IL305765B2

IL305765B2 - External nephrostomy tube holders and methods of use thereof

Info

Publication number: IL305765B2
Application number: IL305765A
Authority: IL
Inventors: Elrom Kfir; Konstantinovsky Yevgeny
Original assignee: Cathetrix Ltd; Elrom Kfir; Konstantinovsky Yevgeny
Priority date: 2023-09-07
Filing date: 2023-09-07
Publication date: 2025-05-01
Also published as: WO2025052374A1; IL305765A; IL305765B1

Description

IL 305765/2 TITLE: EXTERNAL NEPHROSTOMY TUBE HOLDERS AND METHODS OF USE THEREOF FIELD OF THE INVENTION The invention is in the field of mechanical medical devices and related methods ofmanufacture and use. 5 BACKGROUND OF THE INVENTION Numerous medical conditions cause blockage of a flow of urine from the kidney(s) tothe urinary bladder. Nephrostomy tube insertion is a percutaneous procedure that diverts theurine from the intrarenal collecting system (the renal pelvis) via a special tube (Nephrostomy 10tube) to an external urinary collecting bag. This procedure is widely performed byInterventional Radiologists or, urologists worldwide.The percutaneous procedure is performed under imaging guidance: Ultrasound and X-ray fluoroscopy. The renal pelvis is punctured and after targeting the collecting systemcontrast media is injected to visualize the collecting system (antegrade pyelography) . Via the 15small needle, in a Seldinger technique a nephrostomy tube is placed in an appropriate positionto allow drainage.Medical conditions that may cause a need for a nephrostomy include, but are notlimited to cancers that blocks the ureters, (metastatic or locally advanced tumors such as,colon cancer), pyonephrosis, hydronephrosis, and kidney stones. 20If a blockage keeps urine from passing from the kidneys (through the ureter and intothe urinary bladder) occurs, pressure rises rise within the urinary system. This pressure has thepotential to damage the kidneys. Thus, the purpose of a nephrostomy tube insertion is torelieve the pressure or to drain the infection. SUMMARY OF THE INVENTION One aspect of some embodiments of the invention relates to a nephrostomy tubeanchor that engages and retains a portion of a nephrostomy tube that is outside the body of apatient. In some exemplary embodiments of the invention, the anchor isolates a portion of anephrostomy tube that is inside the body of the patient (proximal to the anchor; i.e. between 30the anchor and the kidney) from tension applied to a portion of the nephrostomy tube that isoutside distal to the anchor.

