Patent Abstract:
Devices and methods for achieving hemostasis and leakage control in hollow body vessels such as the small and large intestines, arteries and veins as well as ducts leading to the gall bladder and other organs. The devices and methods disclosed herein are especially useful in the emergency, trauma surgery or military setting, and most especially during damage control procedures. In such cases, the patient may have received trauma to the abdomen, extremities, neck or thoracic region. The devices utilize removable or permanently implanted, broad, soft, parallel jaw clips with minimal projections to maintain vessel contents without damage to the tissue comprising the vessel. These clips are applied using either standard instruments or custom devices that are subsequently removed leaving the clips implanted, on a temporary or permanent basis, to provide for hemostasis or leakage prevention, or both. These clips overcome the limitations of clips and sutures that are currently used for the same purposes. The clips come in a variety of shapes and sizes. The clips may be placed and removed by open surgery or laparoscopic access.

Full Description:
This application claims priority benefit under 35 USC § 119(e) from U.S. Provisional Application No. 60/447,110 filed Jun. 9, 2003, and U.S. Provisional Application No. 60/410,635 filed Sep. 13, 2002. 
    
    
     FIELD OF THE INVENTION 
     The field of this invention is trauma surgery, combat medicine, and emergency medical services. 
     BACKGROUND OF THE INVENTION 
     As recently as the early 1990s, surgical operations for trauma were directed at the anatomic repair of all injuries at time of the initial operation. It was observed during these exercises that many patients became hypothermic, acidotic, and coagulopathic. Patients showing these three signs often died. Death often occurred in the operating room due to exsanguination, or postoperatively, due to the complications of prolonged shock and massive transfusion to replace blood lost as a result of the trauma. 
     One of the most notable developments in the recent evolution of surgery has been the reintroduction of the concept of staged laparotomy to overcome the deficiencies of the repair all-at-once approach. This new strategy of staged laparotomy employing new tactics that have been termed damage control is now used in 10% to 20% of all trauma laparotomies. 
     This strategy opens the way for a variety of new devices and methods for control of hemorrhage from solid organs or viscera. Although there are procedures for controlling these injuries, none of these procedures utilize optimal devices or tactics in their execution. Each area offers technological opportunities to improve the devices and procedures for applying those devices. 
     Two of the three immediate goals of damage control operations are to contain or stop, as quickly as possible, hemorrhage from major wounds of the solid viscera and to stop bleeding from injured intra-abdominal blood vessels. The third immediate goal of damage, control operations is to immediately arrest fecal or contents spillage from wounded hollow viscera. Such enteral wounds to the hollow viscera commonly occur in multiple areas of the bowel and colon. While existing methods and procedures, including the use of standard vascular instruments, bowel clamps, umbilical tape, and sutures, do allow the rapid control of vascular and visceral injuries in many cases, the standard techniques and tools have not been designed for temporary placement as part of a staged operation. Specifically, the vascular instruments or clamps have long handles that would be subjected to torque associated with temporary packing and closure of the abdomen. In addition, these instruments are not constructed of materials suitable for medium-term implantation and may have features that would cause the devices to become healed into the wound, rather than be easily removable. 
     During damage control procedures, time is of the essence. Every minute that passes without hemostatic control leads to further blood loss, shock and risk of intraoperative exsanguination. Every minute that passes without control of enteral spillage leads to increased risk of infection and septic death. 
     Typical vascular injuries requiring hemostatic control may include, for example, a wound to the descending abdominal aorta, the iliac arteries and veins, superior mesenteric vessels, vena cava or the portal vein, renal arteries and veins, and lumbar arteries. Typical enteric injuries requiring spillage control include wounds to the duodenum, small bowel, or colon. These wounds are, most commonly, multiple. The existing methods for controlling these include clamping and sewing, stapling, or resection of the involved bowel segment. All these current methods take much more time than the approach enabled by the methods and devices described below. 
     New devices, procedures and methods are needed to support the strategy of damage control in patients who have experienced abdominal injury. Such devices and procedures are particularly important in the emergency, military, and trauma care setting. 
     SUMMARY OF THE INVENTION 
     The devices and methods described below provide for improved treatment of wounds, including achieving hemostasis and leakage control in hollow body vessels such as the small and large intestines, arteries and veins as well as ducts leading to the gall bladder and other organs. The devices are clips for hollow vessels, variously designed to make them suitable for emergency closure of vessels. The clip is capable of partially occluding a structure with a tangential wound or completely obstructing both ends of a completely divided blood vessel or hollow viscus. It is highly desirable that clamps be designed to be left behind for a period of time ranging from several minutes to several days without the attached handles. The clamps are designed to minimize the chance of tissue ingrowth, thus allowing for improved ease of removal. The ideal clamp would have a very low profile, secure holding properties, be incapable of eroding into other structures, would not crush or destroy the wall of the clamped vessel, even if left for a period of days, would be easy to apply, would evenly distribute the compression force on the vessel, would be able to straddle, in a partially occluding way, a tangential wound of a major vessel or bowel. Features of the vascular and bowel clips include broad, controlled, force distribution on the tissue, even force distribution, both longitudinally and laterally on the vessel or bowel tissue. Additional key features of the vascular and bowel clips of the present invention include controlled movement, ease of placement, ease of locking in place, ease of removal, biocompatibility for medium to long-term implantation, minimal projections away from the clip, lack of sharp edges to cause further trauma during placement, and removal of the clip applier so that there are no long surfaces projecting from the clip area. The vascular and bowel clips may be placed through an open surgical access site or through a laparoscopic access and manipulation system. 
