US20130197546A1 - Implantable flow connector - Google Patents

Abstract

A system for coupling a first space within the body of a patient with a second space within the body of the patient including a flow connector insertable into the first and second spaces within the body, the flow connector having a conduit having a lumen having a first orifice at a first portion of the conduit and a second orifice at a second portion of the conduit, the conduit providing communication between the first and second spaces within the body. A retention device retains the conduit with respect to the first space within the body and is engageable with the first space within the body.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application claims the benefit of U.S. Provisional application No. 61/624,375, filed Apr. 15, 2012 and is a continuation in part of U.S. application Ser. No. 13/716,179, filed Dec. 16, 2012 which is a continuation of U.S. application Ser. No. 12/185,811, filed Aug. 4, 2008, now U.S. Pat. No. 8,366,651, which claims the benefit of U.S. Provisional Application No. 60/953,570, filed Aug. 2, 2007. The entire contents of each of these applications are hereby incorporated by reference herein.
BACKGROUND
• 1. Field of the Invention
• The present invention relates generally to implantable medical devices and, more particularly, to implantable flow connectors.
• 2. Related Art
• The mammalian body has numerous tissue-enclosed body spaces. For example, body conduits such as blood vessels, lymph and tear ducts, bowels, urethra, etc., have a lumen through which fluid is carried to facilitate circulation, excretion or other fluid transfer function. Tissue-enclosed body spaces also include body reservoirs such as the stomach, bladder, gall bladder, lymph nodes, etc., which temporarily or permanently retain fluid.
• It is often necessary or desirable to directly or indirectly connect body spaces to one another, to other areas in the body, or to an external or implantable medical device such as a sensor, pump, drug delivery system, or other permanently or temporarily implanted therapeutic device. For example, when vessels are damaged, severed or occluded due to physiological conditions, surgical intervention, or disease, certain sections of those vessels are typically bypassed to allow for the free and continuous flow of fluids. For example, an anastomosis is commonly performed for the purpose of connecting different blood vessels together to optimize or redirect blood flow around a damaged or occluded portion of a vessel or to redirect arterial flow into the venous system for enabling dialysis access.
• In the context of the peripheral vascular and/or the cardiovascular system, atherosclerosis may cause partial or complete occlusion of an arterial vessel. This may result in restricted blood flow which may compromise perfusion to the tissue served by the blood flow. In the case of an occluded coronary vessel, for example, an area of the heart's myocardium would be compromised, which may lead to a myocardial infarction or other ischemic heart syndrome such as congestive heart failure. In the case of peripheral vascular atherosclerotic disease, occluded vessels lead to ischemic syndromes such as threatened limbs, stroke and other morbidities. Many cases, such a blockage or restriction in the blood flow leading to the heart or peripheral vessels, may be treated by a surgical procedure known as an artery bypass graft procedure.
• A bypass procedure involves establishing an alternate blood supply path to bypass a diseased section of a diseased or compromised artery. In the bypass procedure, a surgeon typically dissects one end of a source or ‘pedicled’ artery (such as the internal mammary artery in the case of coronary artery bypass), or a free vessel segment (typically the saphenous vein in the leg), to use as a graft conduit to bypass the obstruction in the affected artery to restore normal blood flow. The graft vessel is connected to the obstructed vessel by means of an anastomosis procedure wherein an opening in the graft vessel is sutured to the obstructed vessel at an arteriotomy site made within the obstructed vessel. There are other indications for vessel anastomoses including revascularizing diseased arteries by creating a side-to side anastomosis between the distal end of the artery and an adjacent vein, thereby allowing the portion of the vein distal the occlusion to become “arterialized.” Another indication includes arterial revascularization by “arterializing” a vein through creation of a conduit downstream of the occlusive disease.
• The creation of an arteriovenous (AV) fistula is another instance where two body conduits are joined together and involves surgically joining an artery to a vein. AV fistulas are formed for a variety of reasons, one being to provide vascular access for hemodialysis patients. In such an application, the most common site for creation of the AV fistula is the upper extremity, though the lower extremity may also be used. Various surgical techniques and methods may be employed to create the AV fistula. Another indication for creation of an AV fistula is the connection of major vessels such as the aorta and the vena cava in patients with chronic obstruction pulmonary disease (COPD).
• The patency of an anastomosis contributes to a successful bypass or AV fistula, both by acute and long-term evaluation. Patency may be compromised due to technical, biomechanical or pathophysiological causes. Among the technical and biomechanical causes for compromised patency are poorly achieved anastomoses due to, for example, poor technique, trauma, thrombosis, intimal hyperplasia or adverse biological responses to the anastomosis. Improperly anastomosed vessels may lead to leakage, create thrombus and/or lead to further stenosis at the communication site, possibly requiring re-operation or further intervention. As such, forming an anastomosis is a critical procedure in bypass or AV fistula surgery, requiring precision and accuracy on the part of the surgeon.
• A common traditional approach for forming an anastomosis is to suture together natural or artificial openings in the vessels. To do so, according to one approach, a surgeon delicately sews the vessels together being careful not to suture too tightly so as to tear the delicate tissue, nor to suture too loosely so as to permit leakage of fluid from the anastomosis. In addition to creating a surgical field in which it is difficult to see, leakage of fluid from the anastomosis can cause serious acute or chronic complications, which may be fatal. In addition to the inherent inconsistencies in suture tightness, incision length, placement of the suture, stitch size, and reproducibility, suturing an anastomosis can be very time consuming. This difficulty is compounded by the relatively small dimensions of the vessels involved or the diseased state of the vessel when creating an AV fistula.
SUMMARY
• In accordance with one aspect of the present invention, an implantable flow connector for fluidly coupling a source tissue-enclosed body space with a destination conduit is provided. The flow connector includes a conduit having a lumen terminating at a first orifice at a first end of the conduit implantable in the source body space through an opening formed in a tissue wall of the source body space, and a second end of the conduit having a second orifice implantable in the destination conduit through an opening at an end of the destination conduit, and a circumferential flange radially extending from the conduit, proximate the conduit first end, configured to be implanted in the source body space adjacent an opening in the tissue wall of the source body space such that the conduit extends through the opening.
• In accordance with another aspect of the present invention, a system for coupling a first space within the body of a patient with a second space within the body of the patient is provided. The system comprises a retention device and a flow connector. The flow connector is insertable into the first and second spaces within the body and has a conduit having a lumen having a first orifice at a first portion of the conduit and a second orifice at a second portion of the conduit, the conduit providing communication between the first and second spaces within the body. The retention device retains the conduit with respect to the first space within the body and is engageable with the first space within the body.
• Preferably, the retention device is movable to a reduced profile position for insertion.
• In some embodiments, the retention device includes a first set of engaging elements extending therefrom configured to penetrate a wall of the first space within the body and/or a second set of engaging elements extending therefrom configured to penetrate a wall of the second space within the body.
• In some embodiments, the flow connector is positioned within an opening in the retention device and in a placement position the retention device is positioned between an outer surface of the flow connector and an inner surface of the second space within the body. The flow connector can apply an outwardly directed radial force to the retention device. In other embodiments, the retention device is positioned about an outer surface of the second space within the body and in a placement position the second body space is positioned between an outer surface of the flow connector and an inner surface of the retention device.
• The flow connector preferably includes a flange extending radially outwardly and insertable into the first body space. The flange can include first and second lateral sections and first and second longitudinal sections, the first and second lateral sections configured to cooperate with walls of the first space such that the flange sealingly conforms to an inner surface of a tissue wall adjacent an opening in the first space. The first and second longitudinal sections can extend further radially from the conduit than the first and second lateral sections.
• In some embodiments, the retention device comprises an inner component and an outer component wherein at least one of the inner and outer components is relatively slidable with respect to the other component. The outer component can include a compression member to provide a proximal force on the inner body member. The inner body member can be movable from a first configuration to a second spread configuration to provide an axial opening therein for side receipt of the second body space.
• In some embodiments, the retention device includes a proximal component and a distal component wherein the proximal component is engageable with the first body space and the distal component is engageable with the second body space, the proximal and distal components interlocking.
• The various retention devices disclosed herein can include a plurality of struts and the plurality of struts can in some embodiments form closed geometric shapes.
• In accordance with another aspect of the present invention, a system for coupling a first space within the body of a patient with a second space within the body of the patient is provided comprising a flow connector having a conduit having a lumen having a first orifice at a first portion of the conduit and a second orifice at a second portion of the conduit, the conduit configured to be implanted into the second space within the body to provide communication between the first and second spaces within the body. The system of this aspect also includes a retention device having an opening to receive the conduit, the retention device having a first set of engaging members to engage the first space within the body and a second set of engaging members to engage the second space within the body, the retention device maintaining the conduit in position with respect to at least of the first and second body spaces. The first set of engaging members can comprise a first set of penetrating elements with penetrating tips protruding radially therefrom to penetrate a wall of the first space within the body and the second set of engaging elements can comprise penetrating elements configured to pierce a wall of the second space within the body when the second space is positioned over the retention device.
• In some embodiments, in a placement position the retention device is disposed between an outer surface of the conduit and an inner wall of the second space within the body.
• The retention device is preferably movable to a reduced profile configuration for insertion.
• In some embodiments, the retention device comprises first and second components movable from a spaced position to an engaged position, the first set of engaging members extending from the first component and the second set of engaging elements extending from the second component.
• In some embodiments, the first set of engaging members extends toward a proximal end of the retention device.
• In some embodiments, the flow connector includes a flange extending radially from the first portion of the conduit and is configured to be implanted in the first space within the body
• In accordance with another aspect of the present invention, a system is provided for coupling a first space within the body of a patient with a second space within the body of the patient comprising a flow connector insertable into the first and second spaces within the body, the flow connector having a conduit having a lumen having a first orifice at a first portion of the conduit and a second orifice at a second portion of the conduit, the conduit providing communication between the first and second spaces within the body. The system of this aspect includes a retention device for retaining the conduit within the second space within the body, the retention device including a plurality of struts and having an axial opening to receive and engage the flow connector
• Preferably, the retention device is movable to a reduced profile position for insertion.
• In some embodiments, the retention device is movable to an expanded open position to receive the flow connector therein.
• In accordance with another aspect of the present invention, a system for fluidly coupling a first space within the body of a patient with a second space within the body of the patient is provided comprising a first device, a second device engageable with the first device, and a flow connector having a conduit having a lumen having a first orifice at a first portion of the conduit and a second orifice at a second portion of the conduit, the conduit configured to be implanted into the second space within the body to provide communication between the first and second spaces within the body. The first device engages with at least one of the flow connector and the first space within the body and the second device engages with at least one of the flow connector and second space within the body.
• In some embodiments, a first plurality of engaging elements extend from the first device to engage a wall of the first body space and a second plurality of engaging elements extend from the second device to engage a wall of the second body space.
• In some embodiments, the second device is positioned over the first device and internal of the second body space. In some embodiments, at least one of the first and second devices can be slidable relative to the other device and the second device can be positioned external of the second body space. The first device can extend distally of the first device when the first and second devices are interlocked.
• In accordance with another aspect of the present invention, an implantable flow connector implantable into a body of a patient for fluidly coupling a first space within the body of the patient with a second space within the body of the patient is provided. The implantable flow connector comprises a conduit having a lumen having a first orifice at a first portion of the conduit and a second orifice at a second portion of the conduit, the conduit configured to be implanted into the second space within the body to provide fluid flow between the first and second spaces within the body, and a retention portion having radially extending wall engaging portions, the retention device engageable with the first and second spaces within the body.
• In some embodiments, the retention portion is embedded in a wall of the conduit.
• The retention portion can include a plurality of struts with radially extending penetrating elements. The flow connector can include a flange extending radially from the conduit.
• In accordance with another aspect of the present invention, a system for coupling a first space within the body of a patient with a second space within the body of the patient is provided, the system comprising a flow connector having a conduit and a flange, the conduit having a lumen having a first orifice at a first portion of the conduit and a second orifice at a second portion of the conduit, the conduit configured to be implanted into the second space within the body to provide communication between the first and second spaces within the body, the conduit dimensioned to receive the second space within the body thereover, the flange extending radially from the first portion of the conduit and configured to be implanted in the first space within the body, and a retention device having an opening to receive the first body space such that in a placement position the first space within the body is positioned between an external wall of the flow connector and an internal wall of the retention device, the retention device having a plurality of anchoring tabs at a distal portion positionable external of the first space within the body. Preferably, the anchoring tabs provide an anchor for suture passed through the first space within the body.
• In accordance with another aspect of the present invention, a retention device for retaining a first body space and a second body space is provided, the retention device comprising a first set of engaging members extending from the first component to engage the first body space and a second set of engaging members extending from the second component to engage the second body space to retain the first and second body spaces to couple the first and second body spaces. In some embodiments, the retention device enables fluid coupling of the first and second body spaces. A non-porous material can be attached internal and/or external of the retention device to enable fluid coupling of the first and second body spaces.
• In some embodiments, the retention device comprises a first component and a second component, the first component movable relative to the second component, and a first set of engaging members can extend from the first component and the second set of engaging members can extend from the second component. Preferably, the first and second engaging members have tissue penetrating tips. In some embodiments, the first and second components releasably interlock. The first and second components can interlock by a protrusion on one of the components engaging an opening in the other component.
• In some embodiments, the retention device is formed of a plurality of struts and has an axial opening.
• The present invention also includes method of implanting the flow connector. In accordance with one method of the present invention a method of implanting and securing an implantable flow connector in a body of a patient for providing communication of a first space within the body of the patient with a second space within the body of the patient is provided comprising the steps of a) providing a flow connector having a lumen having a first orifice at a first portion of the conduit and a second orifice at a second portion. b) providing a retention device having a proximal portion and a distal portion, c) inserting the retention device into the first space within the body, d) subsequently inserting the flow connector through an opening in the retention device so the second portion of the flow connector extends into the first space within the body; and e) placing the second space within the body over the retention device.