IL 305765/2 Another aspect of some embodiments of the invention relates to prevention ofrelative motion of the anchor and the nephrostomy tube with respect to one another. In someexemplary embodiments of the invention, a channel in the anchor snugly accommodates aportion of the nephrostomy tube. In some embodiments the channel has the shape of at leasta portion of a loop. 5An additional aspect of some embodiments of the invention relates to an adhesive padthat adheres the anchor at a fixed location on the patient’s skin.A further additional aspect of some embodiments of the invention relates to an overallthickness of the anchor which approaches twice the diameter of the nephrostomy tube. Insome embodiments this reduced thickness contributes to an increase in patient comfort (e.g. 10when lying on the back or sitting in a chair with a backrest).It will be appreciated that the various aspects described above relate to solution oftechnical problems associated with unwanted removal of a nephrostomy tube.It will be appreciated that the various aspects described above relate to solution oftechnical problems associated with unwanted linear motion of a nephrostomy tube with 15respect to a device engaging the tube.Alternatively or additionally, it will be appreciated that the various aspects describedabove relate to solution of technical problems related to reducing patient discomfort while anephrostomy tube is in place.In some exemplary embodiments of the invention there is provided a nephrostomy 20tube anchor including: (a) a base plate with at least two semicircular tube holders raised abovean upper surface of the base plate by at least a diameter of the tube; and (b) a coverconfigured to engage and retain the base plate, the cover including at least two semicirculartube holders positioned to complement the tube holders in the base plate. In someembodiments the anchor includes two curved channels on the base plate, the channels sized 25to engage and retain the tube. Alternatively or additionally, in some embodiments a tubeengaged by the tube holders and the channels describes a loop, with a portion of the looppassing between and below a portion of the tube engaged by the at least two semicirculartube holders raised above an upper surface of the base plate. Alternatively or additionally, insome embodiments the anchor includes a hinge connecting the base plate and the cover. 30Alternatively or additionally, in some embodiments the anchor includes a latch mechanismconfigured to secure the cover in a closed position relative to the base plate. Alternatively or IL 305765/2 additionally, in some embodiments the anchor includes an adhesive backing on an exteriorsurface of the base plate.In some exemplary embodiments of the invention there are provided molds for thepreparation of a nephrostomy tube anchor as set forth hereinabove.In some exemplary embodiments of the invention there is provided a method 5including: (a) inserting a portion of a nephrostomy tube into two semicircular tube holdersraised above an upper surface of a base plate ; and (b) inserting additional portions of thenephrostomy tube into two curved channels on the base plate so that the additional portionsare engaged and retained in the curved channels and so that a portion of the nephrostomytube passes between and below the two semicircular tube holders. In some embodiments the 10method includes covering the base plate with a cover that engages and retains the base plateand brings at least two semicircular tube holders into proximity with the tube holders in thebase plate to form closed loops that hold a section of tube above the base plate. Alternativelyor additionally, in some embodiments the method includes folding a hinge connecting thecover and the base plate. Alternatively or additionally, in some embodiments the method 15includes securing the cover to the base plate with a latch mechanism. Alternatively oradditionally, in some embodiments the method includes affixing the base plate to a skinsurface of a patient.In some exemplary embodiments of the invention there is provided a nephrostomytube anchor including: (a) a base plate with at least three tube holders shaped to 20accommodate more than half of the circumference of the tube; and (b) a cover configured toengage and retain the base plate. In some embodiments the at least three tube holders are ina linear arrangement. Alternatively or additionally, in some embodiments the anchor includesholes at an edge of the base plate. Alternatively or additionally, in some embodiments theanchor includes a hinge connecting the base plate and the cover. Alternatively or additionally, 25in some embodiments the anchor includes a latch mechanism configured to secure the coverin a closed position relative to the base plate. Alternatively or additionally, in someembodiments the anchor includes an adhesive backing on an exterior surface of the baseplate. Alternatively or additionally, in some embodiments the anchor includes gel pads on anexterior surface of the base plate. Alternatively or additionally, in some embodiments the 30anchor includes adhesive wings engaged by closure of the cover on the base plate, the wingsextending beyond a circumference of the base plate. Alternatively or additionally, in some IL 305765/2 embodiments the anchor includes holes in the adhesive wings through which the tube holderspass.In some exemplary embodiments of the invention there are provided molds for thepreparation of a nephrostomy tube anchor as described above.In some exemplary embodiments of the invention there is provided a method 5comprising: (a) inserting a portion of a nephrostomy tube into at least three tube holders onan upper surface of a base plate ; and (b) covering the base plate with a cover that engagesand retains the base plate. In some embodiments the method includes folding a hingeconnecting the cover and the base plate. Alternatively or additionally, in some embodimentsthe method includes securing the cover to the base plate with a latch mechanism. 10Alternatively or additionally, in some embodiments the method includes affixing the base plateto a skin surface of a patient.Unless otherwise defined, all technical and scientific terms used herein have the samemeaning as commonly understood by one of ordinary skill in the art to which this inventionbelongs. Although suitable methods and materials are described below, methods and materials 15similar or equivalent to those described herein can be used in the practice of the presentinvention. In case of conflict, the patent specification, including definitions, will control. Allmaterials, methods, and examples are illustrative only and are not intended to be limiting.As used herein, the terms "comprising" and "including" or grammatical variants thereofare to be taken as specifying inclusion of the stated features, integers, actions or components 20without precluding the addition of one or more additional features, integers, actions,components or groups thereof. This term is broader than, and includes the terms "consistingof" and "consisting essentially of" as defined by the Manual of Patent Examination Procedure ofthe 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 25essentially of" and/or "consist of" the recited feature. The phrase "consisting essentially of" or grammatical variants thereof when usedherein are to be taken as specifying the stated features, integers, steps or components but donot preclude the addition of one or more additional features, integers, steps, components orgroups thereof but only if the additional features, integers, steps, components or groups 30thereof do not materially alter the basic and novel characteristics of the claimed composition,device or method.

