US20060074447A2 - Implantable graft to close a fistula - Google Patents
Implantable graft to close a fistula Download PDFInfo
- Publication number
- US20060074447A2 US20060074447A2 US11/040,996 US4099605A US2006074447A2 US 20060074447 A2 US20060074447 A2 US 20060074447A2 US 4099605 A US4099605 A US 4099605A US 2006074447 A2 US2006074447 A2 US 2006074447A2
- Authority
- US
- United States
- Prior art keywords
- graft
- fistula
- plug
- bioremodelable
- implantable
- 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.)
- Abandoned
Links
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61D—VETERINARY INSTRUMENTS, IMPLEMENTS, TOOLS, OR METHODS
- A61D1/00—Surgical instruments for veterinary use
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00641—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closing fistulae, e.g. anorectal fistulae
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00646—Type of implements
- A61B2017/00654—Type of implements entirely comprised between the two sides of the opening
Definitions
- a graft for occluding a fistula is provided.
- the graft may be pulled, tail first, into the fistula to completely occlude the fistula, thereby avoiding a surgical fistulotomy and its attendant complications.
- Fistulae occur commonly in man. Such fistulae may be congenital or may be caused by infection, inflammatory bowel disease (Crohn’s disease), irradiation, trauma, childbirth, or surgery, for example.
- Crohn’s disease inflammatory bowel disease
- irradiation trauma, childbirth, or surgery, for example.
- fistulae occur between the vagina and the bladder (vesico-vaginal fistulae) or between the vagina and the urethra (urethro-vaginal fistulae). These fistulae may be caused by trauma during childbirth. Traditional surgery for these types of fistulae is complex and not very successful.
- fistulae include, but are not limited to, tracheo-esophageal fistulae, gastro-cutaneous fistulae, and anorectal fistulae.
- anorectal fistulae may occur between the anorectum and vagina (recto-vaginal fistulae), between the anorectum and bladder (recto-vesical fistulae), between the anorectum and urethra (recto-urethral fistulae), or between the anorectum and prostate (recto-prostatic fistulae).
- Anorectal fistulae may result from infection in the anal glands, which are located around the circumference of the distal anal canal forming an anatomic landmark known as the dentate line 1, shown in Figures 1 and 2. Approximately 20-39 such glands are found in man. Infection in an anal gland may result in an abscess, which then tracks through or around the sphincter muscles into the perianal region, where it drains either spontaneously or surgically. The resulting tract is known as a fistula.
- the inner opening of the fistula usually located at the dentate line, is known as the primary opening 2.
- the outer (external) opening, located in the perianal skin, is known as the secondary opening 3.
- Figures 1 and 2 show examples of the various paths that an anorectal fistula may take. These paths vary in complexity. Fistulae that take a straight line path from the primary opening 2 to the secondary opening 3 are known as simple fistulae 4. Fistula that contain multiple tracts ramifying from the primary opening 2 and have multiple secondary openings 3 are known as complex fistulae 5.
- the anatomic path that an anorectal fistula takes is classified according to its relationship to the anal sphincter muscles 6, 7.
- the anal sphincter includes two concentric bands of muscle—the inner, or internal, sphincter 6 and the outer, or external, anal sphincter 7.
- Fistulae which pass between the two concentric anal sphincters are known as inter-sphincteric fistulae 8.
- Those which pass through both internal 6 and external 7 sphincters are known as trans-sphincteric fistulae 9, and those which pass above both sphincters are called supra-sphincteric fistulae 10.
- Fistulae resulting from Crohn’s disease usually ignore these anatomic paths, and are known as extra-anatomic fistulae.
- fistulae Many complex fistulae contain multiple tracts, some blind-ending 11 and others leading to multiple secondary openings 3.
- One of the most common and complex types of fistulae are known as horseshoe fistulae 12, as illustrated in Figure 2 .
- the infection starts in the anal gland (the primary opening 2) and two fistulae pass circumferentially around the anal canal, forming a characteristic horseshoe configuration 12.
- Surgical treatment of fistulae traditionally involves passing a fistula probe through the tract, in a blind manner, using only tactile sensation and experience to guide the probe. Having passed the probe through the fistula tract, the overlying tissue is surgically divided. This is known as a surgical fistulotomy. Because a variable amount of sphincter muscle is divided during the procedure, fistulotomy may result in impaired sphincter control or even incontinence.
- the fistula tract may be surgically drained by inserting a narrow diameter rubber drain, known as a seton, through the tract. After the seton is passed through the fistula tract, it may be tied as a loop around the contained tissue and left for several weeks or months. This procedure is usually performed to drain infection from the area and to mature the fistula tract prior to a definitive closure or sealing procedure.
- a narrow diameter rubber drain known as a seton
- closure of a fistula using a sealant may be performed as a two-stage procedure, comprising a first-stage seton placement, followed by injection of the fibrin glue several weeks later.
- This procedure reduces residual infection and allows the fistula tract to “mature” prior to injecting a sealant.
- Injecting sealant or sclerosant into an unprepared or infected fistula as a one-stage procedure may cause a flare-up of the infection and even further abscess formation.
- Alternative methods and instruments such as coring-out instruments ( See, e.g., U.S. Patent Nos. 5,628,762 and 5,643,305), simply make the fistula wider and more difficult to close.
- An additional means of closing the primary opening is by surgically creating a flap of skin, which is drawn across the opening and sutured in place. This procedure (the endo-anal flap procedure) closes the primary opening, but is technically difficult to perform, is painful for the patient, and is associated with a high fistula recurrence rate.
- the current invention comprises a graft that may be used to effectively plug or occlude the primary opening of the fistula tract.
- One object of the present invention is to provide a new technique of minimally invasive fistula closure. Another object is to provide a technique that obviates the need for surgical fistulotomy and avoids surgical pain and the attendant complications of the procedure. Still another object of the invention is to provide an accurate and complete closure of a fistula, thereby preventing a recurrent or persistent fistula. Yet another object of the present invention is to provide a technique that involves no cutting of tissue, sphincter damage, or incontinence.
- the present invention may be used in any type of fistula.
- the claimed devices and methods may be used to plug or occlude tracheo-esophageal fistulae, gastro-cutaneous fistulae, anorectal fistulae, fistulae occurring between the vagina and the urethra or bladder, or fistulae occurring between any other two portions of the body.
- a biocompatible graft having a curved, generally conical shape is provided.
- the graft may be used to plug, or occlude the primary opening of the fistula.
- the graft is approximately 5 to 10 centimeters (2 to 4 inches) long and tapers continuously from a thicker, “trumpet-like” head to a thin filamentous tail.
- the diameter of the head is approximately 5 to 10 millimeters and tapers to a diameter of 1 to 2 millimeters at its tail.
- the graft of the present invention may be made of any suitable biological or synthetic materials.
- the head and the tail are one continuous piece made of the same material.
- Suitable biological materials include, but are not limited to, cadaveric allografts from human donors or heterografts from animal tissues.
- Suitable synthetic materials include, but are not limited to, polygalactin, polydioxanone and polyglycolic acid.
- the biological and/or synthetic material used in the graft of the present invention elicits little immunological reaction, has some inherent resistance to infection, and promotes tissue reconstruction (rather than complete absorption of the graft into the surrounding tissue), thereby occluding the fistula.
- the graft of the present invention may be pulled into the fistula, tail first, through the primary opening, toward the secondary opening.
- the graft is drawn into the fistula and the trumpet-like head end of the graft is gradually “wedged” into the primary opening in a manner similar to that of inserting a plug in a hole.
- the head and/or tail may be further secured by sutures or other suitable means, which may be formed as an integral part of the graft.
- a trumpet-like head allows the graft to be used for any diameter of primary opening. By applying adequate force to the graft during its insertion, the head of the graft fits snugly into the primary opening and conforms to the size of the primary opening. Multiple or composite grafts may be used for multiple or complex fistulae.
- Figure 1 shows several possible anatomic courses taken by various forms of anorectal fistula (longitudinal plane);
- Figure 2 shows a perineal view of a simple anorectal fistula and a horseshoe fistula
- Figure 3 shows one embodiment of the graft of the present invention.
- the graft of the present invention may be used to plug or occlude any type of fistula, such as the types of fistula illustrated in Figures 1 and 2.
- Other types of fistula that may be occluded by the present invention include, but are not limited to, tracheo-esophageal fistulae, gastro-cutaneous fistulae, or fistulae occuring between the vagina and bladder (vesico-vaginal fistulae), between the vagina and urethra (urethro-vaginal fistulae), between the anorectum and vagina (recto-vaginal fistulae), between the anorectum and bladder (recto-vesical fistulae), between the anorectum and urethra (recto-urethral fistulae), between the anorectum and prostate (recto-prostatic fistulae) or between any other two portions of the body.
- the graft 13 of the present invention may have any suitable configuration.
- the graft may have a convex configuration, a concave configuration, an S-shaped configuration, a generally straight configuration, or any other configuration capable of being inserted into and secured within a fistula.
- the graft may be curved to conform to the shape of the fistula, thereby facilitating introduction of the graft, a secure fit of the graft within the fistula, and less discomfort for the patient.
- a curved configuration makes it easier for the graft to be introduced into the primary opening and directed toward the secondary opening of a curved fistula.
- the graft 13 is an integral unit with a curved, generally conical configuration that tapers from one end having a first diameter D1 to an opposite end having a second diameter D2, where the first diameter D1 is greater than the second diameter D2, as shown in Figure 3.
- the graft 13 may have one end with a thicker trumpet-like head 14 and a body 16 that continuously tapers to a thin filamentous tail 15, as shown in Figure 3 .
- the degree of taper may vary depending on a number of factors, including but not limited to, the diameter of each of the ends (D1 and D2) and the length L of the graft 13.
- the graft may have any suitable length L, diameter D1, and diameter D2, desirably, the graft 13 has a length L of about 1 to about 15 centimeters, a first diameter D1 of about 1 to about 20 millimeters, and a second diameter D2 of about 0.1 to about 5 millimeters. More desirably, the graft 13 has a length L of about 3 to about 12 centimeters, a first diameter D1 of about 2 to about 15 millimeters, and a second diameter D2 of about 0.5 to about 3.5 millimeters.
- the graft has a length L of about 5 to about 10 centimeters, a first diameter D1 of about 5 to about 10 millimeters, and a second diameter D2 of about 1 to about 2 millimeters.
- the graft of the present invention may be used to close any diameter of primary opening up to the limits of the head diameter D1. By applying adequate force to the graft during insertion, the head 14 of the graft 13 conforms exactly to the size of the primary opening.
- the graft 13 of the present invention may be made of any biocompatible material suitable for implantation into a mammalian body. Desirably, the graft 13 is made of a single, non-allergenic biological or synthetic material.
- Suitable biological materials that may be used in the present invention include, but are not limited to, tissue from the patient themselves (an autograft), tissue from a human cadaveric donor (an allograft), or tissue from an unrelated animal donor (a heterograft). Desirably, the material promotes angiogenesis and/or site-specific tissue remodeling.
- Autograft tissue is grown from a skin biopsy of the patient. Once the fibroblasts have regenerated and formed enough new tissue, the new tissue may be injected back into the surgical site of the same patient. This process takes several weeks to complete, but avoids tissue rejection and disease transmission.
