Abstract:
A device for closing holes tissue is delivered via a catheter to the inside of a body lumen such as a heart. An elastic barbed clip is expanded, pulled into the tissue and released, pulling the tissue with it. The operation is fully reversible.

Description:
FIELD OF THE INVENTION  
       [0001]     The present invention relates to surgery and in particular to closing holes in tissue during minimally invasive surgery. The invention is particularly useful for closing holes left by catheters during percutaneous surgical procedures such as minimally invasive cardiac surgery and other surgeries requiring access to body lumens.  
       BACKGROUND OF THE INVENTION  
       [0002]     More and more surgical procedures are performed percutaneously by the use of catheter-delivered devices. The main advantages are fast patient recovery and lower costs to the medical system. Some tissues, such as muscular tissue or arterial walls, do not seal well and are sometimes subject to blood pressure; therefore they require an immediate hemostatic seal after the surgery. Prior art solutions mainly rely on some form of a plug, such as an expanding foam plug, expanding metal plug or a barbed plug to seal the hole. The main disadvantage of plugs is that in order to form a good seal they are forcing the hole to become larger, rather than the more natural way which is to shrink the hole in order to promote healing. A prior art device operating by shrinking the hole is the Star Closure device sold by Abbott Vascular (www.abbottvasculardevices.com); however this device is only suitable to thin walled body lumens as it relies on folding the tissue. When sealing larger holes in thicker tissue the gripping points for pulling the tissue inwards have to be spread over an area significantly larger than the hole size, similar to what is done in traditional suturing. Attaching the closure device too close to the hole does not allow sufficient forces to be applied, therefore creating a marginal closure.  
         [0003]     Another major shortcoming of the Star Closure and other devices is that the operation is not reversible. It is sometimes required to remove the closure, as in the case of bleeding or an additional procedure.  
         [0004]     It is therefore desired to provide a hole closure method that provides an immediate liquid and gas tight closure and it can be delivered by a catheter to the inside wall of a body lumen.  
         [0005]     It is also desired to provide a closure method suitable for a large range of tissue thicknesses and hole sizes.  
         [0006]     It is also desired to be able to test, and if required to remove, the closure.  
         [0007]     It further would be desired for the closing device to have permanent elastic properties to accommodate any movement or future changes in the tissue. Furthermore, the gripping area of the closure device has to be significantly larger than the original hole.  
       SUMMARY OF THE INVENTION  
       [0008]     In view of the foregoing, the invention provides a method and device for closing holes in body lumens, and in particular in the heart and blood vessels, achieving an immediate hemostatic seal. The device can be applied via a wide range of catheters sizes to close a wide range of round and elongated holes with performance and reliability of traditional sutures but without requiring access to the tissue, except via the catheter. Furthermore, the device can be removed via the same catheter, and by using the same tools, used to install it and can be re-used immediately if so desired. The device has a high degree of elastic compliance allowing a wide accommodation range to changes in the tissue.  
         [0009]     These and other objects of the present invention are achieved by providing a flexible clip that is temporarily attaches to an insertion tool. The clip has three different position: a storage position, in which it is folded inside a delivery tube; and expanded position, in which it opens up to reach an area significantly larger than the hole, and a closed position in which elastic forces try to close the clip, pulling the tissue with it to close the hole. The clip has multiple sharp barbs for gripping the tissue and a stem for attaching to the insertion tool, as well as for re-attaching in case removal is required.  
         [0010]     Methods for implanting and removal of the device are also provided.  
         [0011]     The invention will become apparent by studying the drawings and the detailed description. 
     
    
     BRIEF DESCRIPTION OF THE DRAWING  
       [0012]      FIG. 1  is a perspective view of the invention and the installation tool.  
         [0013]      FIG. 2 - a  to  FIG. 2 - f  are sectional views showing the steps in installing the device using the installation tool.  
         [0014]      FIG. 3  is a perspective “exploded” view of the device.  
         [0015]      FIG. 4  is a perspective “exploded” view of an alternate embodiment.  
         [0016]      FIG. 5  is an “exploded” view of another alternate embodiment.  
         [0017]      FIG. 6 - a  is a perspective view of an alternate embodiment in the relaxed state.  
