,184-bb,184-ccbeing disposed in an angular contact, tandem arrangement. It should be appreciated that the number of ball bearings may vary depending on the construction and application of the vertical support arm74.

A drive member186is located proximate the end172of the elongated member170and the drive member186is configured to selectively actuate an amount of flexibility of the ball train within the elongated member170between a lower flexibility condition and a higher flexibility condition, which enables not only 360° rotation, but also angular adjustment of the elongated member170relative to its receiving member152at joint162. The curve S of the elongated member170amplifies simple rotation into a maximal radial displacement equal to the offset of the curve S. In addition, the elongated member170can be tilted up to about 7° by tilting the terminal flange of end174within the wedge-shaped joint162, and then actuating between a release position to an engagement position of drive member186. As best seen inFIG.10AandFIG.10B, the receiving member152includes the end cap160at the joint162. As shown the elongated member170, which may have a flanged tip at its lower end174, is interposed between the receiving member152and the end cap160at the joint162such that the elongated member170can be rotated and/or pivoted at joint162. That is, in some embodiments, the elongated member170may be manufactured with a curve S built into the elongated member170. Accordingly, in the higher flexibility condition, the elongated member may be moved, rotated, and/or tilted into the desired position, which can then be held in place at the joint162, by actuating the lower flexibility condition of drive member186. Such manipulation may be utilized to reposition the elongated member170. Tilting the elongated member170at joint162provides more subtle positional adjustment.

As previously alluded, the clamp pin154is located proximate the end174of the elongated member170and the clamp pin154is configured to actuate the selectively moveable clamp72between the open position O and the closed position C. In the release position, the drive member186is disengaged from the upper end180of the ball bearing train178; and in the release position, the ball bearing train178is disengaged from the clamp pin154to actuate the selectively moveable clamp72to the open position O. Above the S-shaped curve at the proximal end of the elongated member170, the elongated member170may include a vertical axis A3with the ball bearing train178having relative axial movement about the vertical axis A3with the drive member186in the release position.

On the other hand, in the engagement position, the drive member186is engaged with the upper end180of the ball bearing train178to limit freedom of movement between the ball bearings184-athrough184-cc. Further, in the engagement position, the ball bearing train178is engaged with the clamp pin154to actuate the selectively moveable clamp72to the closed position via the finger lock150.

An upper end cap188may be coupled to the end172of the elongated member170. The upper end cap188may have an interior190and an exterior192and the drive member186may be housed within the interior190of the upper end cap188. As shown, a control knob194may be housed within the upper end cap188and be selectively actuatable from the exterior192of the upper end cap188. The control knob194translates a rotation of the control knob194to a movement of the drive member186. An attachment member198, which may be selectively telescoping, may be secured to the upper end cap188to provide selective attachment to the surgical accessory76, such as a medical device selected from the group consisting of retractor arms, armrests, and the reference frame for image guidance at a coupling joint196. In particular, in the application of certain medical devices, at the end172of the elongated member170, the attachment member198may include a cylindrical sheath200having a slot202to accommodate the control knob194. A cabined recess204may be positioned opposite to the slot202to accept and house the drive member186, which extends from the control knob194. A hand adjustment knob205controls an adjustability, i.e., a telescoping extension and retraction of the attachment member198as shown by double-headed arrow U-D (seeFIG.5). In one embodiment, the cylindrical sheath200may be made of metal and be approximately 20 cm (7.8 in) in length, which contains the slot202, such as 12 cm (4.7 in) to accommodate the control knob194. In this way, the height of the vertical support arm74can be extended and then locked in place with the hand adjustment knob205.

In one embodiment, as mentioned, the drive member186extends from the control knob194. The drive member186may include a threaded section206connected to a conical section208connected to an end shank210. The threaded section206may be inserted through the slot202and threadedly engaged with a threaded opening212which traverses the elongated member170and the upper end cap188. The conical section208engages the ball bearing train178at the upper end180thereof. Engagement of the conical section208with the ball bearing184-aincreases the downward force applied to the ball bearing train178resulting in the engagement position. On the other hand, disengagement of the conical section208decreases the downward force applied to the ball bearing train178resulting in the release position. The end shank210traverses an opening214which passes through the elongated member170and the upper end cap188and exits the elongated member170and the upper end cap188into the cabined recess204of the cylindrical sheath200.

