CN101384228A - Self-sealing residual compressive stress graft for dialysis - Google Patents
Self-sealing residual compressive stress graft for dialysis Download PDFInfo
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- CN101384228A CN101384228A CNA2006800512963A CN200680051296A CN101384228A CN 101384228 A CN101384228 A CN 101384228A CN A2006800512963 A CNA2006800512963 A CN A2006800512963A CN 200680051296 A CN200680051296 A CN 200680051296A CN 101384228 A CN101384228 A CN 101384228A
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Abstract
Vascular access systems for performing hemodialysis are disclosed. Some embodiments relate to vascular access grafts (250) comprising an instant access or self-sealing material (254) reinforced with expanded PTFE (252) to resist stretching of the instant access material (254) and thereby resist leakage associated with stretching or bending. The graft may comprise two end segments (260, 262) comprising ePTFE (252) without the instant access material (254) to allow easier anastomosis of the graft (250) to veins and arteries. The graft (250) may have a unibody design or have modular components that may be joined together to create a graft with customized length or other features. One or more sections of the graft (296) may also be cut or trimmed to a custom length.
Description
Background of invention
[0001] in the U.S., about 400,000 people suffer from the nephropathy in whole latter stage, need secular hemodialysis.By foundation vein is connected to tremulous pulse and coincide the permanent vascular puncture position that can be formed for implementing hemodialysis with the shunting of formation high flow capacity or the arteriovenous (AV) of fistula.Vein can directly link to each other with tremulous pulse, but the vein segment of fistula ripe to the blood flow that is enough to provide enough to be used for the hemodialysis needs time in 6 to 8 weeks.And because the factor of dissecting, not all patient is fit to directly coincide.Other patient may need to use artificial graft materials to provide the site of puncture between tremulous pulse and Venous system.Also attempted being used for the dialysis puncture although be used for making many materials of the artificial blood vessel who is used for the tremulous pulse replacement, expanded PTFE (ePTFE) is a preferable material.Its reason comprises that ePTFE is easy to pin puncture, especially complication rate low (false aneurysm, infection and thrombosis).Yet the AV graft still needed the time to wait for this graft maturation before using, and therefore must insert in patient's body to set up the hemodialysis path, until AV graft maturation such as the interim access device of Quinton conduit.Use the temporary catheter path except uncomfortable, also make the patient face additional risk hemorrhage and that infect.In addition, still very high the same with total graft failure rate, the patency rate of ePTFE access graft does not make satisfaction yet.60% graft failure is arranged every year, normally cause owing to vein end is narrow.(referring to Besarab, A ﹠amp; Samararpungavan D., ＂ Measuring theAdequacy of Hemodialysis Access (measuring the adequacy of hemodialysis path) ＂.CitrrOpin Nephrol Hypertens 5 (6) 527-531,1996, Raju, S. ＂ PTFE Grafts forHemodialysis Access (the PTFE graft of hemodialysis path) ＂ .Ann Surg 206 (5), 666-673, Nov.1987, Koo Seen Lin, LC ﹠amp; Burnapp, L. ＂ ContemporaryVascular Access Surgery for Chronic Hemodialysis (being used for the contemporary vascular access operation of chronic hemodialysis) ＂ .J RColl Surg 41,164-169,1996, and Kumpe, DA ﹠amp; Cohen, MAH ＂ Angioplasty/Thrombolytic Treatment of Failing andFailed Hemodialysis Access Sites:Comparison with Surgical Treatment (angioplasty/thrombolytic therapy of the hemodialysis puncture site of failing and failing :) ＂ .Prog Cardiovasc Dis 34 (4) with the comparison of operative treatment, 263-278,1992, during the full content of all these documents mode by reference is incorporated herein).In the more high-risk patient such as diabetics, these mortalitys further increase.These path failures have destroyed the progress of conventional hemodialysis, and the annual hospitalization cost that produces more than 20 hundred million dollars.(referring to Sharafuddin, MJA, Kadir, S., et al. ＂ Percutaneous Balloon-assistedaspiration thrombectomy of clotted Hemodialysis access Grafts (the auxiliary attraction thrombectomy of the sacculus of the percutaneous of the hemodialysis access graft of obstruction) ＂ .J VaseInterv Radiol 7 (2) 177-183,1996, its full content is incorporated herein by reference).
Summary of the invention
[0002] vascular access system of implementing hemodialysis is disclosed.An embodiment relates to the vascular access system that comprises graft material, and described graft material is reinforced with varicosity PTFE, resisting the stretching of this graft material, and prevents the seepage relevant with tensile or crooked graft material thus.Another embodiment of the invention relates to the vascular access system with auxiliary channel chamber, can be sealed and be removed from the major part of this vascular access system in described auxiliary channel chamber.Other embodiment relates to the vascular access graft that comprises the IMU pipeline material, and described IMU pipeline material is reinforced with varicosity PTFE, resisting the stretching of this IMU pipeline material, and prevents thus and stretches or crooked relevant seepage.Described graft can comprise two latter ends, and described latter end comprises ePTFE and do not have the IMU pipeline material, so that this graft is easier and vein and arterial anastomosis.But the design of described graft integral type maybe can have the modular assembly (component) that can link together to produce the graft of customized lengths or further feature.One or more parts (section) of described graft also can be cut or be cropped to customized lengths.
[0003] in one embodiment, biocompatible graft material is provided, it comprises and the bonded anti-leakage layer of stretch-proof structure, and the prevention of wherein said stretch-proof structure can cause any pin site of puncture in the anti-leakage layer to open expansion with the anti-leakage layer of seepage basically.Described anti-leakage layer can comprise silicones.Described silicones can be a silicone tube.Described silicone tube can be the silicone tube of turning up.Described stretch-proof structure can be and the bonded stretch-proof layer of anti-leakage layer.Described stretch-proof layer can comprise ePTFE.Described ePTFE can have an appointment 25 microns to about 30 microns internode distance.
[0004] in another embodiment, implantable fluid line (conduit) is provided, it comprises first pipeline, described first pipeline has first end, second end, the chamber between two ends and has adapter with the contiguous opening in the chamber of first pipeline, and wherein first terminally is suitable for being connected with the body fluid pipeline with second end; With second pipeline, described second pipeline has elasticity first end, the second terminal and chamber between two ends, and elasticity first end of wherein said second pipeline releasably is connected with the adapter of first pipeline.This implantable fluid line also can comprise the pipe pressurizing device, and described pipe pressurizing device comprises and is configured to the second terminal distal tip that engages of second pipeline, is configured to seal the stopper in chamber of second pipeline and near the first terminal fluid volume that is configured to stopper is advanced to from the distal tip of pipe pressurizing device second pipeline.Described implantable pipe pressurizing device can be a syringe.Described pipe pressurizing device can be a fluid pump.
[0005] in another embodiment, implantable fluid line is provided, it comprises first pipeline, described first pipeline has first end, second end, the chamber between two ends and has adapter with the contiguous opening in the chamber of first pipeline, and wherein first terminally is suitable for being connected with the body fluid pipeline with second end; Second pipeline, described second pipeline has first end, the second terminal and chamber between two ends, first end of wherein said second pipeline can be connected with the adapter of first pipeline, and first end of wherein said second pipeline has pressure-sensitive compressed configuration and expanded configuration, and wherein first end of second pipeline pressure that can be configured to the intracavity along with second pipeline and increase becomes described expanded configuration from described pressure-sensitive compressed configuration.Implantable fluid line also can comprise the pipe pressurizing device, and described pipe pressurizing device comprises and is configured to the second terminal distal tip that engages of second pipeline, is configured to seal the stopper in chamber of second pipeline and near the first terminal fluid volume that is configured to stopper is advanced to from the distal tip of pipe pressurizing device second pipeline.
[0006] in another embodiment, the syringe that is used for sealing duct is provided, it comprises the distal tip that is configured to sealably to be connected with the end of conduit, be configured to seal the stopper in the chamber of described conduit, and is configured to stopper is advanced the pressurisable fluid volume that approaches this stopper most in the described conduit.
[0007] in another embodiment, provide treatment patient's test kit, the prefabricated stopper that it comprises vascular access system, cuspidated syringe and is configured to be positioned at syringe tip.
[0008] in another embodiment, treatment patient's method is provided, it comprises provides first pipeline, described first pipeline has first end, second end, the chamber between two ends and has adapter with the contiguous opening in the chamber of first pipeline, and wherein first terminally is suitable for being connected with the body fluid pipeline with second end; And second pipeline, described second pipeline has elasticity first end, the second terminal and chamber between two ends, and elasticity first end of wherein said second pipeline releasably is connected with the adapter of first pipeline; And first end of first pipeline is connected with the patient body pipeline, and second end of first pipeline is connected with patient's second body conduit, second end with second pipeline places the patient external simultaneously.Described method also can comprise separates second pipeline and first pipeline, and second pipeline is removed on one's body from the patient.Described method also can comprise by with syringe stopper being pushed in first pipeline, second pipeline and first pipeline is intercepted open.
[0009] in one embodiment, biocompatible graft is provided, it comprises and the bonded anti-leakage layer of stretch-proof structure, and the prevention of wherein said stretch-proof structure can cause any pin site of puncture in the anti-leakage layer to open expansion with the anti-leakage layer of seepage basically.Described anti-leakage layer can comprise silicone layer, and described stretch-proof layer can comprise the ePTFE layer.Described anti-leakage layer can comprise the antiseep tubular material, and this stretch-proof layer can comprise stretch-proof tubulose material.Described ePTFE layer can be the ePTFE pipe that comprises certain-length, outer surface, external diameter, first end, second end, the chamber between two ends and internal diameter.Silicone layer can include the silicone tube of first end and second end.Described silicone tube can be applied to the chamber of the outer surface or the described ePTFE pipe of described ePTFE pipe.Described silicone tube can be the silicone tube of turning up.The length of described silicone tube can be less than the length of ePTFE pipe.This biocompatible graft also can comprise the ePTFE layer that covers on the silicone tube.Described ePTFE cover layer can cover silicone tube fully.Described silicone tube can be positioned at first end apart from the ePTFE pipe at least about 0.25cm, 0.5cm or 1cm place.Described silicone tube can be positioned at second end apart from the ePTFE pipe at least about 0.25cm, 0.5cm or 1cm place.The chamber of ePTFE pipe can comprise the less diameter region in chamber, chamber transition region and chamber than the major diameter district.Silicone tube can be applied in chamber transition region and chamber in the chamber than near the ePTFE pipe the major diameter district.The outer surface of ePTFE pipe can comprise outside less diameter region, outside transition region and outside than the major diameter district.Described silicone tube can be applied to the outer surface of ePTFE pipe.Described silicone tube can be applicable near the outer surface of the ePTFE pipe the less diameter region of chamber transition region and chamber at least.Described anti-leakage layer and described stretch-proof layer can form the IMU highway section between the first ePTFE latter end and the 2nd ePTFE latter end.A described ePTFE latter end and IMU highway section can wholely form or be connected together by the sections adapter.Described biocompatible graft also can comprise antitorque junction structure near second end of first end of described silicone tube or silicone tube, perhaps all comprise antitorque junction structure near second end of the first terminal and silicone tube of described silicone tube.Described biocompatible graft also can comprise be embedded in the described silicone tube usually or described silicone tube and ePTFE pipe between separating member (separation member).Described separating member is spiral helicine unwinding member.
[0010] in another embodiment, treatment patient's method is provided, it comprises provides implantable medical treatment device, described medical treatment device comprises and the bonded silicone layer of ePTFE layer, wherein said ePTFE layer can be configured to stop described silicone layer to be stretched to opens any puncturing hole in this silicone layer, be enough to degree that fluid is passed through in body conduit, and described implantable medical treatment device is connected with body conduit.Described implantable medical treatment device can comprise vascular access graft or vascular access mouth.
[0011] in another embodiment, provide the method for implantable intravascular graft, it comprise provide have first latter end, the biocompatible graft of IMU highway section and second latter end; One of described latter end is connected to tremulous pulse; And another latter end is connected to vein; Wherein said IMU highway section can comprise and the bonded anti-leakage structure of stretch-proof structure.Described anti-leakage structure can be the tubular structure of anti-seepage material.Described stretch-proof structure can be the tubular structure of stretch-proof material.This anti-leakage structure can comprise the anti-seepage material that longitudinal length is at least about 5cm, 7cm, 9cm or 11cm.This longitudinal length can link to each other.Described anti-leakage structure can comprise and the bonded silicone layer of described stretch-proof structure, and described stretch-proof structure comprises ePTFE or PTFE.This method also can comprise with adapter one of described latter end is connected with described IMU highway section, or with the device that connects the vascular access section one of described latter end is connected with described IMU highway section.One of described latter end can whole formation in manufacture process with the IMU highway section.This method also can comprise the inferior section of the first instant path and the second instant path Asia section are cut in described IMU highway section.This method also can comprise one in one of inferior section of described instant path and the described latter end is connected.Remaining inferior section can be dropped.Described IMU highway section also can comprise be usually located in the anti-leakage structure or anti-leakage structure and stretch-proof structure between separating member.Described method also can comprise cutting described IMU highway section and/or the application of force to described separating member so that the part of described anti-leakage structure is separated with described stretch-proof structure to small part.This method also can comprise remove described anti-leakage structure form described second latter end with a part to the small part separating part by described IMU highway section.The diameter of described first latter end can be less than second latter end, or the diameter of described first latter end and second latter end is less than the IMU highway section.
[0012] in another embodiment, provide implantable vascular access graft, described vascular access graft is designed to enter blood flow fast by this graft when implanting this graft in patient's body.Described graft includes inner surface, outer surface and extends to the polyurethane tube of the length of second end from first end; And the structure of pin puncture back antiseep, described structure is included near the layer that is connected with described pipe described inner surface or the outer surface, and the length of extending is less than the length of the described pipe between described first end and second end, so that the no described structure division of described pipe is provided at the end of described pipe.
[0013] in one embodiment, biocompatible graft is provided, it comprises and the bonded anti-leakage layer of stretch-proof structure, wherein said stretch-proof structure has stoped any pin site of puncture that can cause basically in the anti-leakage layer to open expansion with the anti-leakage layer of seepage, and wherein said anti-leakage layer has the structure that turns up.Anti-leakage layer can comprise silicone layer, and described stretch-proof layer can comprise the ePTFE layer, or described anti-leakage layer can comprise the antiseep tubular material, and the stretch-proof layer can comprise stretch-proof tubulose material.Described ePTFE layer can be the ePTFE pipe that comprises certain-length, outer surface, external diameter, first end, second end, the chamber between two ends and internal diameter.Silicone layer can comprise the silicone tube that can have first end and second end.Described silicone tube may be used on the chamber of the outer surface and/or the described ePTFE pipe of described ePTFE pipe.The length of this silicone tube is less than the length of this ePTFE pipe.Biocompatible graft also can comprise the ePTFE layer that covers on the described silicone tube.The cover layer of described ePTFE can cover silicone tube fully.This silicone tube can be positioned at first end apart from this ePTFE pipe at least about the 0.25cm place, or apart from first end of this ePTFE pipe at least about the 0.5cm place, or apart from second end of this ePTFE pipe at least about the 0.25cm place, or apart from first end of this ePTFE pipe at least about the 1cm place.Silicone tube can be positioned at second end of the described ePTFE pipe of distance at least about the 0.5cm place, or apart from second end of this ePTFE pipe at least about the 1cm place.The chamber of described ePTFE pipe can comprise the less diameter region in chamber, chamber transition region and chamber than the major diameter district.Described silicone tube can be applied in this chamber transition region and chamber in the chamber than near the ePTFE pipe the major diameter district.The outer surface of described ePTFE pipe can comprise outside less diameter region, outside transition region and outside than the major diameter district.Described silicone tube can be applied near the outer surface of the described ePTFE pipe the less diameter region of described chamber transition region and chamber at least.Described silicone tube can be applied to the outer surface of described ePTFE pipe.Described anti-leakage layer and stretch-proof layer can form the IMU highway section between the first ePTFE latter end and the 2nd ePTFE latter end.The one ePTFE latter end and IMU highway section can wholely form.A described ePTFE latter end and IMU highway section can be linked together by the sections adapter.Described biocompatible graft also can comprise at least one antitorque junction structure near first end of described silicone tube or near second end of this silicone tube.Described biocompatible graft also can all comprise antitorque junction structure near second end of first terminal and this silicone tube of described silicone tube.Described biocompatible graft also can comprise in the common embedding silicone tube or the separating member between silicone tube and the ePTFE pipe.Described separating member can be spiral helicine unwinding member.Described anti-leakage layer can vertically be compressed.