     Once a clip has been placed, it remains in place either temporarily or permanently. Temporary placement necessitates removal of the clip after a period of time. Long-term placement necessitates that the clip be able to sustain its function indefinitely. In this application, the clip is fabricated from materials that permit medium to long-term implantation. The clip design minimizes undercuts and features that would promote tissue ingrowth, thus restricting removal. In another embodiment, the clip may be fabricated, completely or partially, from resorbable materials that obviate the need to remove the clip in a subsequent surgical procedure. The clip applier is fabricated from materials that are suitable for short-term tissue or vascular contact. The clips themselves are fabricated from materials with smooth outer surfaces that do not encourage tissue or clot ingrowth. Thus, the clips may be removed with minimal re-bleeding. 
     The clips may be partially or entirely radiopaque so that they can be visualized on fluoroscopy or X-ray and easily located on subsequent follow-up. 
     The current medical practice of using sutures and current clips is not an optimized solution to open visceral and vascular wound repair. The current techniques almost always cause a tourniquet effect and require substantially more time to place than is desired, thus increasing the chance of accelerated deterioration of the patient&#39;s condition. The devices and methods described herein distinguish over the current medical practice because the present invention is tailored to the needs of open vascular or bowel repair. The clips have soft serrated jaws to grab the vessel wall and prevent spillage, but not strangulate the vasculature within the wall. They have short stubby grasping handles that are activated by tools that provide mechanical advantage and extension of reach into small spaces. The clips are suited for either open surgical implantation and removal, or they are suited for laparoscopic placement and removal using specialized access, grasping and delivery instruments. When the clips of the present invention are removed from the patient, re-bleeding does not occur because there is minimal penetration of the wound tissues or clot into the interstices of the clips. 
     Another feature of the clips is reduction in the length of those portions of the implantable clip (the actuating lever arms) that projects away from the actual clamping surface. This minimization of projection away from the clamping surface is accomplished by use of more than one hinge point, telescoping members and applier grasping points located between the hinge point and the clamping surface. In another embodiment, the grasping tabs projecting away from the clip are minimized by folding them in a direction opposite to that in which they are compressed to open the clip. Folding the tabs back onto the clip allows the tabs to be completely or nearly completely eliminated as a projection. The folding tabs have their own hinge points or they rotate around the main clamp axis. In another embodiment, the tabs are rotated perpendicular to the direction of compression to move them out of the way so that they do not project away from the clip jaws. 
     Another feature of the clips is the parallelism of the jaws. In the closed or nearly closed configuration, the jaws separate and close along a linear path rather than an arcuate path. Thus, there are no pinch points near the hinge area of the clips. The clips comprise hinges that permit linear or nearly linear travel. This linear travel feature near the closed position means that the jaws close with even, predictable force distribution on the vessel. 
     Another feature of the clips is the broad force distribution both longitudinally along the vessel to be clipped and laterally across the vessel being clipped. These clips of the present invention are not narrow but, instead, are broad. They typically comprise circular or elliptical pads that can encompass a substantial amount of vessel tissue. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1A  illustrates a side view of the clip in its open state. 
         FIG. 1B  illustrates a side view of the clip in the closed state. 
         FIG. 1C  illustrates a top view of a generally circular clip. 
         FIG. 2A  illustrates a side view of the clip in the open position around a vessel with a clip applier attached. 
         FIG. 2B  illustrates a side view of the clip in the closed position occluding the vessel with the clip applier removed. 
         FIG. 3A  illustrates a section of bowel with multiple transverse wounds; 
         FIG. 3B  illustrates the section of bowel with clips applied to prevent fecal spillage. 
         FIG. 4  illustrates a packaging system that delivers multiple clips in a convenient manner. 
         FIG. 5A  illustrates a top view of an elliptical clip with its major axis oriented perpendicular to the clip hinge. 
         FIG. 5B  illustrates a top view of an elliptical clip oriented with its major axis parallel to the clip hinge. 
         FIG. 5C  illustrates a top view of a circular clip. 
         FIG. 5D  illustrates a top view of a clip of with a rounded triangular configuration. 
         FIG. 6A  illustrates a cross-sectional view of a bowel vessel wall showing the internal vasculature. 
         FIG. 6B  illustrates a cross-sectional view of a bowel vessel wall with a clip applied preventing enteral spillage but maintaining blood flow within the internal vasculature. 
         FIG. 6C  illustrates a cross-sectional view of a bowel vessel with a clip applied preventing enteral spillage but also causing collapse of the vasculature internal to the bowel vessel wall. 
         FIG. 7A  illustrates a top view of a blood vessel that is completely occluded by a clip. 
         FIG. 7B  illustrates a top view of a blood vessel that is partially occluded by a clip. 
         FIG. 7C  illustrates a top view of a blood vessel that is completely severed and is completely occluded by a single clip. 
         FIG. 8A  illustrates a side view of a clip wherein the jaws move on linear axes and are open. 
         FIG. 8B  illustrates a side view of the clip wherein the jaws move on linear axes and are closed. 
         FIG. 8C  illustrates a side view of the clip wherein the jaws move on linear telescoping axes and are open. 
         FIG. 8D  illustrates a side view of the clip wherein the jaws move on linear telescoping axes and are closed. 
         FIG. 9A  illustrates a side view of a clip, shown with the jaws fully opened, wherein the jaws rotate angularly to encompass a wide vessel but close in a linear fashion on spring loaded telescoping linear bearings. 