• In some embodiments, the step of inserting the retention device into the first space within the body comprises compressing the retention device to reduce its outer diameter.
• In some embodiments, the step of inserting the retention device includes placing the retention device in a delivery cannula wherein it is compressed and then releasing the retention device from the cannula so it returns to a non-compressed position.
• In some embodiments, the retention device includes a first set of engaging elements with penetrating tips penetrating the first space within the body when the distal portion of the retention device is in a placement position within the first space within the body and/or a second set of engaging elements with penetrating tips penetrating a wall of the second space within the body when the second space within the body is in a placement position over the retention device.
• The second portion of the flow connector can include a flange extending radially from the connector and engaging an inner wall of the first space within the body.
• In some embodiments, the retention device includes a first component and a second component, and the method further includes the step of interlocking the first and second components. In some embodiments, the first component is distal of the second component and the second component engages the first space within the body and the first component engages the second space within the body.
• In some embodiments, one of the first and second components has at least one locking tab and the other component has at least one slot, and the step of interlocking the components includes the step of causing the at least one locking tab to locking engage the at least one slot, and preferably the components can be released after locking if desired.
• In some embodiments, the step of inserting the flow connector through an opening in the retention device includes the step of placing the flow connector in a reduced profile position within a delivery member and inserting the delivery member through the opening in the retention device.
• In some embodiments, the first space within the body is a source body space and a proximal portion of the flow connector is inserted through an opening formed in a tissue wall of the source body space, and the second space within the body is a destination element and a distal portion of the flow connector is insertable into the destination element through an opening in a surface of the destination element.
• In accordance with another aspect of the present invention, a method for forming a sutureless anastomosis between a first space within a body of a patient and a second space within the body of the patient is provided, the method comprising the steps of a) providing a flow connector having a lumen having a first orifice at a first portion of the conduit and a second orifice at a second portion, b) providing a retention device having a plurality of penetrating members engageable with the wall of at least one of the spaces within the body; and c) positioning the flow connector internally of the retention device.
• In some embodiments, the flow connector includes a flange extending radially outwardly from the second portion, and the flange of the flow connector can be positioned in the first space within the body and the first orifice can be positioned within the second space within the body.
• The method can further comprise the step of inserting the retention device into the first space within the body wherein the step of positioning the flow connector internally of the retention device occurs subsequent to the step of inserting the retention device into the first space within the body. The step of positioning the flow connector internally of the retention device can further comprise the step of opening the retention device to provide a side entry to receive the flow connector therein.
• The method may further comprise the step of placing the second space within the body over an external wall of the retention device, and this step can occur in some embodiments subsequent to the step of positioning the flow connector internally of the retention device.
• In some embodiments, the retention device includes first and second components, and the method further comprises the step of interlocking the first and second components to secure the components together and to maintain a fluid connection between the first space within the body and the second space within the body. The step of interlocking the components can include the step of sliding the first component over the second component.
• In accordance with another aspect of the present invention, a method of implanting and securing an implantable flow connector in a body of a patient for providing communication of a first space within the body of the patient with a second space within the body of the patient is provided, the method comprising a) providing a flow connector having a lumen having a first orifice at a first portion of the conduit, a second orifice at a second portion and a retention portion, the retention portion having a first plurality of penetrating members to engage the first body space, b) inserting the flow connector into the first space within the body, and c) placing the second space within the body over the flow connector.
• A second plurality of penetrating members can be positioned proximal of the first plurality of penetrating members to penetrate the second body space when positioned over the flow connector.
• In some embodiments, the step of placing the second space within the body over the retention device occurs subsequent to the step of inserting the flow connector into the first space within the body.
• In accordance with another aspect of the present invention, a method of implanting and securing an implantable flow connector in a body of a patient for providing communication of a first space within the body of the patient with a second space within the body of the patient is provided, the method comprising the steps of a) providing a flow connector having a lumen having a first orifice at a first portion of the conduit and a second orifice at a second portion, b) providing a retention device having a proximal portion and a distal portion, c) inserting a proximal portion of the flow connector into the first body space, d) placing the second space within the body over the flow connector and e) subsequently placing the retention device over the second space within the body.
• The step of placing the retention device over the second space within the body can comprise the step of opening the retention device to provide a side entry for the second space within the body.
• In some embodiments, the retention device has an outer component and an inner component, wherein the outer component engages the first space within the body, and the method may further comprise the step of moving one of the first and second components relative to the other component to interlock the first and second components.
• In some embodiments, the step of placing the retention device over the second body space places a plurality of suture tabs on an external surface of the first body space.
BRIEF DESCRIPTION OF THE DRAWINGS
• Embodiments of the present invention are described herein in conjunction with the accompanying drawings, in which:
• FIG. 1A is a side view of one embodiment of a flow connector of the present invention;
• FIG. 1B is a modified top view of the embodiment of the present invention illustrated inFIG. 1A taken along cross-section line1B-1B inFIG. 1A;
• FIG. 1C is an isometric view of another embodiment of the flow connector of the present invention;
• FIG. 1D is another isometric view of the embodiment of the flow connector illustrated inFIG. 1C;
• FIG. 1E is yet another isometric view of the embodiment of the flow connector illustrated inFIG. 1C;
• FIG. 1F is a further isometric view of the embodiment of the flow connector illustrated inFIG. 1C;
• FIG. 2A is a cross-sectional view of a first tissue-enclosed body space in a recipient having one embodiment of the present invention implanted therein;
• FIG. 2B is another cross-sectional view of a first tissue-enclosed body space in a recipient having one embodiment of the present invention implanted therein;
• FIG. 3 is a perspective view of another embodiment of the flow connector of the present invention illustrated with respect to a tissue-enclosed body space into which the flow connector of the present invention is to be implanted;
• FIG. 4 is a perspective view of one embodiment of the present invention with an imaginary plane having an imaginary midline;
• FIG. 5 is a cross-sectional view of one embodiment of the present invention with an imaginary plane having an imaginary midline;
• FIG. 6 illustrates a bottom view of another embodiment of the flow connector of the present invention;
• FIG. 7A illustrates a perspective view of an alternate embodiment of the flow connector of the present invention having shorter longitudinal sections than the embodiment illustrated inFIG. 1A;
• FIG. 7B illustrates a perspective top view of the embodiment of the flow connector illustrated inFIG. 7A;
• FIG. 8A is a simplified side of another embodiment of the present invention,
• FIG. 8B is a simplified bottom view of another embodiment of the present invention,
• FIG. 9A is a high level flowchart of a method for implanting a flow connector according to one embodiment of the present invention;
• FIG. 9B is a detailed flowchart of one method for implanting the flow connector of the present invention, in accordance with one embodiment of the present invention;
• FIG. 10A illustrates tying off all branches from the second tissue-enclosed body space, according to one embodiment of the present invention;
• FIG. 10B illustrates occluding flow of liquids within the second tissue-enclosed body space;
• FIG. 10C illustrates marking an orientation line along the second tissue-enclosed body space and also forming an artificial opening on the second tissue-enclosed body space;
• FIG. 10D illustrates inserting a flow connector according to one embodiment of the present invention in the second tissue-enclosed body space;
• FIG. 10E illustrates a flow connector according to one embodiment of the present invention inserted and secured in a second tissue-enclosed body space with a portion of the second tissue-enclosed body space removed;
• FIG. 10F illustrates marking a position on the first tissue-enclosed body space where an opening will be formed;
• FIG. 10G illustrates a first tissue-enclosed body space after an artificial opening is manually formed;
• FIG. 10H illustrates a first tissue-enclosed body space connected to a second tissue-enclosed body space via one embodiment of the present invention;
• FIG. 11A illustrates a simplified schematic view of a portion of the second interface according to one embodiment of the present invention;
• FIG. 11B illustrates a perspective view of a portion of the second interface according to a further embodiment of the present invention;
• FIG. 11C illustrates a cross-sectional view of a portion of the second interface according to another embodiment of the present invention;
• FIG. 11D illustrates a cross-sectional view of a portion of the second interface according to a yet further embodiment of the present invention;
• FIG. 11E illustrates a cross-sectional view of a portion of the second interface according to another embodiment of the present invention;
• FIG. 11F illustrates a cross-sectional view of a portion of the second interface according to yet another embodiment of the present invention;
• FIG. 11G illustrates a cross-sectional view of a portion of the second interface according to a further embodiment of the present invention;
• FIG. 11H illustrates a cross-sectional view of a portion of the second interface according to a yet further embodiment of the present invention;
• FIG. 11I illustrates a cross-sectional view of a portion of the second interface according to another embodiment of the present invention;
• FIG. 11J illustrates a cross-sectional view of a portion of the second interface according to yet another embodiment of the present invention;
• FIG. 11K illustrates a perspective view of a portion of the second interface according to one embodiment of the present invention;
• FIG. 11L illustrates a perspective view of a portion of the second interface according to another embodiment of the present invention;
• FIG. 11M illustrates a perspective view of a portion of the second interface according to yet another embodiment of the present invention;
• FIG. 11N illustrates a perspective view of a portion of the second interface according to a yet further embodiment of the present invention;
• FIG. 11O illustrates a perspective view of a portion of the second interface according to another embodiment of the present invention;
• FIG. 11P illustrates a perspective view of a portion of the second interface according to yet another embodiment of the present invention;
• FIG. 11Q illustrates a perspective view of a portion of the second interface according to a further embodiment of the present invention;
• FIG. 12A illustrates another embodiment of the present invention in which the second interface further comprises barbs;
• FIG. 12B illustrates yet another embodiment of the present invention in which the second interface comprises an elbow as well as a retention collar;
• FIG. 13 is a cross-sectional view of a second interface according to one embodiment of the present invention in which the outer diameter increases while the wall thickness of the second interface remains substantially constant;
• FIG. 14 is a cross-sectional view of a second interface according to yet another embodiment of the present invention in which the outer diameter remains substantially constant while the wall thickness decreases;
• FIG. 15 is a cross-sectional view of a second interface according to yet another embodiment of the present invention in which the distal end of the second interface is uneven;
• FIG. 16 illustrates an embodiment according to the present invention in which the first interface and second interface are formed separately and then joined together before implantation;
• FIG. 17A is a perspective view of the second interface of a flow connector according to one embodiment of the present invention in its naturally collapsed state prior to implantation;
• FIG. 17B is a perspective view of the second interface of a flow connector according to one embodiment of the present invention in its expanded state after implantation and forced expansion;
• FIG. 18A is a perspective view of the second interface of a flow connector according to yet another embodiment of the present invention in its naturally expanded state prior to implantation;
• FIG. 18B is a perspective view of the second interface of a flow connector according to yet another embodiment of the present invention in its forced collapsed state, ready for implantation in the recipient;
• FIG. 19 is a perspective view of one embodiment of the present invention in which an artificial conduit and two flow connectors are provided for implantation in a recipient;
• FIG. 20 is a perspective view of a first embodiment of a retention device for use with the flow connector;
• FIG. 21 is a top view of the retention device ofFIG. 20;
• FIG. 22 is a perspective view of the retention device ofFIG. 20;
• FIG. 23 is a perspective view of the retention device ofFIG. 20 shown prior to insertion through the opening in the first body space, e.g. artery, and shown in a reduced profile position within an insertion cannula;
• FIG. 24 is a perspective view of the retention device ofFIG. 20 shown inserted through the opening in the artery;
• FIG. 25 is a view similar toFIG. 24 showing expansion of the retention device when removed from the insertion cannula;
• FIG. 26 is a perspective view illustrating a flow connector being inserted in a reduced profile configuration within a delivery sheath (cannula) through the axial opening of the retention device and into the artery;
• FIG. 27 illustrates the flow connector released from the delivery sheath to expand within the axial opening in the retention device;
• FIG. 28 is a view similar toFIG. 27 showing proximal movement of the flow connector and retention device so the hooks of the retention device penetrate the wall of the artery adjacent the opening in the artery;
• FIG. 29 is a view similar toFIG. 28 showing the second body space, e.g. a vein, prior to placement over the retention device ofFIG. 20;
• FIG. 30 illustrates the vein ofFIG. 29 being placed over the retention device, with the tines of the retention device penetrating through the wall of the vein;
• FIG. 31 is a perspective view of an alternate embodiment of the retention device of the present invention;
• FIG. 32 is a perspective view of another alternate embodiment of the retention device of the present invention showing both the inner and outer member;
• FIG. 33 is a perspective view of the retention device ofFIG. 32 with the outer member shown separated from the inner member;
• FIG. 34 is a front view of the inner member of the retention device ofFIG. 32;
• FIG. 35 is a side view of the inner member of the retention device ofFIG. 32;
• FIG. 36 is a rear view of the inner member of the retention device ofFIG. 32;
• FIG. 37 is a top view of the retention device ofFIG. 32 in the normal placement configuration;
• FIG. 38 is a top view of the retention device ofFIG. 32 shown starting to be spread to an open position for receiving the second body space, e.g. a vein;
• FIG. 39 is a top view of the retention device ofFIG. 32 shown in the open (spread) position for receiving the vein;
• FIG. 40 illustrates a flow connector positioned within the first body space, e.g. an artery, a vein positioned over the flow connector, and the retention device ofFIG. 32 being moved toward the vein for positioning thereover;
• FIG. 41 illustrates the retention device ofFIG. 32 positioned over the vein and flow connector and further showing the distal portion of the outer body member secured to the artery and the outer and inner members interlocked;
• FIG. 42 is a perspective view of another alternate embodiment of the retention device of the present invention, the retention device embedded in a flow connector;
• FIG. 43 is a top view of the retention device ofFIG. 42;
• FIG. 44 is front view of the retention device ofFIG. 42;
• FIG. 45 illustrates the distal portion of the retention device ofFIG. 42 placed within a first body space, e.g., an artery, and further showing a vein placed over the retention device with the tines of the retention device penetrating the wall of the vein;
• FIG. 46 is a view similar toFIG. 45 illustrating the retention device ofFIG. 42 pulled proximally so the hooks of the retention device penetrate the wall of the artery around the opening;
• FIG. 47 is a perspective view of an alternate embodiment of the retention device of the present invention illustrating the proximal and distal connectors separated;
• FIG. 48 is a top view of the distal connector ofFIG. 47;
• FIG. 49 illustrates the distal connector ofFIG. 47 positioned within the artery and the proximal connector ofFIG. 47 being moved toward the distal connector and having a second body space, e.g. a vein (shown in cross-section) positioned thereover;
• FIG. 50 is a view similar toFIG. 49 showing the proximal connector interlocked with the distal connector;
