Abstract:
A single-use surgical irrigation system for use with a surgical tool and including a sleeve to be slidably received over the tool, a fluid reservoir for storing a irrigation and cooling liquid, a tube mounted on the sleeve for conducting fluid from the reservoir to a dispensing tip at an opposing end of the tube, the dispensing tip configurable to aim the stream of ejected fluid in one or a plurality of directions. A flow control mechanism controls the volume of fluid flowing from the nozzle portion.

Description:
TECHNICAL FIELD  
       [0001]     The present invention pertains to devices for irrigating surgical wounds and tools, and, more particularly, to a single-use device with adjustable nozzle and flow control for removable attachment to a surgical tool, to a surgical irrigation system that includes a compressible fluid reservoir, and to a surgical instrument that combines the surgical irrigation system with a surgical tool.  
       BACKGROUND OF THE INVENTION  
       [0002]     Most bone cutting in foot and hand surgery is performed with a sagittal saw  10  or an oscillating saw  12 , as shown in  FIGS. 1A-1B . These saws are designed to be lightweight for handheld use. Typically, they are coupled to a source of power via a conduit, cable, or wire appropriate to the power source. The tools  10 ,  12  depicted in  FIGS. 1A-1B  have an elongated body portion  14  that is gripped by the user&#39;s hand. The two saws  10 ,  12  differ in that the sagittal saw  10   15  has a blade  16  that moves orthogonal to the plane of the reciprocating blade  18  of the oscillating saw  12 .  
         [0003]     Because the saw blades move at a high speed in order to cut through the dense bone material, substantial friction and heat are generated at the surgical site, both in the bone tissue and in the saw blades  16 , 18 . Higher-powered saws are provided to accommodate geometric bone cuts, which can generate higher amounts of heat.  
         [0004]     Cutting through the bone tissue will destroy some cells; however, the heat caused by the cutting operation kills additional bone cells on the end of the bone tissue, which is known as thermal necrosis (death of bone cells). The destruction of bone cells on the ends of the bone can slow healing and knitting of the bone back together and in some cases prevent a union of the bone tissue.  
         [0005]     In order to reduce thermal necrosis, most surgeons will attempt to reduce the heat during sawing by applying a cooling liquid, as shown in  FIG. 2 . Here, the sagittal saw  10  being held by the surgeon&#39;s hand  20  has the saw blade  16  cutting into bone tissue  22 . To provide access to the bone tissue  22 , the wound  24  is held open by retractors  26  held in position by a surgical assistant. A second surgical assistant uses a syringe  32  to drop saline solution  30  onto the wound  24  and the saw blade  16 . This method has the disadvantages of obscuring the field of vision at the wound site  24  and inconsistently applying the saline solution  30 , resulting in the generation of heat in the bone tissue  22 .  
         [0006]     Attempts have been made to overcome the disadvantages of prior methods by utilizing powered pumps. One system designed for burring tools utilizes a rigid metal nozzle clamped to the tip of the burring tool and hooked to a motorized pump controlled by a foot pedal. Fluid is applied directly on the burring tool. System pressure is adjusted by a knob on a remote control panel for the pump. The disadvantage here is that the controls are located outside the sterile operative field. Consequently, a non-sterile assistant must be used to control the fluid pump. In addition, the nozzle clip is adaptable only to one size of tool, and the nozzle cannot be adjusted to direct the flow of fluid as desired. The foregoing system also requires expensive power equipment to push the saline solution through the system. While an I.V. bag can be used to allow gravity to push the saline through the system, both methods require a portion of the irrigation system to be contained outside of the sterile operative field. The I.V. bag and the supporting pole are not sterile. The motor to push the saline through the system is also not sterile. In addition, these systems are bulky, awkward, expensive, and can interfere with the handling of the surgical saw.  
         [0007]     Another proposed system is described in U.S. Pat. No. 2,012,886 for dental hand pieces wherein a squeezable bulb containing fluid is manipulated With hand pressure to project water from a spray tube through a tapered end and onto a grinding wheel. Here, the entire hand must be used to squeeze the bulb. In U.S. Pat. No. 6,030,356, an irrigation clip is attached to a malleable metal tube for manually directing the flow of irrigation fluid near the cutting tip of a rotatable tool implement. Here, repeated bending of the metal tube can result in kinking, which will restrict the flow of fluid, and eventually metal fatigue will cause failure of the tube, resulting in leakage and eventually complete fracture.  
