Described are peritoneal catheter devices and methods for positioning these devices in a medical patient. The peritoneal catheter includes a catheter tube having a proximal end portion opposite a distal end portion, a stationary flange attached to the catheter tube near the distal end portion, and a mobile flange positioned on the catheter tube between the stationary flange and the proximal end portion. In use, the stationary flange is positioned to cover a hole in the rectus muscle and the mobile flange is selectively moved along the catheter tube to sandwich the rectus muscle of the patient between the stationary flange and the mobile flange. Optionally an interior cuff is mounted on the catheter tube adjacent to the stationary flange but between the stationary flange and the mobile flange and wherein the selectively positioning the mobile flange includes sandwiching the interior cuff between the stationary flange and the mobile flange.

BACKGROUND

The present disclosure relates generally to medical technology and in particular aspects to devices and methods for positioning a peritoneal catheter in a body of a patient to begin a medical treatment immediately after placement of the peritoneal catheter.

One use of a peritoneal catheter is during end-stage renal disease (ESRD) to instill dialysis fluid into the peritoneum into the peritoneal cavity. The peritoneal catheter must be inserted through the skin, subcutaneous fat, rectus muscle and parietal peritoneum into the peritoneal cavity. Most peritoneal catheters are equipped with a polyester synthetic cuff that is placed within the rectus muscle which encourages incorporation of the cuff into the surrounding tissue. This ingrowth requires 2 to 3 weeks to heal completely. If the site does not heal properly or heal completely, the dialysis fluid is able to leak out of the peritoneal cavity, through the rectus muscle and along the length of the peritoneal catheter. This leakage causes a variety of problems including inflammation of the tunneled area and infection by providing a means of bacterial colonization into the tunnel tract.

Another cause of improper healing is movement of the peritoneal catheter. If the polyester synthetic cuff does not properly affix the peritoneal catheter by tissue ingrowth, the cuff may slide into the cavity. Under these conditions the peritoneal catheter will be able to move, the peritoneal catheter tunnel site will be open to the dialysate solution and the cuff and catheter tunnel can become a site of bacterial colonization.

One type of catheter is available which does not require the 2 to 3 weeks of healing before the initiation of peritoneal dialysis; however this catheter has shortcomings also. This catheter has a silicone ball and flange at the site of a cuff. The ball and flange are pushed into the rectus muscle and the flange is sutured to the muscle. This effectively closes the peritoneal cavity from the tunneled catheter site. This type of catheter requires dilation of the insertion site to create adequate space for the ball and flange which creates a larger hole. In addition, suturing the flange to the muscle increases catheter placement time. This method requires additional time-consuming measures and increases the size of the hole in the muscle.

There remain needs for improved and/or alternative systems and methods for positioning a peritoneal catheter in a body of a patient to begin a medical treatment immediately after placement of the peritoneal catheter by closing the peritoneal cavity off from the tunneled catheter thus decreasing the risk of leakage and tunneling infections. The present disclosure is addressed to those needs.

SUMMARY

The present disclosure provides, in certain aspects, unique methods and devices for positioning a peritoneal catheter in a body of a patient.

In one embodiment, a distal tip of a catheter tube of the peritoneal catheter is advanced through the body of a patient to a target site in a peritoneal cavity of the patient and then a stationary flange circumferentially surrounding and mounted on the catheter tube is advanced through a hole in the rectus muscle of the patient. Next, the hole in the rectus muscle of the patient is covered with the stationary flange and a mobile flange circumferentially surrounding and positioned on the catheter tube is advanced into the body of the patient. The mobile flange can be selectively positioned on the catheter tube to sandwich the rectus muscle between the stationary flange and the mobile flange.

In another embodiment, a peritoneal catheter includes a catheter tube having a proximal end portion opposite a distal end portion. This embodiment includes a stationary flange attached to the catheter tube near the distal end portion wherein the stationary flange circumferentially surrounds the catheter tube and a mobile flange is positioned on the catheter tube between the stationary flange and the proximal end portion wherein the mobile flange circumferentially surrounds the catheter tube. The mobile flange is configured for selective placement along the catheter tube. In one form, the mobile flange is configured to slide along or cinch down the catheter tube.

In an alternative embodiment, a peritoneal catheter includes a catheter tube having a proximal end portion opposite a distal end portion. This embodiment includes a stationary flange attached to the catheter tube near the distal end portion wherein the stationary flange circumferentially surrounds the catheter tube and a mobile flange is positioned on the catheter tube between the stationary flange and the proximal end portion wherein the mobile flange circumferentially surrounds the catheter tube. The mobile flange is configured for selective placement along the catheter tube. The peritoneal catheter also includes an interior cuff mounted on the catheter tube between the stationary flange and the mobile flange wherein the interior cuff is positioned adjacent the stationary flange. Additionally in some forms this alternative embodiment includes an outer cuff mounted on the catheter tube and positioned between the mobile flange and the proximal end portion of the catheter tube.

In yet another embodiment, the peritoneal catheter includes a catheter tube, a stationary flange, a mobile flange, and an interior cuff as described above, and additionally at least one bead positioned on the catheter tube between the interior cuff and the mobile flange wherein the bead is configured to retain the mobile flange adjacent to and/or pressed against the interior cuff. Optionally, the peritoneal catheter includes two beads positioned in a lineal or a substantial perpendicular orientation along a longitudinal axis of the catheter tube. The bead is configured to retain the mobile flange against the interior cuff.

In any embodiment, the interior cuff can be made of a biomaterial to accommodate tissue ingrowth or alternatively a sheet of biomaterial can be wrapped around the interior cuff to accommodate tissue ingrowth.

Further forms, objects, features, aspects, benefits, advantages, and embodiments of the present disclosure will become apparent from a detailed description and drawings provided herewith.

DESCRIPTION OF THE SELECTED EMBODIMENTS

While the present disclosure may be embodied in many different forms, for the purpose of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the disclosure is thereby intended. Any alterations and further modifications in the described embodiments and any further applications of the principles of the present disclosure as described herein are contemplated as would normally occur to one skilled in the art to which the disclosure relates.

In certain aspects, the present disclosure provides unique devices and methods for positioning a peritoneal catheter in a body of a patient to begin a medical treatment. The present disclosure provides for a peritoneal catheter including a catheter tube having a proximal end portion opposite a distal end portion, a stationary flange attached to the catheter tube near the distal end portion wherein the stationary flange circumferentially surrounds the catheter tube, and a mobile flange positioned on the catheter tube between the stationary flange and the proximal end portion wherein the mobile flange circumferentially surrounds the catheter tube. Alternative embodiments include one or more of an interior cuff, an outer cuff, and one or more beads positioned on the catheter tube. In any embodiment, the mobile flange is configured for selective placement along the catheter tube. Briefly describing the method of positioning the peritoneal catheter in a body of a patient to begin a medical treatment includes advancing the distal end portion of the catheter tube of the peritoneal catheter through the body of the patient to a target site in a peritoneal cavity of the patient, and then advancing the stationary flange circumferentially surrounding and mounted on the catheter tube through a hole in the rectus muscle of the patient. Next, a medical practitioner covers the hole in the rectus muscle of the patient with the stationary flange and thereafter the practitioner advances the mobile flange circumferentially surrounding and positioned on the catheter tube into the body of the patient. Finally, the medical practitioner selectively positions the mobile flange along the length of the catheter tube to a position on the catheter tube to thereby sandwich the rectus muscle between the stationary flange and the mobile flange.

Relative movement of the mobile flange along the length of the catheter tube enables proper positioning of the catheter tube in the rectus muscle sheath to substantially prevent movement of the peritoneal catheter in the body of a patient. The seal provided by the stationary flange over the hole in the rectus muscle sheath also allows immediate initiation of peritoneal dialysis. The seal provided by the stationary flange prevents dialysate leakage before healing of the hole in the rectus muscle and incorporation of the stationary flange is completed. Moreover, the mobile flange also provides a seal and a physical barrier that occludes the peritoneal cavity from the tunnel site from the skin surface. Simultaneously, the mobile flange allows for proper healing of the rectus muscle and tissue ingrowth around the catheter tube. These benefits are highly advantageous during ESRD to instill dialysis fluid immediately into the peritoneal cavity without additional waiting time.

FIG. 1illustrates one non-limiting example of a peritoneal catheter according to one embodiment of the present disclosure.FIG. 2illustrates a second non-limiting example of a peritoneal catheter according to another embodiment of the present disclosure that includes at least an interior cuff. Additionally in those embodiments that utilize an interior cuff on the catheter tube, the relative movement of the mobile flange along the length of the catheter tube to engage and press against the interior cuff ensures the interior cuff is properly positioned within the rectus muscle sheath. This proper positioning of the interior cuff allows for proper tissue ingrowth and healing of the sheath muscle.FIG. 3illustrates another non-limiting example of a peritoneal catheter according to another embodiment of the present disclosure that also includes at least an interior cuff, an outer cuff, and one or more beads on a catheter tube.

With reference now toFIG. 1, there is shown a peritoneal catheter10according to one embodiment of the present disclosure. In this illustrative arrangement, the peritoneal catheter10includes a catheter tube12, a stationary flange14attached to the catheter tube12, and a mobile flange16positioned on the catheter tube12and configured for movement along the catheter tube12.

In this illustrative embodiment as seen inFIG. 1, the hollow catheter tube12defines an outer surface18and an inner surface20surrounding a lumen22that extends axially between proximal and distal ends24and26, respectively. The lumen22is sized to permit delivery of medication, dialysate solution, or other solutions as directed by a physician therethrough directly into the patient's peritoneal cavity. In one form, the thickness of the catheter tube12from the inner surface20to the outer surface18is about 0.010 inch. The diameter of lumen22is substantially uniform through most of catheter tube12in the illustrated embodiment. It is estimated that particularly useful diameters of lumen22range from about 0.05 inch to about 0.2 inch. Of course, there may be applications that require larger or smaller dimensions for catheter tube12. The catheter tube12can be curved or straight as may be desired or necessary for a particular medical procedure.

In some embodiments, the catheter tube12is made of or includes a biocompatible radiopaque material, so as to give the physician the option to visualize catheter tube12by fluoroscopy or X-rays. For example, catheter tube12can be made of silicone, polyurethane, or any other biocompatible material in which barium sulfate or another radiopaque material is mixed or suspended. As another example, distal end26of catheter tube12may be configured to include a guidance element for visualizing, guiding and/or positioning the rotational orientation of catheter tube12within the patient. Such guidance elements include one or more markers, sensors, and/or emitters. For instance, the distal end26and/or other part(s) of catheter tube12may include a radiopaque marker (e.g. a bead of biocompatible metal) to permit visualization or other location of such part(s), in particular their position and/or orientation within a patient's body.

Turning now to the stationary flange14(illustrated inFIG. 4) that is attached to the catheter tube12(illustrated inFIG. 1), the stationary flange14circumferentially surrounds the catheter tube12wherein the stationary flange14has a wall30that defines an opening32sized to snugly receive outer surface18of the catheter tube12. The stationary flange14is positioned near or close to the distal end26of the catheter tube12. In the illustrated embodiment, the stationary flange14is attached to the catheter tube12in a perpendicular orientation relative to a longitudinal axis of the catheter tube12. In another embodiment, the stationary flange14is attached to the catheter tube12in a non-perpendicular orientation relative to a longitudinal axis of the catheter tube12. The wall30is substantially flat; however in other embodiments the wall30is concave or convex relative to the longitudinal axis of the catheter tube12.

As illustrated, the opening32has a corresponding diameter and shape to receive the outer surface18of catheter tube12. The opening32is sized to snugly receive the outer surface18of the catheter tube12such that there are no gaps or space between the opening32and the outer surface18of the catheter tube12. The illustrated embodiment of the stationary flange14has a diameter between the range of about 1 centimeter to about 8 centimeters and a thickness of between about 0.5 millimeters to about 3 millimeters. In one embodiment, the stationary flange14has a diameter of about 27 millimeters. The stationary flange14has a circular or disc shape; however in other embodiments the stationary flange14can be shaped differently such as oval, polygonal, or other curved shape. Moreover in other embodiments, the stationary flange14has a fluted disk shape wherein the stationary flange14is deployed into the patient in a folded configuration and then expands to a substantially flat circular disc once it is inside the patient's body. In any embodiment, the stationary flange14is sized to cover a hole in a rectus muscle of a patient. The stationary flange14can be the same size as the mobile flange16or the stationary flange14can be larger than the mobile flange16.

The stationary flange14is attached to the catheter tube12with any of adhesive, glue, silicone, or any other means that ensures the stationary flange14does not move relative to the catheter tube12. The stationary flange14is made of silicone, plastic, polyethylene, polyurethane, polytetrafluoroethylene, polyvinylidene fluoride, polyvinylidene difluoride, polypropylene, other biocompatible materials, or any combination of these materials.

The mobile flange16as illustrated inFIG. 5is also positioned on the catheter tube12but unlike the stationary flange14, the mobile flange16is configured for movement along the length of the catheter tube12. The mobile flange16circumferentially surrounds the catheter tube12wherein the mobile flange16has a wall34that defines an opening36sized to snugly receive outer surface18of the catheter tube12. The mobile flange16is positioned on the catheter tube12at a location between the stationary flange14and the proximal end24of the catheter tube12. In the illustrated embodiment, the mobile flange16is positioned on the catheter tube12wherein the mobile flange16is configured to slide or cinch over the outer surface18of catheter tube12to move along the length of the catheter tube12. In one embodiment, the force required to push the mobile flange16along the length of and over the outer surface18of the catheter tube12is about 4 Newtons or 0.9 pounds. When the peritoneal catheter10is positioned in a medical patient, the mobile flange16is selectively positioned on the catheter tube12to a location on the catheter tube12that sandwiches the rectus muscle between the stationary flange14and the mobile flange16. In one embodiment, the mobile flange16is in a non-perpendicular orientation relative to the longitudinal axis of the catheter tube12. In another embodiment, the mobile flange16is positioned on the catheter tube12in a perpendicular orientation relative to the longitudinal axis of the catheter tube12. In another embodiment, when the peritoneal catheter10is positioned in a medical patient, the mobile flange16is moved along the length of the catheter tube12to contact the rectus muscle such that the mobile flange16is substantially parallel to the stationary flange14.

The wall34is substantially flat; however in other embodiments the wall34is concave or convex relative to the longitudinal axis of the catheter tube12. As illustrated, the opening36has a corresponding diameter and shape to snugly receive the outer surface18of catheter tube12. As such, the opening36corresponds to the shape and size of a portion of the catheter tube12over which the mobile flange16slides. There are no openings or gaps between the opening36and the outer surface18of the catheter tube12. The illustrated embodiment of the mobile flange16has a diameter between the range of about 1 centimeter to about 8 centimeters and a thickness of between about 0.5 millimeters to about 3 millimeters. In one embodiment, the mobile flange16has a diameter of about 22 millimeters. The mobile flange16has a circular or disc shape; however in other embodiments the mobile flange16can be shaped differently such as oval, polygonal, or other curved shape. In any embodiment, the mobile flange16is sized to cover a hole in a rectus muscle of a patient. The mobile flange16can be the same size as the stationary flange14or the mobile flange16can be smaller than the stationary flange14. The mobile flange16is made of silicone, plastic, polyethylene, polyurethane, polytetrafluoroethylene, polyvinylidene fluoride, polyvinylidene difluoride, polypropylene, or any biocompatible material, or any combination of these materials.

Turning now to positioning the peritoneal catheter10in a body of a patient to begin a medical treatment includes making a small incision in the skin of a medial patient and forming a micropuncture through the rectus muscle and parietal peritoneum of the patient to create a tunnel or opening into the peritoneal cavity. Next an over the wire catheter tube is advanced through the tunnel and a dilator is passed through the tunnel to increase the diameter of the tunnel or dilate out the tunnel. The dilator is removed from the tunnel. Other techniques can be used as are known in the medical field for insertion of a catheter tube into the body of the patient. Next, the distal end26of the catheter tube12is advanced through the tunnel of the body of the patient to a target site in a peritoneal cavity of the patient. Next, the stationary flange14circumferentially surrounding and mounted on the catheter tube12is advanced through the tunnel to a hole in the rectus muscle of the patient. Next, a medical practitioner covers the hole in the rectus muscle of the patient with the stationary flange14. In one embodiment, the medical practitioner pushes the stationary flange14through the hole in the rectus muscle and then pulls the stationary flange14back or away from the body of the medical patient to create a seal over the hole. Thereafter the practitioner advances or pushes the mobile flange16circumferentially surrounding and positioned on the catheter tube12into the body of the patient. Finally, the medical practitioner selectively positions or cinches the mobile flange16along the length of the catheter tube12to a position or location on the catheter tube12to thereby sandwich the rectus muscle between the stationary flange14and the mobile flange16. The mobile flange16also covers the hole in the rectus muscle to create a seal over the hole to begin a medical treatment or peritoneal dialysis immediately. The peritoneal catheter10is immobilized so that the medical treatment can begin immediately by preventing dialysate leakage before the healing and incorporation is completed. No sutures are needed to secure the peritoneal catheter10in the medical patient with the use of the stationary flange14and the mobile flange16.

Turning now to a second embodiment of a peritoneal catheter100illustrated inFIG. 2, the peritoneal catheter100is similar in all aspects to the peritoneal catheter10described above except for the addition of an interior cuff150mounted on a catheter tube112. As such, the peritoneal catheter100includes a catheter tube112, a stationary flange114, a mobile flange116, and an interior cuff150. The catheter tube112, stationary flange114, and the mobile flange116are similar in all aspects to the catheter tube12, stationary flange14, and mobile flange16, respectively, therefore for the sake of brevity these elements will not be described again.

The interior cuff150is mounted on the catheter tube112between the stationary flange114and the mobile flange116wherein the interior cuff150is positioned adjacent to and in contact with the stationary flange114. In one form, the interior cuff150is wrapped around an outer surface118of the catheter tube112to form a tube-like shape that spans between a distal end152to a proximal end154. Alternatively, the interior cuff150is formed in a tube shape with an inner diameter that corresponds to the diameter and outer surface118of the catheter tube112. In this alternative embodiment, there is no space or gaps between the inner diameter of the interior cuff150and the outer surface118of the catheter tube112. The length of the interior cuff150corresponds to about the thickness of a rectus muscle of a medical patient. The length of the interior cuff150ranges from about 5 millimeters to about 50 millimeters; however other lengths can be used as desired by a medical practitioner. The interior cuff150has a wall thickness that spans between the proximal and distal ends152and154, respectively.

Turning now to a discussion of materials that can be used in interior cuff150, such materials can include any suitable biocompatible material. Generally, the material may include synthetic materials, such as a polyester felt, polyethylene terephthalate, polyester, or reconstituted or naturally-derived collagenous materials, or a combination of materials. Such biocompatible materials that are at least bioresorbable will provide advantages in embodiments of the invention, with materials that are bioremodelable and promote cellular invasion and ingrowth providing particular advantage. Illustratively, remodelable materials may be used in this context to promote cellular growth.

Bioremodelable materials of the invention can be provided by collagenous extracellular matrix (ECM) materials possessing biotropic properties, including in certain forms angiogenic collagenous ECM materials. For example, suitable collagenous materials include ECM materials, such as submucosa, renal capsule membrane, dermal collagen, dura mater, pericardium, serosa, facia lata, peritoneum, or basement membrane layers including liver basement membrane. The preferred medical graft products of the invention will include submucosa, such as submucosa derived from a warm-blooded vertebrate. Suitable submucosa materials for these purposes include, for instance, intestinal submucosa, including small intestinal submucosa, stomach submucosa, urinary bladder submucosa, and uterine submucosa. Mammalian submucosa materials are preferred. In particular, submucosa materials derived from animals raised for meat or other product production, e.g. pigs, cattle or sheep, will be advantageous. Porcine submucosa provides a particularly preferred material for use in the present invention, especially porcine small intestine submucosa (SIS), more especially porcine small intestine submucosa retaining substantially its native cross-linking.

The submucosa or other ECM material used in the interior cuff embodiments described herein, such as interior cuff150, can be derived from any suitable organ or other biological structure, including for example submucosa derived from the alimentary, respiratory, intestinal, urinary or genital tracts of warm-blooded vertebrates. Submucosa useful in the present invention can be obtained by harvesting such tissue sources and delaminating the submucosa from smooth muscle layers, mucosal layers, and/or other layers occurring in the tissue source. For additional information concerning submucosa useful in certain embodiments of the present invention, and its isolation and treatment, reference can be made, for example, to U.S. Pat. Nos. 4,902,508, 5,554,389, 5,993,844, 6,206,931, and 6,099,567.

Submucosa or other ECM materials can be derived from any suitable organ or other tissue source, usually sources containing connective tissues. The ECM materials processed for use in certain embodiments will typically include abundant collagen, most commonly being constituted of at least about 80% by weight collagen on a dry weight basis. Such naturally-derived ECM materials will for the most part include collagen fibers that are non-randomly oriented, for instance occurring as generally uniaxial or multi-axial but regularly oriented fibers. When processed to retain native bioactive factors, the ECM material can retain these factors interspersed as solids between, upon and/or within the collagen fibers. Particularly desirable naturally-derived ECM materials for use in embodiments of the invention will include significant amounts of such interspersed, non-collagenous solids that are readily ascertainable under light microscopic examination. Such non-collagenous solids can constitute a significant percentage of the dry weight of the ECM material in certain embodiments, for example at least about 1%, at least about 3%, and at least about 5% by weight in various embodiments of the invention.

The submucosa or other ECM material used in illustrative embodiments may also exhibit an angiogenic character and thus be effective to induce angiogenesis in a host engrafted with the material. In this regard, angiogenesis is the process through which the body makes new blood vessels to generate increased blood supply to tissues. Thus, angiogenic materials, when contacted with host tissues, promote or encourage the formation of new blood vessels. In some instances, it is preferable for a portion of an interior cuff, such as the outer portion, to have an angiogenic character so as to further secure the cuff within the body of the patient and/or resist infection. Methods for measuring in vivo angiogenesis in response to biomaterial implantation have recently been developed. For example, one such method uses a subcutaneous implant model to determine the angiogenic character of a material. See, C. Heeschen et al., Nature Medicine 7 (2001), No. 7, 833-839. When combined with a fluorescence microangiography technique, this model can provide both quantitative and qualitative measures of angiogenesis into biomaterials. C. Johnson et al., Circulation Research 94 (2004), No. 2, 262-268.

As prepared and used, the submucosa material or any other ECM material may optionally retain and/or include growth factors or other bioactive components native to the source tissue. For example, the submucosa or other ECM material 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 material used in embodiments of 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. In certain preferred embodiments of the invention, the ECM material will exhibit the capacity to promote angiogenesis.

Further, in addition or as an alternative to the inclusion of native bioactive components, non-native bioactive components, such as those synthetically produced by recombinant technology or other methods, may be incorporated into the submucosa or other ECM material. These non-native bioactive components may be naturally-derived or recombinantly produced proteins that correspond to those natively occurring in the ECM material, 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. Illustrative drug substances that may be incorporated into and/or onto the ECM material can include, for example, antibiotics and/or thrombus-promoting substances such as blood clotting factors, e.g. thrombin, fibrinogen, and the like. These substances may be applied to the ECM material as a premanufactured step, immediately prior to the procedure (e.g. by soaking the material in a solution containing a suitable antibiotic such as cefazolin), or during or after positioning of the ECM material around the catheter and/or within the patient.

Submucosa or other ECM material used in embodiments of the invention is preferably highly purified, for example, as described in U.S. Pat. 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. The ECM material used in embodiments of the invention is preferably disinfected with an oxidizing agent, particularly a peracid, such as peracetic acid. These and additional properties of submucosa or other ECM materials taught in U.S. Pat. No. 6,206,931 may be characteristic of the submucosa used in aspects of the present invention.

In some embodiments, a sheet of biomaterial is wrapped around the interior cuff150to accommodate tissue ingrowth.

Turning now to positioning the peritoneal catheter100in a body of a patient to begin a medical treatment includes making a small incision in the skin of a medical patient and forming a micropuncture through the rectus muscle and parietal peritoneum of the patient to create a tunnel or opening into the peritoneal cavity. Next an over the wire catheter tube is advanced through the tunnel and a dilator is passed through the tunnel to increase the diameter of the tunnel or dilate out the tunnel. The dilator is removed from the tunnel. Other techniques can be used as are known in the medical field for insertion of a catheter tube into the body of the patient.

Next, a distal end126of the catheter tube112is advanced through the tunnel of the body of the patient to a target site in a peritoneal cavity of the patient. Next, the stationary flange114circumferentially surrounding and mounted on the catheter tube112is advanced through the tunnel to a hole in the rectus muscle of the patient. Next, a medical practitioner covers the hole in the rectus muscle of the patient with the stationary flange114. In one embodiment, the medical practitioner pushes the stationary flange114through the hole in the rectus muscle and then pulls the stationary flange114back or away from the body of the medical patient to create a seal over the hole. The interior cuff150is now positioned in the hole in the rectus muscle. Thereafter the practitioner advances or pushes the mobile flange116circumferentially surrounding and positioned on the catheter tube112into the body of the patient. Finally, the medical practitioner selectively positions or cinches the mobile flange116along the length of the catheter tube112adjacent to and in contact with the interior cuff150to thereby sandwich the rectus muscle and the interior cuff150between the stationary flange114and the mobile flange116. The mobile flange116also covers the hole in the rectus muscle to create a seal over the hole to begin a medical treatment or peritoneal dialysis immediately. The peritoneal catheter100is immobilized so that the medical treatment can begin immediately by preventing dialysate leakage before the healing and incorporation is completed. No sutures are needed to secure the peritoneal catheter100in the medical patient with the use of the stationary flange114, interior cuff150, and the mobile flange116.

Turning now to a third embodiment of a peritoneal catheter200illustrated inFIG. 3, the peritoneal catheter200is similar in all aspects to the peritoneal catheter100described above except for the addition of an outer cuff270and two beads280mounted on a catheter tube212. As such, the peritoneal catheter200includes a catheter tube212, a stationary flange214, a mobile flange216, and an interior cuff250. The catheter tube212, stationary flange214, mobile flange216, and interior cuff250are similar in all aspects to the catheter tube112, stationary flange114, mobile flange116, and interior cuff150, respectively, therefore for the sake of brevity these elements will not be described again. Other embodiments may not include any beads280or alternatively other embodiments may include a different number of beads280or different configuration or arrangement of beads280.

The outer cuff270is mounted on the catheter tube212between the mobile flange216and a proximal end224of the catheter tube212wherein the outer cuff270is positioned nearer to the interior cuff250. Typically, the outer cuff270is mounted on the catheter tube212in a location that would correspond to positioning the outer cuff270in the skin layer when the peritoneal catheter200is implanted in a medical patient. In one form, the outer cuff270is wrapped around an outer surface218of the catheter tube212to form a tube-like shape that spans between a proximal end272and a distal end274. Alternatively, the outer cuff270is formed in a tube shape with an inner diameter that corresponds to the diameter and outer surface218of the catheter tube212. In this alternative embodiment, there is no space or gaps between the inner diameter of the outer cuff270and the outer surface218of the catheter tube212. The length of the outer cuff270ranges from about 10 millimeters to about 25 millimeters; however other lengths can be used as desired by a medical practitioner. The outer cuff270has a wall thickness that spans between the proximal end272and the distal end274.

Turning now to a discussion of materials that can be used in outer cuff270, such materials can include any suitable biocompatible material. Generally, the material may include synthetic materials, such as a polyester felt, polyethylene terephthalate, polyester, or reconstituted or naturally-derived collagenous materials, or a combination of materials, or any material described above for interior cuff250.

The beads280are positioned on the catheter tube212adjacent the interior cuff250and between the interior cuff250and the mobile flange216. The beads280have a dome-like shape but can be shaped differently in other embodiments such as oval, square, polygonal, barb-like, a nub, or any other shape. The beads280are linearly arranged along the longitudinal axis of the catheter tube212; however the beads280can be arranged perpendicular to the longitudinal axis of the catheter tube212. The beads280are positioned at a distance from the interior cuff250that is slightly greater than the thickness of the mobile flange216. The beads280are made of a material that is harder than the material used for the mobile flange216such that the mobile flange216can flex over the beads280and snap into position adjacent the interior cuff250. The beads280can be made of silicone or other plastic material.

Turning now to positioning the peritoneal catheter200in a body of a patient to begin a medical treatment includes making a small incision in the skin of a medical patient and forming a micropuncture through the rectus muscle and parietal peritoneum of the patient to create a tunnel or opening into the peritoneal cavity. Next an over the wire catheter tube is advanced through the tunnel and a dilator is passed through the tunnel to increase the diameter of the tunnel or dilate out the tunnel. The dilator is removed from the tunnel. Other techniques can be used as are known in the medical field for insertion of a catheter tube into the body of the patient.

Next, a distal end226of the catheter tube212is advanced through the tunnel of the body of the patient to a target site in a peritoneal cavity of the patient. Next, the stationary flange214circumferentially surrounding and mounted on the catheter tube212is advanced through the tunnel to a hole in the rectus muscle of the patient. Next, a medical practitioner covers the hole in the rectus muscle of the patient with the stationary flange214. In one embodiment, the medical practitioner pushes the stationary flange214through the hole in the rectus muscle and then pulls the stationary flange214back or away from the body of the medical patient to cover and create a seal over the hole. The interior cuff250is now positioned in the hole in the rectus muscle. Thereafter the practitioner advances or pushes the mobile flange216circumferentially surrounding and positioned on the catheter tube212into the body of the patient. Finally, the medical practitioner selectively positions or cinches the mobile flange216along the length of the catheter tube212adjacent to and in contact with the interior cuff250to thereby sandwich the rectus muscle and the interior cuff250between the stationary flange214and the mobile flange216. If the beads280are present on the catheter tube212, the mobile flange216is pushed over the beads280to contact the interior cuff250and snap into position against the interior cuff250. The mobile flange216also covers the hole in the rectus muscle to create a seal over the hole to begin a medical treatment or peritoneal dialysis immediately. The peritoneal catheter200is immobilized so that the medical treatment can begin immediately by preventing dialysate leakage before the healing and incorporation is completed. No sutures are needed to secure the peritoneal catheter200in the medical patient with the use of the stationary flange214, interior cuff250, and the mobile flange216.

While at least one embodiment has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that the preferred embodiment has been shown and described and that all changes, equivalents, and modifications that come within the spirit of the inventions defined by following claims are desired to be protected. It will be evident from the specification that aspects or features discussed in one context or embodiment will be applicable in other contexts or embodiments. All publications, patents, and patent applications cited in this specification are herein incorporated by reference as if each individual publication, patent, or patent application were specifically and individually indicated to be incorporated by reference and set forth in its entirety herein.