• FIG. 51 is a view similar toFIG. 50 showing the retention device and flow connector pulled proximally so the hooks of the distal connector penetrate the wall of the artery around the opening;
• FIG. 52 is a perspective view of another alternate embodiment of the retention device of the present invention;
• FIG. 53 is a top view of the retention device ofFIG. 52;
• FIG. 54 is a top view of the retention device shown in the open (spread) position to receive a second body space, e.g. a vein, within the opening; and
• FIG. 55 illustrates the retention device ofFIG. 52 positioned around a vein having a flow connector therein and abutting an outer surface of the wall of the artery.
DETAILED DESCRIPTION
• Aspects of the present invention are generally directed to an implantable flow connector. Other aspects of the present invention are also directed to an implantable flow connector and a retention device for securing the flow connector. The flow connector of the present invention is configured to be implanted in a tissue-enclosed body space such as a body conduit or body reservoir to provide a flow path for fluid from the source body space to another body space, a man-made or body conduit, an external or implanted medical device, or other destination element.
• Embodiments of the flow connector comprise a conduit having a lumen that terminates at an orifice on opposing ends of the conduit, and a flange radially extending from one of the two ends of the conduit. The flow connector is configured to be implanted into the source body space via a natural or artificial opening (e.g., a man-made opening) in a region of the tissue wall that defines the body space. The flange surrounds the conduit orifice through which the conduit lumen is fluidically coupled to the interior of the body space, and is configured to be self-retained in the body space.
• The conduit is also configured to be retained in the noted destination device or body space or body region (collectively and generally referred to herein as the destination element). For example, when the destination element is a tissue-enclosed body space, the conduit is configured to be implanted into the destination body space via a natural or artificial opening in the tissue wall defining that body space. Once implanted, fluid exiting the conduit orifice at the distal end of the flow connector flows into the destination element. As such, the flow connector of the present invention fluidically couples the source body space and destination device or body space.
• As noted, embodiments of the flow connector of the present invention may be used to fluidically couple any tissue-enclosed body space or implanted medical device to any type of destination including any other tissue-enclosed body space, other areas in the body, or an external or implanted medical device. Embodiments of the flow connector may be configured to be implanted in any tissue-enclosed body space including, but not limited to, body conduits such as blood vessels, lymph ducts, tear ducts, bowels, urethra, etc., which have a lumen through which fluid is carried to facilitate circulation, excretion or other fluid transfer, as well as body reservoirs such as the stomach, bladder, gall bladder, lymph nodes, etc., which temporarily or permanently retain fluid. For ease of description, embodiments of the flow connector described below are specifically configured for implantation to create an arteriovenous (AV) fistula and, more specifically, an AV fistula in the upper or lower extremity to provide vascular access for hemodialysis patients.
• FIG. 1A is a side view of one embodiment of a flow connector of the present invention. InFIG. 1A,flange102 is a circumferential flange and is configured to radially extend fromconduit104 proximate to its first orproximal end131 ofconduit104.Conduit104 terminates atproximal end131 ofconduit104 at an orifice. A second orifice is disposed on the opposite side ofconduit104 at itsdistal end132.Flange102 comprises acontact surface126, which is configured to contact an inner surface of the tissue wall defining the source body space of a recipient when it is implanted therein. On the opposite side offlange102 fromcontact surface126 is an exposed surface128 which is exposed to fluids passing through the source body space (not shown).
• In one embodiment of the present invention,flange102 comprises a plurality of circumferentially adjacent sections. For example, a pair of opposingflange sections112A and112B can be provided. In those embodiments designed for implantation in a body conduit,flange sections112 are referred to as longitudinal flanges, andflange section112A is referred to asheel section112A whileflange section112B is referred to astoe section112B. In addition tolongitudinal sections112, there is a pair of substantially similar lateral sections114A,114B extending from opposing sides ofconduit104 approximately equidistant fromflanges112A,112B. Circumferentially opposed sections114A,114B, also referred to herein as lateral sections114 due to their substantially orthogonal positioning relative tolongitudinal sections112, are configured to extend fromflange102 as illustrated inFIGS. 1C-1E, on opposing sides ofconduit104, and are further configured to extend circumferentially around alongitudinal axis110 of the source body space in which flange102 is to be implanted. The circumferential radius of lateral sections114A,114B is selected based on the radius of curvature of the region of the source body space in which flowconnector100 is to be implanted. In one embodiment, theradius297 defined fromlongitudinal axis110 to contactsurface126 of lateral sections114A,114B is substantially equal to theradius298 defined fromlongitudinal axis110 to the inner surface of the source body space. In other embodiments,radius297 defined fromlongitudinal axis110 to contactsurface126 of lateral sections114A,11413 is larger than theradius298 defined fromlongitudinal axis110 to the inner surface of the source body space. Furthermore, in those embodiments,flange102 is constructed of shape-memory material such that external forces exerted onflange102 made of memory material may causeflange102 to at least partially bend, but the nature of the memory material will generate forces to returnflange102 to its original shape. In such embodiments where the radius of lateral sections114A, B is greater, that radius defined fromlongitudinal axis110 to contactsurface126 of lateral sections114A, B may be 1 to 10% larger than the radius defined fromlongitudinal axis110 to the inner surface of the source body space. The larger radius of lateral sections114A, B combined with the nature of the memory material with which it is constructed will generate a chronic outward force whenflow connector100 is implanted within the source body space, which will in turn cause the walls of the source body space to resist the outward force, thereby providing a compression force to lateral sections114A, B. The compression force applied to lateral sections114A, B in turn urgescontact surface126 offlange102 towards the opening in the tissue wall of the source body space, thus providing a seal betweencontact surface126 offlange102 and the tissue wall such that fluid within the source body space will not leak after implantation offlow connector100. It is to be understood that in one embodiment of the present invention, some fluid from the source body space may or may not leak immediately after implantation. However, with normal physiological healing processes, such leakage will soon thereafter cease as the aforementioned seal will be provided bycontact surface126 onflange102 with the tissue wall, thereby eliminating the need for additional elements such as glue, sutures etc. in order to stop or prevent fluid leakage.
• In addition to providing a seal betweencontact surface126 andflange102, as described above, the larger radius of lateral sections114A, B combined with the nature of the memory material with which it is constructed also acts to provide support forflow connector100. As used herein, supportingflow connector100 refers to physically supportingflow connector100 such that it retains its position within the source body space, after implantation, without other components or objects contributing towards the retaining of its implanted position.
• In one embodiment of the present invention, lateral sections114A, B extend circumferentially around the interior surface of the source body space so as to leave approximately 180° of the source conduit's interior surface circumferentially uncovered by lateral sections114A, B andflow connector100 generally. By leaving approximately 180° uncovered, obstruction to the flow of fluid within the source body space is minimized while enhancing stability provided by lateral sections114A, B to flowconnector100 when implanted.Longitudinal sections112 are also circumferentially curved with respect to the interior surface of the source body space such thatcontact surface126 makes contact with the interior surface of the source body space in asealing region116, thereby providing a fluid tight or hydrophobic seal as well as stability betweenflow connector100 and the source body space.
• Adjacent to sealingregion116 isreinforcement region118, configured to provide physical support to flowconnector100 by being constructed and arranged to oppose various explanting or other forces that may be exerted onflange102 andconduit104 whenflow connector100 is implanted in the source body conduit.Reinforcement region118 is configured to have a rigidity that it aids in the opposition of deflection forces, and is therefore less prone to flexing of portions offlange102 and/orconduit104. The rigidity ofreinforcement region118 decreases in a radially-increasing direction thereby aiding in the implantation offlange102 in the source body space. It should be appreciated that the rigidity may be provided in various ways, according to various embodiments of the present invention. For example,reinforcement region118 may have a composition with a rigidity which makes it more rigid than sealingregion116 or other portions offlange102. For example, in one embodiment of the present invention, sealingregion116 may be manufactured with material having a Shore value of 80 A andreinforcement region118 may be manufactured with material having a Shore value of 55 D. In other embodiments,reinforcement region118 may be manufactured with the same material as its adjacent or other sections offlange102, butreinforcement region118 may be configured to be thicker than adjacent sections offlange102, thereby makingreinforcement region118 more rigid. By avoiding substantial deflecting or bending,flange102 remains larger than the aperture in the source body space through whichflange102 was inserted, thus preventing explanting or pull-out from the source body space. As used herein, substantial deflecting byflange102 refers to the reduction of the surface area offlange102 to asize allowing flange102 in its deflected state to fit through aperture in the source body space through whichflange102 was inserted.
• Reinforcement region118 is proximal toconduit104 so as to provide structural integrity toconduit104 such at the orifice at theproximal end131 ofconduit104 can withstand a greater amount of compression force than withoutreinforcement region118 being present. As will be further discussed below,reinforcement region118 also may assist in opposing explant forces that may be applied, intentionally or inadvertently, onflow connector100. Althoughreinforcement section118 is illustrated inFIGS. 1A-1C to be substantially contiguous, it is to be understood that in other embodiments of the presentinvention reinforcement section118 may not be contiguous but may havemultiple reinforcement regions118 disposed circumferentially aroundconduit104. Similarly, it is to be understood that althoughreinforcement region118 is illustrated inFIG. 1B is shown as having a similar or at least a corresponding perimeter as that offlange sections112,114, in other embodiments of the present invention,reinforcement region118 may have a perimeter which is shaped differently from that offlange sections112,114.
• Longitudinal sections112 are configured to facilitate implantation offlow connector100 while also opposing pullout forces which may otherwise pullflow connector100 out from the source body space (not shown) afterflow connector100 is implanted. Lateral sections114A, B are also configured to facilitate implantation and further configured to maintain the position offlow connector100 with respect to the source body space (not shown) afterflow connector100 is implanted. In one embodiment of the present invention, lateral sections114A, B have a radius of curvature substantially identical to the radius of curvature of the source body space into which it is to be implanted. In other embodiments of the present invention, lateral sections114A, B has a curvature radius which is slightly larger than the curvature radius of the source body space into which it is to be implanted. When this embodiment is implanted in the source body space, the larger curvature radius of lateral sections114A, B will cause the source body space to generate compression forces on the larger lateral sections114A, B which will in turn promote the maintenance of the position offlow connector100 in the source body space.
• FIG. 1B is a cross-sectional view along the line1B-1B noted inFIG. 1A, in which a substantial portion of theconduit body130 is shown as if removed for the purpose of showing an unobstructed view of thelongitudinal sections112 and lateral sections114. In the embodiment shown inFIG. 1B,heel section112A andtoe section112B have apices,heel section apex121 andtoe section apex122, respectively, when viewed from the perspective illustrated inFIG. 1B. In this embodiment,heel section apex121 andtoe section apex122 come to a sharp point which may be helpful in redirecting fluid flowing within the source body space so as to prevent or minimize disturbances in flow shear stress, eddy flow, foil effects, turbulence, resistance, tube wall deformation, and tensile stress/strain distributions that can lead to intimal hyperplasia and other similar or associated conditions. Similarly, as depicted inFIG. 1A,flange edge140 may be chamfered to an angle, for example 60°, so as to similarly redirect fluid flowing within the source body space for the same purpose.
• Multiple cutout regions124 are disposed betweenlongitudinal sections112 and lateral sections114.Cutout regions124 represent an absence of material between thoseflanges112,114 and are dimensioned and configured to facilitate temporary foldover offlanges112,114 during implantation offlow connector100.Sealing region116 is also disposed over a portion ofcutout regions124 to ensure that thecontact surface126 aroundconduit body130 is sealed with respect to the source body space so that fluids flowing through the source body space remains either within the source body space or through the lumen ofconduit104.
• As noted above,flow connector100 also comprisesconduit104 which is connected to flange102 alongjoint region106. Atjoint region106, theproximal end131 ofconduit body130 andflange102 are joined such thatfirst conduit orifice120 leads into the lumen ofconduit body130, as illustrated inFIGS. 1E and 1F, which shows at least a partial view of exposed surface128 offlange102, as well asfirst conduit orifice120 leading into the lumen ofconduit body130. In the embodiment illustrated inFIGS. 1A and 1B,conduit portion106 is depicted largely as comprising acylindrical conduit body130. However, it is to be appreciated by one having ordinary skill in the art thatconduit body130 may have other shaped tubular bodies other than a cylindrical one in other embodiments of the present invention. For example, in other embodiments of the present invention,conduit body130 may comprise aconduit body130 with a rectangular or irregular cross section and a similarly shaped longitudinal lumen disposed therein. On the opposite end ofconduit body130 fromproximal end131 isdistal end132 ofconduit body130 as well assecond conduit orifice134 which is disposed atdistal end132.Second conduit orifice134 allows fluid flow traveling through the lumen ofconduit body130 to exit throughsecond conduit orifice134. For example, in one embodiment of the present invention in which a source body space, such as a vein or artery, is coupled toconduit104, fluid flowing through the source body space into which flange102 is implanted is diverted throughfirst conduit orifice120, through the lumen ofconduit body130 and out ofsecond conduit orifice134 into the source body space.
• Although the construction offlow connector100 may vary depending on the one or more source conduits in which flowconnector100 is to be implanted, embodiments of the present invention may differ in terms of the material comprisingflow connector100, the durometer values of materials selected, thicknesses of the various components offlow connector100 described herein or shown in the figures, and are considered a part of certain embodiments of the present invention. In one embodiment,flange102 has a thickness ranging between approximately 0.15 mm and approximately 0.35 mm. Similarly, the outside diameter ofconduit body130 has a similar thickness range between approximately 0.15 mm and 0.50 mm and more preferably, of between approximately 0.30 mm and approximately 0.45 mm. In another embodiment, the outside diameter ofconduit body130 has a thickness of approximately 0.35 mm. The thickness offlange102 may be decreased asflange102 is made to extend further which will maintain the pullout forces necessary forflange100 to be pulled out of the source body space in which it is implanted. Similarly, the thickness offlange102 may be increased as theflange102 is made to extend less.
• As shown inFIG. 1C-1F and in cross-section inFIG. 5,conduit body130 may comprise a series of barbs orprotrusions129 which extend radially fromconduit body130. In one embodiment of the present invention, theprotrusions129 provide periodic increases in the outside diameter ofconduit body130 so that the source body space within whichconduit body130 is inserted are positioned overconduit body130 in a friction fit over the increased diameter portions ofprotrusions131. Furthermore, once the source body space is positioned overconduit104 overprotrusions131, one or more sutures may be disposed circumferentially aroundconduit body130 and in the areas betweenconduit body130 and the outer diameter ofprotrusions131, thereby snugly retaining the source body space in place with respect toconduit104. When one or more sutures are thus disposed, the one or more sutures that compress the source body space towards theconduit portion104 will maintain its position since the diameter of the one or more sutures are fixed to be smaller than the outer diameter of the protrusions, which therefore provides an interference fit to prevent the one or more sutures from translating along thelongitudinal axis108 ofconduit body130.
• In certain embodiments of the present invention,conduit body130, shown inFIGS. 2A and 2B asconduit body230, has aconduit recess236 disposed thereon.Conduit recess236 is configured such that a source body space, such assource body space260, rests withinconduit recess236 whenflange102, shown inFIGS. 2A and 2B asflange202, is positioned within the source body space as described below. In one embodiment of the present invention,conduit recess236 is configured to have a depth of between 0.5 mm and 1.0 mm in order to accommodate a source body space to allow it to rest therein. In other embodiments of the present invention,recess236 may be configured to have a deeper recess, for example 1.0 mm. The height of theconduit recess236, measured fromflange202 toward the distal end ofconduit body204 is approximately 0.8 mm, which will vary depending on the thickness of thesource body space260 which is accommodated withinconduit recess236, as depicted inFIG. 2A. Also as shown inFIG. 2B,conduit204 of one embodiment of the present invention is shown to be angled approximately 60° from the horizontal axis in the illustration with respect toflange202. This angle may vary in other embodiments of the present invention depending on the situation or the needs of the recipient. For example, in other embodiments of the present invention,conduit204 may be configured with an angle between 10° to 90° from the horizontal axis shown inFIG. 2B. As one having skill in the art would appreciate, this angle can be from the opposite side as well with respect toflange202.
