Abstract:
The present invention is a multipurpose medical device for use as a dilator, calibrator, suture guide and perfusion device. The device has an tapered, elongated tube; a valve having an opening coupled to the proximal end of the elongated tube; a connecting tube disengagably coupled to a second opening of the valve; a cylindrical sleeve slidably mounted on a portion of the elongated tubular member and having at least one radial groove configured for guiding a suture needle; and a plurality of diameter indicia marks located on the elongated tubular member. The cylindrical sleeve slides between a use position towards the distal end of the elongated tubular member and a park position towards the proximal end of the elongated tubular member.

Description:
FIELD OF THE INVENTION 
     The present invention relates to a multipurpose medical device, more particularly, a singular device configured for use as a vascular dilator, calibrator, occluder, suture guide and perfusion device. 
     BACKGROUND OF THE INVENTION 
     Numerous medical devices used for vascular dilation, calibration, suturing or perfusion are in existence. However, most devices are designed for providing a singular function. Designing a multipurpose medical device is a significant challenge in that the device must be cost effective to produce, reliable and the structures which provide each function must be complimentary rather than interfere with each other. Some existing devices do provide more than one function however none perform all of the functions that are accomplished by the present invention. 
     One example of a multipurpose device is the Fogarty® Flexible Calibrator manufactured by American Edwards Laboratories. This device is used as a dilator and calibrator, however it is not and can not be used for suturing or perfusion. Also, this device can only calibrate a single size, since the device has a uniform diameter. This is not cost effective since surgeons on average require 2.5 devices per patient per procedure to properly calibrate the size. At approximately $75 per device, which are single use only (i.e., disposed of after use in a patient), this is a significant cost. Another device which is sometimes used in place of the Fogarty® Flexible Calibrator is the metal olive tip probe. Although this device is reuseable, it is very traumatic to vessels as it is very hard and inflexible. 
     Other devices exist for performing singular functions. The Coronary Artery Occluder manufactured by DLP is a typical device that is used to occlude the coronary artery. This is done by inserting the device into the artery and suturing the device in place. Every 15 minutes the sutures and the device must be removed to allow for perfusion of fluids or blood to the artery. This is time consuming and must be performed by the surgeon. 
     The Fogarty® Bi-pass Shunt is used to bi-pass an artery from one end of a diseased segment to another in order to maintain blood flow. Catheter are known in the art for use as perfusion devices. On example of such a catheter is found in U.S. Pat. No. 5,364,344, which discloses a dual lumen catheter. 
     The lack of a multipurpose medical device that functions as a dilator, calibrator, occluder, suture guide and perfusion device is an important problem in the medical field. Currently, multiple devices must be used to perform these functions. This results in higher surgical costs since additional instruments must be used during surgery. Also, time is lost since a surgeon must switch from one instrument to another in order to perform these different functions, rather than smoothly transitioning from one function to the next with a single instrument. Additionally, time is lost every time the surgeon must remove an occluder and sutures to perfuse an artery and then re-insert the occluder and sutures. This means time that the surgeon must spend in the operating room and the patient is anesthetized. Switching from one instrument to another is also problematic in that the surgeons attention shifts from the hand off of the instrument from the nurse and away from the patient. 
     The present invention provides a multipurpose medical device that helps solves these problems by packaging a multitude of functions into a singular medical device. In particular, the present invention is intended to replace the Fogarty® Flexible Calibrator (or the metal olive tip probe), the DLP Coronary Artery Occluder, the Fogarty® Bi-pass Shunt and perfusion catheters with a singular device that provides these functions and more. 
     SUMMARY OF THE INVENTION 
     The present invention is a multipurpose medical device which functions as a vascular dilator, calibrator, suture guide and perfusion device. All of these functions are provided in a singular device 
     An object of the invention is to combine multiple medical functions into a singular device. 
     Another object of the invention is to provide a multipurpose medical device where the structures which provide each function are complimentary and do not interfere with each other. 
     A further object of the invention is to provide a cost effective medical device where multiple functions are combined in a singular device. 
