Access kit for hemodialysis drug delivery

Abstract

An access assembly (10) for hemodialysis management includes an intravascular tube assembly (20), a catheter assembly (40), a first and a second catheter sleeve assembly (60), and a first and a second catheter assembly (90). The intravascular tube assembly (20) includes an intravascular tube (22) and a subcutaneous cuff (24). The catheter assembly (40) includes a first and a second catheter (42 and 44) ​​having respective catheter threads (50 and 52). The first and second catheter sleeve assemblies (60) have foldable sidewalls (62) that define a cavity (70), and a coupler (76) is defined within the cavity (70). The first and second catheter assemblies (90) each have a catheter sidewall (92) and a fastener (104). The intravascular tube (22) is implanted within a vascular structure. The catheter inner wall (92) is located within each foldable sidewall (62). The foldable sidewall (62) is folded until the respective fastener (104) is screwed onto the respective coupler (76).

Description

Technical Field

[0001] The present invention relates to medical devices, and more particularly to a drug delivery device for hemodialysis. Background Art

[0002] The applicant believes that the closest reference patents are as follows:

[0003] U.S. Patent No. 4,762,517, issued to McIntyre et al. on August 9, 1988, for intravenous subcutaneous implantable drug delivery systems, etc.

[0004] U.S. Patent No. 4,778,452, issued on October 18, 1988 to Moden et al., for an implantable infusion port.

[0005] U.S. Patent No. 5,026,344, issued on June 25, 1991 to Dijkstra et al., for an implantable injection chamber device.

[0006] U.S. Patent No. 5,527,278, issued on June 18, 1996 to Ensminger et al., for an implantable drug delivery device.

[0007] U.S. Patent No. 5,628,784, issued on May 13, 1997 to Ernst P. Strecker, for an endoprosthesis that can be percutaneously implanted into a patient's body.

[0008] US Patent No. 5,848,989 issued to Giuseppe Villani on December 15, 1998, for an implantable port with a thin housing for delivering / collecting fluids and a method of implantation.

[0009] U.S. Patent No. 6,053,901, issued on April 25, 2000 to Finch Jr. et al., for a subcutaneous cannula and arterial access method.

[0010] U.S. Patent No. 6,398,764, issued on June 4, 2002 to Finch Jr. et al., for a subcutaneous cannula and arterial access method.

[0011] U.S. Patent No. 6,582,409, issued on June 24, 2003 to Rafael Squitieri, for hemodialysis and vascular drug delivery systems.

[0012] Applicant considers another close reference patent to be U.S. Patent No. 7,261,705 issued on August 28, 2007 to Edoga et al. for implantable dialysis access port.

[0013] US Patent No. 7,632,263 issued on December 15, 2009 to Denoth et al., for a connection device for a percutaneously implantable port system.

[0014] U.S. Patent No. 7,699,821, issued on April 20, 2010 to Piotr Nowak, for a multi-function port.

[0015] U.S. Patent No. 7,803,143, issued on September 28, 2010 to Tallarida et al., for an implantable hemodialysis drug delivery device.

[0016] U.S. Patent No. 7,828,781, issued on November 9, 2010 to Edoga et al., for an implantable dialysis drug delivery port.

[0017] US Patent No. 7,850,666 issued on December 14, 2010 to Schon et al. for a catheter infusion port.

[0018] US Patent No. 8,079,990 issued on December 20, 2011 to Powley et al. for an implantable catheter port.

[0019] U.S. Patent No. 8,182,453, issued on May 22, 2012 to Kenneth Arden Eliasen, for a reduced volume reservoir insert for an infusion port.

[0020] US Patent No. 8,262,629 issued on September 11, 2012 to Oster et al. for a catheter port.

[0021] U.S. Patent No. 8,337,464, issued on December 25, 2012 to Young et al., for vascular access ports and related methods.

[0022] US Patent No. 8,377,014 issued on February 19, 2013 to Jean-Paul Ricol for an implantable site for a cannula having a plurality of perforations.

[0023] U.S. Patent No. 8,398,577, issued on March 19, 2013 to Daniel R. Burnett, for an implantable fluid management device for releasing excess fluid.

