Abstract:
A system is disclosed for creating a hole in a body vessel or hollow organ. Such holes are useful in surgically preparing the hollow organ or body vessel for connection with another hollow organ, body vessel or prosthetic conduit. For example, an assist device is generally connected to the left ventricle through a ventriculotomy created at the apex of the left ventricle. This ventriculotomy is most easily created with a punch or trephine. Control over such a procedure must be precise so as not to damage the ventricular wall or intracardiac structures such as papillary muscles, chordae tendinae, etc. The punch of the current invention allows for precise location and alignment of the cutting segment. The punch of the current invention also allows for precise advance of the cutting blade and a very clean cut of the tissue. Such clean cuts improve the healing when the hole in the body vessel or hollow organ is closed or attached to a connection, either prosthetic or natural.

Description:
PRIORITY INFORMATION  
       [0001]     This application is a continuation-in-part of U.S. patent application Ser. No. 09/938,428, filed Aug. 23, 2001, now U.S. Pat. No. 6,863,677. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The field of this invention is related to instrumentation and devices for surgery and especially, interventional, cardiovascular, general or peripheral vascular surgery.  
       BACKGROUND OF THE INVENTION  
       [0003]     During surgical procedures such as placement of a ventricular assist device, blood vessel anastomosis, aortotomy, gastrotomy, enterotomy, or access to other hollow organs and vessels, it is useful to have a specialized tool to create a circular opening or fenestration in the wall of the vessel or organ. Punches have been developed for use in surgery that create such fenestrations. Examples of the prior art include U.S. Pat. No. 3,776,237 to Hill, U.S. Pat. No. 3,949,747 to Hevesy, U.S. Pat. No. 4,018,228 to Goosen, U.S. Pat. No. 4,122,855 to Tezel, U.S. Pat. No. 4,216,776 to Downie et al., U.S. Pat. No. 5,129,913 to Ruppert, U.S. Pat. No. 5,403,338 to Milo, U.S. Pat. No. 5,868,711 to Kramer et al., U.S. Pat. No. 5,827,316 to Young et al., U.S. Pat. No. 5,910,153 to Mayenberger, and U.S. Pat. No. 5,972,014 to Nevins. More recent patents include U.S. Pat. No. 6,033,419 to Hamblin, Jr. et al., U.S. Pat. No. 6,080,173 to Williamson IV et al., U.S. Pat. No. 6,080,176 to Young, U.S. Pat. No. 6,176,867 to Wright, and U.S. Pat. No. 6,187,022 to Alexander Jr. et al.  
         [0004]     Problems with the current punches or coring devices occur both when the punch is positioned and actuated. With current systems, the cutting occurs by application of manual force by the surgeon. By requiring manual force to punch the hole in the organ or vessel wall without an adequate point of reference, the surgeon is not able to ascertain that the hole will be created along the correct path and at the selected location, prior to actually punching the hole. In addition, the current punches operate by means of a die without opposing back-up-plate cutting members. Examples of current punch mechanisms are similar to scissors where the cutting blade passes by an opposing brace or other cutting blade. These systems all create sub-optimal openings and leave ragged tissue edges.  
         [0005]     New devices and methods are needed which facilitate creation of a hole in the hollow organ or vessel and allow confirmation of proper location, orientation, and coring path prior to actual creation of the hole in the hollow organ or vessel wall. In addition, devices are needed to make more precise, cleaner holes in the tissue. Such cleaner holes allow for more precise surgery, more controlled placement of anastomoses, more control over surgically created geometry, reduced blood loss and resultant improved patient outcome.  
       SUMMARY OF THE INVENTION  
       [0006]     This invention relates to a trephine, coring tool, or punch for creating a hole or stoma at a precise, desired location in a hollow organ or body vessel. The present invention is a cutting surface or edge that is opposed by an anvil to create a clean cut. The anvil comprises a tapered nose to facilitate penetration into the organ or vessel once a preliminary incision has been performed. The cutting surface or edge is spring loaded to perform the actual cutting under pre-assigned force. The system allows for location reference by allowing the punch to rest, under spring, or otherwise generated, force, against the tissue to be cut while final alignment is completed, thus allowing a more accurate cut. The system further provides for rotation of the cutting surface or edge as it approaches the anvil. Preferably, the cutting edge rotation is substantial, and greater than ¼ revolution (90 degrees) as it approaches, or is approached by, the anvil. The anvil in this type of system may be described as a Hammer Anvil since the face of the anvil that faces the cutting surface serves as a stop for the cutting surface as the distance between the anvil and the cutting surface or edge is reduced to zero.  
