Abstract:
A percutaneous surgical instrument system includes a handle to be manipulated by an operator, a carrier and a trocar to be manipulated by the handle. The trocar is inserted through the carrier for penetration to a surgical site and removed from the carrier to permit insertion of a surgical instrument through the carrier. A syringe supplies fluid to the trocar during penetration to the surgical site. A method for percutaneously inserting a surgical instrument to a surgical site is also provided.

Description:
BACKGROUND OF THE INVENTION  
       [0001]     1. Field of the Invention  
         [0002]     The invention relates to a percutaneous surgical instrument system and method. A carrier and its trocar are used as an insertion aid and access portal for percutaneous surgical instruments, such as chest tubes, percutaneous abdominal instrumentations, biopsy needles, endoscopes and laparoscopes.  
         [0003]     2. Description of the Related Art  
         [0004]     Percutaneous surgical instrument carriers, with their pointed lumen-filling trocars, must penetrate several tissue layers to reach the intended operative or diagnostic site. The carrier, with its insertion trocar removed, is a tube-like portal or sleeve through which the surgical instrument functions internally. The carrier and trocar are inserted as a single unit, and then the carrier with its selected surgical instrument are used operatively as a single unit.  
         [0005]     Such relatively large-bore carriers, having the tapered and pointed central lumen filler or trocar to aid insertion, meet with exaggerated resistance related to a phenomenon of pressure desiccation or pressure drying of the invaded tissue. The advancement force or pressure of the large bore insertions, forces the normally present tissue fluids away from the invading path, and in-effect dry the tissue and increase insertion resistance. Furthermore, the advancement of the trocar and carrier stretches and tightens the encircling fibers of the tissue layers causing a gripping resistance much like a Chinese finger trap. That elevated resistance depresses, distorts, or tents downward the impinged tissue layers and impairs the controlled safe advancement of the carrier and trocar. More importantly, the operators&#39; modulating proprioceptive feedback or feel of proper advancement is prevented. That elevated insertion force increases the risk of sudden break-through or over-insertion and collateral damage to nearby organ systems and the downward tenting of the tissue layers or abdominal wall brings the sharpened trocar unsafely close to nearby organ systems.  
         [0006]     Such devices, which suffer from the disadvantages described above, are known in the prior art from U.S. Pat. No. 4,972,827 to Kishi et al., U.S. Pat. No. 5,059,186 to Yamamoto et al., U.S. Pat. No. 5,368,574 to Antonacci et al., U.S. Pat. No. 4,897,081 to Poirier et al. and U.S. Pat. No. 5,626,597 to Urban et al.  
       SUMMARY OF THE INVENTION  
       [0007]     It is accordingly an object of the invention to provide a percutaneous surgical instrument system and method, which overcome the hereinafore-mentioned disadvantages of the heretofore-known systems and methods of this general type and which are safer and have a low insertion resistance.  
         [0008]     With the foregoing and other objects in view there is provided, in accordance with the invention, a percutaneous surgical instrument system. The system comprises a handle to be manipulated by an operator and a carrier. A trocar is to be manipulated by the handle, inserted through the carrier for penetration to a surgical site, and removed from the carrier to permit insertion of a surgical instrument through the carrier. A syringe is provided for supplying fluid to the trocar during penetration to the surgical site.  
         [0009]     In accordance with another feature of the invention, the trocar has a tip through which the syringe supplies the fluid to the surgical site. The tip has at least one opening formed therein for supplying the fluid to the surgical site. The tip has an outer periphery with channels formed therein for directing the fluid, and the at least one opening is disposed in at least one of the channels. The channels extend substantially in axial direction of the trocar and are spaced apart circumferentially entirely over the outer periphery of the tip. The carrier has an outer periphery with channels formed therein for directing the fluid along with the channels formed in the tip of the trocar.  
         [0010]     According to the invention, the fluid and channels provide a pressure-limited, lubricated carrier and trocar with reduced contact area, to safely reduce percutaneous insertion resistance, improve operator feed back and control, reduce tissue damage, lessen post operative discomfort and reduce the risk of collateral organ damage during percutaneous instrument carrier insertion.  
