Abstract:
The in-line specimen trap operates in conjunction with a suction or irrigation line and a second line leading to a surgical site. The trap includes a specimen container, a cap coupled to the specimen container and an operator controlled, multi-modal valve disposed in or on the cap. The valve includes at least a bypass passage and a container input port and a container output port. The bypass passage limits flow exclusively between the first and second lines, that is, between the suction/irrigation line and the line leading to the surgical site. The position of an operator control interface determines the selection of the bypass mode or trap and collection mode. The method establishes, under operator control, a bypass channel between the first and second lines channels under operator control, the specimen fluid and debris from the second line through the specimen container to the first line, and, closes the specimen container after the channeling step.

Description:
This is a regular patent application based upon and claiming the benefit of provisional patent application Ser. No. 60/241,467 filed Oct. 18, 2000. 
    
    
     The present invention relates to an in-line specimen trap, a biomedical device utilized in conjunction with a controlled irrigation/suction system proximal to a surgical site, and a method therefor. 
     BACKGROUND OF THE INVENTION 
     During certain types of surgical procedures, the surgical site (for example, the site of the wound) is irrigated with irrigation fluid and fluid and debris is suctioned away from the surgical site via a suction line. Irrigation fluid is delivered to this irrigation site via an irrigation line. Many times, the suction and irrigation lines are coupled to a valve control system which is controlled by the surgeon or other medical professional. The output of the valve system, opposite the suction line and irrigation line, is coupled to a probe which leads to the surgical site. The valve is sometimes called a trumpet valve. Various trumpet valves are illustrated and discussed in U.S. Pat. No. 6,062,429 to West et al.; U.S. Pat. No. 6,148,857 to West et al. and U.S. Pat. No. 6,171,072 B1 to West et al. In general, these trumpet valves and other irrigation/suction valves operate by permitting the surgeon to control either the degree of irrigation or the degree of suction delivered through the probe or line leading to the surgical site. 
     Sometimes there is a need to collect specimens from the surgical site. 
     OBJECTS OF THE INVENTION 
     It is an object of the present invention to provide an in-line specimen trap adapted to be used in conjunction with the controlled delivery of suction and/or irrigation and a surgical probe or line leading to the surgical site. 
     It is another object of the present invention to provide an in-line specimen trap that has multiple operating modes, one of which is a bypass mode permitting substantially direct coupling between the suction or irrigation line (dependent upon the valve control) and the line leading to the surgical site and a second control mode wherein fluids and particulate debris from the surgical site are cycled through a specimen container. 
     It is an additional object of the present invention to have an in-line specimen trap with a third control mode in which the suction/irrigation line and the line leading to the surgical site are blocked off thereby permitting the trap to be uncoupled from these lines and carried away. Preferably, specimen fluid and/or particulate debris remain in the specimen trap container. 
     It is a further object of the present invention to enable the specimen trap to be used to infuse liquid to the surgical site. 
     SUMMARY OF THE INVENTION 
     The in-line specimen trap operates in conjunction with a first line carrying controlled suction or irrigation and a second line leading to a surgical site. The trap includes a specimen container, a cap coupled to the specimen container and an operator controlled, multi-modal valve disposed in or on the cap. The valve includes at least a bypass passage and a container input port and a container output port. The bypass passage limits flow exclusively between the first and second lines, that is, between the suction/irrigation line and the line leading to the surgical site. The container input and output ports permit flow through the container via the first and second lines. The position of an operator control interface determines the selection of the bypass mode or trap and collection mode through the container input and output ports. In an enhanced embodiment, the specimen trap has a third mode of operation (the first mode of operation being the bypass operation and the second mode of operation being flow through the container via the input and output ports) wherein, in the third control mode, the suction/irrigation line and the second line leading to the surgical site are blocked. In the third control mode, the in-line specimen trap can be removed and withdrawn from the suction/irrigation line and the line leading to the surgical site. Preferably, the valve for the specimen trap includes a valve manifold with the bypass and input and output ports and an operator interface on the cap of the