- Isolagen Isolagen Inc. – Houston, TX.
- Suitable cadaveric materials include, but are not limited to, cadaveric fascia and cadaveric dura matar.
- Specific suitable cadaveric allografts include, but are not limited to, AlloDerm, (LifeCell Corp. - Branchburg, New Jersey), Cymetra, (LifeCell Corp. – Branchburg, New Jersey), Dermaloga, Fascion (Fascia Biosystems, LLC - Beverly Hills, CA), and Suspend (Mentor – Irving, TX). These products are freeze-dried, or lyophilized, acellular dermal tissue from cadaveric donors. Some require reconstitution before implantation. Although disease transmission or antigenic reaction is possible, the risk may be minimized by an extensive screening and processing of the material.
- Heterograft materials are taken from a donor of one species and grafted into a recipient of another species. Examples of such materials include, but are not limited to, Surgisis (Cook Surgical – Bloomington, IN), Permacol (TSL - Covington, GA), Pelvicol (Bard Inc. – Murray Hill, NJ) and Peri-Guard, (Bio-Vascular Inc. - St Paul, MN).
- an injectable heterograft such as a heterograft of small intestinal submucosa or other material having a viscosity sufficient to prevent the material from running out or being squeezed out of the fistula, is used.
- Such biological materials may be rendered non-cellular during processing to avoid immunological rejection.
- Suitable biological tissues may be implanted in potentially infected surgical fields and resist infection, unlike some synthetic preparations that may elicit a foreign body reaction or act as a nidus for infection.
- a bioremodelable material is used in the devices and methods of the present invention. More desirably, a bioremodelable collagenous material is used.
- Bioremodelable collagenous materials can be provided, for example, by collagenous materials isolated from a suitable tissue source from a warm-blooded vertebrate, and especially a mammal. Such isolated collagenous material can be processed so as to have bioremodelable properties and promote cellular invasion and ingrowth and eventual reconstruction of the host tissue itself. Bioremodelable materials may be used in this context to promote cellular growth within the site in which a medical device of the invention is implanted.
- Suitable bioremodelable materials can be provided by collagenous extracellular matrix materials (ECMs) possessing biotropic properties.
- ECMs extracellular matrix materials
- suitable extracellular matrix materials for use in the invention include, for instance, submucosa (including for example small intestinal submucosa, stomach submucosa, urinary bladder submucosa, or uterine submucosa, each of these isolated from juvenile or adult animals), renal capsule membrane, dermal collagen, amnion, dura mater, pericardium, serosa, peritoneum or basement membrane materials, including liver basement membrane or epithelial basement membrane materials. These materials may be isolated and used as intact natural forms (e.g.
- Renal capsule membrane can also be obtained from warm-blooded vertebrates, as described more particularly in International Patent Application serial No. PCT/US02/20499 filed June 28, 2002, published January 9, 2003 as WO03002165.
- submucosa or other ECMs may include one or more growth factors such as basic fibroblast growth factor (FGF-2), transforming growth factor beta (TGF-beta), epidermal growth factor (EGF), and/or platelet derived growth factor (PDGF).
- FGF-2 basic fibroblast growth factor
- TGF-beta transforming growth factor beta
- EGF epidermal growth factor
- PDGF platelet derived growth factor
- submucosa or other ECM when used in the invention may include other biological materials such as heparin, heparin sulfate, hyaluronic acid, fibronectin and the like.
- the submucosa or other ECM material may include a bioactive component that induces, directly or indirectly, a cellular response such as a change in cell morphology, proliferation, growth, protein or gene expression.
- non-native bioactive components such as those synthetically produced by recombinant technology or other methods, may be incorporated into the material used for the covering.
- These non-native bioactive components may be naturally-derived or recombinantly produced proteins that correspond to those natively occurring in an ECM tissue, but perhaps of a different species (e.g. human proteins applied to collagenous ECMs from other animals, such as pigs).
- the non-native bioactive components may also be drug substances.
- one drug substance that may be incorporated into and/or onto the covering materials is an antibiotic.
- Submucosa or other ECM tissue used in the invention is preferably highly purified, for example, as described in U.S. Patent No. 6,206,931 to Cook et al.
- preferred ECM material will exhibit an endotoxin level of less than about 12 endotoxin units (EU) per gram, more preferably less than about 5 EU per gram, and most preferably less than about 1 EU per gram.
- EU endotoxin units
- the submucosa or other ECM material may have a bioburden of less than about 1 colony forming units (CFU) per gram, more preferably less than about 0.5 CFU per gram.
- CFU colony forming units
- Fungus levels are desirably similarly low, for example less than about 1 CFU per gram, more preferably less than about 0.5 CFU per gram.
- Nucleic acid levels are preferably less than about 5 ⁇ g/mg, more preferably less than about 2 ⁇ g/mg, and virus levels are preferably less than about 50 plaque forming units (PFU) per gram, more preferably less than about 5 PFU per gram.
- PFU plaque forming units
- Suitable synthetic materials that may be used in the present invention include, but are not limited to, polygalactin, polydioxanone, hyaluronic acid, polyglycolic acid, and polyethylene terephthalate. These materials avoid foreign body rejection and may be eventually incorporated into the host tissue.
- the biological or synthetic material used in the present invention assists in reconstruction of the host tissues, elicits little immunological reaction, and has some inherent resistance to infection.
- Such material allows incorporation of the graft into the fistula (rather than complete absorption of the graft into the surrounding tissue), thereby occluding the fistula.
- a drug such as an antibiotic
- the graft may also be used in conjunction with a sealant or sclerosing solution which may be injected into the main fistula tract and any side branches .
- a sealant or sclerosing solution which may be injected into the main fistula tract and any side branches .
- sealants are described in the prior art.
- One of the more commonly used sealants is fibrin glue, known as Tisseal (Baxter Inc.).
- the glue is prepared by mixing coagulation activation factors with fibrinogen, which react to form fibrin.
- the fibrin forms a matrix, which acts as a scaffold for tissue ingrowth and results in the sealing of the fistula tract.
- the graft 13 of the present invention may be inserted into the fistula by pulling the tail 15 of the graft 13 through the primary opening 2 of the fistula and towards the secondary opening 3. This may be accomplished by using, for example, a pair of surgical hemostats or a fistula probe or scope, which is passed through the secondary opening 3 and out through the primary opening 2. The tail 15 of the graft 13 may then be grasped by the hemostats, or secured to the probe or scope, and withdrawn retrograde into the fistula.
- the head 14 of the graft 13 may be gradually “wedged” into the primary opening 2 causing the graft 13 to become lodged in place so that it does not fall out or exude, as with the fibrin glue technique.
- the outer surface of the graft may contain protrusions 18 that interact with the fistula.
- Anorectal fistulae pass through the cylindrical, well-defined internal sphincter muscle 6 containing an almost rigid hole, which is the narrowest point along the fistula tract.
- the protrusions on the graft are adapted to be pulled through the hole and wedged against the distal portion of the hole to further anchor the graft.
- either end of the graft or both ends of the graft are secured by sutures and trimmed to avoid either end from protruding excessively from the fistula tract after the procedure.
- the suture may be formed as an integral part of the graft or as a separate component.
- the graft is anchored within the fistula by threading a securing device having a central lumen, over the tail of the graft and securing it into position at skin level (e.g., by crimping it).
- further anchoring of the graft is achieved by using a material such as a small intestinal submucosa heterograft (a freeze-dried material that requires rehydration before use) for the graft and inserting the graft into the tract before the graft material has been fully expanded by hydration.
- a material such as a small intestinal submucosa heterograft (a freeze-dried material that requires rehydration before use) for the graft and inserting the graft into the tract before the graft material has been fully expanded by hydration.
- Any other suitable means of securement such as introducing adhesive into the fistula tract, may also be used to anchor the graft within the fistula.
- antologous fibrin glue is used in conjunction with the fistula graft to supplement the adhesive and occlusive properties of the disclosed invention.
- the composite may be derived from a fresh sample of blood drawn from the patient at the time of surgery.
- the blood may then be centrifuged, and the platelets, which contain growth factors such as epidermal growth factor (EGF) and transforming growth factor - beta (TGF ⁇ ), harvested. Having centrifuged the blood, retrieved the platelet “pellet” and prepared the composite, the sealant may then be injected into the fistula tract(s) to help maintain the graft in place.
- EGF epidermal growth factor
- TGF ⁇ transforming growth factor - beta
- Closure of a fistula tract may be performed as a one-stage or two-stage procedure.
- a one-stage procedure the fistula tract is closed or sealed at the same time as the initial surgery.
- the advantage of this method is that it avoids a second operation and minimizes expense and inconvenience.
- the main disadvantage is that immediate implantation of the graft into an “unprepared” and possibly infected fistula tract may result in secondary infection of the graft.
- a seton is first placed through the fistula tract to allow mechanical drainage of the fistula tract. Several weeks later, the seton is removed and the graft is inserted into the fistula.
- An alternative methodology involves preliminary endoscopic visualization (fistuloscopy) and “cleaning” of the fistula tract, as disclosed in co-pending application Serial No. 10/945,634 (Armstrong).
- This procedure may be performed by a very thin flexible endoscope, which is inserted into the secondary opening of the fistula tract, and advanced under direct vision through the fistula tract and out the primary opening.
- the primary opening is accurately identified and the tracts are “cleaned out” by means of an irrigating fluid. Any inflammatory or necrotic tissue within the tract is therefore removed, prior to inserting the graft.
- the tail of the graft may be attached to the fistuloscope, which may then be withdrawn through the fistula tract so that the graft gets wedged in place, as described above.
- multiple grafts may be inserted until all fistula tracts have been closed.
- a graft may be configured with one “head” component (larger diameter end), and two “tails” (smaller diameter ends).
- head large diameter end
- tails small diameter ends
- accurate identification of all fistula tracts and the primary opening is facilitated by first performing fistuloscopy.
- each tail may be pulled through the primary opening into each fistula in turn, desirably using a fistuloscope or an instrument passed through the instrument channel of a scope. Adequate force may be applied to the tail to ensure that the head of the graft is firmly secured in the primary opening.
- the head of the graft and/or each of the tails may be further secured by any of the methods described above.
Abstract
Abstract of the Disclosure
An implantable graft, which may be inserted into a fistula tract to occlude the primary opening of the fistula, is provided. The graft may have a curved, generally conical shape with a trumpet-like head end that continuously tapers to a smaller tail end. The graft may be an integral unit made of a single material, such as a heterograft material. Methods of closing single and multiple fistulae are also provided.
Description
- The present patent document claims the benefit of the filing date under 35 U.S.C. §119(e) of Provisional U.S. Patent Application Serial No. 60/538,365, filed January 21, 2004, which is hereby incorporated by reference.
- A graft for occluding a fistula is provided. The graft may be pulled, tail first, into the fistula to completely occlude the fistula, thereby avoiding a surgical fistulotomy and its attendant complications.
- Fistulae occur commonly in man. Such fistulae may be congenital or may be caused by infection, inflammatory bowel disease (Crohn’s disease), irradiation, trauma, childbirth, or surgery, for example.