         [0007]     In the prior art previously cited, including U.S. Pat. No. 4,018,228 to Goosen, U.S. Pat. No. 4,216,776 to Downie et al., U.S. Pat. No. 5,129,913 to Ruppert, U.S. Pat. No. 5,827,316 to Young et al., U.S. Pat. No. 5,910,153 to Mayenberger, U.S. Pat. No. 5,972,014 to Nevins, U.S. Pat. No. 6,080,173 to Williamson IV et al., and U.S. Pat. No. 6,080,176 to Young use a shearing or scissoring action between two blades to cut tissue. U.S. Pat. No. 3,949,855 to Hevesy, U.S. Pat. No. 4,122,855 to Tezel, and U.S. Pat. No. 6,187,022 to Alexander et al. use a knife or single sharpened edge with no opposing blade or surface to cut tissue. Both of these methods produce a ragged cut. The invention distinguishes over the cited prior art because the tissue is cut between a sharp edge and an opposing, flat, anvil-like surface to produce a clean cut. The embodiments of the punch disclosed herein provide further advantages over the prior art in that they create a hole that is closer to the diameter of the cutting edge than the holes made by the prior art punches.  
         [0008]     The invention is most useful in cardiac surgery to create an opening or channel for cannula access to the ventricles of the heart or blood vessels near the heart. It is also useful for vascular surgery where side-to-side or end-to-side anastomoses need to be made. Alternatively, the system allows for general tissue biopsies and other general surgical applications on hollow organs or vessels such as a tracheostomy. Another aspect of the invention includes a method for creating a hole in a body vessel via an endovascular or interventional approach. Access to the vessel is created using a percutaneous approach such as the Seldinger technique. The method consists of creating an incision in the body vessel with a sharp object, inserting a sheath having a fluid-tight seal into the body vessel, and advancing a punch, further comprising a cutting blade and an anvil located at the distal end of a catheter, through the lumen of the sheath and extending out the distal end of the sheath into the body vessel until the distal end of the punch has reached a target location within the body vessel. The method further comprises advancing a sharp tip, affixed to the distal end of the punch, through the body vessel at the target site to create a puncture in the vessel wall. Next, an anvil with a tapered tip is advanced through the puncture in the body vessel at the target site and a circular cutting blade is located so that the cutting blade is positioned with the wall of the body vessel between the anvil and cutting blade. Next, the cutting blade is advanced through said body vessel wall under controlled force until the cutting blade fully rests against a distal surface of the anvil whose outside diameter is no less than the outer diameter of said cutting blade so that a hole is cut in the body vessel from the inside. The method further includes removing the cutting blade and excised tissue from the body vessel. It is advantageous that the cutting blade is rotated at least one revolution while said cutting blade is being advanced toward said anvil. It is further advantageous that a hemostatic plug or closure be provided to seal the vessel, generally on a temporary basis, immediately following creation of the punch hole and prior to further procedures on the vessel that require the presence of the punch hole.  
         [0009]     For purposes of summarizing the invention, certain aspects, advantages and novel features of the invention are described herein. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular embodiment of the invention. Thus, for example, those skilled in the art will recognize that the invention may be embodied or carried out in a manner that achieves one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein. These and other objects and advantages of the present invention will be more apparent from the following description taken in conjunction with the accompanying drawings.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0010]     A general architecture that implements the various features of the invention will now be described with reference to the drawings. The drawings and the associated descriptions are provided to illustrate embodiments of the invention and not to limit the scope of the invention. Throughout the drawings, reference numbers are re-used to indicate correspondence between referenced elements.  
