External nephrostomy tube holders and methods of use thereof

Abstract

A nephrostomy tube anchor comprising: (a) a base plate with at least two semicircular tube holders raised above an upper surface of the base plate by at least a diameter of the tube; and (b) a cover configured to engage and retain said base plate, said cover including at least two semicircular tube holders positioned to complement the tube holders in said base plate.

Description

[0001] TITLE: EXTERNAL NEPHROSTOMY TUBE HOLDERS AND METHODS OF USE THEREOF

[0002] RELATED APPLICATIONS:

[0003] This PCT application claims priority from Israeli application 305765 filed on September, 7, 2023 which has the same title and inventor(s) as the present application and is fully incorporated by reference.

[0004] FIELD OF THE INVENTION

[0005] The invention is in the field of mechanical medical devices and related methods of manufacture and use.

[0006] BACKGROUND OF THE INVENTION

[0007] Numerous medical conditions cause blockage of a flow of urine from the kidney(s) to the urinary bladder. Nephrostomy tube insertion is a percutaneous procedure that diverts the urine from the intrarenal collecting system (the renal pelvis) via a special tube (Nephrostomy tube) to an external urinary collecting bag. This procedure is widely performed by Interventional Radiologists or, urologists worldwide.

[0008] The percutaneous procedure is performed under imaging guidance: Ultrasound and X- ray fluoroscopy. The renal pelvis is punctured and after targeting the collecting system contrast media is injected to visualize the collecting system (antegrade pyelography) . Via the small needle, in a Seidinger technique a nephrostomy tube is placed in an appropriate position to allow drainage.

[0009] Medical conditions that may cause a need for a nephrostomy include, but are not limited to cancers that blocks the ureters, (metastatic or locally advanced tumors such as , colon cancer), pyonephrosis, hydronephrosis, and kidney stones.

[0010] If a blockage keeps urine from passing from the kidneys (through the ureter and into the urinary bladder) occurs, pressure rises rise within the urinary system. This pressure has the potential to damage the kidneys. Thus, the purpose of a nephrostomy tube insertion is to relieve the pressure or to drain the infection. SUMMARY OF THE INVENTION

[0011] One aspect of some embodiments of the invention relates to a nephrostomy tube anchor that engages and retains a portion of a nephrostomy tube that is outside the body of a patient. In some exemplary embodiments of the invention, the anchor isolates a portion of a nephrostomy tube that is inside the body of the patient (proximal to the anchor; i.e. between the anchor and the kidney) from tension applied to a portion of the nephrostomy tube that is outside distal to the anchor.

[0012] Another aspect of some embodiments of the invention relates to prevention of relative motion of the anchor and the nephrostomy tube with respect to one another. In some exemplary embodiments of the invention, a channel in the anchor snugly accommodates a portion of the nephrostomy tube. In some embodiments the channel has the shape of at least a portion of a loop.

[0013] An additional aspect of some embodiments of the invention relates to an adhesive pad that adheres the anchor at a fixed location on the patient's skin.

[0014] A further additional aspect of some embodiments of the invention relates to an overall thickness of the anchor which approaches twice the diameter of the nephrostomy tube. In some embodiments this reduced thickness contributes to an increase in patient comfort (e.g. when lying on the back or sitting in a chair with a backrest).

[0015] It will be appreciated that the various aspects described above relate to solution of technical problems associated with unwanted removal of a nephrostomy tube.

[0016] It will be appreciated that the various aspects described above relate to solution of technical problems associated with unwanted linear motion of a nephrostomy tube with respect to a device engaging the tube.

[0017] Alternatively or additionally, it will be appreciated that the various aspects described above relate to solution of technical problems related to reducing patient discomfort while a nephrostomy tube is in place.

