WO2006130133A1 - Ensemble catheter port pour traitement extracorporel - Google Patents

Ensemble catheter port pour traitement extracorporel Download PDF

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Publication number
WO2006130133A1
WO2006130133A1 PCT/US2005/018851 US2005018851W WO2006130133A1 WO 2006130133 A1 WO2006130133 A1 WO 2006130133A1 US 2005018851 W US2005018851 W US 2005018851W WO 2006130133 A1 WO2006130133 A1 WO 2006130133A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
distal
lumen
port assembly
suture
Prior art date
Application number
PCT/US2005/018851
Other languages
English (en)
Inventor
Bernard Canaud
John Stephens
Original Assignee
Medical Components, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medical Components, Inc. filed Critical Medical Components, Inc.
Priority to EP05753985A priority Critical patent/EP1883441A4/fr
Priority to JP2008513442A priority patent/JP4979691B2/ja
Priority to PCT/US2005/018851 priority patent/WO2006130133A1/fr
Priority to CA2608714A priority patent/CA2608714C/fr
Publication of WO2006130133A1 publication Critical patent/WO2006130133A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/24—Check- or non-return valves

Definitions

  • the present invention relates to a catheter port assembly and a method of inserting
  • Catheters for extracorporeal blood purification may be located in various venous locations and cavities throughout the body of a patient for administration of solutes and for removal of toxins and fluids from the body via an extracorporeal blood circulation.
  • Such venous catheterization may be performed by using a single catheter having multiple lumens.
  • a typical example of a multiple lumen catheter is a dual lumen catheter in which one lumen serves to aspirate blood (arterial line) and the other lumen serves to restitute cleaned blood (venous line).
  • An example of such a dual lumen catheter assembly is the SPLIT CATH® catheter, manufactured by Medical Components, Inc. of Harleysville, Pennsylvania.
  • Catheterization may also be performed by using separate, single lumen catheters inserted through the same incision into the deep vein to be catheterized.
  • dual catheter assemblies are also manufactured by Medical Components, Inc. of Harleysville, Pennsylvania.
  • An example of a dual single lumen catheter assembly is the Tesio® catheter system, sold by Medical Components, Inc.
  • the vessel is identified by aspiration with a long hollow needle in accordance with the well known Seldinger technique.
  • a thin guide wire is then introduced, typically through the syringe needle or other introducer device into the interior of the vessel.
  • the introducer device is then removed, leaving the distal end portion of the guide wire that has been inserted into the vessel within the vessel and the opposing proximal end of the guide wire projecting beyond the surface of the skin of the patient.
  • several options are available to a physician for catheter placement.
  • the simplest option is to pass a semi-rigid catheter into the vessel directly over the guide wire.
  • the guide wire is then removed, leaving the catheter in position within the vessel.
  • a vein dilator device generally within a sheath, is passed over the guide wire to enlarge the guidewire entrance site and to facilitate the introduction of the catheter.
  • the guidewire and dilator are removed and the catheter is inserted through the sheath, into the vein.
  • the sheath is then removed, leaving the catheter in place.
  • the present invention discloses a catheter port assembly having a body having a distal end, a proximal end and a longitudinal channel extending therethrough between the distal end and the proximal end.
  • the catheter port assembly further comprises a valve disposed along the longitudinal channel.
  • the valve is adapted to restrict flow in at least one direction.
  • the distal end is adapted to be connected to a catheter.
  • the distal end is also adapted to be at least partially subcutaneously inserted into a patient after being connected to a catheter and the proximal end is adapted to be connected to an extracorporeal device.
  • the present invention also discloses a catheter port assembly comprising a tubular body having a first end, a second end, a center portion and a longitudinal passageway extending between the first end and the second end.
  • the catheter port assembly further comprises a valve disposed along the longitudinal passageway.
  • the second end of the assembly comprises at least one barb adapted to be inserted within a catheter lumen, thereby engaging the catheter lumen.
  • the center portion is wider than the catheter lumen.
  • the second end further comprises a distal cover adapted to further engage the catheter lumen with the second end and provide a transition between the catheter lumen and the center portion.
  • the second end is adapted to be partially subcutaneously inserted into a patient at a subcutaneous tunnel exit site.
  • the present invention also discloses a method of inserting a catheter port assembly.
  • the method comprises providing a catheter, having at least one lumen, the at least one lumen of the catheter comprising at least one distal end and at least one proximal end.
  • a trocar is also provided.
  • the trocar includes a distal end and a proximal end.
  • a suture having a first end and a second end, and a port assembly are also provided.
  • the port assembly comprises a body having a distal end and a valve, and a distal cover.
  • the method further includes inserting the distal end of the at least one lumen into a vessel of a patient, then connecting the proximal end of the at least one lumen and the first end of the suture, to the distal end of the trocar.
  • the method further includes tunneling the trocar, the proximal end of the at least one lumen and the first end of the suture through the flesh of the patient to an exit site and pulling the proximal end of the at least one lumen and the first end of the suture at least partially through the exit site.
  • the method includes attaching the proximal end of the at least one lumen and the first end of the suture to the distal end of the body and pulling the second end of the suture until at least a portion of the assembly is disposed within the patient.
  • Fig. 1 is an exploded side view of a preferred embodiment of a catheter port assembly according to the present invention.
  • Fig. 2 is a sectional view of a body of the catheter port assembly according to a preferred embodiment of the present invention.
  • FIG. 3 is an enlarged sectional view of a distal cover of the catheter port assembly according to a preferred embodiment of the present invention.
  • Fig. 4 is an exploded side view of a catheter port assembly, including a distal cover and catheter lumen, partially in section.