[0014] in one embodiment, provide the hemodialysis graft, it comprises the elastic tubular structure of turning up.Described hemodialysis graft also can comprise and the bonded gillies' graft material of elastic tubular structure that turns up.
[0015] in one embodiment, biocompatible blood vessel graft is provided, its comprise have outer surface, the tubulose anti-seepage material of inner surface, first end, second end, the longitudinal axis and the inner chamber between first terminal and second end, wherein the tubulose seepage material of at least a portion is circumferentially to compress.Described tubulose anti-seepage material can be axial compression and/or radial compression.The radial compression of this tubulose anti-seepage material can be that described tubulose anti-seepage material is inherent.Near this tubulose anti-seepage material outer surface can have circumferential tension force, near the tubulose anti-seepage material this tubulose anti-seepage material inner surface of this tension force radial compression.Described tubulose anti-seepage material can present the compression stress of the increase from its outer surface to its inner surface.The outer surface of this tubulose anti-seepage material can be an expanded configuration, and the inner surface of this tubulose anti-seepage material can be a compressed configuration.This tubulose anti-seepage material can be the tubular material that turns up.Described tubulose anti-seepage material can be silicone tube or polyurethane tube.Described biocompatible graft also can comprise the radial compression structure.Described radial compression structure can be the tubular compression structure.Described biocompatible graft also can comprise one or more that be connected with the tubulose anti-seepage material and be configured to resist the tensile stretch-proof structure of this tubulose anti-seepage material.Described one or more stretch-proof structure can comprise a plurality of stretch-proof structures that are embedded in this tubulose anti-seepage material.Described a plurality of stretch-proof structure can be discontinuous fiber or strand (strands).Described one or more stretch-proof structure can comprise the stretch resistant tube with described tubulose anti-seepage material concentric arrangement.Described stretch resistant tube can be attached to the outer surface of this tubulose anti-seepage material.Described stretch resistant tube can be incorporated into the inner surface of this tubulose anti-seepage material.Described stretch resistant tube can be the ePTFE pipe.Described stretch-proof material can be ePTFE.Described ePTFE has an appointment 25 microns to about 30 microns average internode distance along the longitudinal axis of described tubulose anti-seepage material.The compression of tubulose anti-seepage material can be radial.
[0016] in one embodiment, provide the method for making blood vessel graft, it comprises elastic polymer pipe is turned up, and stretch-proof structure and this elastic polymer tube are linked together.Described elastic polymer tube can be a silicone tube.Described stretch-proof structure can be the stretch-proof graft structure.Described stretch-proof graft structure can comprise ePTFE.Described stretch-proof structure has tubular structure.This stretch-proof structure can be attached to the outer surface of this elastic polymer tube.The method of making blood vessel graft also can comprise the elastic polymer tube of will turn up and be positioned on the gillies' graft.Each can have certain-length this gillies' graft, the elastic polymer tube of turning up and stretch-proof structure, and the length of wherein stretch-proof structure can be shorter than the length of gillies' graft.The stretch-proof structure can vertically be compressed.The method of making blood vessel graft also can be included in before the elastic polymer tube of turning up, and gillies' graft is placed on the outer surface of elastic polymer tube, and the elastic polymer tube of wherein turning up also makes gillies' graft turn up.
[0017] in one embodiment, treatment patient's method is provided, it comprises provides implantable medical treatment device, described medical treatment device comprises and the bonded silicone layer that turns up of ePTFE layer, wherein said ePTFE layer is configured to stop this silicone layer to be stretched to opens arbitrary puncturing hole in this silicone layer, be enough to degree that fluid is passed through in body conduit, and should be connected with body conduit by implantable medical treatment device.Described implantable medical treatment device can comprise vascular access graft.Described implantable medical treatment device can comprise the vascular access port.
[0018] in one embodiment, provide the method for implantable intravascular graft, it comprise provide have first latter end, the biocompatible graft of IMU highway section and second latter end; One of described latter end is connected to tremulous pulse; And another described latter end is connected to vein; Wherein the IMU highway section can comprise and the bonded anti-leakage structure that turns up of stretch-proof structure.The described anti-leakage structure that turns up can be the tubular structure of anti-seepage material.The described anti-leakage structure that turns up can vertically compress.Described stretch-proof structure can be the tubular structure of stretch-proof material.Anti-leakage structure can comprise and has at least about 5cm, at least about 7cm, at least about 9cm or at least about the anti-seepage material of the continuous or clean longitudinal length of 11cm.Anti-leakage structure can comprise and the bonded silicone layer of stretch-proof structure, and described stretch-proof structure comprises ePTFE or PTFE.Described method also can comprise with adapter one of described latter end is connected with described IMU highway section.Described method also can comprise by using the device that connects the vascular access section that one of described latter end is connected with described IMU highway section.One in the described latter end can whole formation in manufacture process with described IMU highway section.Described method also can comprise the inferior section of the first instant path and the second instant path Asia section are cut in described IMU highway section.Described method also can comprise one of inferior section of described instant path is connected with one of described latter end.This IMU highway section also can comprise be usually located in the anti-leakage structure or anti-leakage structure and stretch-proof structure between separating member.Described method also can comprise the described IMU of cutting highway section.Described method also can comprise the application of force to described separating member from described stretch-proof structure, to isolate the part of anti-leakage structure to small part.As the method for the described implantable intravascular graft of claim 86, also can comprise removing with the part by the IMU highway section to the small part separating part of described anti-leakage structure formed second latter end.The diameter of first latter end can be less than second latter end, or the diameter of first latter end and second latter end is less than the IMU highway section.
[0019] in one embodiment, implantable vascular access graft is provided, described vascular access graft is designed to when implanting described graft in patient's body, enter blood flow fast by this graft, described graft comprise have inner surface, outer surface and extend to the polyurethane tube of the length of second end from first end; And the structure of pin puncture back antiseep, described structure is included near the layer that is connected with described polyurethane tube described inner surface or the outer surface, and extend length, so that the part of the described pipe that does not have described structure is provided at the end of described pipe less than the described pipe between described first end and second end.
Brief description of drawings
[0020] by following detailed description and accompanying drawing to embodiment of the present invention, structure of the present invention and using method will better be understood, wherein:
[0021] Figure 1A is the cross sectional representation of an embodiment of adapter.Figure 1B and 1C have described the connector edge of adapter among Figure 1A.
[0022] Fig. 2 A is the exploded view of an embodiment of connector system.Fig. 2 B is the cross-sectional view in connector system when assembling among Fig. 2 A.
[0023] Fig. 3 is the front view of one embodiment of the invention, comprises the multicompartment vascular access system of the passage area with self-enclosed material.
[0024] Fig. 4 is the diagram that has the vascular access system of percutaneous port.
[0025] Fig. 5 is the front view that the graft parts of antitorque knot support are arranged.
[0026] Fig. 6 A and Fig. 6 B are respectively the front schematic view and the cross-sectional views of an embodiment of parts of vessels that has the reinforcement material of embedding.
[0027] Fig. 7 A is the detail elevation of an embodiment of the parts of vessels reinforced with removable agglutinating fibril to Fig. 7 C.Fig. 7 B has shown removed a part of fibril from Fig. 7 A.Prepare parts of vessels among Fig. 7 C displayed map 7A and Fig. 7 B with the adapter installation.
[0028] Fig. 8 A is the sketch map of an embodiment of the two section of implantation of the present invention vascular access system to Fig. 8 F.
[0029] Fig. 9 A is the sketch map of another embodiment of the two section of implantation of the present invention vascular access system to Fig. 9 E.
[0030] Figure 10 is the sketch map that comprises multiwalled self-sealing pipeline.
[0031] Figure 11 is the sketch map of the vascular access system of subsidiary temporary catheter.
[0032] Figure 12 A is the detailed sketch map that vascular access system is connected with temporary catheter with the compression interface with 12B.
[0033] Figure 13 is the cross-sectional view that is used to connect the adapter that has biasing ala (flap) of blood access.
[0034] Figure 14 A and Figure 14 B be respectively the pipe jointer that has an a pair of mechanical valve open with close structure in be connected the cross sectional representation of temporary catheter.
[0035] Figure 15 A is the sketch map that has the temporary catheter of total length plug (full-length plug) to Figure 15 C.
[0036] Figure 16 A is the sketch map of using the temporary catheter of most proximal end stopper and the use of conduit cutter sweep locking to Figure 16 C.
[0037] Figure 17 A is the sketch map that has the vascular access system of subsidiary conduit and hydraulic pressure removal system to Figure 17 D.
[0038] Figure 18 is the cross sectional representation of instant access graft device.
[0039] Figure 19 is the cross sectional representation of another kind of instant access graft device.
[0040] Figure 20 is the cross sectional representation of another kind of instant access graft device.
[0041] Figure 21 is the cross sectional representation of another kind of instant access graft device.
[0042] Figure 22 is the cross sectional representation of another kind of instant access graft device.
[0043] Figure 23 is the elevational schematic view of another kind of instant access graft device.
[0044] Figure 24 is the front elevational schematic that has the instant access graft device of multistage of adapter.
[0045] Figure 25 A and 25B are the cross sectional representation before and after the silicone tube structure is turned up.
[0046] Figure 26 A and 26B are the cross sectional representation that the silicone tube structure is compressed to the interior intracavity of compressed pipe.
[0047] Figure 27 A is a strained form of describing prediction in the silicone tube of turning up.Figure 27 B is a chart of describing the material strain percent of prediction in the silicone tube of turning up.
[0048] Figure 28 is a chart of describing the stretch-proof characteristic of ePTFE.
Detailed description of the preferred embodiments
[0049] studies show that from the graft of AV graft vein end place local stenosis failure mainly is because neointimal hyperplasia, graft and the autogenous vein compliance between coincideing is mismatched, and due to the turbulent flow of anastomotic position.Kanterman R.Y.et al ＂ Dialysis accessgrafts:Anatomic location of venous stenosis and results of angioplasty (dialyzing access graft: the anatomical position of phlebostenosis and the result of angioplasty). ＂ Radiology 195:135-139,1995. we infer can be by without venous anastomosis, but makes blood flow directly into Venous system and evade these inducements with conduit.We use at the duct element of vein end with the synthetic graft construction element of standard mode and arterial anastomosis, have developed the vascular access system of removal venous anastomosis in the AV shunting.We believe that such system should eliminate or reduce the vein hypertrophy, and described vein hypertrophy is the maximum reason of AV shunting failure.
A.
Vascular access system (VAS)
[0050] although these devices can be used as the integrating device of single-piece constructs, also can design many devices that comprise the separation assembly that is joined together subsequently.The multicompartment device has several advantages.The first, many devices allow the disconnection of one or more assemblies of this device.This makes multiple equipment energy characteristic be suitable for specific dissection and/or morbid state with regard to allowing, and for example, realizes by the assembly that uses different size.This has also reduced the expense for the treatment of the patient aspect several.Its multiple assembly by the depots storage, rather than the various intact device of depots storage and reduced the quantity in stock of specific device.Equally, if selected wrong device to be used for the patient at first, only need abandon wrong assembly and get final product, and need not to abandon whole device.The second, compare the easier manufacturing of a plurality of assemblies that separates of device with the device of integrated form.The 3rd, the separation assembly of doctor's implanting device then links together them, and integrated device is easier than implanting.The 4th, it allows assembly is adjusted as required to adapt to various patients' anatomical structure.Integrated device volume is excessive, and has slowed down implantation process, has therefore increased operating time and expense, has also increased the risk of doctor's error.
[0051] Fig. 1 has described one embodiment of the invention.The present invention includes adapter 2, described adapter 2 has first end 4, mid portion 6 that is connected to the first fluid pipeline and second end 8 that is connected to second fluid line, and the chamber from first end to second end 10.With reference to figure 2A and 2B, first fluid pipeline 12 is hemodialysis graft assembly normally, and second fluid line 14 conduit normally, but also can use other combination, such as graft/graft, conduit/graft or conduit/conduit.
[0052] in one embodiment of the invention, as shown in Figure 3, vascular access system (VAS) 100 comprises first parts 102 of graft material, first parts 102 have the integrated adapter end 104 that can be connected to second parts 106, second parts 106 comprise and are fit to transportation blood, also be fit to venesection or even littler invasive operation insert conduit tube component in the Venous system.The diameter of second parts 106 is little, about 7mm or littler, and preferably about 6mm or littler, and most preferably about 5mm or littler, implanting second parts 106 does not so need big venesection, and second parts 106 do not account for too much space in Venous system thus.VAS100 preferably has thin-walled so that available via the maximization of the mobile area of VAS100, can use the light-wall pipe of reinforcement to realize this purpose.Second parts 106 have the opening that is fit to be positioned at vein itself, and wherein said opening is at far-end or be positioned at the downstream that second parts 106 insert intravenous insertion position.The external diameter that inserts intravenous part of second parts 106 is less than its venous internal diameter of inserting, so that in force, blood can flow into intravenous by second parts, also can flow through at the vein of the external surface peripheral of second parts 106 itself.Second parts 106 can be suitable for subcutaneous application fully, and are configured in use avoid blood to accumulate there, so that successive blood flow to be provided.Insertion length that can be by assessment VAS100 vein to be inserted, second parts 106 and/or may assess is implemented diameter and the length that hemodialysis desired flow rates and pressure decline standard are determined two parts 102,106.
[0053] second parts 106 can be carried out cutting, be connected to graft parts 102 then to reach needed total length.Graft parts and parts of vessels 102,106 are made into to resist kink and extruding, but can not be too stiff.In one embodiment of the invention, these characteristics can reinforce 108 by the spiral in the silicone tube 110 provides.Operable other material comprises the polymer of PTFE, polyurethane and other blood compatibility.Fig. 3 has also shown duct element 106 parts that comprise self-styled closed zone 112, and self-styled closed zone 112 provides temporarily or provide for a long time the inserting needle path of implementing dialysis when graft 102 recovers.Self-styled closed zone 112 is preferably self-support type (for example frameless), has parts of vessels and/or identical diameter and the shape of graft parts with VAS usually, has tubular structure usually, makes and can puncture along its length and/or any point of girth.Self-styled closed zone 112 can comprise the self-enclosed material of the parietal layer of the graft parts of at least a portion that forms VAS and/or parts of vessels.Different with the self-enclosed material that provides at access port, self-styled closed zone 112 keeps elasticity to promote the implantation of VAS along its length or the longitudinal axis, also provides than the longer self-styled closed zone 112, self-styled closed zone on the access port of large volume.Longer length allows dialysis needle to insert in the bigger surface area, thereby makes identical little skin region not need repeated localised puncture, has therefore significantly reduced to cause infecting and/or the chance of hemorrhage formation sinus tract.This also makes specific needle track have more time to go to recover between the pin puncture, therefore compares with traditional access port, can further reduce and infect and/or risk of bleeding.In one embodiment, the length of self-styled closed zone 112 is at least about 2 inches, in another embodiment at least about 3 inches, and in other embodiments at least about 4 inches or 5 inches.VAS also can randomly comprise the flow transducer that is embedded in the VAS wall, and/or can adjust the conduit component with the control flow after implantation, and described flow transducer can externally be putd question to provide the flow reading in the device.These and other feature can be described below in more detail.