Referring now toFIG.14throughFIG.16, the elongated member170is configured to selectively actuate between the release position and the engagement position by actuation of the control knob194. In the release position, the selectively moveable clamp72is actuated to an open position where the selectively moveable clamp72may slide on the arcuate rail member106—or arcuate rail member110—to be repositioned. On the other hand, in the engagement position, the selectively moveable clamp72is in the closed position and locked in position on the arcuate rail member106—or arcuate rail member110. The cabined recess204, which is depicted as presenting a bulge, may be positioned opposite to the slot202to accept and house the end shank210of the control knob194. The hand adjustment knob218may provide rotatory adjustment of a ring member216. Attachment to the ring member216of the vertical support arm74provides a coupling to the surgical accessory76. More particularly, the ring member216is set over the cylindrical sheath200in a circumscribing manner. As mentioned, hand adjustable knob218tightens or loosens the ring member216to allow rotational adjustment around the vertical support arm74. The top of the ring member216is closed and supports a metal ball220attached at its dorsal center. The metal ball220is the bottom ball of a two-ball-joint clamp222having a knob223and is adjustably oriented in a more or less vertical position. A metal ball224serving as an upper ball of the two-ball-joint clamp222arises from the inferior surface of a device clamp226having a knob227, to which a surgical accessory76, such as a brain retractor arm, an armrest, or an image guidance reference frame, for example, can be attached. As shown inFIGS.15and16, a rail support member228may hold one or multiple brain retractor devices.

The rail support members228may be chosen from a variety of lengths and/or geometries according to the patient's size, surgical positioning, as well as the preference of the surgeon. The rail support member228may be angled with a double-T-profile defining tracks230,232. A brain retractor arm234having a body236with a flexible arm238extending therefrom is secured to the track230. A clamp240, under the control of a positioning knob242, extends from the body236and ensures the adjustable securement to the track230and minor repositioning of the brain retractor arm234as shown by arrows M2, M3. A tension knob244provides control of the flexible positioning in the flexible arm238. A pivot knob246provides axial control. On the other hand, one or more additional retractor arms can be attached to a single rail support member228to facilitate simultaneous use of multiple brain retractors in close proximity-three brain retractors inFIG.16, for instance.

Referring now toFIG.17, by way of example, the base station assembly10may include the selectively moveable clamp72attached thereto with the vertical support arm74extending therefrom. The vertical support arm includes the elongated member134. A reference frame250for intraoperative image guidance is secured to the two-ball-joint clamp222of the vertical support arm74.FIG.17shows the cylindrical sheath200having been modified for specific use with the image guidance reference frame250. The adjustment knobs194,205have been lowered below the level of operative sterility, so that none of the surgical participants—doctors, nurses, and OR technicians—be tempted accidentally to “adjust” the position of the reference frame, thereby disabling image guidance. Once the position of the reference frame has been provided to the image guidance computer (prior to prepping and draping), there is never a reason to change the position of the frame.

Referring now toFIG.18, in another implementation, the base station70includes a horizontal support member260having ends262,264with a midpoint266therebetween. In this implementation, a single orbit for the selectively moveable clamp72is provided as compared to the two orbits presented inFIG.5, for example. A horizontal support member268has ends270,272. The end270of the horizontal support member268is coupled to the midpoint266of the horizontal support member260such that the horizontal support member268is perpendicular to the horizontal support member260. A horizontal support member274includes ends276,278with the end278being connected to the horizontal support member260between the end262and the midpoint266. The horizontal support member274may extend caudally from the horizontal support member260such that the horizontal support member274is perpendicular to the horizontal support member260. Similarly, a horizontal support member280includes ends282,284with the end284being connected to the horizontal support member260between the end264and the midpoint266. As shown, the horizontal support member280may extend caudally from the horizontal support member260such that the horizontal support member280is perpendicular to the horizontal support member260. The horizontal support members274,280of the base station70join the base station assembly10to the operating room table12. An arcuate rail member290, which may be an upright bar, includes a radius r4and ends292,294. The end292is coupled to the end262of the horizontal support member260and the end294is coupled to the end264of the horizontal support member260.