         [0011]      FIG. 1A  illustrates a side view of the trephine, punch or coring tool with the cutter fully retracted, according to an embodiment of the invention;  
         [0012]      FIG. 1B  illustrates a side view of the trephine, punch or coring tool with the cutter fully advanced against the anvil, according to an embodiment of the invention;  
         [0013]      FIG. 2  illustrates the trephine, punch or coring tool applied to the apex of the ventricle of the heart prior to advancing the cutting blade, according to an embodiment of the invention;  
         [0014]      FIG. 3  illustrates the trephine, punch or coring tool after the blade has been advanced through the apex of the ventricular wall of the heart, according to an embodiment of the invention;  
         [0015]      FIG. 4  illustrates the ventricular wall after removal of the trephine, punch or coring tool and the excised tissue, according to an embodiment of the invention;  
         [0016]      FIG. 5A  illustrates a side view of the trephine, punch or coring tool with the anvil fully advanced, according to an embodiment of the invention;  
         [0017]      FIG. 5B  illustrates a side view of the trephine, punch or coring tool with the anvil fully retracted against the cutter, according to an embodiment of the invention;  
         [0018]      FIG. 6A  illustrates a longitudinal cross-sectional view of the trephine, punch or coring tool comprising a jackscrew to replace the function of the spring, according to an embodiment of the invention;  
         [0019]      FIG. 6B  illustrates a side view of the trephine, punch or coring tool comprising the jackscrew, wherein the cutter has been advanced against the anvil, according to an embodiment of the invention;  
         [0020]      FIG. 7A  illustrates a side view of the trephine, punch or coring tool comprising a hydraulic cylinder to replace the function of the spring, according to an embodiment of the invention;  
         [0021]      FIG. 7B  illustrates a side view of the trephine, punch or coring tool comprising the hydraulic cylinder, wherein the cutter has been advanced against the anvil, according to an embodiment of the invention;  
         [0022]      FIG. 8A  illustrates a longitudinal cross-sectional view of the trephine, punch or coring tool comprising a jackscrew to replace the function of the spring, wherein the jackscrew is shown in detail, according to an embodiment of the invention;  
         [0023]      FIG. 8B  illustrates a side detailed view of the trephine, punch or coring tool comprising the jackscrew, wherein the cutter has been advanced against the anvil, according to an embodiment of the invention;  
         [0024]      FIG. 9A  illustrates a side detailed view of the trephine, punch or coring tool comprising a hydraulic cylinder to replace the function of the spring, according to an embodiment of the invention; and  
         [0025]      FIG. 9B  illustrates a side detailed view of the trephine, punch or coring tool comprising the hydraulic cylinder, wherein the cutter has been advanced against the anvil, according to an embodiment of the invention.  
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0026]     The invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is therefore indicated by the appended claims rather than the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.  
         [0027]     The invention, which is generally termed a surgical instrument, can be described as being an axially elongate structure having a proximal end and a distal end. The axially elongate structure further has a longitudinal axis. As is commonly used in the art of medical devices, the proximal end of the device is that end that is closest to the user, typically a surgeon. The distal end of the device is that end closest to the patient or that is first inserted into the patient. A direction being described as being proximal to a certain landmark will be closer to the surgeon, along the longitudinal axis, and further from the patient than the specified landmark.  
         [0028]      FIG. 1A  illustrates a hollow organ coring tool, trephine, or punch  10  of the present invention. The coring tool  10  comprises a cutter  12 , a central axially elongated shaft  14 , an anvil  16 , a trocar or tapered tip  18 , a handle  20 , a spring  22 , and a knob  24 . The cutter  12  comprises a plurality of holes  28 . The handle  20  further comprises a plurality of wide flange-like members or wings  26 . The handle  20  optionally comprises a setscrew  30 . The cutter  12 , the anvil  16 , the trocar or tapered tip  18 , the handle  20 , the spring  22 , and the knob  24  are disposed concentrically on the axially elongate shaft  14 . The knob  24  is affixed to the proximal end of the shaft  14 . The handle  20  is affixed to the cutter  12  with the optional setscrew  30 . The handle  20  and attached cutter  12  slide rotationally and longitudinally in a one to one motion along and around the shaft  14 . The spring  22  is slidably disposed between the knob  24  and the handle  20  and imparts a pre-determined force on the handle  20 -cutter  12  assembly. The anvil  16  is affixed to the proximal end of the trocar or tip  18  and the tip  18  is affixed to the distal end of the shaft  14 .  
         [0029]      FIG. 1A  shows the coring tool  10  with the cutter  12  in the fully retracted position. The cutter  12  is a cylindrical blade made from materials capable of being sharpened and with a high degree of hardness. Such materials include but are not limited to stainless steel, cobalt-nickel-chrome alloys, titanium alloys and the like. The cutter  12  has a sharpened configuration on its distal most edge to permit surgical cutting of body tissue. The distal cutting edge of the cutter  12  is, preferably, smooth but sharpened. Alternatively, the distal cutting edge may be serrated like a bread knife. The hollow interior of the cutter  12  is sufficiently long to allow the cored-out tissue to reside therein without being compressed. Holes  28  are optionally provided in the proximal end or sides of the cutter  12  to allow for fluid escape during cutting, thus preventing pressure buildup within the cutter  12 . The cutter  12  may be any diameter necessary for the surgical procedure. The diameter of the cutter  12  ranges from 0.5 mm to 100 mm or even larger with the diameter range preferably being from 1 mm to 50 mm.  