       SUMMARY OF THE INVENTION  
       [0008]     The disclosed embodiments of the invention are directed to a surgical irrigation device having an adjustable nozzle and flow control for removable attachment to a surgical tool, to a surgical irrigation system that includes a compressible fluid reservoir, and to a surgical instrument that combines a surgical tool with the surgical irrigation system.  
         [0009]     In accordance with one embodiment of the invention, a surgical irrigation device is provided for use with a surgical tool that includes means for retaining and dispensing fluid; means for conducting the fluid from the dispensing means to the surgical wound; means for removably attaching the conducting means to the surgical tools; and means for controlling flow of fluid through the conducting means.  
         [0010]     In accordance with another embodiment of the present invention, a surgical irrigation device for use with a surgical tool is provided. The device includes a sleeve attached to the tool; a conduit having a distal tip and a proximal end, the conduit mounted on the sleeve; and a flow control mounted on the sleeve and the conduit. Ideally, the sleeve is formed of expandable, compliant material to be received on the tool.  
         [0011]     In accordance with another aspect of the foregoing embodiment, the conduit comprises a tube formed of flexible material, and the distal tip is formed of a positionable nozzle portion.  
         [0012]     In accordance with a further aspect of the foregoing embodiment, the nozzle portion is formed of two or more nozzles, each nozzle individually adjustable to a desired position.  
         [0013]     In accordance with another aspect of the foregoing embodiment, the flow control comprises a clamping member that is configured to enable selective clamping of the conduit or tube to control volume flow to the nozzle portion. Ideally, the clamping member is configured to enable selective clamping for stepped or proportional volume flow control.  
         [0014]     In accordance with another embodiment of the invention, a surgical irrigation system for use with a surgical tool is provided. The system includes a sleeve sized and shaped to be slidably received on the surgical tool; a conduit mounted on the sleeve; a flow control mounted on the sleeve and attached to the conduit; and a reservoir coupled to the conduit. Ideally, the conduit has a distal dispensing tip formed at a distal end that can be positioned at a desired orientation.  
         [0015]     In accordance with another aspect of the foregoing embodiment, the distal tip is formed of flexible non-metal material having a piece of malleable metal attached thereto to enable selective positioning of the dispensing tip at a desired orientation that will retain its position.  
         [0016]     In accordance with another aspect of the foregoing embodiment, the reservoir comprises a compressible bladder, such as an elastomeric bulb formed of a flexible membrane, or a collapsible housing or shell, or a syringe. Means are provided for collapsing or compressing the reservoir, such as an elastic, resilient band.  
         [0017]     In accordance with another embodiment of the invention, a surgical instrument is provided that includes a surgical tool having a cylindrical body and a surgical irrigation system mounted on the tool. The surgical irrigation system is preferably a single-use system that includes a sleeve formed of compliant material and sized to be slidably received over the cylindrical body of the tool. A fluid reservoir comprising a compressible container is attached to a tube mounted on the sleeve, the tube having a first end configured for dispensing the fluid from the fluid reservoir and a second end connectable to the fluid reservoir. The first end of the tube includes a nozzle portion formed of flexible material to enable selective positioning of the nozzle for directing fluid therefrom at a desired location, such as on the wound itself, on the tool or a blade associated with the tool, or both. A fluid control mechanism is mounted on the sleeve and associated with the tube for controlling the volume of fluid passing through the tube to the nozzle portion. The flow control mechanism is positioned ideally on the tool to enable operation thereof by the user&#39;s hand, preferably one or two fingers of the user&#39;s hand.  