[0018] In some exemplary embodiments of the invention there is provided a nephrostomy tube anchor including: (a) a base plate with at least two semicircular tube holders raised above an upper surface of the base plate by at least a diameter of the tube; and (b) a cover configured to engage and retain the base plate, the cover including at least two semicircular tube holders positioned to complement the tube holders in the base plate. In some embodiments the anchor includes two curved channels on the base plate, the channels sized to engage and retain the tube. Alternatively or additionally, in some embodiments a tube engaged by the tube holders and the channels describes a loop, with a portion of the loop passing between and below a portion of the tube engaged by the at least two semicircular tube holders raised above an upper surface of the base plate. Alternatively or additionally, in some embodiments the anchor includes a hinge connecting the base plate and the cover. Alternatively or additionally, in some embodiments the anchor includes a latch mechanism configured to secure the cover in a closed position relative to the base plate. Alternatively or additionally, in some embodiments the anchor includes an adhesive backing on an exterior surface of the base plate.

[0019] In some exemplary embodiments of the invention there are provided molds for the preparation of a nephrostomy tube anchor as set forth hereinabove.

[0020] In some exemplary embodiments of the invention there is provided a method including: (a) inserting a portion of a nephrostomy tube into two semicircular tube holders raised above an upper surface of a base plate ; and (b) inserting additional portions of the nephrostomy tube into two curved channels on the base plate so that the additional portions are engaged and retained in the curved channels and so that a portion of the nephrostomy tube passes between and below the two semicircular tube holders. In some embodiments the method includes covering the base plate with a cover that engages and retains the base plate and brings at least two semicircular tube holders into proximity with the tube holders in the base plate to form closed loops that hold a section of tube above the base plate. Alternatively or additionally, in some embodiments the method includes folding a hinge connecting the cover and the base plate. Alternatively or additionally, in some embodiments the method includes securing the cover to the base plate with a latch mechanism. Alternatively or additionally, in some embodiments the method includes affixing the base plate to a skin surface of a patient.

[0021] In some exemplary embodiments of the invention there is provided a nephrostomy tube anchor including: (a) a base plate with at least three tube holders shaped to accommodate more than half of the circumference of the tube; and (b) a cover configured to engage and retain the base plate. In some embodiments the at least three tube holders are in a linear arrangement. Alternatively or additionally, in some embodiments the anchor includes holes at an edge of the base plate. Alternatively or additionally, in some embodiments the anchor includes a hinge connecting the base plate and the cover. Alternatively or additionally, in some embodiments the anchor includes a latch mechanism configured to secure the cover in a closed position relative to the base plate. Alternatively or additionally, in some embodiments the anchor includes an adhesive backing on an exterior surface of the base plate. Alternatively or additionally, in some embodiments the anchor includes gel pads on an exterior surface of the base plate. Alternatively or additionally, in some embodiments the anchor includes adhesive wings engaged by closure of the cover on the base plate, the wings extending beyond a circumference of the base plate. Alternatively or additionally, in some embodiments the anchor includes holes in the adhesive wings through which the tube holders pass.

[0022] In some exemplary embodiments of the invention there are provided molds for the preparation of a nephrostomy tube anchor as described above.

[0023] In some exemplary embodiments of the invention there is provided a method comprising: (a) inserting a portion of a nephrostomy tube into at least three tube holders on an upper surface of a base plate ; and (b) covering the base plate with a cover that engages and retains the base plate. In some embodiments the method includes folding a hinge connecting the cover and the base plate. Alternatively or additionally, in some embodiments the method includes securing the cover to the base plate with a latch mechanism. Alternatively or additionally, in some embodiments the method includes affixing the base plate to a skin surface of a patient.

[0024] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although suitable methods and materials are described below, methods and materials similar or equivalent to those described herein can be used in the practice of the present invention. In case of conflict, the patent specification, including definitions, will control. All materials, methods, and examples are illustrative only and are not intended to be limiting.