specimen trap. The valve manifold is typically disposed in the cap. The operator rotates the cap relative to the specimen container and thereby selects the bypass mode, the trap mode or the seal (blocking) mode. The method of selectively (a) trapping specimen fluid and debris and (b) permitting suction and irrigation flow includes providing a specimen container, establishing, under operator control, a bypass channel between the first and second lines (the suction/irrigation line and the leading to the surgical site), channeling, under operator control, the specimen fluid and debris from the second line through the specimen container to the first line, and, closing the specimen container after the channeling step. Fluid infusion to the surgical site involves loading the container with the infusion substance and flushing the container with irrigant and outputting the resultant mixture to the surgical site line. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     Further objects and advantages of the present invention are found in the detailed description of the preferred embodiments when taken in conjunction with the accompanying drawings in which: 
     FIG. 1 diagrammatically illustrates the in-line specimen trap coupled between the suction/irrigation line and a second line leading to a surgical site and further diagrammatically illustrates a trumpet valve and the suction line and the irrigation line coupled to the suction/irrigation control valve; 
     FIGS. 2A,  2 B and  2 C diagrammatically and graphically illustrate the bypass control mode, the trap control mode and the seal control mode in accordance with the principles of the present invention; 
     FIG. 3 graphically illustrates the multi-modal valve in the cap of the in-line specimen trap; 
     FIG. 4 diagrammatically illustrates a perspective view of the in-line specimen trap; and 
     FIGS. 5A and 5B diagrammatically illustrate a linear valve and valve manifold in accordance with the principles of the present invention. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The present invention relates to an in-line specimen trap and a method for selectively (a) trapping specimen fluid and debris and (b) permitting suction and irrigation flow between a suction/irrigation line and a second line leading to a surgical site. 
     FIG. 1 diagrammatically illustrates in-line specimen trap  10  coupled between a suction/irrigation or first line  12  and a second line  14  leading to a probe (not shown) at a surgical site. Irrigation fluid is provided via an irrigation line  16  to a valve system  18 . In the illustrated embodiment in FIG. 1, valve system  18  is a trumpet valve having a pair of user control interfaces  20 ,  22  which control the degree of irrigation fluid to suction/irrigation line  12  (disposed on the proximal side of control valve  18 ) or suction on line  12 . The term “distal” refers to objects remotely disposed from the surgical site whereas the term “proximal” refers to items relatively closer to the surgical site. Suction on line  12  is obtained by depression of one of the controls  20 ,  22  due to the opening of an internal valving mechanism (not shown) and the presence of a partial vacuum on suction line  24 . At the distal end of suction line  24  (not shown) is a sump for discharged fluid, debris and particulate. Actuator valve controls  20 ,  22  are depressed by the operator as shown by arrows  20   a  and  22   a.  Other types of suction/irrigation control valves could be utilized. 
     In-line specimen trap  10  includes a specimen container  30 , a cap  32  and an operator controlled, multi-modal valve. In the illustrated embodiment, the operator control is a rotating control actuator surface  34 . The operator selects one of three control modes: bypass mode (illustrated in FIG.  1 ), trap control mode or seal control mode by rotating operator interface  34  in the direction shown by arrow  36 . As explained later, in the bypass control mode, suction or irrigation is provided between line  12  and line  14  exclusively through the value system in the specimen trap. In the trap control mode, suction and irrigation passes through interior  38  of specimen container  30 . In the third or sealed control mode, the valve system in the in-line specimen trap  10  blocks line  14  leading to the surgical site and blocks suction/irrigation line  12 . This enables specimen trap  10  to be decoupled from lines  12 ,  14  and withdrawn from the surgical site. 
     Specimen container  30  includes container wall  40  and a lower container wall  42 . Walls  40 ,  42  include interior surfaces. Particularly, lower wall  42  includes interior surface  44 . In-line specimen trap  10  also includes a leader tube  46  disposed in the interior of specimen container  30 . Leader tube  40  has a port or opening  48  somewhat adjacent or proximate interior surface  44  of lower wall  42 . 
     In a preferred embodiment, specimen container  30  is transparent. Transparent container  30  enables the medical professional to determine the amount of fluid and debris collected in the specimen container during the trap control mode. Debris, mainly particulate, falls to lower interior surface  44  of container  30 . 