[0054] can use one or more other assemblies, structure or material that other site of puncture is provided, but the parts of vessels place that is included in part or all uses tubular material anti-puncture, circumferentially compression, is clipped in the gel rubber material in the tube wall, graft parts or its combination in any of low-durometer material inserting needle, but the implantation port of inserting needle, and/or need not pierce through the percutaneous port one 14 that skin 116 can enter, as shown in Figure 4.In these features some can discuss in more detail below.
[0055] in some embodiments of the present invention, also available one or more therapeutic agents coating graft parts and/or parts of vessels include but not limited to antithrombotic, reduction infection, fast track rehabilitation time, promote the cell growth and/or improve arterial anastomosis to realize any effect of various VAS dependent interactions.These reagent are including but not limited to heparin, carbon, silver compound, collagen, antibiotic with such as the anti-restenosis reagent of rapamycin or paclitaxel (paclitaxel).These reagent can be attached to the surface of VAS, as known in the art, realize with heparin with in conjunction with the material of chlorhexidine, or these reagent can be gone out by eluting from the eluted substance polymer coating.
[0056] similarly, also can change the porosity of self-styled closed zone 112 and further feature to amplify its effect.For example, this can realize by the porosity, structure and the wall thickness that change pipeline material.Some materials commonly used are combinations of ePTFE, polyurethane, silicones or these materials, described material so that the porous mode of the outer wall surface of this pipeline make.Porosity characteristic has promoted to help tissue ingrowth, can help to reduce infection rate.Think in the material that about 20 μ m or littler porosity provide the antiseep of bulk material before the pin puncture.Therefore the wall thickness that material is configured at least a portion has about 20 μ m or littler porosity is preferred, but optional.Yet about on the outer surface 10 μ m can promote the inside growth of porous surface inner cell to about 1000 μ m or bigger porosity, and this can reduce serosity and gathers around graft, and it has reduced again and the relevant infection rate of pin puncture conversely.More preferably, use the porosity of about 20 μ m, and most preferably use the porosity of about 100 μ m to about 200 μ m to about 200 μ m.For antiseep is provided and improve the ingrown material of cell, multilayer material can be provided, its surface layer has the ingrown porosity of cell of promotion and/or further feature, its subsurface stratum material has the feature that promotes antiseep.Yet, be applied to various substrate or therapeutic agent on graft parts and/or the parts of vessels by use, also can realize the inside growth of cell with the smooth surface device.And in the zone of not being intended to acupuncture of VAS, those regional available porous layers or coating provide the inside growth of organizing to promote, and do not need the antiseep subgrade.These materials also are biocompatible, and can be manufactured into, and for example, make they and the tremulous pulse that is connected suitable compliance be arranged with the foundation that impels arterial anastomosis and unobstructed.Side opposite also can be different materials, different surface textures with outer surface, and the coating with body reactions such as promotion such as unobstructed, resistance infection and tissue ingrowths.
1.
The graft parts
[0057] the graft parts of described vascular access system can comprise ePTFE, polyurethane, silicones, Da Kelun
Or other analog material.The length of the graft parts 102 of VAS 100 is preferably greater than about 40cm at least about 20cm, and most preferably greater than about 60cm.The internal diameter of graft parts 102 can arrive about 6.5mm for about 5.5mm, arrives about 7mm for about 5mm sometimes.The wall thickness of graft parts 102 can be that about 0.3mm arrives about 2mm, and about sometimes 0.4mm is to about 1mm, and preferably about 0.5mm is to about 0.8mm.
[0058] as previously mentioned, provide strain relief in some embodiments of the present invention.Strain relief is favourable to pipeline or the graft that comprises PTFE or other elastomeric material, and can prevent this pipeline or graft obturation.The strain relief structure comprises from described adapter usually or connector ferrule begins and on the outer surface of described pipeline/graft or elastic helix that extends in the wall or coil.Described strain relief can comprise biocompatible metals or plastics.
[0059] in a selectable embodiment of the present invention, the strain relief structure that begins to stretch out from described adapter or connector ferrule on being provided at the graft parts, also the strain relief structure directly can be connected with described graft parts.In the particular that Fig. 5 shows, graft parts 102 comprise the ePTFE material 118 that has PTFE spiral chain strain relief structure 120, described spiral chain strain relief structure 120 is usually located at the adapter end 119 of graft parts 102, adapter terminal 119 with or can be connected with the parts of vessels 106 or the pipe jointer 122 of vascular access system (VAS) 100.Fig. 5 embodiments shown is a spiral chain strain relief structure, but person of skill in the art will appreciate that, other strain relief structure also can be connected with graft parts 102.In some instances, helical form PTFE support is configured to usually in the terminal termination of the adapter of graft parts, and in other embodiments, the end that has extended beyond the graft parts of spiral chain strain relief structure contacts with described adapter or connector ferrule.In other embodiments, the spacing of the adapter end 119 of helical form PTFE support and graft parts 102 is in about 0.2cm.The length of described helical form PTFE support can be that about 1cm arrives about 8cm, and preferably about 2cm is to about 6cm, and most preferably from about 2cm is to about 4cm.Helical form PTFE support can be supported (hot and cold, warm and/or ultrasonic) in the PTFE graft material, combines with this graft material with binding agent, or is held in the appropriate location by the coating protection on the graft parts 102.
[0060] in another embodiment, be used near the adapter silicones in the district or other elastomeric material and apply and/or embed described graft material, to improve contacting when the crooked time shift plant walls of this graft and adapter.This point is useful because the ePTFE graft material is natural plastically deformable, and when it during at adapter terminal crooked, the breach that it has been opened upset blood flow (cause turbulent flow and compile) and has caused blood clot to form.Add elastomeric material and help to keep cooperating more closely between graft and the adapter surface.In a preferred embodiment, use silicones-xylene mixture spraying or described graft of dip coated with about 200cps viscosity.Viscosity can arrive about 1000cps for about 50cps, and more preferably from about 100cps most preferably from about 150 arrives about 250cps to about 300cps.Succedaneum comprises low viscous silicone, polyurethane rubber, styrene block copolymer or solvent-free or other elastomer of dimethylbenzene, toluene, napthas, ketone, THF or other suitable easy miscible solvent arranged.
[0061] randomly, the graft parts of described VAS can have length mark on its surface, with convenient the graft parts are cropped to the needed length that makes the device personalization according to the anatomical structure of particular patient.The length mark that provides in described graft parts or other labelling also can be radiopaque, so that the development of the ray of these graft parts is visual.
2.
Parts of vessels
[0062] as previously mentioned, the parts of vessels of described VAS can comprise the pipeline of different-diameter.The end that is fit to the parts of vessels of insertion vein or other blood vessel can have the internal diameter of about 3mm to 10mm, and about 4mm arrives about 6mm sometimes, preferably about 5mm, and helical form support embedding or outside can be arranged so that antitorque knot to be provided.The end of the suitable parts of vessels that is connected with adapter or graft parts can have bigger diameter, because it is not positioned at the intracavity of blood vessel.The selection of the internal diameter of described parts of vessels, external diameter and length can be selected based on following factor by those skilled in the art, this factor include but not limited to insert the second body fluid section vein, wait to pass the catheter length that wall of vein inserts, and desired flow rates and fluid resistance characteristic.
[0063] described parts of vessels comprises PTFE, polyurethane or silicones usually.Other available biocompatible material comprises polyethylene, homopolymer and copolymer such as the vinyl acetate of ethene-vinyl acetate copolymer, polrvinyl chloride, homopolymer and copolymer such as the acrylate of polymethyl methacrylate, polyethyl methacrylate, polymethacrylates, ethylene glycol dimethacrylate, Ethylene glycol dimethacrylate and hydroxy methyl methacrylate, polyurethane, polyvinylpyrrolidone, 2-Pyrrolidone, the polyacrylonitrile butadiene, Merlon, polyamide, such as the homopolymer of politef and polyvinyl fluoride and the fluoropolymer of copolymer, polystyrene, the homopolymer of styrene-acrylonitrile and copolymer, cellulose acetate, the homopolymer of acrylonitrile-butadiene-styrene (ABS) and copolymer, polymethylpentene, polysulfones, polyester, polyimides, polyisobutylene, polymethylstyrene, such as medical grade silicone rubber, the polrvinyl chloride elastomer, polyolefin homopolymer and copolymer elastomer, SB, elastomer based on urethanes, natural rubber or other elastomeric biocompatible elastomer, and other similar compound well known by persons skilled in the art.Referring to Polymer Handbook (polymer handbook), Fourth Edition (the 4th edition), Ed.By J.Brandup, E.H.Immergut, E.A.Grulke and D.Bloch, Wiley-Interscience, NY, Feb.22,1999.
[0064] preferably, the size of the inserted intravenous of described parts of vessels part allows blood around the conduit that is inserted and carry out side shoot by the position that this parts of vessels inserts blood vessel and flow.In some embodiments, also preferably make the parts of vessels of described VAS form required size to allow application Seldinger technology rather than the parts of vessels percutaneous to be inserted intravenous by venesection or the complete surgical exposure of venous.The external diameter of parts of vessels is no more than about 6mm, preferably is no more than about 5mm or 4mm, helps this parts of vessels percutaneous is inserted intravenous, for example internal jugular vein.
[0065] in one embodiment of the invention, the parts of vessels of described VAS makes up with polymerization fibril, tinsel, fiber or its and reinforces, and preferred helical form structure.Compare with the similar parts of vessels that lacks reinforcing, the reinforcing of the insertion section of VAS, the especially reinforcing with tinsel or fiber can be used for providing the insertion section of reduced diameter and have the antitorque knot of improvement and/or the insertion section of resistance to crusing characteristic.Tinsel or line can be incorporated into the outer surface or the inner surface of this parts of vessels, perhaps can be squeezed into or injection moulding is gone in the silastic material to form this parts of vessels.In some embodiments, helical metal wire is placed or is attached to the outer surface of pipeline material, spraying or dip coated material are not reinforced the smooth outer surface that is hindered to provide by tinsel then.It should be understood by those skilled in the art that, except the helical form structure, can also use other to reinforce structure, comprise arrangements of embarking on journey, staggered or place at random discontinuous or interconnective ring on the interior or wall of the wall of described VAS, around and/or fiber longitudinally.
[0066] in an example, described parts of vessels comprises the silicones extruded tube of reinforcing with the nylon coil.Silicones can contain about 1% the barium barium to about 30%, to improve the radiopaque degree of this parts of vessels.In other embodiments, silicones can contain about 5% to about 20% barium.In other embodiments, silicones can contain about barium of 10% to 15%.Other radiopaque material also can substitute barium or use with barium.This nylon coil can comprise diameter and be about 0.005 inch and form to about 0.050 inch nylon monofilament that preferred diameter is about 0.010 inch to about 0.025 inch.Described coil can be configured to the wire turn that per inch about 10 encloses 60 circles, and preferably per inch about 20 encloses 40 circles.Can also use silicones injection moulding again, substep injection moulding and/or silicones spraying, so that there are more homogeneous and/or more slick external diameter in a plurality of parts place of described parts of vessels.
[0067] in other embodiment of accompanying drawing 6A and accompanying drawing 6B description, described parts of vessels comprises the silicone tube 124 of reinforcing with Nitinol coil 126.The diameter of Nitinol coil 126 is about 0.002 inch to about 0.020 inch, about 0.003 inch to about 0.012 inch of preferred diameter.Nitinol coil 126 can be configured to the wire turn that per inch about 10 encloses 100 circles, and preferred per inch about 20 encloses the wire turn of 60 circles.The outer surface of parts of vessels 106 is with silicones 128 sprayings, so that more homogeneous and more slick external diameter to be provided.
[0068] in a specific embodiment, the parts of vessels of described VAS comprises insertion section of reinforcing with helical form Nitinol coil and the linkage section of reinforcing with polymeric helical form fibril.The insertion section of described parts of vessels is suitable for inserting intravenous, and described linkage section is suitable for being connected with pipe jointer and/or the described graft parts of VSA.By the insertion section of described parts of vessels is used tinsel, can reach littler external diameter and insert in vein or other blood vessel through skin with the parts of vessels of convenient this VSA.On the other hand, reinforce, can reduce the diameter of this linkage section, keep the ability of the linkage section of this parts of vessels of cutting simultaneously, and when cutting off the tinsel footing of this parts of vessels, do not produce sharp distal end or burr by the polymer that linkage section is provided.The length of inserting section can be for approximately 11cm be to 50cm, and preferably about 15cm is to about 35cm, and most preferably from about 20cm is to about 25cm.The linkage section of described parts of vessels can have the length of about 10cm to the cutting in advance of about 50cm, and preferably approximately 15cm is to 35cm, and most preferably from about 20cm is to about 25cm.In tool embodiments more of the present invention, the total length of described parts of vessels for about 20cm to about 250cm, about sometimes 30cm arrives about 60cm, other the time about 120cm arrive about 250cm.When at axillary fossa/when this device is implanted at the thigh position, can use long length.
[0069] in another embodiment of the present invention that accompanying drawing 7A describes, the polymer of described parts of vessels 106 is reinforced 130 combinations or is attached to the outer surface 132 of linkage section 134, rather than is embedded in the wall of linkage section 134.In some embodiments, for example among Fig. 7 A and the 7B, controllably peel off or separate from the outer surface 132 of linkage section 134 to allow that the polymer of a part is reinforced 130, and do not destroy or hinder linkage section 134 remaining structure integrity mode in conjunction with or mucoadhesive polymers reinforce 130.7C with reference to the accompanying drawings, this feature is useful in embodiments of the invention, wherein the helical form of polymer is reinforced 134 opposings or is prevented to connect terminal 136 expanded radially, for the tip engages pipe jointer 122 that will connect end 136 needs this expanded radially.Remove the part of polymer reinforcing 130 by allowing controllability, after the linkage section 134 of parts of vessels 106 is cut out needed length, can remove polymer from linkage section 124 and reinforce a part 136 of 130, so that parts of vessels 106 is matched with pipe jointer 122 on the graft parts of VAS or integrated adapter.In similar mode, this reinforcing can preferably embed in the catheter wall, rather than tightly invests outer surface it is removed easily.
[0070] in order to reduce damage risk, and/or in order to reduce turbulent blood flow, the edge of the distal tip of this parts of vessels can be done circular at the distal openings place of described parts of vessels to the blood vessel structure of parts of vessels and/or parts of vessels insert division.In some embodiments, can by soak silicones, shade sprayed silicon resin does circular, also can be molded as circle.
3.