         [0011]     In accordance with a further feature of the invention, the carrier has a widened proximal entrance for receiving the trocar or surgical instrument and a distal opening with a sharpened edge. The widened proximal entrance facilitates insertion of the trocar or surgical instrument. The sharpened edge aids insertion into subject tissue at the surgical site.  
         [0012]     In accordance with an added feature of the invention, the handle has a bore formed therein for at least partly receiving the syringe and at least one passageway leading to a passageway in the trocar. The syringe supplies the fluid through the at least one passageway in the handle and the passageway in the trocar to the at least one opening in the tip of the trocar.  
         [0013]     In accordance with an additional feature of the invention, the handle has a threaded nipple and a threaded nut. The nipple and nut connect the at least one passageway in the handle through the nipple to the passageway in the trocar.  
         [0014]     In accordance with yet another feature of the invention, the syringe has a plunger and a body with a cylindrical container for receiving the plunger. The plunger is manually depressed for injecting the fluid into the handle. The plunger has a head with a recess formed therein and a projection disposed in the recess. The recess and projection form a ring seal with play allowing the fluid to leak out for limiting and controlling injection pressure while adequately lubricating the carrier.  
         [0015]     With the objects of the invention in view, there is also provided a method for percutaneously inserting a surgical instrument to a surgical site. The method comprises inserting a trocar through a carrier. The carrier and the trocar are inserted to the surgical site while guiding a fluid through the trocar. The trocar is removed from the carrier and the surgical instrument is inserted through the carrier.  
         [0016]     In accordance with another mode of the invention, the fluid is directed through at least one opening in at least one channel in an outer periphery of a tip of the trocar. The channels extend substantially in axial direction of the trocar and are spaced apart circumferentially entirely over the outer periphery of the tip. The fluid is directed along the channels formed in the tip of the trocar and along channels formed in an outer periphery of the carrier. Thus, the lengths of the trocar and carrier are lubricated during insertion.  
         [0017]     In accordance with a concomitant mode of the invention, the fluid is supplied from a syringe through a handle to be manipulated by an operator and through the trocar to the at least one opening during penetration to the surgical site. The fluid is allowed to leak out of a ring seal in the syringe for limiting and controlling injection pressure while adequately lubricating the carrier. It is therefore ensured that the pressure of the fluid from the syringe to the tip of the trocar cannot exceed safe limits.  
         [0018]     Other features which are considered as characteristic for the invention are set forth in the appended claims.  
         [0019]     Although the invention is illustrated and described herein as embodied in a percutaneous surgical instrument system and method, it is nevertheless not intended to be limited to the details shown, since various modifications and structural changes may be made therein without departing from the spirit of the invention and within the scope and range of equivalents of the claims.  
         [0020]     The construction and method of operation of the invention, however, together with additional objects and advantages thereof will be best understood from the following description of specific embodiments when read in connection with the accompanying drawings. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0021]      FIG. 1  is a diagrammatic, side-elevational view of a handle, trocar, carrier and syringe of a percutaneous surgical instrument carrier and trocar system according to the invention;  
         [0022]      FIG. 2  is a perspective view, similar to  FIG. 1 , of the system according to the invention;  
         [0023]      FIG. 3  is an exploded, side-elevational view of the handle and nut of the system according to the invention;  
         [0024]      FIG. 4  is a view similar to  FIG. 3 , but in which the handle and nut are transparent to reveal internal features;  
         [0025]      FIG. 5  is an exploded, side-elevational view of a plunger and body of the syringe of the system according to the invention;  
         [0026]      FIG. 6  is a perspective view of the syringe, similar to  FIG. 5 ;  
         [0027]      FIG. 7  is a longitudinal-sectional view of the syringe of  FIGS. 5 and 6 ;  
         [0028]      FIG. 8  is a perspective, longitudinal-sectional view of the syringe of  FIGS. 5, 6  and  7 ;  
         [0029]      FIG. 9  is a side-elevational view of the carrier of the system according to the invention;  
         [0030]      FIG. 10  is a fragmentary, enlarged, side-elevational view of the carrier showing its fluting;  
         [0031]      FIG. 11  is a perspective view of the carrier similar to  FIG. 10 ;  
         [0032]      FIG. 12  is a perspective view of the trocar of the system according to the invention;  
         [0033]      FIG. 13  is a fragmentary, enlarged, side-elevational view of the trocar showing its fluting;  
         [0034]      FIG. 14  is a fragmentary, side-elevational view of the tip of the trocar within the carrier;  
         [0035]      FIG. 15  is an exploded, side-elevational view, prior to assembly, of the syringe, handle, trocar and carrier of the system according to the invention;  
         [0036]      FIG. 16  is a perspective view similar to  FIG. 15 ;  
         [0037]      FIG. 17  is a side-elevational view, after assembly, of the syringe, handle and carrier of the system according to the invention; and  
         [0038]      FIG. 18  is a perspective view similar to  FIG. 17 . 
