HK1150526B - Implantable tissue connector - Google Patents

Abstract

An implantable tissue connector (1; 1 a) adapted to be connected to a tubular part of living tissue (70; 80) within a patient's body (100) comprises a conduit (2) and at least one flexible sleeve (10) adapted to axially extend and closely fit around at least part of the outer surface (6) of the conduit. The conduit is inserted into the tubular part of living tissue and the flexible sleeve placed over the tubular part of living tissue. Various alternatives are described of how the living tissue may be prevented form slipping off of the conduit.

Description

Implantable tissue connector

Technical Field

The present invention relates to an implantable tissue coupler which is particularly suitable for coupling to a tubular section of living tissue in a patient, such as the large intestine of a human when setting an artificial exit opening of the large intestine. However, the implantable tissue connector of the present invention is not limited to such applications and, as will be described in greater detail below, may be used in connection with many other types of tubular living tissue.

Background

The operation of connecting the end of the human large intestine to an artificial outlet, such as a fecal waste collection container, or connecting the shortened large intestine to the patient's own intestinal outlet is often difficult and unreliable. If the joint is not tight enough, leakage can occur over the life of the joint. The circulation of blood in the end regions of the intestinal tissue may be hindered, which may negatively affect the muscular function of the intestine and the peristalsis of the intestine and may even lead to malnutrition of various parts of the intestine. In addition, the peristaltic movement of the intestine will continue to act on the joint, which may be damaged over time.

Disclosure of Invention

It is therefore an object of the present invention to provide an implantable tissue coupler for coupling tubular living tissue in a patient's body, which coupling should be reliable over time and not cause serious damage to the living tissue.

It is another object of the present invention to provide such a tissue connector for various uses and methods of implanting the tissue connector in a patient.

Accordingly, the implantable tissue connector of the present invention includes a catheter having at least first and second ends and an outer surface, and at least one flexible sleeve disposed on the outer surface of the catheter and extending axially around at least a portion of the catheter. According to a first embodiment, the flexible sleeve initially overlies the outer surface in a folded or rolled over itself. According to a second embodiment, the flexible sleeve initially overlies the outer surface so that the sleeve may be folded over itself.

The first end of the conduit of the tissue connector is connected to the tubular portion of living tissue by inserting the first end into the tubular portion of living tissue. According to a first embodiment, the flexible sleeve is folded or rolled over itself onto the outer surface of the catheter, in which case the flexible sleeve is unrolled or rolled so that at least part of the living tissue extending over the outer surface of the catheter is located between the sleeve and the outer surface of the catheter. According to a second embodiment, the flexible sleeve initially covers the outer surface of the catheter so that the sleeve can be folded over itself, in which case the flexible sleeve is folded over itself so that at least part of the living tissue is located between the folded sleeve or the outer surface of the catheter and the sleeve.

In either case, the tubular tissue is located at a position between the catheter and the flexible sleeve and can be held at that position in various forms as will be described hereinafter, which forms can be used independently or in combination with each other.

Advantages achieved by the tissue connector of the invention include a good sealing of the living tissue between the catheter and the flexible sleeve, and a good protection of the living tissue by the flexible sleeve. In this way, the connection can be made reliable over time while also protecting the tissue from injury.

When the flexible sleeve covers living tissue overlying the first end of the catheter, it is necessary to cause the flexible sleeve to exert radial pressure on the tissue. In practice, this arrangement may be sufficient to hold the tissue connector in place when no movement is desired. In other instances, when movement of tissue material is desired, such as when the tissue connector is used as an intestinal connector, the radial pressure will help hold the components in place until they are fixed relative to each other. In any case it is preferred that the flexible sleeve is designed to minimize the radial pressure so as not to obstruct blood circulation in living tissue.

In addition, the conduit should be designed such that it is less flexible than the flexible conduit, at least in the radial direction, to provide a support effect for the sleeve against radial forces, in particular against radial pressure forces of the sleeve as described above. In this way, the open inner cross-section of the conduit will not be affected by radial forces caused by the flexible sleeve.

Another particularly preferred way of securely connecting living tissue to the tissue connector involves a flexible sleeve comprising a porous ingrowth layer allowing ingrowth of living tissue. This not only strengthens any connection between the tissue connector and the tissue, but also acts as a further seal against the connection to prevent any leakage.

The ingrowth layer should be made of a material that stimulates tissue ingrowth. Preferably, the ingrowth layer has a network which is pierceable by ingrown tissue, thereby allowing it to surviveA durable connection is created between the tissue and the flexible sleeve. Of course, the ingrowth layer should be made of a biocompatible material such as dacronAnd (4) preparing.