[0024] U.S. Patent No. 8,608,728, issued on December 17, 2013 to Michels et al., for an infusion system and method.

[0025] U.S. Patent No. 8,708,979, issued on April 29, 2014 to Honaryar et al., for an implantable coupling device.

[0026] US Patent No. 8,852,160 issued on October 7, 2014 to Schweikert et al. for a venous access port with molded and / or radiopaque markers.

[0027] U.S. Patent No. 8,852,217 issued on October 7, 2014 to Woodruff et al. for an implantable injection port with a tissue ingrowth promoter.

[0028] U.S. Patent No. 8,858,514, issued on October 14, 2014 to Pierre Sarradon, for an internal device for injecting and sampling fluids in a living organism.

[0029] U.S. Patent No. 8,876,788, issued on November 4, 2014 to Bradley J. Glenn, for a stable implantable vascular access port.

[0030] U.S. Patent No. 8,882,728, issued on November 11, 2014 to Harders et al., for an implantable injection port.

[0031] US Patent No. 8,926,573 issued on January 6, 2015 to Smith et al. for implantable access port.

[0032] U.S. Patent No. 8,932,271, issued on January 13, 2015 to Hamatake et al., for an implantable medical device including a diaphragm-based indicator.

[0033] US Patent No. 8,974,422 issued on March 10, 2015 to Gill et al. for a neurological device including a transdermal drug delivery device.

[0034] US Patent No. 9,033,931 issued on May 19, 2015 to Young et al. for a subcutaneous vascular access port with attachment features.

[0035] U.S. Patent No. 9,174,037, issued on November 3, 2015 to Schutz et al., for implantable access port.

[0036] U.S. Patent No. 9,295,809, issued to Kevin W. Sheetz on March 29, 2016, for fixation and protection of implantable medical devices.

[0037] U.S. Patent No. 9,415,187, issued to Charles W. Agnew on August 16, 2016, for dialysis catheters.

[0038] U.S. Patent No. RE44639, issued to Rafael P. Squitieri on December 10, 2013, for hemodialysis and vascular drug delivery systems.

[0039] US Patent Application Publication No. 2011 / 0125129, issued May 26, 2011 to Mark A. Saab, for a medical device with an adjustable tissue ingrowth cuff.

[0040] However, the prior art fails to teach, disclose or even indicate the limitations of the claimed invention.

[0041] Other patents that are closest to the described subject matter have many more or less complex functions that cannot be solved in an economical and effective manner. None of the above patents reflect the novel functions of this invention. Summary of the invention

[0042] The present invention is an access assembly for hemodialysis drug delivery, comprising an intravascular tube assembly, a catheter assembly, a first and a second catheter sleeve assembly, and a first and a second catheter sleeve assembly.

[0043] The intravascular tube assembly includes an intravascular tube, a subcutaneous cuff, a tube end and a ring with a hole. The catheter assembly includes a first and a second catheter each having a first and a second catheter thread. The catheter assembly also includes a first and a second tube end each having a first and a second septum. The first and second catheters are connected within the intravascular tube and extend therefrom together until a bifurcation, whereby the first and second catheters are separated.

[0044] The first and second catheter sleeve assemblies include first and second foldable sidewalls, first and second ends, and first and second connecting ends. The first and second foldable sidewalls define corresponding first and second cavities, and first and second couplers are respectively defined in the first and second cavities and extend from the first and second engaging ends, respectively. The first and second couplers include first and second external threads and first and second internal threads, respectively.

[0045] The first and second conduit assemblies include first and second conduit sidewalls, respectively, including respective first and second inlet / outlet ports and respective first and second inner ends. The first and second conduit assemblies also include respective first and second fasteners, which have respective first and second fastener internal threads. The first and second conduit assemblies also include respective first and second conduit external threads. The first and second conduit sidewalls include a plurality of holes extending from the first and second inner ends, respectively.

[0046] The endovascular tube is implanted in the vascular structure. The ring is surgically secured to the patient through the hole. The first and second couplers are located on the corresponding first and second catheters, whereby the respective first and second internal threads are screwed onto the corresponding first and second catheter threads. The first and second catheter sidewalls are located on the inner side of the first and second foldable sidewalls, respectively. The first and second foldable sidewalls are folded until the corresponding first and second fasteners are screwed onto the corresponding first and second external threads of the first and second couplers.