[0025] As used herein, the terms "comprising" and "including" or grammatical variants thereof are to be taken as specifying inclusion of the stated features, integers, actions or components without precluding the addition of one or more additional features, integers, actions, components or groups thereof. This term is broader than, and includes the terms "consisting of" and "consisting essentially of" as defined by the Manual of Patent Examination Procedure of the United States Patent and Trademark Office. Thus, any recitation that an embodiment "includes" or "comprises" a feature is a specific statement that sub embodiments "consist essentially of" and / or "consist of" the recited feature. The phrase "consisting essentially of" or grammatical variants thereof when used herein are to be taken as specifying the stated features, integers, steps or components but do not preclude the addition of one or more additional features, integers, steps, components or groups thereof but only if the additional features, integers, steps, components or groups thereof do not materially alter the basic and novel characteristics of the claimed composition, device or method.

[0026] The phrase "adapted to" as used in this specification and the accompanying claims imposes additional structural limitations on a previously recited component.

[0027] The term "method" refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of architecture and / or computer science.

[0028] BRIEF DESCRIPTION OF THE DRAWINGS

[0029] In order to understand the invention and to see how it may be carried out in practice, embodiments will now be described, by way of non-limiting example only, with reference to the accompanying figures. In the figures, identical and similar structures, elements or parts thereof that appear in more than one figure are generally labeled with the same or similar references in the figures in which they appear. Dimensions of components and features shown in the figures are chosen primarily for convenience and clarity of presentation and are not necessarily to scale. The attached figures are:

[0030] Fig. 1A is a top perspective view of a nephrostomy tube anchor according to an exemplary embodiment of the invention in an open position;

[0031] Fig. IB is a top perspective view of a nephrostomy tube anchor as in Fig. 1A in a closed position with a nephrostomy tube installed;

[0032] Fig. 2A is a perspective view of a nephrostomy tube anchor as in Fig. 1A in transition to a closed position;

[0033] Fig. 2B is a top perspective view of a nephrostomy tube anchor as in Fig. 1A in an open position with a nephrostomy tube installed;

[0034] Fig. 3 is a simplified flow diagram of a method according to some embodiments of the invention;

[0035] Fig. 4A is a top perspective view of a nephrostomy tube anchor according to another exemplary embodiment of the invention in an open position; Fig. 4B is a top perspective view of a nephrostomy tube anchor as in Fig. 4A in an open position with a nephrostomy tube installed;

[0036] Fig. 4C is a perspective view of a nephrostomy tube anchor as in Fig. 4A in an open position with a nephrostomy tube installed;

[0037] Fig. 5 is a simplified flow diagram of a method according to some additional embodiments of the invention;

[0038] Fig. 6A is a bottom perspective view of a nephrostomy tube anchor according to an exemplary embodiment of the invention in an open position with a nephrostomy tube installed;

[0039] Fig. 6B is a top view of a nephrostomy tube anchor as in Fig. 6A in an open position with a nephrostomy tube installed; and

[0040] Fig. 6C is an exploded view of a nephrostomy tube anchor as in Fig. 6A and Fig. 6B illustrating installation of adhesive wings.

[0041] DETAILED DESCRIPTION OF EMBODIMENTS

[0042] Embodiments of the invention relate to a nephrostomy tube anchor, molds for production of such anchors and methods for their use. Specifically, some embodiments of the invention can be used to reduce the likelihood that a patient will remove a nephrostomy tube (whether accidentally or intentionally) by a portion of the tubing to the patient's skin using an anchor attached to the tubing.

[0043] The principles and operation of a nephrostomy tube anchor, molds for production of such anchors and methods for their use according to exemplary embodiments of the invention may be better understood with reference to the drawings and accompanying descriptions.

[0044] Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details set forth in the following description or exemplified by the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.

[0045] Exemplary anchor device

[0046] Fig. 1A is a top perspective view of a nephrostomy tube anchor device, indicated generally as 100, according to an exemplary embodiment of the invention in an open position.