Another way to secure living tissue reliably to the tissue connector is to take measures to suture a flexible sleeve to the living tissue. Alternatively, the suturing may be performed through the flexible sleeve and the outer wall of the catheter and the portion of living tissue therebetween. Thereby, the tissue is simultaneously secured to the flexible sleeve and the catheter. Even if leakage occurs through a needle hole grown by suturing, it will automatically close over time due to tissue material growth.

Suturing may also be performed through the living tissue and the outer wall of the catheter prior to placing the flexible sleeve over the living tissue. This solution eliminates any leakage problems through the puncture caused by the suture as the sleeve will overlie and seal such a puncture.

Preferably, the thread for suturing is made of a material that is absorbable by the patient's body. Typically, the thread will be absorbed by the body within about 6 weeks. However, at this point the degree of tissue ingrowth will be sufficient to replace the loss of strength initially provided by the thread.

Instead of or in addition to suturing the flexible sleeve to the catheter with a preferably absorbable thread, the sleeve may be fixedly attached to the catheter in other suitable ways along the axially extending portion of the sleeve. For example, the conduit and the sleeve may be bonded together along at least part of the axial extension of the sleeve. A primer may be applied to the outer surface of the catheter and/or to the flexible sleeve to enhance bonding.

The flexible sleeve may comprise a multilayer material. This is particularly advantageous when the flexible sleeve comprises a porous ingrowth layer as described above. For example, the porous ingrowth layer may not be sufficiently stable on its own to safely process and cover the tubular tissue and/or the porous ingrowth layer may not be able to exert radial pressure on the tissue. In either case, it is advantageous to provide the flexible sleeve with a support layer to support the porous ingrowth layer.

The support layer may be made of, for example, polyurethane or expanded polytetrafluoroethylene (ePTFE). ePTFE is particularly preferred because it can be designed with pores of sufficient size to allow the necessary exchange of particles and/or elements between the underlying tissue and the surrounding area of the patient's body. In addition, the support layer may provide better protection to tissue than the ingrowth layer.

Preferably, the support layer forms the outer layer of the flexible sleeve after implantation, or at least the ingrowth layer will be located radially inwardly with respect to the support layer. Thus, in the case of a flexible sleeve overlaying the outer surface of a catheter to enable the flexible sleeve to be folded over itself, the ingrowth layer will be located between portions of the support layer when the flexible sleeve is folded over itself. Alternatively, where the flexible sleeve is folded or rolled upon itself over the outer surface of the catheter, the ingrowth layer will be located radially inward of the support layer when the sleeve is unrolled or rolled.

In terms of materials, the catheter and the flexible sleeve are preferably both made of biocompatible materials. For the sleeve, polymers such as Polytetrafluoroethylene (PTFE), ePTFE, silicone, and/or polyurethane are preferably included.

For catheters, the same or other biocompatible polymeric materials may be used, including, for example, Polyetheretherketone (PEEK). However, other materials such as ceramics and metals, particularly titanium and stainless steel, may also be used and are preferred due to their strength.

The catheter may be much longer than the particular portion of the catheter that is connected to the tubular tissue. In this case, it is preferred that the flexible sleeve be located near each end of the catheter so that the portion of tissue overlying the catheter is not too large. The larger the portion of tissue covered, the more serious the problems that may arise from blood circulation within this portion of tissue.

The tissue connector may be used to connect two dissimilar ends of a tubular living tissue to each other. In this case, the catheter has a flexible sleeve at each of the first and second ends of the catheter. Likewise, a flexible sleeve is preferably located proximate to the first and second ends.

In order to facilitate the step of inserting the catheter tip into the tubular living tissue, it is advantageous to take measures for tapering the free end portion in the catheter tip towards the edge of said free end portion. Alternatively or additionally, the free end portion may have a rounded edge. The rounded edge will help to prevent any damage to living tissue when the tissue covers the free end of the catheter.

In another particularly preferred embodiment of the invention, special elements are provided for preventing tubular tissue from slipping out of the catheter. Likewise, these members may be combined with any of the above alternatives for securing living tissue to the tissue connector.

More particularly, in accordance with the preferred embodiment, the tissue connector includes at least one protrusion extending outwardly from an outer surface of the catheter around at least a portion of the catheter circumference in the direction of the catheter circumference. In addition, at least one snap ring is loosely fitted on the outer surface of the catheter with a gap between the outer surface of the catheter and the snap ring to place living tissue into the gap. An inner cross-sectional diameter of the snap ring is less than or substantially equal to an outer cross-sectional diameter of the at least one projection to prevent the snap ring from sliding past the projection when placing living tissue into the void.