- Some fistulae occur between the vagina and the bladder (vesico-vaginal fistulae) or between the vagina and the urethra (urethro-vaginal fistulae). These fistulae may be caused by trauma during childbirth. Traditional surgery for these types of fistulae is complex and not very successful.
- Other fistulae include, but are not limited to, tracheo-esophageal fistulae, gastro-cutaneous fistulae, and anorectal fistulae. For example, anorectal fistulae may occur between the anorectum and vagina (recto-vaginal fistulae), between the anorectum and bladder (recto-vesical fistulae), between the anorectum and urethra (recto-urethral fistulae), or between the anorectum and prostate (recto-prostatic fistulae). Anorectal fistulae may result from infection in the anal glands, which are located around the circumference of the distal anal canal forming an anatomic landmark known as the dentate line 1, shown in Figures 1 and 2. Approximately 20-39 such glands are found in man. Infection in an anal gland may result in an abscess, which then tracks through or around the sphincter muscles into the perianal region, where it drains either spontaneously or surgically. The resulting tract is known as a fistula. The inner opening of the fistula, usually located at the dentate line, is known as the primary opening 2. The outer (external) opening, located in the perianal skin, is known as the
secondary opening 3. - Figures 1 and 2 show examples of the various paths that an anorectal fistula may take. These paths vary in complexity. Fistulae that take a straight line path from the primary opening 2 to the
secondary opening 3 are known as simple fistulae 4. Fistula that contain multiple tracts ramifying from the primary opening 2 and have multiplesecondary openings 3 are known as complex fistulae 5. - The anatomic path that an anorectal fistula takes is classified according to its relationship to the anal sphincter muscles 6, 7. The anal sphincter includes two concentric bands of muscle—the inner, or internal, sphincter 6 and the outer, or external, anal sphincter 7. Fistulae which pass between the two concentric anal sphincters are known as inter-sphincteric fistulae 8. Those which pass through both internal 6 and external 7 sphincters are known as trans-sphincteric fistulae 9, and those which pass above both sphincters are called supra-
sphincteric fistulae 10. Fistulae resulting from Crohn’s disease usually ignore these anatomic paths, and are known as extra-anatomic fistulae. - Many complex fistulae contain multiple tracts, some blind-ending 11 and others leading to multiple
secondary openings 3. One of the most common and complex types of fistulae are known as horseshoe fistulae 12, as illustrated inFigure 2 . In this instance, the infection starts in the anal gland (the primary opening 2) and two fistulae pass circumferentially around the anal canal, forming a characteristic horseshoe configuration 12. - Surgical treatment of fistulae traditionally involves passing a fistula probe through the tract, in a blind manner, using only tactile sensation and experience to guide the probe. Having passed the probe through the fistula tract, the overlying tissue is surgically divided. This is known as a surgical fistulotomy. Because a variable amount of sphincter muscle is divided during the procedure, fistulotomy may result in impaired sphincter control or even incontinence.
- Alternatively, the fistula tract may be surgically drained by inserting a narrow diameter rubber drain, known as a seton, through the tract. After the seton is passed through the fistula tract, it may be tied as a loop around the contained tissue and left for several weeks or months. This procedure is usually performed to drain infection from the area and to mature the fistula tract prior to a definitive closure or sealing procedure.
- More recently, methods have evolved to inject sclerosant or sealant (collagen or fibrin glue) into the tract of the fistula. Such sealants are described in Rhee, U.S. Patent No. 5,752,974, for example. The main drawback with these methods is that the glues have a liquid consistency and tend to run out of the fistula tract once the patient becomes ambulatory. In addition, failure rates of these methods are high (up to 86% failure). See Buchanan et al., Efficacy of Fibrin Sealant in the Management of Complex Anal Fistula, Dis Colon and Rectum Vol. 46, No. 9, 46:1167-1174 (Sept. 2003). Usually, multiple injections of glue are required to close the fistula. In some instances, closure of a fistula using a sealant may be performed as a two-stage procedure, comprising a first-stage seton placement, followed by injection of the fibrin glue several weeks later. This procedure reduces residual infection and allows the fistula tract to “mature” prior to injecting a sealant. Injecting sealant or sclerosant into an unprepared or infected fistula as a one-stage procedure may cause a flare-up of the infection and even further abscess formation. Alternative methods and instruments, such as coring-out instruments (See, e.g., U.S. Patent Nos. 5,628,762 and 5,643,305), simply make the fistula wider and more difficult to close.
- An additional means of closing the primary opening is by surgically creating a flap of skin, which is drawn across the opening and sutured in place. This procedure (the endo-anal flap procedure) closes the primary opening, but is technically difficult to perform, is painful for the patient, and is associated with a high fistula recurrence rate.
- An important step in successful closure of a fistula is accurate identification and closure of the primary opening. An accurate means of identifying the primary opening involves endoscopic visualization of the fistula tract (fistuloscopy), as disclosed in co-pending application Serial No. 10/945,634 (Armstrong). Once the primary opening has been accurately identified, effective closure is necessary to prevent recurrence. The current invention comprises a graft that may be used to effectively plug or occlude the primary opening of the fistula tract.
- One object of the present invention is to provide a new technique of minimally invasive fistula closure. Another object is to provide a technique that obviates the need for surgical fistulotomy and avoids surgical pain and the attendant complications of the procedure. Still another object of the invention is to provide an accurate and complete closure of a fistula, thereby preventing a recurrent or persistent fistula. Yet another object of the present invention is to provide a technique that involves no cutting of tissue, sphincter damage, or incontinence.
- The present invention may be used in any type of fistula. For example, the claimed devices and methods may be used to plug or occlude tracheo-esophageal fistulae, gastro-cutaneous fistulae, anorectal fistulae, fistulae occurring between the vagina and the urethra or bladder, or fistulae occurring between any other two portions of the body.
- In one embodiment of the present invention, a biocompatible graft having a curved, generally conical shape is provided. The graft may be used to plug, or occlude the primary opening of the fistula. Desirably, the graft is approximately 5 to 10 centimeters (2 to 4 inches) long and tapers continuously from a thicker, “trumpet-like” head to a thin filamentous tail. Desirably, the diameter of the head is approximately 5 to 10 millimeters and tapers to a diameter of 1 to 2 millimeters at its tail.
- The graft of the present invention may be made of any suitable biological or synthetic materials. Desirably, the head and the tail are one continuous piece made of the same material. Suitable biological materials include, but are not limited to, cadaveric allografts from human donors or heterografts from animal tissues. Suitable synthetic materials include, but are not limited to, polygalactin, polydioxanone and polyglycolic acid. Desirably, the biological and/or synthetic material used in the graft of the present invention elicits little immunological reaction, has some inherent resistance to infection, and promotes tissue reconstruction (rather than complete absorption of the graft into the surrounding tissue), thereby occluding the fistula.
- The graft of the present invention may be pulled into the fistula, tail first, through the primary opening, toward the secondary opening. In one embodiment, the graft is drawn into the fistula and the trumpet-like head end of the graft is gradually “wedged” into the primary opening in a manner similar to that of inserting a plug in a hole. The head and/or tail may be further secured by sutures or other suitable means, which may be formed as an integral part of the graft. A trumpet-like head allows the graft to be used for any diameter of primary opening. By applying adequate force to the graft during its insertion, the head of the graft fits snugly into the primary opening and conforms to the size of the primary opening. Multiple or composite grafts may be used for multiple or complex fistulae.
- Additional features and advantages of the present invention will be apparent to one of ordinary skill in the art from the drawings and detailed description of the preferred embodiments below.
- Figure 1 shows several possible anatomic courses taken by various forms of anorectal fistula (longitudinal plane);
- Figure 2 shows a perineal view of a simple anorectal fistula and a horseshoe fistula; and
- Figure 3 shows one embodiment of the graft of the present invention.
- The graft of the present invention may be used to plug or occlude any type of fistula, such as the types of fistula illustrated in Figures 1 and 2. Other types of fistula that may be occluded by the present invention include, but are not limited to, tracheo-esophageal fistulae, gastro-cutaneous fistulae, or fistulae occuring between the vagina and bladder (vesico-vaginal fistulae), between the vagina and urethra (urethro-vaginal fistulae), between the anorectum and vagina (recto-vaginal fistulae), between the anorectum and bladder (recto-vesical fistulae), between the anorectum and urethra (recto-urethral fistulae), between the anorectum and prostate (recto-prostatic fistulae) or between any other two portions of the body.
- The
graft 13 of the present invention may have any suitable configuration. For example, the graft may have a convex configuration, a concave configuration, an S-shaped configuration, a generally straight configuration, or any other configuration capable of being inserted into and secured within a fistula. The graft may be curved to conform to the shape of the fistula, thereby facilitating introduction of the graft, a secure fit of the graft within the fistula, and less discomfort for the patient. A curved configuration makes it easier for the graft to be introduced into the primary opening and directed toward the secondary opening of a curved fistula. Desirably, thegraft 13 is an integral unit with a curved, generally conical configuration that tapers from one end having a first diameter D1 to an opposite end having a second diameter D2, where the first diameter D1 is greater than the second diameter D2, as shown in Figure 3. - The
graft 13 may have one end with a thicker trumpet-like head 14 and abody 16 that continuously tapers to athin filamentous tail 15, as shown inFigure 3 . The degree of taper may vary depending on a number of factors, including but not limited to, the diameter of each of the ends (D1 and D2) and the length L of thegraft 13. - Although the graft may have any suitable length L, diameter D1, and diameter D2, desirably, the
graft 13 has a length L of about 1 to about 15 centimeters, a first diameter D1 of about 1 to about 20 millimeters, and a second diameter D2 of about 0.1 to about 5 millimeters. More desirably, thegraft 13 has a length L of about 3 to about 12 centimeters, a first diameter D1 of about 2 to about 15 millimeters, and a second diameter D2 of about 0.5 to about 3.5 millimeters. Even more desirably, the graft has a length L of about 5 to about 10 centimeters, a first diameter D1 of about 5 to about 10 millimeters, and a second diameter D2 of about 1 to about 2 millimeters. The graft of the present invention may be used to close any diameter of primary opening up to the limits of the head diameter D1. By applying adequate force to the graft during insertion, the head 14 of thegraft 13 conforms exactly to the size of the primary opening. - The
graft 13 of the present invention may be made of any biocompatible material suitable for implantation into a mammalian body. Desirably, thegraft 13 is made of a single, non-allergenic biological or synthetic material. - Suitable biological materials that may be used in the present invention include, but are not limited to, tissue from the patient themselves (an autograft), tissue from a human cadaveric donor (an allograft), or tissue from an unrelated animal donor (a heterograft). Desirably, the material promotes angiogenesis and/or site-specific tissue remodeling.
- Autograft tissue is grown from a skin biopsy of the patient. Once the fibroblasts have regenerated and formed enough new tissue, the new tissue may be injected back into the surgical site of the same patient. This process takes several weeks to complete, but avoids tissue rejection and disease transmission. One such product is Isolagen (Isolagen Inc. – Houston, TX).
- Suitable cadaveric materials include, but are not limited to, cadaveric fascia and cadaveric dura matar. Specific suitable cadaveric allografts include, but are not limited to, AlloDerm, (LifeCell Corp. - Branchburg, New Jersey), Cymetra, (LifeCell Corp. – Branchburg, New Jersey), Dermaloga, Fascion (Fascia Biosystems, LLC - Beverly Hills, CA), and Suspend (Mentor – Irving, TX). These products are freeze-dried, or lyophilized, acellular dermal tissue from cadaveric donors. Some require reconstitution before implantation. Although disease transmission or antigenic reaction is possible, the risk may be minimized by an extensive screening and processing of the material.