• As noted previously,flow connector100, shown inFIG. 3 asflow connector300, is configured to be at least partially placed within a source body space. In the embodiment illustrated inFIG. 3,flange102 is configured to be positioned through anopening303 onsource body space360. More specifically, one or more ofheel section312A, toe section312B, andlateral sections314A, B are temporarily deformed or bent with respect to flowconnector100 so thatflange102 can be inserted throughopening303. Opening303 may be an existing opening or may be manually and/or intentionally formed, at least in part, to allowflange102 to be inserted therethrough during the implantation offlow connector300 withinsource body space360. In the embodiment shown inFIG. 3,heel section312A is longer than toe section312B. The greater length ofheel section312A is configured to promote stability and the position offlange102 withinsource body space360. Additionally, the shorter length of toe section312B, in the present embodiment of the invention, is configured to promote easier insertion offlange102, especially in implantation methods where onlylateral sections314A, B are temporarily deformed, with longitudinal sections312 inserted throughopening303 in their substantially extended position.
• In the embodiment illustrated inFIG. 3, the fluid flowing substantially alonglongitudinal axis310 throughsource body space360 is flowing from the direction ofheel section312A and flowing towards the direction of toe section312B. As is seen in the embodiment illustrated inFIGS. 1 and 3, thelongitudinal axis108 ofconduit body130 is angled with respect to thelongitudinal axis310 ofsource body space360 at an angle of approximately 60° towards to direction ofheel section312A. In this embodiment of the present invention, the 60° angledsource body space360 is provided to promote, among other things, a controlled rate and/or volume of fluid flow fromsource body space360 intoconduit body330. In other embodiments of the present invention, that angle may not be 60°, but may instead be some other angle, depending on the placement offlow connector300 within the recipient or the purpose for which flowconnector300 will be used once implanted. For example, in other embodiments of the present invention,conduit body330 may be angled 90 or 120° with respect tolongitudinal axis310 in order to achieve a desired rate or volume of flow fromsource body space360.
• InFIGS. 4 and 5, an imaginary plane having amidline409 is shown with respect to flowconnector400 andlongitudinal axis410 of source body space (not shown), according to one embodiment of the present invention.Midline409 is parallel with respect tolongitudinal axis410 and is disposed on the exposed surface128 aroundfirst conduit orifice120. In the embodiment depicted,longitudinal sections412 are angled upwards 10° frommidline409 starting attransition points415 as shown. In other embodiments of the present invention,longitudinal sections412 may be angled by a different amount, for example between 0 and 15°. The angling oflongitudinal sections412 upwards towards the inner surface of the source body space in which flowconnector400 is implanted will cause to be generated one or more deflection forces as a result oflongitudinal sections412 being pressed into the wall of the source body space. These deflection forces will cause a deflection oflongitudinal sections412 downward such thatlongitudinal sections412 will be more parallel withmidline409 andlongitudinal axis410 of the source body space. This deflection downward will permit later flanges414A, B to be disposed closer to the inner wall of the source body space than if the deflection did not occur, and will also cause a broader contact betweencontact surface126 and the inside wall of the source body space onceflow connector400 is positioned within the source body space.FIG. 5 illustrates the imaginary line withmidline409, now shown asmidline509, as well as the 10° angling oflongitudinal sections412, now shown as longitudinal sections512, with respect tolongitudinal axis510 of the source body space.
• Embodiments of the present invention include embodiments having different configurations of longitudinal and lateral sections. In the embodiment illustrated inFIG. 6,longitudinal sections612A and612B have about the same dimensions. InFIG. 6,heel section612A is configured to be longer and to come to a pointed apex as illustrated.Toe section612B is configured to be shorter thanheel section612A and has an apex which is more round than the apex of theheel section612A. The shorter length oftoe section612B is sufficient, in cooperation withlonger heel section612A, to oppose the pullout forces described previously, while promoting easier insertion of flange602 into the opening (not shown) of the source body space. In certain embodiments of the present invention,sections612A, B are configured to each be approximately 35-65% in length of the outside diameter offirst conduit orifice620. In alternative embodiments of the present invention,sections612A, B are each configured to be approximately 50% in length of the outside diameter offirst conduit orifice620.
• Similarly, in the embodiment illustrated inFIGS. 7A and 7B, longitudinal sections712 are configured substantially identically to one another. As shown,heel sections712A and toe section712B are both shorter than in other embodiments shown and described herein.FIG. 7B is a view alongcross-section line7B-7B and shows conduit body730 as if it were partially removed fromflow connector700. The embodiment of the present invention illustrated inFIGS. 7A and 7B is appropriately configured and dimensioned so as to maintain the compensation for pullout forces by longitudinal andlateral sections712 and714, respectively. As noted previously, the thickness of sealingregion116 andreinforcement118 may offlanges712,714 may be increased in order to provide makeflanges712,714 more rigid. Alternatively, in other embodiments of the present invention, those components may be constructed of a more rigid material.FIGS. 7A and 7B also depictscutout regions724 which at least partly promotes flexibility offlanges712,714 as one or more offlanges712,714 are temporarily brought together during implantation of flow connector into the recipient's source body space.
• FIGS. 8A and 8B illustrates yet another embodiment of the present invention in whichcutout region824 has zero to little reduction in the material which comprises theflange802 offlow connector800.Flange802 may be constructed and dimensioned to be readily bendable upon receiving an external force, such as from a pickup tool being operated by a surgeon, despite having a very minimal or no absence of material in thecutout region824. It should be understood by persons having skill in the art that cutoutregion824, and other parts offlange802 andconduit portion804 may be modified before or during the implantation procedure, as will be further discussed below. Therefore,cutout region824, or longitudinal sections812 andlateral sections814 may be modified in vivo to accommodate the dimensions of the source body space or the opening through whichflange802 is to be inserted during implantation offlow connector800.
• In operation, embodiments of the present invention may be implanted in numerous ways. In one particular method of operation as depicted inFIG. 9A, the source body space is mobilized900 from other conduits fluidically coupled to the destination body space. The destination body space, for example a vein of a recipient, is ligated and then cut910 to receive theconduit104 offlow connector100. Once the destination body space hasconduit104 fitted therein, an opening is formed920 in the source body space.Flange102 of the flow connector, having the destination body space coupled thereto, is inserted through the formed opening in order to join930 the source and destination body spaces together. In an alternate method, the flow connector is first inserted through the opening into the source body space and then the destination body space is placed over the flow connector.
• Expanding on the method outlined above and as further shown inFIG. 9B andFIGS. 10A-10H generally, according one embodiment of the present invention, allbranches1003 of other conduits within the body of the recipient are severed or otherwise fluidically decoupled or tied-off902 fromdestination body space1050, as illustrated inFIG. 10A. As shown in FIG.10B,destination body space1050 itself is then tied-off or otherwise occluded911 using a tie or suture1100.FIG. 10C shows that anorientation line1102 line is marked ondestination body space1050, and anopening1104 is formed alongorientation line1102. As illustrated inFIG. 10D,conduit portion102 offlow connector1000 is inserted914 throughopening1104.FIG. 10E illustrates twosutures1006 which are secured ontodestination body space1050 prior to the occluded end being cut away916 from the destination body space portion now havingflow connector1000 secured thereto. InFIG. 10F, a location is identified and marked922 where an opening insource body space1060 is to be formed. Once anopening1112 is formed924, as shown inFIG. 10G,flange1002 offlow connector1000 is inserted throughopening1112 and permitted to be securely retained within the walls ofsource body space1060 in cooperation with lateral sections114 andlongitudinal sections112.
• A cross-section of a portion ofconduit1404 according to one embodiment of the present invention is illustrated inFIG. 14. InFIG. 14, the portion shown illustrates a ramp configured to improve the flow fromproximal end1431 todistal end1432 and outconduit orifice1434 as it enters the destination element (not shown), for example a blood vessel. InFIG. 14, for the portion illustrated, the inside diameter ofconduit1404 gradually increases while the outside diameter ofconduit1404 remains substantially unchanged. By making the inside diameter ofconduit1404 substantially equal to the inside diameter of the destination element, the flow can across the cross-section oforifice1434 is as uniform or consistent as possible, thus minimizing turbulence and other disturbances in flow which can lead to undesirable biological responses such as intimal hyperplasia. It will be understood that the ramp feature may be provided at either end ofconduit1404, to provide a smooth flow into and/or out ofconduit1404. For example, in one embodiment of the present invention, a ramp feature is disposed at both ends ofconduit1404 and promotes a smooth inflow of fluid intoconduit1404 for a limited length ofconduit1404, followed by a length ofconduit1404 in which the inside diameter remains constant, followed by a final distal length ofconduit1404 wherein a ramp having a gradually increasing inside diameter is provide and facilitates a non-turbulent outflow of the fluid out ofconduit orifice1434.
• In other embodiments of the present invention, the outside diameter ofconduit1404 may change from theproximal end1431 todistal end1432. For example, in one embodiment, the outside diameter at each end may decrease gradually along its length. In another embodiment of the present invention, the outside diameter may increase gradually along its length. In yet further embodiments, the outside diameter may increase for some length, before decreasing for another length, and vice versa. As one having ordinary skill in the art will recognize, the outside diameter may be adjusted to be constantly or variably changing to meet specific needs or for specific uses.
• In certain embodiments of the present invention, the second end ofconduit104 is configured to have an inside diameter approximately equal to the inside diameter of the destination element's lumen, for example the lumen in a blood vessel. As discussed previously, matching the inside diameters of the distal end ofconduit104 and the destination element at the point in each where fluid flow transitions from one to the other significantly reduces eddy current flow and other disturbances in the flow, which in turn reduces the occurrence of clots, thrombus, intimal hyperplasia, and other conditions which are largely undesirable. In other words, these features enable embodiments of the flow connector of the present invention to restore anatomical blood flow; that is, laminar flow, which is the normal condition for blood flow throughout most of the circulatory system. As one of ordinary skill in the art would appreciate, laminar flow is characterized by concentric layers of blood moving in parallel down the length of a blood vessel. In other words, the highest velocity is found in the center of the vessel while the lowest velocity is found along the vessel wall.
• Other types of flow disturbances may include, but are not limited to, dead flow areas where a swirling or other types of flow pattern which deviates from a generally linear flow are formed by too steep of a step or diameter change with respect to certain factors such as the rate of flow, the viscosity of the fluid, the inside diameters ofconduit104 and the destination element, among others. In one embodiment of the present invention,conduit104 has a chamfereddistal end132 or a gradually taperingdistal end132 in which the inside diameter gradually increases approaching the opening of the destination conduit. In another embodiment of the present invention,conduit104 terminates atorifice134 proximal the destination conduit at a knife-edge, where the wall thickness immediately proximal to the destination element approaches zero.
• As illustrated in FIGS.1F and13-15, the inside surface of conduit104 (also1304,1404,1504), is a substantially frictionless surface configured to allow fluid flow over the surface without undergoing friction. This smooth surface minimizes or eliminates turbulence which might otherwise be generated during the flow throughconduit104.
• FIG. 12B illustrates another embodiment of the present invention in which bend1260 is provided at a point alongconduit1204. The internal surface ofbend1260 inconduit1204 redirects fluid flowing throughconduit1204, fromflange1202 to the destination elements, for example a blood vessel. In the embodiment illustrated inFIG. 12B, a first pre-bendlongitudinal axis1266 is shown as well as a second post-bendlongitudinal axis1268. In the illustrated embodiment, fluid flowing fromflange1202 through a firstpre-bend portion1265 is redirected bybend1260 before the fluid enters asecond post-bend portion1267. While the fluid is thus redirected,conduit1204 atbend1260 absorbs the force from the fluid flowing towardsbend1260 as it is redirected towards the destination element (not shown), thus avoiding those forces being applied to a body vessel which would otherwise have received the forces. Using embodiments of the present invention having one ormore bends1260 as described, it is possible to provide an improved connection between the source body space and the destination element. For example, where the source body space is a artery and the destination element is a vein, as illustrated according to a different embodiment of the present invention inFIGS. 10A-10H,flow connector1200B may be utilized to connect body space orvein1050 with body space orartery1060 but such thatvein1050 need not be bent as shown inFIG. 10H. Instead,connector1200B is configured with abend1260 which would extend fromartery1060 and then bend towards the opening invein1050 such thatvein1050 remains substantially straight.
• In further embodiments of the present invention, as illustrated inFIG. 15,distal end1532 ofconduit1504 is beveled such thatorifice1534 atdistal end1532 is not 90° with respect to the longitudinal axis ofconduit1504. In the embodiment illustrated, the beveleddistal end1532 is approximately 30° from a plane orthogonal to the longitudinal axis ofconduit1504. However, a person having ordinary skill in the art will appreciate that the angle may be different depending on the situation in which an embodiment of the present invention is to be used. Beveleddistal end1532 facilitates a better transition of fluid flowing throughconduit1504 and exiting at beveleddistal end1532 into the destination element by accommodating a bend in the destination element by allowing an earlier exit of the fluid flow in the direction of the bend inconduit1504. For example, the embodiment illustrated inFIG. 15 has abeveled end1532 such thatorifice1534 is biased towards the left. This left-facingorifice1534 may be used where the destination element is coupled to and extends up fromconduit1504 and bends towards the left. In addition to permitting an earlier exit fromconduit1504, beveleddistal end1532 also minimizes situations where a bend in the destination element, for example a conduit or blood vessel, causes the inside surface of the vessel to become constricted or reduced.
• In yet further embodiments of the present invention, where the source body space and the destination element have different outside diameters, the outside diameters may be configured to accommodate the different outside diameters. As illustrated inFIG. 13, according to one such embodiment of the present invention, the outside diameter ofconduit1304 may vary from itsproximal end1331 to itsdistal end1332. As shown, the inside diameter ofconduit1304 may also increase at the same rate as the change in the outside diameter ofconduit1304. However, it is to be understood that in other embodiments of the present invention, the inside diameter may change at a different rate, or not at all, as the change in the outside diameter.
• As shown inFIGS. 17A, B, and18A, B, according to other embodiments of the present invention,flow connector1700 and1800 may be configured to be collapsible (FIGS. 17A, B) or expandable (FIG. 18A, B) to further accommodate differences in the inside diameters of the source body space and the destination element. Furthermore, the collapsible and expandable embodiments may be used to assist implantation by implantingconduit1704,1804 while having a reduced physical size and then being forced (or being allowed) to take on a larger shape to fit, for example seal and retain, the destination or source body space.Conduits1704 and1804 may be composed of a mesh material which has various joints or hinges or other manipulable series of parts which permit the overall shape ofconduit1704 and1804 to be manipulated.Expandable conduit1704 may be configured with a small cross-sectional shape, as illustrated inFIG. 17A and later forced to take on and retain an expanded cross-sectional shape, as illustrated inFIG. 17B. In one embodiment of the present invention,expandable conduit1704 may be expanded with a balloon inserted into implantedconduit1704 and expanded. In another embodiment of the present invention,expandable conduit1704 may have a mechanical expanding force applied at aproximal end1731 which is communicated through the expanding portion ofconduit1704 in order to openconduit1704 as illustrated inFIG. 17B. In the embodiment illustrated,conduit1704 comprises finger-like portions which overlap one another as illustrated inFIG. 17A but which expand and separate as illustrated inFIG. 17B. It is to be understood that a portion of the finger-like portions may be used to retain the destination body space while a different portion may be used to provide a seal betweenconduit1704 and the destination body space.