[0047] The first and second conduit side walls extend within the first and second conduits, respectively, and both extend a predetermined length from the tube ends to thereby emerge from the plurality of holes in the intravascular tube.

[0048] Therefore, one of the main objects of the present invention is to provide an access assembly for hemodialysis drug delivery.

[0049] Another object of the present invention is to provide an access assembly for hemodialysis drug delivery having a single intravascular tube.

[0050] Another object of the present invention is to provide an access assembly having a catheter hub assembly with collapsible side walls.

[0051] Another object of the present invention is to provide an access assembly that can be used for chemotherapy infusions, long-term antibiotic therapy, and any other long-term therapy.

[0052] Another object of the present invention is to provide an access assembly that is durable and reliable in structure.

[0053] Another object of the present invention is to provide such a device which is inexpensive to manufacture and maintain while maintaining its effectiveness.

[0054] Further objects of the present invention will appear in the following portion of the specification, wherein the detailed description is for the purpose of fully disclosing the present invention without imposing limitations. BRIEF DESCRIPTION OF THE DRAWINGS

[0055] In view of the foregoing and other related objects, the present invention, including the details of construction and combination of parts, will be more fully understood from the following description when read in conjunction with the accompanying drawings, in which:

[0056] Figure 1 is a first isometric view of the present invention

[0057] Figure 2 A second isometric view of the present invention wherein a first catheter assembly is within a first catheter hub assembly connected to a first catheter.

[0058] Figure 3 is a third isometric view of the present invention with the first catheter-hub assembly collapsed and the first catheter assembly extended through the first catheter and the second catheter assembly within the second catheter-hub assembly connected to the second catheter.

[0059] Figure 4 is along Figure 1 A cross-sectional view of the first catheter assembly taken along line 4-4 as seen in FIG.

[0060] Figure 5 is along Figure 1 A cross-sectional view of the second catheter sleeve assembly taken along line 5-5 as seen in FIG.

[0061] Figure 6 is along Figure 1 A cross-sectional view of the second catheter taken along line 6-6 as seen in FIG.

[0062] Figure 7 is along Figure 3 A cross-sectional view taken along line 7-7 as seen in FIG. DETAILED DESCRIPTION

[0063] Referring now to the drawings, the present invention is an access assembly for hemodialysis drug delivery, generally indicated by the numeral 10. It can be seen that it basically includes an intravascular tube assembly 20, a catheter assembly 40, first and second catheter hub assemblies 60, and first and second catheter assemblies 90.

[0064] like Figure 1 and 2 As shown, the intravascular tube assembly 20 includes an intravascular tube 22 , a subcutaneous cuff 24 , a tube end 26 , and a ring 30 with a hole 32 .

[0065] The intravascular tube 22 is implanted within the patient's vascular structure, which is not shown, wherein the intravascular tube 22 is a vascular access device for passing a large amount of fluid including blood through an extracorporeal circuit during the patient's hemodialysis process. The subcutaneous cuff 24 is made of a porous material that allows tissue ingrowth to adhere the subcutaneous cuff 24 to the patient's subcutaneous tissue, which is not shown. In a more preferred embodiment, the ring 30 is surgically secured to the patient's skin through the hole 32 with sutures. This secures the intravascular tube assembly 20 to the patient's body.

[0066] The catheter assembly 40 includes a first catheter 42 having catheter threads 50 and a second catheter 44 having catheter threads 52. The catheter assembly 40 also includes a first end 46 having a septum 54 and a second end 48 having a septum 56.

[0067] The first and second catheters 42 and 44 are positioned within the intravascular tube 22 to allow the first and second catheter assemblies 90 to enter the vascular structure. In a more preferred embodiment, the first and second catheter assemblies 90 are disposable.

[0068] The first and second catheters 42 and 44 are connected within the intravascular tube 22 and extend therefrom together until a bifurcation, whereby the first catheter 42 and the second catheter 44 separate. In addition, the first and second catheters 42 and 44 protrude from the patient's body, whereby they extend from the ring 30. When the corresponding catheter assembly 90 is removed from the catheters 42 and 44, respectively, the septums 54 and 56 respectively keep the first and second ends 46 and 48 relatively closed.