  • Fig. 5 is a front view of a bracket according to the preferred embodiment of the present invention.
  • Fig. 5a is a sectional view of the bracket of Fig. 5, taken along the line 5a-5a.
  • Fig. 5b is a front view of a bracket according to an alternative embodiment of the present invention.
  • Fig. 5c is a front view of the bracket of Fig. 5b, in an open position.
  • Fig. 5d is a front view of a bracket according a second alternative embodiment of the present invention.
  • Fig. 5e is a front view of a bracket according to a third alternative embodiment of the present invention.
  • Fig. 5f is a bottom plan view of a portion of the bracket of Fig. 5e.
  • Fig. 6 is a partially broken away diagrammatic view of two catheter port assemblies subcutaneously tunneled and inserted into a patient according to the preferred embodiment of the present invention.
  • Fig. 7 is a side view of a catheter port assembly, including a catheter and a suture, according to the present invention.
  • Fig. 7a is a side view of the catheter port assembly of Fig 7, further including a distal cover, according to the present invention.
  • proximal and distal refer to directions away from and closer to, respectively, the insertion tip of the catheter in a catheter port assembly 100 according to the present invention.
  • the terminology includes the words above specifically mentioned, derivatives thereof, and words of similar import. The following describes preferred embodiments of the invention. However, it should be understood, based on this disclosure, that the invention is not limited by the preferred embodiments described herein.
  • the assembly 100 has a body 101, comprising a distal portion 110 and a proximal portion 120.
  • a longitudinal axis 102 extends between the distal portion 110 and the proximal portion 120.
  • a central portion 130 is disposed along the longitudinal axis 102 between the distal portion 110 and the proximal portion 120.
  • the assembly further comprises a distal cover 170.
  • the distal portion 110 preferably is adapted to be inserted into a proximal end of a catheter lumen (not shown in Fig. 1).
  • the distal portion 110 is adapted to engage the catheter lumen when the proximal end of the lumen is disposed about at least a portion of the distal portion 110.
  • the distal portion 110 comprises at least one barb 112 adapted to restrict the movement of the body 101 in a proximal direction relative to the lumen. While the at least one barb 112 is shown here comprises two barbs 112, those skilled in the art will recognize that movement of the catheter in relation to the body 101 may be restricted in other ways without departing from the scope of the present invention.
  • the distal portion 110 of the body 101 has a distal opening 114 and a distal passageway 116.
  • the distal passageway 116 is adapted to facilitate the flow of liquids, preferably blood or medicaments, therethrough.
  • a proximal part 115 of the distal portion 110 has a squared cross section, comprised of four flat sides 115a (only one side 115a being shown).
  • the present embodiment discloses a proximal part 115 of the distal portion 110 having four sides, those skilled in the art will recognize that the proximal part 115 of the distal portion 110 may have any number of sides, or alternatively be rounded or any other suitable shape.
  • the proximal portion 120 is adapted to releasably connect to an extracorporeal treatment device, such as a hemodialysis machine (not shown), or a cap (not shown).
  • the means for connection is a luer connection 122, which is well known to those skilled in the art.
  • the luer connection 122 has a proximal opening 124 with a tapered inner wall 123.
  • male threads 125 are disposed on the outer surface of the proximal portion 120.
  • male threads 125 and a luer connection 122 are shown here, those skilled in the art will recognize that the proximal end 120 may comprise any other suitable means of connecting the assembly 100 to an extracorporeal device.
  • the central portion 130 has a larger cross section than either of the proximal or distal portions 120, 110 when taken along a plane perpendicular to the paper.
  • the central portion 130 has a generally circular cross section.
  • the central portion 130 is sized to accommodate a valve 150 disposed therein along the longitudinal axis 102.
  • at least a portion of the central portion 130 has a tapered outer surface 132 that tapers from wider, at a proximal point 132a on the tapered outer surface 132, to narrower, at a distal point 132b on the tapered outer surface 132.
  • the body 101 comprises at least a first body section 103, comprising the proximal portion 120 and a portion of the center portion 130, and a second body section 104, comprising the distal section 110 and a portion of the center portion 130.
  • the first body section 103 is adapted to engage and connect to the second body section 104.
  • the connection may be welding, threads, a press fit or any other suitable means that is known to those skilled in the art.
  • a circumferential reveal 156 is formed between the first body section 103 and the second body section 104 when the first body section 103 and the second body section 104 are connected together.
  • the valve 150 is disposed between the first body section 103 and the second body section 104 before the first body section 103 and the second body section 104 are connected together, thereby retaining the valve 150 therein. While the valve 150 is shown here retained between the first body section 103 and the second body section 104, those skilled in the art will recognize that many other means for retaining the valve 150 within the body 101 maybe used without departing from the scope of the present invention.
  • an indicator ring 160 is disposed about the outer surface of the central portion 130. hi the preferred embodiment, the indicator ring 160 is disposed about the tapered outer surface 132 between the proximal point 132a and the distal point 132b of the tapered outer surface 132.
  • the indicator ring 160 is also tapered so that there is a smooth surface between the proximal point 132a and the distal point 132b of the tapered outer surface 132.
  • the indicator ring 160 is colored to indicate whether the lumen that the assembly 100 is attached to is a venous lumen, an arterial lumen, or used for some other purpose, such as delivering medicaments to the bloodstream.
  • a color coded indicator ring 160 is desirable for the present invention because, when the assembly is properly installed in a patient, the lumen may be completely covered by the patient's flesh or the distal cover 170.
  • the color coding system is well known to those skilled in the art.