• Similarly,collapsible conduit1804 may be configured with a shape-memory material, in a mesh or other configuration, which is expanded at rest but can be made to collapse when sufficient force is applied to it. As shown inFIGS. 18A, B, a portion ofconduit1804 may comprise the collapsible portion while another portion may be a non-collapsible portion. In one embodiment of the present invention,collapsible conduit1804 may be disposed in a delivery tube (not shown) which is configured to receiveconduit1804 in a collapsed position before being inserted and then delivered in a destination body space. In another embodiment of the present invention, delivery tube (not shown) may be made of a resorbable material such thatcollapsible conduit1804 may be delivered into the destination body conduit within the resorbable delivery tube. Subsequent to delivery, the resorbable delivery tube begins to be resorbed and cause thecollapsible conduit1804 to be released and permitted to return to its naturally expanded configuration.
• According to embodiments of the present invention, as illustrated inFIGS. 11K and 11L,conduit1104 may be modified or reduced subsequent to factory manufacturing. For example, according to one embodiment of the present invention,conduit1104 is configured to allow a surgeon in vivo to evaluate the opening in the destination element, for example a vein, into which the distal end ofconduit1104 is to be inserted. After mentally or physically marking where theconduit1104 is to be reduced, the surgeon cuts away material fromdistal end132 in order to better fitflow connector100 into the destination element. In other embodiments of the present invention,conduit1104 may be configured with perforations adjacent one ormore recesses1181 or visual markers such asprotrusions1129 which can aid in the measuring of the portion to be cut or removed. In certain embodiments of the present invention, markers on the outside ofconduit1104 facilitate cutting ofconduit1104 at increments of 0.25 mm, 0.5 mm or 1.0 mm, or variations thereof. In other embodiments of the present invention, perforations alongconduit1104 are provided to facilitate in the cutting or otherwise modifyingconduit1104 at those increments of 0.25 mm, 0.5 mm or 1.0 mm, or variations thereof.Conduit1104 may be constructed of a material that is resiliently flexible, such as silicone or other materials that are resiliently flexible, as will be appreciated by a person having ordinary skill in the art. Alternatively,conduit1104 may be constructed of one or more materials so as to be rigid or hard, thus necessitating different tools in order to reduce or otherwise modify it than in embodiments of the present in whichconduit1104 is resiliently flexible.
• Additionally, certain embodiments of the present invention may have one or more active elements inconduit104 orflange102 which are configured and arranged to provide one or more therapeutic benefits. For example, in one embodiment of the present invention,flow connector100 is constructed of a material so that one or more portions offlow connector100 is radiopaque. In other embodiments of the present invention, the active element is one or more drug compounds or pharmaceutical materials configured to be released byflow connector100 and to act on into the area near the flow connector or systemically throughout the recipient. In certain embodiments of the present invention, the one or more pharmaceutical materials may be configured to require heat or fluid-contact activation in order to begin its being released. In other embodiments of the present invention, the pharmaceutical materials onflow connector100 is further configured to be time-released such that the compounds therein are released gradually over a period of time at a constant or varying rates of release. In yet further embodiments of the present invention, the active element comprises pharmaceutical materials disposed within a heat or fluid-contact activated dissolving capsule shell.
• As shown inFIG. 12B, other embodiments of the present invention may comprise amalleable conduit1204 configured to take on and hold a different configuration upon receiving sufficient external force. For example, in one embodiment of the present invention, the surgeon may apply a bending force toconduit1204 in order to accommodate the source and destination body conduits. Upon receiving sufficient bending force from the surgeon,conduit1204 will retain the bend and direct or channel fluid flowing therethrough according to the shape, specifically the internal surface, ofconduit1204.Malleable conduit1204 is configured from a mesh or other structure having cooperating elements such as shape memory metals which allowmalleable conduit1204 to retain a shape upon receiving the bending force described.
• Embodiments of the present invention may be configured to aid in the retention of the destination element (not shown) on thedistal end1132 ofconduit1104. In certain embodiments of the present invention, as illustrated inFIGS. 11A and 11B,protrusions1129 are disposed circumferentially around the exterior surface ofconduit1104.FIG. 11A illustratesconduit1104 in a simplified profile view, and shows the silhouette ofradial protrusions1129 which are disposed aroundconduit1104.FIG. 11B illustrates a plurality of extrusions or projections which are disposed on, or extend from, the exterior ofconduit1104. As shown inFIG. 11M, according to another embodiment of the present invention, a plurality ofradial protrusions1129 onconduit1104 may be provided along the substantial length ofconduit1104, or at least along a section, for exampledistal end section1132. According to another embodiment of the present invention,protrusions1129 may be disposed on a separate collar and positioned onconduit1104 prior to implantation of flow connector1100. As illustrated inFIGS. 11P and 11Q, theretention protrusions1129 need not be uniform or simple. Amatrix protrusion configuration1129 is illustrated inFIG. 11P, according to another embodiment of the present invention. In a yet further embodiment of the present invention,sinusoidal protrusions1129 are illustrated inFIG. 11Q.
• In other embodiments of the present invention, the retention feature provided on the surface ofconduit1104 may be surface treatments. In an exemplary embodiment of the present invention illustrated inFIG. 110, the exterior surface ofconduit1104 may be dimpled or dented such that the treated exterior surface provides retention. Depending on the size of the dimpling or denting surface treatment, the exterior surface can be configured to provide a friction fit on the interior surface of the destination element, for example a blood vessel. Other retention features may be provided on the exterior ofconduit1104. For example, in another embodiment of the present invention, a plurality ofbarbs1229 or other sharp projections are disposed on the exterior ofconduit1204.Barbs1229 are configured such that they at least partially pierce the wall of the destination element, for example a blood vessel, in order to retainingly secure the element onconduit1204. In other embodiments of the present invention,barbs1229 pierces through the destination element while retainingly securing the destination element onconduit1204.
• Flow connector100,200 further comprises arest surface136,236 onconduit104 adjacent thejoint region106, as illustrated inFIGS. 1D and 2B according to yet further embodiments of the present invention. In the embodiment illustrated inFIG. 1D,rest surface136 is a recess in the body ofconduit104 configured to receive a wall of the source body space aroundrest surface136 onceflange102 is implanted therein. In the embodiment illustrated,rest surface136 is substantially smooth and free ofprotrusions129 described above which are configured to retain the destination element once the destination element is positioned overprotrusions129. In the embodiment illustrated inFIGS. 1D and 2B,rest surface136 is shaped with a curve, andsource body space227 is shown inFIG. 2B as conforming to the curved shape ofrest surface136. However, the degree to whichbody space227 is shown to curve inFIG. 2B is exaggerated for illustrative purposes and may not always take the degree of curvature depicted.
• In addition to the protrusions described above being used to retain the destination element upon being fit on the protrusions, the protrusions may also be used to receive one or more retaining elements such as sutures or a securing collar, or combinations thereof, as in embodiments illustrated inFIGS. 10E,11A-11N.FIG. 10E illustrates one embodiment of the present invention in which two sutures are placed on the destination element, in this case a vein, in order to compress the vein towards recesses disposed along the exterior surface ofconduit1004.FIG. 11A illustrates one embodiment in which the plurality ofadjacent protrusions1129 cooperatively form angled recess therebetween into which retaining elements such assutures1190, as illustrated inFIGS. 11E,11F,11I,11J, can compress the destination element at least partly into. In the embodiment illustrated inFIG. 11B, the retaining elements can compress the destination element, such as the tissue wall of a vein, in between the spaces betweenprotrusions1129. In the embodiments of the present invention illustrated inFIGS. 11C,11D,11G,11H, asecuring collar1169 may be used with a portion of the destination element, for example the tissue wall of a vein, disposed between securingcollar1169 andconduit1104 to secure the destination element onconduit1104. In certain embodiments of the present invention, the destination element portion may be compressed by securingcollar1169 against the exterior surface ofconduit1104. In other embodiments of the present invention, securingcollar1169 may press the destination element portion into correspondingly shaped recesses along the exterior surface ofconduit1104 such that an interference fit between the recesses and securingcollar1169 will retain the destination element portion onconduit1104. Although a plurality ofprotrusions1129 may be disposed along a length ofconduit1104 according to certain embodiments of the present invention, such that a surgeon may have a wide variety of choices ofprotrusions1129 to use in order to secure the destination element onconduit1104,protrusions1129 may also be provided at distinct locations in order to simplifyconduit1104, where the surgeon is provided with a reduced number ofprotrusions1129, for example two as shown inFIG. 11N according to one embodiment of the present invention. As shown inFIG. 11N,protrusions1129 may flare out from a smooth exterior surface ofconduit1104 such that a securing element such assutures1190, configured with a smaller diameter thanprotrusions1129, may be placed nearer theproximal end1131 ofconduit1104 such that an interference fit is formed betweensutures1190 andprotrusions1129. In such embodiments, in addition to the one or more sutures acting to retain the destination element onconduit1104, the flare at the distal end ofconduit1104 itself may be sufficient to provide a compression fit to also retain the destination element onconduit1104. Such a compression fit also acts to provide a seal to prevent leakage flowing throughconduit1104 into the destination element. In alternative embodiments of the invention, flare portions1129 (referred to previously as protrusions1129) may be constructed as a separate component fromconduit1104 such thatconduit1104 can rotate 360° about a longitudinal axis offlare portion1129 whileflare portion1129 remains stationary and secure to the destination element.
• It is to be understood that embodiments of the present invention may be used to connect flow connector described herein with anartificial conduit1999, as illustrated inFIG. 19. As shown, afirst flow connector1900 is configured to be coupled toartificial conduit1999 and retained by securingcollar parts1269A, B. Securingcollar parts1269A, B combine to form securing collar1269. Securingcollar parts1269A, B each may be configured with a retention feature such as the recess shown for fitting around a correspondingly configured protrusion on the exterior of conduit. In the embodiment illustrated inFIG. 19, each end ofartificial conduit1999 is positioned between each of theconduits1904 and retaining collars1269, wherein each of theflanges1902 of the flow connectors are implanted without the same or different body spaces, such that theflow connectors1900 become fluidically coupled. In this manner,flow connectors1900 may be used in bypass or other procedures which can benefit from one or more flanges which provide fluidic coupling as well as self-sealing and self-supporting features, among others.
• Alternate embodiments to aid retention of the first and second body spaces on the flow connector and to hold the flow connector in the body spaces to keep the flow connector from migrating are illustrated inFIGS. 20-55. These retention devices are described herein as used with vessels, e.g. connecting a vein and artery, but can also be used with grafts, other body conduits, etc. as described above. Therefore, although the terms first and second body spaces (or “spaces within the body”) are used herein, each body space can encompass a vessel, graft, conduit or other natural or artificially implanted enclosed element as described above. Further, although in the methods and devices described herein the first body space can be an artery and the second body space a vein, this is by way of example only since the first body space can be a vein and the second body space can be an artery, or can be grafts, body conduits, etc. described herein.
• In one approach, illustrated in the embodiments ofFIGS. 20-31 and47-51, the securement/retention (or stability) device is placed within the vessel and external of the flow connector so the retention device is positioned between the external wall of the flow connector and the internal wall of the vessel. The flow connector asserts a radial outward force against the retention device which engages the vessel(s) as the outer diameter of the flow connector is slightly greater than the internal diameter of the retention devices. In another approach, illustrated in the embodiments ofFIGS. 32-41 and52-55, the securement/retention (or stability) device is placed outside the vessel (or graft or body conduit) so the vessel is positioned between the internal wall of the securement/retention device and the external wall of the flow connector and the retention device applies a radial inward clamping force against the vessel and flow connector as the inner diameter of the retention device is slightly smaller than the outer diameter of the flow connector and/of vessel. Further, in some embodiments, the retention devices are one piece units which lockingly engage with both the first and second body spaces; in other embodiments the retention devices are two pieces with one piece engaging the first body space and the other piece engaging the second body space and then the two retention devices are connected or interlocked.
• The retention devices ofFIGS. 20-51 provide a sutureless connection of the first and second body spaces and sutureless connection of the flow connector to the body spaces which facilitates and simplifies the procedures and improves the consistency of the anastomosis since reliance on the suturing technique of the surgeon is avoided. However, a surgeon would not be precluded from applying a suture(s) if desired. The retention device ofFIGS. 52-55 enables a sutureless connection to the second body space, e.g., destination element such as a vein, but, has tabs for sutures for securement to the first body space, e.g., a source element such as an artery. Each of these retention devices are described below.
• Turning first toFIGS. 20-30, which illustrates one embodiment of an internal retention device, retention device is designated generally byreference numeral2010.Retention device2010 has a proximal end2012 and adistal end2014, the distal end defined herein in the direction of blood flow—flowing in a distal direction. Thedevice2010 is preferably composed of a metallic material with sufficient springiness so that it can be compressed (collapsed) to a reduced profile position during delivery and return to its original position once delivered. In some embodiments, thedevice2010 can be, composed of a shape memory material such as Nitinol. Other materials are also contemplated.
• Thedevice2010 is preferably formed from a tube having cutouts therein forming a series of struts. The cutouts can be formed from laser cutting or other methods. The struts form a pattern to create substantially diamond shapedopenings2016, shown inFIGS. 20 and 22. The strut pattern and diamond shaped openings enable collapse of thedevice2010 for delivery. The strut pattern includes a first (distal) set of connected V-shapedstruts2020 and a second (proximal) set of connected V-shapedstruts2022, each set2020 and2022 extending around 360 degrees to form a closed ring. Theproximal vertices2025 of the first set ofstruts2020 is joined to thedistal vertices2023 of the second set ofstruts2022, designated asregion2024. For clarity, not all of the struts and vertices are labeled in the drawings as not all identical parts are labeled.
• At the proximal end2012 ofdevice2010, the strut pattern includes an elongated longitudinally extendingstrut2026, extending from theproximal vertex2027 of theproximal struts2022, and each terminating in ahook2028. Eachhook2028 curves radially outwardly from thelongitudinally extending strut2026 and curves in a 180 degree arc so that the penetrating (sharpened)tip2036 which engages and penetrates the first body space points toward thedistal end2014 of thedevice2010. Other hook configurations and angles are also contemplated to achieve the purpose of engaging and penetrating the wall of the body space for the reasons described below. An example of such alternate configuration is described below and illustrated inFIG. 31. Additionally a fewer number of hooks can be provided. Although six V-shapedstruts2020 and2022 are shown, it is also contemplated that a fewer or greater number of V-shaped struts could be provided.
• At thedistal end2014 of thedevice2010 are a series oftines2030. Thetines2030 extend from thedistal vertex2029 of thedistal struts2020. In the illustrated embodiment, thetines2030 extend from every otherdistal vertex2029 of thedistal strut2020, however, it is also contemplated that a greater number oftines2030 could be provided, e.g., extending from eachvertex2029, or alternatively a fewer number oftines2030 could be provided. Thetines2030 extend proximally from thedistal vertex2025, extend radially outwardly, and terminate in sharpened penetratingtips2032. Other tine configurations and angles are also contemplated to achieve the purpose of engaging and penetrating the wall of the body space for the reasons described below in conjunction with the method of use.
• Thedevice2010, as well as the other retention devices ofFIGS. 31-55 described hereinbelow, is preferably formed from a cut tube so the struts are integral, however, in alternate embodiments, the struts are formed by separate elements, e.g., wires, strips, etc., that are bonded or welded together to form the strut pattern ofFIG. 20.
• In the normal position of thedevice2010, thedevice2010 by way of example can have an inner diameter of about 2 mm to about 8 mm, and preferably about 4 mm, and an outer diameter of about 2.2 mm to about 9 mm, and preferably about 4.4 mm. Thedevice2010 can be compressed to an outer diameter of about 1 mm to about 4 mm, and preferably about 2 mm for delivery and then allowed to expand to its original position. Other diameters are also contemplated.
