CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation-in-part of application Ser. No. 11/095,586 filed Apr. 1, 2005 and entitled “Support System for Use When Performing Medical Imaging of a Patient” which claims the benefits of Provisional Application No. 60/559,414 filed Apr. 2, 2004, Provisional Application No. 60/575,792 filed May 28, 2004, and Provisional Application No. 60/614,593 filed Oct. 1, 2004 under 35 U.S.C. § 119(e), and the entire contents of each of these applications are expressly incorporated herein by reference thereto.
In addition, the benefits of Provisional Application No. 60/709,098 filed Aug. 18, 2005, Provisional Application No. 60/730,853 filed Oct. 28, 2005, Provisional Application No. 60/772,863 filed Feb. 14, 2006, and Provisional Application No. 60/773,638 filed Feb. 16, 2006, each entitled “System for Positioning a Laparoscopic Device,” as well as Provisional Application No. 60/821,692 filed Aug. 7, 2006 and entitled “System and Method for Positioning a Laparoscopic Device” are claimed under 35 U.S.C. § 119(e), and the entire contents of these provisional applications are expressly incorporated herein by reference thereto.
FIELD OF THE INVENTION The invention relates to a system for positioning a laparoscopic device. In particular, the invention relates to a holder and curvilinear articulating arm for positioning a laparoscopic device such as an endoscopic camera.
BACKGROUND OF THE INVENTION During laparoscopy, a minimally invasive surgical procedure in which tissue for example may be removed from the abdomen or chest through a small puncture wound, the laparoscopic surgery is performed with the aid of an endoscopic camera. The camera is placed through a port in the skin into a working cavity and may be used for example to visually examine the interior of the cavity such as the peritoneum or surgical planes or spaces created for purposes of dissection. Typically, the camera includes a light source. Correct positioning and aim of the laparoscopic camera and light throughout a procedure are fundamental to laparoscopy.
Most commonly, the endoscopic camera is held by an assistant who must continually watch the video monitor and hold a steady position until the surgeon requests a change in the field of view. Alternatively, a variety of robotic arms have been designed to hold the camera and move for example on voice command by the surgeon. Such systems include the AESOP® (Automated Endoscopic System for Optimal Positioning) voice controlled robot system and the Zeus® minimal invasive surgical robot system from Computer Motion Inc./Intuitive Surgical Inc. Mechanical/electrical servomotor controlled systems that move by foot controls, palm and fingertip controls include the LAPMAN® by MedSys s.a. of Belgium, while a remote, manual control system da Vinci® is available from Intuitive Surgical Inc.
In addition, a variety of known mechanical frameworks that have multiple adjustment and locking points can be used to hold an endoscopic camera including a laparoscopic retractor from Thompson Surgical Instruments, the Martin Arm System from Gebrüder Martin GmbH & Co. KG, and the Omni-Tract® surgical retractors from Minnesota Scientific Inc. These devices have the capability of holding other laparoscopic instruments as well, although different connections at the instrument interface may be required depending on the instrument and the application.
The first choice for any surgeon is to have a good human assistant, who can continuously and accurately aim and focus the camera and light on the moving surgical field. Unfortunately, good assistance, or any assistance for that matter, is frequently unavailable, and the surgeon must work solo. Also, occasions frequently arise where an assistant's hands may be occupied by other tasks, such as retraction and suction, and in these circumstances other means for holding the camera also are required. The alternatives for holding and positioning the camera cited above then come into play. However, these alternatives each have one or more troublesome drawbacks. The high end robotic arms (such as da Vinci) are expensive, have high maintenance requirements, are time consuming and cumbersome to set up and may have high cost disposable components. They also require an experienced assistant or technician to be present. The simpler, voice controlled (AESOP) or palm radio controlled (LAPMAN) robotic arms also require significant maintenance and set up time, move too slowly for many surgeons, and are hard to precisely control. The mechanical arms and frameworks that are available typically have too many movable parts that require adjustment, require two hands for re-positioning, may have a large footprint near the surgical field, and are very slow to re-position because of the several joints that must be loosened and retightened.
Thompson Surgical Instruments also offers a Flexbar Scope Holder (product #42133C). This device has a clamp to the bedside railing and a set of stainless steel rods that may be clamped at a desired length with right angle clamps to position the base attachment of a curvilinear flexible arm. The arm uses a combination of a screw and cam locking mechanism to achieve an adjustable friction lock of the arm. In this device, the clamp that holds the laparoscopic camera at the free end of the flexible arm has limited capabilities; the clamp becomes locked dimensionally with the arm and is not a universal joint. The design of the scope holder generally requires a user to loosen and then retighten the locking mechanism for the arm whenever it is necessary to reposition the laparoscope.
Thus, there remains a need for better holding and positioning devices for laparoscopic instruments in general and for the laparoscopic camera (laparoscope) in particular. In particular there is a need for a device that will hold a laparoscope steady when it is not in hand, may be quickly re-positioned using one hand, allows quick engagement and disengagement to a laparoscopic instrument, and has a minimal and movable footprint on the surgical field.
SUMMARY OF THE INVENTION The invention relates to a system for positioning a laparoscopic device, the system having a holder. The holder includes a central portion having a first member operatively associated with a second member, the members selectively movable with respect to one another along a central axis, the central portion having a proximal end defined by the first member and a distal end defined by the second member. The holder also has at least three proximal rotational joints coupled to the first member proximate the proximal end, at least two distal rotational joints coupled to the second member proximate the distal end, a clamp configured and dimensioned for retaining a laparoscopic device, and a coupling portion proximate a first of the proximal rotational joints. A first of the distal rotational joints is coupled to the distal end of the central portion and a second of the distal rotational joints is coupled to the clamp.
In some embodiments, the members may telescope with respect to one another. The second member may be slidably received in the first member. The first member may have a slot and the second member may have a protrusion, the protrusion movable within the slot. For example, the protrusion may include a roller key. Also, in some embodiments, the second member may include a piston member proximate an end thereof the piston member disposed within the first member. The piston member may be spring-loaded with a spring oriented transverse to the central axis.
The first member may include a receiving end for receiving the second member and a bushing coupled to the receiving end, with the bushing having a plurality of fingers disposed radially with respect to the central axis.
Each of the proximal and distal rotational joints may include a thrust bearing which may be a steel ball thrust bearing. In addition, each of the proximal rotational joints may include a washer abutting a spacer and rotatable with respect to each other. In some embodiments, the spacer may be formed of a material that is polytetrafluoroethylene-based. Each of the distal rotational joints may include a washer abutting a spacer and rotatable with respect to each other. In some embodiments, the spacer may be formed of a material comprising acetal homopolymer. Each of the proximal and distal rotational joints may include a spacer, each of the spacers of the proximal rotational joints having a first thickness and each of the spacers of the distal rotational joints having a second thickness, the first thickness being smaller than the second thickness.
The at least three proximal rotational joints may be three proximal rotational joints that each permit movement in a separate plane, and at least two of the planes may be parallel to one another.
The first of the distal rotational joints may permit rotation about an axis coinciding with the main axis and the second of the distal rotational joints may permit rotation about an axis transverse to the main axis. Also, the second of the distal rotational joints may permit rotation about an axis generally perpendicular to the main axis.
The clamp may include a pair of spring-biased jaw members each having a cover formed of a material softer than aluminum, the clamp being configured and dimensioned to retain the laparoscopic device while contacting the covers. For example, each cover may be formed of polyurethane.
The laparoscopic device may have a cylindrical portion. The first member may be tubular. Each of the proximal and distal rotational joints may have a first portion rotatable with respect to a second portion about a fixed axis. The first and second members may be movable with respect to each other along the central axis but may not be rotatable with respect to each other.
The system may further include a curvilinear articulating arm, the holder being coupled to the curvilinear articulating arm. In addition, the system may further include a tray configured and dimensioned for supporting a mammal, the curvilinear articulating arm being coupled to the tray.
The coupling portion may include a clamp for coupling to a support, wherein the support is selected from the group consisting of a rail of a table and a rail of a bed.
Each proximal rotational joint and each distal rotational joint may permit 360° of rotation about an axis thereof.
The invention also relates to a system for positioning a laparoscopic device including a curvilinear articulating arm and a holder having at least two rotational regions and a clamping portion for receiving the laparoscopic device, the holder being coupled to the curvilinear articulating arm. The at least two rotational regions are permitted to articulate. The holder may further include a central portion with a selectively adjustable length along a central axis, wherein the at least two rotational regions are disposed between the central portion and the clamping portion. In some embodiments, the holder further includes a central portion with a selectively adjustable length along a central axis, the central portion having a proximal end and a distal end, wherein the at least two rotational regions includes at least three proximal rotational joints disposed proximate the proximal end and at least two distal rotational joints disposed between the distal end and the clamping portion. The at least two rotational regions may include a thrust bearing.
In addition, the invention relates to a method of positioning a laparoscopic device in a skin port of a mammal, the method including: coupling the laparoscopic device to a holder comprising a clamping portion and five rotational joints, the laparoscopic device being partially retained in the clamping portion; disposing the laparoscopic device partially within the skin port; positioning the laparoscopic device by selectively rotating portions of the holder with respect to one another. The method may further include positioning the laparoscopic device by selectively adjusting a length of the holder along a central axis. The holder may further include first and second members selectively movable with respect to one another. The length may be selectively adjustable by moving the first and second members with respect to each other. The length may be selectively adjustable by telescoping the first member with respect to the second member. Movement of the first and second members may be restricted to linear movement along the central axis, and the holder may be manually operated.
In some embodiments, the method may further include: coupling the holder to a curvilinear articulating arm; and articulating the curvilinear articulating arm. Also, the method may further include: coupling the curvilinear articulating arm to a tray configured and dimensioned for supporting the mammal. Moreover, the method may further include: coupling the curvilinear articulating arm to a support, wherein the support may be selected from the group consisting of a rail of a table and a rail of a bed. The laparoscopic device may be held in a selected position while disposed partially within the skin port without locking movement of the rotational joints of the holder.
The invention also relates to a method of positioning a laparoscopic device in a skin port of a mammal, the method including: securing the laparoscopic device to a holder comprising at least two rotational joints; coupling the holder to a curvilinear articulating arm; disposing the laparoscopic device partially within the skin port; positioning the laparoscopic device by selectively articulating the curvilinear articulating arm and selectively rotating portions of the holder with respect to one another.
The method may further include: positioning the laparoscopic device by selectively adjusting a length of the holder along a central axis, wherein the holder further comprises first and second members selectively movable with respect to one another, and wherein the length is selectively adjustable by moving the first and second members with respect to each other. Also, the laparoscopic device may be held in a selected position while disposed partially within the skin port without locking movement of the rotational joints of the holder.
The invention further relates to a system for positioning a laparoscopic device such as a camera, the system including a curvilinear articulating arm and a holder that has at least two rotational regions as well as a clamping portion for receiving the laparoscopic device. The holder is coupled to the curvilinear articulating arm, and wherein the at least two rotational regions are permitted to articulate. The at least two rotational regions may be provided by one or more types of structures selected from the group consisting of a rotational joint, a rocking joint, and a living hinge. The at least two rotational regions may be permitted to freely articulate.
The invention also relates to a method of positioning a laparoscopic device in a skin port of a patient, the method including: securing the device in a holder permitted to articulate about at least two rotational regions; coupling the holder to a curvilinear articulating arm; disposing the device partially within the skin port; positioning the device by articulating the curvilinear articulating arm with the device moving in response to the articulation. The orientation of the device, such as a laparoscopic camera, thus may be set. The holder may be permitted to freely articulate about at least two rotational regions.
The present invention further relates to a new set of devices and a method that is particularly suited for holding, positioning and repositioning a laparoscopic camera throughout a laparoscopic surgical procedure. The device includes a holder with joints for permitting rotational movement and positioning of a clamping end for securing a laparoscopic instrument. Fixed positioning and manual re-positioning may be quickly accomplished by simply overcoming the modest frictional resistance to movement within the devices without any mechanical adjustments after the initial set up. The joints of the holder may remain free to move at all times. When the holder is static it preferably will not move, and thus, in effect, becomes self locking because of the physical/mechanical relationship of the various system components including the laparoscopic instrument such as an endoscopic camera which is secured in the holder and extending through the skin of the patient. In addition, the multi-modality holder has alternative functionality for holding and positioning other laparoscopic instruments.
