Patent Document

FIELD OF THE INVENTION 
     The present invention relates, in general, to devices for the treatment and control of bleeding, and in particular, to devices using adhesives for the treatment of bleeding. 
     BACKGROUND OF THE INVENTION 
     There are several clinical situations or disease states that would result in the small hemorrhages from varices, veins and small arteries. One possible use of this invention is the treatment of esophageal variceal bleeding which has not responded to typical endoscopic therapy, pharmacological therapy, or a surgical shunt. 
     Variceal bleeding in the esophagus is caused by portal hypertension. Portal hypertension is an increase in the pressure within the portal vein (the vein that carries blood from the digestive organs to the liver). This increase in pressure is caused by a blockage in the blood flow throughout the liver. Increased pressure in the portal vein causes enlarged veins (varices) to develop across the esophagus and stomach to bypass the blockage. The walls of the varices become fragile and can rupture and bleed easily. In some cases this bleeding can result in massive uncontrollable bleeding, which left unchecked, could cause severe health issues. Alternately, surgical trauma or other trauma to the esophageal region could also result in a similar bleeding situation. 
     If the patient has gastric reflux disease, the situation can be exacerbated by acid reflux intrusion into the esophagus. This intrusion of stomach acids can cause thinning or removal of the mucosal lining of the esophagus and could expose the underlying vein or varices structures to the chronic acid reflux. Enlarged veins have thinner walls, and acid reflux exposure can thin them further. In some cases, coughing or vomiting might overload the thinned vein or varices, cause a bleeding cycle to occur, and require surgical treatment. 
     Enlarged vein structures or varices are not limited to the esophageal areas and neither are the veinus and arterial stresses induced by coughing, vomiting, trauma, pregnancy, obesity, prolonged standing, hard stools, or other bodily functions. As a consequence, varices are found in hemorrhoids, varicoceles, and varicose veins in areas such as the legs, stomach, and feet. Hemorrhages can be found at these sites, but can occur in any arena where small veins and arteries are near the surface of a structure that is being subjected to stresses or trauma. 
     Consequently, a significant need exists for a surgical device that can atraumatically acquire the bleeding site, prevent further damage to the vein or artery, and place a barrier at the bleeding site to stop the bleeding, and leave a barrier that is secure to prevent reoccurrence of the bleeding cycle. 
     BRIEF SUMMARY OF THE INVENTION 
     In accordance with the present invention, there is provided a surgical device for staunching the flow of blood from tissue. The surgical device comprises an adhesive implantable in the body and a vacuum system for capturing tissue. An adhesive system is provided to apply the adhesive to tissue captured within the vacuum system to staunch the flow of blood. 
     These and other objects and advantages of the present invention shall be made apparent from the accompanying drawings and the description thereof. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
       The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention, and, together with the general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the present invention. 
         FIG. 1  is an isometric view of a surgical device inserted into an endoscope with a vacuum source and a vacuum control and an adhesive system attached. 
         FIG. 2  is a cross sectional view of an end effector of the surgical device of  FIG. 1 . 
         FIG. 3  is an enlarged isometric view of a distal end of the endoscope with the end effector of the surgical device extending therefrom and an unexpanded vacuum chamber partially extending from the end effector. 
         FIG. 4  is an enlarged isometric view of the end effector of the surgical device of  FIG. 3  with the vacuum chamber in a partially opened configuration. 
         FIG. 5  is an enlarged isometric view of the end effector of the surgical device of  FIG. 3  with the vacuum chamber in a fully opened configuration. 
         FIG. 6  is a cross sectional view of the esophagus and stomach of a patient and showing a varices with small bleeders close to the inner surface of the esophagus and above the gastroesophageal junction. 
         FIG. 7  is the cross sectional view of  FIG. 6  with the endoscope and surgical device inserted therein, wherein a fully opened vacuum chamber of the surgical device is placed over the varices. 
         FIG. 8  is a side view of the vacuum chamber of the device drawing a vacuum to pull the varices with the bleeders into the vacuum chamber with an applicator tip of an adhesive system piercing the esophageal wall. 
         FIG. 9  is the side view of  FIG. 8  showing an adhesive being injected about the varices. 
         FIG. 10  illustrates an alternate method to stop the bleeders where an adhesive barrier is being placed over the bleeders and the varices. 