• The conduit portion of the flow connector can, by way of example, have an inner diameter of about 1.5 mm to about 7.5 mm, and preferably about 3.5 mm, and an outer diameter of about 2 mm to about 8 mm, and preferably about 4.0 mm.
• An alternate embodiment of the hook configuration is illustrated inFIG. 31. The securement/retention device is designated generally byreference numeral2050 and is identical todevice2010 except for the hook configuration. Therefore, theretention device2050 has a first (distal) set of V-shapedstruts2060 and a second (proximal) set of V-shapedstruts2062, each set2060 and2062 extends around 360 degrees to form a closed ring as indevice2010. Thesets2060 and2062 are joined at their vertices, designated asregion2064 and form substantially diamond shapedopenings2066. Thedevice2060 also has a series oftines2070 identical totines2030 ofFIG. 20 which extend fromdistal vertices2068 ofdistal struts2060. Further details of thedevice2060, other than thehooks2070 will not be further described herein, sincedevice2060 and2010 differ only in the hook design.
• A longitudinally proximally extendingstrut2074 extends from theproximal vertices2072 of the proximal set ofstruts2062. The proximal end of theelongated strut2074 branches outwardly into opposing directions, forming barb shapedhooks2076, rather than the U-shaped hooks ofFIG. 20. More specifically, eachbranch2078 extends outwardly fromstrut2074 and then curves distally so thehooks2076 point in a distal direction. Thehooks2076 terminate in penetrating (sharpened)tips2079. Although ahook2076 extends from eachproximal strut2062, it is also contemplated that a fewer number ofhooks2076 could be provided.
• The method of insertion of the flow connector and retention device ofFIG. 20 will now be described with reference toFIGS. 23-29. Note the method is described for attaching a vein to an artery, however, connection of spaces within the body including, grafts, other conduits, etc. are also contemplated. The device ofFIG. 31 would be inserted in an identical manner.
• First, as shown inFIG. 23, after an opening A is made in the arterial wall B of the artery, theretention device2010, contained in a compressed (collapsed) position within a cannula C to reduce its profile for insertion, is moved toward the vessel opening A. Note in some embodiments, depending on the internal diameter of the cannula and/or the outward extension of thetines2030, thetines2030 are compressed by the cannula wall to a more straightened position. Note also in the compressed position thehooks2028 maintain their curved configuration. However, it is also contemplated that the hooks in the compressed configuration could be maintained in a more straightened position and return to their curved position when released from the cannula C. Materials such as shape memory Nitinol could be used to achieve this.
• The cannula C is placed adjacent, in abutment with or slightly into the opening A and a pusher D is advanced distally to advance thedevice2010 through the opening A and into the artery lumen as shown inFIG. 24. In a preferred method, however, the cannula C would be inserted through the opening A and into the lumen of the artery with theretention device2010 contained inside and then the pusher D advanced to move theretention device2010 out of the confines of the cannula. In either case, after the proximal portion of theretention device2010, with thehooks2028, is positioned within the vessel lumen, the cannula C is removed and theretention device2010 returns (expands) to its original, non-compressed position as shown inFIG. 25. Theretention device2010 preferably applies a radial force around the opening A of the artery to facilitate insertion of the flow connector delivery sheath.
• With thehooks2028 within the vessel lumen, theflow connector100A is inserted through theaxial opening2031 inretention device2020 as shown inFIG. 26. In the illustrated method, theflow connector100A is inserted through theretention device2010 before theretention device2010 is pulled away (retracted) for thehooks2028 to penetrate the vessel wall B. However, it is also contemplated in an alternate insertion method, that theretention device2010 is first retracted so thehooks2028 penetrate the vessel wall B prior to insertion of theflow connector100A. In this version, cannula C is moved proximally with proximal portions of theretention device2010 contained therein to move thehooks2028 distally to penetrate the vessel wall (as in the hook position ofFIG. 28) prior to insertion of theflow connector100A.
• Returning toFIG. 26, theflow connector100A is contained in a folded or collapsed low profile insertion position within a delivery sheath F. Note that theflange102A of theflow connector100A is positioned within the vessel lumen, extending distally beyond thehooks2028 ofretention device2010. Theflow connector100A, when released from the delivery sheath F by advancement of pusher G, expands toward its original diameter such that the outer diameter is slightly greater than the inner diameter of theretention device2010 to provide a slight radial outward force against theretention device2010 to provide an interference fit to hold the two together as shown inFIG. 27. In an exemplary embodiment, the outer diameter of the flow connector could be between about 2 mm and about 8 mm, and preferably about 4 mm. With theflow connector100A andretention device2010 held together, the unit is pulled away as shown inFIG. 28 so thehooks2028 engage and penetrate the vessel wall adjacent the vessel opening A. As shown, thehooks2028 surround the opening and extend 360 degrees around the opening. Note in this position, theelongated struts2026 are positioned external of the vessel B. As noted above, it an alternate embodiment, the hooks would already be in position prior to insertion of theflow connector100A.
• Next the vein V which is intended to be connected to the artery B to provide a fluid connection (communication) is placed over the outer wall of theretention device2010 as shown inFIGS. 29 and 30. That is, the proximal end of the vein V is placed over theretention device2010, and pulled (stretched) over theretention device2010. Note thetines2030 can be flexed inwardly by the vein V until in the desired position. Once fully positioned over theretention device2010, the penetrating ends2032 of thetines2030 penetrate the wall of the vein V to retain the vein V thereon. Thus, thetines2030 secure the vein V to theretention device2010 which is secured to the artery B viahooks2028. Fluid flow is then allowed between the two vessels, which are now connected to form an end to side anastomosis. Note that theretention device2020, by holding the vessels B and V in place also helps to maintain theflow connector100 in place so theflow connector100 can maintain the fluid tight seal between theflange100A of theimplantable flow connector100 and the wall of the artery B. This seal is described in detail above with respect to the discussion of the flow connector flange.
• Note that theflow connectors100aillustrated and described herein are substantially identical to theflow connector100 ofFIG. 1A in that it has a conduit104aand aflange102a, identical toconduit104 andflange102, except since it does not require suture attachment, it need not be provided with protrusions as shown inFIG. 1C.
• FIGS. 47-51 illustrate an alternate embodiment of an internal retention/securement device. In this embodiment, instead of a one piece retention device placed internally, two pieces, one attached to the first space within the body, e.g. the artery (source element), and the other attached to the second space within the body, e.g., the vein (destination element), are provided and are connected in situ. It should be appreciated that if other body spaces are being connected, e.g., artificial grafts or other body conduits, one piece would be attached to one body space and the other piece to the other body space to join the two body spaces.
• More particularly, the retention device ofFIGS. 47-51 is designated generally byreference numeral4010.Retention device4010 has a first proximal component ormember4012 for attachment to the first body space, e.g., an artery, and a second distal component ormember4040 for attachment to the second body space, e.g., the vein.Proximal component4012 has adistal end4018 and aproximal end4016. Theproximal component4012 is substantially identical toretention device2010, except for thetines4030, and has a strut pattern forming a first (distal) set of joined V-shapedstruts4020, a second (proximal) set of V-shapedstruts4022, substantially diamond shapedopenings4036,regions4037 where the distal vertex ofproximal struts4022 are joined with the proximal vertex ofdistal struts4020, anelongated strut4026 extending from theproximal vertex4027 of theproximal struts4022, and hooks4028 with penetratingtips4029 extending fromelongated struts4026. Since these components are identical to those ofFIG. 20, further discussion of these components is not necessary since their configuration, structure and function can be understood by reference to the description of theretention device2010 ofFIG. 20. Also note as in the discussion of the other embodiments herein, for clarity, not all identical parts are labeled.
• Lockingmembers4030 extend from alternatingdistal vertices4031 of thedistal struts4020 and perform a different function thantines2030 ofretention device2010. More specifically, lockingmembers4030, which extend radially outwardly fromdevice4010, are configured to engage slots formed in thedistal component4040 as described below. Note thelocking members4030 can also be configured of sufficient length and have penetrating tips to engage and penetrate the second body space to provide supplemental retention of the second body space. In this configuration, the locking members would then also function as wall penetrating tines and would be similar totines2030 ofretention device2010.
• Thedistal component4040, like theproximal component4012, is formed from a cut tube, preferably laser cut, although other cutting methods are contemplated.Distal component4040 has adistal end4042 and aproximal end4044. A series ofsolid wall portions4045 connected by aweb4046. Thesolid wall portions4045 have substantially triangular regions and substantially rectangular regions. More particularly, the more distal regions are somewhat triangular with sides4048a,4048bextending proximally fromvertex4049. After angling outwardly in triangular-like form, the sides4048a,4048beach extend proximally in substantially linear sides4050a4050b, forming a substantially rectangular region. Elongatedaxial slots4060 extend distally from the proximal edges and terminate inradial slot4062 to receive lockingmembers4030 ofproximal component4012 as described below. Alternatively, upper (distal)slot4064 can receivelocking members4030 ofcomponent4012, also described below. Structure can also be provided so that theproximal component4012 interlocks with structure atvertex4046 ofdistal component4040 or with other regions ofdistal component4040.
• Note that that thecomponents4012,4040 can be moved in the opposite direction, e.g.,distal component4040 moved distally with respect toproximal component4012, to disengage thelocking members4030 to release thecomponents4012,4040 from the interlocked position to allow removal of the flow connector if desired.
• A series of interconnecting V-shapedstruts4052, atdistal end4042, havedistal vertices4054 and proximal vertices4056. Extending proximally and radially outwardly from each of thedistal vertices4054 is atine4058 with a penetratingtip4059, substantially identical totines2030 of retention device2012 and configured to engage and penetrate the wall of the second body space placed thereover.
• In use, with reference toFIGS. 49-51,proximal component4012 is inserted through an opening in the first body space, e.g., artery B, in the same manner as described above with respect toFIGS. 24 and 25, i.e., inserted through a cannula, like cannula C, so thehooks4028 are positioned in the lumen of the artery B. The cannula C is then withdrawn in the same manner as described above with respect toFIG. 25, and theflow connector100ais inserted through the axial opening in theproximal component4012 in the same manner as described above in conjunction withFIG. 26 above, i.e., inserted in a folded or collapsed position through a delivery sheath like delivery sheath F, and then the delivery sheath is withdrawn, leaving theflange102aof theflow connector100apositioned in the lumen of the artery B in the same manner as inFIG. 27. This positioning of the flow connector and distal component is shown inFIG. 49.
• A second body space, e.g., a vein V, is placed over thedistal component4040 as inFIG. 49, and together placed over theproximal component4012 as shown inFIG. 50. (Note it is also contemplated that the vein V is placed overcomponent4040 beforecomponent4012 is placed in the artery). The distal andproximal components4040 and4012 interlock, preferably releasably interlock, as the lockingmembers4030 extend through upper (distal)slots4064 and are held within the widened slot area4064adue to the narrowing of the slot (slot area4064b) above the widened area4064a. That is, as the two components are moved together, the lockingmembers4030 are forced through the narrowedslot area4064binto the widened slot area4064a(seeFIG. 50). It should also be appreciated, that in an alternate embodiment, the lockingmembers4030 could engage the lower (proximal)slots4062 and held therein by theproximal wall4062aand narrowedslot4060. With the twocomponents4012 and4040 interlocked as shown, and with theflow connector100aapplying an outward radial force on theretention device4010, thedevice4010 and flowconnector100aare retracted so that penetratinghooks4029 ofhooks4028 penetrate the wall of the artery B as shown inFIG. 51. Note that alternatively, theproximal component4012 and flowconnector100apositioned therein can be retracted first so the hooks penetrate the artery wall, and then the distal component4040 (with attached vein V) can be interlocked with theproximal component4012. In either case, the interlocking of thecomponents4040 and4012 retains theflow connector100aand artery B and vein V in position to achieve an end to side anastomosis which fluidly connects the artery B and vein V and maintains the above described fluid tight seal.
• FIGS. 42-46 illustrate an alternate embodiment of a retention device. In this embodiment, a one piece retention device is provided, however, the flow connector and retention device are provided as a single unit. That is, instead of the user having to place the flow connector through the retention device in a separate step, the flow connector and retention device are already attached so the user can insert the flow connector and retention device together through the vessel opening. In this embodiment, the retention device is encapsulated in a polymer material of the fluid connector so there is no need for a separate retention device or the need for the additional steps of pre-inserting a retention device or of attaching a retention device.
• The device, or implant, of this embodiment is designated generally byreference numeral5010 and has an integrated flow connector and retention device. Stated another way, theflow connector100bincludes aconduit104bsimilar to theconduit104 ofFIG. 1A, aflange102bsimilar to theflange102 ofFIG. 1A, and aretention portion5012 having a strut pattern embedded between the inner andouter walls107b,109bof theconduit104b. Theflow connector100bis similar to theflow connector100 ofFIG. 1A in that it has aconduit104band aflange102b, identical toconduit104 andflange102, except as in the other embodiments herein that do not require suture attachment, it need not be provided with protrusions as shown inFIG. 1C. Thedevice5010 as noted above provides theflow connector100bformed integrally with theretention device5012. Such integration can be achieved by various methods such as overmolding, dip forming, etc. Additional details of theflow connector100bare not discussed herein as they are substantially identical to that offlow connector100.
• Theretention portion5012 has adistal end5014 and aproximal end5024.Retention device5012 is formed from a series of struts forming two rings of substantially diamond shaped openings—substantially diamond shapedopenings5020 being in the distal ring and substantially diamond shapedopenings5022 being in the proximal ring. Theseopenings5020,5022 are formed by the strut pattern shown inFIG. 42 which has a first (distal) set of interconnected V-shapedstruts5026, a second (proximal) set of interconnected V-shapedstruts5028 oriented in the same direction as thedistal struts5026 and an intermediate set of interconnecting V-shapedstruts5030 oriented in the opposite direction of the proximal anddistal struts5028,5026. Theproximal vertices5032 of thedistal struts5026 are joined to thedistal vertices5034 ofintermediate struts5030 and thedistal vertices5036 ofproximal struts5028 are joined to theproximal vertices5038 ofintermediate struts5030. Anelongated strut5040 extends from theproximal vertex5042 of theproximal struts5028, terminating invessel penetrating hooks5044 with penetratingtips5046 similar tohooks2028 ofFIG. 20. A set oftines5048 with penetratingtips5049 extend radially outwardly and proximally from thedistal vertices5035 ofdistal struts5026. The strut pattern can be formed by cutting, e.g., laser cutting, a tube. Note for clarity, not all identical parts are labeled in the drawings.
• In use, the device (implant) orimplantable flow connector5010 is inserted into the first space within the body, e.g., artery B, through a delivery sheath, such as delivery sheath F ofFIG. 26. When delivery sheath F is withdrawn as in the manner described above with respect to the embodiment ofFIGS. 20-31, thedevice5010 moves from its reduced profile insertion position to its original position. With theflange102bpositioned in the lumen of the artery B, a second body space, e.g., vein V, is positioned over the device as shown inFIG. 45, with thetines5048 penetrating the wall of the vein V when the vein V is in position. Thedevice5010 is then pulled proximally as shown inFIG. 46, with thehooks5044 penetrating the wall of the artery B around the opening, e.g., circumferentially around the opening as in the other embodiments described herein, thereby securing together and fluidly coupling the vein V and artery B forming a seal tight end to side anastomosis as with the other embodiments described below. Note that the method also contemplates that thedevice5010 is first retracted so thehooks5044 penetrate the artery wall B, and then the vein V is placed over thedevice5010.
• Turning now to the embodiments wherein the securement/retention devices are placed external of the body space rather than internal of the body space as in the embodiments described above, reference is initially made to the embodiment ofFIGS. 32-41. With reference toFIGS. 32 and 33,retention device3010 includes a first outer body member orcomponent3012 and a second inner body member orcomponent3014 which are connectable or lockable together as described below. In use, theretention device3010 is placed on the outer surface of the second body space, e.g., vein, rather than internal of the vein as in the embodiments ofFIGS. 20-31. Theinner body member3014 receives within its axial opening the second body space which is positioned over the flow connector, and theouter body member3012 engages the first body space, e.g., the artery, and is slidable along the outer surface of theinner body member3012 to lockingly engage theinner body member3012, thereby securing the flow connector and retaining the first and second body spaces, e.g., the artery and vein, so the flow connector can sealingly fluidly couple the body spaces. The inner andouter members3012,3014 can be packaged pre-assembled or alternatively assembled by the user.