[0047] Fig. 2A is a perspective view of a nephrostomy tube anchor device as in Fig. 1A in transition to a closed position indicated generally as 101. Some embodiments of the invention relate to a nephrostomy tube anchor (e.g. 100; 101). In the depicted embodiment, the anchor includes a base plate 110 with at least two semicircular tube holders 112; 114. In the depicted embodiment, the tube holders are raised above an upper surface 116 of base plate 110 by at least a diameter of the tube. This height permits installation of the tube in holders 112 and 114 and formation of a loop with a portion of the tube passing below and between holders 112 and 114 on upper surface 116 of baseplate 10.

[0048] In the depicted embodiment, the anchor device includes a cover 120 configured to engage and retain base plate 110. In some exemplary embodiments of the invention, cover 120includes at least two semicircular tube holders 122 and 124 positioned to complement the tube holders 112 and 114 in base plate 110. According to this embodiment, when cover 120 engages base plate 110, the tube holders 112;122 and 114;124 form closed loops that hold a section of tube above the base plate. This arrangement contributes to a reduction of a tendency of the tube and anchor to move linearly with respect to one another.

[0049] In the depicted embodiment, the anchor device includes two curved channelsl30 and 140 on base plate 110. In some embodiments the channels are sized to engage and retain the tube.

[0050] In some embodiments a tube engaged by the tube holders (e.g. 112;122; 114; and 124) and the channels (e.g. 130 and 140) describes a loop, with a portion of the loop passing between and below a portion of the tube engaged by tube holders 112 and 114 raised above an upper surface 116 of the base plate.

[0051] In the depicted embodiment, the anchor device includes a hinge 150 connecting base plate 110 and cover 120. Alternatively or additionally, in some embodiments the anchor device includes a latch mechanism (e.g. 160 and 162) configured to secure cover 120 in a closed position relative to base plate 110.

[0052] In some exemplary embodiments of the invention, the anchor device includes an adhesive backing (not visible in the figures) on an exterior surface of base plate 110. In some embodiments the adhesive backing is provided as a pad fastened to the base plate. In some embodiments the pad has a larger area than the base plate. In some embodiments an increase in an area of the pad contributes to an increase of strength of attachment of the device to the skin.

[0053] Fig. IB is a top perspective view of a nephrostomy tube anchor as in Fig. 1A in a closed position with a nephrostomy tube installed indicated generally as 103. One end 99 of the nephrostomy tube is held in a substantially linear alignment with a distal port 97 of the nephrostomy tube.

[0054] Fig. 2B is a top perspective view of a nephrostomy tube anchor as in Fig. 1A in an open position with a nephrostomy tube installed indicated generally as 105. In this view engagement of the nephrostomy tube by 112, 114, 130 and 140, and the resultant loop formation, is visible. Note that one portion of the tube passes below another portion between 112 and 114.

[0055] In some exemplary embodiments of the invention, when the nephrostomy tube is installed in the anchor device as described, there is substantially no linear translation of the tube with respect to the device.

[0056] Exemplary method of use

[0057] Fig. 3 is a simplified flow diagram of a method, indicated generally as 200, of using a nephrostomy tube anchor according to some embodiments of the invention.

[0058] Depicted exemplary method 200 includes inserting 210 a portion of a nephrostomy tube into two semicircular tube holders raised above an upper surface of a base plate and inserting 220 additional portions of said nephrostomy tube into two curved channels on the base plate so that the additional portions are engaged and retained in the curved channels and so that a portion of said nephrostomy tube passes between and below said two semicircular tube holders. These actions form a loop of tubing held to baseplate 110.

[0059] In some exemplary embodiments of the invention, the method includes covering 230 the base plate with a cover that engages and retains the base plate and brings at least two semicircular tube holders into proximity with the tube holders in the base plate to form closed loops that hold a section of tube above the base plate. This action fixes one portion of the loop of in a fixed position relative to baseplate 110.