- Heterograft materials are taken from a donor of one species and grafted into a recipient of another species. Examples of such materials include, but are not limited to, Surgisis (Cook Surgical – Bloomington, IN), Permacol (TSL - Covington, GA), Pelvicol (Bard Inc. – Murray Hill, NJ) and Peri-Guard, (Bio-Vascular Inc. - St Paul, MN). In one embodiment of the present invention, an injectable heterograft, such as a heterograft of small intestinal submucosa or other material having a viscosity sufficient to prevent the material from running out or being squeezed out of the fistula, is used.
- Such biological materials may be rendered non-cellular during processing to avoid immunological rejection. Suitable biological tissues may be implanted in potentially infected surgical fields and resist infection, unlike some synthetic preparations that may elicit a foreign body reaction or act as a nidus for infection.
- Desirably, a bioremodelable material is used in the devices and methods of the present invention. More desirably, a bioremodelable collagenous material is used. Bioremodelable collagenous materials can be provided, for example, by collagenous materials isolated from a suitable tissue source from a warm-blooded vertebrate, and especially a mammal. Such isolated collagenous material can be processed so as to have bioremodelable properties and promote cellular invasion and ingrowth and eventual reconstruction of the host tissue itself. Bioremodelable materials may be used in this context to promote cellular growth within the site in which a medical device of the invention is implanted.
- Suitable bioremodelable materials can be provided by collagenous extracellular matrix materials (ECMs) possessing biotropic properties. Illustrative suitable extracellular matrix materials for use in the invention include, for instance, submucosa (including for example small intestinal submucosa, stomach submucosa, urinary bladder submucosa, or uterine submucosa, each of these isolated from juvenile or adult animals), renal capsule membrane, dermal collagen, amnion, dura mater, pericardium, serosa, peritoneum or basement membrane materials, including liver basement membrane or epithelial basement membrane materials. These materials may be isolated and used as intact natural forms (e.g. as sheets), or reconstituted collagen layers including collagen derived from these materials and/or other collagenous materials may be used. For additional information as to submucosa materials useful in the present invention, and their isolation and treatment, reference can be made to U.S. Patent Nos. 4,902,508, 5,554,389, 5,733,337, 5,993,844, 6,206,931, 6,099,567, and 6,331,319. Renal capsule membrane can also be obtained from warm-blooded vertebrates, as described more particularly in International Patent Application serial No. PCT/US02/20499 filed June 28, 2002, published January 9, 2003 as WO03002165.
- As prepared and used, the ECM and any other collagenous material used, may optionally retain growth factors or other bioactive components native to the source tissue. For example, submucosa or other ECMs may include one or more growth factors such as basic fibroblast growth factor (FGF-2), transforming growth factor beta (TGF-beta), epidermal growth factor (EGF), and/or platelet derived growth factor (PDGF). As well, submucosa or other ECM when used in the invention may include other biological materials such as heparin, heparin sulfate, hyaluronic acid, fibronectin and the like. Thus, generally speaking, the submucosa or other ECM material may include a bioactive component that induces, directly or indirectly, a cellular response such as a change in cell morphology, proliferation, growth, protein or gene expression.
- Further, in addition or as an alternative to the inclusion of such native bioactive components, non-native bioactive components such as those synthetically produced by recombinant technology or other methods, may be incorporated into the material used for the covering. These non-native bioactive components may be naturally-derived or recombinantly produced proteins that correspond to those natively occurring in an ECM tissue, but perhaps of a different species (e.g. human proteins applied to collagenous ECMs from other animals, such as pigs). The non-native bioactive components may also be drug substances. For example, one drug substance that may be incorporated into and/or onto the covering materials is an antibiotic.
- Submucosa or other ECM tissue used in the invention is preferably highly purified, for example, as described in U.S. Patent No. 6,206,931 to Cook et al. Thus, preferred ECM material will exhibit an endotoxin level of less than about 12 endotoxin units (EU) per gram, more preferably less than about 5 EU per gram, and most preferably less than about 1 EU per gram. As additional preferences, the submucosa or other ECM material may have a bioburden of less than about 1 colony forming units (CFU) per gram, more preferably less than about 0.5 CFU per gram. Fungus levels are desirably similarly low, for example less than about 1 CFU per gram, more preferably less than about 0.5 CFU per gram. Nucleic acid levels are preferably less than about 5 μg/mg, more preferably less than about 2 μg/mg, and virus levels are preferably less than about 50 plaque forming units (PFU) per gram, more preferably less than about 5 PFU per gram. These and additional properties of submucosa or other ECM tissue taught in U.S. Patent No. 6,206,931 may be characteristic of any ECM tissue used in the present invention.
- Suitable synthetic materials that may be used in the present invention include, but are not limited to, polygalactin, polydioxanone, hyaluronic acid, polyglycolic acid, and polyethylene terephthalate. These materials avoid foreign body rejection and may be eventually incorporated into the host tissue.
- Desirably, the biological or synthetic material used in the present invention assists in reconstruction of the host tissues, elicits little immunological reaction, and has some inherent resistance to infection. Such material allows incorporation of the graft into the fistula (rather than complete absorption of the graft into the surrounding tissue), thereby occluding the fistula.
- In one embodiment of the present invention, a drug, such as an antibiotic, is incorporated into the graft of the present invention, as an extra precaution or means of treating any residual infection within the fistula. The graft may also be used in conjunction with a sealant or sclerosing solution which may be injected into the main fistula tract and any side branches . Several possible sealants are described in the prior art. One of the more commonly used sealants is fibrin glue, known as Tisseal (Baxter Inc.). The glue is prepared by mixing coagulation activation factors with fibrinogen, which react to form fibrin. The fibrin forms a matrix, which acts as a scaffold for tissue ingrowth and results in the sealing of the fistula tract.
- The
graft 13 of the present invention may be inserted into the fistula by pulling thetail 15 of thegraft 13 through the primary opening 2 of the fistula and towards thesecondary opening 3. This may be accomplished by using, for example, a pair of surgical hemostats or a fistula probe or scope, which is passed through thesecondary opening 3 and out through the primary opening 2. Thetail 15 of thegraft 13 may then be grasped by the hemostats, or secured to the probe or scope, and withdrawn retrograde into the fistula. As thegraft 13 is being withdrawn through the fistula, the head 14 of thegraft 13 may be gradually “wedged” into the primary opening 2 causing thegraft 13 to become lodged in place so that it does not fall out or exude, as with the fibrin glue technique. - To assist in anchoring the graft within the fistula, the outer surface of the graft may contain
protrusions 18 that interact with the fistula. Anorectal fistulae pass through the cylindrical, well-defined internal sphincter muscle 6 containing an almost rigid hole, which is the narrowest point along the fistula tract. Desirably, the protrusions on the graft are adapted to be pulled through the hole and wedged against the distal portion of the hole to further anchor the graft. - In an alternative embodiment of the present invention, either end of the graft or both ends of the graft are secured by sutures and trimmed to avoid either end from protruding excessively from the fistula tract after the procedure. The suture may be formed as an integral part of the graft or as a separate component.
- In another embodiment, the graft is anchored within the fistula by threading a securing device having a central lumen, over the tail of the graft and securing it into position at skin level (e.g., by crimping it). In yet another embodiment, further anchoring of the graft is achieved by using a material such as a small intestinal submucosa heterograft (a freeze-dried material that requires rehydration before use) for the graft and inserting the graft into the tract before the graft material has been fully expanded by hydration. Any other suitable means of securement, such as introducing adhesive into the fistula tract, may also be used to anchor the graft within the fistula.
- In one embodiment, antologous fibrin glue is used in conjunction with the fistula graft to supplement the adhesive and occlusive properties of the disclosed invention. This involves the use of an autologous composite of platelets and growth factors derived from the patient’s own blood. (Symphony PCS, DePuy AcroMed Inc.). The composite may be derived from a fresh sample of blood drawn from the patient at the time of surgery. The blood may then be centrifuged, and the platelets, which contain growth factors such as epidermal growth factor (EGF) and transforming growth factor - beta (TGFβ), harvested. Having centrifuged the blood, retrieved the platelet “pellet” and prepared the composite, the sealant may then be injected into the fistula tract(s) to help maintain the graft in place.
- Closure of a fistula tract may be performed as a one-stage or two-stage procedure. As a one-stage procedure, the fistula tract is closed or sealed at the same time as the initial surgery. The advantage of this method is that it avoids a second operation and minimizes expense and inconvenience. The main disadvantage is that immediate implantation of the graft into an “unprepared” and possibly infected fistula tract may result in secondary infection of the graft. As a two-stage procedure, a seton is first placed through the fistula tract to allow mechanical drainage of the fistula tract. Several weeks later, the seton is removed and the graft is inserted into the fistula.
- An alternative methodology involves preliminary endoscopic visualization (fistuloscopy) and “cleaning” of the fistula tract, as disclosed in co-pending application Serial No. 10/945,634 (Armstrong). This procedure may be performed by a very thin flexible endoscope, which is inserted into the secondary opening of the fistula tract, and advanced under direct vision through the fistula tract and out the primary opening. By performing preliminary fistuloscopy of the fistula tracts, the primary opening is accurately identified and the tracts are “cleaned out” by means of an irrigating fluid. Any inflammatory or necrotic tissue within the tract is therefore removed, prior to inserting the graft. The tail of the graft may be attached to the fistuloscope, which may then be withdrawn through the fistula tract so that the graft gets wedged in place, as described above.
- For multiple fistula, multiple grafts may be inserted until all fistula tracts have been closed. In the case of a complex fistula, for instance the horseshoe fistula, there may be one primary opening and two or more tracts leading from that opening. In this instance, a graft may be configured with one “head” component (larger diameter end), and two “tails” (smaller diameter ends). Desirably, accurate identification of all fistula tracts and the primary opening is facilitated by first performing fistuloscopy. Once the entire tract has been identified and cleaned out, each tail may be pulled through the primary opening into each fistula in turn, desirably using a fistuloscope or an instrument passed through the instrument channel of a scope. Adequate force may be applied to the tail to ensure that the head of the graft is firmly secured in the primary opening. The head of the graft and/or each of the tails may be further secured by any of the methods described above.
- The success of the present invention was demonstrated in a clinical trial evaluating the efficacy of a biodegradable lyophilized porcine submucosa plug, as compared to the fibrin glue technique, in closing anorectal fistulae. Thirteen of fifteen patents (87%) treated with the plug had complete closure of all fistula tracts, whereas only four of ten (40%) patents treated with the fibrin glue technique had complete closure.
- It is intended that the foregoing detailed description be regarded as illustrative rather than limiting, and that it be understood that it is the following claims, including all equivalents, that are intended to define the spirit and scope of this invention.
Claims (50)
1. An implantable graft for closing a fistula, comprising a curved, generally conical body having a first end with a first diameter and a second end with a second diameter that is smaller than the first diameter, where the body comprises a continuous taper between the first end and the second end, and where the graft comprises a biological material selected from the group consisting of a cadaveric material from a human donor and a heterograft material from a non-human donor.