• With reference toFIGS. 32-36,outer body member3012 has aproximal portion3016, adistal portion3018 and anintermediate portion3020. Theouter body member3012 is substantially C-shaped, extending in an arc of about 180 degrees (although arcs of other degrees are contemplated) and slides along the outer surface of theinner body member3014.Outer body member3012 is preferably formed from a tube, cut to form the illustrated strut pattern, such as by laser cutting or other methods. The strut pattern includes first and second (proximal and distal) radial struts3022,3024, separated by axial struts orwalls3026, forming five closed geometric shapes or windows—two outer windows3028a, twoinner windows3028band anintermediate window3028cbetween the twoinner windows3028b. Outer windows3028ainclude inner region3029aandouter region3029b, withouter region3029braised with respect to inner region3029ato form aledge3030.Outer region3029bextends distal ofwall3031 of inner region3029ato form anelongated slot region3029c. The configuration of thewindows3028a-cprovides for sliding movement of theouter component3012 with respect to theinner component3014 in the manner described below. Note the edges of thewindows3028a-3028care substantially linear. However, alternatively, one or more of the edges could be radiused.
• Each of the twoinner windows3028bhas a compression member, illustratively in the form of aU-shaped spring3032, positioned therein, with the base of the U extending proximally and thearms3036 of the U curving in a somewhat S-shape into theaxial struts3026. Thesprings3032 deflect when the inner andouter components3014.3012 are interlocked in the manner described below.
• Proximal radial struts3022 have adistal wall3022awhich is configured to engage a portion of theinner body3014 to limit relative movement of the components as described below.
• Theaxial struts3026 extend proximally beyond theproximal radial strut3022 and terminate in a hook orspike3036, extending radially inwardly to engage the first body space, e.g., the artery, as described below. Thehook3036 terminates in a penetrating (sharpened)tip3038 configured to penetrate the artery wall from the outside in (in contrast to thehooks2028 ofFIG. 20 which penetrate the artery from the inside out). Although eachaxial strut3026 is shown terminating in ahook3036, it is also contemplated that alternatively a fewer number of hooks could be provided such that not all axial struts terminate in hooks.
• Turning now to theinner body member3014, this component has adistal portion3040, aproximal portion3042 and anintermediate portion3044.Inner body member3014 is preferably formed from a tube, cut to form the illustrated strut pattern, such as by laser cutting or other methods. The strut pattern forms a series axially stacked interleaved radially extendingfingers3050. These interleavedfingers3050 are positioned inradial openings3055 formed ininner member3014 and are positioned in an axial row. Note that the fingers350 extend in alternating opposite directions so that the first (distalmost) and third fingers extend radially in a first direction and the second and fourth (proximalmost) fingers extend in an opposite second direction. Each of thefingers3050 terminates inend region3052 which as shown is spaced from thewall3054 to form agap3056. Each of thefingers3050 has a series of elongated axially extendingopenings3058 formed therein to reduce the mass of theinner body member3014 and increase flexibility. Note that for clarity, not all identical features of the components have been labeled in the drawings.
• Theintermediate portion3044 includes a pair oftool engagement tabs3060, located on opposite ends of theinner member3014, preferably spaced about 180 degrees apart. Theengagement tabs3060 extend radially outwardly from theinner body member3014 and are configured to be engaged by a tool to move theinner body member3014 from its normal position as shown inFIG. 37 to an open (spread) position shown inFIG. 39, thereby opening theinner body member3014 into a substantially C-shape configuration to provide an opening to receive therein a second body space, e.g., a vein, and attached flow connector as described below in the discussion of the method of use. Note when theinner body member3014 is moved out of its 360 degree substantially cylindrical configuration, expanded to the position ofFIG. 39,fingers3050 move away from walls3054 (see alsoFIG. 38), and out of theradial opening3055 to open theinner body member3014. Note theinner body member3014 is made of material that enables it to return to its normal substantially cylindrical position after it is opened so it can clamp around the circumference of the second body space. One material that can be used is shape memory material, although other materials are also contemplated.
• A series oframps3062 are positioned in theproximal portion3042 ofinner body member3014. Theramps3062 extend radially outwardly from theinner body member3014 and are spaced apart about the proximal portion. Theramps3062 include a lower (proximal)edge3062ato engage thedistal wall3022aof proximalradial strut3022. Note theproximal portion3042 ofinner body member3014 preferably does not extend about the full 360 degrees as does the intermediate anddistal portions3044 and3040. This enables it to better accommodate the connection between the first and second body spaces since the second body space (and flow connector) is preferably connected at an angle to the first body space (see e.g.,FIGS. 40 and 41).Inner body member3014 further includes a series ofreliefs3072 formed in theproximal portion3042. Thesereliefs3072 shield thehooks3036 of theouter body member3012 during delivery and deployment. Bent guide hooks3066 ofinner body member3014 extend from theintermediate portion3044 and engageaxial struts3026 ofouter body member3012 to provide guides for theouter body member3012 as it slides along theinner body member3014. A pair of lockingtabs3070, with a substantially planarupper surface3071, extend radially from theintermediate portion4044 of theinner body member3014 and engage the proximal surface of thespring3032 ofouter body member3012 to lockingly engage the inner andouter body members3014 and3012 in the manner described below.
• As shown inFIG. 32, in the initial position of theouter body member3012 with respect to theinner body member3014, theproximal radial strut3022 is blocked from proximal movement by theradially extending ramps3060. Also note in this position, theengagement tabs3060 are in abutment with theledges3030 of outer windows3028aand radially extendinglocking tabs3070 ofinner body member3014 are positioned proximally of and out of contact with the U-shaped springs3032. Note also in this position, thehooks3066 ofouter body member3012 are shielded within thereliefs3072 ofinner body member3014. Two of theaxial struts3026 are received in the opening formed in bent guide hooks3066 so that thehooks3066 serve as guides for thestruts3026 to help maintain alignment of theouter body member3012 and facilitate its sliding movement with respect to theinner body member3014.
• A series of other cutouts in the body ofinner body member3014 reduce the overall mass of the component and increase its flexibility.
• Turning now to the method of insertion utilizing theretention device3010 and with reference toFIGS. 40 and 41, theflow connector100ais inserted through an opening in the first body space, e.g., an artery, through a cannula (not shown). The cannula is similar to the cannula C described above inFIG. 26 and retains theflow connector100ain the collapsed or reduced profile position. Note the insertion of theflow connector100adiffers from that ofFIG. 26 since in this embodiment it is being placed in the artery as inFIGS. 3-5, and does not pass through a retention device as inFIG. 26. Once placed in the artery and positioned so thatflange102aengages the internal wall of the artery B, the second body space, e.g., the vein V, is placed over the conduit portion of theflow connector100a. Note that it is also contemplated that alternately the vein V is first placed over theflow connector100aand then the flow connector is inserted into the artery B.
• Once theflow connector100aand vein V are positioned as shown inFIG. 40,retention device3010 is moved to its open C-shaped position (seeFIG. 39) by a tool applying a force toengagement tabs3060 and then placed about the outer wall of the vein V. The force on thetabs3060 are then released, allowing theretention device3010 to return to its normal closed position to clamp about the vein V. (Preferably the inner diameter of theretention device3010 is slightly smaller than the outer diameter of the vein to provide an interference fit). Consequently, the vein V is positioned between an internal wall of theinner member3014 and an external wall of the flow connector. (In contrast to the inner retention devices ofFIGS. 20 and 47 which are positioned so that the devices are between the external wall of the flow connector and the internal wall of the vein).
• Once theretention device3010 is positioned about the vein V to surround the circumference in a 360 degree arc, theouter body member3012 is slid distally with respect to theinner member3014 to lockingly engage theinner body member3014 to prevent further movement. More specifically, as a force is applied to theouter body member3012 to slide it proximally,proximal radial strut3022 is forced over the inclined surface oframps3062, forcing theramps3062 radially inwardly, and the axial struts3076 are maintained in axial alignment by the guide hooks3066 ofinner member3014. Theouter member3012 is advanced sufficiently to advanceradial strut3022 past theramps3062. Once passed the ramps, theramps3062 return to their initial position and thedistal wall3022aofradial strut3022 engages theproximal surface3062aoframp3062. By this engagement, in this position, distal movement of theouter body member3012 is prevented. Also, in this position, theU-shape spring3032 ofouter member3012 and thetabs3070 ofinner member3014 are engaged, with thetabs3070 deflecting thesprings3032, and the springs applying a force to return to their original shape. With this spring/tab and rail/ramp interaction, the outer andinner members3014,3012 are lockingly, and preferably releasingly lockingly, engaged. Note further that thehooks3036 of theouter body member3012 engage and penetrate the wall of the artery, extending through the artery wall from the outside into the inside. Consequently, with the inner andouter components3014,3012 lockingly engaged, the hooks of the outer component2012 engaging the arterial wall, and theinner member3014 clampingly engaging the vein V which is fit over the flow connector, the vein and artery are fluidly and sealingly connected forming a secure end to side anastomosis.
• Note that thecomponents3014,3012 can be moved in the opposite direction, e.g., theramps3062 pressed inwardly and theouter body member3012 slid proximally to disengage from the interlocked position to allow removal of the flow connector if desired.
• FIGS. 52-55 illustrate an alternate embodiment of an external retention device. This device differs from the retention devices ofFIG. 20-51 in that it is configured to receive a suture wherein the embodiments ofFIGS. 20-51 as noted above, can provide a sutureless system if desired. The external securement/retention device ofFIG. 52 is designated generally byreference numeral6010 and has adistal portion6012, aproximal portion6014 and an intermediate portion6016. Retention device6016 is somewhat similar to theinner body member3014 ofretention device3010 ofFIG. 32 in that it has a series of radially extending interleavedfingers6020, except it differs fromretention device3010 in various respects.Retention device6010 does not receive an outer member which is positioned in the first body space. Instead,retention device6010 has at its proximal portion6014 a plurality of radially extendingtabs6018 with a proximal undersurface configured to abut the external wall of the first body space, e.g., the artery. As shown, thetabs6018 lie in a plane angled with respect to a longitudinal axis of thedevice6010 to better conform to the outer wall of the first body space since the flow connector (and second body space) are preferably positioned at an angle to the first body space as shown inFIG. 55.
• As in the embodiment ofFIG. 32,device6010 is preferably formed from a tube, cut to form the illustrated strut pattern, such as by laser cutting or other methods. The strut pattern forms a series axially stacked interleaved radially extendingfingers6020. These interleavedfingers6020 are positioned inradial openings6024 and are positioned in an axial row. Thefingers6020 extend in alternating opposite directions so that the first (distalalmost) and third fingers extend radially in a first direction and the second and fourth (proximalmost) finger extend in an opposite second direction. Each of thefingers6020 terminates inend region6022 which as shown is spaced from thewall6025 to form agap6026. Each of thefingers6020 has a series of elongated axially extendingopenings6028 formed therein to reduce the mass thereof and increase flexibility. Note that for clarity, not all identical features of thedevice6010 have been labeled.
• A series oftabs6030 which havetips6032 extending radially inwardly are configured to mate with an anastomotic connector100csimilar to the flow connector ofFIG. 1D in that it has barbs or protrusions extending from the conduit portion. Thetabs6030 preferably engage the overlapping wall of the protrusions. As shown, thetabs6030 are positioned such that withinopenings6031 and6032 twotabs6030 extend toward each other. A similar arrangement oftabs6030 is provided spaced about 90 degrees apart (seeFIG. 53).
• A pair oftool engagement tabs6034, located on opposite ends ofretention device6010, are preferably spaced about 180 degrees apart. Theengagement tabs6034 extend radially outwardly and are configured to be engaged by a tool to move thedevice6010 from its normal position as shown inFIG. 52 to a spread position shown inFIG. 54 (in the same manner as described above with respect toFIG. 39), thereby opening thedevice6010 into a substantially C-shape configuration to provide an opening to receive a second body space, e.g., a vein, and attached flow connector, as described below in the discussion of the method of use. Note when the body is moved out of its 360 degree substantially cylindrical configuration, expanded to the position ofFIG. 54,fingers6020 move away fromwalls6025, and out of theopenings6024 to open the body member. Note thedevice6010 is made of material that enables it to return to its normal substantially cylindrical position after it is opened so it clamps around the circumference of the second body space as its internal diameter is preferably slightly less than the outer diameter of the second body space. A shape memory material such as Nitinol can be used to achieve this, although other materials are also contemplated.
• In use, the flow connector, e.g., flow connector100c, similar to the flow connector ofFIG. 1D, is inserted into the first body space, e.g. artery B, with the flange102cpositioned in the body lumen in the same manner as inFIG. 40. After placement of flow connector100c, the second body space, e.g. the vein, is placed over the flow connector100c. (Alternatively, the vein could be placed over the flow connector before inserted into the artery). Next,tabs6032 ofdevice6010 are pressed by a tool (not shown) to open thedevice6010 from its substantially closed (substantially cylindrical) configuration to its open position so that the flow connector100cand vein can be placed into thedevice6010. After such placement, thetabs6032 are released, allowing thedevice6010 to return to its original position to extend circumferentially around and clamp the vein against the flow connector with thetabs6030 engaging the protrusions on the conduit portion of the flow connector100c, thereby securely retaining the vein. Thetabs6018 ofdevice6010 remain external of the artery B, resting on the outer surface of the arterial wall. Asuture6040 is then applied through the vessel wall, interweaving between thetabs6018, i.e., the suture extends over onetab6018 and into the vessel wall and then out from the vessel wall and over thenext tab6018, etc., to secure theretention device6010 to the artery B, thereby maintaining the flow connector100cin position and maintaining a secure fluid connection between the artery B and vein V.
• The method of implanting the flow connector, attaching the retention device and attaching the vein are described above. It should be appreciated that the retention devices and flow connector can be removed and placed at an alternate location one or multiple times if the user is not satisfied with the original placement. This can be achieved by removal of the retention devices and compression of the flow connector. In certain instances, it might be desirable to remove the flow connector and retention device altogether from the body. This can also be achieved by removing the retention device and compressing the flow connector to reduce its profile for withdrawal from the body. In the embodiments where the retention device includes two interlocking components, the components can be unlocked and separated to a non-interlocked position, and then re-interlocked if desired. This locking/unlocking can be repeated multiple times if necessary.
• The retention devices disclosed herein can be used with any of the flow connectors described above. Additionally, the retention devices disclosed herein could have structure to engage the protrusions, recesses, or other irregular outer structure of the flow connectors ofFIGS. 11A-11Q.
• The retention devices described herein can be packaged as a kit with one or more of the flow connectors. However, it is also contemplated that the retention devices can be packaged as a separate unit for utilization with any of the foregoing flow connectors as well as for utilization with other flow connectors or other implants. Still further, in some embodiments, the retention devices described herein can be used itself to couple first and second body spaces without the aforedescribed flow connectors. In these embodiments, the retention device would engage, both the first and second body spaces in the various manners discussed above, such as for example by penetrating members penetrating the wall of the body spaces, to enable fluid coupling of the body spaces or to otherwise join these two body spaces. To enable fluid coupling, in some embodiments, the flow connector can include a non-porous material positioned internal and/or external of the retention device.
• It is to be understood that although embodiments of the present invention have been largely described as being used to connect two tissue-enclosed body spaces, for example veins and arteries, other embodiments of the present invention may be used to connect a body space to an artificial device, such as a pump, an artificial conduit connected to theflow connector100 conduit, sensors, plugs, among others.
• While various embodiments of the present invention have been described above, it should be understood that they have been presented by way of example only, and not limitation. It will be apparent to persons skilled in the relevant art that various changes in form and detail can be made therein without departing from the spirit and scope of the invention. Thus, the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims and their equivalents. All patents and publications discussed herein are incorporated in their entirety by reference thereto.