     FIGS. 2A,  2 B and  2 C diagrammatically and graphically illustrate the valve disposed, in the preferred embodiment, in the cap  32  of in-line specimen trap  10 . It should be noted that the valve could be disposed on top of cap  32  and an intermediate cap, between upper surface  32  and specimen container  30  could be provided with closeable through passages. 
     In FIGS. 2A-2C, cap  32  includes an upper, stationary member  50  and a lower, rotating member  52 . Similar numerals designate similar items in FIGS. 2-2C. FIG. 2A shows the in-line specimen trap in the bypass control mode. Stationary cap member  50  has a port  60  that is coupled to line  14  (FIG.  1 ). An interior passage way  62  leads to an interior port  64 . Stationary cap member  50  also includes port  66 , interior passage way  68  and interior port  70 . Port  66  is coupled to section/irrigation line  12 . Hence, in FIG. 2A, port  60  is coupled to line  14  which leads to the surgical site and port  66  is coupled to a line  12  which leads to the controlled irrigation source or controlled suction line to the sump. The term “control” refers to the controlled nature of irrigation flow or degree of suction provided the operator by valve control system  18  shown in FIG. 1 or other similar valving control system. 
     Movable member  52  includes a bypass passage  72  communicating with ports  74  and  76 . In the bypass control mode shown in FIG. 2A, port  74  is aligned with port  64  and hence is in communication with the surgical site via line  14  (FIG.  1 ). Port  76  is in communication with port  70  and hence is in communication with suction/irrigation line  12 , valving system  18  and irrigation supply line  16  and suction vacuum line  24 . See FIG. 1. A seal  78  may be provided at a peripheral location between cap members  50 ,  52 . In a working embodiment, stationary cap member  50  is cylindrical and movable cap member  52  is cylindrical. Hence, seal  78  is disposed radially beyond mating ports  64 ,  74  leading to the surgical site and ports  70 ,  76  leading to the suction/irrigation line and control source and sump. In the bypass control mode, specimen container  30  is not coupled to fluid ports  60 ,  66  in stationary cap member  50 . Hence, bypass passage  72  limits flow exclusively between the first and second lines, that is, suction/irrigation line  12  and surgical site line  14 . 
     FIG. 2B diagrammatically illustrates the trap control mode. In order to position the containment system in the trap control mode, movable cap member  52  is rotated in direction  36  shown in FIG. 1 relative to the stationary cap member  50 . Operator control surface  34  (FIG. 1) is coupled to movable cap member  52 . In the trap control mode shown in FIG. 2B, movable cap member  52  includes a first input port  80  having interior port  82 , interior passage  84  and container port  86 . Port  82  mates with port  64  of stationary cap member  50 . Chamber port  86  is in communication with interior  38  of specimen container  30 . Movable cap member  52  also includes an output port  90 . Output port  90  includes an interior port  92 , a through passage  94  and a chamber port  96 . In a preferred embodiment, chamber port  96  is permanently coupled to or mounted with leader tube  46 . In operation, suction is applied at port  66  of stationary cap member  50 . This draws fluid and particulate debris or other materials from the surgical site, into port  60 , through ports  64  and  82  and chamber port  86  (that is, input port system  80 ) and into interior chamber  38  of specimen container  30 . Since leader tube  46  has an upper opening  49  in communication with port  96 , fluid and, to some extent, particulate debris is suctioned into opening  48  of leader tube  46 , through ports  49 ,  96 , intermediate passage  94 , through ports  92  (defining output port system  90 ), port  70  and out port  66 . Opening  48  of leader tube  46  is spaced an appropriate distance d apart from lower interior wall  44 , that is, a distance sufficient to trap a requisite amount of fluid and/or particulate debris in the lower regions of interior  38  of specimen container  30 . 
     In a preferred embodiment, specimen chamber  30  rotates concurrently with movable cap member  52 . Hence, there may be a permanent continuity between interior passage  94  and the interior of leader tube  46 . Another words, ports  96  and  49  may be eliminated. FIGS. 2A-2C and  3  graphically illustrate the invention. Alternatively, specimen container  30  can be statically mounted to stationary cap member  50  and movable cap member  52  could rotate to open and close bypass passage  72  and input port  80  and output port  90 . In this construction, leader tube  46  moves with respect to output port  90 . A further static cap is mounted on container  30  in this alternative embodiment. Further in all embodiments, container  30  may be threadably mounted on cap system  50 ,  52 . 