2. The graft of claim 1 where the body has a length of about 5 to about 10 centimeters.
3. The graft of claim 2 where the first diameter is about 2 to about 15 millimeters and the second diameter is about 0.5 to about 3.5 millimeters.
4. The graft of claim 1 where the graft is made of a single material.
5. The graft of claim 1 where the graft is an integral unit.
6. (Canceled).
7. The graft of claim 1 where the graft comprises an extracellular matrix material.
8. The graft of claim 7 where the graft comprises small intestinal submucosa.
9. The graft of claim 4 where the graft comprises small intestinal submucosa.
10. The graft of claim 1 where the graft comprises an injectable heterograft material.
11. The graft of claim 1 further comprising protrusions on an external surface of the body.
12. The graft of claim 1 where the graft comprises a material having a portion that remains intact to allow for ingrowth of host cells.
13. The graft of claim 1 where the graft comprises a material that promotes angiogenesis.
14. The graft of claim 1 where the graft comprises a material that promotes site-specific tissue remodeling.
15. The graft of claim 1 where the graft comprises a material that resists infection.
16. The graft of claim 1 where the graft further comprises a drug.
17. An implantable plug for closing a fistula, comprising a generally conical body having a continuous taper between a head end with a first diameter and a tail end with a smaller second diameter, where the body has a length of about 5 to about 10 centimeters.
18. The plug of claim 17 where the plug is made of a single heterograft material from a non-human donor.
19. The plug of claim 18 where the heterograft material is small intestinal submucosa.
20. The plug of claim 17 where the body is curved.
21. A method for closing a fistula having a first end and a second end, the method comprising: providing a plug having an elongate plug body, the elongate plug body having a length sufficient to extend from the first end of the fistula to the second end of the fistula, the plug body having a tail end portion and a head end portion; and inserting the tail end portion of the plug into the fistula through the first end of the fistula until the tail end portion of the plug protrudes from the second end of the fistula and the head end portion of the plug contacts the first end of the fistula.
22. The method of claim 21 further comprising securing the tail end portion of the plug, the head end portion of the plug, or both end portions of the plug with suture.
23. The method of claim 21 further comprising providing a securing device having a central lumen, placing the securing device over the tail end portion of the plug, and securing the securing device into position at skin level.
24. The method of claim 21 where the elongate plug body comprises small intestinal submucosa.
25. The method of claim 21 , where the plug is pulled into the fistula with a probe or scope.
26. The method of claim 25 , where the tail end portion of the plug is attached to the probe or scope.
27. The method of claim 25 , further comprising introducing an adhesive into the fistula.
28. A method of surgically treating an anorectal fistula of a human patient, the anorectal fistula having a tract with a primary opening, the method comprising inserting a plug in the primary opening of the tract, wherein said plug is comprised of a bioremodelable material that promotes cellular invasion and ingrowth in the patient.
29. The method of claim 28 , wherein said bioremodelable material is an allograft extracellular matrix material.
30. The method of claim 28 , wherein the bioremodelable material is a heterograft extracellular matrix material.
31. The method of claim 28 , wherein the bioremodelable material retains growth factors native to a source tissue from which it was obtained.
32. The method of claim 31 , wherein the growth factors comprise one or more of fibroblast growth factor-2, transforming growth factor-beta, epidermal growth factor, and platelet derived growth factor.
33. The method of claim 32 , wherein the bioremodelable material comprises submucosa.
34. The method of claim 32 , wherein the bioremodelable material comprises dermal collagen.
35. The method of claim 28 , wherein the bioremodelable material incorporates an antibiotic agent.
36. The method of claim 28 , wherein the bioremodelable material is angiogenic.
37. An implantable graft for closing an anorectal fistula in a human patient, comprising a tapered plug graft sized and configured to close an anorectal fistula, said tapered plug graft comprising a bioremodelable material that promotes cellular invasion and ingrowth in the patient.
38. The implantable graft of claim 37 , wherein said bioremodelable material is an allograft extracellular matrix material.
39. The implantable graft of claim 37 , wherein the bioremodelable material is a heterograft extracellular matrix material.
40. The implantable graft of claim 37 , wherein the bioremodelable material retains growth factors native to a source tissue from which it was obtained.
41. The implantable graft of claim 40 , wherein the growth factors comprise one or more of fibroblast growth factor-2, transforming growth factor-beta, epidermal growth factor, and platelet derived growth factor.
42. The implantable graft of claim 41 , wherein the bioremodelable material comprises submucosa.
43. The implantable graft of claim 42 , wherein the bioremodelable material comprises dermal collagen.
44. The implantable graft of claim 37 , wherein the bioremodelable material incorporates an antibiotic agent.
45. The implantable graft of claim 10 , wherein the biological material is angiogenic.
46. The method of claim 21 , wherein the fistula is an anorectal fistula.
47. The method of claim 46 , wherein the elongate plug body comprises a bioremodelable extracellular matrix material.
48. The method of claim 34 , wherein the bioremodelable material comprises acellular dermal tissue from a human cadaveric donor.
49. The implantable graft of claim 37 , wherein the bioremodelable material comprises acellular dermal tissue from a human cadaveric donor.
50. The method of claim 21 where the elongate plug body is made of a single material.
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/040,996 US20060074447A2 (en) | 2004-01-21 | 2005-01-21 | Implantable graft to close a fistula |
US11/807,801 US8764791B2 (en) | 2004-01-21 | 2007-05-30 | Implantable graft to close a fistula |
US14/282,399 US9526484B2 (en) | 2004-01-21 | 2014-05-20 | Implantable graft to close a fistula |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US53836504P | 2004-01-21 | 2004-01-21 | |
US11/040,996 US20060074447A2 (en) | 2004-01-21 | 2005-01-21 | Implantable graft to close a fistula |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US11/807,801 Division US8764791B2 (en) | 2004-01-21 | 2007-05-30 | Implantable graft to close a fistula |
Publications (2)
Publication Number | Publication Date |
---|---|
US20050159776A1 US20050159776A1 (en) | 2005-07-21 |
US20060074447A2 true US20060074447A2 (en) | 2006-04-06 |
Family
ID=34807182
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US11/040,996 Abandoned US20060074447A2 (en) | 2004-01-21 | 2005-01-21 | Implantable graft to close a fistula |
US11/807,801 Active 2027-04-24 US8764791B2 (en) | 2004-01-21 | 2007-05-30 | Implantable graft to close a fistula |
US14/282,399 Active 2025-10-31 US9526484B2 (en) | 2004-01-21 | 2014-05-20 | Implantable graft to close a fistula |
Family Applications After (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US11/807,801 Active 2027-04-24 US8764791B2 (en) | 2004-01-21 | 2007-05-30 | Implantable graft to close a fistula |
US14/282,399 Active 2025-10-31 US9526484B2 (en) | 2004-01-21 | 2014-05-20 | Implantable graft to close a fistula |
Country Status (12)
Country | Link |
---|---|
US (3) | US20060074447A2 (en) |
EP (2) | EP1706040B1 (en) |
JP (1) | JP5080087B2 (en) |
KR (1) | KR101066769B1 (en) |
CN (2) | CN102551814B (en) |
AT (1) | ATE468815T1 (en) |
AU (1) | AU2005206195B2 (en) |
BR (1) | BRPI0507014A (en) |
CA (1) | CA2553275C (en) |
DE (1) | DE602005021454D1 (en) |
MX (1) | MXPA06008238A (en) |
WO (1) | WO2005070302A1 (en) |
Cited By (18)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20050070759A1 (en) * | 2003-09-26 | 2005-03-31 | Armstrong David N. | Instrument and method for endoscopic visualization and treatment of anorectal fistula |
WO2007002260A2 (en) | 2005-06-21 | 2007-01-04 | Cook Incorporated | Implantable graft to close a fistula |
US20070129757A1 (en) * | 2005-12-02 | 2007-06-07 | Cook Incorporated | Devices, systems, and methods for occluding a defect |
US20070233278A1 (en) * | 2004-01-21 | 2007-10-04 | Cook Incorporated | Implantable graft to close a fistula |
US20080051831A1 (en) * | 2006-08-24 | 2008-02-28 | Wilson-Cook Medical Inc. | Devices And Methods For Occluding A Fistula |
US20090012558A1 (en) * | 2007-07-02 | 2009-01-08 | Steve Chen | Fistula grafts having a deflectable graft body portion |
US20090112238A1 (en) * | 2007-10-26 | 2009-04-30 | Vance Products Inc., D/B/A Cook Urological Inc. | Fistula brush device |
US20100049246A1 (en) * | 2005-04-29 | 2010-02-25 | Obermiller F Joseph | Volumetric grafts for treatment of fistulae and related methods and systems |
US20100082056A1 (en) * | 2008-04-04 | 2010-04-01 | Akshay Mavani | Implantable fistula closure device |
US20100249827A1 (en) * | 2008-09-04 | 2010-09-30 | Akshay Mavani | Inflatable device for enteric fistula treatment |
US20120150219A1 (en) * | 2008-06-16 | 2012-06-14 | Morris Innovative, Inc. | Method and apparatus for sealing access |
US9023094B2 (en) | 2007-06-25 | 2015-05-05 | Microvention, Inc. | Self-expanding prosthesis |
US9131941B2 (en) | 2011-06-17 | 2015-09-15 | Curaseal Inc. | Fistula treatment devices and methods |
US9211116B2 (en) | 2011-06-16 | 2015-12-15 | Curaseal Inc. | Fistula treatment devices and related methods |
