CA2539382C - Systems and methods for hemorrhage control and or tissue repair - Google Patents

Systems and methods for hemorrhage control and or tissue repair Download PDF

Info

Publication number
CA2539382C
CA2539382C CA2539382A CA2539382A CA2539382C CA 2539382 C CA2539382 C CA 2539382C CA 2539382 A CA2539382 A CA 2539382A CA 2539382 A CA2539382 A CA 2539382A CA 2539382 C CA2539382 C CA 2539382C
Authority
CA
Canada
Prior art keywords
bandage
esophagus
treatment area
stomach
duodenum
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
CA2539382A
Other languages
French (fr)
Other versions
CA2539382A1 (en
Inventor
Kenton W. Gregory
Paul F. Bente, Iv
Heather Margaret Bryan
Jeffrey Yihyuan Lin
Aileen Nuguid
Daniel Allen Pederson
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Providence Health System Oregon
Original Assignee
Providence Health System Oregon
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Providence Health System Oregon filed Critical Providence Health System Oregon
Publication of CA2539382A1 publication Critical patent/CA2539382A1/en
Application granted granted Critical
Publication of CA2539382C publication Critical patent/CA2539382C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/14Bandages or dressings; Absorbent pads specially adapted for the breast or abdomen
    • A61F13/148Abdomen bandages or bandaging garments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/1114Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2002/044Oesophagi or esophagi or gullets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2002/045Stomach, intestines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00361Plasters
    • A61F2013/00365Plasters use
    • A61F2013/00463Plasters use haemostatic

Abstract

A bandage application system of the present for hemorrhage control and/or tissue repair of the gastrointestinal tract, such as the gastrointestinal tract is provided. The system comprises a bandage for hemorrhage control and/or tissue repair of the gastrointestinal tract. It also includes an apparatus for introducing the bandage into a treatment area of the gastrointestinal tract requiring hemorrhage control and/or tissue repair, and for removing the apparatus from the treatment area without displacing the bandage from being adhered to the treatment area, and without damaging the gastrointestinal tract. Furthermore, it also has a device for adhering the bandage to the treatment area.

Description

SYSTEMS AND METHODS FOR HEMORRHAGE CONTROL
AND OR TISSUE REPAIR

Background of the Invention This invention relates to systems and methods for hemorrhage control and/or tissue repair of the gastrointestinal tract, and more particularly, an application system and method for effectively and efficiently bandaging a treatment area of an esophagus, stomach, duodenum, small intestine and large intestine or other structures in the gastrointestinal tract requiring hemorrhage control and/or tissue repair without damaging the gastrointestinal tract.
The esophagus is the muscular, membranous tube, through which food is passed, which extends from the pharynx to the stomach. Hemorrhage control and tissue repair are difficult to affect within the esophageal tract.
The esophagus can be severely injured resulting in hemorrhage and tissue injury through penetrating trauma or from forceful emesis causing tears termed Mallory Weiss Tears. Ulceration of the esophagus and other gastrointestinal tissues can have hemorrhage and tissue injury. The esophagus is also injured and perforated by physicians using endoscopes. Surgical resections of esophageal cancers and other lesions requiring end to end and other anastomosis can hemorrhage and have tissue injury. In cases with perforations or surgical resections of the esophagus, frequently the most serious, life threatening consequences are caused by leaks of esophageal contents into the mediastinum resulting in debilitating and life threatening infection due to lack of adequate sealing of the esophageal injury.
Esophageal varices are dilated veins of the portal systemic system which pass through the distal end of the esophagus where it meets with the lesser curvature of the stomach. These veins dilate from a diameter of a few millimeters to a diameter of up to 1 cm due to an increase in blood pressure within them, which pushes against their thin, elastic walls. This portal hypertension is a consequence of the blockage in blood flow further down the path of the portal vein at the liver when fibrosis (scar tissue) is present due to cirrhosis.

When the blood through the portal vein cannot follow its usual path through the liver, it is forced back up the vein in the direction from which it came.
Because the portal vein is not constructed to withstand such strong forces, it tends to balloon out at sites of vessel weakness, such as at the base of the esophagus where the vein passes very close to the surface, causing what is clinically known as varices. Esophageal varices are a subject of much concern among the medical community due to the high rate of occurrence and severe complications of the condition. Additionally, of the incidents of esophageal varices, 50% of them will be so severe that the vein will rupture into the esophagus resulting in critical bleeding situations. Patients presenting with an initial case of bleeding esophageal varices have a 40 - 70% fatality rate, and recurrent bleeding is typical.
Currently there are few effective acute treatment options for patients with bleeding esophageal varices. Ideally, a treatment would be as non-invasive as possible, would not cause any side-effects, would be effective for all cases presented, and would allow for the restoration of the patient's daily lifestyle soon afterward. Unfortunately none of the treatments currently available offer all of these characteristics.
Two common treatments for esophageal varices involve the use of an endoscope to deploy a device at the bleeding site to stop the bleeding. The endoscope is a tool used in most gastrointestinal procedures. It is often used for investigation and diagnosis of upper and lower GI problems. The standard endoscope is a long tubular device. It has a control held by the doctor that manipulates the tip, which is inserted down the patient's esophagus. The endoscope has its own optics system, which is transmitted to a monitor and possible video sampling or recording system. Down the center of the endoscope is a 4 mm hole. This hole is used to insert balloons, forceps or other surgical devices to perform whatever operation is necessary in the GI tract.
One of these devices places a rubber band securely around the opening of the bleeding varix, which simply closes off the injury to the harsh environment of the gastrointestinal (GI) tract with the expectation that it will eventually heal over. However, this method of treatment is only an option for bleeding varices that are relatively small, whereas most problematic varices are often very large.
The other endoscopic method of treating acute bleeding in the esophagus utilizes a balloon apparatus which is extended by a wire down the esophagus, past the esophageal-stomach junction and into the upper stomach. It is then blown-up and pulled upwards toward the esophagus. This motion applies pressure to the esophagus at the esophageal-stomach junction, which acts to stop or slow down bleeding from the ruptured varices. Unfortunately, this method is not very effective, and at times physicians find it necessary to assist the process by pouring ice water down the esophagus. Ultimately, this procedure is ineffective against large bleeds, and is only a very temporary solution as it prevents the passage of food into the stomach.
The most extreme method of treating esophageal varices involves the insertion of a transjugular intrahepatic Porto systemic shunt (TIPS) into the hepatic vein in an effort to reduce portal venous pressure. Unfortunately the TIPS procedure is a highly invasive surgery. In addition, it will not cure the immediate problem of bleeding in the esophagus.
Therefore, a need exists for effectively and efficiently controlling esophageal hemorrhaging and/or repairing esophageal or other gastrointestinal tissues. Similarly, such devices could be deployed in the urologic tracts such as the urethra using endoscopic techniques or in the bronchus using bronchoscopes to treat bleeding, perforations, fistulas or other lesions. The ability to deploy a dressing that can stop hemorrhage and seal the lesion, as well as create an antimicrobial barrier, offers great promise to substantially reduce morbidity as a result of these injuries that is poorly addressed by present endoscopic and surgical technologies and techniques. The potential to deliver dressings that clot and seal these lesions rapidly and safely using conventional endoscopes would be of great benefit.