When the tissue connector is implanted in a human or animal body, the living tissue will cover the outer surface of the catheter, including the protrusions. The collar will then sleeve the living tissue from outside the protrusion towards the protrusion so that at least part of the living tissue is located between the outer surface of the catheter and the collar. The effect of this arrangement is that when tissue has a tendency to slip off the catheter, the tissue will carry the snap ring towards and against the protrusion. By this action, living tissue will be squeezed between the protrusion and the snap ring, thereby preventing further sliding. This effect increases automatically as the sliding force increases. When the force has a tendency to decrease again, the compression force is reduced, so that the blood circulation in the living tissue is not adversely affected for longer than necessary.

The size of the gap in the radial direction depends on the intended use of the tissue connector, i.e. on the thickness of the tubular living tissue connected to the tissue connector. Therefore, the average value of the size may be 0.1 to 0.4mm, 0.4 to 0.8mm, 0.8 to 1.3mm, 1.3 to 2mm, 2 to 3mm, 3 to 4mm, 4 to 5mm, 5mm or more. The void should be slightly less than the thickness of the living tissue so as not to significantly affect blood circulation in or of the tissue, while ensuring sufficient frictional contact.

The cross-sectional diameter of the snap ring should preferably be smaller than the cross-sectional diameter of the protrusion, however in some instances the cross-sectional diameter of the snap ring is equal to or even larger than the cross-sectional diameter of the protrusion, since the thickness of the living tissue will be superimposed on the cross-sectional diameter of the protrusion even in the squeezed state, and thus the combined total thickness prevents the snap ring from sliding over the protrusion. Thus, in the case of particularly thick living tissue, the inner cross-sectional diameter of the snap ring may be even larger than the outer cross-sectional diameter of the protrusion.

Of course, it is still preferred that the snap ring is made of a biocompatible material, in particular those materials mentioned above which are also suitable for the catheter.

In the case where the tissue connector is used to connect two dissimilar ends of a tubular living tissue material, the tissue connector may have two of the above-described projections, the collar preferably being located adjacent each end of the catheter, and preferably having at least two collars each located between the two projections. Of course, each end of the conduit may be provided with more than one snap ring and/or more than one protrusion.

As mentioned at the outset, the tissue connector of the present invention is not limited to application at the end of the human large intestine. It may be advantageously used in many other applications.

For example, the tissue connector may be positioned in the esophagus of a human. In this case, the inner diameter of the catheter of the tissue connector should be between 2-3.5cm to provide a snug fit. The gap between the conduit and the collar should be in the range of 2.5-5 mm.

In the case of the tissue connector being connected to a person's trachea, the inner diameter should be chosen between 1.5-2.5cm, depending on the position in the person's trachea to be connected, to provide a snug fit. The gap between the conduit and the collar should be in the range of 1-2 mm.

The inner diameter of the catheter may vary over a greater range when the tissue connector is positioned in a human stomach. The clearance between the conduit and the snap ring should be in the range of 3.5-5 mm.

The tissue connector may also be positioned in a person's gallbladder or in a duct connecting the gallbladder to the outlet. In this case, the inner diameter of the conduit should be between 0.5 and 1.3 cm. The gap between the conduit and the snap ring should be between 0.5 and 1.5 mm.

In case the tissue connector is positioned in the small intestine of a human, the inner diameter of the catheter should be between 2-3 cm. The gap between the conduit and the snap ring should be between 3-4 mm.

In the case of the human large intestine, which is of a diameter that can be extended considerably, the inner diameter of the catheter should be between 3-5.5cm to provide a snug fit. The clearance between the conduit and the snap ring should be in the range of 2-3.5 mm.

The tissue connector may also be positioned in a urethra of a person. In this case, the inner diameter of the conduit should be between 0.4 and 0.8 cm. The gap between the conduit and the snap ring should be between 0.5 and 1.5 mm.

The tissue connector may also be placed in a human ureter, in which case the inner diameter of the catheter should be chosen between 0.4-0.7 cm. The clearance between the conduit and the snap ring should be in the range of 2-4 mm.

The tissue connector may also be connected to a kidney. In order to be slidingly positioned to the renal pelvis portion, the inner diameter of the catheter should be in the range of 1-5cm, depending on the location in the human renal pelvis to be connected. The gap between the conduit and the snap ring should be between 0.5 and 1.5 mm.

The tissue connector may also be positioned in a blood vessel of a person. In this case, the inner diameter of the catheter should be selected to approximately approximate the inner diameter of the respective blood vessel. For example, when the blood vessel is particularly small, the inner diameter may be selected to be between 0.1 and 0.5 cm. The tissue connector may also be attached to the aorta or the atrium or ventricle of the human being, in which case the inner diameter of the catheter is in the range of 2-3 cm. The clearance between the conduit and the snap ring should be in the range of 1-2 mm.

The tissue connector may also be used as a mid-section part instead of a part of a tubular living tissue, and may also be used to connect different types of tubular living tissue, as is the case for connecting a biological graft of a third party's body to a diseased organ.