     
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0039]     Referring now to the figures of the drawings in detail and first, particularly, to  FIGS. 1 and 2  thereof, there is seen a percutaneous surgical instrument carrier and trocar system according to the invention, including a handle  1 , a trocar  20 , a carrier  40  and a syringe  60 .  
         [0040]     As is seen in  FIG. 3 , the handle  1  has a body  2  with ridges  3  and recesses  4  to facilitate gripping by an operator at the proximal end of the system. It can also be seen that the body  2  has a nipple  5  with external screw threads  6 . An adjusting nut  7  has internal screw threads  8  shown in  FIG. 4  for mating with the external threads  6 .  FIG. 4  additionally shows that a cylindrical container-receiving bore  9  leads to a tapered nozzle-receiving bore  10 , formed in the body  2 . Channels or passageways  11 ,  12 ,  13  and  14  lead in succession from the bore  10  to the nipple  5 . The channels  11 ,  12 ,  13  are closed where they reach the outer surface of the handle.  
         [0041]     The syringe  60  shown in  FIGS. 5, 6 ,  7  and  8  has a body  61  and a plunger  65 . The body  61  has a cylindrical container  62  and a tapered nozzle  63  which correspond in size and shape to the cylindrical bore  9  and the tapered bore  10  of the handle  1 . The body  61  also has a lip  64  with a periphery having flattened portions, as is seen in  FIGS. 6 and 8 . The plunger  65  has ribs  66  extending between a disk  67  to be pressed by the thumb of an operator of the system and a disk  68  in the vicinity of a head  70  of the plunger  65 . A T-shaped projection at the end of the plunger  65  has a shaft  71  and a crosspiece  72 . The head  70  of the plunger  65  has a mushroom-shaped recess  73  formed therein for receiving the shaft  71  and the crosspiece  72  of the T-shaped projection.  
         [0042]     The cylindrical container  62  of the pressure-limiting syringe  60  is pre-filled with saline or other acceptable lubricant and the tapered nozzle  63  is secured to the tapered nozzle-receiving bore  10  at the bottom of the protected, cylindrical, container-receiving bore  9  in the handle  1 .  
         [0043]     The projection  71 ,  72  and the recess  73  of the lubricating syringe  60  provide a unique reverse-angle or with-the-flow ring seal, configured to intentionally bypass or leak fluid at pressures exceeding the average human systolic pressure of 120 mm of mercury and cause over-pressure release or venting, along the side of the plunger  65 . It is noted that conventional syringes have seals that face against-the-flow, or are configured to expand and seal more firmly with increasing pressure.  
         [0044]     By limiting and controlling the injection pressure, adequate lubrication of the advancing carrier is permitted without unnecessary lubricant extravasation. The over-pressure release or venting, along the side of the syringe plunger is easily felt by the operator for better modulation and control. The reverse-angled syringe seal vents excess or harmful pressure, while still allowing effective lubrication, and protection of tissue. The seal material is manufactured in a strength and contour to yield predictably at design pressures.  