  • a blue marked lumen generally represents the venous lumen, or the lumen that facilitates the return of blood to the body
  • the red marked lumen generally represents the arterial lumen, or the lumen that facilitates the withdrawal of blood from the body.
  • an indicator ring 160 is used in the present embodiment to indicate the type of lumen that the assembly 100 is connected to, those skilled in the art will recognize that any other suitable means of identifying the lumens may be used as well.
  • the central portion 130 further preferably includes a flattened portion 134.
  • the outer surface of the flattened portion 134 has a hexagonal cross section comprised of six flattened sides 134a (only three sides 134a being shown).
  • the flattened portion 134 is disposed proximally of the tapered outer surface 132. While the preferred embodiment shown here discloses a flattened portion 134 having a hexagonal cross section, those skilled in the art will recognize that flattened portions 134 having any number of sides may be used without departing from the scope of the present invention. Alternatively, the flattened portion 134 may be oblong or some other shape as known to those skilled in the art.
  • the central portion 130 and the proximal portion 120 define a central passageway 136 that extends from the proximal opening 124 to the distal passageway 116.
  • the central passageway 136 is generally tubular and extends along the longitudinal axis 102.
  • the valve 150 is disposed within the central passageway 136 along the longitudinal axis 102.
  • the valve 150 includes a retaining ridge 152.
  • the retaining ridge 152 is at least partially disposed within the circumferential reveal 156 that extends around the central passageway 136.
  • the retaining ridge 152 is at least partially disposed within the circumferential reveal 156, thereby retaining the valve 150 within the assembly 100, those skilled in the art will recognize that the valve 150 may be retained within the assembly 100 by any other suitable means.
  • the body 101 is constructed of stainless steel, titanium or some other suitable material.
  • the valve 150 restricts flow in a first direction and facilitates flow in a second direction. It is also preferable that the valve 150 provides sufficient resistance to flow in all directions to reduce the occurrence of leakage of blood out of the patient or air or contaminants into the patient.
  • the orientation of the valve 150 may be altered so that, in a pair of assemblies 100, the valve 150 of a first assembly 100 would restrict flow in a first direction and the valve 150 of a second assembly 100 would restrict flow in a second direction.
  • the valve 150 shown in the present embodiment is a bi-directional pressure relief valve.
  • the valve 150 is constructed according to the teachings of U.S. Patent No. 4,434,810. However, those skilled in the art will also recognize that the valve 150 may be a bidirectional valve (not shown), or any other suitable type of valve.
  • the valve 150 is constructed from silicone, a polymer or some other material.
  • the assembly 100 further comprises the distal cover 170 having a proximal end 172, a distal end 174 and a longitudinal passageway 176 extending therethrough between the proximal end 172 and the distal end 174.
  • the proximal end 172 of the distal cover 170 comprises a proximal opening 178.
  • the distal end 174 of the distal cover 170 comprises a distal opening 180.
  • the distal cover 170 is preferably conical in shape, having a widest part nearest the proximal end 172 and a narrowest part nearest the distal end 174.
  • the distal cover 170 is adapted to be connected to the body 101 by inserting the distal portion 110 of the body 101 through the proximal opening 178 of the distal cover 170.
  • the longitudinal passageway 176 of the distal cover 170 is sized to engage the body 101 and the outside of a catheter lumen 200 that is disposed over the distal portion 110 of the body 101.
  • the proximal end 172 of the distal cover 170 is adapted to engage the four flat sides 115a of the proximal part 115 of the distal portion 110 of the assembly.
  • the longitudinal passageway 176 of the distal cover 170 preferably comprises four flats 184a (only one flat 184a being shown) that frictionally engage the four flat sides 115a of the distal portion 110 of the body 101.
  • four flat sides 115a and four flats 184a are shown here, any number of flat sides 115a and flats 184a may be used and that preferably, there is the same number of flat sides 115a and flats 184a.
  • proximal end 172 of the distal cover 170 is sized so that widest part of distal cover 172 has a similar cross sectional size as the portion of the central portion 130 located at the distal point 132b on proximal outer surface 132. This facilitates a smooth transition between the proximal outer surface 132 and the distal cover 170 when the assembly 100 is assembled.
  • the distal cover 170 preferably comprises at least one retaining ridge 182.
  • the retaining ridge 182 is generally helical in shape and extends approximately 360 degrees around the distal cover 170. While a generally helical retaining ridge 182 is shown here, those skilled in the art will recognize that retaining ridges having various configurations may also be used without departing from the scope of the present invention.
  • the retaining ridge 182 is adapted to retain at least a portion of the assembly 100 within the flesh of a patient.
  • a rounded indentation 183 is circumferentially disposed around the distal cover 170 between the retaining ridge 182 and the proximal end 172.
  • the rounded indentation 183 is preferably positioned along the distal cover 170 so that a part of the rounded indentation 183 will be disposed within the patient when the assembly is inserted and a portion of the rounded indentation 183 will remain outside of the patient after insertion.
  • the distal cover 170 is constructed from silicone, a polymer or some other material.
  • a plurality of assemblies 100, 100' may be held together with a stabilizing bracket 190.
  • the bracket 190 is adapted to engage at least one assembly 100.
  • the present embodiment shows a bracket 190 adapted to engage two assemblies 100, 100'.
  • the adapter 190 has a first passageway 191 and a second passageway 192, through which at least a portion of the assemblies 100 is to pass before the bracket 190 engages the assemblies 100.
  • the first and second passageways 191, 192 comprise first and second circular portions 193, 194 and first and second hexagonal portions 195, 196.
  • the circular portions 193, 194 are located distally of the hexagonal portions 195, 196 so that the circular portions 193, 194 engage the central portion 130 of the body 101 on each assembly 100, 100'.