Referring now toFIGS.19A,19B, and19C, as previously mentioned, other embodiments of the base station assembly10are within the teachings presented herein. In one such embodiment, the base station assembly10may have a larger presentation as indicated by center-point configuration300. InFIGS.19A,19B, and19C, the relative footprints of a single rail base station302, a double rail base station304, and the center-point base station300are comparatively shown together, utilizing the same scale.

Referring now toFIG.19A, in another implementation, which is similar to the configuration introduced inFIG.18, the base station70includes a horizontal support member310. In this implementation, a single orbit for the selectively moveable clamp72is provided as compared to the two orbits presented inFIGS.5and6, for example. A horizontal support member312is coupled the horizontal support member310such that the horizontal support member322perpendicular to the horizontal support member310. Horizontal support members314,316of the base station70join the base station assembly10to the operating room table12. An arcuate rail member318is coupled to the horizontal support member310.

Referring now toFIG.19B, in another implementation, which is similar to the configuration introduced inFIG.7, the base station70includes a horizontal support member320, which may include horizontal support submembers320-a,320-b. A horizontal support member322is coupled to the horizontal support member320such that the horizontal support member322is perpendicular to the horizontal support member320. Horizontal support members324,326of the base station70join the base station assembly10to the operating room table12. Arcuate rail members328,330are coupled to the horizontal support member320, t-o, in this implementation, to provide two orbits for the selectively moveable clamp72.

Referring now toFIG.19C, in another implementation, which is similar to the configuration introduced inFIG.7, the base station70includes a horizontal support member340. A horizontal support member342is coupled to the horizontal support member340such that the horizontal support member342is perpendicular to the horizontal support member340. Blocks344,346have horizontal support members348,350of the base station70to join the base station assembly10to the operating room table12. In this implementation, arcuate rail members352,354are coupled to the horizontal support member340to provide two orbits for the selectively moveable clamp72.

That is, as shown inFIG.19C, in some implementations of this embodiment of the base station70, arcuate rails of the same 9″ (22.86 cm) and 12″ (30.48 cm) radiuses as the double rail embodiment depicted inFIG.7are presented. This larger embodiment of base station70inFIG.19Cencompasses a greater portion of a complete circle, and the respective arcuate rail members106,110may have arcs of 308.5 degrees and 276.2 degrees, for example, thereby significantly increasing the potential arcuate excursion distances for selectively moveable clamps72. Moreover, as illustrated inFIGS.20,22, and24, an additional advantage of this embodiment allows the base station70to be positioned partially underlapping the rostral end of the OR table. This can be easily accomplished by re-positioning the cross bar24of the base station70from its usual position just rostral to the “W” shaped connection bar of the OR table to a position caudal to the “W” connection bar. For tiny newborns and premature infants, underlapping the positioning of the base station70relative to the rostral end of the OR tabletop20allows the infant's body to be physically supported by the OR table, while the head remains centered on the universal headrest10or the center point thereof. The center point “T” onFIGS.7,18,19A,19B, and19Crepresents points on the concentric center axes of both arcuate rails106,110depicted in the respective figures. As discussed previously, the brain retractors supported by various selectively moveable clamps72on the arcuate rails106,110of base station70allow the surgeon to move retractors along orbital paths with the surgical target being approximately at or near the center of these orbital excursions, thereby simplifying the adjustment and repositioning of brain retractors. Furthermore, having the infant's body on the OR table provides physical support of the baby and facilitates keeping the baby warm.