The tissue connector is particularly useful and adapted for coupling to at least one of an implantable container, an implantable pump, an implantable motor, an implantable medical device, and a bioimplant. These artifacts may even form part of the tissue connector by being integrally formed with the tissue connector or separately attached to the tissue connector. The container, pump, motor and/or medical device may also incorporate the tissue connector between the first and second ends of the catheter.

The biological graft can be any graft, such as a transplanted heart to be connected to the patient's aorta and/or other blood vessels (pulmonary arteries, etc.) with the tissue connector.

The containers described above may be constructed of biological implants in place of artificial implants, but may also be made of the patient's tissue material into which the container is to be implanted. For example, the container may be a fecal waste collection container, such as a bladder or small intestine.

The container may also be a reservoir for a medical drug required by a patient and is preferably adapted to be filled with at least one medical drug. Such a medical drug reservoir may or may not be connected to a medical device, such as an implantable drug delivery device, which may additionally comprise a pump for pumping drug from the reservoir to the patient's body, and possibly a motor for use by the pump.

Any other implantable medical device may also be connected to the patient's organ through the tissue connector with or without a pump, motor and/or reservoir. Examples of such implantable medical devices are artificial hearts, artificial penis, artificial bladder, artificial urethra, artificial esophagus, artificial trachea, and the like. Examples of biological grafts include bladder, small intestine, urethra, ureter, kidney, large intestine, heart, esophagus, trachea, blood vessels, and the like.

The tissue connector of the present invention may be implanted in a human or animal body in open surgery or by subcutaneous surgery. In either case, the skin must be incised and then freely-dissected (free-dissected) in the patient's body in a suitable position adjacent to the tubular living tissue, and at least suturing of the skin is required at the end of the procedure after attaching one or both ends of the catheter of the tissue connector to the tubular tissue.

When the tissue connector is implanted by subcutaneous surgery, the steps of incising the skin and freely dissecting the appropriate site within the patient's body include the steps of:

-inserting needle tubes into the body of a patient, such as the chest and abdomen,

-inflating gas into the patient through the needle, i.e. into the thoracic or abdominal cavity,

-cutting open a lock hole,

-inserting at least one, preferably two laparoscopic trocar through said keyhole towards said location,

-advancing one or more medical instruments through the at least one trocar to the location, i.e. into the chest or abdomen, and

-dissecting a region of the tubular portion of living tissue by means of a dissecting tool,

-the tissue connector can be delivered to the site through the at least one trocar or through a separate incision.

The invention will now be described in more detail in connection with some preferred embodiments thereof as illustrated in the accompanying drawings.

Drawings

Figure 1 is a schematic view of a patient with one tissue connector connected to the aorta of the patient and another tissue connector connected to the end of the large intestine of the patient.

Fig. 2a and 2b are cross-sectional views of a first embodiment of the tissue connector in a mounted and connected state.

Fig. 3a and 3b are cross-sectional views of an alternative to the first embodiment of the tissue connector in an installed and connected state.

Fig. 4a and 4b show a second embodiment of the tissue connector in a mounted and connected state.

Fig. 5 shows an alternative arrangement for placing living tissue on the free end of the tissue connector.

Fig. 6a and 6b show a combination of an embodiment similar to that shown in fig. 2a and 2b with a further installation method as shown in fig. 5.

FIG. 7 shows a particular embodiment of a tissue connector with both ends attached to living tissue.

Detailed Description

Fig. 1 schematically shows a patient's body 100 with a first tissue connector 1 connected to the end of the patient's large intestine 50 and a second tissue connector 1a connecting the patient's two major arteries 60 from the middle. The tissue connector 1 may connect the large intestine 50 to the anus of a patient or an artificial anus which may include a waste collection receptacle. The tissue connector 1a may comprise a heart valve, a blood pump, a drug delivery device or similar device between its two ends.

The tissue connectors 1 and 1a shown in fig. 1 represent only a few of the many different possible locations and applications of the tissue connectors in the human or animal body. Other examples of possible applications have been outlined further above.

Fig. 2a and 2b show a first embodiment of the tissue connector 1 in a state where the tissue connector 1 is mounted to a tubular part of a living tissue 70. The tissue connector 1 comprises a catheter 2 having a first end 3 and a second end 4. In fig. 2a, the first end 3 of the catheter 2 has been inserted into the end of a living tissue 70. The inner cross-section of the catheter 2 is chosen to substantially match the inner cross-section of the tubular living tissue 70 so as not to obstruct the flow of any substance. The thickness of the generally annular wall 5 of the catheter is selected to provide sufficient strength to ensure that the forces to which the catheter is subjected in use do not collapse the catheter, whilst providing sufficient flexibility as required. On the other hand, the thickness should not be chosen too large, since the living tissue 70 has to be stretched over the outer surface 6 of the catheter 2 without damaging and without excessively affecting the blood circulation in the end 71 of said living tissue.