Claims (20)

1. A system for coupling a first space within the body of a patient with a second space within the body of the patient, the system comprising:

a flow connector insertable into the first and second spaces within the body, the flow connector having a conduit having a lumen having a first orifice at a first portion of the conduit and a second orifice at a second portion of the conduit, the conduit providing communication between the first and second spaces within the body; and

a retention device for retaining the conduit with respect to the first space within the body and engageable with the first space within the body.

2. The system ofclaim 1, wherein the retention device is movable to a reduced profile position for insertion.

3. The system ofclaim 1, wherein the retention device includes a first set of engaging elements extending therefrom configured to penetrate the first space within the body.

4. The system ofclaim 1, wherein the retention device includes a second set of engaging elements extending therefrom configured to penetrate the second space within the body.

5. The system ofclaim 1, wherein the flow connector is positioned within an opening in the retention device and in a placement position, the retention device is positioned between an outer surface of the flow connector and an inner surface of the second space within the body.

6. The system ofclaim 5, wherein, the flow connector applies an outwardly directed radial force to the retention device.

7. The system ofclaim 1, wherein the retention device is positioned about an outer surface of the second space within the body and in a placement position the second body space is positioned between an outer surface of the flow connector and an inner surface of the retention device.

8. The system ofclaim 1, wherein the flow connector includes a flange extending radially outwardly and insertable into the first body space, wherein the flange includes first and second lateral sections and first and second longitudinal sections, the first and second lateral sections are configured to cooperate with walls of the first space such that the flange sealingly conforms to an inner surface of a tissue wall adjacent an opening in the first space.

9. The system ofclaim 1, wherein the retention device comprises an inner component and an outer component, at least one of the inner and outer components being relatively slidable with respect to the other component.

10. The system ofclaim 9, wherein the inner component is movable from a first configuration to a second spread configuration to provide an axial opening therein for side receipt of the second body space.

11. The system ofclaim 1, wherein the retention device includes a proximal component and a distal component, the proximal component engageable with the first body space and the distal component engageable with the second body space, the proximal and distal components interlocking.

12. An implantable flow connector implantable into a body of a patient for fluidly coupling a first space within the body of the patient with a second space within the body of the patient, the implantable flow connector comprising:

a conduit having a lumen having a first orifice at a first portion of the conduit and a second orifice at a second portion of the conduit, the conduit configured to be implanted into the second space within the body to provide fluid flow between the first and second spaces within the body; and

a retention portion having radially extending wall engaging portions, the retention device engageable with the first and second spaces within the body.

13. The implantable flow connector ofclaim 12, wherein the retention portion is embedded in a wall of the conduit.

14. The implantable flow connector ofclaim 12, wherein the retention portion includes a plurality of struts with radially extending penetrating elements.

15. The implantable flow connector ofclaim 12, further comprising a flange extending radially from the conduit;

16. A retention device for retaining a first body space and a second body space within a patient, the retention device comprising a first set of engaging members extending from the first component to engage the first body space and a second set of engaging members extending from the second component to engage the second body space to retain the first and second body spaces for coupling of the first and second body spaces.

17. The retention device ofclaim 16, wherein the retention device comprises a first component and a second component, the first component movable relative to the second component, and the first set of engaging members extends from the first component to engage and the second set of engaging members extends from the second component.

18. The retention device ofclaim 16, wherein the first and second engaging members have tissue penetrating tips.

19. The retention device ofclaim 16, wherein the first and second components releasably interlock.

20. The retention device ofclaim 16, further comprising a non-porous material attached thereto to enable fluid coupling of the first and second body spaces.

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