Use of an adhesive to treat intraluminal bleeding

A surgical device to stanch the flow of blood is disclosed. The surgical device can place an implantable adhesive over or around varices or other bleeders. The surgical device has a vacuum system for capturing tissue and an adhesive system to apply adhesive to the captured tissue. A vacuum chamber is used to contact tissue and contains a chamber therein for the reception of tissue. An adhesive applicator is provided within the vacuum chamber and moves longitudinally therein to apply adhesive to tissue. The surgical device can apply an adhesive patch to tissue or inject adhesive into tissue. Alternately, an adhesive actuator and a chemical agent can be dispensed to tissue within the vacuum chamber.

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.

DETAILED DESCRIPTION OF THE INVENTION

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 2illustrates an example of a surgical device25capable of stopping the flow of blood with an adhesive65at a surgical site such as the esophagus. Surgical device25can 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 device25as shown inFIG. 1has a distal portion that is small in cross section so it can be inserted into a working channel85of an endoscope80. Endoscope80is a common surgical access instrument that has a scope handle81, a steerable flexible shaft82, a viewing element84at a distal tip83to view the surgical site, and the working channel85extending from handle81to distal tip83. Endoscopes are commonly inserted into the mouth or anus to use natural body orifices to gain access to surgical sites within the patient. Surgical device25generally extends from a handle34to an end effector30.FIG. 1shows the handle34extending from a proximal end of the working channel85and the end effector30extending from a distal end of the working channel85. The surgical device25is positionable with respect to the operative channel85of endoscope80in rotation, insertion, and extraction. A flexible shaft32operatively couples end effector30to the handle34.

Vacuum System

The vacuum system50of the surgical device25has a vacuum source51and a vacuum control56to control the delivery of vacuum to the handle34. Vacuum is supplied through a hose54extending from vacuum control56. A longitudinally moveable vacuum cannula52(FIG. 2) is operably connected to hose54and extends from handle34, through flexible shaft32, to the end effector30. Vacuum cannula52moves proximally and distally within handle34and flexible shaft32in response to proximal and distal manipulation of chamber control53on handle34. A conical vacuum chamber55attaches to a distal tip of the vacuum cannula52and is operably coupled to vacuum source51and vacuum control56by vacuum cannula52and hose54. As shown inFIG. 2, vacuum passageways58are provided in vacuum cannula52to conduct vacuum to vacuum chamber55.

Vacuum chamber55is best shown inFIGS. 1-5, and is a collapsible and expandable structure. Vacuum chamber55has a fully open conical shape ofFIGS. 1 and 5and can be collapsed to a partially closed position ofFIG. 4, to the nearly closed position ofFIG. 3, and to a fully closed cylindrical shape with pleats and folds within flexible shaft32(not shown). As vacuum chamber55is collapsed, a series of pre-induced folds59located about the periphery are used to control collapsing, and are best shown inFIGS. 3 and 4. As shown, vacuum chamber55is formed from a spring material that has a naturally open conical shape. In the full open position, the folds59could induce local distortion and prevent vacuum chamber55from attaining a smooth conical shape.