         [0045]     As is seen in  FIG. 9 , the carrier  40  has a handle  41  at a proximal end. The handle  41  has at least one control ring  42  and a conically-tapered entrance  43  for a trocar or surgical instrument. The entrance  43  of the carrier  40  is conically shaped or tapered to the lumen of the carrier at the proximal end for facilitating the introduction of the surgical instrument and trocar  20  without abrasion, damage or dulling of their sharpened edges. The carrier  40  also has an opening  44  at a distal end. The opening  44  of the tube-like surgical instrument and trocar carrier  40  is tapered to facilitate and protect the insertion of the trocar  20  or surgical instrument. The opening  44  at the distal end has a right angle or straight across termination, which is tapered and has a sharpened edge around its entire circumference as is best seen in  FIGS. 10 and 11 , to aid insertion into the subject tissue. A passageway extends within the carrier  40  from the entrance  43  to the opening  44 . As is seen particularly well in  FIGS. 10 and 11 , fluted or concave channels  45  are provided around the entire circumference of the carrier  40  from the distal-most control ring  42  to the opening  44 .  
         [0046]     The carrier  40  is constructed of metal or other suitable material, in matching variations of lengths from 8 cm to 40 cm and in equivalent cross-sectional diameters of 10 to 18 gauge. The carrier  40  has cross-sectional shapes matching the surgical instruments and trocars  20 , but is slightly larger, since the carrier is constructed to fit snuggly over the surgical instrument or trocar, for ease of introduction through the body layers and to safely contain and support the surgical instrument to the proper location and anglulation through the carrier  40 .  
         [0047]     The trocar  20  shown in  FIGS. 1, 2 ,  12  and  13  has a gripping handle  21  at a proximal end and a tip  22  at a distal end. A continuous passageway  23  leads from the handle  21  to the tip  22 . As is seen in  FIG. 13 , the tip  22  has a tapered and sharpened point with fluted or concave channels  24  around its entire circumference. One or more fluid outlets  25  are formed within the channels  24 . The injected lubricant fluid or saline is guided through the passageway  23  and evenly from the outlets  25  along all areas.  
         [0048]      FIG. 14  also shows that the tapered and sharpened point at the tip  22  of the trocar  20  extends beyond the carrier  40 . The protruding tapered and sharpened tip  22  is constructed with the fluted surface of concave channels  24  around its entire circumference, running in line with and straight back from the tip to the carrier  40  and matching the fluted or concave channels  45  of the forward portion of the carrier. The fluted or concave channels  24  around the circumference of the trocar lead the injected lubricant fluid or saline from the tip of the trocar to the carrier and along the matching and similarly fluted or concave channels  45  of the carrier. These fluted or concave channels reduce the actual contact surface area, since the fibers touch only the very tips of each concave ridge, and additionally channel the remaining interstitial fluid evenly along the sides of the trocar  20  and carrier  40  for further reduction of insertion resistance.  
         [0049]     The fluted or concave channels  45 ,  24  of the carrier  40  and the tip  22  of the trocar  20  facilitate insertion and penetration of high density, high fiber layers. The channels  45 ,  24  of the high-density, high-fiber layer penetrating trocar tip and carrier improve lubrication and reduce contact surface and tissue resistance from pressure desiccation. The concave channel shapes also increase reflectivity and visibility by all imaging systems for better guidance and location control. The fluted or faceted channels reflect ultrasound, X-ray and echoed MRI energy more efficiently, which increases the visibility of the carrier and trocar by remote imaging systems, for improved control and placement.  
         [0050]     Insertion of the relatively large bore round object through multiple fibrous layers meets with an exaggerated resistance related to the phenomenon of pressure desiccation or drying and stretching by the compression of tissue layers ahead of the trocar  20  and carrier  40 . The forced advancement of the encased round trocar  20  drives the normal interstitial fluid from the contacting tissue and stretches the fibrous layers, creating a collapsing, tightening, fibrous tube surrounding the carrier  40  and trocar  20 , much like a Chinese finger trap. This pronounced increase in resistance takes significant pressure to overcome, decreases the tactile feel or proprioceptive feedback to the operator and increases the risk of misplacement or break-through-over-insertion trauma to other organ systems.  