Referring again toFIG.19AthroughFIG.19C, in embodiments with two arcuate rail members, the arcuate rail members are concentric with the center T. Further, in some implementations, the arcuate rail members have different radii, with as shown inFIG.19BandFIG.19C, one radius is greater than the other. As shown inFIG.19AthroughFIG.19C, in some embodiments, the horizontal support member passes proximate to the center T or may be offset from the center T by a distance to accommodate a surgical head holder. It should be appreciated, however, that in other embodiments, depending on the design of the surgical head holder, the horizontal support member may pass through the center.

Further, two of the three base station devices (FIG.19BandFIG.19C) have two arcuate rails on which one or more selectively moveable clamps72may be placed to support retractor arms, image guidance, and/or a surgical armrest which can be moved around the axis of the center point T of each of the respective base stations. Indeed, it is suggested that surgeons who do microneurosurgery intuitively position their patients in a surgical headrest attached to the OR table so that the surgical field, the operative target, and the actual surgical approach can all be readily and adequately visualized with the operating microscope. Moreover, a microsurgeon operating on an adult would likely not undertake surgery if the head position were not rigidly fixed. Accordingly, these three base station embodiments ofFIGS.19A,19B, and19Cnot only provide pin stabilization of the skull utilizing the surgical head holder14with multiple low-pressure pins, but also allow efficient and reliable positioning and repositioning of brain retractors and/or a surgical armrest.

Now referring toFIG.19AthroughFIG.26, it is apparent that the center-point base station300increases the arcuate limits of both the upper and lower rails. Like the single rail base station302and the double rail base station304, the center-point base station300attaches to the OR table12, utilizing the horizontal support member which receives the two horizontal rods that adjustably attach to the cross bar24. The cross bar24also supports two fixed vertical rods28,30, which adjustably connect to respective bottom blocks32,34of the center-point base station300.

With reference toFIG.2,FIG.3, andFIG.19C, using the center-point base station300for patients ranging from children to adults, the cross bar24is positioned rostral to the horizontal support member22of the OR table12and the “W” table brace23, best seen inFIG.2. Such a design provides a maximal arcuate excursion of, by way of example, 286° of mobility for the selectively moveable clamp72on the upper arcuate rail352and, by way of example, a 274° excursion on the lower arcuate rail354, as summarized inFIG.20, with the mobility illustrated by arrows400,402. As shown, the selectively moveable clamp72is appropriately positionable and repositionable about the patient P resting on gel pads404of the headrest40.FIG.21shows a lateral view of this adult-sized patient positioned on the surgical head holder14supported by the center-point base station configuration300of the base station70. Pins and other components have been omitted for clarity.

However, the setup of the center-point base station300for a small infant (4-months-old, for example) or a premature baby [thirty-five (35)-weeks gestational age, as another example] are illustrated inFIGS.22and23andFIGS.24and25, respectively. For these small patients, the cross bar24is positioned caudal to the “W” table brace23so that the shoulders and torsos of these very small children are supported by the top of the OR table. In essence, moving the cross bar24behind the “W” table brace23of OR table12relocates the entire center-point base station300caudally, causing the caudal-most end of the center-point base station300to rest beneath the cephalic end of the OR table12. Accordingly, the maximal arcuate excursions of the selectively moveable clamps72are reduced on both arcuate rails352,354, when used for these smallest children, but the versatility and efficiency of positioning and repositioning of brain retractors and/or a surgical armrest are entirely preserved. For instance, the maximal arcuate excursions of the selectively moveable clamp72on the arcuate rails352,354are diminished by this maneuver to, by way of example, 260° on the arcuate rail352and, by way of example, 237° on the arcuate rail354for the four (4)-month-old infant. For the thirty-five (35)-week gestational age premature infant, the maximal arcuate excursions of the moveable clamp72on arcuate rails352,354are, by way of example and not by way of limitation, 244° and 228°, respectively. As best shown inFIG.26, in any of these embodiments inFIG.20through25, various instruments may be appropriately placed and utilized with great mobility as shown by the arrows400,402.