         FIG. 9B  illustrates a side view of the clip, shown with the jaws rotated to the parallel but slightly open configuration, wherein the jaws rotate angularly to encompass a wide vessel but close in a linear fashion on spring loaded telescoping linear bearings, shown with the jaws fully opened. 
         FIG. 9C  illustrates a side view of the clip, shown with the jaws rotated to the parallel configuration and are fully closed, wherein the jaws rotate angularly to encompass a wide vessel but close in a linear fashion on spring loaded telescoping linear bearings. 
         FIG. 10A  illustrates a side view of the clip with the jaws rotated angularly to the open position wherein Pad material of variable thickness is used to equalize pressure distribution over the closed pads. 
         FIG. 10B  illustrates a side view of the clip with the jaws rotated angularly to the closed position, wherein pad material of variable thickness is used to equalize pressure distribution over the closed pads. 
         FIG. 11A  illustrates a side view of the clip in the open position around a vessel with a clip applier attached, according to aspects of an embodiment of the invention. In this embodiment, the opening tabs are rotated outward with the clip in the open position; 
         FIG. 11B  illustrates a side view of the clip in the closed position occluding the vessel with the clip applier removed, according to aspects of an embodiment of the invention. In this embodiment the opening tabs are rotated inward to minimize projections with the clip in the closed position; 
         FIG. 12A  illustrates a side view of the clip in the closed position with folding tabs unfolded and ready for compression. 
         FIG. 12B  illustrates a side view of the clip in the open position with the folding tabs compressed together and the jaws spread apart 
         FIG. 12C  illustrates a side view of the clip in the closed position with the jaws in opposition and the tabs folded inward to minimize projections. 
         FIGS. 13A and 13B  are side views of a clip with no tab projections beyond the hinge. 
         FIG. 13C  is a top view of the clip of  FIGS. 13A and 13A . 
         FIGS. 14A ,  14 B and  14 C illustrate the clip applicator for use with the clip shown in  FIGS. 13A through 13C . 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       FIG. 1A  illustrates a side view of a clip  10  of the present invention. The clip  10  comprises a plurality of jaws  12 , further comprising a frame  14  and a pad  16 , a main hinge  18 , a plurality of main struts  20 , a plurality of opening tabs  22 , a plurality of grasping detents  24 , and a plurality of optional serrations  26  on one or more of the pads  16 . The clip  10  further comprises an optional secondary hinge  28 , a plurality of optional secondary struts  30 , a plurality of main pivot points  32 , an optional spring  34 , an optional lock  36 , an optional hinge bracket  38 , and a plurality of optional secondary pivot points  40 . 
     Referring to  FIG. 1A , the jaws  12  of the clip  10  are shown in their open configuration. The frame  14  provides rigid support and orientation for the pads. 16 . The top and bottom frames  14  are connected to a main hinge  18  through a plurality of main struts  20 . Each of the main struts  20  is rigidly affixed to the opening tab  22  with the grasping detent  24  formed into the opening tab  22 . In this embodiment, the main hinge  18  is connected to the secondary hinge  28  by a plurality of hinge brackets  38 . The main struts  20  are rotationally connected to the main hinge  18  and the main pivot points  32 . The secondary struts  30  are connected to the secondary hinge  28  and the secondary pivot points  40 . The serrations  26  are formed on the surface of the pads  16 . The spring  34  is affixed between the main pivot points  32  and causes both of the frames  14  to be forced toward each other. 
     Further, referring to  FIG. 1A , the clip  10  utilizes a parallelogram hinge design to facilitate parallelism in the jaws  12  in the open, closed and partially open configurations. 
     The clip frame  14 , the main struts  20  and secondary struts  30  as well as the main pivot points  32 , secondary pivot points  40 , the main hinge  18 , the secondary hinge  28 , the plurality of hinge brackets  38  and the opening tabs  22  are fabricated from generally rigid materials such as, but not limited to, stainless steel, cobalt-nickel alloys, nitinol, tantalum, titanium, polylactic acid, polyglycolic acid, platinum, polypropylene, polyethylene, polyimide and the like. Where resorbable materials such as polylactic acid and polyglycolic acid are used, the clips will disintegrate within the body over a period of time, thus obviating the need to remove the clip  10 , and preventing or limiting ingrowth or overgrowth of body tissue over the clip components, thus facilitating removal. The pads  16  are fabricated from non-rigid, compliant materials such as open or closed cell foam, low durometer elastomers, resorbable compliant materials, and the like. The foams may be fabricated from a variety of polymers including but not limited to polyurethane, polyvinyl chloride and the like. The frame  12  or at least one other component of the clip  10  is preferably radiopaque and visible under fluoroscopy or X-Ray. All or most components of the clip  10  are fabricated from resorbable materials such as PLA or PGA so that the clip  10  eventually erodes or dissolves and goes away (preferably after healing is complete). 
     The opening tabs  22  are rigidly affixed to the main struts. Inward force applied to the opening tabs  22  causes a moment arm to rotate the main struts  20  around the main hinge  18  to the open position. The grasping detents  24  permit an instrument, such as forceps, Allis Clamp, Kocher Clamp, or the like, to grasp the opening tabs  22  in such a way that they do not slip off inadvertently. 