Distal and proximal movement of chamber control53on handle34moves vacuum cannula52and attached vacuum chamber55distally and proximally relative to flexible shaft32. Distal movement of vacuum cannula52moves vacuum chamber55out of the confines of flexible shaft32and allows the vacuum chamber55to expand. Alternately, proximal motion of a fully open vacuum chamber55into flexible shaft32closes vacuum chamber55by bringing vacuum chamber55into camming action with an inner surface33of flexible shaft32. An angle57is cut onto a distal end of vacuum chamber55to enhance angular contact of the vacuum chamber55with 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 chamber55can be withdrawn fully into flexible shaft32. Vacuum chamber55can 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 chambers55could undergo a phase change as they are opened or collapsed. Alternately, by way of example, vacuum chamber55can be constructed with an umbrella-like construction as shown inFIG. 5with a series of ribs59ajoined to a thinner conical section of flexible fabric or film material59b.Film material59bcould also be springy. Alternately, by way of example, ribs59acan be constructed as thicker ribs59amolded onto the film material59b,rigid separate ribs attached to an opening structure like that used in an umbrella (seeFIG. 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 material59b.Film material59bcan 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 system60has an adhesive reservoir61containing an adhesive65and a pump62. Pump62moves adhesive65from the adhesive reservoir61, into an adhesive cannula63extending therefrom, and out of an applicator tip64at a distal end of adhesive cannula63. Adhesive cannula63of surgical instrument25extends from adhesive reservoir61, passes through handle34, through flexible shaft32into end effector30, and operably attaches to applicator tip64. Adhesive cannula63is movable proximally and distally by proximal and distal movement of an applicator control66located at a proximal end of handle34. Distal motion of applicator control66moves applicator tip64distally out of a distal end of flexible shaft32. Proximal motion of applicator control66moves applicator tip64and adhesive cannula63proximally back into the distal end of the flexible shaft32. The extension of vacuum chamber55and applicator tip64from flexible shaft32creates the end effector30.

Additionally, the adhesive system60could be a multiple chamber adhesive system60acontaining any number of chambers greater than one. Each chamber can contain contents such as adhesive65which can be single or multi-part, an adhesive initiator68, or alternate chemical agents69listed below. For example, a multiple chamber adhesive system60acould have the adhesive reservoir61containing an adhesive65and a second chemical agent chamber61a.Both chambers61,61aare operably attached to pump62and an alternate adhesive cannula63ato dispense the contents of chambers61and61a.Alternate adhesive cannula63acan comprise a dual or multi-lumen tube that distributes both adhesive65and adhesive initiators68and/or chemical agents69from applicators64,122in any combination. A mixer70could be placed downstream from pump62and pump62could 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 applicators64,122(see below).

The cross section ofFIG. 2shows end effector30with adhesive cannula63slidably moveable in vacuum cannula52and surrounded by passageways58for the passage of vacuum to vacuum chamber55. Adhesive tip64has a sharp67on the distal end and is fixedly attached to longitudinally moveable adhesive cannula63and moves in response to movement of the applicator control66. To prevent unwanted tissue damage from the sharp67during insertion into the patient and positioning in the body, adhesive tip64is moved proximally into flexible shaft32to present the blunt end of flexible shaft32. Distal motion of applicator control66moves adhesive tip64and sharp67distally to pierce tissue. Activation of pump22forces adhesive65from the sharp67of the adhesive tip64.

The Adhesive and Compounds

By way of example, adhesive65could 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 adhesive65can 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 adhesive76acan be a rigid or flexible and can be non-permeable or permeable. If desired, adhesive76can be a single part or dual part adhesive, and/or can contain one or more additives77. Adhesive65can be polymerized by moisture, blood, saline or adhesive initiators68. Adhesive initiators68can also be used to set up or polymerize the adhesive65and can be but are not limited to base compounds and the like.

Examples of suitable chemical agents69include, 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 adhesives65, adhesion initiators68, and chemical agents69may be found in United States Application 20040190975 by Goodman et al. which is hereby incorporated by reference in its entirety.

Method of Use

FIG. 6shows an esophagus90, the gastro-esophageal junction91and the stomach92. A plurality of vascular structures are located about the esophagus90. The patient has experienced chronic acid reflux which has eroded and thinned the esophagus90and a mucosal layer93to create a thin area94above the gastro-esophageal junction91on the right side of the esophagus90. 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 varices95to develop across the esophagus90and stomach92, with one behind thin area94. The varices95are distended and fragile, and can rupture and bleed easily when the patient suffers from severe coughing or vomiting. As shown the varices95above the gastroesophageal junction91have a bleeder96. The thin mucosal layer allows acid reflux to reach and irritate the varices95which slows or prevents proper healing, as well as providing reduced reinforcement of varices95.