In some operational implementations, the base station assembly10supports various surgical accessories, such as the surgical accessory76, during a surgical procedure, such as an operation on the skull and brain. The base station70can accept either or both of two large orbital arcuate rails106,110of base station70may receive one or more selectively moveable clamps72to be adjustably positioned by actuation of the control knobs194within the slot(s)202of the cylindrical sheaths200on the vertical support arm74. Additionally, the height of a vertical support arm74may be adjusted as required using the control knob205. Furthermore, a vertical support arm74can be selectively rotated and/or tilted slightly at its connection to end cap160on the dorsal surface of the selectively moveable clamp72. This versatility in positioning mitigates spatial restrictions while providing enhanced surgeon control without the required assistance of others who are not scrubbed and without increased risk of contamination of the surgical field.

The use of the base station assembly10as part or component of a larger surgical system will now be discussed. With reference toFIG.1throughFIG.9, during some operational embodiments, the vertical support arm74is attached at an inferior end174to the selectively moveable clamp72, as well as a superior end172to the cylinder sheath200along with the respective knobs194,205. The resulting assembly can thereby be sterilized as an assembled unit prior to surgery and be ready to be handed to the scrub technician by a circulating operating room nurse, according to standard operating room protocol. When the surgeon wishes to attach the selectively moveable clamp72to one of the arcuate rail members106,110, he or she simply holds the entire assembly, comprised of the cylindrical sheath200, the vertical support arm74, and the selectively moveable clamp72at its upper end, grasping the cylindrical sheath200, thereby suspending the selectively moveable clamp72such that it hovers over the intended appropriate arcuate rail member106,110. It should be noted that arcuate rail member106,110would be approximately at knee level and would therefore not be considered sterile. As discussed herein, the selectively moveable clamp72may be moved between the arcuate rail member106and the arcuate rail member110, if and when it were required, as shown by arrow M1. The circulating operating room nurse may then take hold of the selectively moveable clamp72at the body130, guiding the body130so that the arcuate rail member106or arcuate rail member110is accepted into the distance d formed between the rollers140,144and the rollers142,146.

Moreover, with some practice, the surgeon will likely be able to connect the selectively moveable clamp72attached to the vertical support arm74and the cylindrical sheath200to the base station70without any external help. Accordingly, with the control knob194in the release position, the surgeon can move the entire selectively moveable clamp72with the vertical support arm74around the base station70attached to the operating room table12by moving the top of the cylindrical sheath200. Standard operating room protocol considers surgical drapes to be sterile above a horizontal plane that approximates the bottom edge of the operating room tabletop14, below which surgical sterility is assumed questionable. Scrubbed operating room personnel are taught that they are considered sterile down to their waist, but not below. Similarly, the base station assembly10should be considered sterile down to this same approximate level, and the surgical team must avoid contaminating themselves by touching the lower part of the base station assembly10. Indeed, the lower half of the vertical support arm74may have a different color or a distinctive brushed or ribbed finish as a reminder that this area is not considered sterile. This should not present any problem, however, since the operating room team should already know that one cannot lower his or her arms below the waist.

It is suggested that the bottoms of the surgical drape36that fall naturally from the draping of the head of the patient P be gathered with sterile gloves by a circulating operating room nurse and tucked inside the inner rail member110of the two rail, vertically offset embodiment. If the surgeon is utilizing a single rail embodiment, the drapes should be positioned within the single rail, whether it be rail member106or110. As mentioned, if the surgeon has the OR table set to be very high, the bottoms of the drapes may be higher than any of the rails, regardless of which embodiment is being utilized, and the drape holder120will be required to control the drapes within the arcuate space122defined by the drape holder120. In this way, both arcuate rail members106,110may be easily seen by the surgeon, and the selectively moveable clamps72and their respective vertical support arms74can be attached and moved about their respective arcuate rail members106,110as the surgeon so desires from the start of surgery and throughout the operative procedure. Obviously, the surgeon may prefer to use the drape holder120for all occasions, because it ensures the best visualization of the arcuate rails106,110, which may facilitate the placement of various selectively moveable clamps72on the base station70. If the surgeon requires the height of the operating room table12to be unusually high, the tails of the surgical drape36may end above the height of the arcuate rail member106, which would normally hold the surgical drape36out of the way, as discussed previously. In this case, the drape holder120can simply be adjustably moved toward the top of the OR table as necessary.