In one exemplary embodiment, the present invention comprises an articulating arm that may be attached at one end to a surgical table, and that has the capability of movement in three dimensions (i.e., at least three degrees (x, y and z) of freedom) at a free end. This arm has a receiving mechanism at the free end that can accept a variety of instrument holding devices one of the main ones of which is a laparoscopic instrument holder for coupling to the free end of the articulating arm and for positioning a laparoscopic device such as an endoscopic camera.
BRIEF DESCRIPTION OF THE DRAWINGS Preferred features of the present invention are disclosed in the accompanying drawings, wherein:
FIG. 1 is a perspective view of a laparoscopic instrument holder system according to the present invention, showing an exemplary arrangement with aholder100 although the other exemplary holders disclosed herein may instead be used in such a system in place ofholder100;
FIGS. 2A-2I show a first embodiment of a laparoscopic instrument holder according to the present invention, including (2A) a perspective view, (2B) a partial cross-sectional front view of a portion of the holder, (2C) a front view, (2D) a back view, (2E) a first side view, (2F) a second side view, (2G) a bottom view, (2H) a top view, and (2I) a perspective view of the mating ofmovable clamping jaws122 andfinger rest portion126;
FIGS. 3A-3G show another embodiment of a laparoscopic instrument holder according to the present invention, including (3A) a perspective view, (3B) a front view, (3C) a back view, (3D) a first side view, (3E) a second side view, (3F) a bottom view, and (3G) a top view;
FIGS. 3H-3N show yet another embodiment of a laparoscopic instrument holder according to the present invention, including (3H) a perspective view, (3I) a front view, (3J) a back view, (3K) a first side view, (3L) a second side view, (3M) a bottom view, and (3N) a top view;
FIG. 3-O shows a perspective view of the holder ofFIGS. 3H-3N with a modified member and clamping portion mounted thereon;
FIG. 3P-3Q show another embodiment of a laparoscopic instrument holder according to the present invention, including (3P) a perspective view and (3Q) a front view;
FIG. 3R shows a perspective view of a portion of another clamping system for use with the present invention;
FIG. 3S shows a partial cross-sectional side view of the clamping system ofFIG. 3Q;
FIGS.3AA-3EE show another embodiment of a laparoscopic instrument holder according to the present invention, including (3AA) a perspective view with a laparoscopic instrument retained by said holder, (3BB) a partial perspective view, (3CC) a partial cross-sectional perspective view, (3DD) another perspective view, and (3EE) another partial cross-sectional perspective view;
FIGS.3FF-3-UU show another embodiment of a laparoscopic instrument holder according to the present invention, including (3FF) a perspective view with a laparoscopic instrument retained by said holder, (3GG) a partial perspective view including several rotational joints, (3HH) a partial cross-sectional perspective view including the rotational joints of the previous figure, (3II) another partial perspective view including the rotational joints of the previous figure, (3JJ) a partial bottom view of the linear length adjustment portion of the holder, (3KK) a partial top view thereof and (3LL) a partial cross-sectional side view thereof, (3MM) a partial cross-sectional side view of a coupling assembly, (3NN) a partial perspective view of several rotational joints, (3-OO) another partial cross-sectional perspective view of several rotational joints and clamp, (3PP) a side view of a clamp, (3QQ) another side view of the clamp, and (3RR to3UU) partial perspective views of the clamp;
FIGS.3VV-3WW show an embodiment of a rotational joint for use with laparoscopic instrument holders of the present invention, including (3VV) a partial side view and (3WW) a partial cross-sectional side view;
FIGS.3XX-3ZZ show another exemplary embodiment of a coupling portion for use with laparoscopic instrument holders of the present invention, including (3XX) a first side view, (3YY) a second side view, and (3ZZ) a partial cross-sectional perspective view;
FIGS.3AAA-3HHH show another embodiment of a laparoscopic instrument holder according to the present invention, including (3AAA) a perspective view with a laparoscopic instrument retained by said holder, (3BBB) a first partial side view, (3CCC) a second partial side view, (3DDD) a third partial side view, (3EEE) a partial cross-sectional side view of a piston member couple to a sliding member, (3FFF) a partial perspective view of several rotational joints, (3GGG) a partial perspective view of a rotational joint with joint members, and (3HHH) a partial perspective view of a clamp;
FIGS. 4A-4C show the curvilinear articulating arm assembly ofFIG. 1, including (4A) a perspective view, (4B) a partial cross-sectional perspective view, and (4C) a partial side view;
FIGS. 4D-4L show the base handle ofFIG. 1, including (4D) a first side view, (4E) a second side view, (4F) a partial perspective view of a first set of components thereof, (4G) a partial side view of a second set of components thereof, (4H) another partial side view of the second set of components thereof, (4I) a front view, (4J) a back view, (4K) a top view, and (4L) a bottom view;
FIG. 4M shows a perspective view of a rail clamp for use with the present invention;
FIGS. 4N-4T show the free handle ofFIG. 1, including (4N) a first side perspective view showing a portion of a tensioning wire therewith, (4-O) a second side perspective view, (4P) a partial perspective view showing a first set of components thereof, (4Q) a front perspective view, (4R) a back perspective view, (4S) a top perspective view, and (4T) a bottom perspective view;
FIG. 4U shows a side perspective view of the interface lock of the free handle ofFIGS. 4N-4T;
FIG. 5 shows a perspective view of a support system according to the present invention; and
FIGS. 6A-6C show the tray ofFIG. 5, including (6A) a top view, (6B) a cross-section taken perpendicular to the central axis of the tray, and (6C) a partial cross-section showing detail taken at VIC.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The instrument holders described herein are particularly useful in minimally invasive surgical procedures using a laparoscope (laparoscopic camera), which is a type of endoscope (endoscopic camera). It should be understood that each of the terms laparoscope, laparoscopic camera, endoscope, and endoscopic camera as individually used with respect to any particular embodiment are not meant to limit that embodiment to a laparoscopic or endoscopic context.
Referring initially toFIG. 1, an exemplary embodiment of a laparoscopicinstrument holder system10 according to the present invention is shown.Holder system10 includes a curvilinear articulatingarm assembly12 and alaparoscopic instrument holder14 coupled toassembly12 as indicated by arrow A. As will be further described,arm assembly12 includes aclamp16 at a first free end thereof forcoupling system10 to a structure such as the rail18 (shown schematically in phantom) of an operating room table.
Turning next toFIGS. 2A-2G, a first exemplary embodiment of alaparoscopic instrument holder100 according to the present invention is shown.Holder100 includes acoupling portion102 in the form of a post. Couplingportion102 preferably is configured to be received inportion681 offree handle662 of articulatingarm assembly12, as will be described later.Holder100 includes abody portion104 with ashaft portion106 extending from an end thereof and forming a first rotational joint. As shown in the partial cross-sectional side view ofFIG. 2B,shaft portion106 may be formed as a screw with ahead106a, a cylindrical shaft106b, and a threadedend106cthat may be received in threaded hole104ainbody portion104. Afirst member108 is mounted onshaft portion106 and particularly cylindrical shaft106bso thatshaft portion106 extends within abore108ainfirst member108. In the preferred exemplary embodiment, there is minimal frictional resistance to rotational movement ofportion106 andfirst member108 with respect to one another so that these components are freely rotatable with respect to one another. However, the tolerance between the components preferably is selected to minimize other play therebetween, and the coupling between the components preferably is such that minimal translation of one component with respect to the other component is permitted along their central axis of rotation.
In alternate embodiments,portion106 andfirst member108 are mechanically associated with each other such that frictional engagement of these components provides limited resistance to rotational movement ofportion106 andfirst member108 with respect to each other. However, the frictional engagement preferably permits relative rotation ofportion106 andfirst member108 when sufficient manual, external force is applied as by asurgeon using holder100 during a medical procedure.
Shaft portion106 andfirst member108 are disposed preferably at right angles with respect to each other.First member108 preferably includes ashaft portion110 that may be formed as a screw with ahead110a, a cylindrical shaft110b, and a threadedend110cthat may be received in threaded hole108binfirst member108.Shaft portion110 forms a second rotational joint.
Holder100 further includes asecond member112 that is mounted onshaft portion110 and particularly cylindrical shaft110bso thatshaft portion110 extends within abore112ainsecond member112. In the preferred exemplary embodiment, there is minimal frictional resistance to rotational movement ofsecond member112 andportion110 with respect to one another so that these components are freely rotatable with respect to one another. However, the tolerance between the components preferably is selected to minimize other play therebetween, and the coupling between the components preferably is such that minimal translation of one component with respect to the other component is permitted along their central axis of rotation.
In alternate embodiments,portion110 andsecond member112 are mechanically associated with each other such that frictional engagement of these components provides limited resistance to rotational movement ofportion110 andsecond member112 with respect to each other. However, the frictional engagement preferably permits relative rotation ofportion110 andsecond member112 when sufficient manual, external force is applied as by asurgeon using holder100 during a medical procedure.Shaft portion110 andsecond member112 are disposed preferably at right angles with respect to each other.
In one preferred exemplary embodiment, the joints formed by rotational movement ofportion106 andfirst member108 with respect to each other, and by rotational movement ofportion110 andsecond member112 with respect to each other, do not lock and are disposed at about 90° to each other. Preferably, the joints provide loose coupling between the components so that they may freely rock back and forth and be angulated.
In a preferred exemplary embodiment, a stop104bis created at the transition from a first circumference ofbody portion104 to a smaller circumference of cylindrical shaft106b. Preferably, the length of cylindrical shaft106bis chosen to be approximately the length ofbore108ainfirst member108 so that a portion offirst member108 may be retained betweenhead106aandbody portion104.
In some alternate embodiments,portion106 optionally may be tightened to provide substantial resistance to rotational movement ofbody portion104 andfirst member108 with respect to one another.
Similarly, a stop108cis created at the transition from a first circumference offirst member108 to a smaller circumference of cylindrical shaft110b. Stop108cmay includewasher113 disposed betweenfirst member108 andsecond member112. Preferably, the length of cylindrical shaft110bis chosen to be approximately the length ofbore112ainsecond member112 so that a portion ofsecond member112 may be retained betweenhead110aandfirst member108. In the preferred embodiment,portion110 provides minimal frictional resistance to rotational movement. However, in an alternate embodiment,portion110 optionally may be tightened to provide substantial resistance to rotational movement offirst member108 andsecond member112 with respect to one another.
Second member112 includes a preferablyarcuate clamping portion114. In addition, a pair ofholes116 extend intosecond member112 and are disposed on either side of centrallongitudinal axis118 thereof.Holes116 are configured and dimensioned to receive end portions ofsprings120, which extend out ofholes116 and each may partially be disposed in agroove120ainsecond member112. Movable clampingjaws122 are “spring loaded,” with end faces122aabutting ends ofrespective springs120. Thus, springs120bias clamping jaws122 so that face122fis biased toward clampingportion114. The slot formed between face122fand clampingportion114 is designed so that the spring loading alone is sufficient to hold a laparoscope securely in place therein, but also to let the laparoscope rotate with sufficient frictional resistance to prevent undesired movement.
Aset screw assembly124 releasably and adjustably couples movable clampingjaws122 tosecond member112. Preferably, only slight rotation ofassembly124 is permitted, e.g., one-quarter turn clockwise or counterclockwise. Such turning may loosen or tighten the engagement ofmovable clamping jaws122 andfinger rest portion126 with respect to one another thus respectively permitting or hindering movement of spring-loadedclamping jaws122.
In alternate embodiments, setscrew assembly124 may be any component(s) or manner of fixedly couplingfinger rest portion126 tosecond member112.