         [0018]      FIG. 6 - b  is a perspective view of the same alternate embodiment in the expanded state.  
         [0019]      FIG. 7 - a  is a sectional view of the tool used to install the device embodiment of  FIG. 6 - a  in the relaxed state.  
         [0020]      FIG. 7 - b  is a sectional view of the tool used to install the device embodiment of  FIG. 6 - a  in the expanded state.  
         [0021]      FIG. 8 - a  to  FIG. 8 - f  are sectional views showing the steps in removing the device. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0022]     Referring to  FIG. 1 , a hole closure clip  3  is inserted into a body lumen such a cavity in the heart via catheter  1 . Catheter  1  has a seal allowing insertion and removal of tools without much blood loss. This is well known in the art of minimally invasive surgery. When the surgical procedure is completed and hole needs to be closed, tube  5  carrying clip  3  mounted on rod  4  is inserted via catheter  1  through the tissue  2 . Both rod  4  and tube  5  have flanges  7  and  8  allowing a pulling tool  6  to exert a significant pulling force on rod  4  relative to tube  5 . Pulling tool  6  may be made of plastic or metal, plastic being preferred if tool is to be disposable. Rod  4  and tube  5  are preferable made of stainless steel and closure device  3  is made of Nitinol, a highly flexible Nickel-Titanium alloy well known in the art of medical devices. Tool  5  is similar in construction to the well known clothe-pin. Since the elastic range of Nitinol is about ten times larger than steel, the clip  3  can be made to fold into a small diameter tube and expand to grip the tissue over an area significantly larger than the area of the hole, in order to establish reliable closure. When clip  3  is released it tries to return to its natural (relaxed) shape, which covers a significantly smaller area, pulling the tissue with it and forming an instant hemostatic seal. These steps are shown in  FIG. 2 - a  to  FIG. 2 - f.    
         [0023]     In  FIG. 2 - a  the tube  5  containing the folded clip  3  mounted on rod  4  is inseterd via catheter  1  through the wall of the tissue  2 . Rod  4  is pushed forward by finger pressure till it is felt that clip  3  is released from tube  5  (or moved till it reaches a pre-determined distance), as shown in  FIG. 2 - b.  At this pint it is pulled back and pulling tool  6  is installed by sliding it on rod  4 . Pulling tool  6  can be permanently mounted on rod  4  or slide in and out via two slots as shown in FIG  1 . The slots rest against flanges  7  and  8 . Flange  7  is rigidly connected to rod  4  while flange  8  is rigidly connected to tube  5 . Using pulling tool  6 , rod  4  is pulled out a pre-determined amount which forces clip  3  to open as shown in  FIG. 2 - c , as it rests against end of tube  5 . At this point the whole assembly, including catheter  1 , is pulled back to engage the sharp barbs of tool  3  in tissue  2 . This is shown in  FIG. 2 - d.  An enlarged view of clip  3  is shown in  FIG. 3 . In  FIG. 3 , clip  3  comprises of multiple sharp barbs  11  held by a threaded stem  8 . Clip  3 , including barbs  11  are made of Nitinol wire typically 0.6-0.8 mm in diameter, Stem  8  can be made of type 316 stainless steel and held to wires by crimping. It contains a threaded portion  10  for attaching to rod  4 . The end of rod  4  has a mating thread  12 . When clip  3  rests on edge of tube  5  it can be opened widely by pulling rod  4  and barbs  11  can reach over an area having a diameter from 1.5 to over 3 times the diameter of the hole. This is important to achieve proper hemostatic closure.  
         [0024]     When rod  4  is detached from clip  3 , the natural elasticity pulls barb  11  in the direction shown by arrows  13  and the tissue is pulled with them. Centering ferrule  19  on rod  4  keeps the location of clip  3  centered to tube  5 , therefore centered to hole in tissue.  
         [0025]     Returning now to  FIG. 2 - e,  pulling tool  6  is released and removed allowing clip  3  to compress the tissue. Rod  4  is removed by turning flange  7  to unthread rod. After rod is removed the closure can be tested for leaks by leaving tube  5  in place. When used in the heart, any imperfection in closure will cause blood to come out of tube  5 . In such a case the clip  3  can be removed and re-installed as shown later on in this disclosure. One verified, both tube  5  and catheter  1  are removed.  