FIG. 7shows the flexible shaft82of the endoscope80inserted into the patients esophagus90. The end effector30of the surgical device25extends from the working channel85in distal tip83of endoscope80. Viewing element84is used to locate the thin area94and the bleeders96(FIG. 6) in the esophagus90. The end effector30of the surgical device has been extended from the working channel85of the endoscope80and vacuum chamber55has been expanded and placed over thin area94. A vacuum is being applied from vacuum source51to capture the thin area94and varices95within vacuum chamber55.

FIG. 8is a cross section of the end effector30on the thin area94of the esophageal tissue. Vacuum chamber55is capturing and drawing the thin area94comprising mucosa93and varices95into vacuum chamber55with the application of vacuum from vacuum source51. The sharp67on applicator tip64has been moved distally from flexible shaft32and is piercing the mucosal layer93and tissue about varices95.

FIG. 9is the cross sectional view ofFIG. 8after the applicator tip64is extended further into the esophageal tissue and adhesive65has been injected about the varices95. Adhesive65emerges from sharp67of applicator tip64under pressure from pump62and has separated mucosal layers93about varices95. Adhesive95begins to set from bodily moisture to stop or staunch the bleeding and creates a protective cap97of adhesive about the varices95. The protective cap97is integrated into tissue to prevent falling off, and prevents the patient from experiencing additional chronic bleeding. To remove the surgical device25, the applicator tip64is first withdrawn from tissue, the vacuum is released to de-capture thin area94of the esophagus90, the vacuum chamber55is pulled distally to close into the flexible shaft32, and the endoscope80and surgical device25are removed from the patient.

FIG. 10shows an alternate method of sealing a bleeder with surgical device25and adhesive65. In this view, the thin area94is drawn into vacuum chamber55with vacuum, and adhesive65is pumped over the surface of mucosal layer93. When adhesive65sets from moisture in the tissue, it forms an exterior protective cap97awithin the esophagus90. Once protective cap97ais 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 cap97are-strengthens the area to prevent varices95from protruding into esophagus90when 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 endoscope80.FIG. 11. shows a handheld surgical device100having a treatment head120suitable for placement at a desired surgical location. Treatment head120is 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 device100has a flexible or malleable shaft105attached to treatment head120and a handle101. Grips102are fixedly attached to handle101for the surgeon to grasp. Vacuum source51and vacuum control56provide vacuum to treatment head120to draw tissue therein, the vacuum conducted through vacuum cannula52and shaft105to a cylindrical vacuum head121. Vacuum head121is clear so the surgeon can view inside during use. An alternate applicator tip122is located within treatment head120and is attached to a longitudinally moveable applicator cannula123. Applicator cannula123is operably attached to a longitudinally moveable control124such that proximal and distal motion of control124results in proximal and distal motion of applicator cannula123and alternate applicator tip122. Adhesive system60contains adhesive65in an adhesive reservoir61and is operably attached to applicator cannula123by cannula67. Activation of pump62moves adhesive65from adhesive reservoir61into cannula67, into applicator cannula123, and dispenses adhesive65from alternate applicator tip122. A sharp122acan be placed on a distal end of alternate applicator tip122. Alternately, by way of example, surgical device100could use an expanding and contracting vacuum chamber55rather than a fixed vacuum head121.

An example of treatment using surgical device100would involve inserting the surgical device100into a patient through a trocar cannula. As shown inFIG. 12, the device is moved to a desired site to treat one of a number of varices95. The vacuum head121is placed at the desired site and vacuum is applied from vacuum source51to draw tissue therein. The surgeon maneuvers the endoscope to view the site through the clear vacuum head121(not shown) and has decided to extend the alternate applicator tip122close to the tissue rather than pierce the tissue with sharp122a. Adhesive65is being applied over the varices95to staunch the bleeding.

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.