The implantation of vascular access system
[0071] in some embodiments of the present invention, the low incisura of described VAS combines the operation of permission use minimally-invasive so that this device is implanted with the easiness that the parts of vessels of this VAS inserts vascular system.Depend on the diameter of the parts of vessels of the VAS of institute, available open surgical technology, or preferred venesection, or most preferably parts of vessels is inserted vein by Seldinger (Sai Erdingge) technology.These technology are operations as well known to those skilled in the art.
[0072], uses in the dissecting tool of the tunnelling utensil of multiple special use or other blunt circle any can set up and insert the subcutaneous path of position to needed graft parts connecting portion from this parts of vessels in case established the insertion position of the parts of vessels of described VAS.Then this VAS system is passed through this subcutaneous path, and these graft parts are connected to target site.Can between the insertion position of VAS and connecting portion, set up single successive subcutaneous path, particularly all the more so when this VAS device comprises the integral type design.Depend on the flexibility of selected position, patient's specific anatomical structure, needed subcutaneous path and/or the modularity of VAS, expectation is along the one or more intermediary surperficial sites of puncture of this subcutaneous path setting, so that the subcutaneous tunnelling of easier enforcement and/or along the one or more parts of this path by this VAS.When implanting multi-part VAS, it is ideal especially using intermediary surperficial site of puncture, but optional.Several separate parts of described VAS can be implanted respectively along a plurality of parts of subcutaneous path, connect by pipe jointer or other structure at this intermediary surperficial puncture site place then, are embedded in subcutaneous then.
[0073] with reference to figure 8A to 8F, in one embodiment of the invention, disinfection way is prepared the patient routinely, the shop aseptic towel.Finish local anesthesia or general anesthesia.In Fig. 8 A, palpation patient's brachial artery, the whole tip penetration of labelling position 164.(IJ) vein in the neck of location is selected the initial site of puncture 166 of IJ venous with anatomic landmark and/or such as hyperacoustic ray image visual (radiographicvisualization).Seal wire is penetrated the IJ vein, then dilator is passed above this seal wire, introducer is inserted the IJ intravenous with convenient.If skin and/or subcutaneous tissue have produced extra resistance when dilator inserts, then inserting the position at seal wire may need little scalpel otch.Remove dilator, above seal wire, introducer 168 is inserted the IJ intravenous.Introducer 168 can be standard or customization type introducer.Parts of vessels 106 with described VAS inserts in the introducer then, inserts superior vena cava or right atrium by the IJ vein.The position of the distal tip of parts of vessels 106 is determined by radioautography, checks that the patient has or not the unexpected pulmonary collapse that causes because of incorrect insertion.By near-end tractive introducer, if possible, perhaps remove introducer 168 then by peeling off introducer (if exfoliated introducer is provided) at parts of vessels.
[0074] in Fig. 8 B, then surgery rod 170 is inserted subcutaneous space by described initial site of puncture.Surgery rod 170 be used for subcutaneous open lead to before the passage of shoulder.In other embodiment, the implantation of subcutaneous tunnelling and VAS parts can be carried out usually simultaneously.In case shoulder before arriving is set up the middle site of puncture 172 that leads to rod 170 with scalpel.In Fig. 8 C, rod 170 is removed from initial site of puncture 166, then the near-end 174 of parts of vessels 106 is passed subcutaneous path and withdraw from from middle site of puncture 172.In the middle of then same surgery rod 170 or different rod being inserted site of puncture 172 and subcutaneous to arm far downstream end tunnelling, up to the brachial artery site that reaches labelling.The whole tip penetration position 164 of described rod is led in foundation, and further it is exposed near brachial artery.Shown in Fig. 8 D, identical terminal 171 of the graft parts 102 of described VAS are connected to brachial artery.Selectively, this coincide and can carry out behind subcutaneous location at graft parts 102.Next with reference to figure 8E, the adapter end 178 that will have the graft parts 102 of the pipe jointer 180 that connects in advance passes to middle site of puncture 172 from whole tip penetration position 164.The connector ferrule that has integrated strain relief structure can pass above the near-end 170 of parts of vessels 172.Check whether initial site of puncture 166 and whole tip penetration position 164 have any unnecessary pipeline, if desired, it is strained from middle lancet and means 172.The near-end 174 of cutting parts of vessels 106 is to needed length.About 0.5cm at the cutting end place of parts of vessels is separated and cuts away to the nylon coil segment of about 1cm.The near-end 174 of parts of vessels 106 matches with the pipe jointer that is connected in advance 180 of graft parts 102.With crimped loops parts of vessels 106 and pipe jointer 180 are bound.Connector ferrule places the top of pipe jointer again.Shown in Fig. 8 F, the expose portion of the pipe jointer 180 that will be connected with the near-end 174 of the far-end 178 of graft parts 102 and parts of vessels 106 is pulled out from the graft end, or pushes subcutaneous space by middle point of puncture 172.By palpation or preferably reconfirm blood flow by VAS100 by ultrasonic and/or angiography.164,166,172 stitchings of three sites of puncture are closed.Enter the VAS100 that implanted to carry out hemodialysis with hemodialysis needles puncture then.
[0075] as Fig. 9 A to shown in the 9E, in a preferred embodiment of the invention, the patient is anaesthetized sb. generally labelling graft path on patient's arm.Position, sterilization and shop aseptic towel make arrangements for surgery.Do otch 166 to enter the downstream part of internal jugular vein at cervical region.Little tinsel is inserted by site of puncture 166.With the described little tinsel of medium sized introducer device (about 5F is to about 14F) displacement, remove tinsel.Available angiography is assessed vein, can stop conduit progressive narrow if define, and can enlarge venous lumen with angioplasty.Big tinsel is inserted via medium sized introducer.Replace medium sized introducer with the introducer of 20F.Before removing dilator, the preferred Trendelenberg of patient (Te Lundelunbai (family name) clinostatism) position is to reduce the probability that enters air when conduit inserts.Remove dilator and clamp introducer, close introducer with finger.Conduit 106 is full of the saline of heparinization, clamps, and insert via introducer.When inserting conduit, randomly the ventilation installation is closed to reduce the probability of air admission.Shown in Fig. 9 A, peel off introducer, conduit 106 is stayed in the IJ.Can use " Christmas tree (Christmas Tree) " valve or not have wound clamp (preferred Fogarty (Fu Gedi) clamp) and prevent that blood from refluxing by conduit.The patient can leave the Trendelenberg position.Under fluoroscopy, whether the position of checking catheter tip be in approaching most-position of right atrium (RA), then adjust if desired.Shown in Fig. 9 B,, make Δ (delta)-thoracic incision at the subcutaneous path of opening conduit.The mode of sweeping (sweeping) then to push away makes conduit 106 be tunneling to Δ-thoracic incision by open path above sternocleidomastoid.Depend on the feature of conduit 106, in some cases, should note not making diameter to produce bending, to avoid kink less than the conduit 106 of about 2.5cm.With the strand of the nylon fibril on the conduit 106 down, cut off conduit 106, outside Δ-thoracic incision, stay about 1 inch.Barb (barb) length on the adapter 2 is removed an amount of nylon coil.Joint sleeve 156 (at first being lower end (flower endfirst)) and crimped loops are placed the conduit top, normally such order, this depends on employed specific mechanism of ammonium fixation.Shown in Fig. 9 C, adapter 2 is connected with graft 102 in advance, be connected with conduit 106 then.With crimped loops conduit 106 and adapter 2 are bound.Detect and connect to guarantee integrity.Connector ferrule 156 places the metal surface of major part or whole exposure.Make arm otch 164 to expose brachial artery.Make complementary cutting part 165 in the side of arm cutting part 164.With graft 102 from Δ-thoracic incision position 172 or the adapter incision site with side-below direction tunnelling until the side that arrives arm.The shallow epi-position and the side that remain in respect to biceps brachii m. are preferred, but optional.Below continue tunnelling until arriving auxiliary incision position 165.Implement tunnelling then, with armlet 167 on the weak point that produces the ＂ J ＂ configuration that is close to ancon from auxiliary position 165 to arm position 164.Then along the centre position of upper arm, with graft to the head tunnelling to arm incision site 164.Preferably, graft 102 should parallelly with brachial artery coincide can make up cochlear (spatulated).Check rhumb line or labelling with the orientation of two ends 171,178 of graft 102 whether in same direction, not mobile to examine conduit 106 from approaching most RA.Check whether graft 102 is enough lax.Make up parallel end-to-side anastomosis by cutting graft with the oblique angle and carrying out arteriotomy then along the major axis of brachial artery.Such structure is favourable, because it causes less turbulent flow at anastomotic position, and is not easy to oppress the anastomosis.Shown in Fig. 9 E,, implement coincideing between tremulous pulse and the graft then as known in those skilled in the art.Before end, bottom right arm and palm place carry out Doppler scanning to check that surreptitiously blood syndrome has taken place whether to be accompanied by shunting.By along the backfill of VAS length, implement the angiography inspection and coincide.Tip location in RA and along with the integrity of the motion VAS of experimenter's arm is also checked possibly.Also to check whether unobstructed and whether obviously not crooked or kink.Closure of incisions and wrapping.
[0076] although above-described embodiment has adopted internal jugular vein and brachial artery respectively as the insertion and the connecting portion of implant system, but it should be appreciated by those skilled in the art, also can use other insertion and connecting portion, and these positions were described in front.For example, can be used for other tremulous pulse of the present invention including but not limited to ulnar artery, radial artery, femoral artery, tibial artery, aorta, axillary artery and subclavian artery.Other vein connecting portion can be positioned at cephalic vein, basilic vein, median cubital vein, axillary vein, subclavian vein, external jugular vein, femoral vein, saphena, postcava and superior vena cava.Implantation that also can modifier to be being configured to implant system common linear configuration or ring-type configuration, and insertion of the present invention and connecting portion need not to be the next-door neighbour's in vivo.For example, can be respectively at axillary artery and femoral vein place, or from the femoral artery to the axillary vein, carry out the connection and the insertion of device respectively.
B.
Instant path
[0077] in some embodiment of the present invention, described VAS is configured to provide the path of hemodialysis immediately when implanting, and reduces simultaneously or has eliminated before the graft maturation or enter relevant hemorrhage risk with the graft parts of described VAS when inserting the extra pipe that interim hemodialysis path can be provided.Can provide instant site of puncture be used as using self-enclosed material or can be when removing hemodialysis needles the hypodermic needle site of puncture of other structure of hemostatic.Instant site of puncture also can comprise the provisional conduit that is connected to VAS, and described provisional conduit withdraws from skin so that the external path to VAS to be provided, and the other benefit that is had is to have eliminated with skin puncture to obtain the relevant discomfort of hemodialysis path.These and other embodiment of the present invention can go through below further.These embodiments are very suitable for being incorporated in the medical treatment device except that VAS, include but not limited to any in the multiple traditional design of dialysis graft, the design of puncture graft (access graft), conduit, pin puncture port or the intravenous fluid conduit.
1,
The IMU pipeline material
[0078] in one embodiment of the invention, described graft material or tube material can have self-enclosed characteristic.The self-enclosed VAS wall that has a part at least that typically refers to has the ability to seal again after the sharp instruments puncture of using such as pin.Compare with traditional graft material, the material with self-enclosed characteristic can use when transplanting at once.Do not need biological maturation process to improve the leakage characteristics of material.Self-enclosed material can also shorten the needed time of the hemostasis of site of puncture after removing hemodialysis needles.In addition, this material can also be used for providing instant path position at other parts place of VAS or be used for benefiting from other curable product of self-enclosed characteristic.This IMU pipeline material can be positioned at any position along VAS.In one embodiment of the invention, low-durometer material can be used as instant site of puncture.In one embodiment of the invention, low-durometer material is included in that hardness is about material of 10 to 30 on the Shore A scale, preferably is about 10 to about 20 hardness on the Shore A scale.Other structure with self-enclosed characteristic will be described below.
A.
Compressive residual stress
[0079] in another embodiment, the invention provides to comprise and have compressive residual stress and think that graft or conduit provide the graft or the conduit of the pipeline of self-enclosed characteristic.In one embodiment, by with polymer, preferred silicones sprays on the pipe of being made by pipeline material that is pre-existing in, and the strain that simultaneously this pipe is subjected to one or more directions makes up self-enclosed pipeline material.This self-enclosed material provides the mechanical close characteristic, and this material adds or the blood substitute platelet condenses carries out self-isolation.In one embodiment, described VAS comprises the self-encapsulant of the two or more alternations of bed with residual stress coating.
[0080] in the particular that Figure 10 describes, described pipeline material comprises four layers, wherein internal layer 138 by axial tension pipeline material 140, spray this pipeline material and coating solidified, then pipeline material is discharged from tension and forms.The second layer 142 (from internal layer) is by along self axle distortion pipeline material 142, spraying and solidified coating, then pipeline material discharged from twisted state and forms.The 3rd layer 144 by recovering pipeline material from back, and with it along self axially opposite direction distortion with back, spray and solidified coating, then pipeline material is discharged from twisted state and forms.The 4th layer 146 by product is recovered from back, utilizes internal pressure to make its expansion, and spraying and solidified coating discharge material then and make from pressure state.Note, because described pipe along with pressure extends, therefore also can produce axial strain.Other strain coating or the 5th optional layer 148 of neutral coating can also be provided.This additional layer 148 helps to realize consistent external diameter.
[0081] although the example that produces self-closed type graft material or tube material above is provided, it should be appreciated by those skilled in the art, can use many distortion of top method to produce the self-closed type tube material.Distortion is exactly by material being expanded and being drawn into thin-walled and by dipping or spraying polymer applications being created in residual stress in the graft material in this wall.The amount of the circumferential and/or axial stress in final pipe can be controlled by the amount of adjusting expansion or axial tension respectively.In addition, above-mentioned steps also can be implemented with different orders, and/or repeats or eliminate one or more steps.Other distortion is included in painting spindle in one or more steps and does not use the pipe that is pre-existing in or with the pipeline material upset, make inside out (for the ring stress of compression).
[0082] in another embodiment, can use the silicone tube that is reversed that compressive residual stress is provided.With the silicone tube upset, this pipe is turned up, cause stress and strain, this stress and strain produces by the silicones of high compression around the inner chamber of the pipe that turns up.With reference to figure 25A and 25B, turning up of silicone tube 450a produced circumferential tension force 452 and circumferential pressure 454 in the pipe 450b that turns up.By the silicone tube 450a that turns up, the outer surface 456a before turning up has been formed the inner chamber 456b of the pipe 450b that turns up by elastic compression, and the inner surface 458a before turning up with tension force 452 by elastic expansion, form the outer surface 458b of the pipe 450b that turns up.Tension force 452 on the outside of the pipe 450b that turns up causes radial compression force 454 around the inner surface 456b of the pipe 450b that turns up.Tension force 452 also can apply internal-direction-force 453 radially around the inner surface 456b of the pipe 450b that turns up.Therefore these power work to compress described self-enclosed material further to the vector that increases in radially.
[0083] different with the multilamellar self-closed type structure that has discontinuous compression stress through being everlasting every layer, the pipe 450b that turns up has compression stress gradually or that continue to change along the radius of pipe 450b.In some instances, the pipe 450b that turns up is characterised in that having cancelled external tension 452 places in the inside compression stress 454 of quilt has the intermediary radius or the degree of depth.In other words, the described pipe that turns up carries out the transition to the inner region of the elastomeric material with greater density reposefully from the outskirt of more uncompacted elastomeric material, the mesozone of the density of described elastic tube before having density to approximate between outskirt and inner region to turn up.