The wall 5 of the conduit 2 is tapered towards its leading edge 7. In addition, the leading edge 7 is rounded. Both of these treatments prevent injury to the living tissue 70 when the catheter 2 is inserted into the tip 71 of the living tissue 70.

Second end 4 may serve as and be adapted to be coupled to an implantable medical device, an implantable container, an implantable pump, an implantable motor, or a combination thereof, generally indicated by reference numeral 200. It may also be connected to any other implantable device 200. The implantable device 200 may even be integrated or connected to the tissue connector 1 so as to constitute a part of the tissue connector 1.

The implantable device 200 may also be a medical device that replaces one or more organs of a patient, such as an artificial bladder, a collection receptacle for fecal waste, an artificial urethra, an artificial heart, an artificial esophagus, an artificial trachea, or the like. Alternatively, the second end 4 of the catheter 2 may be connected to a biological implant from a third body, such as the bladder, small intestine, urethra, ureter, kidney, large intestine, heart, esophagus, trachea, blood vessel, or the like.

The device 200 may also include a flow restrictor for partially or completely restricting flow through the conduit. This arrangement may be suitable where the tissue connector is located at the end of the patient's large intestine.

The device 200 may also be provided between the tissue connector 1 and a second tissue connector 1b with a catheter 2b, as shown in fig. 2a with dashed lines. This arrangement is useful in the case where the device 200 must be located in an organ of a patient, such as a blood vessel, in which case the blood vessel is severed and the device 200 is placed between two tissue connectors 1 and 1b connected to the respective free ends of the severed blood vessel. For example, the device 200 may include a flow restrictor, such as an artificial heart valve or a drug delivery reservoir.

In addition to the catheter 2 and optional device 200, the tissue connector 1 of the embodiment shown in fig. 2a has an axially extending flexible sleeve 10 that surrounds and mates with a portion of the outer surface 6 of the catheter 2. The flexible sleeve 10 may be delivered separately from the catheter 2 and applied to the outer surface 6 of the catheter just prior to placement in a patient. However, it is preferred that the catheter 2 is provided with the flexible sleeve 10 as a unitary body, the flexible sleeve 10 being preferably secured to the outer surface 6 by gluing, welding and/or crimping. In the case of bonding, it may be advisable to pretreat the outer surface 6 with, for example, a primer, depending on the combination of materials to be bonded together.

In fig. 2a the flexible sleeve 10 is rolled over itself and may be rolled over a portion 71 of the living tissue 70 to cover, seal and protect the portion 71 on the first end 3 of the catheter 2, as shown in fig. 2 b. The tissue portion 71 and the covering portion 11 of the flexible sleeve 10 are fixed to the first end 3 of the catheter 2 by means of a suture 20 passing through the tissue portion 71 and the covering portion 11 of the flexible sleeve 10 and the wall 5 of the catheter 2, as shown in dashed lines in fig. 2 b.

The flexible sleeve 10 is a multi-layer material that includes a porous ingrowth layer to allow ingrowth of living tissue. For this purpose, it has a net structure. On top of the ingrowth layer 11 there is a support layer 12. The support layer 12 may have one or more different functions. One possible function is to provide support for the growth layer 11 to make processing easier and/or to prevent growth confusion (missing) of the growth layer. In addition, the support layer 12 may also provide some tension, thereby applying a compressive force in a radial direction to gently clamp the tissue portion 71 against the outer surface 6 of the catheter 2. For this purpose, the support layer should have a suitable elasticity. Finally, the support layer may provide protection for tissue portion 71.

Preferably, the support layer should be porous to allow for exchange between the tissue portion 71 and the surrounding area within the patient's body. This is an important aspect for the process of ingrowth of living tissue material into the ingrowth layer 11. Expanded polytetrafluoroethylene (ePTFE) is particularly suitable because it is flexible, inert, and can be made with any desired porosity. Other biocompatible polymers, such as polyurethane and the like, are also suitable.

Fig. 3a and 3b show an alternative to the first embodiment of the tissue connector, which differs from the connector shown in fig. 2a and 2b in that the flexible sleeve 10 is not rolled over itself, but instead is folded over itself. The folded-up cannula 10 may be applied over the tissue portion 71 by unfolding it, as shown in fig. 3b, in the same manner as described in the discussion related to fig. 2a, 2b above.

Fig. 4a and 4b show a second embodiment of the tissue connector, wherein the flexible sleeve 10 is configured such that it can be folded over itself. More particularly, the first end 3 of the catheter 2 is inserted into the tissue portion 71 of the living tissue 70 to such an extent that the tissue portion 71 overlaps the first portion 13 of the flexible sleeve 10. The remaining portion 14 of the flexible sleeve 10 not covered by the tissue portion 71 is rolled upon itself and may be unrolled to cover the tissue portion 71. As a result, shown in FIG. 4b, the flexible sleeve 10 is folded over itself with the tissue portion 71 disposed in the middle of the folded sleeve 10.