[0060] In some exemplary embodiments of the invention, the method includes folding 240 a hinge connecting the cover and the base plate. In some embodiments the method includes securing 250 the cover to the base plate with a latch mechanism. These actions further secure the loop of tubing to the device.

[0061] In some exemplary embodiments of the invention, method 200 includes affixing 260 said base plate to a skin surface of a patient. This action anchors the loop of tubing to a fixed location on the patient's skin. According to various exemplary embodiments of the invention affixing 260 includes suturing and / or gluing.

[0062] Additional exemplary anchor device Fig. 4A is a top perspective view of a nephrostomy tube anchor, indicated generally as 400, according to another exemplary embodiment of the invention in an open position.

[0063] Fig. 4B is a top perspective view of a nephrostomy tube anchor as in Fig. 4A, indicated generally as 401, in an open position with a nephrostomy tube installed.

[0064] Fig. 4C is a perspective view of a nephrostomy tube anchor as in Fig. 4A in an open position with a nephrostomy tube installed indicated generally as 403.

[0065] In the depicted embodiment, the nephrostomy tube anchor includes a base plate 410 with at least three tube holders (e.g. 412, 414 and 416). In the depicted embodiment, the tube holders are in a linear arrangement. In some exemplary embodiments of the invention, each tube holder is shaped to accommodate more than half of the circumference of the tube. In some embodiments this configuration contributes to a reduction in linear motion of the tube with respect to the holders after installation. In the depicted embodiment, the anchor also includes a cover 420 configured to engage and retain the base plate. In some exemplary embodiments of the invention, the nephrostomy tube anchor includes holes 470 at an edge of base plate 410. In the depicted embodiment, the holes are distributed about a circumference of base plate 410. In some exemplary embodiments of the invention, holes 470 contribute to an ability to suture base plate 410 to the skin. In the depicted embodiment, the anchor includes a hinge connecting said base plate and said cover. In some exemplary embodiments of the invention, the anchor includes a latch mechanism (e.g. 460 and 462) configured to secure cover 420 in a closed position relative to base plate 410. Alternatively or additionally, in some embodiments the anchor includes an adhesive backing on an exterior surface of base plate 410.

[0066] In some exemplary embodiments of the invention, when the nephrostomy tube is installed in the anchor device as described, there is substantially no linear translation of the tube with respect to the device.

[0067] Fig. 6A is a bottom perspective view, indicated generally as 600, of a nephrostomy tube anchor according to an exemplary embodiment of the invention in an open position with a nephrostomy tube installed.

[0068] Fig. 6B is a top view, indicated generally as 601, of a nephrostomy tube anchor as in Fig. 6A in an open position with a nephrostomy tube installed; and

[0069] Fig. 6C is an exploded view, indicated generally as 603, of a nephrostomy tube anchor as in Fig. 6A and Fig. 6B illustrating installation of adhesive wings. In each of Figs. 6A, 6B and 6C the nephrostomy tube is indicated as 599 and the cover is indicated as 620.

[0070] In the depicted embodiment, gel pads 650 are provided on an exterior surface 612 of base plate 610. In some embodiments the pads are hemispherical. In some embodiments the pads are constructed of silicon or other compressible material. In some embodiments use of gel pads 650 contributes to a reduction in pressure sores.

[0071] In the depicted embodiment, adhesive wings 660 are engaged by closure of cover 620 on base plate 610. In some embodiments wings 660 extending beyond a circumference of base plate 610. In some exemplary embodiments of the invention, wings 660 contribute to an ability to secure the anchor in a desired position on a subject's skin. In some embodiments holes 670 in adhesive wings 660 accommodate tube holders 630. In some exemplary embodiments of the invention, having tube holders 630 pass through holes 670 contributes to stability of the spatial configuration between the anchor, tube 599 and the patient's skin (via wings 660).