         [0030]     In another embodiment, the cutter  12  may be an electrocautery or electrocutting device consisting of an electrode. The electrode is electrically connected to a cable leading to one pole of an external electrocautery power supply. Another electrical pole of the power supply is an electrically conducting grounding pad electrically affixed to the patient&#39;s skin or other body organ, often with the aid of electrically conducting gel.  
         [0031]     In a further embodiment, the cutter  12  may be rotationally vibrated using an electrical motor or one or more electrical actuators. Examples of electrical actuators include those fabricated from shape-memory nitinol with or without an elastic substrate. Ohmic heating of the nitinol actuators by application of electrical current causes reversible length change in said actuators. Opposably mounted actuators, energized one at a time, provide torque to rotationally vibrate the cutter  12  about the shaft  14 . The actuators and cutter  12  operate at frequencies up to about 200 Hz. Electrical current is provided through an electrical cable leading to an external set of batteries and a controller. Alternatively, said controller and batteries could be mounted integral to the coring tool  10 , such as in the knob  24 , for example. Such rotational vibration makes the cutter  12  function like an electric bread knife with enhanced cutting capability over a stationary knife-edge. In another embodiment, however, a circumferential vibrational, reciprocating, or reciprocal motion using microactuators affixed at or near the distal end of the punch  10  can be performed. An electrical switch on the handle  20  or knob  24  (not shown) cause the microactuators to alternately pull the cutter  12  in one direction and then the other direction. The microactuators can be located at the distal end of the punch  10  and serve to vibrate or oscillate the cutter  12  circumferentially relative to the shaft  14 . A description of the microactuators can be found in U.S. Pat. No. 5,405,337 to R. S. Maynard, the entirety of which is incorporated herein by reference. The vibrational motion generated by these microactuators is small and generally less than ¼ of a rotation. Further application of such actuators to cause rotational vibration of a device is disclosed in U.S. Pat. No. 6,110,121 to Lenker, the entirety of which is included herein by reference.  
         [0032]     In a preferred embodiment, the handle  20  is affixed to the cutter  12 . The handle  20  provides rotational force to the cutter  12  to assist in tissue penetration. The optional setscrew  30  may be used to attach the handle  20  to the cutter  12 . Other ways to attach the handle  20  to the cutter  12  are the use of a rolled-pin, adhesives or over-molding. Mechanical advantage for manual rotation is derived from the wide flange like members or wings  26  on the handle  20  that allow increased moment arm to be applied to the handle  20  by the fingers of the surgeon. The handle  20  is preferably made from polymers such as but not limited to polycarbonate, acetal copolymers, acrylonitrile butadiene styrene, polyvinyl chloride and the like. The handle  20  optionally is provided with holes or openings that communicate with the optional holes  28  in the cutter  12  to allow for air and fluid escape from the interior of the cutter  12  through the handle  20  to the external environment during the coring process.  
         [0033]     Optionally, the handle  20  comprises a latch or lock to maintain its position on shaft  14  in the retracted position under force of the spring  22 . To move the handle  20  distally, the optional lock is released allowing the handle  20  to be advanced along the shaft  14  toward the anvil  16 . The handle  20  further optionally comprises a damper or shock absorber to prevent the high velocity accidental release of the handle  20  and cutter  12  into the tissue.  
         [0034]     Alternatively, as illustrated in  FIGS. 6A and 6B , the handle  20  may be rotated by a motor or gear motor  110 , which is electrically powered by a battery disposed either external to or internal to the punch  10 . External battery power is delivered to the motor  110  through a cable with a plurality of conductors. On and off operation of the motor  110  is controlled through a switch on the punch knob  24  or the handle  20 , by a foot switch, or by a sound activated switch.  
         [0035]      FIG. 1B  shows the handle  20 -cutter  12  assembly fully advanced against the anvil  16 . The spring  22  is disposed between the knob  24  and the handle  20  and applies the desired force to the handle  20 -cutter  12  assembly distally toward the anvil  16  with a pre-determined force. The pre-determined force is between 0.10 and 25 pounds and, preferably, between 1 and 10 pounds. This force is advantageous in performing a controlled tissue excision. The spring  22  also allows the cutter  12  to be disposed against the tissue prior to actual excision, without cutting, so that correct alignment may be determined by the surgeon. The spring  22  is, preferably, made from spring hardened metals such as stainless steel 304, stainless steel 316, nitinol, titanium alloys and the like. The spring  22  ensures that a seal is maintained between the cutter  12  and the tissue so that hemostasis is maximized or leakage of body fluids is minimized.  