[0084] although the silicone tube 450a shown in Figure 25 A has the density and the structure of homogeneous, in other embodiments, along with one or more sizes of silicone tube 450a, silicone tube 450a can have variable density and/or geometry.Therefore, that silicone tube 450a can have is variable, radially, circumferentially, vertically or the density of its combination in any or structure, comprises the helical form variant.In other embodiments, the elastic construction of existing self-enclosed characteristic can be further strengthened by turning up.
[0085] be appreciated that internal diameter and/or the external diameter that turns up and can change or can not change described elastic tube, same, the length change before the length that can make or can not make pipe of turning up is turned up from it.If have, the degree of change depends on elastomeric material behavior, also has and elastomer coupling or bonded any other properties of materials.In some embodiments, circumferentially tension force and compression stress can be cancelled out each other to a great extent, cause the vary in diameter of this elastic tube very little.Equally, in most of embodiments of the present invention, seldom observe any variation of the length after the upset.
[0086] in a specific embodiment, there are 50 hardness silicone tube of 0.197 ＂ (5mm) ID and 0.236 ＂ (6mm) OD and 50mm length to be reversed.Length after the upset does not change, and the diameter after the upset is 0.202 ＂ ID and 0.240 ＂ OD.Because the measurement error of ID be about 0.001 ＂ to 0.003 ＂, the measurement error of OD be about 0.001 ＂ to 0.002 ＂, so this silicone tube turn up the back diameter do not have significant change.These experiment discoveries are corresponding to the variation that 5mm ID * 6mm OD silicone tube is predicted.The tabular of Figure 27 A has gone out the strain of the silicones of being predicted that turns up.Figure 27 B has illustrated the circumferential strain of the pipe of being predicted that turns up with figure.
[0087] reduced the seepage of pin puncture back silicone tube although turn up, the big strain that silicone tube bending or tractive produce still may cause the obvious seepage of the pipe that turns up.This may occur in that silicone tube is bent or when stretching, and for example, stretches and opens the pin puncture orifice along the silicone material than deep camber of bending, causes seepage.
[0088] for resist these big strains that may cause seepage, such as big strained effect from bending or tractive, available expanded PTFE (ePTFE) is reinforced the anti-seepage material such as silicones.The characteristic of ePTFE is relevant with its longitudinal biasing (bias), because it is when resting state, it has relatively limited axial tension characteristic, and can axial compression to bigger degree.Figure 28 has described the stretch-proof characteristic of ePTFE with chart.Data among the figure are from the ePTFE blood vessel graft of 6mm * 7.3mm.When this graft is stretched to approximately 170% the time, ePTFE has only produced a spot of tensile resistence.Yet, in case being stretched, ePTFE exceeds at about 170% o'clock, tensile resistence begins to increase greatly.In order to utilize this specific character of ePTFE, the ePTFE coating can be placed, for example, on the silicone tube to resist the stretching of this silicone tube.Described pipe still can free bend (although slightly poorer than the pipe that does not have stretch-proof material coating sometimes), and this is because being compressed than small curve of this bending, and does not outsidely stretch.If there is not ePTFE, when incurvature was compressed, extrinsic curvature can stretch.Usually, ePTFE be stretched to about 25 microns to about 30 microns internode apart to be used to reinforce silicone layer.In other embodiments, ePTFE can be stretched to about 20 microns and arrive about 35 microns average internode distance, be about 20 microns sometimes and arrive about 40 microns average internode distance.
[0089] with reference to figure 26A and 26B, in elastic construction, also can form circumferential compression stress, for example, 450a realizes by the radial compression silicone tube.In an example, by silicone tube 450a is inserted in the inner chamber 460 of less compressed pipe 462, or by being coupled to some other circumferential pressure texture, 450a compresses to silicone tube.When bigger silicone tube 450a was forced into less compressed pipe 462, silicone tube 450a was compressed into the silicone tube 450c of compression, had increased the self-enclosed characteristic of pipe 450c like this.The big young pathbreaker of described power depends on the degree of radial compression and changes.In some embodiments of these embodiments, compare with the silicone tube 450b that turns up, circumferential compression stress 464 along silicone tube 450c radial depth can distribute more equably, but the suppressed range that reaches around the inner surface of the silicone tube of turning up may be more difficult.Also can apply radial internal-direction-force 453 by the less compressed pipe 462 on the silicone tube 450c of compression.Yet, different with the silicone tube of turning up, depend on the degree of radial compression, the inner chamber of the silicone tube of radial compression is littler usually.
[0090] except the stretching of using the silicone tube of turning up such as the stretch-proof materials limitations of ePTFE, also can with silicone tube with before the material of stretch-proof combines, this silicone tube is placed under in various degree vertical compression.Like this can be by placing the antiseep characteristic of further improving the self-enclosed material that turns up under vertical compression.In some embodiments, in cohesive process, vertical compression strain of about 1% to about 10% can be applied to silicone tube, preferably in about 3% strain of arriving in about 4% scope.Although can use the strain greater than 10%, when big strain, silicone tube may begin distortion, becomes to be difficult to make.The formation of vertical compression stress can cause the external diameter expansion and the internal diameter of this pipe to reduce in the silicone tube.In some embodiments, before enforcement is turned up, can be with ePTFE material and self-enclosed elastomeric material coupling.
[0091] although other combination of materials also can be used to anti-seepage material that stretch-resistance is provided, ePTFE has secular use historical in vascular applications.EPTFE allows cell to grow in outer surface, and this has reduced possibility of infection, and has improved the stability of device.Silicones and ePTFE also have repeatably performance, and along with the time palliating degradation degree is minimum.In other embodiments, another kind of stretching resistance is higher than the biocompatible of resistance to compression but the material that needs not to be blood compatibility can replace ePTFE or use with ePTFE.Similarly, having the another kind of material of the mechanical property similar to silicones, may be polyurethane, can be used for replacing silicones.Thereby above-described example is the embodiment of more broad concept that contains the graft of anti-leakage layer, and described anti-leakage layer has the stretch-proof structure to limit the excessive stretching of this anti-leakage layer.The stretch-proof structure can be the stretch-proof layer that is attached to anti-leakage layer, or embeds the stretch-proof structure of anti-leakage layer inside.Preferably, described anti-leakage layer comprises the wall of silicones or silicone tube.Preferably, described stretch-proof structure is the stretch-proof layer, and ePTFE layer most preferably.Other suitable stretch-resistance is higher than resistance to compression, bio-compatible but the material that needs not to be blood compatibility can be united with ePTFE or PTFE and used or replace ePTFE or PTFE.
[0092], preferably has the medical grade silicon resin copolymer of suitable biocompatibility and stability although the silicones of many types can present above-described characteristic.Can use silicones crosslinked, heat cure and/or room temperature vulcanization (RTV) moisturecuring.In preferred embodiments, use the silicones of soft (being about 5 to about 50), pliable and tough, high-tear strength on the Shore A scale, be obedient to the pin that is inserted because such silicones is easier.Those skilled in the art also will appreciate that and also can use other material with elastic characteristic to come to form by turning up self-enclosed material.These other materials comprise polyurethane, also the polyurethane of preferred soft.
[0093] in one embodiment, provide the method for making the IMU pipeline material.Silicone tube is placed axle, and be sprayed with one or more layers silicones.Described silicone tube is axially rolled to present the outside configuration in the inside.The Nitinol coil is used for this pipe so that for this pipe provides antitorque knot, this coil is scribbled one or more layers silicones.EPTFE transplants the part of property management and expands with conical mandrel.Also can use such as nylon or stainless other coil or screw thread.The internal diameter of ePTFE transplanting property management is generally equal to or is slightly larger than the internal diameter of silicone tube.Described graft has constant internal diameter (ID) and/or external diameter (OD), or has the ID and/or the OD of small variation, perhaps has gradually thin ID and/or OD.In one embodiment, the silicone tube with 5mm internal diameter and 1.25mm wall thickness is used with the ePTFE blood vessel graft material of the 6mm ID of standard.Expansible graft material is placed the top of aforesaid silicone tube, and use an end that the ePTFE graft material is bonded to described silicone tube such as the binding agent of silicon resin adhesive.When remaining ePTFE graft material is placed in tension force following time, the remainder of this silicone tube is just compressed gently, with the residue of ePTFE graft material terminal with binding agent in conjunction with in position.Usually, be applied to that tension force on the ePTFE equates with compression stress on affacting silicones and opposite, but in other embodiments, the size of this power or this multiple power can difference.
[0094] in a specific embodiments of the present invention, be about 0.24 inch to about 0.30 inch with turning over and be sprayed with silicones so that its mean outside diameter in the silicone tube, preferred about 0.25 inch to about 0.29 inch, most preferably from about 0.25 inch to about 0.29 inch.Preferably, the two component silicones (for example Nusil MED 6233) that are diluted to 40% silicones with dimethylbenzene can be used as spray-up.But person of skill in the art will appreciate that, also can use various silicones or non-silicones sprayed on material that similar features is arranged usually.Stretching ePTFE graft (Boston Scientific Exxce1) above the exfoliated dilator of 22 French Cook C-PLI-22-38, and this ePTFE graft is placed the top of silicone tube conduit.With silicon resin adhesive graft is connected with this conduit and makes its curing at the near-end of described graft.Then with the tension of this graft, or place under the slight tension force, simultaneously this conduit is placed relaxed length or place under the slight compression.Then the far-end of this graft is used and turned round wire loop from the circumferential tinsel of terminal about 0.25 ＂ of this graft and be fixed on conduit and sentence just and clamp temporarily.Then that the ledge of graft material is bonding with silicon resin adhesive.This device was solidified about 10 minutes in about 125 degrees centigrade stove, then remove tinsel and turn round wire loop.At about 127cm H
2Water detects the seepage of this device under the O.The pin of 17 specifications is inserted this with an angle install interior three times, all do not observe seepage during insertion or after removing pin.
[0095] in the alternative embodiment of said apparatus and method, ePTFE can be adhered to the inside of institute's silicone tube or be embedded in the silicone tube.Described silicone tube needs not to be ready-formed, and for example, it can be formed simultaneously by naked axle of direct spraying or ePTFE.Also can at any time use other silicones application process to replace spraying such as dipping and injection molding.The size of ePTFE also can change, and also can place the top of described silicone tube, and not expand, for example, by making with lubricator and/or realizing by silicone tube being shunk with vacuum pressure.Silicone material needs not to be tubular form, and it can have maybe and can not have inherent compressive residual stress, because in case with the ePTFE material preparation and be adhered to silicone material, just can provide compression.Equally, described ePTFE material needs not to be the graft form of tubes that is prefabricated into.Described ePTFE can be the band that is wound onto or is attached on the described silicone tube.EPTFE available silicon resin sprays and may be turned up in inside; Or inside turned up, is coated with silicones, and once more turned up in inside.The also available coil of for example being made by Nitinol, nylon or Stainless Steel of described pipe is reinforced.
[0096] in another embodiment, control the stretching or the prolongation of this anti-seepage material by the strand that embeds flexible fiber or material along the length of anti-seepage material.In some embodiments, described fiber or strand can be directed along the specific axis of anti-seepage material.In other embodiments, described fiber or strand may be without any specific directions, but when anti-seepage material was stretched, they were more by portrait orientation.The member of described fiber, strand or other elongated structure can comprise nylon or not have tangible stretching or extended characteristic but show other analog material of bigger compression property.These compression properties allow anti-seepage material to keep its pliability, still have stretch-resistance or anti-prolongation property simultaneously.In some embodiments, the compression of increase is the result of fine fibre bending under compression.In other embodiments, fiber can or can directly not embed in the self-enclosed layer, but this fiber is the inner surface of self-enclosed layer or the part of outer surface, or is embedded in this self-enclosed layer and is connected or adherent sublevel.Embed in other embodiment of described self-enclosed layer at described fiber, can use the self-enclosed graft of monolayer,, and do not need another layer because this self-enclosed layer has the characteristic of stretch-proof layer.
B.
Open loose structure
[0097] in another embodiment of the invention, loose structure in the wall this VAS conduit or graft (for example, to Perma-Seal that is provided by PossisMedical or the similar material of Vectra that provided by Thoratec) is provided the self-enclosed part of described VAS.This device can stop blood leakage to be because the porous wall design is arranged, and this porous wall design provides the surface area that increases to promote the blood coagulation.In addition, the design of described porous is in that pin is stayed can easier recovery after several hours in the wall.The outer surface of described conduit is preferably porous to promote the inside growth of tissue, so that further promote sealing, and the more important thing is possibility of infection is dropped to minimum.
C.
The wall inner gel
[0098] in another embodiment of the present invention, described self-enclosed material comprises one or more soft inner gel layers in the wall district of described VAS.This wall district and gel layer are available pin punctures.When removing described pin, this gel sealing needle track, this is because described gel is flexible semigel shape.Can use a full range of materials.In the United States Patent (USP) 5,904,967 of Ezaki, a specific embodiment has been described.Another materials classification is by the following organic siloxane polymer of forming:
[0099] 65%-dimethyl siloxane
The 17%-Silicon stone
9％-Thixotrol?ST
The 4%-polydimethylsiloxane
The 1%-decamethylcyclopentasiloxane
1%-glycerol
1%-titanium dioxide
D.
Instant access graft device
[0100] as above-mentioned, IMU pipeline material disclosed herein can use with the preferred embodiments of the invention that comprise graft assembly and conduit tube component, but also can incorporate in more traditional vascular access graft design.
[0101] for example, described IMU pipeline material also can combine with the conventional tube vascular access graft that comprises ePTFE.Except the instant characteristics of channel were provided, this instant passage region can also provide faster or instant hemostasis.This can help to implement dialysis, and is hemorrhage because it has reduced by graft.Reduce hemorrhagely can ease the pain, swelling, infection rate and such as the hemorrhage complication of hematoma.If, can reduce hemorrhage when pin is removed or described graft when unexpectedly being pierced through (backwalled) ＂ (sticking a needle into whole grafts) by ＂.Pierce through graft and be standard graft significantly pay close attention to because in order to stop blooding, must apply sizable pressure to stop hemorrhage on the inwall to graft.This pressure may inaccessible graft, forces to adopt thrombectomy or other operation of removing blood clot to recover blood flow.Described instant passage region can also more anti-ly subside or be incompressible.The insertion that this can help to locate this instant passage region and help dialysis needle.Described IMU pipeline material can provide along the total length and the circumference of ePTFE graft, or uses it for limited parts or several parts of this ePTFE graft.Described IMU pipeline material can be incorporated into the inner surface and/or the outer surface of described graft, and comprises between each layer of graft of ePTFE.The application that has the IMU pipeline material of ePTFE provides the closure property of IMU pipeline material and has been familiar with and the ePTFE parts of traditional use for the clinician.