As shown for example inFIG. 2I, afinger rest portion126 includes a central raisedportion126aan a lower face126b. Central raisedportion126ais slidably received in aslot122binmovable clamping jaws122. Travel of clampingjaws122 is limited and governed byslot122bwhich includes astop portion122e. Slot122bis symmetrically disposed with respect toaxis118. Finger rests122c,122dare disposed at a free end ofmovable clamping jaws122.Finger rest portion126 is positionally fixed with respect tosecond member112, with a threadedscrew124aofscrew assembly124 extending throughhole126c. A knurled knob124bmay be provided as well as aset screw124c(shown inFIG. 2E) extending into the shaft ofscrew124a.
Finger rest portion126 includes afinger rest surface126dwhich provides sufficient surface area for accommodating a portion of a user's finger such as the fleshy tip of a user's thumb. Similarly, finger rests122c,122dofmovable clamping jaws122 each provide sufficient surface area for accommodating a portion of another of a user's fingers. Thus, in use, in order to adjust the spacing between arcuate clampingportion114 and clamping face122fofmovable clamping jaws122, a user may graspfinger rest portion126 with his or her thumb disposed onsurface126dand two other fingers disposed on rests122c,122d, and squeeze so that the spacing d between arcuate clampingportion114 and clamping face122fis increased. Movement of clampingjaws122 also is limited by the combined lateral distance defined by spacings d, e, particularly because of the fixed position offinger rest portion126 with respect tosecond member112 as well as the maximum travel ofsurfaces122aofmovable clamping jaws122 with respect to surfaces112bofsecond member112.
Thus, an object such as an endoscopic camera may be releasably retained in the space betweenportion114 and clamping face122f.Finger rest portion126 thus serves as a quick-release for such an object. Because clamping end face122fis movable with respect toarcuate clamping portion114 ofsecond member112, a variety of sizes and geometries of laparoscopic devices such as a endoscopic camera may be releasably retained within the region between clampingportion114 and clamping end face132a,132b. Although a single end face132ais shown, other configurations may be used including a bifurcated arrangement of clamping faces, or more than two distinct end faces or extensions such as a three “tine” fork configuration.
In use, when an object such as an endoscopic camera is secured byholder100, the rotational joints thereof are freely movable. However, once the camera is passed through a hole in a patient's skin, the camera may be aligned to provide the desired view through the use of curvilinear articulatingarm assembly12. Because the size of the entry hole in the patient's skin is limited, such an object disposed therein is unable to move substantially laterally, but may be angulated as by usingarm assembly12.
Arm assembly12 andholder100 may be disposed in a sterile sleeve cover so that a sterile environment may be maintained for example when an endoscopic camera is coupled thereto and in use. Sterile covers for holder systems such assystem10 preferably are designed to cover the entire apparatus and slide on easily when articulatingarm assembly12 is in the semi-rigid “gooseneck lamp” mode (i.e. withonly lever682 locked, as will be explained). Such covers, preferably formed of transparent or semi-transparent flexible polymer as known in the art, obviate the need for much cleaning and enable full function and use ofsystem10 in a sterile field. The scope retained byholder100 is engaged by opening the spring-loaded slot between face122fand clampingportion114 and working the mechanism ofholder100 through the cover, invaginating the cover into this slot with the scope then retained. The cover preferably withstands repeated engage/disengage cycles and scope rotations.
A variety of materials may be used to form the holder systems of the present invention. For example, components may be formed of polymer such as injection molded polymer, or metallic materials such as aluminum. Wherein springs are used, the springs for example may be formed of steel.
Although the center ofsecond member112 ofholder100 may be offset a distance d1from the central longitudinal axis ofcoupling portion102 andbody portion104, in some embodimentsfirst member108 may be configured so that the center ofsecond member112 may be aligned to be coaxial with the central longitudinal axis ofcoupling portion102 andbody portion104.
Turning toFIGS. 3A-3G, a second exemplary embodiment of alaparoscopic instrument holder300 according to the present invention is shown.Holder300 includes acoupling portion302 in the form of a post that optionally may include a circumferential groove therein (not shown). Couplingportion302 preferably is configured to be received in portion82 of free handle62 of articulatingarm assembly14, as will be described later.Holder300 includes abody portion304 with a preferably cylindricalfree end portion306 forming a first rotational joint. In particular, afirst member308 is mounted onend portion306 so thatend portion306 extends within a bore308ainfirst member308. In the preferred exemplary embodiment, there is minimal frictional resistance to rotational movement ofportion306 andfirst member308 with respect to one another so that these components are freely rotatable with respect to one another. However, the tolerance between the components preferably is selected to minimize other play therebetween, and the coupling between the components preferably is such that minimal translation of one component with respect to the other component is permitted along their central axis of rotation.
In alternate embodiments,portion306 andfirst member308 are mechanically associated with each other such that frictional engagement of these components resists rotational movement ofportion306 andfirst member308 with respect to each other. However, the frictional engagement preferably permits relative rotation ofportion306 andfirst member308 when sufficient manual, external force is applied as by a usingholder300 surgeon during a medical procedure.
End portion306 andfirst member308 are disposed preferably at right angles with respect to each other.First member308 preferably includes a cylindricalfree end portion310 forming a second rotational joint.
Holder300 further includes asecond member312 that is mounted onend portion310 so thatend portion310 extends within abore312ainsecond member312. Again, in the preferred exemplary embodiment, there is minimal frictional resistance to rotational movement ofportion310 andsecond member312 with respect to one another so that these components are freely rotatable with respect to one another. However, the tolerance between the components preferably is selected to minimize other play therebetween, and the coupling between the components preferably is such that minimal translation of one component with respect to the other component is permitted along their central axis of rotation.
In alternate embodiments,portion310 andsecond member312 are mechanically associated with each other such that frictional engagement of these components resists rotational movement ofportion310 andsecond member312 with respect to each other. However, the frictional engagement preferably permits relative rotation ofportion310 andsecond member312 when sufficient manual, external force is applied as by asurgeon using holder300 during a medical procedure.
End portion310 andsecond member312 are disposed preferably at right angles with respect to each other.
Second member312 includes a clampingportion314 that may be arcuate such as U-shaped or may be another retaining shape such as V-shaped. In addition, a pair ofholes316 extend intosecond member312 and are disposed on either side of centrallongitudinal axis318 thereof.Holes316 are configured and dimensioned to receive end portions ofsprings320, which extend out ofholes316. Movable clampingjaws322 are “spring loaded,” with end faces322a,322babutting ends ofrespective springs320. Aset screw assembly324 andrespective washer326 releasably and adjustably couples movable clampingjaws322 tosecond member312. As shown for example inFIG. 3E, which shows a view withscrew assembly324 andwasher326 removed, aslot328 guides movement ofmovable clamping jaws322 alongaxis318, with the shaft portion ofscrew assembly324 being threadably received in central threaded hole330 insecond member312. Oval shapedslot328 permits limited movement, with the shaft ofscrew assembly324 being stopped from further movement at either end ofslot328.
Clamping end faces332a,332bthat are movable with respect toarcuate clamping portion314 ofsecond member312, and thus a variety of sizes and geometries of laparoscopic devices such as a endoscopic camera may be releasably retained within the region between clampingportion314 and clamping end faces332a,332b. Although end faces332a,332bare shown in a bifurcated arrangement, other configurations may be used including a single clamping face such as a larger end face332aor332b, or more than two distinct end faces or extensions such as a three “tine” fork configuration.
In some embodiments,screw assembly324 may include a threaded screw324a, a knurled thumb portion324b, and a set screw324c(shown inFIG. 3D) extending into the shaft of screw324a.
Holders100,300 thus each incorporate a system of freely articulating joints and that supports a clamp for a laparoscope which may be aligned and attached along the long axis of the laparoscope. The instrument shaft may be held in alignment within the clamp opening by the spring-loaded clamp or in an alternate embodiment by using elastic band(s). The clamping mechanism ofholders100,300 preferably is of sufficient tension to hold the laparoscope in fixed alignment with the clamp body and yet allow rotation of the laparoscope about its long axis within the clamp. Proper functioning of this mechanism will allow for simple fixation ofholder100,300 to secure the laparoscope in a steady position without actually locking the individual joints in the universal system. Such a retention is permitted because the laparoscope shaft is firmly attached in three dimensions to the joint at the end ofholder100,300 and also passes through a second joint (the laparoscopic port) that is fixed in two dimensions at the skin. Bypositioning holder100,300, the camera may be positionally fixed unless the various frictional resistances previously set and controlled are overcome.
This design and method allows instantaneous and free movement and instant “re-locking” of the laparoscope position merely by relying on frictional resistance of the arm and clamp that is easily overcome for example by articulation by a surgeon, when desired, preferably by one handed positioning and re-positioning. Advantageously, thislaparoscope holder system100,300 is very simple mechanically, yet quick, reliable and easy to use. Also, it is a very quick and simple process to engage or disengage the laparoscope when desired.
The rotational joint provided, for example, by the coupling ofend portion310 andsecond member312 preferably allows a 360° range of rotation, because the range of motion required for the laparoscope is extreme. Offsetting the points of rotation of the joints is one preferred design solution.
In use, a straight, rod-like laparoscope extends both above and below the point of attachment of any clamp that is used to grasp it. Typically the laparoscope has power/light cords attached at the outer end that increase bulk in that region. Offsetting the rotational joints advantageously may permit better clearance between the outer end ofholder100,300 proximatesecond member112,312 and the bulkier external end of the laparoscope.
Referring next toFIGS. 3H to3-O, a third exemplary embodiment of alaparoscopic instrument holder400 according to the present invention is shown.
Holder400 includes acoupling portion402 in the form of a post that optionally may include a circumferential groove therein (not shown). Couplingportion402 preferably is configured to be received in portion82 of free handle62 of articulatingarm assembly14, as will be described later.Holder400 includes abody portion404 with a preferably threadedhole406 formed therein. Arotatable cradle408 is mounted on afree end404aofbody portion404, with awasher410 disposed therebetween. Ahole412 with a upper broadenedportion412ais disposed incradle408 and is configured and dimensioned to receive the shaft and head of a threadedscrew414. Rotation ofcradle408 aboutlongitudinal axis416 is permitted.
In one exemplary embodiment,body portion404,washer410, andcradle408 are mechanically associated with each other such that there is minimal frictional resistance to rotational movement between components so thatcradle408 and screw414 are freely rotatable with respect to one another (screw414 includes an unthreaded portion for this purpose). However, the tolerance between the components preferably is selected to minimize other play therebetween, and the coupling between the components preferably is such that minimal translation of one component with respect to the other component is permitted along their central axis of rotation. In alternate embodiments, frictional engagement of these components resists rotational movement of these components with respect to each other. However, the frictional engagement preferably permits relative rotation ofportion404 andfirst member408 when sufficient manual, external force is applied as by asurgeon using holder400 during a medical procedure.
Cradle408 includes spaced, preferablyparallel extensions418 defining aspace420. Alignedholes422a,422binrespective extensions418 receive a rod-shapedmember424 that extends therethrough.Member424, for example, may be press-fit inholes422a,422bso as to be fixed therein. Afirst clamping portion426 with a preferably generally C-shaped orarcuate face426ais mounted onmember424, such as bymember424 extending through a hole inportion426. First clampingportion426 is disposed betweenextensions418 and is permitted to swivel onmember424 about swivel orrotational axis428.
In one exemplary, preferred embodiment, there is minimal frictional resistance to rotational movement ofmember424 andfirst clamping portion426 with respect to one another so that these components are freely rotatable with respect to one another. However, the tolerance between the components preferably is selected to minimize other play therebetween, and the coupling between the components preferably is such that minimal translation of one component with respect to the other component is permitted along their central axis of rotation.
In alternate embodiments,member424 andfirst clamping portion426 may be mechanically associated with each other such that frictional engagement of these components resists rotational movement of these components with respect to each other. However, the frictional engagement preferably permits relative rotation ofmember424 andfirst clamping portion426 when sufficient manual, external force is applied as by asurgeon using holder400 during a medical procedure.
In a preferred embodiment, axes416,428 are oriented perpendicular to one another.