         [0036]     In another embodiment, as illustrated in  FIGS. 6A and 6B , the function of the spring  22  is replaced by a threaded jackscrew assembly  104 . The shaft  14  is threaded and engages mating threads on the handle  20 . By rotating the handle  20 , the cutter  12  is rotated and simultaneously advanced proximally or distally in a positive displacement fashion.  FIG. 6A  shows the coring tool  10  with the cutter  12  retracted away from the anvil  16 .  FIG. 6B  shows the coring tool  10  with the cutter  12  advanced against the anvil  16 . The anvil  16 , serves as a stop for the cutter  12 . This type of anvil  16  is also known as a hammer anvil.  
         [0037]     In yet another embodiment, as illustrated in  FIGS. 7A and 7B , the function of the spring  22  is replaced by a hydraulic cylinder  106  and hydraulic pressure source  108  with a valve or switch to control pressure into said cylinder  106 .  FIG. 7A  shows the coring tool  10  with the cutter  12  retracted away from the anvil  16 .  FIG. 7B  shows the coring tool  10  with the cutter  12  advanced against the anvil  16 .  
         [0038]     The central shaft  14  maintains axial and longitudinal orientation of the punch  10  components. The shaft  14  is preferably fabricated from metals such as stainless steel, cobalt-nickel-chrome alloys, titanium alloys and the like. The shaft  14  may also be fabricated from hardened polymers such as glass-filled polycarbonate and the like. Holes or circumferential depressions in the shaft  14  permit attachment of components using setscrews or over-molding techniques. The shaft  14  geometry allows for expeditious replacement of optionally disposable components such as the cutter  12 , anvil  16  and tip  18 . The central shaft  14 , optionally, comprises one or more circumferential alignment marks to confirm the position of the cutter  12  from the proximal end of the punch  10 .  
         [0039]     The tapered tip  18  is affixed to the distal end of the shaft  14  in a stationary manner. Fixation of the tip  18  to the shaft  14  is accomplished by over-molding, a setscrew or by internal threads on the trocar or tapered tip  18  engaging male threads on the shaft  14 . The trocar or tapered tip  18  has a conical configuration and allows penetration of the hollow organ or vessel by the entire tip  18  anvil  16  assembly following an initial incision with a sharp surgical instrument. The distal end of the trocar  18  may be either sharp or rounded. Use of the sharp end on the trocar  18  permits use of the coring tool  10  without first making a separate surgical incision in the tissue. Longitudinal edges or ridges  102  are optionally disposed on the conical surface of trocar or tip  18  to enhance tissue penetration. Alternatively, the tip  18  may be oscillated or vibrated with an electrical actuator or motor to facilitate penetration into the tissue. The oscillation is useful for either blunt dissection or sharp dissection of the tissue.  
         [0040]     The anvil  16  is a flat surface disposed distally to the cutter  12  and aligned in a plane generally perpendicular to the axis of the shaft  14 . The anvil  16  is at least as wide as the largest exterior cutting dimension of the cutter  12 . In this way, the anvil  16  serves to positively stop the cutter  12 . The cutter  12  is advanced against the anvil  16  during the cutting procedure. The cutter  12  does not pass beyond the proximal surface of the anvil  16 . In its lowest energy or inactive state, the cutter  12  rests against the anvil  16  with a net compressive force and the spring  22  expanded to its maximum allowable amount. The compressive force between the closed cutter  12  and the anvil  16  serves to maintain contact between the surfaces and promote cutting at the end of the stroke.  
         [0041]     The anvil  16  and the tapered tip  18  are, preferably fabricated from the same piece of material for economy and ease of fabrication. Alternatively, the anvil  16  and the tapered tip  18  may be separate components and may be longitudinally disconnected or they may be longitudinally connected. Both the anvil  16  and the trocar or tapered tip  18  are radially constrained by the shaft  14 . The anvil  16  is attached to shaft  14  by a setscrew, internal threads for engagement with male threads on the shaft  14 , adhesive bonding or over-molding. The anvil  16  and the trocar or tapered tip  18  are, preferably, fabricated from polymeric materials such as but not limited to polyvinyl chloride, acetal copolymers, polycarbonate, acrylonitrile butadiene styrene and the like. They may alternatively be fabricated from metals such as stainless steel, cobalt-chrome-nickel alloys, titanium alloys and the like.  
         [0042]     The anvil  16  optionally comprises pre-placed attachment devices, such as staples, sutures or posts that remain in the tissue around the coring site to facilitate subsequent placement of anastomotic devices.  
         [0043]     The knob  24  terminates the proximal end of the shaft  14  and allows for positioning of the punch  10  by the surgeon. The knob  24  is blunt and preferably is fabricated from the same materials as the trocar or tip  18  or the anvil  16 . The knob  24  is affixed to the shaft  14  with setscrews, adhesives, or over-molding or the knob  24  is affixed by female threads that engage male threads on the shaft  14 .  