Unlike the previously described embodiments, the suturing of the tissue portion 71 to the wall 5 of the catheter 2 is performed before covering the tissue portion 71 with the remaining portion 14 of the flexible sleeve 10. The remaining portion 14 thus seals all the puncture holes created by the suture.

In a not shown alternative of said second embodiment, the first end 3 of the catheter 2 is inserted into the tissue portion 71 only to such an extent that the tissue portion 71 does not overlap the cannula 10. Thus, after unwinding flexible sleeve 10, only a portion of folded sleeve 10 will cover tissue portion 71.

In addition, although also not shown, the remainder 14 of the sleeve 10 does not necessarily need to be rolled upon itself as shown in fig. 4a, but may be flattened against the outer surface 6 of the catheter 2, similar to the embodiment shown in fig. 3 a.

As will be appreciated, the portion 13 of the flexible sleeve 10 is seated in a circumferential groove provided in the outer surface 6 of the catheter 2. This solution is advantageous when the depth of the groove corresponds to the thickness of the flexible sleeve 10. This will facilitate the introduction of the first end 3 of the catheter 2 into the living tissue 70.

Fig. 5 shows one possible solution for fixing the catheter 2, such as connecting the second end 4 of the catheter to a tubular part of living tissue 80 or a length of a flexible tube belonging to or connected to a medical device, container or the like. Thus, at least one protrusion 15 extends outwardly from the outer surface 6 of the catheter 2 around at least part of the circumference of the catheter in the circumferential direction of the catheter. In addition, at least one snap ring 30 is loosely fitted on the outer surface 6 of the catheter 2 with a gap between the outer surface 6 and the snap ring 30, such snap ring being provided to place the tubular living tissue 80 (or the hose) into the gap. The inner cross-sectional diameter of the snap ring is approximately the same as the outer cross-sectional diameter of the protrusion 15. This arrangement prevents the snap ring from sliding past the projection when the living tissue 80 shown in fig. 5 is placed in the void.

When an axial force has a tendency to pull the tubular living tissue 80 against the outer surface 6 of the catheter 2, the snap ring 30 will move together with the tubular tissue 80, thereby pressing the tubular tissue 80 against the protrusion 15 to prevent any further sliding of the tubular tissue 80 beyond the protrusion 15. This is a self-enhancing effect.

Such a locking mechanism may be combined with any of the above-described embodiments of the tissue connector. Of these variants, only one will be exemplarily described below in connection with fig. 6a and 6 b. The embodiment shown in figures 6a and 6b is substantially identical to that of figures 2a and 2b, with the flexible sleeve 10 rolled upon itself and then unrolled to cover the tubular tissue 80, in this case the tubular tissue 80 being covered sufficiently long on the second end 4 of the catheter 2 that the protrusions 15 are also covered. After the flexible sleeve 10 has been rolled out and covered over the tubular tissue 80, the snap ring 30 is pushed over the flexible sleeve towards the protrusions 15. After a certain time, the thread 20 (fig. 6 a) sutured to the tubular tissue 80 and to the wall 5 of the catheter 2 will be absorbed by the patient's body and, during the same time, living tissue will form therein and connect the tubular tissue 80 to the ingrowth layer 11 of the flexible sleeve 10. Thus, when the tubular tissue 80 has a tendency to be pulled away from the second end 4 of the catheter 2, the snap ring 30 will also be moved, pressing the tubular tissue 80 and the flexible sleeve 10 towards the protrusions 15 and thereby preventing any further sliding of the tubular tissue 80 past the protrusions 15. The coefficient of friction between the snap ring 30 and the outer surface of the flexible sleeve should be higher than the coefficient of friction of the outer surface 6 of the catheter against the tubular tissue 80.

It is noted that the flexible sleeve 10 does not necessarily need to extend over the protrusion 15 in the rolled-out state as shown in fig. 6b, but may end at a distance from said protrusion. In this case, the snap ring 30 will not clamp the sleeve 10 at the protrusion 15.

The description of the above embodiments primarily relates to a tissue connector for attachment to tubular living tissue at only one or both ends. However, as also mentioned before, there are various applications where the tissue connector can be connected to two pieces of tubular living tissue, such as when bridging two identical pieces of tubular living tissue or connecting tubular living tissue to tissue of a biological graft. To this end, the second end 4 of the catheter 2 of the tissue connector may be designed according to any of the above embodiments. Fig. 7 shows an example illustrating how such a tissue connector may be designed. Thereby, two flexible sleeves 10 are integrally formed to form a single flexible sleeve 10a, each of the sleeves 10 being rolled upon itself, similar to the embodiment shown in fig. 2 a. Of course, the two flexible sleeves 10 may be provided independently of each other. Alternatively, the protrusion 15 and snap ring 30 may be provided at one or both of the catheter ends 3 and 4. Additionally, a medical device, flow restrictor or similar device may be incorporated between the two ends 3 and 4.