US9238090B1 (en) | 2014-12-24 | 2016-01-19 | Fettech, Llc | Tissue-based compositions |
US10028733B2 (en) | 2015-05-28 | 2018-07-24 | National University Of Ireland, Galway | Fistula treatment device |
US11452512B2 (en) | 2017-06-09 | 2022-09-27 | Signum Surgical Limited | Implant for closing an opening in tissue |
US11701096B2 (en) | 2015-05-28 | 2023-07-18 | National University Of Ireland, Galway | Fistula treatment device |
Families Citing this family (17)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1408847B1 (en) | 2001-07-26 | 2005-05-04 | Oregon Health Sciences University | Vessel closure member and delivery apparatus |
US8465516B2 (en) | 2001-07-26 | 2013-06-18 | Oregon Health Science University | Bodily lumen closure apparatus and method |
EP1980275B1 (en) * | 2005-04-29 | 2016-01-27 | Cook Biotech, Inc. | Fistula graft with deformable sheet-form material |
US7850985B2 (en) * | 2005-07-05 | 2010-12-14 | Cook Biotech Incorporated | Tissue augmentation devices and methods |
US9271817B2 (en) * | 2005-07-05 | 2016-03-01 | Cook Biotech Incorporated | Tissue augmentation devices and methods |
AU2007210970B2 (en) * | 2006-01-31 | 2013-09-05 | Cook Biotech Incorporated | Fistula grafts and related methods and systems for treating fistulae |
US8652090B2 (en) * | 2006-05-18 | 2014-02-18 | Cannuflow, Inc. | Anti-extravasation surgical portal plug |
CA2662901A1 (en) * | 2006-06-21 | 2007-12-27 | Cook Incorporated | Fistula grafts and related methods and systems useful for treating gastrointestinal fistulae |
US9636438B2 (en) | 2007-03-07 | 2017-05-02 | Coloplast A/S | Fistula plug comprising ECM |
GB2461461B (en) * | 2007-04-06 | 2012-07-25 | Cook Biotech Inc | Fistula plugs having increased column strength and fistula plug delivery apparatuses and methods |
US9113851B2 (en) | 2007-08-23 | 2015-08-25 | Cook Biotech Incorporated | Fistula plugs and apparatuses and methods for fistula plug delivery |
US20090069843A1 (en) * | 2007-09-10 | 2009-03-12 | Agnew Charles W | Fistula plugs including a hydration resistant component |
JPWO2010110286A1 (en) * | 2009-03-25 | 2012-09-27 | 国立大学法人京都大学 | Fistula treatment material |
US8915941B2 (en) | 2011-06-14 | 2014-12-23 | Cook Medical Technologies Llc | Fistula closure devices and methods |
US10080863B2 (en) | 2011-07-08 | 2018-09-25 | C.R. Bard, Inc. | Implantable prosthesis for fistula repair |
WO2017100600A2 (en) | 2015-12-11 | 2017-06-15 | Lifecell Corporation | Methods and systems for stiffening of tissue for improved processing |
US9943414B2 (en) | 2015-12-30 | 2018-04-17 | Wasas, Llc. | System and method for non-binding allograft subtalar joint implant |
Citations (50)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US2127903A (en) * | 1936-05-05 | 1938-08-23 | Davis & Geck Inc | Tube for surgical purposes and method of preparing and using the same |
US3996921A (en) * | 1975-04-17 | 1976-12-14 | Pharmacia Inc. | Method and apparatus for endoscopy |
US4511653A (en) * | 1981-11-26 | 1985-04-16 | Foundation Merieux | Process for the industrial preparation of collagenous materials from human placental tissues, human collagenous materials obtained and their application as biomaterials |
US4578076A (en) * | 1984-03-20 | 1986-03-25 | The Population Council, Inc. | Medicated intracervical and intrauterine devices |
US4579110A (en) * | 1982-03-15 | 1986-04-01 | Jacques Hamou | Tubular pessary as a contraceptive means |
US4902508A (en) * | 1988-07-11 | 1990-02-20 | Purdue Research Foundation | Tissue graft composition |
US4956178A (en) * | 1988-07-11 | 1990-09-11 | Purdue Research Foundation | Tissue graft composition |
US5275826A (en) * | 1992-11-13 | 1994-01-04 | Purdue Research Foundation | Fluidized intestinal submucosa and its use as an injectable tissue graft |
US5281422A (en) * | 1991-09-24 | 1994-01-25 | Purdue Research Foundation | Graft for promoting autogenous tissue growth |
US5330503A (en) * | 1989-05-16 | 1994-07-19 | Inbae Yoon | Spiral suture needle for joining tissue |
US5345948A (en) * | 1993-04-08 | 1994-09-13 | Donnell Jr Francis E O | Method of performing translactrimal laser dacryocystorhinostomy |
US5374261A (en) * | 1990-07-24 | 1994-12-20 | Yoon; Inbae | Multifunctional devices for use in endoscopic surgical procedures and methods-therefor |
USRE34866E (en) * | 1987-02-17 | 1995-02-21 | Kensey Nash Corporation | Device for sealing percutaneous puncture in a vessel |
US5514158A (en) * | 1992-12-28 | 1996-05-07 | Kanesaka; Nozomu | Sealing device for a percutaneous puncture |
US5522840A (en) * | 1992-11-23 | 1996-06-04 | Krajicek; Milan | Device for the non-surgical seal of the interstice in the wall of a vessel |
US5554389A (en) * | 1995-04-07 | 1996-09-10 | Purdue Research Foundation | Urinary bladder submucosa derived tissue graft |
US5584827A (en) * | 1992-05-18 | 1996-12-17 | Ultracell Medical Technologies, Inc | Nasal-packing article |
US5620461A (en) * | 1989-05-29 | 1997-04-15 | Muijs Van De Moer; Wouter M. | Sealing device |
US5628762A (en) * | 1994-11-18 | 1997-05-13 | Al-Tameem; Moshin | Method of using a device for excision of a fistula |
US5733337A (en) * | 1995-04-07 | 1998-03-31 | Organogenesis, Inc. | Tissue repair fabric |
US5752974A (en) * | 1995-12-18 | 1998-05-19 | Collagen Corporation | Injectable or implantable biomaterials for filling or blocking lumens and voids of the body |
US5755791A (en) * | 1996-04-05 | 1998-05-26 | Purdue Research Foundation | Perforated submucosal tissue graft constructs |
US5846183A (en) * | 1995-06-07 | 1998-12-08 | Chilcoat; Robert T. | Articulated endoscope with specific advantages for laryngoscopy |
US5860978A (en) * | 1990-09-25 | 1999-01-19 | Innovasive Devices, Inc. | Methods and apparatus for preventing migration of sutures through transosseous tunnels |
US5947994A (en) * | 1995-06-07 | 1999-09-07 | Baxter International Inc. | Endoscopically-assisted device for endoluminal occlusion of anatomical passageway side branches |
US5955110A (en) * | 1995-04-07 | 1999-09-21 | Purdue Research Foundation, Inc. | Multilayered submucosal graft constructs and method for making the same |
US5993844A (en) * | 1997-05-08 | 1999-11-30 | Organogenesis, Inc. | Chemical treatment, without detergents or enzymes, of tissue to form an acellular, collagenous matrix |
US6090996A (en) * | 1997-08-04 | 2000-07-18 | Collagen Matrix, Inc. | Implant matrix |
US6099567A (en) * | 1996-12-10 | 2000-08-08 | Purdue Research Foundation | Stomach submucosa derived tissue graft |
US6149581A (en) * | 1997-06-12 | 2000-11-21 | Klingenstein; Ralph James | Device and method for access to the colon and small bowel of a patient |
US6206931B1 (en) * | 1996-08-23 | 2001-03-27 | Cook Incorporated | Graft prosthesis materials |
US6270515B1 (en) * | 1995-02-06 | 2001-08-07 | Scimed Life Systems, Inc. | Device for closing a septal defect |
US6296632B1 (en) * | 1994-08-17 | 2001-10-02 | Boston Scientific Corporation | Ball-shaped fiber implant, and method and device for inserting the implant |
US6315787B1 (en) * | 1998-11-24 | 2001-11-13 | Embol-X, Inc. | Sutureless vessel plug and methods of use |
US6331319B1 (en) * | 1997-09-11 | 2001-12-18 | Purdue Research Foundation | Galactosidase modified submucosal tissue |
US20020077658A1 (en) * | 2000-12-14 | 2002-06-20 | Ginn Richard S. | Apparatus and methods for sealing vascular punctures |
US6475232B1 (en) * | 1996-12-10 | 2002-11-05 | Purdue Research Foundation | Stent with reduced thrombogenicity |
US20030013989A1 (en) * | 2001-06-29 | 2003-01-16 | Joseph Obermiller | Porous sponge matrix medical devices and methods |
US20030051735A1 (en) * | 2001-07-26 | 2003-03-20 | Cook Biotech Incorporated | Vessel closure member, delivery apparatus, and method of inserting the member |
US6638312B2 (en) * | 2000-08-04 | 2003-10-28 | Depuy Orthopaedics, Inc. | Reinforced small intestinal submucosa (SIS) |
US6666892B2 (en) * | 1996-08-23 | 2003-12-23 | Cook Biotech Incorporated | Multi-formed collagenous biomaterial medical device |
US20040034357A1 (en) * | 1999-08-03 | 2004-02-19 | University Of Massachusetts, A Massachusetts Corporation | Controlled release implantable devices |
US20040064017A1 (en) * | 2002-07-23 | 2004-04-01 | Gerard Cappiello | Apparatus and method of identifying rectovaginal fistulas |
US6800056B2 (en) * | 2000-04-03 | 2004-10-05 | Neoguide Systems, Inc. | Endoscope with guiding apparatus |
US20050013844A1 (en) * | 2000-01-31 | 2005-01-20 | The General Hospital Corporation, A Massachusetts Corporation | Neural regeneration conduit |
US20050049626A1 (en) * | 1999-06-07 | 2005-03-03 | Novomed Gmbh | Fistula blocker |
US20050070759A1 (en) * | 2003-09-26 | 2005-03-31 | Armstrong David N. | Instrument and method for endoscopic visualization and treatment of anorectal fistula |
US20050155608A1 (en) * | 2001-07-26 | 2005-07-21 | Cook Incorporated | Bodily lumen closure apparatus and method |
US20050182495A1 (en) * | 2004-02-13 | 2005-08-18 | Perrone Rafael C.A. | Prosthesis for aero-digestive fistulae |
US20060015142A1 (en) * | 2002-09-13 | 2006-01-19 | Zafer Malazgirt | Plug made of mesh material for closing large trocar wounds |
Family Cites Families (46)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US522840A (en) * | 1894-07-10 | Coal-dump | ||
US1887526A (en) * | 1931-11-02 | 1932-11-15 | Joseph M Spielberg | Medical tampon |
DE2335858A1 (en) * | 1973-07-14 | 1975-01-30 | Schenk Wolfgang Dr Med | DEVICE FOR TEMPORARY LOCKING OF THE ARTIST (ANUS PRAETERNATURALIS) |
DE2722286C2 (en) * | 1977-05-17 | 1986-04-17 | Coloplast A/S, Espergaerde | Non-magnetic tampon for closing an artificial anus and process for its production |
US4693236A (en) * | 1983-06-09 | 1987-09-15 | Leonardo Leprevost | Closure appliance for use in connection with surgical ostomy |
US4563404A (en) | 1984-06-18 | 1986-01-07 | Duracell Inc. | Cell gelling agent |
DK153122C (en) * | 1985-01-15 | 1988-11-14 | Coloplast As | CLOSURE FOR SINGLE USE FOR AN ARTIFICIAL OR INCONTINENT NATURAL TREATMENT |