         [0044]     Referring to  FIGS. 2, 3 , and  4 , the procedure for hollow organ coring or trephination is accomplished by first creating a small incision at the desired penetration location using a sharp surgical instrument such as a scalpel. The cutter  12  is retracted by manually withdrawing the handle  20  wings  26  proximally toward the knob  24 . The spring  22  is compressed when retracting the handle  20  and cutter  12 . The tapered tip  18  and anvil  16  assembly is advanced into the incision until the anvil  16  has passed beyond the interior surface of the hollow organ or vessel. The handle  20  is next released and the cutter  12  is positioned against the exterior of the hollow organ as shown in  FIG. 2 . Once position has been confirmed or adjusted, the handle  20  is manually rotated to initiate cutting of the tissue by the cylindrical cutter  12 . As shown in  FIG. 3 , the handle  20  and cutter  12  are rotated until full penetration of the hollow organ has occurred, under force of the spring  22 , and the distal edge of the cutter  12  rests against the anvil  16 .  
         [0045]     Complete penetration and cutter  12  to anvil  16  contact may be confirmed by placement of a plurality of alignment marks on the shaft  14 . The alignment marks become visible once the cutter  12  and handle  20  have been advanced sufficiently. The punch  10  is next withdrawn proximally, removing the cored-out piece of tissue from the organ as shown in  FIG. 4 . Prevention of hemorrhage or fluid leakage from the hollow organ or vessel is accomplished by manual compression or placement of a temporary plug. This device and procedure are especially useful when performing coring on the beating heart.  
         [0046]     Typically, the surgeon manually cores the patient&#39;s hollow organ or vessel using the punch or coring tool  10 . The coring tool  10  can alternatively, be held and manipulated by a robotic arm, endovascularly routed device such as a catheter, or a laparoscopic instrument. The laparoscopic instrument is generally placed through a sheath or trocar that has been inserted into the body through a percutaneous puncture site. In a laparoscopic embodiment, the shaft  14  is extended in length, relative to the device shown in  FIG. 1A  or  FIG. 8A . The anvil  16  and tapered tip  18  reside at the distal end of the shaft  14  and are within the body distal to the distal end of the sheath. Furthermore, the region between the cutter  12  and the handle  20  is correspondingly extended in length so that the rotational force can be transmitted to the cutter  12 , which resides within the body while the handle  20  and knob  24  are outside the body. Thus, all operational controls are outside the body and proximal to the proximal end of the laparoscopic sheath and a pressure seal. Visual control of the cutter is accomplished using a laparoscope routed through another trocar or sheath, or it is accomplished using ultrasound, fluoroscopy, or magnetic resonance imaging. The laparoscopic device is generally rigid and flexibility is not required, although it could be advantageous to make the shaft  14  flexible to allow some curvature. The laparoscopic device cutter and anvil  16  are generally between 1 and 15 mm in diameter. The length of the shaft  14  between the handle  20  and the proximal end of the cutter  12  can range between 5 and 50-cm.  
         [0047]     An endovascular, interventional, or endoluminal device embodiment comprises a flexible shaft  14  that is capable of being routed through a sheath into a body vessel or lumen. The punch in this embodiment is affixed to a catheter. A hemostasis valve, fluid-tight seal or other gasket is provided at the proximal end of the sheath to prevent loss of blood, or body fluids, or the retrograde flow of air into the body. Typical cardiovascular access sheaths known in the art of endovascular access are appropriate for this application. The cutter  12  and anvil  16  reside at the distal end of the shaft  14 . The shaft  14  is a torqueable axially elongate structure that also has column strength. The region between the handle  20  and the cutter  12  is generally very long in this embodiment. This length and the corresponding length of the shaft  14  may range from 10-cm to over 200-cm depending on the distance between the access site and the treatment site. The diameter of the cutter  12  is small enough to fit through the sheath, generally less than 24 French, or 8 mm in diameter. The cutter  12  and the anvil  16  can also be fabricated from structures that are radially expandable to allow them to fit through small diameter sheaths and then be enlarged to perform their coring function. The endovascular embodiment can also comprise a guidewire lumen (not shown) which is a central lumen extending from the proximal end of the knob  24  to the distal end of the tapered tip  18  so that the device can be routed over a guidewire, a slideable fit with a lumen diameter of 0.010 inches to 0.042 inches. All rotational operations and cutter  12  to anvil  16  closure operations are performed from the proximal end of the punch  10 .  