Angulation offirst clamping portion426 onmember424 permits a laparoscopic device such as a endoscopic camera, schematically shown inFIG. 3H ascomponent430, to be selectively positioned by a surgeon in a desired orientation.
Finally, asecond clamping portion432 is provided.Portion432 preferably is elastic, and in one preferred exemplary embodiment is a resilient rubber o-ring. Advantageously,member424 extends outward fromextensions418 such that a clampingportion432 in the form of an o-ring may be demountably coupled proximate ends thereof.Member424 may include a head or lip at each free end thereof to further assist incaptivating clamping portion432. Thus, acomponent430 may be releasably secured toholder400 by: restingcomponent430 against first clampingportion426 onsurface426a, coupling afirst loop section434aofsecond clamping portion432 tomember424, extendingsecond clamping portion432 overcomponent430, and coupling a second loop section434bofsecond clamping portion432 tomember424.
Although a resilient o-ring is shown, other alternate embodiments include for example a flexible clip.
An alternate embodiment ofholder400 is shown inFIG. 3-O. In this embodiment,member424 comprises a pair of opposing, aligned set screws440. Thus, clampingportion426 swivels on an axis defined byscrews440, with the screws extending in holes in clampingportion426. In addition, clampingportion426 further includes a recessedportion442 and a raisedportion444 separated byarcuate transition446 on the outer sides of eachextension418. Movement of clampingportion426, in some embodiments, may in part be guided bytransition446, which also may provide a stop to prevent over-rotation of clampingportion426 onmember440 but otherwise permits free and loose movement.
Another embodiment of aholder500 is shown inFIG. 3P.Holder500 is similar toholder400 with the rotatable body, however a one-piece Y-shaped cradle oryoke508 is provided for use with an elastic clamping band as described above. Rotation is permitted aboutaxis510 as indicated by R1, and additional rotation is permitted about pivot region P disposedproximate axis510 at and proximate the center ofyoke512. In particular, an object such as anendoscopic camera514 my rock transverse toaxis510, for example in a plane throughaxis510 and extending into and out of the page. As shown for example inFIG. 3K, an elastic band may be retained proximate regions512a,512b, extending overobject514. In the preferred exemplary embodiment,tines512 are rigid. However, in some alternate embodiments,tines512 may have limited flexibility in positioning. In particular, a laparoscopic device such as an endoscopic camera could be held in the Y-axis using the elastic band.
In yet another embodiment, shown inFIGS. 3R-3S, aholder system550 includes a holder551 with a clampingportion552 for receiving a laparoscopic device such as an endoscopic camera (shown schematically as object558). Clampingportion552 is mounted at one end of abody554 with asplit shaft556. Holder551 is formed of unitary construction, and for example could be mounted onbody portion560 having a preferably unthreadedhole562. In particular, splitshaft556 may be releasably disposed inhole562 so thatbody554 and clampingportion552 may rotate with respect tobody portion560.Portion556amay be used to engage a suitably configured region in hole562 (such as a ledge564) to releasablylock clamping system550 inhole562. Acoupling portion566 in the form of a post may be provided as previously described with respect to other embodiments.Body554 may rotate aboutcentral axis567 in direction R2 as shown. In addition, further rotation may be provided by preferablyrigid member568 extending frombody554 to clampingportion552.Member568 forms a living hinge and permits rotation in the form of rocking transverse toaxis567 and preferably in the plane of the page for the orientation shown inFIG. 3S. In a preferred exemplary embodiment,member568 is rigid such that torsion aboutaxis567 is substantially resisted.Arms570 serve as levers upon which a user may grasp with his or her fingers to assist in stabilizing the assembly during insertion or withdrawal of anobject558 such as an endoscopic camera from clampingportion552.
Portions of the holders described above, such as holder551, for example, could be made injection molded parts that could be made to function as described. Holder551, for example, may be a single-use, sterile, disposable component and thus in some embodiments a sterile drape for use withsystem550 need only coverbody portion560 thereof and not holder551.
Referring next to FIGS.3AA-3EE, another exemplary embodiment of alaparoscopic instrument holder800 according to the present invention is shown.Holder800 includes acoupling portion802 in the form of a post that optionally may include a circumferential groove therein (not shown). Couplingportion802 preferably is configured to be received in portion82 of free handle62 of articulatingarm assembly14, as will be described later.Holder800 includes abody portion804 coupled alongaxis806 at a first rotational joint808 to a firstjoint member810. In the exemplary embodiment, first rotational joint808 may permit a 360° range of rotation aboutaxis806.
In some embodiments, a series of rotational joints may be provided. In the exemplary embodiment,first member810 is coupled along anaxis812 at a second rotational joint814 to a secondjoint member816. Second rotational joint814 may permit a 360° range of rotation aboutaxis812. Secondjoint member816 is coupled along anaxis818 at a third rotational joint820 to a thirdjoint member822. Third rotational joint820 may permit a 360° range of rotation aboutaxis818.
Holder800 further includes a linearlength adjustment portion824, which will be described shortly. In the exemplary embodiment,portion824 is coupled along anaxis826 at a fourth rotational joint828 to thirdjoint member822. Preferably, fourth rotational joint828 is disposed proximate a free end ofportion824.
In one preferred exemplary embodiment, axes806,812 are disposed at about 90° with respect to each other, axes812,818 are disposed at about 90° with respect to each other, and axes818,826 are disposed at about 90° with respect to each other. In addition, the combination ofrotational joints808,814,820,828 permit movement in four separate planes, it being possible for at least one pair of said planes (e.g., as defined byjoints808,820 or as defined byjoints814,828) to be parallel to one another and it also being possible for there to be two pairs of parallel planes provided by the joints (e.g., as defined byjoints808,820 and as defined byjoints814,828). The combination ofrotational joints808,814,820,828 also preferably permits movement in four separate planes which may be nonparallel to one another.
In the exemplary embodiment, linearlength adjustment portion824 forms a sliding mechanism in which a first slidingmember830 is coupled to a second slidingmember832 and slidably associated with one another. Preferably, constant friction sliding is provided bymembers830,832. Also in the exemplary embodiment,members830,832 are restricted to move with respect to one another along central slidingaxis834.
Member830 for example may be coupled to acoupling portion836 such as with a plurality ofscrews838. Preferably,coupling portion836 is configured and dimensioned to be received and slide in a grooved portion or track832aformed inmember832.Members830,832 may be coupled to one another with aset screw839 which extends through and is permitted to translate along the length of slot840 inmember832. The shaft ofset screw839 extends intomember834. In some embodiments, setscrew839 may be tightened so that the head thereof bears againstmember832 to adjust the friction between themembers830,832 with respect to each other.
In alternate embodiments, the shaft ofset screw839 and the width of slot840 may be sized so that if nocoupling portion836 is provided, movement ofmembers830,832 is guided alongaxis834.
Another rotational joint842 is disposed proximate the free end ofportion824 opposite the free end at which rotational joint828 is disposed.Joint842 is disposed along anaxis844. In particular, anextension830aofmember830 is coupled alongaxis844 at rotational joint842 to ajoint member846. Rotational joint842 may permit a 360° range of rotation aboutaxis844. Preferably, axes834,844 are parallel and disposed in different planes.
Joint member846 is coupled along anaxis848 at yet another rotational joint850 to a laparoscopicdevice retaining portion852. Rotational joint850 may permit a 360° range of rotation aboutaxis848. Laparoscopicdevice retaining portion852 for example may be a clamp formed by a pair ofjaw members852a,852bthat are spring biased toward one another with aspring852cat a laparoscopicdevice grasping region852d. Preferably, laparoscopicdevice grasping region852dis sized to receive a laparoscopic device such as an endoscopic camera, shown schematically asdevice854. Thus, graspingregion852dmay be sized, for example, to grasp a 5 mm and/or 10 mm laparoscope. In the exemplary embodiment, axes844,848 are disposed at about 90° with respect to each other.
Retainingportion852 preferably may be used to secure the shaft portion of a laparoscopic device such as an endoscopic camera. A sterile sleeve drape may be used to cover the entire apparatus and to be imbricated into graspingregion852d. Preferably, while spring-biased jaw members are configured to hold the laparoscopic device securely, they also permit the device to be manually rotated about its linear axis with enough frictional resistance to prevent undesired rotational movement.
The rotational joints ofholder800 such asrotational joints814,816 for example may be formed as follows. A threadedscrew856 is disposed with the head thereof abutting a first washer858awhich optionally rests on a second washer858b. Washers858a,858brest on a ledge such asledge860 inmember816. The shaft ofscrew856 extends throughcoaxial holes862,864 in adjacent components such asmembers810,816, and is threadably received in anut866 that rests against awasher868 abuttingledge870 inmember810.Members810,816 may be separated from one another with a washer872. A sleeve874 optionally may be provided with a hole therein through which the shaft ofscrew856 extends and is guided. Sleeve874 may be disposed proximate the head ofscrew856 or remote from the head.
Thus,laparoscopic device854 may be positioned as desired using the combined freedom of movement provided byrotational joints808,814,820,828,842,850, linearlength adjustment portion824, as well as the rotation provided bycoupling portion802 when received in portion82 of free handle62 of articulatingarm assembly14.
In one preferred exemplary embodiment,holder800 moves with five degrees of freedom, with the sixth degree being accommodated by rotation oflaparoscopic device854 within laparoscopicdevice retaining portion852. Preferably, frictional movement is provided byrotational joints80S,814,820,828,842,850, linearlength adjustment portion824, as well ascoupling portion802 when received in portion82 of free handle62 of articulatingarm assembly14. Preferably, the friction is sufficient to hold the laparoscopic device regardless of orientation but selected so that the device is easily movable for reorientation through manual manipulation by a user. Higher frictional resistance to allow for movement of the working envelope may be provided by curvilinear articulatingarm assembly12, as described herein. It should be noted, however, that the ease of movement between relatively moving components may be selected as desired as a function of the friction between said components. Thus, different embodiments ofholder800 may be provided with different amounts of friction forrotational joints808,814,820,828,842,850, linearlength adjustment portion824, as well ascoupling portion802.
Turning next to FIGS.3FF to3-UU, yet another exemplary embodiment of alaparoscopic instrument holder900 according to the present invention is shown.Holder900 includes acoupling portion902 in the form of a post that optionally may include a circumferential groove therein (not shown). Couplingportion902 preferably is configured to be received in portion82 of free handle62 of articulatingarm assembly14, as will be described later.Holder900 includes abody portion904 coupled alongaxis906 at a first rotational joint908 to a firstjoint member910. In the exemplary embodiment, first rotational joint908 may permit a 360° range of rotation aboutaxis906.
In some embodiments, a series of rotational joints may be provided. In the exemplary embodiment,first member910 is coupled along anaxis912 at a second rotational joint914 to a secondjoint member916. Second rotational joint914 may permit a 360° range of rotation aboutaxis912. Secondjoint member916 is coupled along anaxis918 at a third rotational joint920 to a linearlength adjustment portion924, which will be described shortly. Third rotational joint920 may permit a 360° range of rotation aboutaxis918. Preferably, third rotational joint914 is disposed proximate a free end ofportion924.
In one preferred exemplary embodiment, axes906,912 are disposed at about 90° with respect to each other, and axes912,918 are disposed at about 90° with respect to each other. In addition, the combination ofrotational joints908,914,920 permits movement in three separate planes, it being possible for at least one pair of said planes (e.g., as defined byjoints908,920) to be parallel to one another. The combination ofrotational joints908,914,920 also preferably permits movement in three separate planes which may be nonparallel to one another.
In the exemplary embodiment, linearlength adjustment portion924 forms a sliding mechanism in which a first slidingmember930 is coupled to a second slidingmember932 and slidably associated with one another. Preferably, constant friction sliding is provided bymembers930,932. Also in the exemplary embodiment,members930,932 are restricted to move with respect to one another along central slidingaxis934. Advantageously, linearlength adjustment portion924 permits a user to reposition alaparoscopic device954, for example into and out of an opening in a patient, with gross movement in a linear direction, as compared to angulation. For example, linearlength adjustment portion924 may permit about 6 inches of linear movement of adevice954 held byholder900.