     The spring  34  is, preferably, a leaf spring and is fabricated from materials such as, but not limited to, stainless steel 316L, titanium, Elgiloy, nitinol and the like. The spring  34  is affixed between the two jaws and is pre-loaded to force the jaws toward the closed position. The spring  34  is designed to compress the pads  16  around the body vessel or lumen with enough force to close the lumen of the vessel but not enough force to close the vasculature within the body vessel wall. For example, a bowel can be closed with a distributed pressure of 20 mm Hg or less while a blood vessel would be closed with a pressure exceeding blood pressure. Typical diastolic blood pressures in a shock patient may be as low as 50 mm Hg so this would be the typical upper limit of the pressure generated by a clamp designed to compress a section of bowel. Thus, the bowel clamp spring system will provide pressures in the range of 2 to 50 mm Hg and more preferably between 10 and 20 mm Hg. The pressure may be calculated as the force applied by the spring  34  divided by the surface area of one of the pads  16 . The spring characteristics, such as the spring material, size, thickness, etc. are selected to achieve the desired spring force and resultant clamping force applied by the clip. When used to close a blood vessel, the clamping force is preferably much higher. A vascular clamp system is required to seal off a blood vessel at a systolic blood pressure of 100 to 300 mm Hg in hypotensive and hypertensive patients, respectively. Accordingly, clamps intended for use on blood vessels are provided with springs of sufficient strength such that the clamps can apply a force of 100 to 300 mm Hg on the vessels to which they are applied. The pads  16  are soft and distribute the applied pressure evenly over the surface of the body vessel. 
     The pads  16  comprise optional serrations  26  that prevent slippage of the pads on the surface of the body vessel. The serrations  26  may be configured so as to impinge on each other tip to tip or they may be configured to interlock with each other. The pads  16  preferably comprise a central opening so that they provide a line of tissue compression, not a broad plane of compression. The supporting frame  14  is, also, preferably hollow and provides exposure to the tissue in its central region when looking in a direction perpendicular to the plane of the frame  14 . 
       FIG. 1B  illustrates a side view of the clip  10  with the jaws  12  in their closed position. The opening tabs  22  are rotated apart and the serrations  26  on the pads  16  are in parallel touching contact. The maintenance of the parallel position of the jaws  12  permits closure of the vessel between the pads  16  without pinching and overcompression at one point and under-compression at another point. This feature of the clip  10  may be termed force parallelism and refers to an even force distribution on the tissue along the entire hinge-to-tip length of the clip. 
     The total projection of the non-jaw parts of the clip  10  with the jaws  12  in the closed position does not extend a distance greater than the distance D between the exterior of the closed frames  14  of the jaws  12 . Thus, if the clip jaws  12  open to a maximum outside frame distance of 15 mm, the maximum total projection of any non-jaw  12  structure along a given axis when the jaws  12  are in the closed position will not be greater than 15 mm. Such non-jaw  12  projections include opening tabs  22 , struts  20  and  30  and the like. 
       FIG. 1C  illustrates a top view of the clip  10  comprising the jaws  12 , further comprising the plurality of frames  14 , the main pivot points  32 , the secondary pivot points  40 , the main hinge  18 , the secondary hinge  28 , the plurality of main struts  20  (not shown), the plurality of secondary struts  30  (not shown), the plurality of opening tabs  22 , the spring  34  (not shown), and the plurality of grasping detents  24 . The plurality of pads  16  are not visible in this view as they are on the other side of the frame  14 . 
     Referring to  FIG. 1C , the jaws  12 , further comprising the frames  14  and the pads  16 , are of a circular or donut configuration. In the preferred embodiment, the center of the frame  14  is open. In another embodiment, the center of the frame  14  could advantageously be closed. The jaws  12  project along a major axis (line  19 ), generally leading perpendicularly away from the main hinge  18 . The jaws  12  project also along a minor axis (line  21 ) leading generally parallel to the direction of the main hinge  18 . The jaws  12  are broad and are designed to encompass a large amount of tissue and, therefore have substantial major and minor axes. The minor axis (along line  21 ) of the jaw  12  should be no smaller than 25% of the major axis (along line  19 ) of the jaw  12  and, preferably no smaller than 40% of the distance subtended by the major axis. In another embodiment, the minor axis and major axis are switched, such that the major axis is parallel to the hinge and the longitudinal axis of the vessel to be closed. 
     In  FIG. 1C , the opening tabs  22  are aligned so that the main hinge  18  is located between the opening tabs  22  and the main struts  20 . In yet another embodiment of the clip  10 , the opening tabs  22  are positioned between the main hinge  18  and the frames  14 . In this embodiment, the main struts  20  are forced open by force applied to the opening tabs  22 . However, the projection of the opening tabs  22  beyond the main hinge  18  is eliminated, thus minimizing the projection of the clip  10  and minimizing its profile. Such minimized profile is advantageous when leaving the clip  10  implanted within the patient. Referring to  FIGS. 2A and 2B , depending on the position of the opening tabs  22 , the grasper jaws  52  on the graspers will be closed or overlapped closed to open the jaws  12  on the clip  10 . The opening tabs  22  can also be positioned so that the grasper jaws  52  are open when the clip  10  jaws  12  are open. In a further embodiment, the grasper jaws  52  grab the main hinge  18  on the clip  10 . A central shaft (not shown) is then advanced or retracted, pushing the opening tabs  22  to open jaws  12 . 
       FIG. 2A  illustrates a side view of a clip  10  of the present invention in the open position and aligned around a blood vessel  70 . A grasping instrument  50  is positioned to open the clip  10 . The grasping instrument  50  comprises a plurality of grasper jaws  52 , a hinge  54 , shafts  56 , a ratchet lock  58  and finger loops  60 . 