         [0048]      FIGS. 5A and 5B  illustrate another embodiment of a hollow organ coring tool, trephine, or punch  38 . The coring tool  38  comprises the cutter  12 , the anvil  16 , the trocar or tapered tip  18 , the handle  20 , the spring  22 , and the knob  24 . The coring tool  38  also comprises an inner shaft  32 , an outer shaft  34 , a pin  36 , and an axial slot  40 . The handle  20  further comprises the plurality of wide flange-like members or wings  26 .  
         [0049]     The cutter  12 , the handle  20 , the spring  22 , and the knob  24  are disposed concentrically on the axially elongate outer shaft  34 . The anvil  16  and the trocar or tip  18  are both disposed concentrically on the axially elongate inner shaft  32 . The inner shaft  32  is slideably disposed inside the outer shaft  34  and the inner shaft  32  extends beyond the outer shaft  34  at least the thickness of the vessel or organ to be cored.  
         [0050]     The handle  20  is not affixed to the cutter  12 . Instead, the handle  20  is affixed to the inner shaft  32  by the pin  36  through the axial slot  40  in the outer shaft  34 . The cutter  12  is affixed to the distal end of the outer shaft  34 . The handle  20 , which is affixed to the inner shaft  32 , sets above the cutter  12 , which is affixed to the outer shaft  34 .  
         [0051]     The knob  24  is affixed to the proximal end of the outer shaft  34 . The anvil  16  is affixed to the proximal end of the trocar or tip  18  and the tip  18  is affixed to the distal end of the inner shaft  32 .  
         [0052]     The spring  22  sets around the outer shaft  34 , between the knob  24  and the handle  20 . The spring  22  forces the tip  18  and anvil  16  distally away from the cutter  12 . Manual retraction of the handle  20  proximally causes proximal retraction of the anvil  16  toward the cutter  12 . The spring  22  becomes increasingly compressed as the handle  20  is moved proximally toward the knob  24 .  
         [0053]     Referring to  FIG. 5A , the handle  20 , the tip  18 , the anvil  16 , and inner shaft  32  of the trephine  38  are fully advanced. The spring  22  is not compressed and is in its lowest energy position. The pin  36  rests in the distal end of the slot  40  and prevents the handle  20 , the tip  18  and the anvil  16  from advancing further.  
         [0054]     The handle  20  or the knob  24  optionally comprise a lock that is manually operated and selectively prevents movement of the inner shaft  32  relative to the outer shaft  34 .  
         [0055]     Referring to  FIG. 5B , the handle  20 , the tip  18 , the anvil  16 , and the inner shaft  32  are fully retracted. The spring  22  is fully compressed and in its highest energy position. Retraction of the handle  20  is accomplished with one hand over the knob  24  and fingers wrapped around the wings  26  in the handle  20 . Pulling the fingers toward the knob  24  causes the anvil  16  to move proximally toward the cutter  12 . The movement stops when the anvil  16  meets the cutter  12 .  
         [0056]     In an embodiment, as illustrated in  FIGS. 8A and 8B , the function of the spring  22  of  FIG. 1A  is replaced by a threaded jackscrew assembly  104 . The shaft  14  is threaded and engages mating threads on the handle  20 . By application of an electrical energy source, such as a battery, which causes rotation of the motor  110 , the cutter  12  is rotated. Optionally the cutter  12  may be simultaneously advanced proximally or distally in a positive displacement fashion by the threads  104  between the handle  20  and the shaft  14 . This axial travel of the cutter  12  can be generated by the motor  110 , rotation of the handle  20 , or by a spring  22 . The motor  110  can be a linear motor or it can be a rotational motor and actuate rotation of the cutter  12  through a gear assembly  112 . A ratchet or rotational disconnect  114  can controllably and reversibly separate rotational motion of the handle  20  from the cutter  12 . Actuation of the ratchet or rotational disconnect  114  can be accomplished through use of a lever or button (not shown) on the handle  20  or the knob  24 .  FIG. 8A  shows the coring tool  10  with the cutter  12  retracted away from the anvil  16 .  FIG. 8B  shows the coring tool  10  with the cutter  12  advanced against the anvil  16 . The anvil  16 , serves as a stop for the cutter  12 . This type of anvil  16  is also known as a hammer anvil.  FIGS. 8A and 8B  illustrate a more detailed layout of the construction of one of the embodiments of the punch of  FIGS. 6A and 6B .  