Member930 may be provided with afirst slot930aandmember932 may be provided with asecond slot932a, with each ofslots930a,932abeing disposed centrally alongaxis934. First andsecond slots930a,932aeach may have a length S1, S2, respectively, alongaxis934, and lengths S1, S2may be about the same as one another. In an exemplary preferred embodiment, lengths S1, S2each may be about 5.5 inches. In the preferred exemplary embodiment,members930,932 are coupled to each other by couplingassemblies936 extending from fixed positions with respect to and proximate free ends930b,932bthereof.
Eachcoupling assembly936 includes a female threadedround standoff936athat threadably receives truss headPhillips machine screws936b,936cat opposing ends thereof.Standoff936aextends through aplain bearing936dwhich is sized to slide and be guided in arespective slot930a,930bgenerally constrained for movement alongaxis934. Bearing936dextends through a plastic thrust bearing936cpositioned betweenmembers930,932. Amember930,932 is captivated between plastic thrust bearing936eand a second plastic thrust bearing936f. A stainless steel round flat washer936gand acurved disc spring936hare provided between bearing936fand the head ofscrew936cas shown, with bearing936dabutting washer936f.Spring936hmaintains tension betweenthrust bearings936e,936g. Finally, anothercurved disc spring936iis provided and seats in arecess930cor932cof amember930,932, respectively.Curved disc spring936iallows for greater machining tolerances forrecesses930c,932cand preferably keeps bearing936din contact with washer936f. Couplingassemblies936 thus allow some adjustment of tensioning so that a desired level of force permits movement ofmembers930,932 with respect to one another. By loosening or tightening each ofassemblies936, frictional resistance to sliding or telescoping ofmembers930,932 with respect to each other may be selected.
Another rotational joint942 is disposed proximate the free end ofportion924 opposite the free end at which rotational joint920 is disposed.Joint942 is disposed along anaxis944. In particular, anextension930aofmember930 is coupled alongaxis944 at rotational joint942 to ajoint member946. Rotational joint942 may permit a 360° range of rotation aboutaxis944. Preferably, axes934,944 are parallel and disposed in different planes.
Joint member946 is coupled along anaxis948 at yet another rotational joint950 to a laparoscopicdevice retaining portion952. Rotational joint950 may permit a 360° range of rotation aboutaxis948. Laparoscopicdevice retaining portion952, for example, may be a clamp formed by a pair ofjaw members952a,952bwith a laparoscopicdevice grasping region952dformed by jaw portions that are spring biased toward one another and handle regions that are spring biased away from one another, the biasing accomplished using aspring952c. Preferably, laparoscopicdevice grasping region952dis sized to receive a laparoscopic device such as an endoscopic camera, shown schematically asdevice954. Thus, graspingregion952dmay be sized, for example, to grasp a 5 mm and/or 10 mm laparoscope (as shown inFIG. 3-OO, two cylindrical regions are sized for this purpose). In the exemplary embodiment, axes944,948 are disposed at about 90° with respect to each other.
In order to provide sufficient clamping strength so that alaparoscopic device954 may be securely and releasably retained within graspingregion952dof retainingportion952, without undesired slippage or rotation, a strong spring mechanism is provided. In particular, as shown in FIGS.3PP-3UU,spring952cin part elasticallybiases jaw members952a,952btoward one another so that graspingregion952dis in a closed position. In the preferred exemplary embodiment,spring952cis aType 302 stainless steel torsion spring providing a torque of about 21 in.-lbs. (McMaster-Carr part number 9287K103 with the following characteristics: 90° deflection angle clockwise wound, spring outer diameter about 0.9 inch, wire diameter about 0.1 inch, length about 3.5 inches, maximum rod outer diameter about 0.5 inch, body length/spring length at torque about 0.6 inch, and about 3.25 active coils). However, in alternate embodiments, other elastic members instead of a torsion spring may be used and other spring characteristics may be specified as long as proper retention is provided inregion952d. Thus, even forces due to power cords, etc., that may be associated with alaparoscopic device954 may be sufficiently countered whiledevice954 is disposed in graspingregion952d.
Because of the substantial torque provided byspring952cto securely retain alaparoscopic device954 in graspingregion952d, a user may need very significant hand strength to be able to compress the handle portions ofjaw members952a,952btoward one another. To enhance usability in view of the torque ofspring952c,jaw member952ahas a forked, bifurcated design with afirst portion952a1having a U-shaped region that receives asecond portion952a2. Afirst pin953apivotally associatesportions952a1and952a2to one another, while a second pin953bpivotally associatessecond portion952a2to lever link955.Lever link955 is further pivotally associated with jaw member952bwith athird pin953c. A boss959aoffirst portion952a1with a through hole therein is received in the through hole of a boss959bof jaw member952band thesejaw members952a,952bare coupled to one another with ascrew957athat extends in the through hole of boss959aand tightly abuts a coaxial set screw957b.Spring952cis disposed about boss959bwith one leg resting againstledge961aand the other leg resting against ledge961bofjaw members952a,952b, respectively. During operation, in order to open graspingregion952d, a user may grasp in one hand and squeeze (1)portion952a1ofjaw952awhich forms a first handle region and (2) jaw member952bwhich forms a second handle region. The use of ajaw member952ahavingportions952a1and952a2as well aslever link955 provides a mechanical advantage to the user when changing the size of the openings in graspingregion952d, e.g. to allow insertion or release of alaparoscopic device954 therein. Preferably, the mechanical advantage is such that the turning force applied by a user to movejaw members952a,952bwith respect to one another is less than half the turning force otherwise required for thespring952c.
In an exemplary preferred embodiment, whenjaw members952a,952bare closed as shown in FIGS.3PP and3QQ,portion952a2is separated from portion952bby an angle J of about 35°.
Retainingportion952 preferably may be used to secure the shaft portion of a laparoscopic device such as an endoscopic camera. A sterile sleeve drape may be used to cover the entire apparatus and to be imbricated into graspingregion952d. Preferably, while spring-biased jaw members are configured to hold the laparoscopic device securely, they also permit the device to be manually rotated about its linear axis with enough frictional resistance to prevent undesired rotational movement.
The rotational joints ofholder900 such asrotational joints914,920 for example may be formed as follows. An internally threadedbolt956 is disposed with the head thereof abutting a first washer958a. The washer958aabuts a first side of a joint member such asmember916 while a second washer958babuts an opposite side ofmember916 withbolt956 extending therethrough. The shaft ofbolt956 extends throughhole962 and a coaxial hole in an adjacent component such asmember932. An externally threadedbolt964 is threadably received in internally threadedbolt956.
In another exemplary embodiment, the rotational joints ofholder900 such asrotational joints908,914,920,942,950 for example may be formed with thrust bearings as follows. Although in FIGS.3VV and3WW an exemplary rotational joint920 is shown, the construction of this joint also may reflect the construction of exemplaryrotational joints908,914,942,950 according to this embodiment. Rotational joint920 couplesjoint member916 and sliding member932 (shown in phantom).Joint920 includes acentral screw970 which is threadably received in a threaded hole916ainjoint member916. A Belleville orconical washer972 abutshead970aofscrew970 as well as a steel ball thrust bearing974 (which for example may be carbon steel or stainless steel).Washer972 creates a spring tension to broaden the window of adjustability ofholder900 during assembly and accommodates slight wear that may occur in operation ofholder900. In turn, thrustbearing974 is mounted on asleeve976 which extends from within a central opening in thrust bearing974 to within a recessed region injoint member916. Rotational joint920 further includes a pair ofwashers978,980, preferably formed of stainless steel, and aspacer982 disposed therebetween, together mounted onsleeve976.Washer978 abuts and preferably is bonded tojoint member916 whilewasher980 abuts and preferably is bonded to slidingmember932.Washers978,980 may rotate freely with respect tospacer982.Spacer982 for example may be formed of Delrin® AF Blend (Acetal homopolymer, PTFE-filled). As is known in the art, a high performance miniature steel ball thrust bearing974 for example may be formed of a pair of precision chrome-steel washers974a,974band aball cage974cthat is bronze or stainless steel withsteel balls974ddisposed therein (e.g., McMaster-Carr part number 7806K63). In use, rotational joint920 advantageously accommodates thrust loads—it can accommodate axial thrust along the axis of the “shaft” it supports—while also providing desired rotational movement betweenjoint member916 and slidingmember932. Although a steel ball thrustbearing972 is shown, other types of thrust bearing constructions instead may be used, and also other types of bearings instead may be used. Moreover, although rotational joint920 with thrust bearing972 has been shown in the exemplary context ofjoint member916 and slidingmember932, in the present embodiment such joint constructions with thrust bearings may be used in one or more, and preferably each ofrotational joints908,914,920,942,950.
Whileholder900 for example is shown in FIGS.3FF and3GG with acoupling portion902 in the form of a post that couples tobody portion904, another exemplary embodiment of acoupling portion990 coupled tobody portion904 is shown in FIGS.3XX-3ZZ. Couplingportion990 is configured, for example, as an adaptor forcoupling holder900 to other types of arrangements as known in the art. Thus,holder900 may be attached to a variety of positioning arms not limited for example to the curvilinear articulatingarm assembly12 inFIG. 1.Portion990 includes acentral hole992 that receives aprojection904aextending from an end ofbody portion904.Body portion904 andcoupling portion990 are further aligned with apin994 extending in holes inportions904,990 that are coaxial when in alignment with one another. Aninterface lock996 extends intomember990aofcoupling portion990 and is rotatably associated withprojection904aofbody portion904.Interface lock996 for example may include a knurled knob portion996a, a cylindrical post996b, asleeve996c, and aset screw996d. Exemplary operation of such aninterface lock996 is described elsewhere herein with respect to aninterface lock683 shown inFIG. 4U.
Thus,laparoscopic device954 may be positioned as desired using the combined freedom of movement provided byrotational joints908,914,920,942,950, linearlength adjustment portion924, as well as the rotation provided bycoupling portion902 when received in portion82 of free handle62 of articulatingarm assembly14.
Preferably, frictional movement is provided byrotational joints908,914,920,942,950, linearlength adjustment portion924, as well ascoupling portion902 when received in portion82 of free handle62 of articulatingarm assembly14, as described with respect toholder800 above. Preferably the friction is sufficient to hold the laparoscopic device regardless of orientation but selected so that the device is easily movable for reorientation through manual manipulation by a user. Preferably, when a user positions alaparoscopic device954 usingholder900, the rotational and linear movements provided by the components ofholder900 provide a generally uniform feel to the user. In other words, during manual manipulation of adevice954 coupled toholder900, it feels to the user as though the user encounters the same degree of resistance to movement of thelaparoscopic device954 regardless of the direction in whichdevice954 is moved/oriented. In one exemplary preferred embodiment,rotational joints908,914,920proximate coupling portion902 for interfacing with articulatingarm assembly14 may have about two times the frictional resistance to movement asrotational joints942,950 proximate laparoscopicdevice retaining portion952.
Next, with reference to FIGS.3AAA-3HHH, yet another exemplary embodiment of alaparoscopic instrument holder1000 according to the present invention is shown. As with previous embodiments, in anexemplary embodiment holder1000 includes three rotational axes at a proximal end and two rotational axes at a distal end.Holder1000 includes acoupling portion1002 in the form of a post.Coupling portion1002 preferably is configured to be received in portion82 of free handle62 of articulatingarm assembly14, as will be described later.Holder1000 includes abody portion1004 coupled alongaxis1006 at a first rotational joint1008 to a firstjoint member1010. In the exemplary embodiment, first rotational joint1008 may permit a 360° range of rotation aboutaxis1006.
In some embodiments, a series of rotational joints may be provided. In the exemplary embodiment,first member1010 is coupled along anaxis1012 at a second rotational joint1014 to a secondjoint member1016. Second rotational joint1014 may permit a 360° range of rotation aboutaxis1012. Secondjoint member1016 is coupled along anaxis1018 at a third rotational joint1020 to a linearlength adjustment portion1024, which will be described shortly. Third rotational joint1020 may permit a 360° range of rotation aboutaxis1018. Preferably, third rotational joint1014 is disposed proximate a free end ofportion1024.