     Referring to  FIGS. 2A and 1A , the grasper jaws  52  of the grasping instrument  50  are positioned within the grasping detents  24  on the opening tabs  22  of the clip  10 . By applying inward pressure to close the two finger loops  60 , the grasper jaws  52  are closed, thus closing the opening tabs  22  on the clip  10  and rotating the clip jaws  12  open against the force exerted by the spring  34 . The ratchet lock  58  maintains closure of the grasper jaws  52 , until such time as release is desired. The opened clip  10  is positioned around a blood vessel  70 , further comprising a vessel wall  72  and a vessel lumen  74 . In  FIG. 2A , the vessel lumen  74  is open. 
       FIG. 2B  illustrates a side view of the clip  10  of the present invention with its jaws  12  in the closed position and aligned around and occluding or closing the lumen  74  of the blood vessel  70 . The ratchet lock  58  further comprises a ratchet lock top  62  and a ratchet lock bottom  64 . 
     In this illustration, the ratchet lock top  62  on the grasper  50  has been separated from the grasper lock bottom  64 , the finger loops have been rotated open and the grasper jaws  52  are open. The opening tabs  22  on the clip  10  are opened, allowing the spring (not shown) to bring the jaws  12  of the clip  10  into contact with and compress the vessel wall  72 . 
     Referring to  FIGS. 2A and 2B , such graspers  50  may be forceps or other commercially available instruments such as a Kocher Clamp, an Allis Clamp, or the like. In order to fully utilize the benefits of the invention, however, specialized graspers  50  may be desirable. This is especially true in the embodiment where the opening tabs  22  on the clip  10  are located between the main hinge  18  and the jaws  12 . In this embodiment, a grasper jaw  52  that specifically mates with the internal opening tabs  22  and forces the opening tabs  22  open will be advantageous. The long shafts  56  are advantageous for all applications since they extend the reach of the surgeon into tight spaces not normally accessible with the fingers. In addition, the long shafts  56  help apply a large moment around hinge  54  to move the jaws  52  against substantial spring force. 
     Referring to  FIGS. 1A ,  1 B,  1 C,  2 A and  2 B, the diameter of the jaws  12  of the clip  10  ranges from about 0.1 cm to 10 cm depending on the tissue being compressed. More preferably, the diameter of the clip  10  ranges from about 0.2 cm to 5 cm. 
       FIG. 3A  illustrates a longitudinal section of a bowel, blood vessel, or other body vessel  70 . The bowel, blood vessel, or other body vessel comprises the wall  72  and the lumen  74 . A plurality of wounds  76  further comprise this section of bowel, blood vessel, or other body vessel  70 . These wounds  76  project into the lumen  74  but do not transect the entire vessel  70 . 
       FIG. 3B  illustrates the section of the bowel, blood vessel or other body vessel  70  with clips  10  applied over the wounds  76 . The clips  10  are applied to the vessel wall  72  so as to completely seal off the lumen  74  from leakage. However, a through passage is still present within the lumen  74  of the vessel  70 . For example, this configuration would permit perfusion of vasculature and tissue downstream of a blood vessel while stopping hemorrhage though the wounds  76 . 
       FIG. 4  illustrates a top view of a packaging system  80  for the clips  10 . The packaging system comprises the plurality of clips  10 , a carrier  82 , a plurality of dividing walls  84 , a sliding seal  86 , a draw tab  88 , a sterile barrier  90 , an optional secondary sterile barrier  92 , a plurality of guiding detents  94 , and a plurality of notches  96 . 
     Referring to  FIG. 4 , this embodiment shows five clips  10  located within the carrier  82  and separated by dividing walls  84 . The optional secondary sterile barrier  92  is removed prior to accessing the sterile barrier  90  as part of double aseptic technique. The sterile barrier  90  is typically a polymer tray fabricated from thermoformed PVC, PETG, polystyrene, or the like. The secondary sterile barrier  92  is typically a heat sealed polyethylene or Tyvek® bag or polymer tray with a heat sealed Tyvek® lid, or the like. The carrier  82  further comprises a plurality of guiding detents  94  to facilitate positioning of the graspers  50  on the clips  10 . The sliding seal  86  maintains sterility of each unused clip  10  while allowing access to one or more clip  10  at a time. The sliding seal  86  slides along the carrier  82  and seals against the dividing wall  84  to provide such sterile barrier. Optional notches  96  in the carrier and sterile barrier  90  provide tactile feel for locating the sliding seal  86  correctly on the dividing walls  84 . 
       FIG. 5A  illustrates the clip  10  of the present invention with the elliptical jaw  12  configuration. In this embodiment, the ellipse is oriented with its major axis parallel to the axis of the main hinge  18 . The jaws  12  of the present invention project substantially in a direction lateral to the major axis of the jaws  12 , which is generally perpendicular to the axis of the main hinge  18 . The major axis of the jaws  12  can be defined as the axis moving away from the main hinge  18  or other moving part of the clip  10 . 
       FIG. 5B  illustrates the clip  10  of the present invention with the elliptical jaw  12  configuration. In this embodiment, the ellipse is oriented with its major axis perpendicular to the axis of the main hinge  18 . 
       FIG. 5C  illustrates the clip  10  of the present invention wherein the jaws  12  are of circular configuration. 
       FIG. 5D  illustrates the clip  10  of the present invention wherein the jaws  12  are of a rounded triangular configuration. The pointed side of the triangle is on the side of the clip  10  away from the main hinge  18 . In another embodiment, the pointed side of the triangle is on the same side as the main hinge  18 . Other geometric configurations may also be appropriate for the jaws  12 . 