         [0057]     In an embodiment, as illustrated in  FIGS. 9A and 9B , the function of the spring  22  is replaced by a hydraulic cylinder  106  and hydraulic pressure source  108  with a valve or switch to control pressure into said cylinder  106 .  FIG. 9A  shows the coring tool  10  with the cutter  12  retracted away from the anvil  16 .  FIG. 9B  shows the coring tool  10  with the cutter  12  advanced against the anvil  16 .  FIGS. 9A and 9B  illustrate a more detailed layout of the construction of one of the embodiments of the punch of  FIGS. 7A and 7B . In this embodiment, rotation of the cutter  12  is generated by rotating the handle  20 . This cutter  12  rotation can also be generated by an electric motor or gear-motor  110  (see  FIGS. 8A and 8B ) or by a turbine (not shown) driven by the hydraulic pressure source  108 .  
         [0058]     In an embodiment, the cutter  12  is rotated by the motor  110 . The cutter  12  is advanced toward the anvil  16 , or the anvil retracted toward the cutter  12  by being biased by a spring  22 . The cutter  12  can be retracted away from the anvil  16 , or the anvil  16  advanced away from the cutter  12  by applying manual force to the handle  20  relative to the knob  24 . It is beneficial that the cutter  12  be rotated substantially, in excess of ¼ revolution while approaching the anvil  16 . Preferably, the cutter  12  is rotated in excess of 1 revolution as it approaches the anvil  16 . Most preferably, the cutter  12  rotates two (2) or more times while approaching the anvil  16 . This substantial rotation is beneficial in making the cleanest cuts in soft tissue. The substantial rotation is easily accomplished with a motor  110  or gear-motor. The substantial rotation can also be accomplished by manually turning the handle  20  or by a lever-ratchet assembly (not shown) with gearing to provide large rotational motion for a small amount of linear motion in the lever-ratchet assembly.  
         [0059]     The procedure for hollow organ coring or trephination is accomplished by first creating a small incision at the desired penetration location using a sharp surgical instrument such as a scalpel. The tapered tip  18  and anvil  16  assembly is advanced into the incision until the anvil  16  has passed beyond the interior surface of the hollow organ or vessel and the cutter  12  rests on the exterior of the hollow organ or vessel. Once position has been confirmed or adjusted, the handle  20  is pulled toward the knob  24  to initiate cutting of the tissue by the circular cutter  12 . The handle  20  is pulled until the distal edge of the cutter  12  rests against the anvil  16  and the organ has been cored. Complete penetration and cutter  12  to anvil  16  contact may be confirmed by placement of a plurality of alignment marks on the outer shaft  34 . The alignment marks become visible once the anvil  16  and the handle  20  have been retracted sufficiently. The punch  38  is next withdrawn proximally, removing the cored-out piece of tissue from the organ.  
         [0060]     The hollow organ coring tool, trephine, or punch  38  is fabricated from the same materials as the hollow organ coring tool, trephine, or punch  10  and comprises the same or similar options as the hollow organ coring tool, trephine, or punch  10 . In an embodiment, the cutter  12  of the punch  38  can be rotated by a motor or actuator to facilitate tissue penetration.  
         [0061]     The punch, in another embodiment, can comprise elements that plug or close the hole left behind following the coring procedure. The plug (not shown) can be a cylindrical or other axially elongate structure, affixed distal to the anvil such that it can be detached from the anvil  16 . The plug is detached by actuation of a lever or other control element a the proximal end of the punch with the energy being mechanically, electrically, hydraulically, or pneumatically transmitted down the shaft  14  of the punch to the distal end, where a coupler is released to detach the plug. The plug can optionally comprise a line, tether, or string, routed out the proximal end of the punch, so that it can be removed from the tissue after a period of temporary placement. The punch, in another embodiment, can comprise suture elements that are routed through the tissue surrounding the punch hole. These suture elements, optionally tipped with needles or other sharp tissue penetration devices, can be captured and withdrawn from the proximal end of the punch to temporarily or permanently close the punch hole on itself or around a cannula or other axially elongate tube or vessel, placed therethrough. The needles or tissue penetration devices can be “J” shaped to permit easy recapture of the sharp distal end by mechanical motions generated within the punch. In yet another embodiment, the punch can comprise injection ports at its distal end for delivering adhesives to the punch hole site for the purposes of closure or enhanced anastomosis at the punch hole site. Adhesives, such as cyanoacrylate or other biological adhesives known in the art, can be stored in the shaft and injected by actuation at the proximal end, or they can be injected from the proximal end and delivered down the shaft  14  and exit at the injection ports at the distal end of the punch. Such adhesives can include single and multi-part adhesives that require mixing.  
         [0062]     The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is therefore indicated by the appended claims rather than the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.