IL 305765/2 The phrase "adapted to" as used in this specification and the accompanying claimsimposes additional structural limitations on a previously recited component. The term "method" refers to manners, means, techniques and procedures foraccomplishing a given task including, but not limited to, those manners, means, techniques andprocedures either known to, or readily developed from known manners, means, techniques 5and procedures by practitioners of architecture and/or computer science. BRIEF DESCRIPTION OF THE DRAWINGS 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 tothe accompanying figures. In the figures, identical and similar structures, elements or parts 10thereof that appear in more than one figure are generally labeled with the same or similarreferences in the figures in which they appear. Dimensions of components and features shownin the figures are chosen primarily for convenience and clarity of presentation and are notnecessarily to scale. The attached figures are: Fig. 1A is a top perspective view of a nephrostomy tube anchor according to an 15exemplary embodiment of the invention in an open position; Fig. 1B is a top perspective view of a nephrostomy tube anchor as in Fig. 1A in a closedposition with a nephrostomy tube installed; Fig. 2A is a perspective view of a nephrostomy tube anchor as in Fig. 1A in transition toa closed position; 20 Fig. 2B is a top perspective view of a nephrostomy tube anchor as in Fig. 1A in an openposition with a nephrostomy tube installed; Fig. 3 is a simplified flow diagram of a method according to some embodiments of theinvention; Fig. 4A is a top perspective view of a nephrostomy tube anchor according to another 25exemplary 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 openposition with a nephrostomy tube installed; Fig. 4C is a perspective view of a nephrostomy tube anchor as in Fig. 4A in an openposition with a nephrostomy tube installed; 30 Fig. 5 is a simplified flow diagram of a method according to some additionalembodiments of the invention; IL 305765/2 Fig. 6A is a bottom perspective view of a nephrostomy tube anchor according to anexemplary embodiment of the invention in an open position with a nephrostomy tubeinstalled; Fig. 6B is a top view of a nephrostomy tube anchor as in Fig. 6A in an open positionwith a nephrostomy tube installed; and 5 Fig. 6C is an exploded view of a nephrostomy tube anchor as in Fig. 6A and Fig. 6Billustrating installation of adhesive wings. DETAILED DESCRIPTION OF EMBODIMENTS Embodiments of the invention relate to a nephrostomy tube anchor, molds forproduction of such anchors and methods for their use. Specifically, some embodiments of the 10invention 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 ananchor attached to the tubing.The principles and operation of a nephrostomy tube anchor, molds for production ofsuch anchors and methods for their use according to exemplary embodiments of the invention 15may be better understood with reference to the drawings and accompanying descriptions.Before explaining at least one embodiment of the invention in detail, it is to beunderstood that the invention is not limited in its application to the details set forth in thefollowing description or exemplified by the Examples. The invention is capable of otherembodiments or of being practiced or carried out in various ways. Also, it is to be understood 20that the phraseology and terminology employed herein is for the purpose of description andshould not be regarded as limiting.Exemplary anchor device Fig. 1A is a top perspective view of a nephrostomy tube anchor device, indicatedgenerally as 100, according to an exemplary embodiment of the invention in an open position. 25 Fig. 2A is a perspective view of a nephrostomy tube anchor device as in Fig. 1A intransition 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 twosemicircular tube holders 112; 114. In the depicted embodiment, the tube holders are raised 30above an upper surface 116 of base plate 110 by at least a diameter of the tube. This heightpermits installation of the tube in holders 112 and 114 and formation of a loop with a portion IL 305765/2 of the tube passing below and between holders 112 and 114 on upper surface 116 ofbaseplate 10.In the depicted embodiment, the anchor device includes a cover 120 configured toengage and retain base plate 110. In some exemplary embodiments of the invention, cover120 includes at least two semicircular tube holders 122 and 124 positioned to complement the 5tube holders 112 and 114 in base plate 110. According to this embodiment, when cover 120engages base plate 110, the tube holders 112;122 and 114;124 form closed loops that hold asection of tube above the base plate. This arrangement contributes to a reduction of atendency of the tube and anchor to move linearly with respect to one another.In the depicted embodiment, the anchor device includes two curved channels130 and 10140 on base plate 110. In some embodiments the channels are sized to engage and retain thetube.In some embodiments a tube engaged by the tube holders (e.g. 112;122; 114; and124) and the channels (e.g. 130 and 140) describes a loop, with a portion of the loop passingbetween and below a portion of the tube engaged by tube holders 112 and 114 raised above 15an upper surface 116 of the base plate.In the depicted embodiment, the anchor device includes a hinge 150 connecting baseplate 110 and cover 120. Alternatively or additionally, in some embodiments the anchor deviceincludes a latch mechanism (e.g. 160 and 162) configured to secure cover 120 in a closedposition relative to base plate 110. 20In some exemplary embodiments of the invention, the anchor device includes anadhesive backing (not visible in the figures) on an exterior surface of base plate 110. In someembodiments the adhesive backing is provided as a pad fastened to the base plate. In someembodiments the pad has a larger area than the base plate. In some embodiments an increasein an area of the pad contributes to an increase of strength of attachment of the device to the 25skin. Fig. 1B is a top perspective view of a nephrostomy tube anchor as in Fig. 1A in a closedposition with a nephrostomy tube installed indicated generally as 103. One end 99 of thenephrostomy tube is held in a substantially linear alignment with a distal port 97 of thenephrostomy tube. 30 Fig. 2B is a top perspective view of a nephrostomy tube anchor as in Fig. 1A in an openposition with a nephrostomy tube installed indicated generally as 105. In this view IL 305765/2 engagement of the nephrostomy tube by 112, 114, 130 and 140, and the resultant loopformation, is visible. Note that one portion of the tube passes below another portion between112 and 114.In some exemplary embodiments of the invention, when the nephrostomy tube isinstalled in the anchor device as described, there is substantially no linear translation of the 5tube with respect to the device.Exemplary method of use Fig. 3 is a simplified flow diagram of a method, indicated generally as 200, of using anephrostomy tube anchor according to some embodiments of the invention.Depicted exemplary method 200 includes inserting 210 a portion of a nephrostomy 10tube into two semicircular tube holders raised above an upper surface of a base plate andinserting 220 additional portions of said nephrostomy tube into two curved channels on thebase plate so that the additional portions are engaged and retained in the curved channels andso that a portion of said nephrostomy tube passes between and below said two semicirculartube holders. These actions form a loop of tubing held to baseplate 110. 15In some exemplary embodiments of the invention, the method includes covering 230the base plate with a cover that engages and retains the base plate and brings at least twosemicircular tube holders into proximity with the tube holders in the base plate to form closedloops that hold a section of tube above the base plate. This action fixes one portion of the loopof in a fixed position relative to baseplate 110. 20In some exemplary embodiments of the invention, the method includes folding 240 ahinge connecting the cover and the base plate. In some embodiments the method includessecuring 250 the cover to the base plate with a latch mechanism. These actions further securethe loop of tubing to the device.In some exemplary embodiments of the invention, method 200 includes affixing 260 25said base plate to a skin surface of a patient. This action anchors the loop of tubing to a fixedlocation on the patient’s skin. According to various exemplary embodiments of the inventionaffixing 260 includes suturing and/or gluing.Additional exemplary anchor device Fig. 4A is a top perspective view of a nephrostomy tube anchor, indicated generally as 30400, according to another exemplary embodiment of the invention in an open position.