  • the hexagonal portions 195, 196 frictionally engage the flattened portion 134 of the body 101 on each assembly 100, 100'.
  • the bracket 190 preferably engages the assemblies 100, 100' after the assemblies 100, 100' are inserted into the patient 10 preferably, after insertion, the bracket 190, with the side of the openings comprising the circular portions 193, 195 facing the patient, is slid distally about the assemblies 100, 100' until the circular portions 193, 194 engage each respective center portion 130 and the hexagonal portion engages each respective flattened portion 134.
  • the bracket 290 has a first bracket portion 297 and a second bracket portion 297'.
  • the first bracket portion 297 is preferably connected to the second bracket portion 297' by a hinge 298.
  • a first clasp portion 299 engages a second clasp portion 299', thereby retaining the bracket 290 in the closed position.
  • the first clasp portion 299 and second clasp portion 299' comprise a tang and a keeper respectively.
  • the first and second clasp portions 299, 299' may comprise opposing tangs, a tab and a recess or any other configuration known to those skilled in the art to releasably retain the hinged bracket 290 in the closed position.
  • the bracket 290 preferably comprises first and second passageways 291, 292 adapted to engage the assemblies 100, 100'.
  • the passageways 291, 292 comprise first and second circular portions 293, 294 and first and second hexagonal portions 295, 296.
  • the bracket 290 engages the assemblies 100, 100' by closing the bracket 290 around the assemblies 100, 100'.
  • the hexagonal portions 295, 296 engage each respective flattened portion 134 and the circular portions 293, 294 engage each respective center portion 130 of the assemblies 100, 100'.
  • a third embodiment of a bracket 390 is shown in Fig. 5d.
  • the bracket 390 comprises a first and second openings 391, 392 respectively.
  • at least two edges of the first opening 391 and the second opening 392 respectively comprise first and second flattened bracket portions 395, 396.
  • three sides of each of the first and second flattened bracket portions 395, 396 are generally similar to the upper half of a hexagon.
  • two opposing sides of each of the flattened bracket portions 395, 396 are generally parallel to each other and extend along the each side of the openings 391, 392 in a direction that is generally vertical when viewing Fig. 5d.
  • the first and second flattened bracket portions are preferably adapted to engage each respective flattened portion 134 of the assemblies 100, 100'.
  • a first receiving end 393 and a second receiving end 394 are disposed on the opposite side of the first and second openings 391, 392 of the bracket 390 from the flattened bracket portions 395, 396.
  • the bracket is engaged to the assemblies 100, 100' by inserting the assemblies 100, 100' in the first and second receiving ends 393, 394, respectively, and then sliding the bracket 390 around the assemblies 100, 100' so that the first and second flattened bracket portions 395, 396 engage the flattened portion 134 of the assemblies 100, 100'.
  • a fourth embodiment of a bracket 490 is shown in Figs. 5e and 5f.
  • the bracket 490 comprises a first bracket portion 497 and a second bracket portion 497'.
  • the first and second bracket portions 497, 497' are similar to the first and second bracket portions 297, 297' of Figs. 5b and 5c in that each of the first and second bracket portions 497, 497' define a portion of a first passageway 491 and a second passageway 492.
  • the passageways 491, 492 comprise first and second circular portions 493, 494, first and second hexagonal portions 495, 496 and first and second narrowed portions 488, 489.
  • the hexagonal portions 495, 496 engage each respective flattened portion 134 and the circular portions 493, 494 engage each respective center portion 130 of the assemblies 100, 100'.
  • the first and second narrowed portions 488, 489 are adapted to engage each respective proximal portion 120 of the assemblies 100, 100'.
  • the first and second narrowed portions 488, 489 engage the assemblies 100, 100' distally of each of the respective male threads 125 of each respective proximal portion 120 and proximally of the central portion 130.
  • the first and second bracket portions 497, 497' are releasably connectable to each other via at least two tangs 484, 484' and clips 485, 485'.
  • the tangs 484, 484' extend outwardly from the sides of the first bracket portion 497 and the clips 485, 485' extend outwardly and towards the first bracket portion 497 from the second bracket portion 497.
  • the clips 485, 485' are adapted engage the tangs 484, 484' when the bracket 490 is disposed to frictionally engage the assemblies 100, 100'.
  • the first bracket portion 497 is preferably disengaged from the second bracket portion 497' by pushing the clips 485, 485' away from each other and the first bracket portion 497.
  • brackets 190, 290, 390, 490 are constructed from silicone, a polymer or some other suitable material.
  • the brackets 190, 290, 390, 490 may be constructed of a combination of steel, titanium or some other rigid material and silicone, a polymer or some other suitable semirigid material.
  • FIG. 6 two catheters 200, 200' are shown in an inserted position in a patient 10.
  • the insertion is preferably performed one catheter at a time, however those skilled in the art will recognize that the catheters 200, 200' may be inserted simultaneously as well.
  • the insertion of a catheter 200 according to the methods disclosed herein is performed in iterations.
  • a first iteration comprises inserting a first catheter 200 and assembly 100 and a second iteration comprises inserting a second catheter 200' and assembly 100'.
  • separate tools, equipment and accessories to complete the insertion are preferably provided.
  • the separate tools, equipment and accessories preferably comprise at least the catheter 200, a trocar (not shown), a suture 220 and the port assembly 100.
  • a distal end 202, 202' of the catheters into the patient's vessel 18, such as the patient's internal jugular vein. Insertion is preferably performed according to methods that are well known to those skilled in the art. After the distal ends 202, 202' are inserted into the vessel 18, the proximal ends 201, 201 ' are preferably connected to the distal (non pointed) end of the trocar using methods known to those skilled in the art.