Once the surgeon has attached the selectively moveable clamp72to the base station70, the surgeon can make positioning adjustments then or at any subsequent time during surgery without external help. This feature provides remarkable adjustability of surgical accessories such as brain retractors and surgical armrests all controlled by the surgeon without requiring assistance from the circulating operating room nursing staff. Simply loosening the control knob194on the vertical support arm74allows the surgeon to move an accessory such as a brain retractor(s) around the2860or2740arcuate pathways of the rails106,110of the center-point base station300, for example, as required during surgery, and repositioning can be repeated whenever necessary. This remarkable adjustability of positioning of the selectively moveable clamps72is illustrated inFIG.20. On the other hand, a selectively moveable clamp72can be added to or removed from an arcuate rail106,110at any time. Moreover, the surgeon can rotate the elongated member170at its attachment to the selectively moveable clamp72at the joint162, thereby moving an accessory closer or farther away from the operative site because of the curve S configuration of the elongated member170. It may be necessary to adjust the radial positioning of the selectively moveable clamp72on the base station70as part of this maneuver. If desired by the surgeon, the elongated member170will tilt slightly on its attachment at joint162for more subtle adjustment which can be maintained by tightening the control knob194to lock the selectively moveable clamp72and its relationship to the elongated member170in position. With respect toFIGS.7A and7B, there may be space around the joint162, by way of machining or other technique, to allow some “play” when tightening occurs. Approximately 7° of tilt at the joint162can be so achieved, which correspondingly moves the ring member216at the top of the vertical support arm74approximately 3 cm in a plane parallel to the floor. It is therefore suggested that tilting of the vertical support arm74is a quick and simple method to achieve subtle positioning adjustment of the accessory76.

As mentioned, at the superior end172of the elongated member170, the attachment member198may include the cylindrical sheath200with the hand adjustment knob218to adjust the height of the cylindrical sheath200, which can telescope on the vertical support arm74and be locked in place with the hand adjustment knob205. Indeed, the lengths (the height, functionally speaking) of the vertical support arm74may be whatever is comfortable for the operating team, and embodiments of different lengths can be kept sterile to address surgeon preference.

Moreover, various selectively moveable clamps72with vertical support arms74can be added to or removed from the base station70as needed without having to struggle with wet, bloody drapes. After an anesthetized patient is positioned on the headrest40and the surgical site is prepped and draped, the surgical drapes are gathered together within the base station70, such as within the drape holder120, or alternatively, within the arcuate rail member106or the arcuate rail member110in a base station70configured with only the outer arcuate rail member, as mentioned previously. In this way, the2100and1950orbits, for example, of the double rail base station302remain freely accessible initially and throughout the surgical procedure. The surgeon determines how many selectively moveable clamps72may be needed for the procedure. The various vertical support arms74may be positioned where the surgeon thinks they will be required, or they may be clustered at either or both arcuate ends of the base station70to be moved into place later as needed. Additional selectively moveable clamps72with vertical support arms74may be added or removed as needed at any time during the surgery. As mentioned, it should be appreciated that the traffic involving the selectively moveable clamps72may require forethought and planning. Using two arcuate rail members allows one selectively moveable clamp72to be moved past another selectively moveable clamp72without interrupting the process of surgery.

The order of execution or performance of the methods and process flows illustrated and described herein is not essential, unless otherwise specified. That is, elements of the methods and process flows may be performed in any order, unless otherwise specified, and that the methods may include elements than those disclosed herein. For example, it is contemplated that executing or performing a particular element before, contemporaneously with, or after another element are all possible sequences of execution.

While this invention has been described with reference to illustrative embodiments, this description is not intended to be construed in a limiting sense. Various modifications and combinations of the illustrative embodiments as well as other embodiments of the invention, will be apparent to persons skilled in the art upon reference to the description. It is, therefore, intended that the appended claims encompass any such modifications or embodiments.