IL 305765/2 Fig. 4B is a top perspective view of a nephrostomy tube anchor as in Fig. 4A, indicatedgenerally as 401, in an open position with a nephrostomy tube installed. Fig. 4C is a perspective view of a nephrostomy tube anchor as in Fig. 4A in an openposition with a nephrostomy tube installed indicated generally as 403.In the depicted embodiment, the nephrostomy tube anchor includes a base plate 410 5with at least three tube holders (e.g. 412, 414 and 416). In the depicted embodiment, the tubeholders are in a linear arrangement. In some exemplary embodiments of the invention, eachtube holder is shaped to accommodate more than half of the circumference of the tube. Insome embodiments this configuration contributes to a reduction in linear motion of the tubewith respect to the holders after installation. In the depicted embodiment, the anchor also 10includes a cover 420 configured to engage and retain the base plate. In some exemplaryembodiments of the invention, the nephrostomy tube anchor includes holes 470 at an edge ofbase plate 410. In the depicted embodiment, the holes are distributed about a circumferenceof base plate 410. In some exemplary embodiments of the invention, holes 470 contribute toan ability to suture base plate 410 to the skin. In the depicted embodiment, the anchor 15includes a hinge connecting said base plate and said cover. In some exemplary embodimentsof the invention, the anchor includes a latch mechanism (e.g. 460 and 462) configured tosecure cover 420 in a closed position relative to base plate 410. Alternatively or additionally, insome embodiments the anchor includes an adhesive backing on an exterior surface of baseplate 410. 20In some exemplary embodiments of the invention, when the nephrostomy tube isinstalled in the anchor device as described, there is substantially no linear translation of thetube with respect to the device. Fig. 6A is a bottom perspective view, indicated generally as 600, of a nephrostomytube anchor according to an exemplary embodiment of the invention in an open position with 25a nephrostomy tube installed. Fig. 6B is a top view, indicated generally as 601, of a nephrostomy tube anchor as inFig. 6A in an open position with a nephrostomy tube installed; and Fig. 6C is an exploded view, indicated generally as 603, of a nephrostomy tube anchoras in Fig. 6A and Fig. 6B illustrating installation of adhesive wings. 30In each of Figs. 6A, 6B and 6C the nephrostomy tube is indicated as 599 and the coveris indicated as 620.