         [0018]     As will be readily appreciated from the foregoing, the present invention provides a surgical irrigation device and system that provides irrigation of the wound and cooling of the surgical instrument that is contained entirely within an operative field. The system is easily adaptable to a variety of instruments, is controlled at the instrument itself, arid provides adjustment by the user while holding the tool both directionally and in volume. The use of bags, poles, or power equipment is not required inasmuch as the fluid reservoir is compressed using elastomeric materials. Hence, the system lends itself to inexpensive fabrication, ease of use, and is readily disposable. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0019]     The foregoing and other features and advantages of the present invention will be more readily appreciated as the same become better understood from the following description when taken in conjunction with the accompanying drawings, wherein:  
         [0020]      FIGS. 1A-1B  are illustrations of known saws for use in surgical procedures;  
         [0021]      FIG. 2  is an illustration of a surgical site showing the use of a sagittal saw in conjunction with a known irrigation method;  
         [0022]      FIG. 3  is an isometric illustration of a surgical instrument system in disassembled configuration formed in accordance with the present invention;  
         [0023]      FIG. 4  is an isometric illustration of another embodiment of a surgical instrument system utilizing the surgical irrigation device of the present invention; and  
         [0024]      FIG. 5  is a side view of a clamp member formed in accordance with the present invention. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0025]     Referring initially to  FIG. 3 , shown therein are the components of a surgical instrument system  34  formed in accordance with one embodiment of the present invention. The system  34  includes a surgical tool, in this case a surgical saw  36 , along with a surgical irrigation device  38 . The system  34  further includes a syringe  40  attached to a thin, narrow tube  42 . The surgical saw  36  is of the sagittal type, similar to the sagittal saw  10  of  FIG. 1A , and includes the body portion  44 , which is substantially elongate and cylindrical, and the saw blade  46 . This tool is readily commercially available and will not be described in more detail herein. It is to be understood that other tools may be used in the system  34 , including an oscillating saw, burrs, and other tools well known to those of skill in the art. This particular tool  36  includes an optional hand switch  48  pivotally attached to the body  44  to enable a user to activate the tool  36  with a single finger. A power cord  50  is detachably coupled to the tool  36  to provide power, such as pneumatic power, although electric or hydraulic power may be used as well.  
         [0026]     The surgical irrigation device  38  includes a sleeve  52  that is preferably formed of elastic material that contracts and stretches so as to be compliant with the shape of the body  44  of the tool  36 . Ideally the sleeve  52  is sized so as to be stretched over the body  44  to engage the body and provide a non-slip gripping surface for the user. Suitable material for the sleeve includes latex or similar material, including textured or non-slip material to enhance grip, as is known to those in the art.  
         [0027]     In this particular embodiment, the sleeve  52  has a conduit or tubular member  54  integrally formed therewith for conveying fluid from a proximal end  56  to a distal end  58  of the sleeve  52 . Ideally the tubular member  54  is integrally formed with the sleeve, although it may be attached to the exterior or interior of the sleeve. While the tubular member  54  may be separately formed from the sleeve  52 , and then either slid under the sleeve  52  after it is installed on the tool  36  or first placed on the body  44  of the tool  36  and then the sleeve  52  slid thereover, such is not preferred because of the difficulty in positioning the sleeve  52  with respect to the tube and the tool  36 . A connector  60  is formed at the end of the tubular member  54  adjacent the proximal end  56  of the sleeve  52  to facilitate connection and disconnection of the tubular member  54  from a fluid source. Typically, most tools can be uncoupled from the power cord, and this connector  60  provides a means for uncoupling the tubular member  54  from the fluid source when the power cord  50  is uncoupled.  
         [0028]     The tubular member  54  terminates at a distal end  62  that is configured to receive a nozzle portion  64 , shown separately in this depiction of the system  34 . The nozzle portion  64  has a connection end  66  for coupling to the distal end  62  of the tube  54  and a dispensing tip  68 . In this embodiment, the nozzle portion  64  is preferably formed of malleable material that enables it to be bent without kinking or failing from fatigue and to retain its position. The nozzle portion  64  is sized to extend over the cutting member of the tool  36 , in this case the saw blade  46 . While some surgeons may prefer to aim the stream of fluid at the saw blade, others will prefer to aim it at the bone itself. Thus, the ability to reposition the nozzle portion  64  to the desired location while accommodating differing needs and applications.  
         [0029]     The nozzle portion  64  may be formed to have different configurations. For example, the tip can be perforated to provide a shower-like effect from a plurality of small streams of fluid. The nozzle portion  64  may also be dividable, such as having two conduits removably attached together to enable separation and individual positioning as desired, e.g., on both sides of the saw blade  46 , or simultaneously on the saw blade  46  and on the wound  24 . In another embodiment, the nozzle portion  64  can be formed from the tubular member  54  wherein the tubular member  54  is formed of flexible material having a malleable wire attached thereto that positions and aims the tubular member  54 . It can also be bent so that it does not interfere with the saw blade or the bone when the blade is fully inserted into the bone.  