     FIG. 2C shows a sealed control mode. Movable cap member  52  has been rotated, in a preferred embodiment, such that interior port  64  (leading to the surgical site via line  14  (FIG.  1 )) and interior port  70  (leading to suction/irrigation line  12  and the controlled irrigation source and controlled suction and sump) are independently blocked. In order to show this blocking or sealing of interior ports  64 ,  70 , the figure shows cross-hatched areas  110 ,  112 . Movable member  52  may or may not have sealing seats  110 ,  112 . 
     FIG. 3 graphically illustrates the rotating valve manifold defined by movable cap member  52 . Line  14  leads to the surgical site. Suction/irrigation line  12  leads to control valve  18  (FIG. 1) and independent irrigation line  16  and suction line  24  (FIG. 1) which is the controlled irrigation source and controlled suction or vacuum to the sump. Stationary cap member  50  is graphically illustrated by the dash dot dash line in FIG.  3 . Port  74  is illustrated graphically as being in communication with opening  120  of line  14  leading to the surgical site. Port  76  is graphically illustrated in communication with opening  122  of irrigation/suction line  12 . Ports  74  and  76  communicate with bypass passage  72 . 
     When movable member  52  is rotated in direction shown by arrow  36 , ports  82 ,  92  align with openings  120 ,  122  of lines  14  and  12 . This represents the trap control mode shown in FIG. 2B. A plurality of detents  121 ,  123 ,  125 ,  127 ,  129  and  131  cooperate with similar or complementary detents on stationary cap member  50  in order to provide a tactile response to the user when the user rotates movable member  52  relative to stationary member  50 . Detents  121 ,  123  permit accurate alignment of ports  74 ,  76  with openings  120 ,  122 . Detents  125 ,  127  permit accurate alignment of ports  82 ,  92  with openings  120 ,  122 . Of course, ports  74 ,  76  align with interior ports  64 ,  68  shown in FIG.  2 A. The detents are operative to permit the operator to “feel” the alignment of bypass passage  72  and the alignment of ports  74 ,  76  with interior ports  64 ,  68 . Since ports  64 ,  68  lead to ports  60 ,  66  (FIG. 2A) and those latter ports are described as being connected to lines  14 ,  12 , FIG. 3 graphically illustrates the rotatable valve manifold. 
     When movable cap member  52  is further rotated in direction  36 , seal regions  110 ,  112  are placed to close ports leading to openings  120 ,  122 . This positioning of seals  110 ,  112  is tactily noted by the user based on detents  129 ,  131 . A stop  124  limits further movement in direction  36 . The counter stop (not shown) is disposed at an appropriate position on stationary cap member  50 . Another complementary stop is placed on the static cap to limit rotation in a clockwise direction from the position shown in FIG.  3 . Hence, stop  124  is configured to move from the twelve o&#39;clock position shown in FIG. 3 to the nine o&#39;clock position based upon the maximum arcuate rotation in direction  36  of movable cap member  52 . 
     FIG. 4 shows a perspective view of a working embodiment of the in-line specimen trap  10 . Cap  32  includes a stationary cap member  50 . The movable cap member  52  is not shown in FIG. 4 but is interior to cap  32 . User control surface  34  is coupled in a appropriate manner to movable cap member  52 . Upper cap surface  130  includes indicia for the bypass, trap and seal control modes. Operator control surface  34  includes a tab  132  and an indicia marker  134  which points to complementary markers at bypass control position (marker  134 ), trap position and seal position. This enables the operator to visually confirm the control position of the in-line specimen trap. 
     In order to facilitate coupling and uncoupling from the surgical probe and the control valve  18  (FIG.  1 ), in-line specimen trap  10  includes a port extension  140  and a fluid coupling member  144 . Fluid coupling member  144  fits into the proximal end of the trumpet control valve  18  shown in FIG.  1 . Another port extender  146  is configured to a slide on line  14  of the probe via accordion coupler  148 . The surgical probe is inserted into coupler  148  in the direction shown by arrow  150 . 
     Coupling joints  144 ,  148  fluidly seal to the lines at either end of the trap  10 . 
     Specimen container  30  may be designed to screw and unscrew from the cap assembly  32  if necessary. 