         FIG. 11  is an isometric view of an alternate surgical device that can be used without an endoscope. 
         FIG. 12  is a side view of a partial cross section of a vacuum head of the alternate surgical device of  FIG. 11  placing an adhesive on tissue. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The following description of certain examples of the invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive. 
     Enlarged vein structures or varices are found within the body in a variety of locations. These enlarged vein structures can include arteries, and have thinner wall structures that can cause bleeders when subjected to trauma, or disease conditions such as portal hypertension or hemorrhoids. With portal hypertension, the enlarged varices about the esophagus can rupture and cause chronic bleeding into the esophagus. If severe, the condition can require surgical intervention to staunch the bleeding and leave a structure in place that can prevent further damage to the vein or artery. 
       FIGS. 1 and 2  illustrates an example of a surgical device  25  capable of stopping the flow of blood with an adhesive  65  at a surgical site such as the esophagus. Surgical device  25  can control blood loss by capturing tissue with a tissue acquisition system or vacuum system, and then using an adhesive injection system to inject an adhesive into or onto the captured tissue to staunch blood loss, place a barrier about the varices, and protect the wound site. The surgical device  25  as shown in  FIG. 1  has a distal portion that is small in cross section so it can be inserted into a working channel  85  of an endoscope  80 . Endoscope  80  is a common surgical access instrument that has a scope handle  81 , a steerable flexible shaft  82 , a viewing element  84  at a distal tip  83  to view the surgical site, and the working channel  85  extending from handle  81  to distal tip  83 . Endoscopes are commonly inserted into the mouth or anus to use natural body orifices to gain access to surgical sites within the patient. Surgical device  25  generally extends from a handle  34  to an end effector  30 .  FIG. 1  shows the handle  34  extending from a proximal end of the working channel  85  and the end effector  30  extending from a distal end of the working channel  85 . The surgical device  25  is positionable with respect to the operative channel  85  of endoscope  80  in rotation, insertion, and extraction. A flexible shaft  32  operatively couples end effector  30  to the handle  34 . 
     Vacuum System 
     The vacuum system  50  of the surgical device  25  has a vacuum source  51  and a vacuum control  56  to control the delivery of vacuum to the handle  34 . Vacuum is supplied through a hose  54  extending from vacuum control  56 . A longitudinally moveable vacuum cannula  52  ( FIG. 2 ) is operably connected to hose  54  and extends from handle  34 , through flexible shaft  32 , to the end effector  30 . Vacuum cannula  52  moves proximally and distally within handle  34  and flexible shaft  32  in response to proximal and distal manipulation of chamber control  53  on handle  34 . A conical vacuum chamber  55  attaches to a distal tip of the vacuum cannula  52  and is operably coupled to vacuum source  51  and vacuum control  56  by vacuum cannula  52  and hose  54 . As shown in  FIG. 2 , vacuum passageways  58  are provided in vacuum cannula  52  to conduct vacuum to vacuum chamber  55 . 
     Vacuum chamber  55  is best shown in  FIGS. 1-5 , and is a collapsible and expandable structure. Vacuum chamber  55  has a fully open conical shape of  FIGS. 1 and 5  and can be collapsed to a partially closed position of  FIG. 4 , to the nearly closed position of  FIG. 3 , and to a fully closed cylindrical shape with pleats and folds within flexible shaft  32  (not shown). As vacuum chamber  55  is collapsed, a series of pre-induced folds  59  located about the periphery are used to control collapsing, and are best shown in  FIGS. 3 and 4 . As shown, vacuum chamber  55  is formed from a spring material that has a naturally open conical shape. In the full open position, the folds  59  could induce local distortion and prevent vacuum chamber  55  from attaining a smooth conical shape. 