       FIG. 6A  illustrates an enteral vessel  70  in cross-sectional view. The enteral vessel  70  further comprises the wall  72 , the lumen  74  and wall vasculature  78 . The enteral vessel  70  is typically a bowel such as the esophagus, small intestine or large intestine but may also include other body lumens that are highly vascularized. The vasculature  78  includes arteries, veins and capillaries. 
       FIG. 6B  illustrates the enteral vessel  70  with the clip  10  applied to the exterior of the wall  72  so as to completely collapse and seal the lumen  74 . The pressure exerted by the clip  10  is sufficient to close the lumen  74  but not enough to cause collapse of the vasculature  78 . 
       FIG. 6C  illustrates the enteral vessel  70  with the clip  10  applied to the exterior of the wall  72  so as to completely collapse and seal the lumen  74 . The pressure exerted by the clip  10  is sufficient to not only close the lumen  74  but is also sufficient to cause collapse of the vasculature  78 . 
       FIG. 7A  illustrates a top view of a section of vessel  70  with a clip  10  applied so as to completely occlude the lumen  74  all the way across the width of the vessel  70 . 
       FIG. 7B  illustrates a top view of a section of vessel  70  comprising the wound  76  partially severing the vessel wall  72 . The clip  10  applied so as to completely occlude the lumen  74  around the wound  76  but still allowing some flow through lumen  74  in the region not collapsed by the clip  10 . The large width of the clip  10  facilitates completely encircling and sealing the wound  76  to the vessel. 
       FIG. 7C  illustrates a top view of a section of vessel  70  comprising the wound  76  that completely transects the vessel wall  72 . The clip  10  is applied to the vessel wall  72  of both of the severed ends of the vessel  70  so as to completely occlude the lumen  74  of both sections of the severed vessel  70 . The large width of the clip  10  facilitates completely sealing the transecting wound  76  to both ends of the vessel. 
       FIG. 8A  illustrates another embodiment of a clip  10  of the present invention wherein one or more of the jaws  12  move along a linear bearing  90 . In the preferred embodiment, the clip  10  comprises the jaws  12 , the linear bearing  90 , a plurality of linear ratchet teeth  92 , a release  94 , a ratchet lock  96 , a spring  100 , and an optional damper  102 . 
     The clip  10  of the present embodiment is shown with the jaws  12  in the open position. One of the jaws  12  is permanently affixed to the base of the linear bearing  90 . The other jaw  12  is permanently affixed to and moves with the ratchet lock  96  over the linear bearing  90 . The plurality of linear ratchet teeth  92  are permanently affixed along the linear bearing  90  with the ramped ends toward the immovable jaw  12  and the flat ends away from the immovable jaw  12 . The spring  100  is connected between the two jaws  12  so that the jaws are placed under the correct tension. The spring  100  pulls the jaws  12  together. The ratchet lock  96  engages the plurality of linear ratchet teeth  92  with a spring-loaded tooth and may be easily moved away from the immovable jaw  12 . The ratchet lock  96  cannot move toward the immovable jaw  12  unless the release  94  is depressed. At this time, the spring  100  forces the jaws together. The optional damping system  102  (not shown) may be used to prevent too quick a movement of the movable jaw  12  toward the immovable jaw  12 . 
     Referring to  FIGS. 1A and 8A , the jaws  12  of this embodiment of the clip  10  are fabricated from the same materials and in the same configuration as the jaws  12  of the clip in  FIG. 1A . 
       FIG. 8B  illustrates the clip  10  of  FIG. 8A  with the jaws  12  in the closed position. 
       FIG. 8C  illustrates another embodiment of the clip  10  of the present invention. The clip  10  comprises the jaws  12 , a locking, telescoping linear bearing  104 , a spring  100 , an optional damper  102  (not shown) and a release  94 . 
     The jaws  12  are held apart by the locking, telescoping linear bearing  104  against the compression force of the spring  100 . The release  94  engages features within the telescoping, locking, linear bearing  104  to prevent compression until such time as the release  94  is depressed or otherwise activated. At this time, the spring  100  brings the jaws  12  together. The optional damper  102  controls the rate of jaw  12  movement. 
       FIG. 8D  illustrates the clip  10  of the embodiment shown in  FIG. 8C  with the jaws  12  in the closed position. The telescoping, locking, linear bearing  104  is fully compressed and does not project beyond the perimeter of the clip  10  jaws  12 . This embodiment minimizes the projections from the implantable clip  10 , a particularly advantageous feature. 
       FIG. 9A  illustrates another embodiment of the clip  10  of the present invention with its jaws  12  in the fully open position. The clip  10  comprises the jaws  12 , a plurality of ratcheting hinges  110 , a telescoping locking linear bearing  104 , a release  94 , a spring  100  and an optional damper  102  (not shown). 
     Referring to  FIG. 9A , this embodiment of the clip  10  utilizes multiple opening mechanisms of rotation and linear separation. The plurality of ratcheting hinges  110  are affixed to the jaws  12 . The telescoping locking linear bearing  104  is rotationally connected to the ratcheting hinges  110 . The spring  100  is connected between the jaws  12  and acts to force the jaws  12  toward the closed position. The optional damper  102  (not shown) is affixed between the jaws  12  and controls the rate of jaw  12  closure. 
     The ratcheting hinges  110  are manually opened by rotation to allow for maximum separation of the jaws  12  so as to surround a large vessel. 