[0102] with reference to Figure 18, in one embodiment of the invention, instant access graft 250 comprises the ePTFE pipe 252 of a segment length of the IMU pipeline material 254 that has the smaller length that is formed at or is attached in the inner chamber.IMU pipeline material 254 is incorporated between two ends 256,258 of ePTFE pipe 252, so that each end of two ends 256,258 of ePTFE pipe 252 all has the part 260,262 that lacks IMU pipeline material 254.Preferred exposed ePTFE part 260,262 and tremulous pulse, vein or other body conduit are sewed up, and this is because its compliance similar to vascular tissue and its stitching keep due to the intensity.Also preferably ePTFE part 260,262 also is that this has increased blood sealing ability and resistance infection because it promotes tissue ingrowth.For the thrombosis risk that the turbulent flow that is reduced in interface 264 places of IMU pipeline material 254 and ePTFE pipe between 252 causes, can use silicones 266 or another kind of biomaterial filling interface slit 264, so that provide more smooth interior surface for graft chamber 268.In some embodiments, for the variation of the internal diameter that makes graft chamber 268 reduces or minimizes, described ePTFE pipe is expand into than major diameter in advance at instant 278 places, site of puncture, so that hold the volume of IMU pipeline material 254, thereby reduce or eliminate the situation that IMU pipeline material 254 is invaded graft inner chamber 268.Selectively, described ePTFE and IMU pipeline material can expand in conjunction with the back, but may weaken the function of IMU pipeline material like this.
[0103] there is not the end of the ePTFE graft 250 of IMU pipeline material 254 by reservation, with coincide identical similar with the traditional vascular access graft of having only ePTFE of two ends 256,258 of graft 250 and tremulous pulse and venous, therefore do not need further to develop and move skill to implant instant access graft 250.On the contrary, provide in the embodiment of IMU pipeline material in the end of ePTFE graft, the combination of ePTFE and IMU pipeline material and the thickness that increases are connected the surgeon and have more challenge, and owing to, may cause thrombosis to increase at anastomotic position with the different of vascular compliance or owing to low-qualityer surgery operating technology.
[0104] although embodiment shown in Figure 180 is configured to make the variation of the internal diameter 270 of vascular access graft 250 to reduce or minimizes, the external diameter 272 of graft 250 increases, with the seriality of holding chamber 268.In other embodiments, as shown in Figure 19, the variation of the external diameter 272 of vascular access graft 250 can provide IMU pipeline material 254 to reduce by the chamber 268 along ePTFE pipe 252 or minimize, IMU pipeline material 254 has replaced a part of chamber volume like this, causes dwindling of internal diameter 270.Reduce gradually by thickness, the turbulent flow at 264 places, interface between the via material 254 and ePTFE pipe 252 when in sight is reduced the end 274,276 of IMU pipeline material 254.Person of skill in the art will appreciate that, can be adjusted at the ID270 of graft 250 at place, instant site of puncture and the relation between the OD272 adaptively.In addition, can reduce the variation of the internal diameter 270 and the external diameter 272 of graft 250, increase to compensate the thickness that causes owing to IMU pipeline material 254 by being provided at the ePTFE pipe 252 that instant site of puncture 278 has the thickness that reduces on every side.
[0105] the optional antitorque junction structure 280 of one or more terminal 274,276 grafts resisted that provide on every side 250 kinks of IMU pipeline material 254 is provided Figure 19.The tendency of having only different wall between the ePTFE part 260,262 and/or wall compliance to cause kink in conjunction with the part 278 of IMU pipeline material 254 and graft 250 of ePTFE pipe 252.
[0106] in a specific embodiments of the present invention, provides two-layer self-enclosed graft.Described graft comprises the silicone tube of turning up of outer field ePTFE graft material and internal layer.Usually, the ID of described ePTFE is greater than the ID of this silicone tube of turning up.Described ePTFE graft slips over this silicone tube of turning up and bonding with silicon resin adhesive.Preferably, described silicone tube of turning up be shorter in length than described ePTFE graft material, this just makes one or more ends of described device comprise ePTFE rather than silicones.Transition region from the internal diameter of this ePTFE graft to this silicone tube of turning up can be with other silicones injection moulding to provide more level and smooth transition two assemblies.Also can make the part of outside ePTFE layer around the silicone tube of turning up before bonding and/or expanded radially afterwards with the silicone tube of turning up.Expanded radially can reduce the rapid variation (if there is) of the internal diameter of device in transition region, and provides more consistent internal diameter along the length of device.
[0107] in double layer design, the ID of described ePTFE graft is usually greater than the ID of described silicone tube of turning up.For example, silicone tube can have the ID (before turning up) of 5mm, and described ePTFE graft can have the ID of 6mm.The difference of ID can change in the scope from about 1mm to about 3mm, and preferably about 1mm is to about 2mm.Described silicone tube of turning up can have the ID of about 4mm to about 10mm, and preferably about 5mm is to about 8mm, and most preferably from about 5mm is to about 7mm.The ePTFE section of 0.25cm or longer no self-enclosed material, more preferably 1.5cm or longer, most preferably 3cm or longer preferably have an appointment in the one or both ends of described device.The length of described silicone tube can be about 5cm to about 80cm, and preferably about 8cm is to about 25cm, and most preferably from about 10cm is to about 17cm.The length of described graft material can be that about 10cm arrives about 100cm, and preferably about 20cm is to about 50cm, and most preferably from about 30cm is to about 40cm.The exemplary another embodiment of the invention of having described of Figure 20, the internal diameter 270 of graft 250 is constant usually, and instant passage area 278 is provided simultaneously.In this embodiment, IMU pipeline material 254 is adhered to the outer surface of ePTFE pipe 252.Randomly, on can the outer surface that covers IMU pipeline material 254 286 with another sheet or another layer ePTFE pipe 284.By another layer ePTFE is covered on the IMU pipeline material, patient body is only contacted with ePTFE, and do not contact with the IMU pipeline material, in some embodiments, to compare with ePTFE, described IMU pipeline material has less favourable biocompatibility.Also can around the end 274,276 of instant via material 254, provide optional antitorque junction structure 280.
[0108] Figure 20 also shown between the length of IMU pipeline material 254 and the ePTFE pipe 252 relation can great changes will take place.For example, the longer part 260 that does not have IMU pipeline material 254 of ePTFE pipe 252 needs that can be used for providing more traditional make the vascular access of graft 250 endothelializations.By reducing the size of instant passage portion 278 with respect to graft 250 total lengths, can reduce volume, the easness of transplanting, the manufacturing cost of graft 250, and/or the manufacturing defect rate of graft, still can provide simultaneously enough instant access function up to using more traditional path in the part 260,262 of having only ePTFE.Silicones or instant passage area are provided between ePTFE end portion 260,262, and its length can be dependent on graft 250 and places the intravital position of body and change.In some embodiments of the present invention, the clear length of silicones part 278 arrives about 40cm for about 5cm, and the length of every end of ePTFE pipe 252 arrives about 20cm for about 0.5cm.In preferred embodiments, the clear length of silicones part 278 arrives about 30cm for about 7cm, and the length of every end of ePTFE pipe 252 arrives about 10cm for about 1cm; In most preferred embodiment, the clear length of silicones part 278 arrives about 20cm for about 10cm, and the about 3cm of length of every end of ePTFE pipe 252 is to about 7cm.
[0109] another specific embodiments of the present invention comprises three layers of self-closed type device, and internal layer and skin are ePTFE graft material layer, and the intermediate layer is the silicone tube of turning up.Three bed devices have reduced the exposure of self-enclosed material to vascular system and health.Than the two-layer design that self-enclosed material is exposed to vascular system, three layers of design can improve the overall biocompatibility of described device.Three bed devices can slip over the ePTFE graft material by the silicone tube that will turn up, and form two assemblies are bonding.Then larger-diameter ePTFE graft is slipped over the silicone tube part of turning up, and bonding subsequently.Selectively, the ePTFE layer of inside can be adhered to the outer surface of non-silicone tube of turning up, turn up with silicone tube then.With described two-layer design class seemingly, preferably, the length in self-closed type intermediate layer all is shorter than inside and outside ePTFE layer so that the one or more ends without any silicone tube to be provided.The length of described inside and outside ePTFE layer can be identical or different.Preferably, described outside ePTFE layer be shorter in length than inner ePTFE layer so that the thickness of the end of described device can be compared with traditional graft.Although internal layer is shorter than skin and has similar end thickness, such structure places the transition region between two assemblies on the inner chamber of this device, rather than on the outer surface, may show more turbulent flow like this and reduce blood compatibility thus.
[0110] in three layers of design, the ID of described silicone tube of turning up is usually greater than the ID of inner ePTFE graft, and the ID of outside ePTFE assembly is greater than this silicone tube of turning up.In a specific embodiment, be that the silicone tube of 7.5mm is turned up and slipped over the ePTFE graft of 6mm with ID.The ePTFE of 8.5-9.5mm that will be bigger transplants the silicone tube part of turning up that property management slips over above-mentioned assembling then.In other embodiments of the present invention, the ID of inner graft material can be about 4mm to about 10mm, and preferably about 5mm is to about 8mm, most preferably from about 6mm.The ID of intermediary self-enclosed material can be about 4mm to about 11mm, and preferably about 5mm is to about 7mm, most preferably from about 6mm.The ID of outside graft material can be about 5mm to about 12mm, and preferably about 6mm is to about 10mm, and most preferably from about 7mm is to about 8mm.The length of described silicone tube can be about 5cm to about 80cm, and preferably about 8cm is to about 25cm, and most preferably from about 10cm is to about 17cm.The length of the graft material of described inside can be about 10cm to about 100cm, preferred about 20cm is to about 50cm, and most preferably from about 30cm arrives about 40cm, and the length of outside graft material can be about 5cm to about 82cm, preferred about 8cm is to about 27cm, and most preferably from about 31cm is to about 42cm.
[0111] in another embodiment of the invention, provide the vascular access graft 288 of taper, thereby an end 258 of the ePTFE of graft 288 pipe 252 is greater than another end 256 of described pipe 252.By providing less ePTFE end 256 connecting less tremulous pulse, and provide bigger ePTFE end 258 to connect bigger vein, terminal 256,258 size difference can make graft 286 coincide with tremulous pulse and venous and become easy.Describedly can occur in the total length of ePTFE pipe 252 or occur on the one or more less section of ePTFE pipe 252 than the transition region 290 (zones that ID 270 changes) between little end 256 and described big terminal 258.Thereby, the conversion of ID 270 can be gradually or unexpected.Graft 288 also can be tapered at one or two end 256,268 places, the 4mm that for example has an appointment keeps less to the diameter at tapering terminal 256,258 places so that one or two coincide of about 6mm, and coincideing at two simultaneously provides bigger diameter to be beneficial to the insertion of pin between terminal 256,258.In some embodiments as shown in figure 21, IMU pipeline material 254 can be located near the outer surface 282 of the pipe 252 the smaller diameter portion 292 of transition region 290, and randomly extends on pipe 252.This position can be favourable, because it can improve the increase of the OD272 of graft 288, in case IMU pipeline material 254 along the part location that has than the pipe 252 of major diameter 272 increase of the OD 272 of graft 288 will take place.The end 274,276 of IMU pipeline material 254 is preferably taper also, to provide more level and smooth transition between the end 274,276 of the outer surface 282 of ePTFE pipe 252 and IMU pipeline material 254.As in other embodiments, can around any or two ends 274,276 of instant via material 254, provide antitorque junction structure 280.In a selectable embodiment, IMU pipeline material 254 can be located in the chamber 268 than the taper graft 288 around the major diameter part 294 of transition region 290.The end 274,276 of IMU pipeline material 254 is preferably taper also, so that the more level and smooth transition in graft chamber 268 to be provided between the end 274,276 of ePTFE pipe 252 and IMU pipeline material 254.
[0112] can provide above-mentioned multiple instant access graft embodiment with different length, to adapt to the needed different duct lengths of different patient groups.The graft embodiment also can be with being provided by one or more parts that separate that graft parts adapter connects, described graft embodiment can or be adjusted to needed length by cutting, or has the part length that can select that can be incorporated into required length.
[0113] length-adjustable graft can be provided by the graft parts that have only the ePTFE end portion that the layering of IMU pipeline material can be removed to form this graft.With reference to Figure 22, an embodiment of length-adjustable graft 296 comprise embed IMU pipeline material 254 inside or embed unwinding member 298 between IMU pipeline material and the ePTFE pipe 252.After graft 296 is cut or is cropped to its needed length, similar with peel-away catheter, unwinding member 298 can be peeled off, cause the part 300 of IMU pipeline material 254 to be separated with ePTFE pipe 252.Then IMU pipeline material 254 is removed, and do not remove following ePTFE pipe 252.This just allows, and for example, the surgeon at first is cropped to needed length with an end 258 of graft 296, removes a section 300 of IMU pipeline material 254 then, and just having produced only has ePTFE end portion 262 to coincide helping.In one embodiment, IMU pipeline material 254 comprises silicones and the spiral coil 298 that is embedded in the silicones 254 that approaches ePTFE pipe 252 most, so that when tractive spiral coil 298, silicones 254 and ePTFE 252 layerings.Being cropped silicones 254 subsequently by layered portion 300 and unwound coil 298.Selectively, IMU pipeline material 254 and coil member 298 can be in the chambeies 268 of ePTFE graft 296, and with chamber 268 layerings.
[0114] Figure 23 and 24 has shown the embodiment of instant path blood vessel graft 302,312, and described 302,312 comprise and are arranged to first of arterial anastomosis and ePTFE end portion 304, IMU pipeline material part 306 only arranged, be arranged to second of venous anastomosis ePTFE end portion 308 is only arranged.In manufacture process, three parts, 304,306,308 whole formation perhaps as shown in figure 24, can be connected the two or more parts in the part 304,306,308 with one or more graft parts adapters 310.If connect, the number of the graft parts adapter 310 that is then provided depends on that whether IMU pipeline material part 306 only has ePTFE end portion 304,308 whole formation with arbitrary.Comprise two or more sections the instant access graft 302 that connects by graft parts adapter 310 allow (but not being essential) with each end of ePTFE end 304,308 respectively with vascular anastomosis, be connected with other parts 304,306,308 then.Concerning the surgeon, no matter whether the other end 304,308 of graft 302 waves in the operation that coincide, and coincideing not may be easier with an end 304,308 of the graft of the instant passage portion 306 of large volume.Yet, in other embodiments, before beginning to coincide, two ends 304,308 of graft 302 can be connected by adapter 310.Multistage graft 312 also can allow one or more sections 306 of graft 312 to be cut into needed length before being connected by adapter 310.This embodiment of graft 312 has kept the benefit that has the instant access graft that ePTFE end 304,308 is only arranged that the surgeon was familiar with, and provides the IMU highway section 306 that can carry out cutting or adjustment at particular patient for graft 312 simultaneously.This length that not only is used in the graft 312 of particular patient obtains optimization, and by do not need the multiple size of stock can not cutting the graft 302 of regular length also can reduce stock's needs of hospital or Surgicenter.In preferred embodiment shown in Figure 24, therefore whole formation of a part in instant passage portion 306 and the ePTFE part 304 only need a graft parts adapter 310 that three parts 304,306,308 are linked together.The embodiment of having only a graft parts adapter 310 has reduced the risk of the accidental separation of graft 312 by removing a position that disconnects probability.
[0115] selectively, each part 304,306,308 with multiple size of graft 312 can be packed separately or packed together, this multiple size can be mixed coupling so that needed graft length or other graft feature to be provided.Yet, pack the waste that each assembly can reduce arbitrary assembly separately.
[0116] in further embodiment of the present invention, two-part device can be provided, in this two-part device, first has with ID and is the identical element of the whole taper that is connected of the adapter of about 6mm or 7mm, and second portion is configured to whole ID to be about 4mm and to be used for arterial anastomosis.The internal diameter difference of these two parts diminishes gradually to reduce turbulent flow.
2.
The interim path of vascular access system
A.