  • a suture 220, 220' is attached to each of the trocars and subcutaneously tunneled with the catheters 200, 200' from an entrance site 13, located near where the distal end 202, 202' of the catheters 200, 200' enter the vessel 18, to exit sites 14, 14'.
  • the catheters 200, 200' are tunneled through separate subcutaneous tunnels 16, 16'.
  • the sutures 220, 220' are attached to the trocars by tying the suture around the trocar, or by some other method known to those skilled in the art.
  • the catheters 200, 200' are tunneled above the clavicle 12. Tunneling the catheters 200, 200' above the clavicle 12 provides additional anchoring and support, as is well known to those skilled in the art.
  • the catheters 200, 200' are subcutaneously tunneled to a point where the proximal ends 201, 201' of the catheters 200, 200' exit the patient at exit sites 14, 14'.
  • the exit sites 14, 14' are larger than the outer diameter of the catheter 200, 200' but smaller than the outer diameter of the central portion 130 of the body 101.
  • the distal cover 170 is slid over a proximal end 201 of the catheter lumen 200, as shown in Fig. 4.
  • the proximal end 201 of the catheter lumen 200 is disposed around the distal portion of the body 101, as shown in Fig. 7.
  • the proximal end 201 of catheter lumen 200 is preferably disposed about the barbs 112 when disposed around the distal portion of the body 101.
  • the present embodiment shows a distal cover 170 that is slid over the lumen 200 prior to engaging the lumen 200 with the distal portion 110 of the assembly 100
  • the distal cover 170 may have some other configuration that allows the attachment of the distal cover 170 to the assembly at a time before or after said attachment occurs with the present embodiment.
  • the suture 220 is tied, and knotted in a knot 222, around the proximal end 201 of the catheter lumen 200.
  • the suture 220 is tied around the catheter lumen 200 at a position along the distal portion 110 of the body 101 between two barbs 112.
  • the catheter lumen 200 is further restricted from moving relative to the assembly 100 when the suture 220 is tightened around the catheter lumen 200, thereby squeezing the catheter lumen 200 around the distal portion 110 of the body 101.
  • the suture 220 is placed along the catheter lumen 200 and the distal cover 170 is slid proximally along the catheter lumen 200, over the suture 220, toward the body 101.
  • the distal cover 170 is slid proximally until the distal cover 170 engages the body 101, thereby covering the proximal end 201 of the catheter lumen 200 and the knot 202 of the suture 200.
  • the flats 184a of the distal cover 170 engage the flat sides 115a of the body 101.
  • the assemblies 100, 100' are then placed at least partially through the exit sites 14, 14' and into subcutaneous tunnels 16, 16'.
  • the assemblies 100, 100' are at least partially disposed within the exit sites 14, 14', preferably the retaining ridge 182, 182' of each assembly 100, 100' engages the flesh of the patient 10 so that the flesh of the patient 10 heals around the retaining ridge 182, thereby further securing the assemblies 100, 100' at least partially within the patient 10.
  • the catheter assemblies 100, 100' are pulled distally, back into the patient 10 until the assemblies 100, 100' are at least partially within the exit sites 14, 14'.
  • the assemblies 100, 100' at least partially plug the exit sites 14, 14' when pulled distally back into the patient 10. This is performed by pulling on the sutures 220, 220' at the entrance site 13.
  • the assemblies are pulled back into the patient to a point where the rounded indentation 183 is disposed at the skin level, leaving part of the rounded indentation 183 outside of the patient 10 and part of the rounded indentation 183 within the patient 10.
  • the retaining ridge 182 is disposed inside of the patient 10, thereby allowing the patient's 10 flesh to heal around the retaining ridge 182 and further restricting the movement of the assemblies 100, 100' relative to the patient 10.
  • the knot 222 of the suture 220 (shown in Fig. 7) is a first end of the sutures 220, 220' and second ends 224, 224' of the sutures 220, 220' are disposed near the entrance site 13 of the subcutaneous tunnels 16, 16' after the assemblies 100, 100' are tunneled.
  • the second ends 224, 224' of the sutures 220, 220' are knotted together in a second knot 210, located near the entrance site 13. Knotting the sutures 220, 220' together near the entrance site 13 serves to further secure the assemblies 100, 100' within the patient 10.
  • the assemblies 100, 100' are secured to each other using the bracket 190.
  • the bracket 190 engages the assemblies 100, 100' as discussed previously herein, although those skilled in the art will recognize that the bracket 190 may engage the assemblies 100, 100' in other ways without departing from the scope of the present invention.
  • the arterial assembly 100 is connected to the arterial blood line of an extracorporeal treatment device, such as a hemodialysis machine (not shown).
  • the venous assembly 100' is then preferably connected to the venous blood line of an extracorporeal treatment device, such as a hemodialysis machine (not shown).
  • blood is withdrawn from the arterial lumen 200 and treated blood is returned to the vessel 18 via the venous lumen 200'.
  • the respective valves 150 are adapted to facilitate the direction of blood flow preferred for each lumen 200, 200'.
  • each respective valve 150 is adapted to facilitate flow therethrough even if the assemblies 100, 100' are not connected to the proper extracorporeal bloodlines. In a situation involving improper connections, it is preferable that each respective valve 150 would allow flow at decreased levels, and that in a case of disconnection, each respective valve 150 would restrict the flow of blood, air or contaminants therethrough.