[0069] The first and second cannula assemblies 60 each include a foldable sidewall 62 having an end 64 and a coupling end 66. The first and second catheter assemblies 90 each include a sidewall 92 having an inlet / outlet end 100. The sidewall 92 each includes an inner end 96 and a plurality of holes 98 extending therefrom, and the plurality of holes 98 do not reach the inlet / outlet end 100. The plurality of holes 98 are small perforations that allow fluid, medicine and / or blood to be delivered or returned to the patient during the hemodialysis process. The inlet / outlet end 100 serves as an inlet or outlet port through which fluid, medicine and / or blood pass during the hemodialysis process. When the first inlet / outlet end 100 serves as an inlet port, the second inlet / outlet end 100 serves as an outlet port, and vice versa.

[0070] like Figure 3 As shown, the first and second catheter assemblies 90 are positioned within the first and second catheter hub assemblies 60, whereby the respective catheter sidewalls 92 are located within the respective foldable sidewalls 62. The foldable sidewalls 62 are folded so that the fasteners 104 are attached to the respective foldable sidewalls 62. Figure 7 The foldable side wall 62 is made of a suitable material to allow the foldable side wall 62 to fold.

[0071] In the illustrated embodiment, the first catheter sidewall 92 passes through the catheter 42 and extends a predetermined length from the tube end 26, whereby the first plurality of holes 98 are exposed from the intravascular tube 22 to access the vascular structure, which is not shown. Although not shown, it should be noted that in use, the second catheter sidewall 92 passes through the corresponding catheter 44 to also extend a predetermined length from the tube end 26, and the second plurality of holes 98 are also exposed from the intravascular tube 22 to access the vascular structure.

[0072] The catheter assembly 90 is made of a biologically inert polymeric silicone material, which is commonly used for temporary implants in tissues. In a more preferred embodiment, the catheter assembly 90 can be made of a flexible and inert silicone elastomer, such as the trademark of the flexible and inert silicone elastomer is Catheter assembly 90 may include markings that allow a technician to know when to stop flushing with heparin, which is a blood thinner.

[0073] like Figure 4 As shown, the catheter assembly 90 includes a fastener 104 having an internal fastener thread 106. The internal fastener thread 106 is inside the fastener 104 to thread the fastener 104 into the coupler 76. Figure 7 The external threads 72 are shown. The catheter assembly 90 also includes external catheter threads 102. The external catheter threads 102 extend from the fastener 104 to the inlet / outlet end 100 to connect to an external tube for connection to a hemodialysis machine, which is not shown.

[0074] like Figure 5 As shown, the foldable sidewall 62 of the catheter hub assembly 60 defines a cavity 70. A coupler 76 is defined within the cavity 70 extending from the coupling end 66. The coupler 76 includes a coupling end 68, an external thread 72, an outer surface 73, an internal thread 74, and an inner surface 75. The external thread 72 is located on the outer surface 73 near the coupling end 68, and the internal thread 74 is located on the inner surface 75 near the coupling end 66.

[0075] like Figure 6 As shown, the catheter assembly 40 includes a catheter 44 having an end 48 and catheter threads 52. The catheter threads 52 receive corresponding internal threads 74 of a coupler 76, such as Figure 7 shown.

[0076] like Figure 7 As shown, the first conduit sidewall 92 passes through the conduit 42. The first foldable sidewall 62 is folded until the first fastener 104 is connected to the first coupler 76, whereby the first fastener internal thread 106 is screwed to the first external thread 72. The first coupler 76 is connected to the corresponding conduit 42, whereby the corresponding internal thread 74 is screwed to the conduit thread 50. It should be noted that when the second conduit sidewall 92 passes through the conduit 44, the second foldable sidewall 62 is also folded until the second fastener 104 is connected to the second coupler 76, whereby the second fastener internal thread 106 is screwed to the second external thread 72. The second coupler 76 is connected to the corresponding conduit 44, whereby the corresponding internal thread 74 is screwed to the conduit thread 52.