         [0030]     Still referring to  FIG. 3 , the surgical irrigation device  38  has includes a flow control mechanism  70  mounted on the sleeve and associated with the tubular member  54  to control the volume of fluid flowing through the tubular member  54 . The flow control mechanism  70  is preferably integrally formed with the sleeve  52  and positioned so that it can be operated by the thumb of the user when the tool is in use, as described in more detail in connection with  FIG. 4  below. The flow control mechanism  70  can have a number of configurations. In one embodiment, shown in  FIG. 5 , the flow control mechanism  70  consists of a clamp  72  having first and second clamping members  74 ,  76  coupled by a spring member  80  to pivot about a pivot point  78  and biased together by a spring member  80  to a closed position. When the clamp  72  is closed, the clamping members  74 ,  76  pinch the tubular member  54  closed to prevent the flow of fluid. Pressure applied to free the end  82  causes the engaged end  84  to separate from the second clamping member  76 , allowing fluid to flow through the tubular member  54 . A stop member  86  positioned near the free end  82  of the first clamping member  74  has detents  88  formed thereon that enable selective positioning of the degree of opening of the clamp  72 . Thus, the free end  82  of the first clamping member  74  can snap into various positions and is held in place by the detents  88 . In this embodiment, the stop member  86  is fixedly attached to the second clamping member  76 .  
         [0031]     Turing again to the surgical instrument system  34  of  FIG. 3 , the syringe  40  is of conventional configuration and is readily commercially available. Hence, it will not be described in more detail. Briefly, the syringe  40  includes a body  90  having a plunger  92  slidably received therein. The plunger  92  is urged to slide into the syringe body  90  by an elastic band  94  fixedly attached to the syringe body  90  and passing over the top  96  of the plunger  92 .  
         [0032]     Shown in  FIG. 4  is another embodiment of a surgical instrument system  97  in an assembled state. This embodiment differs from the system  34  shown in  FIG. 3  by the use of a compressible bladder  98  sized and shaped to contain the irrigation and cooling fluid, such as a saline solution. An elastic band  100  circumscribes the bladder to urge the bladder to collapse, thus applying pressure to the fluid inside the bladder, urging it to travel through the tube  102  to the connection member  104  associated with the surgical irrigation device  106  mounted to the surgical saw  108 . The device  106  includes the sleeve  110  slidably received over the body  112  of the saw  108 . A flow control mechanism  114  is formed as part of the sleeve  110  and positioned to be operable by the user&#39;s thumb (shown in phantom)  116  while the user&#39;s finger  118  (shown in phantom) operates the hand switch  120 .  
         [0033]     As shown here, the nozzle portion  122  is positioned adjacent the saw blade  124  to direct fluid from the compressible bladder  98  onto the saw blade  124 .  
         [0034]     Ideally, the surgical irrigation device  106  has a low profile and is formed of lightweight materials to facilitate handling and manipulation of the saw  108 . The flow control mechanism  114  is preferably configured as a clamp, as described above for example with respect to  FIG. 5 , that opens and closes to control the flow of saline. The clamp is located where it can be easily pressed while sawing, and it can be positioned on the right side, left side, or bottom of the saw  108 , depending on how the sleeve is slipped over the body  112  of the saw  108 . This makes it possible to accommodate both right- and left-handed surgeons.  
         [0035]     Thus, the disclosed embodiments of the invention provide an inexpensive, disposable method of irrigating a tool and an operating wound that remains within the operative field, is controllable by the user, does not need additional personnel to aid in its use, has a low profile, and does not require foot pedals or other accessories.  
         [0036]     While a preferred embodiment of the invention has been illustrated and described, it is to be understood that various changes may be made therein without departing from the scope of the invention. For example, the flow control mechanism can consist of a roller, thumbscrew, or other known device for restricting the flow of fluid within a tube. And while the sleeve has been described as the preferred method for attaching the tube to the tool, it is to be understood that adhesive or other materials could be used, although this is not preferred because of the residue the adhesive would leave on the tool and its tendency to attract dirt, dust, and other foreign-objects. In addition, elastic bands can be used to attached the tube and flow control mechanism to the tool, which would enable selective positioning of the bands to accommodate the shape and construction of the tool, and which would lower the cost of the system and enhance its disposability.  
         [0037]     In accordance with another embodiment of the invention, the tubular member  54  shown in  FIG. 3  can be externally mounted to the sleeve  52  in a manner that permits adjustment in the positioning of the tubular member with respect to the sleeve, ideally along a longitudinal axis of the sleeve, to enable selective positioning of the nozzle portion  64  with respect to the saw blade  46  and the tool  36 .  
         [0038]     Hence, the invention is to be limited only by the scope of the claims that follow and the equivalents thereof.  
         [0039]     All of the above U.S. patents, U.S. patent application publications, U.S. patent applications, foreign patents, foreign patent applications and non-patent publications referred to in this specification and/or listed in the Application Data Sheet, are incorporated herein by reference, in their entirety.