(extract or tear) temporarily conduit
[0117] " temporarily " be meant conduit be used at short notice (about 90 days or shorter, but normally about one month or shorter), and be convenient to later discarded between being configured in use or remove.This device is used in the mode identical with the occupation mode of present hemodialysis catheter, except it goes out of use after limited use or removes.Temporary catheter can be connected in the permanent part of VAS or be produced on the permanent part of VAS, so that both can be implanted in single operation, but when no longer needing this temporary catheter later on, temporary catheter can be separated or be cut off.As shown in figure 11 in some embodiments, temporary catheter 216 protrudes in outside the skin, just not need skin puncture during use.Thereby an advantage of temporary catheter 216 is to dialyse immediately after its allows operation to implant VAS 100, and not with carry out the relevant severe pain of acupuncture immediately after the operation, and experience this severe pain with present instant puncture graft.Another possible advantage discarded or that remove this conduit is that it can reduce possibility of infection after the limited time period, especially with the relevant risk of vascular access of life-time service hemodialysis catheter and/or extension from skin outside.Temporary catheter more than one can be provided.
[0118] in one embodiment, temporary catheter 216 comprises the pipeline with at least one chamber, but preferably has at least two chambeies, and described pipeline is connected with the adapter 218 of VAS 100.In other embodiments, this temporary catheter can be connected in other position of VAS 100.When having single chamber, can inculcate or get blood by the temporary catheter device, but since recirculation more be difficult to dialyse.When having two or more chambeies, when the graft parts 102 of VAS 100 healed (being less than about one month usually), dialysis can be undertaken by this temporary catheter.In case when graft parts 102 are healed and the patient can dialyse by VAS 100, make temporary catheter 216 ineffective by at least a portion that removes temporary catheter device 216.It is needed making temporary catheter 216 ineffective, because compare with the subcutaneous transplantation thing, the conduit that withdraws from skin has higher long-term infection rate.Described temporary catheter can randomly have terylene cover capsule near the outlet position, to reduce infection rate.
I.
Seal with compression material at joint
[0119], in one embodiment of the invention, compression material 220 is incorporated in the pipe jointer 218, and temporary catheter 216 is connected with adapter 218 at the manufacturing place place with reference to Figure 12 A and Figure 12 B.Temporary catheter used 90 days or shorter, but preferably was less than about one month.After during this period of time, use the mode similar to remove-it is extracted from the position that conduit withdraws from skin temporary catheter to removing current hemodialysis catheter.Shown in Figure 12 B, when conduit 216 by when connector position is extracted, the hole that compression material 220 closes ducts in the adapter 218 stay when removing.
Ii.
Seal with ala at joint
[0120] selectively, hole when replacing using the compression material sealing to remove temporary catheter in adapter, when using temporary catheter or other access device, the biasing ala material similar to pin path check-valves shown in Figure 13 is fit to provide the opening of blood channel.When removing temporary catheter, described biasing ala recovers its biasing, and this ala can be covered or blind hole.
Iii.
The mechanical valve of joint
[0121] another optional embodiment comprises the mechanical valve that replaces ala to seal the hole in the described adapter when removing temporary catheter.Use places the self-closing valve of the other parts of pipe jointer or VAS to make up a specific embodiment.Temporary catheter matches with it to merge and can suppress self-enclosed connection features, until this conduit is removed.
[0122] with reference to figure 14A and Figure 14 B, the central authorities of adapter 222 can be used to install a cover mechanical valve 224,226.A valve is outlet 224, and another is an inlet 226.The present embodiment relates to the generation pressure differential and moves along the internal path between release position and the closed position 229,231 to promote piston 228,230, respectively shown in Figure 14 A and 14B.These pistons 228,230 can be connected to come the balance location with spring 232,234.In static or closed position as shown in Figure 14B, piston head 228,230 flushes with the inner surface 236 of described adapter 222, and piston pipeline 233,235 and inlet pipeline and outlet conduit 237,239 are misaligned.When exerting pressure from connection tube 241,243 and/or during vacuum, piston 228,230 moves to the release position from resting position and makes piston pipeline 233,235 and inlet pipeline and outlet conduit 237,239 in line, cause the beginning of flowing.When closing presure and/or vacuum, piston 228,230 is got back to resting position, has blocked any flowing.In some of the other embodiments, one or two cylinder configuration can be become charge in the chamber 245 of adapter, to reduce or to eliminate flowing of mid portion 247 by adapter 222.Such design is desired, because this helps to prevent or eliminate the recirculation (prevent that promptly blood from directly flowing out from the port of export of temporary catheter, the entrance point from temporary catheter flows into then) of blood in the dialysis procedure.
Iv
With the plug-in type plug closes that has forced locking
[0123] in another optional embodiment, temporary catheter can separate from adapter fully.Stopper is inserted and secured on this position with the hole in the closed connector by temporary catheter.
B.
The parts of vessels of abandoning
I.
Seal by the chamber with stopper that has forced locking or axle
[0124] with reference to figure 15A to 15C, in one embodiment, stopper 238 is inserted and secured on this position with the hole in the closed connector 222 by temporary catheter 216.Stopper 238 can be configured to flush with the chamber 236 of adapter 222 usually, or sharp edges, bump (bumps), hole or other surface irregularity of stopper minimize herein.These surface irregularities can cause the turbulent flow that can cause thrombosis and resulting device obturation.In the present embodiment, the subcutaneous part of temporary catheter 216 still in place, so the part of stopper 238 can be stayed in the conduit 216.In some embodiments, shown in Figure 15 C, can provide one or more additional brakes (detents)/or projection 240,242 with the relative position of further control stopper 238 with the surface, chamber 236 of adapter 222.
Ii.
Closing compound is injected intracavity
[0125] in one embodiment of the invention, can use the described chamber of the clogged with material that to solidify.There is different materials to use, such as binding agent (cement), epoxy material and polymer.Preferable material is from Micro Therapeutics, Inc's
Be the liquid embolic material, can under the visualization method of cryptoscope or other type, inject by tube chamber.When this material contacted with mobile blood, it can form level and smooth surface, and became solid (for example, DMSO can exchange with water) by precipitation in blood.More specifically, Onyx
It is the liquid mixture of the ethylene-vinyl alcohol copolymer (EVOH) that is dissolved in dimethyl sulfoxide (DMSO).Micronized tantalum powder is suspended in liquid polymers/DMSO mixture, so that fluorescent visual to be provided.In fluorescence contrast, the Onyx dispersion of materials in liquid phase to fill catheter lumen.When with blood (or body fluid) when contacting, solvent (DMSO) diffuses away rapidly, causes the in-situ precipitate of soft radiopaque polymeric material.Be filled in described chamber and after packing material solidifies, temporary catheter can be cut off, so it be embedded in subcutaneous.(Clinical Review of MTI (the clinical summary of MTI),
Liquid Embolization System (
The liquid embolic system), in http://www.fda.gov/ohrms/dockets/ac/03/briefmg/3975b1-02-clinic al-review.pdf, obtains August 29 in 2005)
Iii.
Only stop up the chamber at near-end
[0126] in another embodiment, with the near-end of stopper, clamp, coil, suture or other method sealing temporary catheter 216, and with temporary catheter 216 in subcutaneous cut-out.Temporary catheter 216 sealing backs can be cut off, or sealing again after cutting off.The shortcoming of this method is the probability that turbulization is arranged in the temporary catheter end of adapter inside, because this place is unexpected conversion and the blind area that sludging can take place.
[0127] in a particular shown in Figure 16 A, temporary catheter 216 and adapter 2 form complementary lock/door bolt mechanism, wherein the end 244 of temporary catheter 216 comprises or the metal or the hard material of plastics and contain the recess 246 of the clasp 248 of setovering, and terminal 244 can form interfaces with the coupled cavity 252 in the wall 254 of pipe jointer and are connected.Shown in Figure 16 B, coupled cavity 252 is configured to have complemental groove 250, and in the time of wherein in temporary catheter 216 inserts coupled cavity 252 fully, biasing clasp 248 can suck rapidly in the groove 250 so that temporary catheter 216 is locked in the coupled cavity 252 of pipe jointer.In a selectable embodiment, recess and biasing clasp can be arranged in coupled cavity, and the end 244 of temporary catheter 216 has complementary groove.Person of skill in the art will appreciate that, also can use in multiple other safeguard construction any, including but not limited to outstanding spring of biasing and wire rotation interface.
[0128] in a single day no longer needs temporary catheter 216, just can or be full of, and near its near-end 244, cut off its jam-pack.By cutting off temporary catheter 216, reduced the quantity that remains in the intravital foreign body of patient, this so reduced infection risk, immune system is replied and/or the effect of improving looks.
[0129], will have in the chamber 262 of inserting the stopper 256 insertion temporary catheters 216 that one or more slant edges 260 are arranged on lock pin (insertion stop) 258 and the surface again with reference to figure 16B.Slant edge 260 on the stopper 256 prevents that stopper 256 from withdrawing from, and simultaneously, inserts lock pin 258 and makes stopper 256 be positioned at the end 244 of temporary catheter 216, and exceedingly do not give prominence to the wall 254 that surpasses adapter.With the conduit sickle 264 that has retractable blade 266 described stopper 256 is inserted in the temporary catheter 216.Conduit sickle 264 is used for stopper 256 is pushed in the catheter lumen 262.In case stopper 256 is in suitable position, retractable blade 266 will stretch out from conduit sickle 264, then conduit sickle 264 rotation or begin to excise the temporary catheter 216 of at least a portion with other mode of operation from the end 244 of temporary catheter 216.Regain retractable blade 266, and the separated part and the conduit sickle 264 of temporary catheter 216 removed from patient's body together.The end 244 of temporary catheter 216 and stopper 256 are stayed in the coupled cavity 252 of wall 254 of adapter and with its sealing, make it not leak blood.
[0130] in Figure 17 A and the described specific embodiments of 17B, exposed ends 400 interim or subsidiary conduit 402 provides with the adapter configuration, so that allow to use syringe 404.Syringe 404 comprises stopper 406 and carries liquid 408, like this when connecting the piston 410 of syringe 404 and pushing syringe 404, carry liquid 408 can promote the chamber 412 of stopper 406 by subsidiary conduit 402, and be positioned at securely herein, with the far-end 414 and the packing of VAS100 other parts in subsidiary conduit chamber 412.Preferably, syringe 404 and subsidiary conduit 402 only be configured to a spot of conveying liquid of needs just can implantation stopper 406 and discharge subsidiary conduit 402.In preferred embodiments, can use the 1.5cc syringe, wherein approximately the conveying liquid 408 of 1cc is used to carry stopper 406, and approximately the conveying liquid 408 of 0.5cc is used for pressurization and discharges subsidiary conduit 402.Figure 17 C has described an embodiment of stopper 406.Stopper is an elongated shape, and its shape of cross section is normally circular, and forms complementation with the shape of cross section in subsidiary conduit chamber.The outer surface of stopper has one or more elastic projection or alas 416 along circumference.One or more alas 416 have produced the sealing with the chamber 412 of subsidiary conduit 402, thereby the ability with hydraulic drive stopper 406 is provided.No matter how the size or the surface in subsidiary conduit chamber change, the elasticity of ala 416 can both keep the sealing with catheter lumen 412, and can also reduce the frictional resistance in 412 in stopper 406 and subsidiary conduit chamber, this can reduce to promote the stopper 406 needed intensities of pressure.Ala 416 on the stopper 406 is normally angled so that move along a direction in chamber 412, prevents from simultaneously to move round about in chamber 412.This angle can also improve the sealing characteristics of stopper 406.In some embodiments of the present invention, the lip-deep complemental groove in chamber or the projection of the subsidiary conduit by being located at required plug position place, easier appropriate positioning plug 406 is in the position of the distal portions 414 in subsidiary conduit chamber 412.Preferred use taper fit or shoulder (shoulder) between stopper and the distal end of catheter, but optional, to limit too dark that stopper enters, realize sealing closely simultaneously.
[0131] in case stopper 406 in position, the syringe 404 of connection can produce the hydraulic pressure that increases in the near-end chamber 412 of subsidiary conduit 402, this is because stopper 406 forms due to the liquid sealing at distal chamber 414 places of subsidiary conduit 402.The hydraulic ability of this increase can be used for subsidiary conduit 402 is separated at least in part, unclamps or untie from the other parts of VAS 100.With reference to figure 17D, the far-end 418 of subsidiary conduit 402 can be elastic female thread adapter end, the connection that this female thread adapter end is configured to use the external screw thread adapter end 420 on the VAS 100 to seal with formation.In other embodiments, the position of external screw thread/female thread adapter can be put upside down.The elastic characteristic of the distally female ends 418 of subsidiary conduit 402 may be from elastomeric material and/or such as the elasticity fastening element of coil.The elasticity at the other parts place of subsidiary conduit 402 is if unwanted words can reduce by wire coil or the nylon coil 422 reinforcing elastic walls of discussing with others of the present invention.When hydraulic pressure was fully increased by syringe 404, the elasticity between female thread adapter end and external screw thread adapter end 418,420 connected released, and subsidiary conduit 402 can separate with the remainder of VAS 100.When described adapter unclamped, some liquid can infiltrate subcutaneous tissue.In some instances, before subsidiary conduit separated fully, the available liquid in the syringe infiltrated tissue.When seepage took place, the identical or different syringe that has other liquid can be used to finish separable programming.Preferably, consider the ability drop or the disappearance of patients with renal failure removing excess liq, should avoid using excessive liquid to separate subsidiary conduit.In other embodiments of the present invention, the supercharging in subsidiary conduit chamber 412 is only unclamped the coupling part of subsidiary conduit 402, with abundant reduction subsidiary conduit 402 is separated needed power with the remainder of VAS 100, but be not sufficient to destroy the liquid seal between the adapter end 418,420.This can prevent that syringe liquid from infiltrating the gap.
[0132] in selectable embodiment, the far-end of subsidiary conduit can be inelastic or resilient, but under specific hydraulic pressure plastic deformation takes place.Described subsidiary conduit is configured to when the pressure in the subsidiary conduit surpasses the stress level of setting, and therefore distortion quite a while or unlatching for good and all provide long window for disconnecting subsidiary conduit.In other embodiments, the far-end of subsidiary conduit can use the basic material identical with the remainder of subsidiary conduit but have the multi-form of different hardness to make up.The part that described far-end can be used as whole subsidiary conduit forms simultaneously or is made separately, is attached to the other parts of subsidiary conduit then.
C.
The implantation of interim path
[0133] has in the embodiment of VAS of interim access structure an implantation, elder generation's tunnelling is used for the path of the parts of vessels of VAS, then tunnelling is used for the path of the pre-connection graft parts of VAS, and preferably tunnelling withdraws from the path at position from middle site of puncture to temporary catheter subsequently.Preferably, temporary catheter is positioned at the position of withdrawing from of tunnelling, rather than directly outwards outstanding from the middle site of puncture that parts of vessels is connected with the graft parts, so that reduce the infection risk of main VAS assembling parts.Withdraw from the distance of the skin part of health by increasing adapter to temporary catheter, reduced the infection of adapter.After temporary catheter was tunneling to adapter from chest, conduit was locked or is fastened with a bolt or latch in the adapter, as described in the disclosed embodiment of front.Temporary catheter also can be tunneling to from adapter and withdraw from the position.
[0134] although the present invention with reference to embodiment of the present invention, show especially and described the present invention, it should be appreciated by those skilled in the art, when not departing from scope of the present invention, can make various variations to its form and details.For above-described all embodiments, the step of method does not need to operate in regular turn.And, only be intended to for convenience of description about location or above-mentioned any reference of direction, rather than limit the scope of the invention to arbitrary specific location or direction.