IL 305765/2 In the depicted embodiment, gel pads 650 are provided on an exterior surface 612 ofbase plate 610. In some embodiments the pads are hemispherical. In some embodiments thepads are constructed of silicon or other compressible material. In some embodiments use ofgel pads 650 contributes to a reduction in pressure sores.In the depicted embodiment, adhesive wings 660 are engaged by closure of cover 620 5on base plate 610. In some embodiments wings 660 extending beyond a circumference of baseplate 610. In some exemplary embodiments of the invention, wings 660 contribute to anability to secure the anchor in a desired position on a subject’s skin. In some embodimentsholes 670 in adhesive wings 660 accommodate tube holders 630. In some exemplaryembodiments of the invention, having tube holders 630 pass through holes 670 contributes to 10stability of the spatial configuration between the anchor, tube 599 and the patient’s skin (viawings 660).Additional exemplary method of use Fig. 5 is a simplified flow diagram, indicated generally as 500, of a method according tosome additional embodiments of the invention. 15Depicted exemplary method 500 includes inserting 520 a portion of a nephrostomytube into at least three tube holders on an upper surface of a base and covering 520 the baseplate with a cover that engages and retains the base plate.In some exemplary embodiments of the invention, the method includes folding 530 ahinge connecting said cover and said base plate. In some exemplary embodiments of the 20invention, the method includes securing 540 the cover to said base plate with a latchmechanism. In some exemplary embodiments of the invention, the method includes affixing550 the base plate to a skin surface of a patient.Exemplary MoldsIn some exemplary embodiments of the invention, there are provide molds for the preparation 25of a nephrostomy tube anchor as depicted in Fig 1A and/or Fig. 2A and/or 4A.Exemplary measurementsIn some exemplary embodiments of the invention, base plate 110 and/or 410 andcover 120 and/or 420 have a diameter of 30 to 40 mm. In some embodiments the diameter isabout 35 mm. (diameter and thickness; relevant tubing diameters and relevant dimensions for 30adhesive pads.