         [0026]      FIG. 4  shows an alternate design for clip  3 . The main differences are that the Nitinol wire is bent into a loop  15  to add elasticity and a string  14  is used as a method of holding clip  3  to tube  5 . The string can be removed by releasing one end.  
         [0027]      FIG. 5  shows another alternate design, preferred when hole is an elongated cut rather than a round hole. Clip  3  is bent to have barbs  11  move in parallel rather than radially, as shown by arrows  13 . Clip  3  is placed with the direction of motion  11  perpendicular to long dimension of hole in tissue. Loops  15  are used to add elasticity, as in  FIG. 4 .  
         [0028]      FIG. 6  shows yet another alternate design. The clip  3  can be fabricated from Nitinol sheet, tubing or wire. Preferred way would be laser-cut tubing.  FIG. 6 - a  shows the clip in the relaxed state,  FIG. 6 - b  shows it in the expanded state. This design is suitable when a large number of barbs  11  are desired or for thin-walled lumens.  
         [0029]     The tool used to expand the clip is shown in  FIG. 7 - a  (relaxed state) and  FIG. 7 - b  (expanded state). Rod  4  is equipped with a tapered end  17  used to expand four pivoting arms  16 . The sequence of operations is identical to the sequence shown in  FIG. 2 - a  to  FIG. 2 - f.    
         [0030]     It is desirable to be able to reverse the clip installation and, if needed, remove the clip completely via the same catheter used to install it. The current invention, in all its forms, allows this to be done. Referring now to  FIG. 8 - a  to  FIG. 8 - f,  the sequence of partial and full removal is shown.  
         [0031]     In  FIG. 8 - a  a dilator  18  is used to expand the opening in the tissue  2  as well as the surrounding tissue, in order to feed tube  5  back into its original position. In  FIG. 8 - b  Rod  4  is inserted in tube  5  and is attached to clip  3  by threading it onto stem  8  of clip  3 . Centering ferrule  19  keeps rod  4  aligned with stem  8 . Tool  6  in mounted on rod  4  and used to expand slip  3  as shown in  FIG. 8 - c.  Once expanded, the whole assembly of catheter  1  and tube  5  is pushed forward to remove clip  3  from tissue  2 , as shown in  FIG. 8 - d.  At this point clip  3  can be re-installed following the steps in  FIG. 2 - c  to  FIG. 2 - f  or removed completely by pulling clip into tube  5  as shown in  FIG. 8 - e  and  FIG. 8 - f . Once clip  3  is fully inside tube  5 , it can be easily pulled out by hand using rod  4 . If desired, clip  3  can be re-used immediately by pushing it back into tube  5  to assume the position shown in  FIG. 2 - a.  When the clip style shown in  FIG. 4  is used, the retrieval tool is equipped with a small hook to engage with loop  15 .  
         [0032]     The large elastic range of Nitinol allows full removal without permanently deforming clip  3 . Because of this large elasticity, clip  3  can not be manufactured by cold forming. It has to be held in the relaxed position (shown in  FIG. 2 - b ) and heated to about 510 degrees C. for a few minutes. The exact heat treatment details given by the manufacturer of the Nitinol wire have to be carefully followed.  
         [0033]     While the invention will work for any dimension of catheter, the preferred range is for catheters with internal diameters of 4 mm to 15 mm. The Nitinol wire diameter is about 0.4 mm for the 4 mm catheter and about 1 mm for the 15 mm catheter. The thread  10  on stem  8  is from M 1  for the 4 mm catheter to M 4  on the 15 mm catheter, M 2  being a typical value. Tube  5  is made from standard stainless hypodermic tubing. All materials to construct the invention are available from Small Parts Inc (www.smallparts.com).  
         [0034]     While the detailed description showed a specific embodiment of a clip with four barbs, it is obvious that the inventions covers many other configurations of barbs, made from many materials including materials used to make absorbable sutures and other non-metallic clips. It is also obvious that the invention can be configured to be used on the outside rather than the inside wall of the body lumen by sliding a clip shown in  FIG. 6 - b  on the outside of tube  5  and expanding it with the method shown in  FIG. 7 - b.