       FIG. 9B  illustrates the clip  10  of  FIG. 9A  with the jaws  12  in an intermediate position. The jaws  12  are closed manually on the ratcheting hinges  110 . Following complete rotation, the jaws  12  are in the parallel position. The spring  100  is pre-loaded under tension in this configuration. The telescoping linear bearing  104  is in its fully open position. 
       FIG. 9C  illustrates the clip  10  of  FIG. 9A  with the jaws  12  in the fully closed position. The spring  100  forces the jaws  12  closed after the release  94  is activated. The release  94  or a separate release (not shown) can optionally be used to unlock the jaws  12  for rotation about the ratcheting hinges  110 . The telescoping linear bearing  104  is fully compressed in this configuration and does not project beyond the general envelope of the jaws  12 . In practice, the spring  100  and the optional damper  102  are affixed inside the telescoping linear bearing  104 . 
       FIG. 10A  illustrates yet another embodiment of the clip  10  of the present invention. The clip  10  is shown with the jaws  12  in the open position. The clip  10 , in this embodiment, comprises a plurality of jaws  12  that are further comprised by a frame  14  and a pad  16 . The jaws rotate around a main hinge  18 . A plurality of opening tabs  22  are rigidly affixed to the frames  14 . A spring  34  biases the jaws  12  toward the closed position. 
     Referring to  FIG. 10A , by bringing the opening tabs  22  into close proximity, the jaws  12  are separated maximally. The pads  16  are designed with greater thickness toward the hinge  18 . These variable thickness pads  16  help distribute the force on the tissue being clamped. The frames  14  are further apart toward the hinge than toward the outside of the jaws  12 . This extra separation near the hinge helps prevent pinching the tissue and maximizes force distribution over the tissue. The pads  16  are fabricated from the same materials as those used in the clip  10  shown in  FIG. 1A . In yet another embodiment of the clip  10  of  FIG. 10A , the pads  16  may be of constant thickness but of decreasing hardness approaching the hinge  18 . In this embodiment, the frames  14  of the jaws  12  could be roughly parallel to each other in the closed position. 
       FIG. 10B  shows the clip  10  of  FIG. 10A  with its jaws  12  move to the closed position by the spring  34 . Note that the interface between the pads  16  is even and parallel, even though the frame  14  of one jaw  12  is not parallel to the frame  14  of the opposing jaw  12 . The opening tabs  22  are rotated apart around the hinge  18 . While this embodiment of the clip  10  provides for approximately even (but not completely even) force distribution on the tissue with less complexity than the other clip  10  embodiments. The design relies on a very soft material in the construction of the pads  16 . The serrations  26  are shown in an interlocking configuration. 
       FIG. 11A  shows an open clip  10 , comprising a plurality of opening tabs  22  and jaws  12 , further comprising a plurality of frames  14  and pads  16 , which are disposed around a vessel  70 , and a clip applier  50 , according to aspects of another embodiment of the invention optionally, a spring (not shown) is used to bias the jaws open or closed as required. In this embodiment, the opening tabs are angled apart when the clip jaws  12  are in the open position. The clip applier is open enough to grab the opening tabs  22 . 
       FIG. 11B  shows a closed clip  10 , comprising a plurality of opening tabs  22  and jaws  12 , which are clamped to close the vessel  70 . The clip applier  50  is closed sufficiently to force the opening tabs  22  closed, thus forcing the jaws  12  closed. The opening tabs  22  are now aligned parallel to the jaws  12  and have minimal or no projection out of the plane of the jaws, thus facilitating implantation. The clip applier  50  may also be configured to be closed when the jaws  12  of the clip  10  are open and open when the jaws  12  of the clip  10  are closed. This requires that the operator expand the clip applier  50  to close the jaws  12  of the clip  10 , potentially an easier motion on the part of the operator. A ratcheting mechanism or locking mechanism (not shown) maintain the jaws  12  of the clip  10  in the closed position once positioned there by the clip applier  50 . 
     Referring to  FIGS. 2A ,  3 A,  3 B,  4 ,  6 A,  6 B,  7 A,  7 B,  7 C, and  11 A, the methodology for implanting these clips  10 , also known as clamps, is to place them through an open wound or incision. They are generally grasped by a grasping tool  50  and removed from their sterile package with the jaws  12  in the open position. The clips  10  are located properly over the vessel  70  or wound  76 . At this point, the grasping tool  50  is opened and the jaws  12  of the clip  10  are allowed to close. Readjustment may be required in order to obtain the desired hemostasis or leakage control. The clips  10  are left implanted and the wound is covered appropriately until such time as the patient is stabilized and the wound can be correctly and permanently repaired. 
       FIG. 12A  illustrates another embodiment of the clip  10  comprising a plurality of opposing jaws  12 , further comprising a frame  14  and a pad  16 , a hinge mechanism  18 , an upper folding tab  80 , a lower folding tab  82 , and a spring, (not shown). 
     The jaws  12  rotate around the hinge mechanism  18  and are constrained radially by the hinge mechanism  18 . The jaws  12  are fabricated using the frame  14  and the pad  16  which are permanently affixed to each other. The spring is affixed to the jaws  12  and is biased to force the jaws  12  together into the closed position. The upper folding tab  80  is radially constrained around the hinge mechanism  18  and is free to fold inward until it is essentially flush with the frame  14 . The upper folding tab  18  has a projection that engages with the jaw  12  in the region of the hinge mechanism  18  so that when the upper folding tab  80  is forced downward by manual pressure, the upper jaw  12  is forced to rotationally open around the hinge mechanism  18 . The lower folding tab  82  is radially constrained by the hinge mechanism  18  and rotates freely around the hinge mechanism  18  between pre-set limits. The lower folding tab  82 , when forced upward, engages with a projection on the jaw  12  in the region of the hinge mechanism  18  and causes the lower jaw  12  to open. 