     Distal and proximal movement of chamber control  53  on handle  34  moves vacuum cannula  52  and attached vacuum chamber  55  distally and proximally relative to flexible shaft  32 . Distal movement of vacuum cannula  52  moves vacuum chamber  55  out of the confines of flexible shaft  32  and allows the vacuum chamber  55  to expand. Alternately, proximal motion of a fully open vacuum chamber  55  into flexible shaft  32  closes vacuum chamber  55  by bringing vacuum chamber  55  into camming action with an inner surface  33  of flexible shaft  32 . An angle  57  is cut onto a distal end of vacuum chamber  55  to enhance angular contact of the vacuum chamber  55  with the wall of the esophagus, and to ensure a good vacuum seal. To ensure safety and efficacy during insertion into the body and during positioning, vacuum chamber  55  can be withdrawn fully into flexible shaft  32 . Vacuum chamber  55  can be constructed from a number of engineering materials such as but not limited to thin sections of engineering thermoplastics such as mylar, silicone, polytetraflouroethylene (Teflon) and the like, or thin sections of metals such as titanium, nitinol or aluminum. Nitinol vacuum chambers  55  could undergo a phase change as they are opened or collapsed. Alternately, by way of example, vacuum chamber  55  can be constructed with an umbrella-like construction as shown in  FIG. 5  with a series of ribs  59   a  joined to a thinner conical section of flexible fabric or film material  59   b.  Film material  59   b  could also be springy. Alternately, by way of example, ribs  59   a  can be constructed as thicker ribs  59   a  molded onto the film material  59   b,  rigid separate ribs attached to an opening structure like that used in an umbrella (see  FIG. 5 ), or a springy an umbrella type construction with flexible cantilever spring ribs. The flexible cantilever spring ribs can be pre-bent to expand into a conical rib structure to open the film material  59   b.  Film material  59   b  can be materials such as but not limited to rubber compounds such as nitryl, polyethelene, polypropelene, polytetraflouroethylene, papers, and surgical fabrics with or without coatings, or films (not shown) and the like. Additionally, by way of example, a spring could be provided to open the umbrella shape. 
     Adhesive System 
     The adhesive system  60  has an adhesive reservoir  61  containing an adhesive  65  and a pump  62 . Pump  62  moves adhesive  65  from the adhesive reservoir  61 , into an adhesive cannula  63  extending therefrom, and out of an applicator tip  64  at a distal end of adhesive cannula  63 . Adhesive cannula  63  of surgical instrument  25  extends from adhesive reservoir  61 , passes through handle  34 , through flexible shaft  32  into end effector  30 , and operably attaches to applicator tip  64 . Adhesive cannula  63  is movable proximally and distally by proximal and distal movement of an applicator control  66  located at a proximal end of handle  34 . Distal motion of applicator control  66  moves applicator tip  64  distally out of a distal end of flexible shaft  32 . Proximal motion of applicator control  66  moves applicator tip  64  and adhesive cannula  63  proximally back into the distal end of the flexible shaft  32 . The extension of vacuum chamber  55  and applicator tip  64  from flexible shaft  32  creates the end effector  30 . 
     Additionally, the adhesive system  60  could be a multiple chamber adhesive system  60   a  containing any number of chambers greater than one. Each chamber can contain contents such as adhesive  65  which can be single or multi-part, an adhesive initiator  68 , or alternate chemical agents  69  listed below. For example, a multiple chamber adhesive system  60   a  could have the adhesive reservoir  61  containing an adhesive  65  and a second chemical agent chamber  61   a.  Both chambers  61 ,  61   a  are operably attached to pump  62  and an alternate adhesive cannula  63   a  to dispense the contents of chambers  61  and  61   a.  Alternate adhesive cannula  63   a  can comprise a dual or multi-lumen tube that distributes both adhesive  65  and adhesive initiators  68  and/or chemical agents  69  from applicators  64 ,  122  in any combination. A mixer  70  could be placed downstream from pump  62  and pump  62  could contain one or more members operably connected to different chambers. For example, a dual chamber syringe could have dual pistons or pumps to dispense the contents from a chamber. Alternately by way of example, any type of pump could be used such as but not limited to piston, diaphragm, rotary, and siphon. If desired, the contents of both chambers could be applied neat or mixed from applicators  64 ,  122  (see below). 