     It is also an object of the invention to provide a medical device which saves time normally lost when a surgeon must switch from one instrument to another in order to perform different functions. 
     Also, it is an object of the invention to provide a multipurpose medical device that allows smooth transitioning from one function to the next with a single instrument. 
     Additionally, it is also an object of the invention to provide a medical device which saves time normally lost every time the surgeon must remove an occluder and sutures to perfuse an artery and then re-insert the occluder and sutures. 
     Moreover, it is an object of the invention to provide a multipurpose medical device which reduces the time that the surgeon must spend in the operating room and the patient is anesthetized. 
     An additional object of the invention is to provide a multipurpose medical device which helps surgeons maintain attention on the patient rather than on the hand off of multiple instruments from the nurse. 
     Also, it is an object of the invention to provide a multipurpose medical device that reduces the risk of danger to vessels. 
     Another object of the invention is to provide a multipurpose medical device that is reliable and simple in construction. 
     The present invention is a multipurpose medical device for use as a dilator, calibrator, suture guide and perfusion device. The device has an tapered, elongated tube; a valve having an opening coupled to the proximal end of the elongated tube; a connecting tube disengagably coupled to a second opening of the valve; a cylindrical sleeve slidably mounted on a portion of the elongated tubular member and having at least one radial groove configured for guiding a suture needle; and a plurality of diameter indicia marks located on the elongated tubular member. The cylindrical sleeve slides between a use position towards the distal end of the elongated tubular member and a park position towards the proximal end of the elongated tubular member. 
     The present invention has other objects and advantages which are set forth in the description of the Best Mode of Carrying Out the Invention. The features and advantages described in the specification, however, are not all inclusive, and particularly, many additional features and advantages will be apparent to one of ordinary skill in the art in view of the drawings, specification, and claims herein. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a side view of the multipurpose medical device of the present invention. 
     FIG. 2 is a side view of the suture sleeve shown in FIGS. 1 and 3. 
     FIGS. 3A and 3B are side views of the multipurpose medical device of the present invention when used with a guide wire. 
     FIG. 4 is a front and side view of the stopper shown in FIGS.  1  and  3 . 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The present invention is a multipurpose medical device used as a combination dilator, calibrator, suture guide and perfusion device. As depicted in FIG. 1, multipurpose medical device  10  has an elongated tube  12  having a distal end  14  and proximal end  16 , suture sleeve  18 , stopper  19 , valve  20  (which is preferably a 2-way or 3-way stop cock) having openings  22  and  24 , and connecting tube  26 . The use of a 3-way stop cock allows the device along with a transducer to provide an additional egress to elongated tube  12  for pressure monitoring. Elongated tube  12  is coupled to valve  20  by mounting distal end  16  of elongated tube  12  inside opening  22 . When in use, elongated tube  12  is inserted into an artery or vein distal end  14  first. Opening  24  of valve  20  has a female coupling  28  for receiving male coupling  30  of connecting tube  26 . Thus, connecting tube  26  is removably coupled to valve  20 . 
     Suture sleeve  18  (depicted in detail in FIG.  2 ), which is used to occlude coronary vessels while suturing anastomosis, is cylindrical in shape so that it can be slidably and removably mounted on elongated tube  12 . Suture sleeve  18  may slide along elongated tube  12  between use position  32  proximate to distal end  14  and park position  34  proximate to proximal end  16 . When at park position  34 , suture sleeve  18  is stowed so that elongated tube can be used for dilation, calibration and perfusion without interference by suture sleeve  18 . Sleeve  18  may slide along the entire length of elongated tube  12  (or if included as far as stopper  19  at distal end  14 ) and is held at any desired position by friction. 
     When in use position  32 , suture sleeve  18  is used to aid in vascular suturing. At least one, but preferably two or more radial guide grooves  36  are formed in suture sleeve  18 . Guide grooves  36  serve to guide a suture needle radially around suture sleeve  18  by riding the suture needle on one of guide grooves  36 . Suture sleeve  18  is preferably made of an flexible atraumatic material such as silicone, pebax, polyolefins, polyethylene or polyurethane and sufficiently solid to resist a suture needle from piercing suture sleeve  18 . Of these materials, pebax is optimal as it is stiffer to better prevent suture needle penetration. Alternately, a flexible metal such as stainless steel or nitinol could be used. 