Abstract

La présente invention concerne un ensemble cathéter port (100) comprenant un corps (101) doté d'une extrémité distale (110), d'une extrémité proximale (120) et d'un canal longitudinal (102) entre ces deux extrémités. L'ensemble cathéter port comprend en outre une valve (150) disposée le long du canal longitudinal. La valve est conçue pour restreindre le flux dans au moins une direction et l'extrémité distale est adaptée pour être connectée à un cathéter. L'extrémité distale peut être insérée au moins partiellement sous la peau du patient après connexion à un cathéter, tandis que l'extrémité proximale peut être reliée à un dispositif extracorporel. La présente invention porte également sur un procédé d'insertion d'un ensemble cathéter comprenant l'ensemble cathéter port.
PCT/US2005/018851 2005-05-27 2005-05-27 Ensemble catheter port pour traitement extracorporel WO2006130133A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
EP05753985A EP1883441A4 (fr) 2005-05-27 2005-05-27 Ensemble catheter port pour traitement extracorporel
JP2008513442A JP4979691B2 (ja) 2005-05-27 2005-05-27 体外処理用カテーテルポート組立体
PCT/US2005/018851 WO2006130133A1 (fr) 2005-05-27 2005-05-27 Ensemble catheter port pour traitement extracorporel
CA2608714A CA2608714C (fr) 2005-05-27 2005-05-27 Ensemble catheter port pour traitement extracorporel

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2005/018851 WO2006130133A1 (fr) 2005-05-27 2005-05-27 Ensemble catheter port pour traitement extracorporel

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US7377915B2 (en) 2004-04-01 2008-05-27 C. R. Bard, Inc. Catheter connector system
US7785302B2 (en) 2005-03-04 2010-08-31 C. R. Bard, Inc. Access port identification systems and methods
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US8025639B2 (en) 2005-04-27 2011-09-27 C. R. Bard, Inc. Methods of power injecting a fluid through an access port
US8029482B2 (en) 2005-03-04 2011-10-04 C. R. Bard, Inc. Systems and methods for radiographically identifying an access port
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USD676955S1 (en) 2010-12-30 2013-02-26 C. R. Bard, Inc. Implantable access port
USD682416S1 (en) 2010-12-30 2013-05-14 C. R. Bard, Inc. Implantable access port
US8523840B2 (en) 2004-03-18 2013-09-03 C. R. Bard, Inc. Connector system for a proximally trimmable catheter
US8641676B2 (en) 2005-04-27 2014-02-04 C. R. Bard, Inc. Infusion apparatuses and methods of use
US8715244B2 (en) 2009-07-07 2014-05-06 C. R. Bard, Inc. Extensible internal bolster for a medical device
US8932271B2 (en) 2008-11-13 2015-01-13 C. R. Bard, Inc. Implantable medical devices including septum-based indicators
US9079004B2 (en) 2009-11-17 2015-07-14 C. R. Bard, Inc. Overmolded access port including anchoring and identification features
US9265912B2 (en) 2006-11-08 2016-02-23 C. R. Bard, Inc. Indicia informative of characteristics of insertable medical devices
US9474888B2 (en) 2005-03-04 2016-10-25 C. R. Bard, Inc. Implantable access port including a sandwiched radiopaque insert
US9517329B2 (en) 2007-07-19 2016-12-13 Medical Components, Inc. Venous access port assembly with X-ray discernable indicia
US9579496B2 (en) 2007-11-07 2017-02-28 C. R. Bard, Inc. Radiopaque and septum-based indicators for a multi-lumen implantable port
US9610432B2 (en) 2007-07-19 2017-04-04 Innovative Medical Devices, Llc Venous access port assembly with X-ray discernable indicia
US9642986B2 (en) 2006-11-08 2017-05-09 C. R. Bard, Inc. Resource information key for an insertable medical device
US10307581B2 (en) 2005-04-27 2019-06-04 C. R. Bard, Inc. Reinforced septum for an implantable medical device
US10463845B2 (en) 2013-01-23 2019-11-05 C.R. Bard, Inc. Low-profile access port
USD870264S1 (en) 2017-09-06 2019-12-17 C. R. Bard, Inc. Implantable apheresis port
US11420033B2 (en) 2013-01-23 2022-08-23 C. R. Bard, Inc. Low-profile single and dual vascular access device
US11464960B2 (en) 2013-01-23 2022-10-11 C. R. Bard, Inc. Low-profile single and dual vascular access device
US11471647B2 (en) 2014-11-07 2022-10-18 C. R. Bard, Inc. Connection system for tunneled catheters
US11890443B2 (en) 2008-11-13 2024-02-06 C. R. Bard, Inc. Implantable medical devices including septum-based indicators
US11896782B2 (en) 2017-08-23 2024-02-13 C. R. Bard, Inc. Priming and tunneling system for a retrograde catheter assembly

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Cited By (87)

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US8177762B2 (en) 1998-12-07 2012-05-15 C. R. Bard, Inc. Septum including at least one identifiable feature, access ports including same, and related methods
US8608713B2 (en) 1998-12-07 2013-12-17 C. R. Bard, Inc. Septum feature for identification of an access port
US8226632B2 (en) 2002-02-05 2012-07-24 C. R. Bard, Inc. Connection methods
US8523840B2 (en) 2004-03-18 2013-09-03 C. R. Bard, Inc. Connector system for a proximally trimmable catheter