Claims (58)
1. biocompatible graft, it comprises and the bonded anti-seepage material of stretch-proof structure, wherein said stretch-proof structure is resisted the expansion of described anti-seepage material, the expansion of described anti-seepage material causes any pin site of puncture in the described anti-seepage material to be opened and seepage basically, and wherein said anti-seepage material has the structure that turns up.
2. biocompatible graft, it comprises piped anti-seepage material, described piped anti-seepage material has outer surface, inner surface, first end, second end, the longitudinal axis and the inner chamber between described first end and described second end, and at least a portion of wherein said piped anti-seepage material is circumferentially compression.
3. biocompatible graft as claimed in claim 2, it also comprises the stretch-proof structure.
4. as claim 1 or 3 described biocompatible grafts, wherein:
Described anti-seepage material comprises silicone layer, and described stretch-proof layer comprises the ePTFE layer; Or
Described anti-seepage material comprises the tubular material of antiseep, and described stretch-proof structure comprises the tubular material of stretch-proof.
5. biocompatible graft as claimed in claim 4, wherein said ePTFE layer are the ePTFE pipes that comprises length, outer surface, external diameter, first end, second end, the chamber between two ends and internal diameter.
6. as claim 4 or 5 described biocompatible grafts, wherein said silicone layer comprises the silicone tube with first end and second end.
7. biocompatible graft as claimed in claim 6 wherein is applied to described silicone tube the described chamber of the described outer surface or the described ePTFE pipe of described ePTFE pipe.
8. biocompatible graft as claimed in claim 6, the length of wherein said silicone tube is less than the length of described ePTFE pipe.
9. as the described biocompatible graft of arbitrary claim in the claim 6,7 or 8, it also comprises the ePTFE layer that is covered on the described silicone tube.
10. biocompatible graft as claimed in claim 9, the cover layer of wherein said ePTFE covers described silicone tube fully.
11. biocompatible material as claimed in claim 8, wherein said silicone tube are positioned at first end of the described ePTFE pipe of distance at least about 0.25cm or at least about 0.5cm or at least about the 1cm place.
12. biocompatible graft as claimed in claim 11, wherein said silicone tube are positioned at second end of the described ePTFE pipe of distance at least about 0.25cm or at least about 0.5cm or at least about the 1cm place.
13. biocompatible graft as claimed in claim 6, the described chamber of wherein said ePTFE pipe comprise the less diameter region in chamber, chamber transition region and chamber than the major diameter district.
14. biocompatible graft as claimed in claim 13, wherein said silicone tube are applied in described chamber transition region and the described chamber chamber than near the described ePTFE pipe the major diameter district.
15. biocompatible graft as claimed in claim 6, the outer surface of wherein said ePTFE pipe comprise outside less diameter region, outside transition region and outside than the major diameter district.
16. biocompatible graft as claimed in claim 15, wherein said silicone tube are applied near the outer surface of the described ePTFE pipe the less diameter region of described chamber transition region and described chamber at least.
17. biocompatible graft as claimed in claim 6, wherein said silicone tube is applied to the outer surface of described ePTFE pipe.
18. biocompatible graft as claimed in claim 4, wherein said anti-seepage material and described stretch-proof structure form the IMU highway section between the first ePTFE latter end and the 2nd ePTFE latter end.
19. biocompatible graft as claimed in claim 18, a wherein said ePTFE latter end is formed by integral body with described IMU highway section or is connected by the sections adapter.
20. as the described biocompatible graft of arbitrary claim in the claim 6 to 9, it also comprises near at least one second antitorque junction structure terminal in the first terminal or described silicone tube of described silicone tube.
21. as the described biocompatible graft of arbitrary claim in the claim 5 to 7, its also comprise be embedded into usually in the described silicone tube or be embedded into separating member between described silicone tube and the described ePTFE pipe.
22. biocompatible graft as claimed in claim 21, wherein said separating member are spiral helicine unwinding members.
23. as the described biocompatible graft of arbitrary claim in the claim 1 to 22, wherein said anti-seepage material is vertically compression.
24. biocompatible graft, it comprises the elastic tubular structure of turning up.
25. biocompatible graft as claimed in claim 24, it also comprises and the bonded gillies' graft material of described elastic tubular structure of turning up.
26. biocompatible graft as claimed in claim 2, wherein said piped anti-seepage material is an axial compression.
27. biocompatible graft as claimed in claim 2, wherein said piped anti-seepage material is a radial compression.
28. biocompatible graft as claimed in claim 2, the circumferential compression of wherein said piped anti-seepage material are that described piped anti-seepage material institute is inherent.
29. biocompatible graft as claimed in claim 2, the outer surface of wherein said piped anti-seepage material comprises circumferential tension force, near the described piped anti-seepage material of the described circumferential tension force radial compression inner surface of described piped anti-seepage material.
30. biocompatible graft as claimed in claim 2, wherein said piped anti-seepage material have showed the compression that increases from its outer surface to its inner surface.
31. biocompatible graft as claimed in claim 29, the outer surface of wherein said piped anti-seepage material is an expanded configuration, and the inner surface of described piped anti-seepage material is a compressed configuration.
32. biocompatible graft as claimed in claim 2, wherein said tubulose anti-seepage material is the tubular material that turns up.
33. as the described biocompatible graft of arbitrary claim in the claim 1 to 2, wherein said anti-seepage material is silicone tube or polyurethane tube.
34. biocompatible graft as claimed in claim 2, it also comprises the radial compression structure.
35. biocompatible graft as claimed in claim 34, wherein said radial compression structure is the tubular compression structure.
36. as claim 1 or 3 described biocompatible grafts, wherein said stretch-proof structure comprises a plurality of stretch-proof structures that embed in the described piped anti-seepage material.
37. biocompatible graft as claimed in claim 36, wherein said a plurality of stretch-proof structures are discontinuous fiber or strand.
38. as claim 1 or 3 described biocompatible grafts, wherein said stretch-proof structure comprises the stretch resistant tube with described piped anti-seepage material concentric arrangement.
39. biocompatible graft as claimed in claim 38, wherein said stretch resistant tube combines with the outer surface of described piped anti-seepage material or combines with the inner surface of described piped anti-seepage material.
40. biocompatible graft as claimed in claim 38, wherein said stretch resistant tube are the ePTFE pipes.
41. as claim 1 or 3 described biocompatible grafts, wherein said stretch-proof material is ePTFE.
42. biocompatible graft as claimed in claim 41, wherein said ePTFE has an appointment 25 microns to about 30 microns average internode distance along the longitudinal axis of described piped anti-seepage material.
43. make the method for blood vessel graft, it comprises:
Resilient polymer pipe is turned up; And
Stretch-proof structure and described resilient polymer pipe are combined.
44. the method for manufacturing blood vessel graft as claimed in claim 43, wherein said resilient polymer pipe is a silicone tube.
45. the method for manufacturing blood vessel graft as claimed in claim 43, wherein said stretch-proof structure is the stretch-proof graft structure or has tubular structure.
46. the method for manufacturing blood vessel graft as claimed in claim 45, wherein said stretch-proof graft structure comprises ePTFE.
47. the method as the described manufacturing blood vessel graft of arbitrary claim in the claim 43 to 46 wherein combines described stretch-proof structure with the outer surface of described resilient polymer pipe.
48. as the method for the described manufacturing blood vessel graft of arbitrary claim in the claim 43 to 46, it also comprises the top that the described resilient polymer pipe that turns up is placed gillies' graft.
49. the method for manufacturing blood vessel graft as claimed in claim 48, in wherein said gillies' graft, the resilient polymer pipe that turns up and the stretch-proof structure each all has length, and the length that is shorter in length than described gillies' graft of wherein said stretch-proof structure.
50. as the method for the described manufacturing blood vessel graft of arbitrary claim in the claim 43 to 49, wherein said stretch-proof structure is vertically compression.
51. the method for manufacturing blood vessel graft as claimed in claim 43, it also comprises:
Before described resilient polymer pipe is turned up, gillies' graft is placed on the outer surface of described resilient polymer pipe, the described resilient polymer pipe that wherein turns up also makes described gillies' graft turn up.
52. implantable vascular access graft, it is designed to enter blood flow fast by described graft when in the implanted patient's body of described graft, and described graft comprises:
Polyurethane tube, described polyurethane tube have inner surface, outer surface and extend to the length of second end from first end; And
The structure of anti-pin puncture back seepage, described structure is included in the layer that described inner surface or external surface peripheral are connected with described polyurethane tube, and the length that described layer extends is less than the length of the described pipe between described first end and second end, so that the part that does not have described structure of described pipe is provided in the described end of described pipe.
53. implantable fluid line, it comprises:
First pipeline, the adapter that described first pipeline has first end, second end, the chamber between two ends and has the opening that closes on the chamber of described first pipeline, wherein said first end is suitable for being connected with the body fluid pipeline with described second end; And
Second pipeline, described second rubber-like, first end, the second terminal and chamber between two ends, described elastic first end of wherein said second pipeline releasably is connected with the described adapter of described first pipeline.
54. implantable fluid line as claimed in claim 53, it also comprises the pipe pressurizing device, described pipe pressurizing device comprises the described second terminal distal tip that engages that is configured to described second pipeline, be configured to seal the prefabricated stopper in the chamber of described second pipeline, and the fluid volume that is configured to described prefabricated stopper is advanced to from the distal tip of described pipe pressurizing device described resilient first end of described second pipeline.
55. implantable fluid line comprises:
First pipeline, the adapter that described first pipeline has first end, second end, the chamber between two ends and has the opening that closes on the chamber of described first pipeline, wherein said first end is suitable for being connected with the body fluid pipeline with described second end;
Second pipeline, described second pipeline has first end, second end and the chamber between two ends, described first end of wherein said second pipeline is connected with the adapter of described first pipeline, and described first end of wherein said second pipeline has pressure-sensitive compressed configuration and expanded configuration, and the pressure that described first end of wherein said second pipeline is configured to the intracavity along with described second pipeline and increases becomes described expanded configuration from described pressure-sensitive compressed configuration.
56. the syringe of sealing duct, its comprise the end that is configured to the sealing connecting duct distal tip, be configured to seal the stopper in the chamber of described conduit, and be configured to promote the pressurisable fluid volume that approaches described stopper that described stopper enters described conduit.
57. treatment patient's test kit, it comprises vascular access system, cuspidated syringe, and the prefabricated stopper that is configured to be positioned at the tip of described syringe.
58. treatment patient's method, it comprises:
Implantable medical treatment device is provided, described implantable medical treatment device comprises and the bonded silicone layer of ePTFE layer, and wherein said ePTFE layer is configured to stop described silicone layer to be stretched to be opened any puncturing hole in the described silicone layer and be enough to degree that fluid is passed through in body conduit; And
Described implantable medical treatment device is connected with body conduit.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US73765805P | 2005-11-17 | 2005-11-17 | |
| US60/737,658 | 2005-11-17 | ||
| US60/763,240 | 2006-01-30 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101384228A true CN101384228A (en) | 2009-03-11 |
Family
ID=40463715
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA2006800512963A Pending CN101384228A (en) | 2005-11-17 | 2006-11-17 | Self-sealing residual compressive stress graft for dialysis |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101384228A (en) |
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102711663A (en) * | 2009-11-17 | 2012-10-03 | 血管流量技术有限公司 | A tubular conduit |
| CN103068417A (en) * | 2010-06-02 | 2013-04-24 | 阿尔佛雷德·R·扎拉特 | Hemodialysis system and method |
| CN103857416A (en) * | 2011-10-07 | 2014-06-11 | W.L.戈尔及同仁股份有限公司 | Puncturable and resealable graft |
| EP2544623A4 (en) * | 2010-03-09 | 2015-07-08 | Solinas Medical Inc | AUTOMATIC CLOSURE DEVICES AND METHODS FOR THEIR MANUFACTURE AND USE |
| CN110612071A (en) * | 2017-05-08 | 2019-12-24 | Pmu创新股份有限公司 | Aortic graft occluder |
| CN110786973A (en) * | 2018-08-03 | 2020-02-14 | 先健科技(深圳)有限公司 | Assembly, conveyor and system for controlling release of an implantation instrument |
| US10596017B2 (en) | 2016-04-25 | 2020-03-24 | Solinas Medical Inc. | Self-sealing tubular grafts, patches, and methods for making and using them |
| US10595888B2 (en) | 2013-04-13 | 2020-03-24 | Solinas Medical Inc. | Self-closing devices and apparatus and methods for making and delivering them |
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2006
- 2006-11-17 CN CNA2006800512963A patent/CN101384228A/en active Pending
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102711663B (en) * | 2009-11-17 | 2015-04-22 | 血管流量技术有限公司 | A tubular conduit |
| CN102711663A (en) * | 2009-11-17 | 2012-10-03 | 血管流量技术有限公司 | A tubular conduit |
| US9649186B2 (en) | 2009-11-17 | 2017-05-16 | Vascular Flow Technologies Limited | Tubular conduit |
| US9848860B2 (en) | 2010-03-09 | 2017-12-26 | Solinas Medical Inc. | Self-closing devices and methods for making and using them |
| US9427218B2 (en) | 2010-03-09 | 2016-08-30 | Solinas Medical Inc. | Self-closing devices and methods for making and using them |
| EP2544623A4 (en) * | 2010-03-09 | 2015-07-08 | Solinas Medical Inc | AUTOMATIC CLOSURE DEVICES AND METHODS FOR THEIR MANUFACTURE AND USE |
| EP3338736A1 (en) * | 2010-03-09 | 2018-06-27 | Solinas Medical Inc. | Self-closing devices |
| CN103068417A (en) * | 2010-06-02 | 2013-04-24 | 阿尔佛雷德·R·扎拉特 | Hemodialysis system and method |
| CN107184291B (en) * | 2011-10-07 | 2019-11-05 | W.L.戈尔及同仁股份有限公司 | Pierceable and reclosable graft |
| CN107184291A (en) * | 2011-10-07 | 2017-09-22 | W.L.戈尔及同仁股份有限公司 | Pierceable and reclosable graft |
| CN103857416A (en) * | 2011-10-07 | 2014-06-11 | W.L.戈尔及同仁股份有限公司 | Puncturable and resealable graft |
| US10595888B2 (en) | 2013-04-13 | 2020-03-24 | Solinas Medical Inc. | Self-closing devices and apparatus and methods for making and delivering them |
| US10596017B2 (en) | 2016-04-25 | 2020-03-24 | Solinas Medical Inc. | Self-sealing tubular grafts, patches, and methods for making and using them |
| CN110612071A (en) * | 2017-05-08 | 2019-12-24 | Pmu创新股份有限公司 | Aortic graft occluder |
| CN110612071B (en) * | 2017-05-08 | 2022-01-11 | Pmu创新股份有限公司 | Aortic graft occluder |
| US11458006B2 (en) | 2017-05-08 | 2022-10-04 | Pmu Innovations Gmbh | Aortic graft occluder |
| CN110786973A (en) * | 2018-08-03 | 2020-02-14 | 先健科技(深圳)有限公司 | Assembly, conveyor and system for controlling release of an implantation instrument |
| CN110786973B (en) * | 2018-08-03 | 2022-11-08 | 先健科技(深圳)有限公司 | Assembly, conveyor and system for controlling release of an implantation instrument |
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