     To facilitate the use of multipurpose device  10  for perfusion (i.e., directly injecting a fluid through a hole), elongated tube  12  is formed with an inner lumen  40  and blunt distal tip  42 . Placing valve  20  in the open position allows fluids to pass through connecting tube  26 , valve  20  and elongated tube  12  and out though distal opening  48 . This is especially useful to perfuse distal arteries of the heart, because elongated tube  12  does not need to be removed from the artery while switching between occlusion and perfusion as required when switching between conventional devices like the the DLP Coronary Artery Occluder and a perfusion catheter. 
     This also allows for the testing of blood flow through inner lumen  40 . A transducer is connected to valve  20  if a three-way stop cock is used or to connecting tube  26  if a two-way stop cock is used as valve  20  in order to test the blood pressure when valve  20  is opened. Alternately, a simple test for blood flow can be performed without a transducer by opening valve  20  to see if blood is forced out of connection tube  26 . 
     Typically, a syringe is applied to aorta cell saver connection  44  on connecting tube  26 . However, connecting tube  26  can be removed to allow a syringe to be coupled directly to valve  20  to inject fluids such as blood and plasma through elongated tube  12 . Connecting tube  26  preferably is clear in order to see blood clots and air bubbles. 
     This function serves to replace the need for a bi-pass shunt which bi-passes a diseased vessel with blood flow from a native vessel (i.e., the segment proximal to the diseased segment). Multipurpose medical device  10  performs perfusion without the need for a shunt which like a shunt perfuses distal to the diseased segment with fresh blood supply. Rather than using the native vessel, multipurpose medical device  10  uses the blood from either aorta cell saver  44  which filters and oxygenates the patients own blood normally lost during surgery, directly from the aorta, from another artery, or from an external supply. 
     To facilitate the use of multipurpose medical device  10  as a dilator and as explained later a calibrator, elongated tube  12  is tapered from a larger diameter at proximal end  16  to a smaller diameter at distal end  14 . Preferably, distal end  14  has a diameter between 1 and 3 mm with approximately 1.0 mm being optimal with blunt distal tip  42  being 1.5 mm, and proximal end  16  has a diameter between 3 and 8 mm with approximately 4.0 mm being optimal for coronary arteries. Other sizes may be preferable for other types of vessels. 
     The preferred length for elongated tube  12  is 25 cm, thus the diameter of elongated tube  12  tapers by 0.5 mm for every 5.0 cm in length. This results in a gradual uniform taper. For ease of construction, inner lumen  40  is not tapered. Additionally, elongated tube  12  is fabricated from a flexible atraumatic material such as silicone, pebax, polyolefins, polyethylene or polyurethane. These soft materials prevent damage to arteries that is common when using metal probes. 
     As depicted in FIGS. 3A and 3B, elongated tube  12  may be stiffened when necessary by inserting guide wire  50  into inner lumen  40 . The diameter of inner lumen  40  (i.e., inner diameter of elongated tube  12 ) is preferably 0.031″-0.039″ and optimally 0.035″ +/− 0.002″. This configuration is designed to accept a 0.030″ guide wire. This configuration is useful to dilate coronary vessels before bypass as well as radial vessels because guide wire  50  allows elongated tube  12  in combination with guide wire  50  to be removably formable. In other words, elongated tube  12  and guide wire  50  can be bent to facilitate introduction into a vessel and then the bend and stiffness is eliminated from elongated tube  12  by removing guide wire  50  from inner lumen  40  via opening  24  in valve  20 . Once guide wire  50  is removed, connecting tube  26  or any other device may be connected to valve  20 . Guide wire  50  made of annealed ground stainless steel or nitinol so that it will hold its shape when bent. Once elongated tube  12  is introduced into a vessel, guide wire  50  should be removed and valve  20  should be closed when using multipurpose medical device  10  as a dilator. 