       FIG. 12B  illustrates the clip  10  of the embodiment shown in  FIG. 12A , with the jaws  12  in their open configuration. The upper folding tab  80  and the lower folding tab  82  have been compressed together forcing the jaws  12  to open. 
       FIG. 12C  illustrates the clip  10  of the embodiment shown in  FIG. 12A  with the tabs  80  and  82  released and the jaws  12  closed by action of the spring (not shown). The upper tab  80  and the lower tab  82  have each been folded inward to be essentially flush with the respective frame  14  of the jaw  12 . An optional locking detent or lock (not shown) is preferable to ensure that the folding tabs  80  and  82  remain in place once folded inward and until such time as release is desired. When release of the tabs  80  and  82  is desired, manual force is preferably used to overcome the lock and allow the tabs  80  and  82  to be folded outward so that they can be compressed to open the jaws  12 . 
     The folding tabs  80  and  82  enable the clip  10  to be configured without any projections or with minimal projections so that they may be left in the body for a period of time, temporarily or permanently, and will not erode surrounding tissues. 
     In a further embodiment, the tabs  80  and  82  do not fold out but pull out from the clip  10  like a drawer. Once the tabs  80  and  82  have been used to open and then allow the clip  10  to close, the tabs  80  and  82  of this embodiment, are pushed inward so that they now comprise minimal or negligible projections. The tabs  80  and  82  slide on rails or slots in the clip  10 , in this embodiment, and optionally comprise detents or interference locks to prevent unwanted outward expansion after the tabs  80  and  82  are pushed in. 
       FIGS. 13A through 13C  illustrate a clip  10  constructed without rearwardly extending opening tabs.  FIGS. 13A and 13B  are side views of a clip  10  with no tab projections beyond the hinge. The jaws are shown in the open configuration in  FIG. 13A  and in the close position in  FIG. 13B . The jaws  12 , frame  14  and a pad  16  are constructed as described above in relation to other embodiments of the clips. The hinge spring  18 , which biases the clip to the closed position, is covered by a hinge housing  112 . In this embodiment, the clamp jaws  12  are forced open by force applied to the opening tabs  22  with the specially adapted grasping instrument shown in  FIGS. 14A and 14B . The opening tabs are positioned between the hinge  18  and the distal extent of the jaws. The projection of the opening tabs  22  beyond the main hinge  18  is thus eliminated, minimizing the projection of the clip  10  and minimizing its profile. This minimized profile is advantageous when leaving the clip  10  implanted within the patient.  FIG. 13C  is a top view of hinge shown in  FIG. 13A . Though the spring is shown in this view, it will typically be covered by the hinge housing to provide a uniform rounded outer surface to the clip. The spring is concentrically wound around the hinge, having one end embedded in the lower jaw and one end embedded in the upper jaw. The spring biases the clip closed with a pre-determined, controlled force determined by the size and material of the spring. The spring characteristics are chosen to limit the force applied to the vessel, as described in relation to the leaf spring of  FIGS. 1A through 1C . Grasping tabs  22  are visible between the hinge and the jaws. Preferably the tabs are arranged to avoid torsion on the clip, and the illustrated arrangement includes two spaced apart tabs attached one jaw, and a single tab on the opposite jaw, disposed under the gap established by the other tabs. The clip of this embodiment has rounded exterior surfaces and rounded edges. 
       FIG. 14A  the clip applier or grasping instrument  50  to be used with the clips of  FIGS. 13A through 13C . The clip applier exerts force on tabs or surfaces between the hinge and the center of the jaws. The grasping instrument is constructed as described above, with the hinge  54 , shafts  56 , ratchet lock  58  and finger loops  60  described above. The grasper jaws  52  include bosses  114  which extend inwardly toward the opposite grasping jaw, leaving a hinge accommodating space  116  between the grasping jaw hinge  54  and the bosses. With the grasping instrument open, it can be positioned to place the clip hinge  18  into the hinge accommodating space, as shown in  FIG. 14A , with the bosses in apposition to the tabs of the clip. As shown in  FIG. 14B , when the grasping instrument is closed, the bosses force the tabs apart, thereby forcing the jaws open against the bias of the spring.  FIG. 14C  is a top view of the clip and clip applier of  FIG. 14A  and  FIG. 14B . In this view, prongs  118  of one grasping jaw  52  are visible. The prongs of the clip applier project beyond the hinge of the clip so that they may exert force on pads or tabs located inward of the hinge. 
     Application of the implantable vessel clipping system provides improved speed of hollow organ, blood vessel and enteral trauma repair and minimizes the amount of hemorrhage and infection. The implantable nature of these clips facilitates damage control procedures wherein the patient can be allowed to stabilize prior to definitive repair of the injuries. Such damage control procedures have been shown to improve patient outcomes and save lives. 
     The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. For example, the spring-loaded clamps or clips can, instead, be closed on ratcheting mechanisms to a specific amount of compression, rather than by spring action. The spring-loaded clips may also be forced closed under the attraction force of opposite pole permanent or electronic magnets. Permanent magnets manufactured from neodymium iron boron are suitable for this purpose. 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.

Technology Classification (CPC): 8