In one preferred exemplary embodiment, axes1006,1012 are disposed at about 90° with respect to each other, and axes1012,1018 are disposed at about 90° with respect to each other. In addition, the combination ofrotational joints1008,1014,1020 permits movement in three separate planes, it being possible for at least one pair of said planes (e.g., as defined byjoints1008,1020) to be parallel to one another. The combination ofrotational joints1008,1014,1020 may permit movement in three separate planes which may be nonparallel to one another.
In the exemplary embodiment, linearlength adjustment portion1024 forms a sliding mechanism in which a generally tubular first slidingmember1030 is coupled to a generally tubular second slidingmember1032 and are slidably associated with one another.Portion1024 forms an extendable section ofholder1000 that for example provides adjustability to the length ofholder1000. In the exemplary embodiment,members1030,1032 are restricted to move with respect to one another along central slidingaxis1034. Advantageously, linearlength adjustment portion1024 permits a user to reposition alaparoscopic device1054, for example into and out of an opening in a patient, with gross movement in a linear direction, as compared to angulation. For example, linearlength adjustment portion1024 may permit about 5 or about 6 inches of linear movement of adevice1054 held byholder1000.
Member1030 preferably is received within, and telescopes with respect tomember1032. As shown inFIG. 3CCC,member1032 is hollow and is provided with a slot1032a. A roller key1034ais secured tomember1030 with a rivet1034b; apiston member1036 is coupled to a free end of member1030 (seeFIG. 3EEE) and rivet1034bextends in a coaxially disposed holes1036a,1030ainmembers1036,1030 respectively. Roller key1034acoupled tomember1030 is movable within slot1032aofmember1032 and preferably is a miniature high precision stainless steel ball bearing. Acover1037 may be secured tomember1032 over slot1032a, for example, for safety and aesthetic reasons.Member1032 also may be provided with abushing1038 to provide support formember1030 and to assist in preventing a sterile sleevedrape covering holder1000 from being caught during movement ofmember1030 with respect tomember1032.Bushing1038 includes a plurality offingers1038adisposed radially with respect toaxis1034. Advantageously, the use offingers1038aallows an adequate interference fit to be provided with minimal drag betweenfingers1038aand the outer surface ofmember1030 to prevent the sterile sleevedrape covering holder1000 from being inadvertently caught during movement. Bushing1038 may be formed, for example, of Delrin® AF Blend (Acetal homopolymer, PTFE-filled).
As shown inFIG. 3EEE,piston member1036 is spring-loaded. In particular, a spring1036band a plunger1036care disposed within a hollowcylindrical region1036dinpiston member1036 for movement along axis1036e. Preferably axis1036eis disposed perpendicular toaxis1034. By providing the spring/plunger arrangement, a consistent drag force by may be provided for movement ofmembers1030,1032 with respect to each other as plunger1036cbears against the inner wall ofmember1032. In an exemplary embodiment, the following components and materials may be used: spring1036bmay be stainless, ½″ long×0.36″ OD×0.032″ wire; the plunger may be 0.43″ long with an OD of 0.375 and may be made of Delrin® AF Blend; the depth of the hole in the piston may be ¾″ and the diameter of the piston may be 0.86″, sized for clearance to the ID ofmember1032.
Turning back toFIG. 3AAA, another rotational joint1042 is disposed proximate the free end ofmember1030 opposite the free end ofmember1032 at which rotational joint1020 is disposed.Joint1042 is disposed alongaxis1034. Rotational joint1042 may permit a 360° range of rotation aboutaxis1034.Joint member1046 is coupled along anaxis1048 at yet another rotational joint1050 to a laparoscopicdevice retaining portion1052. Rotational joint1050 may permit a 360° range of rotation aboutaxis1048. Laparoscopicdevice retaining portion1052, for example as shown inFIG. 3HHH, may be a clamp formed by a pair of jaw members1052a,1052bwith a laparoscopic device grasping region1052dformed by jaw portions that are spring biased toward one another and handle regions that are spring biased away from one another, the biasing accomplished using a spring1052c. Preferably, laparoscopic device grasping region1052dis sized to receive a laparoscopic device such as an endoscopic camera, shown schematically asdevice1054. Preferably, grasping region1052dis formed by material softer than aluminum to prevent marring or denting of surfaces of delicatelaparoscopic device1054 which typically is thin-walled. In the exemplary preferred embodiment, polyurethane covers1052eare provided.Covers1052efor example may be formed of 85 or 95 durometer polyurethane, permittingdevices1054 to even be twisted out of grasping region1052dwithout damage occurring. In the exemplary embodiment, axes1034,1048 are disposed at about 90° with respect to each other.
Further details concerning retainingportion1052 were previously provided in the context of retainingportion952 of a previous embodiment.
Thus, retainingportion1052 preferably may be used to secure the shaft portion of a laparoscopic device such as an endoscopic camera. A sterile sleeve drape may be used to cover the entire apparatus and to be imbricated into grasping region1052d. Preferably, while spring-biased jaw members are configured to hold the laparoscopic device securely, they also permit the device to be manually rotated about its linear axis with enough frictional resistance to prevent undesired rotational movement.
An exemplary rotational joint1014 is shown inFIG. 3GGG. Each ofjoints1008,1014,1020 for example may have the same construction, and joint1014 is described in particular. Although similar to these joints, thejoints1042,1050proximate retaining portion1052 have similar constructions to joint920 shown in FIGS.3VV-3WW a previously described (e.g., with two stainless steel washers and a Delrin® AF Blend spacer therebetween that is not bonded to its surroundings). However, as will be described, components in these various joints may be formed of different materials depending on whether the joint is located near the proximal or distal end ofholder1000.
In a preferred exemplary embodiment, joint1014 may include a thrust bearing. Rotational joint1014 couplesjoint member1010 to joint member1016 (shown in phantom).Joint1014 includes acentral screw1070 which is threadably received in a threadedhole1010ainjoint member1010. A pair of Belleville orconical washers1072 are disposed proximate head1070aofscrew1070 as well as a high performance miniature steelball thrust bearing1074 that for example may be formed of a pair of precision chrome-steel washers974a,974band aball cage974cthat is bronze or stainless steel withsteel balls974ddisposed therein (e.g., McMaster-Carr part number 7806K63). In turn,thrust bearing1074 is mounted on asleeve1076 which extends from within a central opening inthrust bearing1074 to within a recessed region injoint member1016. Rotational joint1014 further includes a washer1078 preferably formed of stainless steel and aspacer1082adjacent sleeve1076. Washer1078 abutsjoint member1010. Washer1078 preferably is bonded tojoint member1010 while spacer1082 preferably is bonded tojoint member1016, it being possible for washer1078 and spacer1082 to rotate with respect to each other. The use of such a joint with a thrust bearing was described previously with respect to joint920 of another embodiment, and the previous description also applies to this embodiment.
In a preferred exemplary embodiment,members1030,1032 are formed of 6061-T6 aluminum due to the strength to weight ratio of this material. However, other materials could be used for example thin wall steel. Washers such aswashers1072 may be formed of stainless steel.
The spacers such asspacer1082 inrotational joints1008,1014,1020 at the proximal end may be formed of Multifil™ sliding bearing material which is polytetrafluoroethylene (PTFE)-based and available from GGB North America LLC. Advantageously, the Mutifil material has low stiction for the present application—it shows almost no signs of “sticking” in the operating conditions ofholder1000. On the other hand, the spacers in the rotational joints at the distal end such asjoints1042,1050 may be formed of Delrin® AF Blend (Acetal homopolymer, PTFE-filled). Different materials were used for the spacers at the proximal and distal ends for several reasons. First, Multifil was only available in a limited range of thicknesses. Because the spacers at the proximal end were of relatively large diameters (1⅛ inch), forces against the spacers could be spread over this relatively large area thus allowing a “smaller” thickness of spacer to be used without risking plastic deformation. The spacers at the distal endproximate retaining portion1052 have comparatively small diameters (¾ inch), and thus “larger” spacer thickness was needed to accommodate forces on these spacers without risking plastic deformation. Multifil was not available in the thickness needed for the spacers at the distal end and thus another material (Delrin® AF Blend) was chosen. Second, stiction appeared to be more of an issue in joints at the proximal end near body portion1004 (than in joints proximate retaining portion1052); Multifil thus was the preferred material for addressing stiction concerns.
In an exemplary embodiment,holder1000 may have a fully telescoped length of about 19.5 inches as measured from the first rotational joint1008 at the proximal endproximate body portion1004 to the center of theclamp jaw cover1052e; the unextended length ofholder1000 may be about 14.25 inches. Thus, telescoping action may provide about 5 to about 5.5 inches of adjustment in length ofholder1000.
Joints1008,1014, and1020 each are set to about 2 ft-lbs of torque, while joint1042 is set to about 0.8 ft-lbs of torque and joint1050 is set to about 1.2 ft-lbs of torque. The telescoping action ofmembers1030,1032 may be set to have about an axial force of about 1 lb.
In use, the port in a patient into which adevice1054 is introduced may serve as a fulcrum. The clamp ofholder1000 preferably is capable of holding about ¼ lb. of weight fromdevice1054 whenholder1000 is fully extended. Although a typical endoscopic scope may weigh about ¼ lb., various cables associated with the scope increase the weight that must be supported. However, support is further provided by the port formed in the body into which the scope is inserted, helping to assist in accommodating the additional weight.
The rotational joints described herein, for example, may permit limited rotation such as rotation through an angle of about 180° or an angle of about 270°, or may permit about 360° of rotation about an axis of the rotational joint.
Next, an exemplary method of usingholder900 is described although this method applies to other holders described herein such asholder1000. In use, the position ofholder900 should be checked for suitable working range near the planned camera port site. The optimum attachment point for the articulatingarm assembly14 for example on a surgical bed railing should be determined after the patient is positioned and asleep and before the prep. Initially, linearlength adjustment portion924 need not be telescoped, althoughportion924 should be fully extended for draping.Assembly14 should be oriented to near vertical for prepping and draping the patient and the arm. The drape forassembly14 preferably should be placed after the skin prep but before the final large procedure drape is placed. A separate skirt half-sheet drape may be clipped around the base of the system after the large patient drape is placed.Assembly14 then should be contoured closely to the patient to minimize its footprint and brought adjacent to the camera port. In use, theassembly14 should be closely contoured to the patient andholder900 disposed approximately parallel to the skin (perpendicular to the port) to minimize interference and clutter. Also, although it is possible that in one combination joints910,914,920 may be aligned generally in the same plane, it is desirable to have at least one of these joint out of plane relative to the others to start. If thelaparoscopic device954 is an endoscopic camera, preferably the shaft of the device is grasped inclamp952 as close as possible to the camera body. Alaparoscopic device954 coupled toholder900 may be moved, for example, in six degrees of freedom with the combination ofrotational joints942,950 andgrasping region952dofclamp952 which permits rotation ofdevice954 therein.
Holders100,300,400,500,800,900,1000 and clampingsystem550 preferably may be provided with a full cover sleeve drape.Devices100,300,400,500,550,800,900,1000 may be formed as a single use, pre-sterilized device, or as a sterilizable, re-usable device, or as a non-sterile re-usable device that is covered by a sterile drape/cover when required. Portions ofdevices100,300,400,500,550,800,900,1000 may be disposable.
In one exemplary, preferred embodiment, the holders of the present invention may be designed to create a minimum footprint or minimum interference within the surgical field and be easily sterilized or protected by a sterile cover. The holders preferably are long enough to reach from an attachment point on or proximate the location of a bedside railing to well past the skin entry port of a patient to allow for a full range of movement of the laparoscope, and to have enough pathway variability to clear other objects in the surgical field.