     Blunt distal tip  42  which is securely mounted on distal end  14  of elongated tube  12  also helps prevent damage to vessels by virtue of its smooth shape and material, and lack of sharp edges or points. Any sharp edges that may be found at the distal opening  48  of elongated tube  12  are covered by blunt distal tip  42  which can be formed from any of the same materials as elongated tube  12  but is formulated to be softer. Blunt distal tip  42  needs to be the softest of the materials which form multipurpose medical device  10  so that it is the least traumatic and less stiff than elongated tube  12 . Blunt distal tip  42  also prevents suture sleeve  18  and stopper  19  from sliding off elongated tube  12  during use. 
     To facilitate the use of multipurpose medical device  10  as a calibrator, in addition to the taper of elongated tube  12 , diameter indicia marks  46  are placed along elongated tube  12 . Marks  46  indicate the diameter of elongated tube  12  at each marked location, which allows the diameter of a vessel to be determined by inserting elongated tube  12  into the vessel and noting the indicia mark  46  at the point at which the diameter of elongated  12  is the same as the vessel. This is useful for determining the size of a vein or artery to use as a graft and to know if the vessel is of sufficiently large diameter to even warrant a graft. 
     Preferably, a bio-compatible marker ink is used to place radial lines and numbers on elongated tube  12  as indicia marks  46 . The preferred color is blue as it is readily discernible from the blood which will be on elongated tube  12  during use. Alternatively, multicolor inks may be used with each different color representing a different diameter range. The multicolor coding may also be done, although more costly, by changing the color of the material used to form elongated tube  12 . Valve  20  should be closed when using multipurpose medical device  10  as a calibrator. 
     To facilitate the use of multipurpose medical device  10  as an occluder, stopper  19  (depicted in detail in FIG. 4) is slidably mounted on elongated tube  12 . If suture sleeve  18  is included with device  10 , stopper  19  is positioned between blunt distal tip  42  and suture sleeve  18 . Stopper  19  is sufficiently wide in order to block (i.e. occlude) the vessel into which it is inserted. To facilitate the occlusion, stopper  19  is shaped as a truncated cone (i.e., a tapered cyclinder) which has its widest diameter toward proximal end  16 . Preferably, stopper  19  has an inner diameter of 1.0 mm, an outer diameter which tapers from 4.0 mm at the proximal end to 1.0 mm at the distal end, and is 10-30 mm in length with 30 mm being optimal. Also, stopper  19  is made form the same materials as blunt distal tip  42 , elongated tube  12  and suture sleeve  18  but is formulated to have a softness similar to blunt distal tip  42  to minimize trauma, sufficient elasticity so that is can slide the entire length of elongated tube  12 , and sufficient flexibility to allow it to easily compress to fit into a vessel opening without causing trauma. Stopper  19  is held in any desired location on elongated tube  12  by friction. Thus, stopper  19  is atraumatic, flexible and slidable. 
     Unlike with conventional occluders, multipurpose medical device  10  and stopper  19  do not need to be removed from the vessel being occluded in order to allow perfusion of the vessel. Very simply, valve  20  is opened and fluids are introduced via connection tube  26 . This procedure is sufficiently simple that the responsibility for performing the perfusion can be handed over from the surgeon to a nurse or perfusionist, thus saving the surgeon&#39;s valuable time. 
     Multipurpose medical device  10  may be packaged and shipped without suture sleeve  18  and stopper  19 . This reduces the cost when these features are not needed for a given surgical procedure. 
     From the above description, it will be apparent that the invention disclosed herein provides a novel and advantageous multipurpose medical device. The foregoing discussion discloses and describes merely exemplary methods and embodiments of the present invention. One skilled in the art will readily recognize from such discussion that various changes, modifications and variations may be made therein without departing from the spirit and scope of the invention. Accordingly, disclosure of the present invention is intended to be illustrative, but not limiting, of the scope of the invention, which is set forth in the following claims.