     The cross section of  FIG. 2  shows end effector  30  with adhesive cannula  63  slidably moveable in vacuum cannula  52  and surrounded by passageways  58  for the passage of vacuum to vacuum chamber  55 . Adhesive tip  64  has a sharp  67  on the distal end and is fixedly attached to longitudinally moveable adhesive cannula  63  and moves in response to movement of the applicator control  66 . To prevent unwanted tissue damage from the sharp  67  during insertion into the patient and positioning in the body, adhesive tip  64  is moved proximally into flexible shaft  32  to present the blunt end of flexible shaft  32 . Distal motion of applicator control  66  moves adhesive tip  64  and sharp  67  distally to pierce tissue. Activation of pump  22  forces adhesive  65  from the sharp  67  of the adhesive tip  64 . 
     The Adhesive and Compounds 
     By way of example, adhesive  65  could be a single part or a dual part adhesive that is a polymerizable and/or cross-linkable material such as but not limited to a cyanoacrylate adhesive. The adhesive  65  can be fluid and for example, may be but not limited to a monomeric (including prepolymeric) adhesive composition, a polymeric adhesive composition, or any other natural or artificial biocompatible compound that can adhere to tissue. In embodiments, the monomer may be a 1,1-disubstituted ethylene monomer, e.g., an .alpha.-cyanoacrylate. When cross linked, the cyanoacrylate changes from a liquid to a solid. Cross linked adhesive  76   a  can be a rigid or flexible and can be non-permeable or permeable. If desired, adhesive  76  can be a single part or dual part adhesive, and/or can contain one or more additives  77 . Adhesive  65  can be polymerized by moisture, blood, saline or adhesive initiators  68 . Adhesive initiators  68  can also be used to set up or polymerize the adhesive  65  and can be but are not limited to base compounds and the like. 
     Examples of suitable chemical agents  69  include, such as but are not limited to, image enhancement media, anesthetics, sclerotic or necrosing agents plasticizing agents, thixotropic agents, buffers, catalysts, fillers, micro particles, adhesion initiators, thickeners, solvents, drugs, medicaments, natural or synthetic rubbers, stabilizers, pH modifiers, bioactive agents, cross-linking agents, chain transfer agents, fibrous reinforcements, colorants, preservatives, formaldehyde reducing or scavenging agents, flavorants, perfumes, mixtures thereof, and the like. Other suitable single part and dual part adhesives  65 , adhesion initiators  68 , and chemical agents  69  may be found in United States Application 20040190975 by Goodman et al. which is hereby incorporated by reference in its entirety. 
     Method of Use 
       FIG. 6  shows an esophagus  90 , the gastro-esophageal junction  91  and the stomach  92 . A plurality of vascular structures are located about the esophagus  90 . The patient has experienced chronic acid reflux which has eroded and thinned the esophagus  90  and a mucosal layer  93  to create a thin area  94  above the gastro-esophageal junction  91  on the right side of the esophagus  90 . The patient suffers from portal hypertension which is an increase in the pressure within the portal vein caused by a blockage in the blood flow throughout the liver. This reduced blood flow results in increased pressure in the portal vein and has caused enlarged veins or varices  95  to develop across the esophagus  90  and stomach  92 , with one behind thin area  94 . The varices  95  are distended and fragile, and can rupture and bleed easily when the patient suffers from severe coughing or vomiting. As shown the varices  95  above the gastroesophageal junction  91  have a bleeder  96 . The thin mucosal layer allows acid reflux to reach and irritate the varices  95  which slows or prevents proper healing, as well as providing reduced reinforcement of varices  95 . 
       FIG. 7  shows the flexible shaft  82  of the endoscope  80  inserted into the patients esophagus  90 . The end effector  30  of the surgical device  25  extends from the working channel  85  in distal tip  83  of endoscope  80 . Viewing element  84  is used to locate the thin area  94  and the bleeders  96  ( FIG. 6 ) in the esophagus  90 . The end effector  30  of the surgical device has been extended from the working channel  85  of the endoscope  80  and vacuum chamber  55  has been expanded and placed over thin area  94 . A vacuum is being applied from vacuum source  51  to capture the thin area  94  and varices  95  within vacuum chamber  55 . 
       FIG. 8  is a cross section of the end effector  30  on the thin area  94  of the esophageal tissue. Vacuum chamber  55  is capturing and drawing the thin area  94  comprising mucosa  93  and varices  95  into vacuum chamber  55  with the application of vacuum from vacuum source  51 . The sharp  67  on applicator tip  64  has been moved distally from flexible shaft  32  and is piercing the mucosal layer  93  and tissue about varices  95 . 