[0072] Additional exemplary method of use

[0073] Fig. 5 is a simplified flow diagram, indicated generally as 500, of a method according to some additional embodiments of the invention.

[0074] Depicted exemplary method 500 includes inserting 520 a portion of a nephrostomy tube into at least three tube holders on an upper surface of a base and covering 520 the base plate with a cover that engages and retains the base plate.

[0075] In some exemplary embodiments of the invention, the method includes folding 530 a hinge connecting said cover and said base plate. In some exemplary embodiments of the invention, the method includes securing 540 the cover to said base plate with a latch mechanism. In some exemplary embodiments of the invention, the method includes affixing 550 the base plate to a skin surface of a patient.

[0076] Exemplary Molds

[0077] In some exemplary embodiments of the invention, there are provide molds for the preparation of a nephrostomy tube anchor as depicted in Fig 1A and / or Fig. 2A and / or 4A.

[0078] Exemplary measurements

[0079] In some exemplary embodiments of the invention, base plate 110 and / or 410 and cover 120 and / or 420 have a diameter of 30 to 40 mm. In some embodiments the diameter is about 35 mm. (diameter and thickness; relevant tubing diameters and relevant dimensions for adhesive pads. In some exemplary embodiments of the invention, the nephrostomy tube has an outer diameter of 3.5 mm. Alternatively or additionally, in some embodiments the anchor device has a total height when closed of 6 to 9 mm, in some embodiments about 7.5 mm to 8.5 mm, In some embodiments about 7.78 mm.

[0080] Exemplary materials

[0081] According to various exemplary embodiments of the invention base 110 and / or 420 and cover 120 and / or 420 and the adhesive pads are constructed of an FDA approved plastic and / or an FDA approved silicone material.

[0082] In some exemplary embodiments of the invention, the anchor device prevents the motion of the nephrostomy tube by fixing a portion of the tube to the base (e.g. 110 and / or 410) (fit for "COOK" nephrostomy 10.2 Fr).

[0083] Alternatively or additionally, in some embodiments the device includes on an exterior surface of base (e.g. 110 and / or 410) hemispheres or discs of gel. In some exemplary embodiments of the invention, the gel contributes to a reduction in bedsores among patients to whom the device is attached.

[0084] Alternatively or additionally, in some embodiments the device includes holes 470 for suturing to the skin.

[0085] Alternatively or additionally, in some embodiments the device includes a catch for adding a sticker like wrist-watch to also stick the system to the skin.

[0086] It is expected that during the life of this patent many nephrostomy tube configurations will be developed and the scope of the invention is intended to include all such new technologies a priori.

[0087] Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0088] Specifically, a variety of numerical indicators have been utilized. It should be understood that these numerical indicators could vary even further based upon a variety of engineering principles, materials, intended use and designs incorporated into the various embodiments of the invention. Additionally, components and / or actions ascribed to exemplary embodiments of the invention and depicted as a single unit may be divided into subunits. Conversely, components and / or actions ascribed to exemplary embodiments of the invention and depicted as sub-units / individual actions may be combined into a single unit / action with the described / depicted function.

[0089] Alternatively, or additionally, features used to describe a method can be used to characterize an apparatus and features used to describe an apparatus can be used to characterize a method.

[0090] It should be further understood that the individual features described hereinabove can be combined in all possible combinations and sub-combinations to produce additional embodiments of the invention. The examples given above are exemplary in nature and are not intended to limit the scope of the invention which is defined solely by the following claims.

[0091] Each recitation of an embodiment of the invention that includes a specific feature, part, component, module or process is an explicit statement that additional embodiments of the invention not including the recited feature, part, component, module or process exist.

[0092] Alternatively or additionally, various exemplary embodiments of the invention exclude any specific feature, part, component, module, process or element which is not specifically disclosed herein.

[0093] All publications, references, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.

[0094] The terms "include", and "have" and their conjugates as used herein mean "including but not necessarily limited to".