IL 305765/2 In some exemplary embodiments of the invention, the nephrostomy tube has an outerdiameter of 3.5 mm. Alternatively or additionally, in some embodiments the anchor device hasa total height when closed of 6 to 9 mm, in some embodiments about 7.5 mm to 8.5 mm, Insome embodiments about 7.78 mm.Exemplary materials 5According to various exemplary embodiments of the invention base 110 and/or 420and cover 120 and/or 420 and the adhesive pads are constructed of an FDA approved plasticand/or an FDA approved silicone material.In some exemplary embodiments of the invention, the anchor device prevents themotion of the nephrostomy tube by fixing a portion of the tube to the base (e.g. 110 and/or 10410) (fit for "COOK" nephrostomy 10.2 Fr).Alternatively or additionally, in some embodiments the device includes on an exteriorsurface of base (e.g. 110 and/or 410) hemispheres or discs of gel. In some exemplaryembodiments of the invention, the gel contributes to a reduction in bedsores among patientsto whom the device is attached. 15Alternatively or additionally, in some embodiments the device includes holes 470 forsuturing to the skin.Alternatively or additionally, in some embodiments the device includes a catch foradding a sticker like wrist-watch to also stick the system to the skin.It is expected that during the life of this patent many nephrostomy tube configurations 20will be developed and the scope of the invention is intended to include all such newtechnologies a priori.Although the invention has been described in conjunction with specific embodimentsthereof, it is evident that many alternatives, modifications and variations will be apparent tothose skilled in the art. Accordingly, it is intended to embrace all such alternatives, 25modifications and variations that fall within the spirit and broad scope of the appended claims.Specifically, a variety of numerical indicators have been utilized. It should beunderstood that these numerical indicators could vary even further based upon a variety ofengineering principles, materials, intended use and designs incorporated into the variousembodiments of the invention. Additionally, components and/or actions ascribed to exemplary 30embodiments 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 IL 305765/2 and depicted as sub-units/individual actions may be combined into a single unit/action withthe described/depicted function.Alternatively, or additionally, features used to describe a method can be used tocharacterize an apparatus and features used to describe an apparatus can be used tocharacterize a method. 5It should be further understood that the individual features described hereinabove canbe combined in all possible combinations and sub-combinations to produce additionalembodiments of the invention. The examples given above are exemplary in nature and are notintended to limit the scope of the invention which is defined solely by the following claims.Each recitation of an embodiment of the invention that includes a specific feature, 10part, component, module or process is an explicit statement that additional embodiments ofthe invention not including the recited feature, part, component, module or process exist.Alternatively or additionally, various exemplary embodiments of the invention excludeany specific feature, part, component, module, process or element which is not specificallydisclosed herein. 15All publications, references, patents and patent applications mentioned in thisspecification are herein incorporated in their entirety by reference into the specification, tothe same extent as if each individual publication, patent or patent application was specificallyand individually indicated to be incorporated herein by reference. In addition, citation oridentification of any reference in this application shall not be construed as an admission that 20such reference is available as prior art to the present invention.The terms "include", and "have" and their conjugates as used herein mean "includingbut not necessarily limited to".

Claims

IL 305765/4 - 13 -

1. CLAIMS: 1. A method comprising:(a) inserting a portion of a nephrostomy tube into two semicircular tube holders raisedabove an upper surface of a base plate ; and(b) inserting additional portions of said nephrostomy tube into two curved channels on thebase plate so that the additional portions are engaged and retained in the curved channels andso that a portion of said nephrostomy tube passes between and below said two semicirculartube holders.

2. A method according to claim 1, comprising:covering said base plate with a cover that engages and retains said base plate and brings at leasttwo semicircular tube holders into proximity with the tube holders in the base plate to formclosed loops that hold a section of tube above the base plate.

3. A method according to claim 2, comprising: folding a hinge connecting said cover andsaid base plate.

4. A method according to any one of claims 1 to 3, comprising securing said cover to saidbase plate with a latch mechanism.

5. A method according to any one of claims 1 to 4, comprising affixing said base plate to askin surface of a patient.

6. Molds for use in a method according to claim 1, said molds for the preparation of anephrostomy tube anchor comprising:(a) a base plate with at least two semicircular tube holders raised above an upper surfaceof 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 twosemicircular tube holders positioned to complement the tube holders in said base plate.

7. Molds according to claim 6, wherein said nephrostomy tube anchor comprises twocurved channels on said base plate, said channels sized to engage and retain the tube. IL 305765/4 - 14 -

8. Molds according to claim 7, wherein said nephrostomy tube anchor comprises a tubeengaged by said tube holders and said channels describes a loop, with a portion of the looppassing between and below a portion of the tube engaged by said at least two semicircular tubeholders raised above an upper surface of the base plate.

9. Molds according to any one of claims 6 to 8, wherein said nephrostomy tube anchorcomprises a hinge connecting said base plate and said cover.

10. Molds according to any one of claims 6 to 9, wherein said nephrostomy tube anchorcomprises a latch mechanism configured to secure said cover in a closed position relative to saidbase plate.