Claims (61)

1. An implantable tissue connector configured to be connectable to a tubular portion of living tissue in a patient's body, the implantable connector comprising

-a conduit having at least a first and a second end and further having an outer surface, and

-at least one flexible sleeve adapted to extend axially and tightly surround at least part of the outer surface of the catheter

Wherein the flexible sleeve is folded or rolled over itself over the outer surface such that it can be unfolded or rolled out, or the flexible sleeve is rolled over the outer surface such that the flexible sleeve can be folded over itself.

2. The tissue connector of claim 1, wherein the catheter is made of a biocompatible material.

3. The tissue connector of claim 2, wherein the biocompatible material of the catheter is a material from the group of materials consisting of: titanium, stainless steel, ceramics, Polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), Polyetheretherketone (PEEK), silicone, polyurethane, polypropylene, other biocompatible polymeric materials.

4. The tissue connector of claim 1, wherein the flexible sleeve is made of a biocompatible material.

5. The tissue connector of claim 4, wherein the biocompatible material of the flexible sleeve comprises at least one polymer.

6. The tissue connector of claim 5, wherein the at least one polymer is a polymer from the group of polymers consisting of: polytetrafluoroethylene, silicone resin, polyurethane, expanded polytetrafluoroethylene (ePTFE).

7. The tissue connector according to any of claims 1-6, wherein in a situation where the flexible sleeve is fitted over the outer surface of the catheter such that the flexible sleeve is foldable over itself, the flexible sleeve will exert a radial pressure when folded over itself.

8. The tissue connector of claim 7, wherein said tissue connector is adapted to exert said radial pressure on any tubular living tissue located between said folded sleeves when said tissue connector is implanted in a patient with said flexible sleeve folded over itself.

9. The tissue connector of claim 1 wherein the flexible sleeve will exert radial pressure when unrolled or rolled with the flexible sleeve folded or rolled over itself over the outer surface.

10. The tissue connector of claim 9, wherein said tissue connector is adapted to exert said radial compressive force on any tubular living tissue located between said sleeve and an outer surface of said catheter when said tissue connector is implanted in a patient's body in a deployed or rolled-out state of said sleeve.

11. The tissue connector of claim 8 wherein the radial compressive force is a minimum value such that blood circulation within living tissue is not impeded.

12. The tissue connector of claim 9 wherein the radial compressive force is a minimum value such that blood circulation within living tissue is not impeded.

13. The tissue connector of claim 1, wherein the conduit is at least radially less flexible than the flexible sleeve to provide support to the sleeve against radial forces.

14. The tissue connector of claim 1 wherein the flexible sleeve includes a porous ingrowth layer that allows ingrowth of living tissue.

15. The tissue connector of claim 14, wherein the ingrowth layer has a mesh structure.

16. The tissue connector of claim 1 wherein said flexible sleeve comprises a multi-layer material.

17. The tissue connector of claim 14, wherein the flexible sleeve further comprises a support layer for supporting the porous ingrowth layer.

18. The tissue connector of claim 17, wherein the support layer is made of expanded polytetrafluoroethylene (ePTFE) or polyurethane.

19. The tissue connector of claim 15, wherein the flexible sleeve further comprises a support layer for supporting the porous ingrowth layer, and wherein upon folding the flexible sleeve over the outer surface of the catheter such that the flexible sleeve is foldable over itself, the ingrowth layer will be located between portions of the support layer when the sleeve is folded over itself.

20. The tissue connector of claim 15, wherein the flexible sleeve further comprises a support layer for supporting the porous ingrowth layer, and wherein with the flexible sleeve folded or rolled over itself over the outer surface, the ingrowth layer will be located radially inward relative to the support layer when the sleeve is unfolded or rolled.

21. The tissue connector of claim 1, wherein the catheter and the flexible sleeve are fixedly connected to each other along a portion of the sleeve extending axially.

22. The tissue connector of claim 21, wherein said catheter and flexible sleeve are bonded together along at least a portion of said axial extension of said sleeve.

23. The tissue connector of claim 22, wherein a primer is included on at least one of the catheter and the flexible sleeve to enhance adhesion.

24. The tissue connector of claim 1, wherein the at least one flexible sleeve is located near the first end of the catheter.

25. The tissue connector of claim 1, wherein the catheter has at least two of the flexible sleeves.

26. The tissue connector of claim 25, wherein the at least two flexible sleeves are located adjacent one of at least a first end and a second end of the conduit, respectively.

27. The tissue connector of claim 1, wherein the first end of the conduit has a free end and is tapered toward an edge of the free end.

28. The tissue connector of claim 1, wherein the first end of the conduit has a free end portion with rounded edges.

29. The tissue connector of claim 1, further comprising

-at least one protrusion extending outwardly from an outer surface of the catheter around at least part of the circumference of the catheter in a circumferential direction of the catheter, and

-at least one snap ring loosely fitted on the outer surface of the catheter with a gap between the outer surface and the snap ring for placing the tubular living tissue or hose into said gap, said snap ring having an inner cross-sectional diameter smaller than or substantially equal to the outer cross-sectional diameter of said at least one protrusion for preventing said snap ring from sliding past said protrusion when placing the living tissue or hose in said gap.

30. The tissue connector of claim 29, wherein the snap ring is made of a biocompatible material.

31. The tissue connector of claim 30, wherein the biocompatible material of the snap ring is a material from the group of materials consisting of: titanium, stainless steel, ceramic, polytetrafluoroethylene, silicone resin, polyurethane.

32. The tissue connector of claim 29, wherein the at least one protrusion is located near the first end of the conduit.

33. The tissue connector of claim 29, wherein the catheter has at least two of the protrusions with at least two of the clasps positioned between the at least two protrusions.

34. The tissue connector of claim 33, wherein the at least two protrusions are located near one of at least a first end and a second end of the conduit, respectively.

35. The tissue connector of claim 29, wherein the size of the gap is within one of the following ranges, depending on its use: 0.1-0.4mm, 0.4-0.8mm, 0.8-1.3mm, 1.3-2mm, 2-3mm, 3-4mm, 4-5mm, 5mm or more.

36. The tissue connector of claim 1, wherein the second end of the conduit is adapted to connect the tissue connector to at least one of: implantable containers, implantable pumps, implantable motors, implantable medical devices, biological implants.

37. The tissue connector of claim 1, wherein at least one of the following is disposed between or in connection with the first end and the second end of the conduit: container, pump, motor, medical device.

38. The tissue connector of claim 37, wherein the container is an artificial or biological graft or is made of diseased tissue material into which the container is to be implanted.

39. The tissue connector of claim 36, wherein the container is a fecal waste collection container.

40. The tissue connector of claim 39, wherein the fecal waste collection container comprises one of: bladder, small intestine.

41. The tissue connector of claim 36, wherein the container is adapted to be filled with at least one medical drug required by the patient.

42. The tissue connector of claim 37, wherein the medical device is a device of the group of devices consisting of: drug delivery systems, artificial bladder, fecal waste collection container, artificial urethra, artificial heart, artificial esophagus, artificial trachea.

43. The tissue connector of claim 36, wherein the biological graft is a graft of the group of grafts comprising: bladder, small intestine, urethra, ureter, kidney, large intestine, heart, esophagus, trachea, blood vessel.

44. The tissue connector of claim 1, comprising a flow restrictor for partially or fully restricting flow through the conduit.

45. The tissue connector of claim 1, wherein the inner diameter of the conduit is between 0.1-0.5 cm.

46. The tissue connector of claim 1, wherein the inner diameter of the conduit is between 0.5-1 cm.

47. The tissue connector of claim 1, wherein the inner diameter of the conduit is between 1-2 cm.

48. The tissue connector of claim 1, wherein the inner diameter of the conduit is between 2-3 cm.

49. The tissue connector of claim 1, wherein the inner diameter of the conduit is between 3-4 cm.

50. The tissue connector of claim 1, wherein the inner diameter of the conduit is 4cm or greater.

51. The tissue connector of claim 1, wherein the catheter is sized to slidably fit in a human esophagus.

52. The tissue connector of claim 1, wherein the catheter is sized to be slidably mounted in a trachea of a person.

53. The tissue connector of claim 1, wherein the catheter is sized to slidably fit within a human stomach.

54. A tissue connector according to claim 1, wherein the catheter is dimensioned to be slidably mounted in a person's gallbladder or a connection outlet duct of the gallbladder.

55. The tissue connector of claim 1, wherein the catheter is sized to be slidably mounted in a human small intestine.

56. The tissue connector of claim 1, wherein the catheter is sized to slidably fit in a human large intestine.

57. The tissue connector of claim 1, wherein the catheter is sized to slidably fit within a human urethra.

58. The tissue connector of claim 1, wherein the catheter is sized to be slidably mounted in a human ureter.

59. The tissue connector of claim 1, wherein the catheter is sized to slidably fit within a renal pelvis portion of a human.

60. The tissue connector of claim 1, wherein the catheter is sized to slidably fit within a blood vessel of a person.

61. The tissue connector of claim 60, wherein the catheter is sized to be slidably mounted in a human aorta or atrium or ventricle.