     A wide variety of multi-modal valves can be used in conjunction with the in-line specimen trap. Essentially, the specimen trap valve must have at least two positions, a bypass position and a position which permits communication to the interior of specimen container  30 . In other words, a two position valve must have a bypass passage which exclusively limits flow from line  14  leading to the surgical site through the specimen trap valve and to the suction/irrigation line  12 . The other control position must permit flow into specimen container  30  through a container input port and permit flow out of container  30  via container output port. A three position valve is shown and described herein. Although a rotating valve manifold is shown in FIGS. 1-3 other types of valves can be utilized. 
     FIGS. 5A and 5B show a linear valve. The linear valve in FIGS. 5A,  5 B includes a valve manifold  200  which moves in the direction show by double headed arrow  202  based upon the user actuating user interface  204 . Interface  206  represents any typical actuator surface. Ports  60 ,  66  are coupled to the surgical line  14  and suction/irrigation line  12  as described above in connection with FIG.  2 A. In the position shown in FIG. 5A, interior ports  64 ,  70  communicate with primary ports  60 ,  66  but flow through the system is blocked off by port closures or seats shown by the Xs on valve manifold  200 . 
     In contrast in FIG. 5B, the user has linearly moved user actuator surface  204  and valve manifold  200  to the opposite linear position. In this position, port  64  is adjacent and in communication with port  210 . Port  70  is in communication with port  212 . This permits suction, debris and irrigation fluid flow exclusively through bypass channel  214 . Valve manifold  200  moves on tracks  216 ,  218  and  220 . In the intermediate position not shown in the figures, port  64  is aligned with port  230 . This permits fluid and debris to flow from port  60 , through the internal passage way, out of port  64 , into port  230  and out of port  232  and into the interior  38  of specimen container  30 . Also in that position, port  234  is in communication with port  70 , and port  23  is in communication with opening  49  of leader tube  46 . This permits fluid flow and debris flow up leader tube  44 , through port  236 , through the interior port of the valve manifold  200 , out of port  234 , into port  270 , out of port  266 , through the control valve  18  (FIG. 1) and into suction line  24 . 
     The rotating valve shown in FIGS. 2A-2C and  3  rotatably positions the ports for the bypass, trap and seal position. In FIG. 5A-5B, the valve manifold moves linearly to open and close ports in a controlled manner. Flow and blockage of the primary ports  60 ,  66  is established in the specimen trap and through the valve manifold as discussed earlier. 
     The in-line specimen trap device is intended to be inserted in-line with the suction/irrigation probe used in conjunction with trumpet valves. The probe, utilized by a medical professional at the surgical site, is removed and the specimen trap is attached to the valve. The probe is then re-attached to the specimen trap. The purpose of the specimen trap is to enable the physician to capture particulate for analysis that is suctioned through the probe. 
     The specimen trap in one preferred embodiment consists of two main components: the molded plastic in-line connection with a valve and potentially a filter and the removable, transparent plastic specimen cap. The valve mechanism is activated by rotating the plastic cap. There are three positions: by-pass, trap and sealed. In the bypass mode, any fluid or particles suctioned from the surgical site will not be deposited into the cap. Fluid and debris from the site are passed directly through the trumpet valve into the suction system. In the trap position, everything suctioned first goes through the specimen cup, where particulate debris are trapped. In the sealed position, the specimen cup is sealed to keep its contents from spilling and the device can be removed from the trumpet valve. 
     When the specimen trap is attached to the trumpet valve as described above, it is initially set in the bypass position. In this position, suction and irrigation modes function normally. When the cup is rotated to the trap position, it is ready to be used to capture specimen. If the trap is to be used in the normal mode, the cup can be rotated back to the bypass position. Once the necessary particulate specimen is accumulated, the cup is rotated to the sealed position for removal from the trumpet valve and transport to the laboratory. 
     Another use of the in-line specimen trap is to infuse medication. To accomplish this function, the specimen cup is initially filled with whatever is to be infused into the patient. When set in trap mode, and the trumpet valve activated to introduce irrigant, the contents of the specimen cup is carried into the patient. 
     The claims appended hereto are meant to cover modifications and changes within the scope and spirit of the present invention.