US7377915B2 (en) 2004-04-01 2008-05-27 C. R. Bard, Inc. Catheter connector system
US8177770B2 (en) 2004-04-01 2012-05-15 C. R. Bard, Inc. Catheter connector system
US9603993B2 (en) 2005-03-04 2017-03-28 C. R. Bard, Inc. Access port identification systems and methods
US8603052B2 (en) 2005-03-04 2013-12-10 C. R. Bard, Inc. Access port identification systems and methods
US8202259B2 (en) 2005-03-04 2012-06-19 C. R. Bard, Inc. Systems and methods for identifying an access port
US8029482B2 (en) 2005-03-04 2011-10-04 C. R. Bard, Inc. Systems and methods for radiographically identifying an access port
US9682186B2 (en) 2005-03-04 2017-06-20 C. R. Bard, Inc. Access port identification systems and methods
US10179230B2 (en) 2005-03-04 2019-01-15 Bard Peripheral Vascular, Inc. Systems and methods for radiographically identifying an access port
US11077291B2 (en) 2005-03-04 2021-08-03 Bard Peripheral Vascular, Inc. Implantable access port including a sandwiched radiopaque insert
US10905868B2 (en) 2005-03-04 2021-02-02 Bard Peripheral Vascular, Inc. Systems and methods for radiographically identifying an access port
US8382724B2 (en) 2005-03-04 2013-02-26 C. R. Bard, Inc. Systems and methods for radiographically identifying an access port
US8382723B2 (en) 2005-03-04 2013-02-26 C. R. Bard, Inc. Access port identification systems and methods
US10857340B2 (en) 2005-03-04 2020-12-08 Bard Peripheral Vascular, Inc. Systems and methods for radiographically identifying an access port
US10675401B2 (en) 2005-03-04 2020-06-09 Bard Peripheral Vascular, Inc. Access port identification systems and methods
US7959615B2 (en) 2005-03-04 2011-06-14 C. R. Bard, Inc. Access port identification systems and methods
US7785302B2 (en) 2005-03-04 2010-08-31 C. R. Bard, Inc. Access port identification systems and methods
US8585663B2 (en) 2005-03-04 2013-11-19 C. R. Bard, Inc. Access port identification systems and methods
US9603992B2 (en) 2005-03-04 2017-03-28 C. R. Bard, Inc. Access port identification systems and methods
US7947022B2 (en) 2005-03-04 2011-05-24 C. R. Bard, Inc. Access port identification systems and methods
US10238850B2 (en) 2005-03-04 2019-03-26 Bard Peripheral Vascular, Inc. Systems and methods for radiographically identifying an access port
US9474888B2 (en) 2005-03-04 2016-10-25 C. R. Bard, Inc. Implantable access port including a sandwiched radiopaque insert
US10265512B2 (en) 2005-03-04 2019-04-23 Bard Peripheral Vascular, Inc. Implantable access port including a sandwiched radiopaque insert
US8998860B2 (en) 2005-03-04 2015-04-07 C. R. Bard, Inc. Systems and methods for identifying an access port
US8939947B2 (en) 2005-03-04 2015-01-27 C. R. Bard, Inc. Systems and methods for radiographically identifying an access port
US8475417B2 (en) 2005-04-27 2013-07-02 C. R. Bard, Inc. Assemblies for identifying a power injectable access port
US8641688B2 (en) 2005-04-27 2014-02-04 C. R. Bard, Inc. Assemblies for identifying a power injectable access port
US10661068B2 (en) 2005-04-27 2020-05-26 Bard Peripheral Vascular, Inc. Assemblies for identifying a power injectable access port
US8805478B2 (en) 2005-04-27 2014-08-12 C. R. Bard, Inc. Methods of performing a power injection procedure including identifying features of a subcutaneously implanted access port for delivery of contrast media
US10780257B2 (en) 2005-04-27 2020-09-22 Bard Peripheral Vascular, Inc. Assemblies for identifying a power injectable access port
US10625065B2 (en) 2005-04-27 2020-04-21 Bard Peripheral Vascular, Inc. Assemblies for identifying a power injectable access port
US10307581B2 (en) 2005-04-27 2019-06-04 C. R. Bard, Inc. Reinforced septum for an implantable medical device
US8641676B2 (en) 2005-04-27 2014-02-04 C. R. Bard, Inc. Infusion apparatuses and methods of use
US9421352B2 (en) 2005-04-27 2016-08-23 C. R. Bard, Inc. Infusion apparatuses and methods of use
US8025639B2 (en) 2005-04-27 2011-09-27 C. R. Bard, Inc. Methods of power injecting a fluid through an access port
US9937337B2 (en) 2005-04-27 2018-04-10 C. R. Bard, Inc. Assemblies for identifying a power injectable access port
US10052470B2 (en) 2005-04-27 2018-08-21 Bard Peripheral Vascular, Inc. Assemblies for identifying a power injectable access port
US10183157B2 (en) 2005-04-27 2019-01-22 Bard Peripheral Vascular, Inc. Assemblies for identifying a power injectable access port
US10016585B2 (en) 2005-04-27 2018-07-10 Bard Peripheral Vascular, Inc. Assemblies for identifying a power injectable access port
US8545460B2 (en) 2005-04-27 2013-10-01 C. R. Bard, Inc. Infusion apparatuses and related methods
US8617138B2 (en) 2005-06-20 2013-12-31 C. R. Bard, Inc. Connection system for multi-lumen catheter
US8852168B2 (en) 2005-06-20 2014-10-07 C. R. Bard, Inc. Connection system for multi-lumen catheter
US8206376B2 (en) 2005-06-20 2012-06-26 C. R. Bard, Inc. Connection system for multi-lumen catheter
US11878137B2 (en) 2006-10-18 2024-01-23 Medical Components, Inc. Venous access port assembly with X-ray discernable indicia