         [0051]     The gripping resistance of the constricting tissue is reduced by the unique effect of a reduced contact or grip-able surface area created by the contour of the fluted or concave channels  24 ,  45  of the tip  22  of the trocar  20  and the carrier  40 . The stretched and tightened encircling fiber bands are pulled into straight line fibers, therefore contacting only elevated ridges between the fluted channels. Surface contact area and encircling fiber resistance is markedly reduced. Additionally, the lubricating fluid flowing through the fluted concave channels  24 ,  45  prevents the tensioned tissue from touching or resisting the remaining non-contact surface area of the trocar or carrier. By safely injecting sterile normal saline at limited pressures, ahead of and along the body of the trocar and carrier during insertion, and by markedly reducing the actual surface contact area, normal tissue lubrication is preserved, resistance and tissue damage is reduced, post operative discomfort is lessened, proprioceptive feedback and control are returned, and the risk of unintentional over insertion collateral damage is reduced.  
         [0052]     The trocar  20  and carrier  40  are inserted and maneuvered as a single unit. Between uses of the surgical instrument, such as for biopsies, the trocar  20  is reinserted within the carrier  40  for any repositioning or angle change of the carrier. The objective is to insert and maneuver the carrier  40  to the perfect depth and position. The carrier  50  may also be constructed with etched markings of insertion length, in centimeters, on its outer lateral surfaces for more precise placement.  
         [0053]     The trocar  20  and carrier  40  are configured and manufactured of suitable material, in various sizes, lengths and shapes to support and fit the intended surgical instruments. However, the carrier  40  is intentionally shorter than the surgical instruments, such as by four centimeters, providing for precise adjustability of depth in 1 centimeter increments, from 4 cm down to 1 cm in length. It should be noted that these dimensions are given as examples only and are not intended to be limiting.  
         [0054]     The trocar  20  acts as an insertion and strengthening aid for the carrier  40 . In percutaneous biopsy, for example, there are several layers of tissue which a biopsy needle must pass through, in order to reach a biopsy site and since such relatively large bore needles cannot be made with cutting tips because of tissue damage, a tapered and pointed central lumen filler, or trocar  20  with a gripping handle or control ring  21 , must be added to assist insertion. The biopsy needle or other surgical instrument is also relatively long and is maneuvered during insertion with bends and angle changes. These leverages or bending forces also require the stabilizing and strengthening of the carrier  40  with a full size strong trocar  20 . The trocar  20  is constructed to fit snuggly within the lumen of the carrier  40 , matching the carrier in size, cross-sectional shape and being slightly longer in length with a finely tapered point at the tip  22  that protrudes from the carrier  40  as is seen in  FIG. 14 .  
         [0055]     After the trocar and carrier have been inserted to the desired location, the trocar is removed, leaving the carrier to guide a surgical instrument. The entrance  43  at the proximal end of the carrier  40  is adapted to fit the trocar  20  and the various intended surgical instruments.  
         [0056]      FIGS. 15 and 16  show the body  61  and the plunger  65  of the syringe  60 , as well as the handle  1 , the trocar  20  and the carrier  40  immediately before assembly. However, the adjusting nut  7  has been slid over the tip  22  of the trocar  20  to the gripping handle  21  and the nut  7  has then been screwed onto the nipple  5 .  
         [0057]      FIGS. 17 and 18  show that the carrier has been slid over the trocar as far as the adjusting nut  7  so that the tip  22  of the trocar  20  protrudes from the opening  44  of the carrier  40 . The body  61  of the syringe  60  has been inserted into the bore  10  in the handle  1  and the plunger  65  has been depressed by pushing on the disk  67 .  
         [0058]     Therefore, a continuous path is formed for lubricant fluid or saline from the syringe  60 , through the bore  10 , through the channels  11 ,  12 ,  13 , through the nipple  5  with the nut  7 , through the passageway  23  and out of the outlets  25  to flow along the fluted or concave channels  24 ,  45 .