Some embodiments of holders may have several modes of operation. One mode may be free movement with little resistance at the free end. A second mode may be moderate resistance at the free end. This may be most useful when holding an endoscopic camera. In this instance, the resistance in this second mode preferably should be sufficient to maintain camera position in the absence of additional external force while at the same time being weak enough to allow a complete range of three-dimensional manipulation by the surgeon or assistant using only one hand without the need to adjust any locking or unlocking mechanism. A third mode may be fully locked with high resistance to movement at the free end. This mode may be particularly useful in the case where greater force may be required, such as retraction of an internal structure or organ. In this circumstance, an instrument connection other than, or in addition to the rotational joints disclosed herein, may be used.
As described above,coupling portion302 ofholder300 andcoupling portion402 ofholder400 preferably are configured to be received in portion82 of free handle62 of articulatingarm assembly14. This articulating arm assembly now will be described.
Turning toFIGS. 4A-4C, an exemplary preferred curvilinear articulatingarm assembly12 is shown for use with alaparoscopic instrument holder14. Arm assembly includes acentral arm652 with a ball-sleeve arrangement that forms joints. In particular,central arm652 includes a plurality ofsleeves654 withspherical balls656 disposed therebetween thus forming ball and socket connections. In the exemplary embodiment shown in the figures, threeballs656aof a first size are disposed adjacent one another proximate one end ofarm652, while the remaining balls656bare of a second size smaller than the first size.Sleeves654aof a first size andsleeves654cof a second size smaller than the first size are provided for accommodatingballs656a,656b, respectively, while a transition sleeve654bis providedintermediate sleeves654a,654cas shown for accommodating aball656aon one side and a ball656bon the other side thereof.Sleeves654 are configured and dimensioned to receiveballs656a,656bat ends thereof and thus permit articulating of sleeves with respect to each other. Atensioning wire658 runs generally centrally throughsleeves654 andballs656, as will be further described shortly. Preferably,wire658 is formed of metal. In an exemplary preferred embodiment,wire658 isType 302 stainless steel wire rope, 1×19 strand, 5/32 inch diameter, with a breaking strength of 3300 lb. (McMaster-Carr part number 3458T27). One exemplary operation of a wire tensioning mechanism is shown and described in U.S. Pat. No. 3,858,578 to Milo, which is expressly incorporated herein by reference thereto. Preferably, curvilinear articulatingarm assembly12 may move with six degrees of freedom.
In the exemplary preferred embodiment, threeadditional balls656aand threeadditional sleeves654aare provided to thearm assembly12 shown inFIGS. 4A-4C, witharm assembly12 having a fully extended (straightened) length of about 40 inches.End effector14, for example, may add about 4 inches to the length of thearm assembly12. In other embodiments, other desired lengths ofarm assembly12 may be accomplished by changing the number of balls and sleeves. For example, without the threeadditional balls656aand threeadditional sleeves654a,arm assembly12 may have a length of about 32 inches.
Abase handle660 is coupled tocentral arm652 on a first end thereof, preferably adjacent aball656a. In addition, afree handle662 is coupled tocentral arm652 on a second end thereof, preferably adjacent a ball656b.
In one preferred exemplary embodiment, a series oflarger balls656ais provided proximate base handle660 to provide stability to curvilinear articulatingarm assembly12. If for example a user such as a surgeon orientsassembly12 by grasping it proximatefree handle662, substantial bending forces may be exerted oncentral arm652proximate base handle660. Thus, the use oflarger balls656aproximate base handle660 as compared to smaller balls656bproximatefree handle662 provides a system with larger surface area balls near base handle660 for additional resistance to rotational movement in that portion ofcentral arm652 and thus more stability. In alternate embodiments, more than two different sizes ofballs656 or more than two sets of sizes ofballs656 may be used, preferably increasing in size towardbase handle660. In one alternate embodiment, each of theballs656 incentral arm652 is of increasingly larger size fromfree handle662 to base handle660. The use of only two sizes ofballs656 advantageously facilitates manufacture and construction ofarm assembly12 because of the need to only stock two sizes as compared to a larger number of sizes and concomitantly greater ease of construction because only two sizes need be assembled to formcentral arm652. In yet another alternate embodiment,central arm652 may be formed ofballs656 that all are the same size.
Turning toFIG. 4D-4L, base handle660 will be described. Base handle660 includes abody portion660awithlevers666,668 pivotably associated therewith, as well as an extension660bthat turnsscrew coupling663 and rotates in relation to and independent ofbody portion660a. Base handle660 further includescam mechanisms670,672 as will be described. Portion663bofcoupling663 preferably is noncircular and mechanically engages and is fixed to a like-shaped and sized non-circular opening inportion660cof extension660bso that rotation of extensions660bas by gripping and turning by a user imparts like-rotation ofcoupling663 for example for demountable coupling to clamp16 and further coupling to asurgical table rail18, as shown for example inFIG. 1. In the preferred exemplary embodiment,coupling663 comprises a threadedportion663dwhich may be threadably received in a threadedhole16adisposed inclamp16.
Coupling663 is disposed proximate a firstfree end664aof astainless steel shaft664 which extends therethrough and is provided with a head that abuts a shoulder disposed inend663cofcoupling663. Preferably, rotation ofcoupling663 is independent of rotation ofshaft664.Shaft664 preferably extends through a hole in extension660b .
Lever666 is pivotably coupled torocker arm672 with apin666athat is disposed such that rotation oflever666 results in eccentric movement ofrocker arm672. As shown for example inFIGS. 4D-4E, cylindrical projections666boflever666 are received and rotate inarcuate cradle portions660a1ofbody portion660a, whilecylindrical projections672bofrocker arm672 are received and rotate inarcuate cradle portions660a2ofbody portion660a. Rotation oflever666 towardscrew coupling663 in direction K liftspin666a, and becauserocker arm672 rests onpin666a,rocker arm672 is rotated in direction L in an eccentric fashion.
As seen particularly inFIG. 4F,shaft664 includes a threaded portion664bthe free end of which is threadably associated with a nut665a.Shaft664 extends through a hole inrocker arm672 and an unthreaded insert665bwith a hole therein which assists in guiding travel ofrod664 along the longitudinal axis thereof. Pivoting oflever666 in direction K causes rotation ofrocker arm672, and withshaft664 coupled to nut665aand nut665aabutting insert665b,rod664 is translated in direction M.
When coupling663 is threaded into a like threaded hole by rotation of extension660b,arm assembly12 is relatively loosely coupled by the connection ofcoupling663 to the hole. To firmlycouple arm assembly12,lever666 may be pivoted in direction K so that threadedportion663dofcoupling663 also moves in direction M and bears against the threads of the hole in which it is received. The leverage created by even slight movement of the threads against the threaded holes, on the order of tens of thousandths of an inch, creates a wedging effect that strongly locksarm assembly12 to the hole.
Lever668 of base handle660 also is pivotably coupled to arocker arm670 with a pin668athat is disposed such that rotation oflever668 results in eccentric movement ofrocker arm670. As shown for example inFIGS. 4D-4H, cylindrical projections668boflever668 are received and rotate inarcuate cradle portions660a3ofbody portion660a, while cylindrical projections670bofrocker arm670 are received and rotate inarcuate cradle portions660a4ofbody portion660a. Rotation oflever668 towardscrew coupling663 in direction N lifts pin668a, and becauserocker arm670 rests on pin668a,rocker arm670 is rotated in direction P in an eccentric fashion.
A forkedmember676, which for example may be formed of stainless steel, is coupled torocker670 and includes substantiallyparallel prongs676a,676bwhich mate with side walls ofrocker670 as shown.Rocker670 is pivotably associated with forkedmember676, with a shaft677 extending through aligned holes inprongs676a,676bandrocker670. Shaft677 may be provided with ahead677aand an external retaining ring677bsecured in a shaft groove proximate an end oppositehead677ato retain forkedmember676 in association therewith and thus withrocker670. An axial through hole676cis provided intubular portion676dof forkedmember676.Tensioning wire658 is coupled to forkedmember676 by inserting an end portion ofwire658 in hole676cand swagingtubular portion676dso thatwire658, which extends out ofopen end660a5ofbody portion660a, is retained by compression withintubular portion676d.
Whenlever668 is rotated in direction N,shaft676 translates along the longitudinal axis M1towardcoupling663 creating substantial tension intensioning wire658 such that movement of curvilinear articulatingarm assembly12 may be substantially resisted. In particular, actuation ofsecond lever668 may increase or decrease the tension inwire658 as desired by acting onrocker arm670. By increasing tension inwire658,central arm652 preferably becomes increasingly resistant to movement althoughcentral arm652 preferably still may be moved through its full range of motion. Thus, a user may orient curvilinear articulatingarm assembly12 as desired, and then increase the tension ofwire658 so that the orientation ofarm652 is releasably fixed.Lever668 preferably has an angular range of movement about pin668aof up to about 180° to permit substantial tension to be generated intensioning wire658.
Rockers670,672 preferably are associated with each other as with aspring plunger679 extending from within onerocker670 into a hole in theother rocker672. Spring plunger for example may be a stainless steel spring plunger with a round Delrin nose, without a lock element, with ¼″-20 threading, and 3-13 lb. end force (McMaster-Carr part number 84765A33).Spring plunger679 is used as shown because under the force of gravity,first lever666 may otherwise tend to move toward a closed position with in the direction of arrow K. Instead,spring plunger679 applies pressure torocker arm672 to setlever666 to tend to a default open position in whichshaft664 has not otherwise been raised towardopen end660a5ofbody portion660a.
In a preferred exemplary embodiment,rocker670 moves with substantially greater eccentricity thanrocker672.
Clamp16 for use withbase handle660 may be demountably attached tosurgical table rail18. As previously discussed, actuation offirst lever666 permits a user to apply a force on coupling663 so that movement is resisted (e.g., in response to an 8 or 10 pound force applied to arm652). In an alternate embodiment which will be further described later,screw coupling664 as shown inFIG. 4A proximate base handle660 ofarm assembly12 may be threadably associated with a threaded hole in another support surface.
A preferred exemplary embodiment ofclamp16 is shown inFIG. 4M.Clamp16 includes a threadedhole16afor threadably receiving threadedportion664 ofbase handle660. In addition,clamp16 includes fixed jaw portion16bandmovable jaw portion16cwhich is pivotable aboutaxle16dand lockable in place usingscrew mechanism16eto firmly coupleclamp16 to arail18 secured betweenjaw portions16b,16c.
Next turning toFIGS. 4N-4U,free handle662 will be described.Free handle662 includes awire receiving portion680 and an endeffector receiving portion681. In particular,wire receiving portion680 preferably is configured to receive a ball656btherein, along with an end portion ofwire658. As described previously with respect to base handle660, apivotable lever682 is associated withfree handle662 and preferably is coupled totensioning wire658 so that actuation oflever682 may increase or decrease the tension inwire658 as desired by acting onrocker arm684. By increasing tension inwire658,central arm652 preferably becomes less flexible. Thus, a user may orient curvilinear articulatingarm assembly12 as desired, and then increase the tension ofwire658 so that the orientation ofarm652 is releasably fixed.Free handle662 has abody portion662a, andlever682 is rotatable with respect thereto. Aninterface lock683 also is rotatably associated withbody portion662aproximate endeffector receiving portion681, as will be described shortly.
Lever682 is pivotably coupled torocker arm684 with a pin686athat is disposed such that rotation oflever682 results in eccentric movement ofrocker arm684.Cylindrical projections682aoflever682 are received and rotate inarcuate cradle portions662a1ofbody portion662a, whilecylindrical projections684aofrocker arm684 are received and rotate inarcuate cradle portions662a2ofbody portion662a. Rotation oflever682 towardwire receiving portion680 in direction T lifts pin686a, and becauserocker arm684 rests on pin686a,rocker arm684 is rotated in direction U in an eccentric fashion.