[0077] In other embodiments, the present invention 10 provides an access assembly that can also be used for chemotherapy infusions, long-term antibiotic therapy, infusions, and / or other treatments.

[0078] The foregoing description shows the best understanding of the purpose and advantages of the present invention. Different embodiments can be made to the inventive concept of the present invention. It should be understood that all contents disclosed herein are interpreted only as illustrative, not restrictive.

[0079] Industrial availability

[0080] Clearly, the access assembly claimed in the present application, such as for hemodialysis drug delivery, is highly desirable because it has a single intravascular tube, catheter cannula assembly having collapsible sidewalls. The present invention is highly desirable because it can be used for chemotherapy infusions, long-term antibiotic therapy, or any other long-term treatment. The access assembly has a durable and reliable structure that is inexpensive to manufacture and maintain while maintaining its effectiveness.

Claims

1. An access assembly for hemodialysis drug delivery, comprising: A) The intravascular tube assembly includes an intravascular tube, a subcutaneous cuff, a tube end, and a ring with holes; B) the catheter assembly comprises a first catheter and a second catheter, the first catheter having a first catheter thread, and the second catheter having a second catheter thread; C) a first catheter sleeve assembly and a second catheter sleeve assembly, the first catheter sleeve assembly comprising a first foldable side wall, a first end, a corresponding first coupling end, and a first coupler, and the second catheter sleeve assembly comprising a second foldable side wall, a second end, a corresponding second coupling end, and a second coupler; the first foldable side wall defines a corresponding first cavity, and the second foldable side wall defines a corresponding second cavity; the first coupler and the second coupler are defined in the first cavity and the second cavity, respectively extending from the first coupling end and the second coupling end, and the first coupler comprises a first external thread and a first internal thread, and the second coupler comprises a second external thread and a second internal thread, and D) a first catheter assembly and a second catheter assembly, wherein the first catheter assembly includes a first fastener and the second catheter assembly includes a second fastener; in, The first coupler and the second coupler are respectively located on the first conduit and the second conduit, whereby the corresponding first internal thread and the second internal thread are screwed onto the corresponding first conduit thread and the second conduit thread, and the first foldable side wall and the second foldable side wall are folded until the corresponding first fastener and the second fastener are screwed onto the corresponding first external thread and the second external thread of the first coupler and the second coupler.

2. The access assembly for hemodialysis drug delivery according to claim 1, characterized in that: The first conduit includes a first end and the second conduit includes a second end, the first end having a first septum and the second end having a second septum.

3. The access assembly for hemodialysis drug delivery according to claim 1, characterized in that: The first and second catheters are connected within the intravascular tube and extend together therefrom to a junction whereby the first and second catheters are separated.

4. The access assembly for hemodialysis drug delivery according to claim 1, characterized in that: The first catheter assembly includes a first catheter side wall, and the second catheter assembly includes a second catheter side wall.

5. The access assembly for hemodialysis drug delivery according to claim 4, characterized in that: The first catheter side wall includes a first inlet / outlet end and a first inner end, and the second catheter side wall includes a second inlet / outlet end and a second inner end.

6. The access assembly for hemodialysis drug delivery according to claim 1, characterized in that: The first catheter assembly includes a first fastener internal thread and a first catheter external thread, and the second catheter assembly includes a second fastener internal thread and a second catheter external thread.

7. The access assembly for hemodialysis drug delivery according to claim 5, characterized in that: The first catheter side wall includes a plurality of holes extending from the first inner end, and the second catheter side wall includes a plurality of holes extending from the second inner end.

8. The access assembly for hemodialysis drug delivery according to claim 1, characterized in that: The intravascular tube is implanted within a vascular structure.

9. The access assembly for hemodialysis drug delivery according to claim 1, characterized in that: The ring is surgically secured to the patient through the hole.

10. The access assembly for hemodialysis drug delivery according to claim 4, characterized in that: The first catheter side wall and the second catheter side wall are respectively located within the first foldable side wall and the second foldable side wall.

11. The access assembly for hemodialysis drug delivery according to claim 7, characterized in that: The first catheter side wall and the second catheter side wall extend within the respective first and second catheters and both extend a predetermined length from the tube ends, whereby the plurality of holes are exposed from the intravascular tube.

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