US9642986B2 (en) 2006-11-08 2017-05-09 C. R. Bard, Inc. Resource information key for an insertable medical device
US10092725B2 (en) 2006-11-08 2018-10-09 C. R. Bard, Inc. Resource information key for an insertable medical device
US10556090B2 (en) 2006-11-08 2020-02-11 C. R. Bard, Inc. Resource information key for an insertable medical device
US9265912B2 (en) 2006-11-08 2016-02-23 C. R. Bard, Inc. Indicia informative of characteristics of insertable medical devices
US8852160B2 (en) 2007-06-20 2014-10-07 Medical Components, Inc. Venous access port with molded and/or radiopaque indicia
US11938296B2 (en) 2007-06-20 2024-03-26 Medical Components, Inc. Venous access port with molded and/or radiopaque indicia
US11478622B2 (en) 2007-06-20 2022-10-25 Medical Components, Inc. Venous access port with molded and/or radiopaque indicia
US11406808B2 (en) 2007-06-20 2022-08-09 Medical Components, Inc. Venous access port with molded and/or radiopaque indicia
US8257325B2 (en) 2007-06-20 2012-09-04 Medical Components, Inc. Venous access port with molded and/or radiopaque indicia
US9533133B2 (en) 2007-06-20 2017-01-03 Medical Components, Inc. Venous access port with molded and/or radiopaque indicia
US9517329B2 (en) 2007-07-19 2016-12-13 Medical Components, Inc. Venous access port assembly with X-ray discernable indicia
US9610432B2 (en) 2007-07-19 2017-04-04 Innovative Medical Devices, Llc Venous access port assembly with X-ray discernable indicia
US10874842B2 (en) 2007-07-19 2020-12-29 Medical Components, Inc. Venous access port assembly with X-ray discernable indicia
US11547843B2 (en) 2007-07-19 2023-01-10 Innovative Medical Devices, Llc Venous access port assembly with x-ray discernable indicia
US10639465B2 (en) 2007-07-19 2020-05-05 Innovative Medical Devices, Llc Venous access port assembly with X-ray discernable indicia
US10792485B2 (en) 2007-11-07 2020-10-06 C. R. Bard, Inc. Radiopaque and septum-based indicators for a multi-lumen implantable port
US9579496B2 (en) 2007-11-07 2017-02-28 C. R. Bard, Inc. Radiopaque and septum-based indicators for a multi-lumen implantable port
US11638810B2 (en) 2007-11-07 2023-05-02 C. R. Bard, Inc. Radiopaque and septum-based indicators for a multi-lumen implantable port
US10086186B2 (en) 2007-11-07 2018-10-02 C. R. Bard, Inc. Radiopaque and septum-based indicators for a multi-lumen implantable port
US10052471B2 (en) 2008-11-13 2018-08-21 C. R. Bard, Inc. Implantable medical devices including septum-based indicators
US8932271B2 (en) 2008-11-13 2015-01-13 C. R. Bard, Inc. Implantable medical devices including septum-based indicators
US11890443B2 (en) 2008-11-13 2024-02-06 C. R. Bard, Inc. Implantable medical devices including septum-based indicators
US10773066B2 (en) 2008-11-13 2020-09-15 C. R. Bard, Inc. Implantable medical devices including septum-based indicators
US8337484B2 (en) 2009-06-26 2012-12-25 C. R. Band, Inc. Proximally trimmable catheter including pre-attached bifurcation and related methods
US8715244B2 (en) 2009-07-07 2014-05-06 C. R. Bard, Inc. Extensible internal bolster for a medical device
US9717895B2 (en) 2009-11-17 2017-08-01 C. R. Bard, Inc. Overmolded access port including anchoring and identification features
US10912935B2 (en) 2009-11-17 2021-02-09 Bard Peripheral Vascular, Inc. Method for manufacturing a power-injectable access port
US9079004B2 (en) 2009-11-17 2015-07-14 C. R. Bard, Inc. Overmolded access port including anchoring and identification features
US11759615B2 (en) 2009-11-17 2023-09-19 Bard Peripheral Vascular, Inc. Overmolded access port including anchoring and identification features
US9248268B2 (en) 2009-11-17 2016-02-02 C. R. Bard, Inc. Overmolded access port including anchoring and identification features
US10155101B2 (en) 2009-11-17 2018-12-18 Bard Peripheral Vascular, Inc. Overmolded access port including anchoring and identification features
USD676955S1 (en) 2010-12-30 2013-02-26 C. R. Bard, Inc. Implantable access port
USD682416S1 (en) 2010-12-30 2013-05-14 C. R. Bard, Inc. Implantable access port
US11420033B2 (en) 2013-01-23 2022-08-23 C. R. Bard, Inc. Low-profile single and dual vascular access device
US11464960B2 (en) 2013-01-23 2022-10-11 C. R. Bard, Inc. Low-profile single and dual vascular access device
US10463845B2 (en) 2013-01-23 2019-11-05 C.R. Bard, Inc. Low-profile access port
US11471647B2 (en) 2014-11-07 2022-10-18 C. R. Bard, Inc. Connection system for tunneled catheters
US11896782B2 (en) 2017-08-23 2024-02-13 C. R. Bard, Inc. Priming and tunneling system for a retrograde catheter assembly
USD885557S1 (en) 2017-09-06 2020-05-26 C. R. Bard, Inc. Implantable apheresis port
USD870264S1 (en) 2017-09-06 2019-12-17 C. R. Bard, Inc. Implantable apheresis port

Also Published As

Publication number Publication date
CA2608714C (fr) 2012-09-25
JP2008541833A (ja) 2008-11-27
EP1883441A4 (fr) 2010-08-04
CA2608714A1 (fr) 2006-12-07
JP4979691B2 (ja) 2012-07-18
EP1883441A1 (fr) 2008-02-06

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