Rocker arm684 includes a hole in which a self-aligning setup washer690 (a two-piece washer with one portion that rocks in another portion) is disposed.Setup washer690 for example may be an 18-8 stainless steel self-aligning setup washer, ¼ inch in size, 17/64 inch inner diameter, ½ inch outer diameter, and 0.250 inch to 0.281 inch thick (McMaster-Carr part number 91944A028). Anut692 also may abutsetup washer690 on the flat upper surface thereof and rock thereon. A threaded stud (not shown) may be swaged to the end oftensioning wire658 opposite the end attached to forkedmember676, thus couplingwire658 to the threaded stud by compression. The threaded stud may in turn be threadably associated withnut692.Wire658 is provided with suitable length to span from forkedmember676 tonut692.
Pivoting oflever682 in direction T causes rotation ofrocker arm684, and withtensioning wire658 coupled tonut692 andnut692 abuttinginsert690, tension inwire658 may be increased. In particular, actuation oflever682 may increase or decrease the tension inwire658 as desired. By increasing tension inwire658,central arm652 preferably becomes increasingly resistant to movement althoughcentral arm652 preferably still may be moved through its full range of motion. Thus, a user may orient curvilinear articulatingarm assembly12 as desired, and then increase the tension ofwire658 so that the orientation ofarm652 is releasably fixed.Lever668 preferably has an angular range of movement about pin686aof up to about 90° to permit tension to be generated intensioning wire658.
In the preferred exemplary embodiment, actuation oflever682free handle662 permits initial tensioning ofcentral arm652 while still permitting restricted movement. And, actuation oflever668 of base handle660 permits substantially greater tensioning ofcentral arm652 while also still permitting restricted movement thereof. Advantageously, with tension created inwire658 ofcentral arm652 to restrict movement thereof, the orientation oflever668 such as with respect to a patient still may readily be reset or adjusted beforelever666 in base handle660 is actuated to create sufficient force to prevent rotation of threadedportion663dofcoupling663 in the hole in which it is received.
As shown inFIG. 4U,interface lock683 includes aknurled knob portion683aand a cylindrical post683bthat is provided with an arcuate cutout683c.Interface lock683 is coupled tobody portion662awithset screw683dwhich is threadably received in a threaded hole662binbody portion662a. Setscrew683dis further received in aslot683ein post683bto lock post683bin a position with arcuate cutout683coriented to be movable along the longitudinal axis of cylindrical post683b. Cylindrical post683bmay be disposed in a disengaged position in which the axial position of post683bis such that arcuate cutout683cgenerally follows the inner cylindrical contour of endeffector receiving portion681. Also, cylindrical post683bmay be disposed in an engaged position in which the axial position of post683bis such that a portion of cylindrical post683bother than arcuate cutout683cextends past the inner cylindrical contour of endeffector receiving portion681 toward the central longitudinal axis of endeffector receiving portion681.
In use, in order for example to couple articulatingarm assembly12 to an end effector such as aholder100, by capturingpost102 ofholder100 in endeffector receiving portion681 offree handle662,post102 is inserted therein whileinterface lock683 is disposed in the aforementioned disengaged position. Whilelock683 is in the disengaged position, post102 may freely rotate about the central axis of receivingportion681. Once a desired orientation is set,lock683 may be translated along the major axis defined byslot683aso that a portion of cylindrical post683boflock683 is disposed in an engaged position and bears againstpost102. Such interference betweenpost102 ofholder100 and post683boflock683 provides sufficient pressure so thatpost102 will remain fixed in rotational position and translation along the longitudinal axis thereof against the inner cylindrical contour of endeffector receiving portion681.
In one method of conducting a laparoscopic procedure according to the present invention, a curvilinear articulatingarm assembly12 withbase attachment16 is releasably secured to asurgical table rail18.Holder system100 is demountably coupled to the free end ofarm assembly12 atfree handle662, and a laparoscope is releasably retained inholder system100 by locking it in the slot defined between face122fand clampingportion114, with the laparoscope being frictionally held in the slot in the desired rotational orientation. By articulating thelever682 at the free end to a locked position,arm assembly12 will hold position when left alone but can be easily repositioned with one hand without having to loosen or unclamp any other mechanisms. In this mode,arm assembly12 should have sufficient resistance to hold the laparoscope in position absent other external forces, much like a gooseneck lamp. If lockinglever668 near the base ofarm assembly12 is also locked thenarm assembly12 will hold position against a much greater force, but thislever668 will then have to be released when ready movement of the arm/scope combination is required.
Preferably, the two rotating joints ofholder100 have complete freedom of motion and cannot be locked, and the scope is engaged by the slot defined between face122fand clampingportion114 that opens via a syringe-like spring mechanism as previously described. Free movement of the scope is allowed by the freely rotating joints ofholder100 that respond to user-selected positioning of articulatingarm assembly12 while the scope is in the skin port of the patient.
In normal use,knob124 preferably is backed off so that the spring loading ofmovable clamping jaws122 operates freely and the scope may be engaged and disengaged quickly at will.
Once curvilinear articulatingarm assembly12 is fixed in position, the geometry of the swivel joints ofholder100 in combination with the curvilinear articulatingarm assembly12 and the laparoscope passing through a skin port is designed to result in reliable position holding for the scope, yet allow complete freedom of movement by manual repositioning. There is no need to adjust any locking or tensioning mechanisms because of the geometry of the setup and the resistance provided by the arm in its “gooseneck lamp” mode.
In some methods, gross movements of the scope may be accomplished by grabbing the articulatingarm assembly12 proximate the swivel joints and reorient the device from that gripping point. For smaller movements, it is possible to simply grab and torque the scope itself.
In one method of use, curvilinear articulatingarm assembly12 is closely contoured to the patient (approximately parallel to the skin) to minimize interference and clutter, and with the holder such asholder800 extended nearby the endoscopic camera port. The position ofarm assembly12 is checked for suitable working range near the planned port site. The optimum attachment point for the base of thearm assembly12 for example on a surgical bed railing is determined after the patient is positioned and asleep and before the next preparation phase.Arm assembly12 may be oriented out of the way for prepping and draping. An arm drape may be placed after the skin prep but before the final large procedure drape is placed. A separate skirt/sheet drape may be clipped around the base after the large drape is placed.Arm assembly12 may be contoured to the patient and brought adjacent to the camera port. The scope may be engaged working through the drape for example by pinching open the spring loaded clamp ofholder800 and simply invaginating the cover with the scope into the slot. The cover preferably is tough and stretchy and withstands repeated engage/disengage cycles and scope rotation.
Each of the holder systems described herein may be used in accordance with the aforementioned methods, regardless of spring-loading of the clamping arrangements.
Also, although an exemplary curvilinear articulating arm assembly is described herein, it should be understood that other preferably, curvilinear articulating arm assemblies instead may be used which preferably provide six degrees of freedom of movement and permit relatively rigid positioning such as described herein.
In some embodiments of the present invention, an instrument holder system such assystem10 may be coupled to a patient support other than a rail of a table. For example, referring next toFIG. 5, anexemplary support system710 according to the present invention is shown with a variety of components coupled thereto.Support system710 includes atray712, curvilinear articulatingarm assemblies12,716 havingrespective end effectors100,720, anIV pole722, anarm board724, andrail assemblies726,728. A variety of end effectors may be demountably attached for example to articulatingarm assembly716 to assist a technician or practitioner with a medical/imaging procedure or provide other features useful with respect to a patient.End effector720, for example, is configured as a self-centering abdominal probe bracket.
In one preferred exemplary embodiment,tray712 may include two pairs ofhold regions730, each pair being disposed proximate a freecranial end732 or free caudal end734 oftray712. In alternate embodiments, other numbers ofhold regions730 may be provided such as two or more, and holdregions730 may be provided in other regions oftray712 such as intermediate ends732,734proximate sides736,738. Holdregions730 may be configured as hand holds, or alternatively may be configured to receive strapping so thattray712 may be releasably coupled to another object such as an ambulance stretcher, hospital bed, operating room table, or imaging scanner table. In some embodiments, handles may be coupled totray712. As also shown inFIG. 5,attachment regions740 are providedproximate sides736,738 for demountably coupling components as previously described totray712, as will be further described below. In the exemplary preferred embodiment,tray712 is provided with thirteenattachment regions740, although in alternate embodiments another number ofregions740 may be provided such as at least one ortray712 may be provided with a surgical rail or track permitting substantial freedom of coupling of components along the length thereof.
Turning toFIGS. 6A-6C, additional features oftray712 are shown. Although hand holdregions730 are not included in the figure, such regions may be provided as shown inFIG. 5.Attachment regions740 are provided in spaced arrangement along the perimeter oftray712. Preferably,tray712 includes a centralarcuate portion742 disposed betweenouter ledge portions744. Preferably,regions740 are provided onouter ledge portions744. Centralarcuate portion742 preferably has an upperconcave surface742afor receiving a patient and optionally a cushion (not shown) for the patient to rest against, and optionally includes a lowerconvex surface742b. Preferably,outer ledge portions744 include upper and lower surfaces744a,744bconnected by a sidewall744cat an angle α with respect to surface744b. In a preferred exemplary embodiment, sidewall744cis disposed at an angle α between about 60° and about 100°, more preferably between about 70° and about 90°, and most preferably at about 80°.
In a preferred exemplary embodiment,tray712 is formed of natural finish carbon fiber, R-51 foam core, and phenolic. Attenuation preferably is less than 1 mm Al equivalency. Thus,tray712 is radiolucent and suitable for use with computed axial tomography (CT) scanners. In other embodiments,tray712 is formed of a material suitable for use with magnetic resonance imaging (MR) scanners. In addition,tray712 preferably supports a load of 900 lbs. evenly distributed alongcenterline746, about whichtray712 may be substantially symmetric as shown.Indicia748 optionally may be provided, as shown for example proximate ends732,734. The indicia may for example indicate preferred orientation oftray712 with respect to a patient lying thereon.
In the preferred exemplary embodiment,attachment regions740 on each side oftray712 are evenly spaced from each other by about 6 inches between centers thereof. To accommodate patients and equipment attached totray12, in onepreferred embodiment tray712 has a length of about 78 inches, a width of about 21 inches, a generally uniform thickness of about 0.9 inch, and a height h of about 2.5 inches. Corners may be provided with a radius R1of about 2 inches. In the preferred exemplary embodiment,attachment regions740 preferably accommodate threaded inserts, which may be formed of aluminum.
In some embodiments,tray712 is sized to hold an adult patient, and may be between about 180 cm and about 200 cm long. However, it will be appreciated that longer and shorter trays may be provided. In order to accommodate an adult patient,tray712 may support an overall weight capacity of at least about 200 pounds, and preferably at least about 300 pounds. However, if atray712 is sized for use with a pediatric patient,tray712 may only accommodate weights that do not exceed 200 pounds, and more preferably do not exceed 100 pounds.
Although the surface ofportion742 oftray712 is substantially smooth in the preferred exemplary embodiment, in alternate embodiments the surface may be textured to provide additional resistance to motion of objects and/or a patient placed thereon.
Tray712 thus is suitable for use in multiple environments, and thus may “move” with the patient from one environment (e.g., ambulance) to the next (e.g., CT scanner) without removing a patient supported thereon.
While various descriptions of the present invention are described above, it should be understood that the various features can be used singly or in any combination thereof. Therefore, this invention is not to be limited to only the specifically preferred embodiments depicted herein. For example, although the holders described herein are described in the context of laparoscopic instrument holder systems that may place a camera through a port in the skin into a working cavity, the holders also may be used for example in the context of procedures that examine the interior of a bodily canal or hollow organ such as the colon, bladder, or stomach. The present invention may be applied in a variety of fields including but not limited to general surgery, orthopedics, gynecology, urology, and cardiology. In the context of laparoscopy, the systems of the present invention for example may be used to assist in surgical procedures involving the intestines, stomach, or gallbladder which may benefit from the visual inspection made possible by a laparoscope.
Further, it should be understood that variations and modifications within the spirit and scope of the invention may occur to those skilled in the art to which the invention pertains. Accordingly, all expedient modifications readily attainable by one versed in the art from the disclosure set forth herein that are within the scope and spirit of the present invention are to be included as further embodiments of the present invention. The scope of the present invention is accordingly defined as set forth in the appended claims.