Summary of the Invention A bandage application system of the present for hemorrhage control and/or tissue repair of the gastrointestinal tract, such as the esophagus, stomach, duodenum, small intestine and large intestine, can be provided which meets the above-described existing needs. The system comprises a bandage for hemorrhage control and/or tissue repair of the gastrointestinal tract. It also includes an apparatus for introducing the bandage into a treatment area of the gastrointestinal tract requiring hemorrhage control and/or tissue repair, and for removing the apparatus from the treatment area without displacing the bandage from being adhered to the treatment area, and without damaging the gastrointestinal tract.
Furthermore, it also has a device for adhering the bandage to the treatment area.
Preferably, the bandage application system is non-invasive. Thus, the system is preferably constructed to be employed conjunction with an endoscopic device. Furthermore, the bandage application system can be introduced into a treatment area of the esophagus under video or fluoroscopic guidance.
The bandage application system can be designed to adhere the bandage to the treatment area by applying pressure to the bandage against the esophagus.
More specifically, the bandage application system can be expanded for applying pressure to move the bandage against the esophagus for a period of time sufficient to adhere the bandage to the esophagus.
Furthermore, the bandage application system can be expanded using a gas for applying the pressure to move the bandage against the esophagus for a period of time sufficient to adhere the bandage to the esophagus. Thus, the system can include an expandable member which is expanded by applying the pressure, typically employing air or fluid as the expansion medium, to move the bandage against the esophagus for a period of time sufficient to adhere the bandage to the esophagus. The bandage application system can include a tubular sleeve on which is mounted the expandable member.
The bandage can be formed into a generally substantially tubular shape to encompass all sides of the esophagus. The bandage preferably comprises a chitosan bandage. Preferably, the bandage further includes a protective barrier joined to the bandage so that the bandage does not adhere to the bandage application system or to the esophagus en route to the treatment area. An outer sheath can also be disposed about the bandage to protect the bandage from the wet environment of the esophagus when introducing the bandage into the treatment area.
In one embodiment the treatment includes application of the endoscopic chitosan bandage delivery system to a bleeding or ulcerous lesion in the esophagus, stomach, duodenum, small or large intestine. In one embodiment, tissue repair comprises surgical anastomosis of the esophagus, stomach, duodenum, small intestine and large intestine. In another embodiment, hemorrhage control and/or tissue repair comprises treating bleeding or other wounds in the transurethral prostatectomy. In still another embodiment, hemorrhage control and/or tissue repair comprises treating bronchial bleeding, fistulas or other lesions using a bronchoscope.
The bandage of the present invention can include drugs for additional pharmacologic treatment effects. Preferably, these drugs can comprise anticancer drugs, anti inflammatory drugs, anti-ulcerative colitis drugs, anti-Crohns disease drugs, coagulants, antibiotics, and muscle relaxants.
The system of preferably includes a bandage which is in the shape of a patch. Furthermore, a protective covering can be provided which is removable from the bandage. In one form of the invention, the bandage is comprised of chitosan and at least one additional component. Preferably, the bandage is comprised of chitosan acetate. As for the additional components, they preferably comprise biocompatible synthetic polymer or natural protein coatings, and the biocompatible protein coatings preferably comprise elastin or collagen or other matrix proteins.
The bandage can be used to treat an ulceration or burn. It can also be used to treat an infection such as candidiassis, a viral inflammation or a bacterial infection, or to treat and seal a perforation or fistula or leaking anastomosis.
The system of this invention can be configured so that the tubular sleeve is expanded from a location outside the body. And, the device for adhering the bandage to the treatment area can include a guidewire system on which is mounted the expandable member. Moreover, the device for adhering the bandage to the treatment area can include an expandable nitinol tube on which is mounted said expandable member.

In accordance with one embodiment of the present invention, there is provided use of a chitosan bandage application system for stopping bleeding upon adherence of one or more bandages to a treatment area and promoting hemostasis of at least one of an esophagus, stomach, duodenum, small intestine or large intestine.
In accordance with another embodiment of the present invention, there is provided a bandage application system for controlling bleeding and promoting hemostasis of at least one of an esophagus, stomach, duodenum, small intestine or large intestine which comprises:

a chitosan bandage for sealing a wound either alone or in combination with one or more separately delivered bandages and promoting hemostasis of said at least one of an esophagus, stomach, duodenum, small intestine or large intestine;
an apparatus for introducing said bandage into a treatment area of said at least one of an esophagus, stomach, duodenum, small intestine or large intestine, the apparatus capable of being removed from said treatment area without displacing said bandage from the treatment area and without damaging the at least one of an esophagus, stomach, duodenum, small intestine or large intestine; and a device for adhering one or more separately delivered bandages to cover the entire treatment area.

In accordance with a further embodiment of the present invention, there is provided a bandage application system for stopping bleeding upon adherence of one or more bandages to a treatment area and promoting hemostasis of at least one of an esophagus, stomach, duodenum, small intestine or large intestine, which comprises:
an endoscopic device;

a chitosan bandage for sealing a wound either alone or in combination with one or more separately delivered bandages and promoting hemostasis of said at least one of an esophagus, stomach, duodenum, small intestine or large intestine;
an apparatus connected to said endoscopic device for introducing said bandage into a treatment area of said at least one of an esophagus, stomach, duodenum, small intestine or large intestine, the apparatus capable of being removed from said treatment area without displacing said bandage from the treatment area and without damaging the at least one of an esophagus, stomach, duodenum, small intestine or large intestine; and a device for adhering the bandage to the treatment area by application of pressure to the bandage against the at least one of an esophagus, stomach, duodenum, small intestine or large intestine.

Description of the Drawings FIG. 1 is a perspective view of a preferred system of the present invention.
FIG. 2 is an exploded perspective view of the system of FIG. 1.
FIG. 3 is perspective view of the system of FIG. 1 having a bandage wrapped around the system.

FIG. 4 is perspective view of the system of FIG. 3 having a protective sheath wrapped around the bandage.

Detailed Description of Preferred Embodiment Referring to FIGS. 1 and 2, the system 10 of the present invention is compatible with currently available endoscopes. Current available endoscopes (not shown) have optics wired inside of them so that the physician can view the area at the tip of the endoscope on a large monitor. This will aid in quick employment of the system 10 because medical facilities would not need to purchase new, costly endoscopic equipment. Permanent alterations to existing endoscopes would narrow the range of usage of those altered endoscopes. Therefore, the system should not require permanent attachment or alterations to endoscopes which are used to deploy it. To best meet this objective, the system should be detachable after use.
It is important to the success of the system 10 that it be able to accurately deliver the bandage to the treatment used. Accurate delivery typically involves the application of one or more bandages such that the entire treatment area is covered.
The system of this invention is designed for reproducible accuracy.
The speed of effectual application of a bandage 50 (see FIG. 3) after diagnosis of the injury bleeding in the treatment area using the system 10 is important.
The time required to load the bandage 50 onto the system 10, deploy the bandage 50, and to introduce additional bandages 50 to the treatment area (if needed) is a preferred design feature.

6a Viewing the affected area is important for the proper placement of the bandage over the injury. Therefore the device should allow for the maximum viewing capability during diagnosis and treatment (bandage application). If the device blocks the field of view, it would be less favorable than one that does not block any part of the viewing angle. This could happen if viewing depends upon the endoscope's internal optics and the device extends beyond the tip of the endoscope. The device should provide feedback to the user (the physician) in such a way that assures the user of proper deployment of the system 10 and accurate application of the bandage. This should involve visualization of the properly adhered bandage after application.

Oregon Medical Laser Center of Portland, Oregon, and its licensee, Hemcon, have developed a bandage that can staunch the flow of life-threatening bleeding. PCT patent application (WO 02/102276 A3) covering such a wound dressing was published on December 27, 2002. This bandage was designed for use on the battlefield, and has been experimentally shown in a porcine model to prevent fatality in 100% of cases in which the aorta was lesioned, as compared to 40% when only gauze and pressure were used.
Because the bandage is highly effective, it has been FDA approved and has already been in use to save lives by the U.S. Armed Forces.
A key component of the bandage is chitosan, which is a deacylated derivative of the polysaccharide chitin. Chitosan has a positive charge, and thus attracts and binds red blood cells and platelets, which have a negative charge and are the major catalysts for thrombosis. Also, the positive charge imparts strong muco-adhesive properties to the chitosan bandage. Therefore, the bandage has dual functionality: (a) it adheres to the injured surface, protecting it from harsh external conditions and lessening the amount of blood loss, and (b) it prevents continued bleeding by creating an active clotting surface and seals the injured tissues to stop bleeding, stabilize the wound, and creates an antimicrobial surface.
In addition to all of the useful anti-hemorrhagic properties of chitosan, it is also non-immunogenic and has antimicrobial or antibiotic properties. Thus, the chitosan bandage not only works efficiently to stop bleeding, but also helps to seal wounds. Additionally, a polymeric or protein material, preferably in the form of a fine Vicryl or Dexon mesh or the like, or matrix proteins such as collagen or elastin which may also have other important physiologic effects, serves to provide structure for the chitosan without adding unwanted thickness or inhibiting range of movement that is a non-sticking surface to prevent chitosan from sticking to the delivery device as well as sticking to other surface that adhesion is not desired.
As shown in FIG. 3, the bandage 50 is able to maintain an imposed cylindrical shape and stay wrapped around the system 10. The ability of the bandage to stay wrapped around the system was tested in both an inflated and deflated condition. In the deflated scenario, the bandage wrapped securely around the outside of the system and did not fall off when tilted in several directions. As the system was slowly inflated, the bandage diameter increased along with the increased size of the system. However, the bandage maintained the position wrapped around the outside of the inflated system.
The bandage should have an appropriate thickness and flexibility to be effective in adhering to the treatment area and for hemorrhage control and/or tissue repair. Esophageal damage can often be present around the entire circumference of the esophagus, so it must be possible to cover this entire area. If one bandage is not sufficient to do so, then the application of multiple bandages may be possible. The bandage also must be non-toxic because it will be positioned in the body and, after application, the patient will eventually process the bandage through the digestive system.
The bandage's tubular shape is designed to encompass all sides of the esophagus wall. It may also be compact so that there is sufficient space which will allow more flexibility in the design of the deployment device. Depending on the design of the system, the bandage might need a protective barrier so that it will not stick to the device or the sides of the esophagus en route to the affected area.
The bandage should preferably substantially adhere within about 2-5 minutes of applied pressure.

The system 10 will deliver the bandage down the esophagus and maintain the bandage's position on the system. The system will provide protection from moisture of the esophageal wall during the delivery. After reaching the affected treatment area, the system will transfer the bandage from the endoscope or guide wire to the treatment area. The system, will deploy the bandage and then maintain position and apply pressure after the bandage is deployed. The bandage will adhere to the wound and stop bleeding, and the system will provide imaging of the treatment area.
As seen in FIGS. 1 and 2, the backbone of the preferred system 10 is a long thin walled tubular sleeve 12, more preferably a polymeric tube. The sleeve 12 can be formed of a long thin walled piece of polymeric material such as nylon or DELRIN (which is an acetal polymer manufactured by Dupont). The preferred sleeve 12 is designed to slide easily over the outer diameter of the endoscope tip. The ends 14, 16 of the sleeve preferably have slightly smaller outer diameters, more preferably identified as a locking ring recess. This allows locking rings 18 to fit tightly over the ends 14, 16 of the sleeve and remain in a fixed position.
A small hole 22 can be bored close to the edge of the sleeve to allow for the attachment of an inflation tube. Typically, the snug fit of the sleeve over the endoscope tip does not leave room for the inflation tube to run along space between the sleeve and the endoscope. Therefore, the length from the inflation hole to the nearest edge would extend out beyond the tip of the endoscope. To minimize the sleeve's extension beyond the endoscope, the inflation hole was bored as close to the edge as possible. Two small holes 24 directly across from one another on the front-end locking ring recess to allow for the insertion of a positioning wire 60.
Locking rings 18, 18' are preferably used to attach the ends 14, 16 of the sleeve 12 and to create an airtight seal. The locking rings 18, 18' are preferably formed of a polymeric material such as nylon or DELRIN . The edges of the rings 18 are preferably beveled to aid in sliding them on the sleeve 12. The ID of the rings 18, 18' is preferably slightly larger than the sleeve recess OD, to account for the thickness of the expandable sleeve 30. The rings 18, 18' perform a locking function due to their tight fit over the expandable sleeve 30. However, the rings 18, 18' are not permanently attached and can be removed to replace the expandable sleeve 30. The length of the rings 18, 18' are preferably shorter than the length of the front locking ring recess 20 to allow for the insertion of positioning wire 60 on the locking ring recess 20 as well.
The dimension of the front locking ring 18 preferably differs from that of the back locking ring 18'. The front locking ring 18 can be thin and, when secured on the sleeve 12, the OD of the locking ring 18 is similar to the OD
of the sleeve 12. After deploying the bandage 50, the system 10 must be pulled back up the esophagus, during which the front locking ring 18 must pass by the adhered bandage. Limiting the size of the front locking ring 18 allows the front locking ring 18 to smoothly pass by the bandage, whereas a protruding ring might get caught on the edge of the bandage. The back locking ring 18' is generally relatively thick. The thickness of the back locking ring 18' serves to prevent the bandage from sliding backwards up the sleeve 12.
The sleeve 12 can be molded using an injection molding technique. Its composition, if possible should match that of the expandable sleeve 30 so that they can, alternatively, be bonded together instead of being held in place by the locking rings 18, 18'. Typically, bonding is strongest between similar materials.
The sleeve 12 should have a small bending radius without restricting flow, and should be compatible with the final choice of materials for the sleeve 12.
Preferably, a polymeric material such as low udometer polyester (PET) can be employed. A PET expandable sleeve 30 can allow for significantly higher pressures to press the bandage against the wall of the esophagus.
A guide wire with a clip (not shown) can direct the bandage down the esophagus along the side of the endoscope or a tube of fiber optics. The guide wire will extend from the wounded area in the esophagus up to the patient's mouth, where it will be maneuvered.

A positioning wire 60 can be threaded between the two opposite holes 24 on the front end locking ring recess 20 and secured in place with an adhesive material. After the locking ring 18 on the front end 16 is attached to the expandable sleeve 30, the positioning wire 60 can be inserted through the holes 24. Preferably, the positioning wire 60 is only attached to the sleeve 12 and not to the front locking ring 18. This allows the locking ring 18 to be removable.
Forceps can be used to grab the positioning wire 60 in order to maintain the position of the system 10 on the endoscope tip, to push the system 10 off of the endoscope tip, and to maneuver the system 10 inside the esophagus.
An inflation tube 32 is employed to introduce air into the expandable sleeve 30 during adhering of the bandage to the esophagus. The inflation tube can be formed of a polymeric material such as either polyethylene or a silicon material. A segment of the inflation tube 32 can be threaded through the inflation hole 22 from the center of the sleeve 12. An adhesive can be used to secure the segment of the inflation tube 32 to the outer surface of the sleeve 12. The inflation tube 32 preferably extends the length of the endoscope through the center channel of the endoscope. Once through the endoscope, the tube 32 is joined to a Lure-Lock connector (not shown), which connects the tube 32 with a syringe (not shown). The syringe can be used to inflate the expandable sleeve 30 and deploy the bandage.
The expandable sleeve 30 is preferably a hollow substantially cylindrical component comprising a body portion 34 and a neck portion 36 at each end of the body portion. The expandable sleeve 30 is preferably designed so that the body portion 34 assumes an extended tubular shape while the neck portions 36 maintain a uniform ID cylindrical shape. The expandable sleeve 30 can be slid over the sleeve 12, with the neck portions 36 lining up with the locking ring recess 20. The locking rings 18, 18' fit tightly over the locking ring recesses 20, securing the neck portions 36 of the expandable sleeve 30. The expandable sleeve 30 can be inflated using a syringe attached to the inflation tube 32. The bandage is attached to the outside of the expandable sleeve 30 as shown in FIG. 3. A doctor can maneuver the bandage into position using the system 10, and then inflate the expandable sleeve 30 to a diameter slightly larger than the esophagus when it's relaxed.
Sheath 70 is preferably a thin-walled, cylindrical polyester heat-shrink tubing, typically with a substantially constant ID. The sheath 70 is slid over the expandable sleeve 30 such that the front end is aligned with the front end of the system 10 (see FIG. 4).
The front end of the sheath 70 is secured and sealed with a sheath-securing flap 72 onto the system 10. The system, including the attached sheath 70, is fit onto the tip of the endoscope. The back end of the sheath is secured and sealed with surgical tape onto the endoscope. With both ends secured, the bandage is enclosed in a substantially watertight environment. Besides protecting the bandage, a sheath can ideally push off the bandage from the endoscope to the wound. The inner lips from sheath will push against the bandage. Then, once the bandage is dislodged from the endoscope, the sheath will retract to expose the bandage.

The extended expandable sleeve neck 36 on the back end of the sleeve 12 is used to hold the bandage 50 in the same manner that the sheath-securing flap 72 holds the sheath 70 (see FIG. 3). The extended neck is rolled back and over the edge of the bandage. The elastic properties and the texture of the silicon neck secure the bandage with a fair amount of pressure. As a result, the bandage does not easily slip off of the system 50 while the system pushes through the sheath 70 and off of the endoscope towards the treatment area. However, when the expandable sleeve 30 is inflated to deploy the bandage 50, enough pressure is applied such that the bandage-securing flap 52 loses its grip on the bandage and the bandage is deployed.
The extended expandable sleeve neck 36 on the front end of the expandable sleeve 30 is used to hold the sheath 70, which is needed to keep the bandage dry as the system travels down the esophagus. The extended neck is rolled back and over the end of the sheath as one would roll up the bottom of one's pants. Stretching the expandable sleeve neck over the sheath seals the end of the sheath from water entry. The elastic properties and the texture of the silicon neck secures the sheath with enough pressure so that the sheath does not easily slip off of the system. Forceps can be used to push on the wire with enough force.
When this occurs, the sheath-securing flap loses its grip on the sheath. The system slides off the endoscope while the sheath remains secured to the endoscope with surgical tape.
When assembling, the inflation tube and the positioning wire are threaded through their respective holes and permanently secured to the tube with an adhesive. The expandable sleeve is then slid over the tube and enclosing the adhered inflation tube segment in the expandable sleeve's body volume.
Finally, the locking rings are fitted over expandable sleeve necks on the locking ring recesses, securing the expandable sleeve and forming an airtight space between the expandable sleeve's body and the outer surface of the tube.
Before operation of the system, the bandage and sheath must be added.
The pre-rolled bandage wraps around the system and is secured by rolling the excess flaps of the expandable sleeve overtop of the bandage. To protect the bandage from the wet environment of the esophagus, the sheath, which is described above, and which is preferably made of a polymeric material such as a polyester, slides around the system outside of the bandage and is also secured to the system with the front flap of the expandable sleeve.
The system, along with the bandage and sheath, is now ready to be loaded onto the endoscope. First, the expandable tubing is threaded backwards up the channel of the endoscope from the tip toward the doctor's end using the grasping forceps. Once the inflation tube runs up the channel, the syringe attaches to the inflation tube using tubing connectors. Before fixing the back end of the sheath to the endoscope, the system is positioned around the endoscope such that the positioning wire is within grasp of the forceps. Throughout the operation, the forceps control and hold the system by gripping the positioning wire.
Once the system is integrated with the endoscope, the operation can begin.
The endoscope with the system attached is navigated down the esophagus until it reaches the wound. The endoscope will be positioned such that the wound is within view. The system is pushed forward with the forceps until it is released from the sheath and reaches the site. The force of the forceps overcomes the sealing power of the expandable sleeve flaps. The back end of the sheath remains fixed and keeps the sheath in place in order to expose the bandage. Next, the expandable sleeve is inflated with air from the syringe. The flaps of the expandable sleeve roll back off of the bandage as the expandable sleeve inflates to fully expose the bandage to wound. Most importantly, the inflation of the expandable sleeve applies pressure to the bandage against the esophagus. The expandable sleeve must maintain pressure on the bandage to ensure adequate adherence of the bandage to the esophagus. Then, the expandable sleeve is deflated, and the system is retracted from the treatment site back onto the end of the endoscope using the forceps. The performance of the system and bandage can be viewed with the monitor, which is attached to the endoscope's internal imaging equipment. After deployment, the resulting bandage can be examined to check for adherence and accuracy of deployment.

Ex Vivo Testing The subject system's ability to successfully deploy a bandage was tested on an excised esophagus.
The excised esophagus from a 450 lb. pig was attached to a metal ring using clips. This ring was then secured onto a ring stand, and the esophagus was suspended to its full length. The system of the subject invention was loaded onto the endoscope. Next, the system was inserted into the excised esophagus from the proximal end, and pushed down to the approximate center of the esophagus using the endoscope. The system was deployed and the expandable sleeve was left inflated for about 3 minutes to allow for sufficient adherence of a chitosan bandage to the esophagus. The expandable sleeve was then deflated, and the system was pulled out of the esophagus using the endoscope and forceps.
The esophagus was detached from the stand apparatus, and then cut with scissors vertically down its entire length. The bandage was pulled on using forceps in order to assess the degree of adherence to the esophagus.
The sheath functioned successfully. It provided the bandage with appropriate protection from moisture. This was determined based on the fact that the bandage did not adhere to the sheath-an event that would have occurred had the bandage become wet while the sheath was still covering it.

The expandable sleeve functioned with success according to the defined criterion. It was inflated with 20 ml of air, and, based on observation of the outer profile of the esophagus, it retained this volume of air throughout the 3-minute inflation period.
The bandage adhered tightly to the esophageal lumen. The bandage deployed in a uniform manner and covered the entire inner circumference of the esophagus. When the bandage was pulled on with forceps, it took the entire weight of the excised esophagus to begin separating the bandage from the tissue.

In Vivo Testing The subject system's ability to successfully deploy a bandage in vivo was tested in several live swine.
A gastroenterologist and selected medical staff conducted the procedures.
The system was loaded on to the end of an endoscope. The pig was anesthetized to the point of unconsciousness. The pig was incubated, and monitored closely by qualified animal care professionals. The gastroenterologist inserted the endoscope with the system into the pig via its mouth. When the testing site was reached, the system was deployed, and a chitosan bandage was attached to the pig's esophagus.
After the bandage was deployed, and the system was pulled from within the animal, the entire system (including the sheath) was removed from the endoscope so that the site of bandage application could be investigated with the endoscope alone. After thorough video observation, the endoscope was used to gently push on the bandage to test for proper adherence. Additionally, the endoscope was pushed past the bandage to test whether food could still pass through the center hole.
For one of the trials, the system was testing bleeding lacerations in the esophagus. The pig was heparinized to inhibit its natural clotting abilities so that all clotting observed would be due to the presence of the bandage. Next, the esophageal lumen was lacerated using an endoscopic needle system to the point of bleeding. The system was then used to deploy a bandage in the same manner as previously described such that it covered the bleeding wounds.

A bandage was deployed as described at the gastroduodenal junction.
Then, a bandage was deployed at the gastroesophageal junction. Both bandage deployments (at the gastroesophageal junction and the gastroduodenal junction) met all of the criteria and were considered successes.
No adverse consequences were observed as a consequence of delivering the dressing or dressing deployment.
A biopsy forceps was introduced and grabbed the adhered dressing to determine the strength of adhesion. The bonding was strong enough to allow pulling the stomach through the diaphragm, indicating a very strong adhesion of the chitosan dressing to the esophagus Based on both the ex vivo and the in vivo testing results, it was concluded that the system of the present invention could accurately and consistently apply bandages rapidly and safely to tissues in the esophagus and in the duodenum using conventional endoscopes and endoscopic techniques.

Claims (44)

1. Use of a chitosan bandage application system for stopping bleeding upon adherence of one or more bandages to a treatment area and promoting hemostasis of at least one of an esophagus, stomach, duodenum, small intestine or large intestine.
2. The use of claim 1, wherein a bandage is introducible into the treatment area of said at least one of an esophagus, stomach, duodenum, small intestine or large intestine by the bandage application system, the bandage is adherable to the treatment area using the bandage application system and the bandage application system is removable from the treatment area without displacing the bandage from the treatment area and without damaging said at least one of an esophagus, stomach, duodenum, small intestine or large intestine.
3. The use of claim 1 or 2, wherein said bandage application system is non-invasive.
4. The use of any one of claims 1 to 3, wherein said bandage application system is used in conjunction with an endoscopic device.
5. The use of any one of claims 1 to 4, wherein said bandage application system is introducible under video guidance.
6. The use of any one of claims 1 to 4, wherein said bandage application system is introducible under fluoroscopic control.
7. The use of any one of claims 1 to 6, wherein said bandage application system is usable to apply pressure to said bandage against said at least one of an esophagus, stomach, duodenum, small intestine or large intestine.
8. The use of claim 7, wherein the bandage application system is expandable to apply pressure to said bandage.
9. The use of claim 8, wherein the bandage application system is expandable using a gas or fluid.
10. The use of claim 9, wherein said bandage application system comprises an expandable member which is expandable by gas or fluid.
11. The use of claim 10, wherein said bandage application system comprises a tubular sleeve on which is mounted said expandable member.
12. The use of any one of claims 1 to 11, wherein said bandage is substantially tubular in shape.
13. The use of any one of claims 1 to 12, wherein said bandage comprises a protective coating joined to the bandage to prevent adherence of the bandage to the bandage application system or to said at least one of an esophagus, stomach, duodenum, small intestine or large intestine en route to said treatment area.
14. The use of any one of claims 1 to 12, wherein an outer sheath is disposed about the bandage to protect the bandage from a wet environment of said at least one of an esophagus, stomach, duodenum, small intestine or large intestine.
15. A bandage application system for controlling bleeding and promoting hemostasis of at least one of an esophagus, stomach, duodenum, small intestine or large intestine which comprises:

a chitosan bandage for sealing a wound either alone or in combination with one or more separately delivered bandages and promoting hemostasis of said at least one of an esophagus, stomach, duodenum, small intestine or large intestine;
an apparatus for introducing said bandage into a treatment area of said at least one of an esophagus, stomach, duodenum, small intestine or large intestine, the apparatus capable of being removed from said treatment area without displacing said bandage from the treatment area and without damaging the at least one of an esophagus, stomach, duodenum, small intestine or large intestine; and a device for adhering one or more separately delivered bandages to cover the entire treatment area.
16. The system of claim 15 which is non-invasive.
17. The system of claim 15 further comprising an endoscopic device.
18 18. The system of claim 15 which further comprises video guidance for introducing said bandage into the treatment area.
19. The system of claim 15, wherein the device is a device for applying pressure to the bandage to adhere the bandage to the treatment area of the at least one of an esophagus, stomach duodenum, small intestine or large intestine.
20. The system of claim 15, wherein the device is expandable to apply said pressure.
21. The system of claim 15, wherein the device is expandable by a gas or fluid.
22. The system of claim 15, wherein the device comprises an expandable member which is expandable by a gas or fluid.
23. The system of claim 15, wherein the device comprises a tubular sleeve on which is mounted said expandable member.
24. The system of any one of claims 15 to 23, wherein the bandage is substantially tubular in shape.
25. The system of any one of claims 15 to 24, wherein the bandage further comprises a protective coating joined to the bandage to prevent adherence of the bandage to the bandage application system or to the at least one of an esophagus, stomach, duodenum, small intestine or large intestine en route to the treatment area.
26. The system of any one of claims 15 to 24, wherein an outer sheath is disposed about the bandage to protect the bandage from a wet environment of the at least one of an esophagus, stomach, duodenum, small intestine or large intestine on introduction of said bandage into said treatment area.
27. A bandage application system for stopping bleeding upon adherence of one or more bandages to a treatment area and promoting hemostasis of at least one of an esophagus, stomach, duodenum, small intestine or large intestine, which comprises:
an endoscopic device;

a chitosan bandage for sealing a wound either alone or in combination with one or more separately delivered bandages and promoting hemostasis of said at least one of an esophagus, stomach, duodenum, small intestine or large intestine;
an apparatus connected to said endoscopic device for introducing said bandage into a treatment area of said at least one of an esophagus, stomach, duodenum, small intestine or large intestine, the apparatus capable of being removed from said treatment area without displacing said bandage from the treatment area and without damaging the at least one of an esophagus, stomach, duodenum, small intestine or large intestine; and a device for adhering the bandage to the treatment area by application of pressure to the bandage against the at least one of an esophagus, stomach, duodenum, small intestine or large intestine.
28. The system of any one of claims 15 to 27, wherein tissue repair comprises surgical anastomosis of said at least one of an esophagus, stomach, duodenum, small intestine or large intestine.
29. The system of any one of claims 15 to 27, wherein said hemorrhage control and/or tissue repair comprises control of bleeding or repair of wounds in a transurethral prostatectomy.
30. The system of any one of claims 15 to 27 wherein said hemorrhage control and/or tissue repair comprises control of bronchial bleeding, fistulas or other lesions using a bronchoscope.
31. The system of any one of claims 15 to 27, wherein said bandage is in the shape of a patch.
32. The system of any one of claims 15 to 27, wherein said bandage further comprises at least one drug.
33. The system of claim 32, wherein said at least one drug is selected from the group consisting of an anticancer drug, an anti inflammatory drug, an anti-ulcerative colitis drug, an anti-Crohns disease drug, a coagulant, an antibiotic, and a muscle relaxant.
34. The system of claim 13 or 25, wherein said protective coating is removable from the bandage.
35. The system of claim 15 or 27, wherein said bandage is comprised of chitosan and at least one additional component.
36. The system of claim 15 or 27, wherein said bandage is composed of chitosan acetate.
37. The system of claim 35, wherein said at least one additional component comprises biocompatible synthetic polymer or a natural protein coating or covering.
38. The system of claim 37, wherein said natural protein coating comprises elastin or collagen or other matrix proteins.
39. The system of 37, where said biocompatible synthetic polymer comprises Vicryl or Dexon.
40. The system of claim 15 or 27, wherein said bandage is usable to treat an infection selected from the group consisting of candidiasis, a viral inflammation and a bacterial infection.
41. The system of claim 15 or 27, wherein said bandage is usable to treat and seal one of a perforation, a fistula or a leaking anastomosis.
42. The system of claim 15 or 27, wherein said bandage is usable to treat an ulceration or burn.
43. The system of claim 22, wherein the device for adhering the bandage to the treatment area comprises a guide wire system on which is mounted said expandable member.
44. The system of claim 22, wherein the device for adhering the bandage to the treatment area comprises a nitinol tube on which is mounted said expandable member.
CA2539382A 2005-03-17 2006-03-13 Systems and methods for hemorrhage control and or tissue repair Expired - Fee Related CA2539382C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US11/084,688 2005-03-17
US11/084,688 US9204957B2 (en) 2005-03-17 2005-03-17 Systems and methods for hemorrhage control and or tissue repair

Publications (2)

Publication Number Publication Date
CA2539382A1 CA2539382A1 (en) 2006-09-17
CA2539382C true CA2539382C (en) 2012-01-10

Family

ID=37011331

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2539382A Expired - Fee Related CA2539382C (en) 2005-03-17 2006-03-13 Systems and methods for hemorrhage control and or tissue repair

Country Status (2)

Country Link
US (1) US9204957B2 (en)
CA (1) CA2539382C (en)

Families Citing this family (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8741335B2 (en) 2002-06-14 2014-06-03 Hemcon Medical Technologies, Inc. Hemostatic compositions, assemblies, systems, and methods employing particulate hemostatic agents formed from hydrophilic polymer foam such as Chitosan
US7371403B2 (en) * 2002-06-14 2008-05-13 Providence Health System-Oregon Wound dressing and method for controlling severe, life-threatening bleeding
US20060004314A1 (en) * 2001-06-14 2006-01-05 Hemcon, Inc. Antimicrobial barriers, systems, and methods formed from hydrophilic polymer structures such as chistosan
US7482503B2 (en) * 2001-06-14 2009-01-27 Providence Health System-Oregon Wound dressing and method for controlling severe, life-threatening bleeding
US8269058B2 (en) * 2002-06-14 2012-09-18 Hemcon Medical Technologies, Inc. Absorbable tissue dressing assemblies, systems, and methods formed from hydrophilic polymer sponge structures such as chitosan
US20050137512A1 (en) 2003-12-23 2005-06-23 Campbell Todd D. Wound dressing and method for controlling severe, life-threatening bleeding
US9204957B2 (en) 2005-03-17 2015-12-08 Hemcon Medical Technologies, Inc. Systems and methods for hemorrhage control and or tissue repair
WO2007139845A2 (en) * 2006-05-23 2007-12-06 Providence Health System-Oregon D/B/A Providence St. Vincent Medical Center Systems and methods for introducing and applying a bandage structure within a body lumen or hollow body organ
CN101657164B (en) * 2007-02-09 2013-11-06 B&D医学发展有限责任公司 Pelvic balloon tamponade
US8932560B2 (en) * 2007-09-04 2015-01-13 University of Maryland, College Parke Advanced functional biocompatible polymeric matrix used as a hemostatic agent and system for damaged tissues and cells
US9205170B2 (en) 2008-05-02 2015-12-08 Hemcon Medical Technologies, Inc. Wound dressing devices and methods
WO2010042540A1 (en) 2008-10-06 2010-04-15 Providence Health System - Oregon Foam medical devices and methods
US10076644B2 (en) 2014-05-16 2018-09-18 Terumo Kabushiki Kaisha Method and apparatus for treating urethral stricture
US20160045300A1 (en) * 2014-05-16 2016-02-18 Terumo Kabushiki Kaisha Method and apparatus for treating urethral stricture
CN108601860A (en) 2016-02-12 2018-09-28 金珂生物医疗公司 Chitosan ultrafine fiber system
US10441761B2 (en) 2016-07-01 2019-10-15 Boston Scientific Scimed, Inc. Delivery devices and methods
US11406771B2 (en) 2017-01-10 2022-08-09 Boston Scientific Scimed, Inc. Apparatuses and methods for delivering powdered agents
WO2019133936A1 (en) 2017-12-29 2019-07-04 Tricol Biomedical, Inc. Tissue adherent chitosan material that resists dissolution
WO2019133898A1 (en) 2017-12-29 2019-07-04 Tricol Biomedical, Inc. Chitosan dressing for control of gastrointestinal bleeding
WO2019133894A1 (en) 2017-12-29 2019-07-04 Tricol Biomedical, Inc. Delivery systems for control of gastrointestinal bleeding
US11660236B2 (en) 2017-12-29 2023-05-30 Tricol Biomedical, Inc. Delivery systems for control of bleeding in transurethral prostatectomy
WO2019133899A1 (en) 2017-12-29 2019-07-04 Tricol Biomedical, Inc. Chitosan dressing for control of bleeding in transurethral prostatectomy
JP7317839B2 (en) 2018-01-12 2023-07-31 ボストン サイエンティフィック サイムド,インコーポレイテッド Powder to achieve hemostasis
US11766546B2 (en) 2018-01-31 2023-09-26 Boston Scientific Scimed, Inc. Apparatuses and methods for delivering powdered agents
CA3105760A1 (en) 2018-07-31 2020-02-06 Boston Scientific Scimed, Inc. Devices and methods for endoscopic patch delivery
WO2020072439A1 (en) 2018-10-02 2020-04-09 Boston Scientific Scimed, Inc. Devices for fluidization and delivering a powdered agent
AU2019355852A1 (en) 2018-10-02 2021-04-01 Boston Scientific Scimed, Inc. Devices for fluidization and delivering a powdered agent

Family Cites Families (152)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2610625A (en) 1947-10-14 1952-09-16 Armour & Co Surgical sponge and the preparation thereof
US2858830A (en) 1956-10-01 1958-11-04 Frank C Lowe Surgical dressing
US2923664A (en) 1957-09-11 1960-02-02 Johnson & Johnson Hemostatic product
DE1617393C2 (en) 1966-01-06 1982-11-11 Československá akademie věd, Praha Process for the preparation of hydrophilic crosslinked copolymers containing biologically active substances
US3632754A (en) 1968-02-12 1972-01-04 Lescarden Ltd Use of chitin for promoting wound healing
US3801675A (en) 1970-02-20 1974-04-02 Johnson & Johnson Polymer blend containing polyacrylic acid,polyvinyl alcohol,and a polyacrylate
US3911116A (en) 1970-04-13 1975-10-07 Leslie L Balassa Process for promoting wound healing with chitin derivatives
US3849238A (en) 1972-04-07 1974-11-19 S Ronel Artificial skin
US3800792A (en) 1972-04-17 1974-04-02 Johnson & Johnson Laminated collagen film dressing
US3954493A (en) 1972-10-19 1976-05-04 Avicon, Inc. Regenerated cellulose sponge
US3902497A (en) 1974-03-25 1975-09-02 American Cyanamid Co Body absorbable sponge and method of making
US3977406A (en) 1974-06-19 1976-08-31 American Cyanamid Company Medical sponges
US4040884A (en) 1974-06-19 1977-08-09 American Cyanamid Company Medical sponges
CH596233A5 (en) 1975-04-10 1978-03-15 Nestle Sa
US4068757A (en) 1976-11-03 1978-01-17 American Cyanamid Company Chitin derived powder in sterile surgical element package
US4056103A (en) 1977-03-11 1977-11-01 Kimberly-Clark Corporation Wrapper structure for tampons containing superabsorbent material
US4195175A (en) 1978-01-03 1980-03-25 Johnson Edwin L Process for the manufacture of chitosan
JPS6239506Y2 (en) 1979-07-28 1987-10-08
US4292972A (en) 1980-07-09 1981-10-06 E. R. Squibb & Sons, Inc. Lyophilized hydrocolloio foam
US4394373A (en) 1981-04-06 1983-07-19 Malette William Graham Method of achieving hemostasis
US4532134A (en) 1981-04-06 1985-07-30 Malette William Graham Method of achieving hemostasis, inhibiting fibroplasia, and promoting tissue regeneration in a tissue wound
US4373519A (en) 1981-06-26 1983-02-15 Minnesota Mining And Manufacturing Company Composite wound dressing
US4460642A (en) 1981-06-26 1984-07-17 Minnesota Mining And Manufacturing Company Water-swellable composite sheet of microfibers of PTFE and hydrophilic absorptive particles
US4533326A (en) 1981-08-10 1985-08-06 Anthony Albert J Oral pack retention system
US4759348A (en) 1981-09-28 1988-07-26 Cawood Charles David Endoscope assembly and surgical instrument for use therewith
ATE18995T1 (en) 1981-09-30 1986-04-15 Leipzig Arzneimittel ABSORBENT WOUND DRESSING AND METHOD OF PRODUCTION.
US4501835A (en) 1982-03-08 1985-02-26 Polaroid Corporation Polyacrylic acid/chitosan polyelectrolyte complex
JPS58206751A (en) 1982-05-26 1983-12-02 日石三菱株式会社 Wound covering material
US4973493A (en) 1982-09-29 1990-11-27 Bio-Metric Systems, Inc. Method of improving the biocompatibility of solid surfaces
US4452785A (en) 1982-11-08 1984-06-05 Malette William Graham Method for the therapeutic occlusion
EP0122085B1 (en) 1983-04-06 1987-06-24 Smith and Nephew Associated Companies p.l.c. Dressing
US4958011A (en) 1983-06-27 1990-09-18 Bade Maria L Ester-stabilized chitin
JPS60142927A (en) 1983-12-28 1985-07-29 Lion Corp Medical band
DE3527482A1 (en) 1984-07-31 1986-02-06 Fuji Spinning Co., Ltd., Tokio/Tokyo METHOD FOR PRODUCING GRAINY POROUS CHITOSAN
EP0171254B1 (en) 1984-08-03 1991-06-19 Unitika Ltd. Shaped chitin body
SE8501022L (en) 1985-03-01 1986-09-02 Pharmacia Ab FORMAT CREATES AND PROCEDURES FOR ITS PREPARATION
JPS61240963A (en) 1985-04-18 1986-10-27 ユニチカ株式会社 Wound covering protective material
JPS61253065A (en) 1985-05-02 1986-11-10 片倉チツカリン株式会社 Medical composite material of chitosan derivative and collagen and its production
US4684370A (en) 1985-10-02 1987-08-04 Barrett Garret D Stents for bone augmentation by surgical implant
US4960413A (en) 1985-11-09 1990-10-02 The Shirley Institute Wound dressing
US5300494A (en) 1986-06-06 1994-04-05 Union Carbide Chemicals & Plastics Technology Corporation Delivery systems for quaternary and related compounds
CA1326416C (en) 1986-08-25 1994-01-25 Ralph Xavier Ewall Polymeric wound dressings
JPS6390507U (en) 1986-11-29 1988-06-11
US5254301A (en) 1988-03-29 1993-10-19 Ferris Mfg. Corp. Process for preparing a sheet of polymer-based foam
US4952618A (en) 1988-05-03 1990-08-28 Minnesota Mining And Manufacturing Company Hydrocolloid/adhesive composition
US5006071A (en) 1988-05-09 1991-04-09 Carter Dewey G Technique for the prevention of alveolar osteitis
US5110604A (en) 1988-06-30 1992-05-05 Collagen Corporation Processes for producing collagen matrixes and methods of using same
US5024841A (en) 1988-06-30 1991-06-18 Collagen Corporation Collagen wound healing matrices and process for their production
CA1340190C (en) 1988-08-01 1998-12-15 The Kendall Company Discontinuous adhesive surface
US4948540A (en) 1988-08-01 1990-08-14 Semex Medical, Inc. Method of preparing collagen dressing sheet material
US4956350A (en) 1988-08-18 1990-09-11 Minnesota Mining And Manufacturing Company Wound filling compositions
US5062418A (en) 1989-01-31 1991-11-05 Johnson & Johnson Medical, Inc. Napped nonwoven fabric having high bulk and absorbency
JPH07116241B2 (en) 1989-02-08 1995-12-13 サッポロビール株式会社 Method for producing bioactive polysaccharide RON derived from rice bran
GB2228682B (en) 1989-02-23 1992-08-12 Ultra Lab Ltd Wound dressing
CA2030593C (en) 1989-12-29 2002-03-26 Donald H. Lucast Multi-layered dressing
JP2579610B2 (en) 1990-09-28 1997-02-05 鳥取大学長 In vivo filler
IT1243260B (en) 1990-11-26 1994-05-26 Riccardo Muzzarelli METHYL PYROLIDON CHITOSAN, PRODUCTION PROCESS AND ITS USE.
US6054122A (en) 1990-11-27 2000-04-25 The American National Red Cross Supplemented and unsupplemented tissue sealants, methods of their production and use
US5206028A (en) 1991-02-11 1993-04-27 Li Shu Tung Dense collagen membrane matrices for medical uses
US5804213A (en) 1991-10-09 1998-09-08 Lectec Corporation Biologically active aqueous gel wound dressing
US5525710A (en) 1991-12-20 1996-06-11 Alliedsignal Inc. Highly porous chitosan bodies
US5376376A (en) 1992-01-13 1994-12-27 Li; Shu-Tung Resorbable vascular wound dressings
GB9206509D0 (en) 1992-03-25 1992-05-06 Jevco Ltd Heteromorphic sponges containing active agents
US5326350A (en) 1992-05-11 1994-07-05 Li Shu Tung Soft tissue closure systems
US5840777A (en) 1992-06-19 1998-11-24 Albany International Corp. Method of producing polysaccharide foams
US5454719A (en) 1992-08-03 1995-10-03 Hamblen; Lamae E. Sterile dental packs and method of utilizing same
US5458884A (en) 1992-09-10 1995-10-17 Britton; Peter Bioerodible device for administering active ingredients
DE69319921T2 (en) 1992-12-01 1999-04-15 Minnesota Mining & Mfg PERMANENT ANTIMICROBIC AGENTS
US5797960A (en) * 1993-02-22 1998-08-25 Stevens; John H. Method and apparatus for thoracoscopic intracardiac procedures
DE4322956C2 (en) 1993-07-09 1995-12-21 Haack Karl Werner An Chitosan film for wound sealing
DK94693D0 (en) 1993-08-19 1993-08-19 Coloplast As NON-FIBROEST POROEST MATERIALS, SPECIAL BANDING INCLUDING SUCH A BANDAGE AND PROCEDURE FOR MANUFACTURING THE MATERIAL
US5387206A (en) 1993-08-27 1995-02-07 Merocel Corporation Mechanical treatment of dry sponge material to impart flexibility
AU1086795A (en) 1993-11-03 1995-05-23 Clarion Pharmaceuticals, Inc. Hemostatic patch
US5858350A (en) 1993-12-01 1999-01-12 Marine Polymer Technologies Methods and compositions for poly-β-1→4-N-acetylglucosamine cell therapy system
US5420197A (en) 1994-01-13 1995-05-30 Hydromer, Inc. Gels formed by the interaction of polyvinylpyrrolidone with chitosan derivatives
US5765682A (en) 1994-10-13 1998-06-16 Menlo Care, Inc. Restrictive package for expandable or shape memory medical devices and method of preventing premature change of same
US5560878A (en) 1994-11-30 1996-10-01 The Procter & Gamble Company Method and apparatus for making stretchable absorbent articles
US5634936A (en) * 1995-02-06 1997-06-03 Scimed Life Systems, Inc. Device for closing a septal defect
WO1996041818A1 (en) 1995-06-09 1996-12-27 Drohan William N Chitin hydrogels, methods of their production and use
US5827265A (en) 1996-02-07 1998-10-27 Regents Of The University Of California Intraluminal tissue welding for anastomosis
JP2822174B2 (en) 1996-03-01 1998-11-11 オーミケンシ株式会社 Method for producing chitin chitosan fiber and structure
US5952618A (en) 1996-07-11 1999-09-14 Deslauriers; Richard J. Acoustic conduit for use with a stethoscope
US5836970A (en) 1996-08-02 1998-11-17 The Kendall Company Hemostatic wound dressing
US6485667B1 (en) 1997-01-17 2002-11-26 Rayonier Products And Financial Services Company Process for making a soft, strong, absorbent material for use in absorbent articles
NL1005812C1 (en) 1997-04-15 1997-06-04 Claus Jurgen Timmermans Super absorbent wound dressing.
US6156330A (en) 1997-05-14 2000-12-05 Japan As Represented By Director General Of National Institute Of Sericultural And Entomological Sciences Ministry Of Agriculture, Forestry And Fisheries Chitin beads, chitosan beads, process for preparing these beads, carrier comprising said beads, and process for preparing microsporidian spore
ATE247990T1 (en) 1997-07-02 2003-09-15 Coloplast As PRODUCTION METHOD FOR A FIBER-FREE, POROUS MATERIAL
AU7917298A (en) 1997-07-09 1999-02-08 Huntsman Ici Chemicals Llc Compressed hydrophilic polyurethane foams
ZA987019B (en) 1997-08-06 1999-06-04 Focal Inc Hemostatic tissue sealants
FR2776518B1 (en) 1998-03-24 2002-11-29 Oreal ADHESIVE MATRIX PATCH
US6033413A (en) * 1998-04-20 2000-03-07 Endocare, Inc. Stent delivery system
US6042877A (en) 1998-07-28 2000-03-28 3M Innovative Properties Company Method for the manufacture of anti-microbial articles
US6454787B1 (en) 1998-12-11 2002-09-24 C. R. Bard, Inc. Collagen hemostatic foam
GB9900348D0 (en) 1999-01-09 1999-02-24 Bristol Myers Squibb Co Multi layered wound dressing
GB2348136B (en) 1999-03-24 2003-06-04 Johnson & Johnson Medical Ltd Wound dressings having low adherency
EP2305324B1 (en) 1999-03-25 2014-09-17 Metabolix, Inc. Medical devices and applications of polyhydroxyalkanoate polymers
US6726712B1 (en) 1999-05-14 2004-04-27 Boston Scientific Scimed Prosthesis deployment device with translucent distal end
KR100721752B1 (en) 2000-01-24 2007-05-25 쿠라레 메디카루 가부시키가이샤 Water-swellable polymer gel and process for preparing the same
DE10009248C2 (en) 2000-02-28 2002-06-27 Freudenberg Carl Kg Medical dressings
EP1259269B1 (en) 2000-03-03 2008-06-18 Syntacoll AG Agent for the treatment of wounds
US6309454B1 (en) 2000-05-12 2001-10-30 Johnson & Johnson Medical Limited Freeze-dried composite materials and processes for the production thereof
US6548081B2 (en) 2000-07-28 2003-04-15 Anika Therapeutics, Inc. Bioabsorbable composites of derivatized hyaluronic acid and other biodegradable, biocompatible polymers
JP2002233542A (en) 2001-02-09 2002-08-20 Shiseido Co Ltd Wound coating material and method of manufacturing the same
US20020161376A1 (en) 2001-04-27 2002-10-31 Barry James J. Method and system for delivery of coated implants
US20060004314A1 (en) 2001-06-14 2006-01-05 Hemcon, Inc. Antimicrobial barriers, systems, and methods formed from hydrophilic polymer structures such as chistosan
US8741335B2 (en) 2002-06-14 2014-06-03 Hemcon Medical Technologies, Inc. Hemostatic compositions, assemblies, systems, and methods employing particulate hemostatic agents formed from hydrophilic polymer foam such as Chitosan
US7482503B2 (en) 2001-06-14 2009-01-27 Providence Health System-Oregon Wound dressing and method for controlling severe, life-threatening bleeding
US7371403B2 (en) 2002-06-14 2008-05-13 Providence Health System-Oregon Wound dressing and method for controlling severe, life-threatening bleeding
US7897832B2 (en) 2001-06-14 2011-03-01 Hemcon Medical Technologies, Inc. Compositions, assemblies, and methods applied during or after a dental procedure to ameliorate fluid loss and/or promote healing, using a hydrophilic polymer sponge structure such as chitosan
US20050147656A1 (en) 2001-06-14 2005-07-07 Hemcon, Inc. Tissue dressing assemblies, systems, and methods formed from hydrophilic polymer sponge structures such as chitosan
US6599891B2 (en) 2001-07-20 2003-07-29 Qlt Inc. Treatment of macular edema
GB2382775B (en) 2001-12-06 2005-05-25 Johnson & Johnson Medical Ltd Controlled release therapeutic wound dressings
BR0303577A (en) 2002-03-21 2004-04-20 Dow Global Technologies Inc Methods for deriving values for an absorbent medium and for making an absorbent medium, accumulation of superabsorbent polymer and absorbent medium
US6693180B2 (en) 2002-04-04 2004-02-17 China Textile Institute Composite sponge wound dressing made of β-Chitin and Chitosan and method for producing the same
WO2003092756A1 (en) 2002-04-30 2003-11-13 Her Majesty The Queen, In Right Of Canada, As Represented By The Minister Of National Defence Of Her Majesty's Canadian Government Multi-layer synthetic dressing with cooling characteristics
US6992233B2 (en) 2002-05-31 2006-01-31 Medafor, Inc. Material delivery system
WO2003101310A1 (en) * 2002-06-04 2003-12-11 Christy Cummins Blood vessel closure clip and delivery device
US20070066920A1 (en) 2002-06-14 2007-03-22 Hemcon Medical Technologies, Inc. Supple tissue dressing assemblies, systems, and methods formed from hydrophilic polymer sponge structures such as chitosan
US20050137512A1 (en) 2003-12-23 2005-06-23 Campbell Todd D. Wound dressing and method for controlling severe, life-threatening bleeding
US9655753B2 (en) 2002-09-30 2017-05-23 Board Of Regents, The University Of Texas System Stent delivery system and method of use
JP4891547B2 (en) 2002-11-26 2012-03-07 コロプラスト アクティーゼルスカブ Adhesive bandage
US6863924B2 (en) 2002-12-23 2005-03-08 Kimberly-Clark Worldwide, Inc. Method of making an absorbent composite
ES2543082T3 (en) 2002-12-31 2015-08-14 Bsn Medical Gmbh Wound dressing
ES2365709T3 (en) 2003-01-09 2011-10-10 Polyganics B.V. BIOMEDICAL FOAMS.
US7019191B2 (en) 2003-03-25 2006-03-28 Ethicon, Inc. Hemostatic wound dressings and methods of making same
US7637934B2 (en) 2003-03-31 2009-12-29 Merit Medical Systems, Inc. Medical appliance optical delivery and deployment apparatus and method
US20050036955A1 (en) 2003-08-13 2005-02-17 Degould Michael D. Bioresorbable tooth extraction socket dressing
JP5383976B2 (en) 2003-09-08 2014-01-08 エフエムシー バイオポリマー エイエス Gelled biopolymer base foam
WO2005042039A2 (en) 2003-10-31 2005-05-12 Basf Aktiengesellschaft Blood- and/or body fluid-absorbing hydrogel
JP2007516740A (en) * 2003-11-10 2007-06-28 アンジオテック インターナショナル アーゲー Medical implants and scarring inhibitors
US8133500B2 (en) 2003-12-04 2012-03-13 Kensey Nash Bvf Technology, Llc Compressed high density fibrous polymers suitable for implant
ES2384519T3 (en) * 2004-02-23 2012-07-06 Loma Linda University Medical Center Hemostatic agent for topical and internal use
US20050278010A1 (en) 2004-05-27 2005-12-15 Scimed Life Systems, Inc. Stent delivery system with imaging capability
US7402172B2 (en) * 2004-10-13 2008-07-22 Boston Scientific Scimed, Inc. Intraluminal therapeutic patch
US20060083710A1 (en) 2004-10-18 2006-04-20 Joerger Melissa C Process for making antimicrobial polymer articles
KR20060040329A (en) 2004-11-05 2006-05-10 나건 Hemostatic agent which can be applied via endoscope and applying method of the same
US20070083137A1 (en) 2004-12-23 2007-04-12 Hemcon Medical Technologies, Inc. Supple tissue dressing assemblies, systems, and methods formed from softened hydrophilic polymer sponge structures such as chitosan
US7161056B2 (en) 2005-01-28 2007-01-09 Ossur Hf Wound dressing and method for manufacturing the same
GB0501719D0 (en) 2005-01-28 2005-03-02 Green Bruce P Sterilant system
CN1833732A (en) 2005-03-17 2006-09-20 李毅彬 Making method of and use of antibiotic surgical dressing
US9204957B2 (en) 2005-03-17 2015-12-08 Hemcon Medical Technologies, Inc. Systems and methods for hemorrhage control and or tissue repair
US7536962B2 (en) 2005-04-19 2009-05-26 Kamterter Ii, L.L.C. Systems for the control and use of fluids and particles
KR20080030094A (en) 2005-07-13 2008-04-03 헴콘, 인크. Hemostatic compositions, assemblies, systems, and methods employing particulate hemostatic agents formed from hydrophilic polymer foam such as chitosan
EP1951326A2 (en) 2005-11-04 2008-08-06 Lifescience Plus, Inc. Bioabsorbable hemostatic gauze
GB0526505D0 (en) 2005-12-29 2006-02-08 Medtrade Products Ltd Hemostatic material
US20070237811A1 (en) 2006-04-10 2007-10-11 Scherr George H Chitosan wound dressing
US20070255243A1 (en) 2006-04-28 2007-11-01 Kaun James M Dimensionally stable stretchable absorbent composite
US20070276308A1 (en) 2006-05-26 2007-11-29 Huey Raymond J Hemostatic agents and devices for the delivery thereof
CN101138648A (en) 2006-09-07 2008-03-12 电子科技大学中山学院 Method of preparing antimicrobial hemostasis Chinese medicine-containing biological dressings
CA2663372A1 (en) 2006-09-13 2008-03-20 Hemcon Medical Technologies, Inc. Supple tissue dressing assemblies, systems, and methods formed from hydrophilic polymer sponge structures such as chitosan
WO2008036225A2 (en) 2006-09-20 2008-03-27 Entek Manufacturing, Inc. Conformable structured therapeutic dressing
US20080147019A1 (en) 2006-12-19 2008-06-19 Kimberly-Clark Worldwide, Inc. Antimicrobial component system containing metallic nanoparticles and chitosan and/or its derivatives

Also Published As

Publication number Publication date
CA2539382A1 (en) 2006-09-17
US9204957B2 (en) 2015-12-08
US20060211973A1 (en) 2006-09-21

Similar Documents

Publication Publication Date Title
CA2539382C (en) Systems and methods for hemorrhage control and or tissue repair
US10675391B2 (en) Vacuum sponge drainage
US11534149B2 (en) Apparatus for delivering a device to a hollow organ
EP2034908B1 (en) Suction clip
US8828090B2 (en) Liner for tubular body portion and apparatus and methods for application thereof
US20080319258A1 (en) Sterile Access Conduit
EP2651314B1 (en) Systems for bypassing an anastomosis site
US20110172491A1 (en) Detachable balloon catheter
US20220370059A1 (en) Devices and methods for endoscopic patch delivery
US20210022740A1 (en) Devices, systems, and methods for closing a wound
KR102031673B1 (en) A device for the implementation of surgical treatment of intestinal obstructions in narrow and large intestines
CN115427089A (en) Lumen sealing and methods of use
US20220110619A1 (en) Bioadhesive materials and minimally invasive methods for adhering tissues with bioadhesive materials
US20210259865A1 (en) Devices and methods to treat and prevent diverticulitis
Chapter D) Endoscopic armamentarium

Legal Events

Date Code Title Description
EEER Examination request
MKLA Lapsed

Effective date: 20190313