       FIG. 9  is the cross sectional view of  FIG. 8  after the applicator tip  64  is extended further into the esophageal tissue and adhesive  65  has been injected about the varices  95 . Adhesive  65  emerges from sharp  67  of applicator tip  64  under pressure from pump  62  and has separated mucosal layers  93  about varices  95 . Adhesive  95  begins to set from bodily moisture to stop or staunch the bleeding and creates a protective cap  97  of adhesive about the varices  95 . The protective cap  97  is integrated into tissue to prevent falling off, and prevents the patient from experiencing additional chronic bleeding. To remove the surgical device  25 , the applicator tip  64  is first withdrawn from tissue, the vacuum is released to de-capture thin area  94  of the esophagus  90 , the vacuum chamber  55  is pulled distally to close into the flexible shaft  32 , and the endoscope  80  and surgical device  25  are removed from the patient. 
       FIG. 10  shows an alternate method of sealing a bleeder with surgical device  25  and adhesive  65 . In this view, the thin area  94  is drawn into vacuum chamber  55  with vacuum, and adhesive  65  is pumped over the surface of mucosal layer  93 . When adhesive  65  sets from moisture in the tissue, it forms an exterior protective cap  97   a  within the esophagus  90 . Once protective cap  97   a  is formed, the bleeders are stopped, a protective bandage or barrier is in position to prevent acid reflux irritation, the barrier promotes healing, and the protective cap  97   a  re-strengthens the area to prevent varices  95  from protruding into esophagus  90  when the patient coughs or vomits. 
     Alternate Embodiments 
     An alternate embodiment of this device could be used for laparoscopic or arthroscopic surgeries rather than with surgeries that require placement into an endoscope  80 .  FIG. 11 . shows a handheld surgical device  100  having a treatment head  120  suitable for placement at a desired surgical location. Treatment head  120  is well suited for use in open surgeries as well as being sized to fit within a laparoscopic trocar cannula or into a small incision for endoscopic or laparoscopic surgeries. The surgical device  100  has a flexible or malleable shaft  105  attached to treatment head  120  and a handle  101 . Grips  102  are fixedly attached to handle  101  for the surgeon to grasp. Vacuum source  51  and vacuum control  56  provide vacuum to treatment head  120  to draw tissue therein, the vacuum conducted through vacuum cannula  52  and shaft  105  to a cylindrical vacuum head  121 . Vacuum head  121  is clear so the surgeon can view inside during use. An alternate applicator tip  122  is located within treatment head  120  and is attached to a longitudinally moveable applicator cannula  123 . Applicator cannula  123  is operably attached to a longitudinally moveable control  124  such that proximal and distal motion of control  124  results in proximal and distal motion of applicator cannula  123  and alternate applicator tip  122 . Adhesive system  60  contains adhesive  65  in an adhesive reservoir  61  and is operably attached to applicator cannula  123  by cannula  67 . Activation of pump  62  moves adhesive  65  from adhesive reservoir  61  into cannula  67 , into applicator cannula  123 , and dispenses adhesive  65  from alternate applicator tip  122 . A sharp  122   a  can be placed on a distal end of alternate applicator tip  122 . Alternately, by way of example, surgical device  100  could use an expanding and contracting vacuum chamber  55  rather than a fixed vacuum head  121 . 
     An example of treatment using surgical device  100  would involve inserting the surgical device  100  into a patient through a trocar cannula. As shown in  FIG. 12 , the device is moved to a desired site to treat one of a number of varices  95 . The vacuum head  121  is placed at the desired site and vacuum is applied from vacuum source  51  to draw tissue therein. The surgeon maneuvers the endoscope to view the site through the clear vacuum head  121  (not shown) and has decided to extend the alternate applicator tip  122  close to the tissue rather than pierce the tissue with sharp  122   a . Adhesive  65  is being applied over the varices  95  to staunch the bleeding. 
     It should be appreciated that any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material. 
     While the present invention has been illustrated by description of several embodiments and while the illustrative embodiments have been described in considerable detail, it is not the intention of the applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications may readily appear to those skilled in the art. 
     For example, the adhesives listed are merely exemplary and many other adhesives and chemical compounds fall within the scope of the present invention.

Technology Category: 1