Claims

CLAIMS:

1. A nephrostomy tube anchor comprising:(a) a base plate with at least two semicircular tube holders raised above an upper surface of the base plate by at least a diameter of the tube; and(b) a cover configured to engage and retain said base plate, said cover including at least two semicircular tube holders positioned to complement the tube holders in said base plate.

2. A nephrostomy tube anchor according to claim 1, comprising two curved channels on said base plate, said channels sized to engage and retain the tube.

3. A nephrostomy tube anchor according to claim 2, wherein a tube engaged by said tube holders and said channels describes a loop, with a portion of the loop passing between and below a portion of the tube engaged by said at least two semicircular tube holders raised above an upper surface of the base plate.

4. A nephrostomy tube anchor according to any one of claims 1 to 3, comprising a hinge connecting said base plate and said cover.

5. A nephrostomy tube anchor according to any one of claims 1 to 4, comprising a latch mechanism configured to secure said cover in a closed position relative to said base plate.

6. A nephrostomy tube anchor according to any one of claims 1 to 5, comprising an adhesive backing on an exterior surface of said base plate.

7. A method comprising:(a) inserting a portion of a nephrostomy tube into two semicircular tube holders raised above an upper surface of a base plate ; and(b) inserting additional portions of said nephrostomy tube into two curved channels on the base plate so that the additional portions are engaged and retained in the curved channels and so that a portion of said nephrostomy tube passes between and below said two semicircular tube holders.

8. A method according to claim 7, comprising: covering said base plate with a cover that engages and retains said base plate and brings at least two semicircular tube holders into proximity with the tube holders in the base plate to form closed loops that hold a section of tube above the base plate.

9. A method according to claim 8, comprising: folding a hinge connecting said cover and said base plate.

10. A method according to any one of claims 7 to 9, comprising securing said cover to said base plate with a latch mechanism.

11. A method according to any one of claims 7 to 10, comprising affixing said base plate to a skin surface of a patient.

12. Molds for the preparation of a nephrostomy tube anchor according to any one of claims I to 6.

13. A nephrostomy tube anchor comprising:(a) a base plate with at least three tube holders shaped to accommodate more than half of the circumference of the tube; and(b) a cover configured to engage and retain said base plate.

14. A nephrostomy tube anchor according to claim 13, wherein said at least three tube holders are in a linear arrangement.

15. A nephrostomy tube anchor according to claim 13 or claim 14, comprising holes at an edge of said base plate.

16. A nephrostomy tube anchor according to any one of claims 13 to 15, comprising a hinge connecting said base plate and said cover.

17. A nephrostomy tube anchor according to any one of claims 13 to 16, comprising a latch mechanism configured to secure said cover in a closed position relative to said base plate.

18. A nephrostomy tube anchor according to any one of claims 13 to 17, comprising an adhesive backing on an exterior surface of said base plate.

19. A nephrostomy tube anchor according to any one of claims 13 to 18, or any one of claims 1 to 6, comprising gel pads on an exterior surface of said base plate.

20. A nephrostomy tube anchor according to any one of claims 13 to 19, or any one of claims 1 to 6, comprising adhesive wings engaged by closure of said cover on said base plate, said wings extending beyond a circumference of said base plate.

21. A nephrostomy tube anchor according to claim 20, comprising holes in said adhesive wings through which said tube holders pass.

22. A method comprising:(a) inserting a portion of a nephrostomy tube into at least three tube holders on an upper surface of a base plate ; and(b) covering said base plate with a cover that engages and retains said base plate.

23. A method according to claim 22, comprising: folding a hinge connecting said cover and said base plate.

24. A method according to claim 22, comprising: securing said cover to said base plate with a latch mechanism.

25. A method according to claim 22, comprising: affixing said base plate to a skin surface of a patient.

26. Molds for the preparation of a nephrostomy tube anchor according to any one of claims13 to 19.

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