SU1718837A1 (en) | 1989-11-13 | 1992-03-15 | Днепропетровский Научно-Исследовательский Институт Восстановления И Экспертизы Трудоспособности Инвалидов | Method for obturation of large intestine fistulae |
US5171270A (en) * | 1990-03-29 | 1992-12-15 | Herrick Robert S | Canalicular implant having a collapsible flared section and method |
US5480644A (en) | 1992-02-28 | 1996-01-02 | Jsf Consultants Ltd. | Use of injectable biomaterials for the repair and augmentation of the anal sphincters |
US5425757A (en) * | 1993-05-21 | 1995-06-20 | Tiefenbrun; Jonathan | Aortic surgical procedure |
DE9402017U1 (en) * | 1994-02-08 | 1994-03-31 | Steeb Manfred A | Protective device for the uncontrolled drainage of urine |
US5531759A (en) | 1994-04-29 | 1996-07-02 | Kensey Nash Corporation | System for closing a percutaneous puncture formed by a trocar to prevent tissue at the puncture from herniating |
US5723010A (en) * | 1995-03-31 | 1998-03-03 | Toyo Boseki Kabushiki Kaisha | Medical device and method for producing the same |
US5713891A (en) * | 1995-06-02 | 1998-02-03 | Children's Medical Center Corporation | Modified solder for delivery of bioactive substances and methods of use thereof |
AU3186897A (en) | 1996-05-08 | 1997-11-26 | Salviac Limited | An occluder device |
US5792478A (en) | 1996-07-08 | 1998-08-11 | Advanced Uro Science | Tissue injectable composition and method of use |
US6379710B1 (en) | 1996-12-10 | 2002-04-30 | Purdue Research Foundation | Biomaterial derived from vertebrate liver tissue |
EP0894474A1 (en) | 1997-07-28 | 1999-02-03 | Thomas Prof. Dr. Ischinger | Tension holder e.g. for vascular suture or plug device |
US6464999B1 (en) * | 1998-06-17 | 2002-10-15 | Galt Incorporated | Bioadhesive medical devices |
DK173680B1 (en) * | 1999-02-10 | 2001-06-11 | Coloplast As | ostomy Prop |
US6203563B1 (en) * | 1999-05-26 | 2001-03-20 | Ernesto Ramos Fernandez | Healing device applied to persistent wounds, fistulas, pancreatitis, varicose ulcers, and other medical or veterinary pathologies of a patient |
RU2180529C2 (en) | 1999-08-02 | 2002-03-20 | Областная клиническая больница № 1 Свердловской области | Method for extraperitoneally closing formed intestinal fistulae |
WO2002074192A2 (en) | 2001-03-19 | 2002-09-26 | Board Of Regents, The University Of Texas System | Methods and devices for occluding myocardial holes |
US7033348B2 (en) * | 2001-04-10 | 2006-04-25 | The Research Foundation Of The City University Of New York | Gelatin based on Power-gel™ as solders for Cr4+laser tissue welding and sealing of lung air leak and fistulas in organs |
CA2387276A1 (en) * | 2001-05-23 | 2002-11-23 | Sarkis Yeretsian | Cosmetic method for removing hemorrhoids |
AU2002320189B2 (en) | 2001-06-28 | 2007-04-26 | Cook Biotech Incorporated | Graft prosthesis devices containing renal capsule collagen |
US7819918B2 (en) * | 2001-07-16 | 2010-10-26 | Depuy Products, Inc. | Implantable tissue repair device |
DK200101428A (en) * | 2001-09-28 | 2003-03-29 | Coloplast As | An ostomy appliance |
FR2840796B1 (en) * | 2002-06-13 | 2004-09-10 | Novatech Inc | BRONCHICAL SHUTTER |
US20040069312A1 (en) * | 2002-10-10 | 2004-04-15 | Yoshihiro Ohmi | Method of operating for anal fistula |
WO2004103187A1 (en) | 2003-05-15 | 2004-12-02 | Cook Biotech Incorporated | Bodily lumen closure apparatus and method |
US8021692B2 (en) | 2003-08-25 | 2011-09-20 | Cook Biotech Incorporated | Graft materials containing bioactive substances, and methods for their manufacture |
NL1024218C2 (en) | 2003-09-03 | 2005-03-07 | Stichting Sint Annadal | Device for treating fistulas. |
WO2005053617A2 (en) | 2003-11-28 | 2005-06-16 | Alternative Sourced Collagen, Llc | Compositions and methods comprising collagen |
ATE468815T1 (en) * | 2004-01-21 | 2010-06-15 | Cook Inc | IMPLANTABLE TRANSPLANT FOR CLOSING A FISTULA |
WO2005070489A1 (en) | 2004-01-23 | 2005-08-04 | Cook Critical Care Incorporated | Endobronchial blocking device |
US7258661B2 (en) * | 2004-09-13 | 2007-08-21 | Bristol-Myers Squibb Company | Stoma plug |
US9788821B2 (en) * | 2005-04-29 | 2017-10-17 | Cook Biotech Incorporated | Physically modified extracellular matrix materials and uses thereof |
JP4995811B2 (en) * | 2005-04-29 | 2012-08-08 | クック・バイオテック・インコーポレーテッド | Acupuncture positive displacement implants and related methods and systems |
CA2630452C (en) * | 2005-12-02 | 2011-02-22 | Cook Incorporated | Devices, systems, and methods for occluding a defect |
AU2007286657B2 (en) * | 2006-08-24 | 2012-11-15 | Cook Medical Technologies Llc | Devices and methods for occluding a fistula |
US8535349B2 (en) * | 2007-07-02 | 2013-09-17 | Cook Biotech Incorporated | Fistula grafts having a deflectable graft body portion |
US9113851B2 (en) * | 2007-08-23 | 2015-08-25 | Cook Biotech Incorporated | Fistula plugs and apparatuses and methods for fistula plug delivery |
US9492149B2 (en) * | 2007-11-13 | 2016-11-15 | Cook Biotech Incorporated | Fistula grafts and related methods and systems useful for treating gastrointestinal and other fistulae |
US7765006B2 (en) * | 2007-12-13 | 2010-07-27 | Leto Medical, Llc | Method and apparatus for providing continence to a gastrointestinal ostomy |
-
2005
- 2005-01-21 AT AT05722488T patent/ATE468815T1/en not_active IP Right Cessation
- 2005-01-21 EP EP05722488A patent/EP1706040B1/en active Active
- 2005-01-21 JP JP2006551276A patent/JP5080087B2/en active Active
- 2005-01-21 BR BRPI0507014-7A patent/BRPI0507014A/en not_active Application Discontinuation
- 2005-01-21 CA CA2553275A patent/CA2553275C/en active Active
- 2005-01-21 AU AU2005206195A patent/AU2005206195B2/en active Active
- 2005-01-21 CN CN201210018299.4A patent/CN102551814B/en active Active
- 2005-01-21 WO PCT/US2005/001847 patent/WO2005070302A1/en active Application Filing
- 2005-01-21 KR KR1020067014572A patent/KR101066769B1/en active IP Right Grant
- 2005-01-21 DE DE602005021454T patent/DE602005021454D1/en active Active
- 2005-01-21 MX MXPA06008238A patent/MXPA06008238A/en unknown
- 2005-01-21 CN CN200580002867XA patent/CN1909840B/en active Active
- 2005-01-21 EP EP10003192.1A patent/EP2193749B1/en active Active
- 2005-01-21 US US11/040,996 patent/US20060074447A2/en not_active Abandoned
-
2007
- 2007-05-30 US US11/807,801 patent/US8764791B2/en active Active
-
2014
- 2014-05-20 US US14/282,399 patent/US9526484B2/en active Active
Patent Citations (53)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US2127903A (en) * | 1936-05-05 | 1938-08-23 | Davis & Geck Inc | Tube for surgical purposes and method of preparing and using the same |
US3996921A (en) * | 1975-04-17 | 1976-12-14 | Pharmacia Inc. | Method and apparatus for endoscopy |
US4511653A (en) * | 1981-11-26 | 1985-04-16 | Foundation Merieux | Process for the industrial preparation of collagenous materials from human placental tissues, human collagenous materials obtained and their application as biomaterials |
US4579110A (en) * | 1982-03-15 | 1986-04-01 | Jacques Hamou | Tubular pessary as a contraceptive means |
US4578076A (en) * | 1984-03-20 | 1986-03-25 | The Population Council, Inc. | Medicated intracervical and intrauterine devices |
USRE34866E (en) * | 1987-02-17 | 1995-02-21 | Kensey Nash Corporation | Device for sealing percutaneous puncture in a vessel |
US4956178A (en) * | 1988-07-11 | 1990-09-11 | Purdue Research Foundation | Tissue graft composition |
US4902508A (en) * | 1988-07-11 | 1990-02-20 | Purdue Research Foundation | Tissue graft composition |
US5330503A (en) * | 1989-05-16 | 1994-07-19 | Inbae Yoon | Spiral suture needle for joining tissue |
US5620461A (en) * | 1989-05-29 | 1997-04-15 | Muijs Van De Moer; Wouter M. | Sealing device |
US5374261A (en) * | 1990-07-24 | 1994-12-20 | Yoon; Inbae | Multifunctional devices for use in endoscopic surgical procedures and methods-therefor |
US5860978A (en) * | 1990-09-25 | 1999-01-19 | Innovasive Devices, Inc. | Methods and apparatus for preventing migration of sutures through transosseous tunnels |
US5281422A (en) * | 1991-09-24 | 1994-01-25 | Purdue Research Foundation | Graft for promoting autogenous tissue growth |
US5584827A (en) * | 1992-05-18 | 1996-12-17 | Ultracell Medical Technologies, Inc | Nasal-packing article |
US5275826A (en) * | 1992-11-13 | 1994-01-04 | Purdue Research Foundation | Fluidized intestinal submucosa and its use as an injectable tissue graft |
US5516533A (en) * | 1992-11-13 | 1996-05-14 | Purdue Research Foundation | Fluidized intestinal submucosa and its use as an injectable tissue graft |
US5522840A (en) * | 1992-11-23 | 1996-06-04 | Krajicek; Milan | Device for the non-surgical seal of the interstice in the wall of a vessel |
US5514158A (en) * | 1992-12-28 | 1996-05-07 | Kanesaka; Nozomu | Sealing device for a percutaneous puncture |
US5345948A (en) * | 1993-04-08 | 1994-09-13 | Donnell Jr Francis E O | Method of performing translactrimal laser dacryocystorhinostomy |
US6296632B1 (en) * | 1994-08-17 | 2001-10-02 | Boston Scientific Corporation | Ball-shaped fiber implant, and method and device for inserting the implant |
US5628762A (en) * | 1994-11-18 | 1997-05-13 | Al-Tameem; Moshin | Method of using a device for excision of a fistula |
US5643305A (en) * | 1994-11-18 | 1997-07-01 | Al-Tameem; Moshin | Device for excision of a fistula |
US6270515B1 (en) * | 1995-02-06 | 2001-08-07 | Scimed Life Systems, Inc. | Device for closing a septal defect |
US5955110A (en) * | 1995-04-07 | 1999-09-21 | Purdue Research Foundation, Inc. | Multilayered submucosal graft constructs and method for making the same |
US5733337A (en) * | 1995-04-07 | 1998-03-31 | Organogenesis, Inc. | Tissue repair fabric |
US5554389A (en) * | 1995-04-07 | 1996-09-10 | Purdue Research Foundation | Urinary bladder submucosa derived tissue graft |
US5846183A (en) * | 1995-06-07 | 1998-12-08 | Chilcoat; Robert T. | Articulated endoscope with specific advantages for laryngoscopy |
US5947994A (en) * | 1995-06-07 | 1999-09-07 | Baxter International Inc. | Endoscopically-assisted device for endoluminal occlusion of anatomical passageway side branches |
US5752974A (en) * | 1995-12-18 | 1998-05-19 | Collagen Corporation | Injectable or implantable biomaterials for filling or blocking lumens and voids of the body |
US5997575A (en) * | 1996-04-05 | 1999-12-07 | Purdue Research Foundation | Perforated submucosal tissue graft constructs |
US5755791A (en) * | 1996-04-05 | 1998-05-26 | Purdue Research Foundation | Perforated submucosal tissue graft constructs |
US6206931B1 (en) * | 1996-08-23 | 2001-03-27 | Cook Incorporated | Graft prosthesis materials |
US6666892B2 (en) * | 1996-08-23 | 2003-12-23 | Cook Biotech Incorporated | Multi-formed collagenous biomaterial medical device |
US6475232B1 (en) * | 1996-12-10 | 2002-11-05 | Purdue Research Foundation | Stent with reduced thrombogenicity |
US6099567A (en) * | 1996-12-10 | 2000-08-08 | Purdue Research Foundation | Stomach submucosa derived tissue graft |
US5993844A (en) * | 1997-05-08 | 1999-11-30 | Organogenesis, Inc. | Chemical treatment, without detergents or enzymes, of tissue to form an acellular, collagenous matrix |
US6149581A (en) * | 1997-06-12 | 2000-11-21 | Klingenstein; Ralph James | Device and method for access to the colon and small bowel of a patient |
US6090996A (en) * | 1997-08-04 | 2000-07-18 | Collagen Matrix, Inc. | Implant matrix |
US6331319B1 (en) * | 1997-09-11 | 2001-12-18 | Purdue Research Foundation | Galactosidase modified submucosal tissue |
US6315787B1 (en) * | 1998-11-24 | 2001-11-13 | Embol-X, Inc. | Sutureless vessel plug and methods of use |
US20050049626A1 (en) * | 1999-06-07 | 2005-03-03 | Novomed Gmbh | Fistula blocker |
US20040034357A1 (en) * | 1999-08-03 | 2004-02-19 | University Of Massachusetts, A Massachusetts Corporation | Controlled release implantable devices |
US20050013844A1 (en) * | 2000-01-31 | 2005-01-20 | The General Hospital Corporation, A Massachusetts Corporation | Neural regeneration conduit |
US6800056B2 (en) * | 2000-04-03 | 2004-10-05 | Neoguide Systems, Inc. | Endoscope with guiding apparatus |
US6638312B2 (en) * | 2000-08-04 | 2003-10-28 | Depuy Orthopaedics, Inc. | Reinforced small intestinal submucosa (SIS) |
US20020077658A1 (en) * | 2000-12-14 | 2002-06-20 | Ginn Richard S. | Apparatus and methods for sealing vascular punctures |
US20030013989A1 (en) * | 2001-06-29 | 2003-01-16 | Joseph Obermiller | Porous sponge matrix medical devices and methods |
US20030051735A1 (en) * | 2001-07-26 | 2003-03-20 | Cook Biotech Incorporated | Vessel closure member, delivery apparatus, and method of inserting the member |
US20050155608A1 (en) * | 2001-07-26 | 2005-07-21 | Cook Incorporated | Bodily lumen closure apparatus and method |
US20040064017A1 (en) * | 2002-07-23 | 2004-04-01 | Gerard Cappiello | Apparatus and method of identifying rectovaginal fistulas |
US20060015142A1 (en) * | 2002-09-13 | 2006-01-19 | Zafer Malazgirt | Plug made of mesh material for closing large trocar wounds |
US20050070759A1 (en) * | 2003-09-26 | 2005-03-31 | Armstrong David N. | Instrument and method for endoscopic visualization and treatment of anorectal fistula |
US20050182495A1 (en) * | 2004-02-13 | 2005-08-18 | Perrone Rafael C.A. | Prosthesis for aero-digestive fistulae |
Cited By (41)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7645229B2 (en) | 2003-09-26 | 2010-01-12 | Armstrong David N | Instrument and method for endoscopic visualization and treatment of anorectal fistula |
US20050070759A1 (en) * | 2003-09-26 | 2005-03-31 | Armstrong David N. | Instrument and method for endoscopic visualization and treatment of anorectal fistula |
US9526484B2 (en) | 2004-01-21 | 2016-12-27 | Cook Medical Technologies Llc | Implantable graft to close a fistula |
US20070233278A1 (en) * | 2004-01-21 | 2007-10-04 | Cook Incorporated | Implantable graft to close a fistula |
US8764791B2 (en) * | 2004-01-21 | 2014-07-01 | Cook Medical Technologies Llc | Implantable graft to close a fistula |
US11064987B2 (en) | 2005-04-29 | 2021-07-20 | Cook Biotech Incorporated | Volumetric grafts for treatment of fistulae and related methods and systems |
US9687215B2 (en) * | 2005-04-29 | 2017-06-27 | Cook Biotech Incorporated | Volumetric grafts for treatment of fistulae and related methods and systems |
US20100049246A1 (en) * | 2005-04-29 | 2010-02-25 | Obermiller F Joseph | Volumetric grafts for treatment of fistulae and related methods and systems |
EP2989995A1 (en) | 2005-06-21 | 2016-03-02 | Cook Medical Technologies LLC | Implantable graft to close a fistula |
US20110125289A1 (en) * | 2005-06-21 | 2011-05-26 | Cook Biotech Incorporated | Implantable Graft to Close a Fistula |
US8501217B2 (en) | 2005-06-21 | 2013-08-06 | Cook Medical Technologies Llc | Implantable graft to close a fistula |
US9456815B2 (en) | 2005-06-21 | 2016-10-04 | Cook Medical Technologies Llc | Implantable graft to close a fistula |
WO2007002260A2 (en) | 2005-06-21 | 2007-01-04 | Cook Incorporated | Implantable graft to close a fistula |
US20070031508A1 (en) * | 2005-06-21 | 2007-02-08 | Armstrong David N | Implantable graft to close a fistula |
US7897167B2 (en) | 2005-06-21 | 2011-03-01 | Cook Incorporated | Implantable graft to close a fistula |
US8840917B2 (en) | 2005-06-21 | 2014-09-23 | Cook Medical Technologies Llc | Implantable graft to close a fistula |
US20070129757A1 (en) * | 2005-12-02 | 2007-06-07 | Cook Incorporated | Devices, systems, and methods for occluding a defect |
US20080051831A1 (en) * | 2006-08-24 | 2008-02-28 | Wilson-Cook Medical Inc. | Devices And Methods For Occluding A Fistula |
WO2008024920A1 (en) | 2006-08-24 | 2008-02-28 | Wilson-Cook Medical Inc. | Devices and methods for occluding a fistula |
US9023094B2 (en) | 2007-06-25 | 2015-05-05 | Microvention, Inc. | Self-expanding prosthesis |
US20090012558A1 (en) * | 2007-07-02 | 2009-01-08 | Steve Chen | Fistula grafts having a deflectable graft body portion |
US8535349B2 (en) | 2007-07-02 | 2013-09-17 | Cook Biotech Incorporated | Fistula grafts having a deflectable graft body portion |
US20090112238A1 (en) * | 2007-10-26 | 2009-04-30 | Vance Products Inc., D/B/A Cook Urological Inc. | Fistula brush device |
US20100082056A1 (en) * | 2008-04-04 | 2010-04-01 | Akshay Mavani | Implantable fistula closure device |
US20120150219A1 (en) * | 2008-06-16 | 2012-06-14 | Morris Innovative, Inc. | Method and apparatus for sealing access |
US8974493B2 (en) * | 2008-06-16 | 2015-03-10 | Morris Innovative, Inc. | Method and apparatus for sealing access |
US20100249827A1 (en) * | 2008-09-04 | 2010-09-30 | Akshay Mavani | Inflatable device for enteric fistula treatment |
US8377094B2 (en) | 2008-09-04 | 2013-02-19 | Curaseal Inc. | Enteric fistula treatment devices |
US8221451B2 (en) | 2008-09-04 | 2012-07-17 | Curaseal Inc. | Inflatable device for enteric fistula treatment |
US8206416B2 (en) | 2008-09-04 | 2012-06-26 | Curaseal Inc. | Inflatable device for enteric fistula treatment |
US8177809B2 (en) | 2008-09-04 | 2012-05-15 | Curaseal Inc. | Inflatable device for enteric fistula treatment |
US20100249828A1 (en) * | 2008-09-04 | 2010-09-30 | Akshay Mavani | Inflatable device for enteric fistula treatement |
US9993235B2 (en) | 2008-09-04 | 2018-06-12 | Curaseal Inc. | Enteric fistula treatment devices |
US9211116B2 (en) | 2011-06-16 | 2015-12-15 | Curaseal Inc. | Fistula treatment devices and related methods |
US9131941B2 (en) | 2011-06-17 | 2015-09-15 | Curaseal Inc. | Fistula treatment devices and methods |
US9238090B1 (en) | 2014-12-24 | 2016-01-19 | Fettech, Llc | Tissue-based compositions |
US11938246B2 (en) | 2014-12-24 | 2024-03-26 | Fettech, Llc | Tissue-based compositions and methods of use thereof |
US10028733B2 (en) | 2015-05-28 | 2018-07-24 | National University Of Ireland, Galway | Fistula treatment device |
US11166704B2 (en) | 2015-05-28 | 2021-11-09 | National University Of Ireland, Galway | Fistula treatment device |
US11701096B2 (en) | 2015-05-28 | 2023-07-18 | National University Of Ireland, Galway | Fistula treatment device |
US11452512B2 (en) | 2017-06-09 | 2022-09-27 | Signum Surgical Limited | Implant for closing an opening in tissue |
Also Published As
Publication number | Publication date |
---|---|
EP2193749A1 (en) | 2010-06-09 |
KR20070034454A (en) | 2007-03-28 |
CA2553275A1 (en) | 2005-08-04 |
CA2553275C (en) | 2012-03-13 |
EP1706040B1 (en) | 2010-05-26 |
CN102551814A (en) | 2012-07-11 |
JP2007534369A (en) | 2007-11-29 |
EP2193749B1 (en) | 2017-03-01 |
CN102551814B (en) | 2015-09-09 |
US20070233278A1 (en) | 2007-10-04 |
CN1909840A (en) | 2007-02-07 |
EP1706040A1 (en) | 2006-10-04 |
US9526484B2 (en) | 2016-12-27 |
MXPA06008238A (en) | 2007-02-21 |
US8764791B2 (en) | 2014-07-01 |
CN1909840B (en) | 2012-03-21 |
ATE468815T1 (en) | 2010-06-15 |
KR101066769B1 (en) | 2011-09-21 |
BRPI0507014A (en) | 2007-06-05 |
AU2005206195B2 (en) | 2011-05-26 |
US20050159776A1 (en) | 2005-07-21 |
WO2005070302A1 (en) | 2005-08-04 |
JP5080087B2 (en) | 2012-11-21 |
AU2005206195A1 (en) | 2005-08-04 |
DE602005021454D1 (en) | 2010-07-08 |
US20140257376A1 (en) | 2014-09-11 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US9526484B2 (en) | Implantable graft to close a fistula | |
AU2006320507B2 (en) | Devices, systems, and methods for occluding a defect | |
AU2007286657B2 (en) | Devices and methods for occluding a fistula | |
US10470749B2 (en) | Fistula grafts and related methods and systems useful for treating gastrointestinal and other fistulae | |
US8936616B2 (en) | Expandable plugs and related delivery apparatuses and methods | |
US20110060362A1 (en) | Devices and methods for treating rectovaginal and other fistulae |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
AS | Assignment |
Owner name: COOK INCORPORATED, INDIANA Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:ARMSTRONG, DAVID N.;REEL/FRAME:016214/0385 Effective date: 20050120 |
|
STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |