[0001] This application claims priority under 35 U.S.C. § 119 to U.S. Provisional

Patent Application No. 63/215,156, filed on June 25, 2021, and entitled “FRANGIBLE MEMBER FOR CYSTOSCOPE TUBING,” the content of which is incorporated by reference herein in its entirety.

Field of the Invention

[0002] The present disclosure relates to an endoscopic equipment for cystoscopy and in particular a tubing used as part of the endoscopic equipment that has a frangible region to allow controllable disconnection.

Related Art

[0003] Urologists regularly perform various cystoscopy procedures by using endoscopic equipment to examine and treat the lining of a patient’s bladder and the urethra. These procedures involve inserting an endoscopic device into the patient’s urethra and slowly advancing into patient’s bladder. The endoscopic device, described in greater detail below, includes a hollow tube equipped with a lens that allows the lining of the bladder and the urethra to be visually examined. During such procedures, irrigation fluid must be run through the endoscopic device to distend the lower urinary tract and to allow for adequate visualization. This may be done by connecting bags of irrigation fluid to tubing plugged into a port on the endoscopic device.

[0004] Further, Urologists use continuous bladder irrigation (CBI) tubing (i.e., TUR tubing or bladder irrigation tubing). [0005] The entire length of the tubing as it is assembled can be used to run irrigation fluid through cystoscopes during endoscopic surgeries. There is a flexible silicone or rubber piece at the distal end of the tubing that allows it to be connected to a cystoscope.

[0006] As shown in Fig. 8, a same tubing is also used to deliver a treatment called continuous bladder irrigation. Continuous bladder irrigation is a treatment for excessive blood in the urine. The patient has a special foley catheter placed into their bladder that has an inflow channel and an outflow channel. The physician will then use CBI/bladder irrigation/TUR tubing to run fluid into the inflow channel.

[0007] To set up continuous bladder irrigation, the physician needs to remove the flexible rubber/silicone connector from the rest of the tubing and discard it. There is a conical plastic piece (sometimes called a “Christmas tree”) that is exposed once that flexible rubber/silicone connector is removed/discarded. That cone-shaped piece can then be plugged into the foley catheter’s inflow port to run continuous bladder irrigation.

[0008] The problem is that the current rubber/silicone flexible connectors are extremely difficult to remove from the plastic conical piece. Physicians often resort to using extra tools to help with disassembly.

[0009] The exemplary object is to alter the flexible silicone/rubber connector and introduce a frangible component- a pull tab, perforations/scoring, or a combination- to facilitate easier disassembly.

[0010] More specifically, in the conventional devices, the portion of the tubing that connects to the port is a thick rubbery hollow cylinder that is difficult to detach. In many situations, the irrigation tubing provided for the cystoscopy procedures is used to connect to a catheter for bladder irrigation or other fluid irrigation by removing the thick rubbery hollow cylinder. However, the rubbery portion does not easily detach under the best conditions, and operators performing the procedure are often trying to disassemble these pieces with wet gloved hands making the removal even more difficult. Thus, with conventional devices, operators often end up trying to cut away the tubing with scalpels or pry away the rubber component with Kelly forceps, syringes, or other unsuitable surgical equipment. Thus, there is an unmet need for an easier way to remove the tubing from the distal flexible connector piece.

SUMMARY

[0011] Aspects of the present disclosure may include an irrigation tube for endoscopic equipment. The irrigation tube may include a fluid supply connector configured to couple to a fluid container, a primary tubing fluidly communicating with the fluid supply connector, a connector coupled to the primary tubing, and a coupling portion configured to couple to the endoscopic equipment and coupled to the connector downstream of the primary tubing and the fluid supply connector, the coupling portion being formed from thick-walled rubber tubing. The coupling portion may include a frangible section configured to be selectively peeled from the connector.

[0012] Further aspects of the present disclosure may include an endoscopic device. The endoscopic device may include a main body, a tubular body extending from the main body, a viewing window coupled to the main body, an irrigation port coupled to the main body and configured to fluidly communicate with the tubular body; and an irrigation tube. The tubular body may be configured for insertion into the urethra of a patient and may include one or more openings at the end of the tubular body, the one or more openings being configured to emit light and water into the urethra. The viewing window may be configured to allow visual viewing of the interior of the patient’s urethra and bladder through the tubular body. The irrigation tube may include a fluid supply connector configured to couple to a fluid container, a length of primary tubing fluidly communicating with the fluid supply connector, a connector coupled to the primary tubing, and a coupling portion configured to couple to the irrigation port and coupled to the connector downstream of the primary tubing and the fluid supply connector, the coupling portion being formed from thick-walled rubber tubing, wherein the coupling portion includes a frangible section configured to be selectively peeled from the connector.

[0013] Another exemplary aspect of the present disclosure is a method of making a frangible element in an irrigation tube of an endoscopic equipment.

[0014] The method includes passing the irrigation tube through a cutting machine that includes a first blade and a second blade that cut the irrigation tube at a different timing than the first blade, cutting the irrigation tube by the first blade at a later time than the second blade, retracting the second blade during the cutting of the irrigation tube by the first blade, and retracting the first blade during the cutting of the irrigation tube by the second blade. The first blade cuts the irrigation tube with a different shape than the second blade.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] A general architecture that implements the various features of the disclosure will now be described with reference to the drawings. The drawings and the associated descriptions are provided to illustrate example implementations of the disclosure and not to limit the scope of the disclosure. Throughout the drawings, reference numbers are reused to indicate correspondence between referenced elements.

[0016] FIG. 1 illustrates an endoscopic device configured to use irrigation tubing in accordance with example implementations of the present disclosure.

[0017] FIGS. 2-4 illustrate irrigation tubing configured to have a coupling portion in accordance with example implementations of the present disclosure.

[0018] FIG. 5 illustrates the irrigation tubing with the flexible connector piece already removed coupled to three-way Foley catheter to be inserted into a patient. [0019] FIG. 6 illustrates a comparative example of a coupling portion in accordance with related art implementations.

[0020] FIGS. 7A-7F illustrate different example implementations of a coupling portion for irrigation tubing in accordance with the present disclosure.

[0021] FIG. 8 illustrates application of continuous bladder irrigation tubing.

[0022] FIG. 9 illustrates continuous bladder irrigation tubing with the distal connector still attached.

[0023] FIGS. 10A-10C illustrate conventional methods to disconnect connector from plastic conical piece.

[0024] FIGS. 11 A-l IF illustrate an exemplary method of scoring plastic conical piece.

[0025] FIGS. 12A-12F illustrate an exemplary method of perforating plastic conical piece.

[0026] FIGS. 13A-13D illustrate another exemplary method of scoring plastic conical piece.

[0027] FIG. 14A illustrates exemplary shapes of post-production silicone connector piece tubing cuts.

[0028] FIGS. 14B-14G illustrate motions of insertion and removal of silicone connector piece tubing.

[0029] Fig. 15 illustrates exemplary cutting process for silicone tubing.

[0030] Fig. 16 illustrates exemplary outcome of the silicone tubing cutting process.

[0031] Fig. 17 illustrates exemplary double blade cutting process of the silicone tubing.

[0032] Fig. 18 illustrates exemplary silicone tubing cutting process for desired shape of silicone tubing.

[0033] Fig. 19 illustrates exemplary rotation of cuts for the silicone tubing cutting process. [0034] Fig. 20 illustrates exemplary blade shaped to the profile cut in the silicone tubing cutting process.

[0035] Fig. 21 illustrates exemplary blade profiles in the silicone tubing cutting process.

[0036] Fig. 22 illustrates a device of making straight slits in the silicone tubing cutting process.

DETAILED DESCRIPTION

[0037] The following detailed description provides further details of the figures and example implementations of the present disclosure. Reference numerals and descriptions of redundant elements between figures are omitted for clarity. Terms used throughout the description are provided as examples and are not intended to be limiting. For example, the use of the term “automatic” may involve fully automatic or semi-automatic implementations involving user or operator control over certain aspects of the implementation, depending on the desired implementation of one of ordinary skill in the art practicing implementations of the present disclosure. Further, sequential terminology, such as “first”, “second”, “third”, etc., may be used in the description and claims simply for labeling purposes and should not be limited to referring to described actions or items occurring in the described sequence. Actions or items may be ordered into a different sequence or may be performed in parallel or dynamically, without departing from the scope of the present disclosure.

[0038] FIG. 1 illustrates an endoscopic equipment such as an endoscopic device 100 configured to use irrigation tubing in accordance with example implementations of the present disclosure. As illustrated, the endoscopic device 100 includes a main body 102 from which a tubular body 107 extends. The tubular body is designed to be inserted into the bladder of a patient through the patient’s urethra to image, sample, and treat the linings of the bladder and the urethra. The tubular body 107 emits light and water from one or more openings 120 at one end. The main body 102 includes one or more side channels 105 through which various tools may be inserted and fed through the tubular body 107 into the patient’s urethra and bladder. The main body 102 also includes a viewing window 115 through which an operator may visually view the interior of the patient’s urethra and bladder through the tubular body 107. In some example implementations, a camera or other image capture device may couple to the viewing window 115 to capture images from the interior of the patient’s urethra and bladder. [0039] The main body 102 also includes an irrigation port 110 that fluidly communicates with the tubular body, which may be used to inject needed irrigation fluid to distend the lower urinary tract and allow for adequate visualization. Irrigation tubing 125 (shown in FIGS. 2-4) may be coupled to the irrigation port 110 to allow bags of irrigation fluid to be injected through the irrigation port 110. As discussed in greater detail below, the irrigation tubing 125 includes a coupling portion 145, which includes a thick rubbery hollow cylinder that connects to the irrigation port 110, but is not easily detachable from the irrigation tubing 125.

[0040] FIGS. 2-4 illustrate irrigation tubing 125 configured to have a coupling portion

145 in accordance with example implementations of the present disclosure. As illustrated in FIGS. 2 and 3, the irrigation tubing 125 includes a fluid supply connector 130 that is designed to connect to a container or bag of irrigation fluid. The fluid supply connector 130 may connect to the bottom of the bag of irrigation fluid that may then be hung from a stand or tower to pull fluid out of the bag and into the fluid supply connector 130 using gravity. The irrigation tubing 125 may also include a drip chamber 155 downstream of the fluid supply connector 130 to allow gas to rise out from the fluid so that the gas does not pass downstream.

[0041] The irrigation tubing 125 may also include an adjustable clamp 135 downstream of the drip chamber 155 to allow the fluid flow through the irrigation tubing 125 to be varied continuously between full flow and no flow. Specifically, the adjustable clamp 135 may apply pressure to the primary tubing 150, which couples the drip chamber 155 to one end of a connector 140. The pressure applied to the primary tubing may partially or fully block fluid flow through the primary tubing 150.

[0042] The connector 140 may be a Christmas tree connector that is pressure fit at one end to the primary tubing 150. An opposite end of the connector 140 may have a series of sloped flanges 160a, 160b that increase in diameter to allow a coupling portion 145 to be slid onto the connector 140 and then retain the coupling portion 145 without any leakage.

[0043] As illustrated in FIGS. 3 and 4, the coupling portion 145 is formed from a thick- walled tubing such that once placed over the flanges 160a, 160b of the connector 140, significant friction or clamping force occurs between coupling portion 145 and the flanges 160a, 160b. This clamping force makes it difficult to remove the coupling portion 145 from the connector 140 once installed. As explained above, the coupling portion 145 does not easily detach under the best conditions, and operators performing the procedure are often trying to disassemble these pieces with wet gloved hands making the removal even more difficult. Thus, operators regularly resort to cutting the coupling portion 145 with a scalpel or prying the coupling portion 145 off with clamps or other instruments, which may not be safe or efficient. Thus, the example implementations of the provided frangible regions allow the coupling portion 145 to be more easily removed.

[0044] As discussed above, the irrigation tubing 125 may be reused after the cystoscopy for other procedures requiring continued irrigation. For example, the irrigation tubing 125 may be used to treat patients with significant hematuria (blood in the urine). In this situation, urine contains an enzyme that makes it difficult for any bleeding mucosa to heal, so patients are given continuous bladder irrigation to minimize contact between urine and ongoing bleeding. Patients who need this treatment have a three-way Foley catheter placed into their bladder. [0045] FIG. 5 illustrates the irrigation tubing 125 coupled to a three-way Foley catheter

400 to be inserted into a patient. The three-way Foley catheter 400 has 3 ports/channels, 405, 410, and 415. The drainage channel 410 connects to a drainage bag like any regular Foley catheter. The balloon channel 405 connects to a balloon at the proximal end that allows the Foley catheter to be anchored in the bladder. The third channel 415 is an inflow channel where the primary tubing 150 may be connected by the connector 140. The stem 420 of the Foley catheter 400 is inserted into the patient’s bladder.

[0046] Patients will then have the Foley catheter 400 connected to an irrigation bag by the irrigation tubing 125 that continuously sends fluid into the bladder, and then the fluid comes out the drainage channel 410 that is connected to the drainage bag. The irrigation tubing 125 is in a nearly identical state as used during the cystoscopy, except the coupling portion that hooks into the endoscopic device 100 has been removed and the connector 140 has been plugged into the three-way Foley catheter 400.

[0047] FIG. 6 illustrates a comparative example of a coupling portion 145 in accordance with conventional implementations. As illustrated, in the conventional implementations, the coupling portion 145 is a thick-walled rubber tubing that is pressure fit to the connector 140. The flanges described above have been omitted for clarity purposes. The coupling portion 145 is formed from a durable surgical tubing that is resistant to tearing or shearing, which necessitates cutting or slicing to start any tears.

[0048] FIGS. 7A-7F illustrate different example implementations of a coupling portion

745 for irrigation tubing in accordance with the present disclosure. For ease of understanding, same reference numerals are used for similar features in the following descriptions of FIGS. 7A-7F.

[0049] In the example implementation of FIG. 7A, the coupling portion 745 is thick- walled rubber tubing that is pressure fit to the connector 740, like in FIG. 6 above. Moreover, the coupling portion 745 is formed from a durable surgical tubing that is resistant to tearing or shearing. However, in FIG. 7A, the coupling portion 745 is provided with a pull tab 750 extending longitudinally from an end of the coupling portion 745. Further, a scoring perforation 755 extends at a diagonal from the pull tab 750. The combination of the pull tab 750 and the scoring perforation 755 form a frangible section that allows the coupling portion 745 to be controllably peeled from the connector 740 by an operator while the durability of the surgical tubing prevents the coupling portion 745 from being unintentionally torn until desired by an operator.

[0050] In the example implementation of FIG. 7B, the coupling portion 745 is thick- walled rubber tubing that is pressure fit to the connector 740, like in FIG. 6 above. Moreover, the coupling portion 745 is formed from a durable surgical tubing that is resistant to tearing or shearing. However, in FIG. 7B, the coupling portion 745 is provided with a pull tab 760 extending circumferentially around the coupling portion 745 and perpendicular to the connector 740. Further, a scoring perforation 765 extends longitudinally along the pull tab 760 and a midline of the connector 740. The combination of the pull tab 760 and the scoring perforation 765 form a frangible section that allows the coupling portion 745 to be controllably peeled from the connector 740 by an operator while the durability of the surgical tubing prevents the coupling portion 745 from being unintentionally torn until desired by an operator. [0051] In the example implementation of FIG. 7C, the coupling portion 745 is thick- walled rubber tubing that is pressure fit to the connector 740, like in FIG. 6 above. Moreover, the coupling portion 745 is formed from a durable surgical tubing that is resistant to tearing or shearing. However, in FIG. 7C, the coupling portion 745 is provided with a pull tab 770 extending longitudinally from an end of the coupling portion 745. Further, a pair of scoring perforations 775a, 775b extends along the coupling portion 745 at edges of the pull tab 770. Moreover, in this implementation, a gap 777 may be provided in a portion of the connector 740 to be oriented to accommodate a longer pull tab 770 length The combination of the pull tab 770 and the scoring perforations 775a, 775b form a frangible section that allows the coupling portion 745 to be controllably peeled from the connector 740 by an operator while the durability of the surgical tubing prevents the coupling portion 745 from being unintentionally torn until desired by an operator.

[0052] In the example implementation of FIG. 7D, the coupling portion 745 is thick- walled rubber tubing that is pressure fit to the connector 740, like in FIG. 6 above. Moreover, the coupling portion 745 is formed from a durable surgical tubing that is resistant to tearing or shearing. However, in FIG. 7D, the coupling portion 745 is provided with a pull tab 780 extending longitudinally from an end of the coupling portion 745. Further, a slice 785 extends along an edge of the pull tab 780. The combination of the pull tab 780 and the slice 785 form a frangible section that allows the coupling portion 745 to be controllably peeled from the connector 740 by an operator while the durability of the surgical tubing prevents the coupling portion 745 from being unintentionally torn until desired by an operator.

[0053] In the example implementation of FIG. 7E, the coupling portion 745 is thick- walled rubber tubing that is pressure fit to the connector 740, like in FIG. 6 above. Moreover, the coupling portion 745 is formed from a durable surgical tubing that is resistant to tearing or shearing. However, in FIG. 7E, the coupling portion 745 is provided with a pull tab 790 extending longitudinally from an end of the coupling portion 745. Further, a scoring perforation 795 extends along an edge of the pull tab 790. The combination of the pull tab 790 and the scoring perforation 795 form a frangible section that allows the coupling portion 745 to be controllably peeled from the connector 740 by an operator while the durability of the surgical tubing prevents the coupling portion 745 from being unintentionally torn until desired by an operator. [0054] In the example implementation of FIG. 7F, the coupling portion 745 is thick- walled rubber tubing that is pressure fit to the connector 740, like in FIG. 6 above. Moreover, the coupling portion 745 is formed from a durable surgical tubing that is resistant to tearing or shearing. However, in FIG. 7F, the coupling portion 745 is provided with a pull tab 800 extending circumferentially around the coupling portion 745 and perpendicular to the connector 740. Further, a pair of scoring perforations 805a, 805b extend along edges of the pull tab 760 and perpendicular to a midline of the connector 740. The combination of the pull tab 800 and the scoring perforations 805a, 805b form a frangible section that allows the coupling portion 745 to be controllably peeled from the connector 740 by an operator while the durability of the surgical tubing prevents the coupling portion 745 from being unintentionally torn until desired by an operator.

[0055] Based on the exemplary aspects of the present disclosure as set forth above, the mechanism of disassembling conventional CBI/TUR/b ladder irrigation tubing is discussed below with proposed modifications/designs and mechanics of flexible connector removal, along with methods for manufacturing the frangible element.

[0056] Mechanics of disassembling a conventional CBI/TUR/bladder irrigation tubing:

[0057] The portion of CBI tubing that is focused on for explanations of mechanics/motions is the junction where the silicone connector is slid over/attached to a white plastic conical piece (“Christmas tree”) 901, as shown in Fig. 9. The most proximal portion of CBI tubing is the end 902 that plugs into irrigation bags. The most distal end is the end 903 of the silicone connector that would plug into the cystoscope. The proximal end of the silicone connector is what overlies the plastic piece connector.

[0058] To remove the silicone/rubber adapter piece 904 from the rest of the CBI tubing

(in its conventional manufactured design), one can either forcefully separate these pieces with fingers or employ a tool. [0059] The motion of separating the silicone/rubber connector 904 from the conical plastic piece (“Christmas tree”) 901 involves wedging a thumb under the proximal edge of the silicone and trying to roll this away from the Christmas tree 901. The user then keeps working circumferentially and rolling the silicone away from the Christmas tree/onto itself, until there has been a small cuff/collar created at the proximal end of the silicone piece. At this point, there is typically less surface area of the Christmas tree 901 in contact with the silicone connector 904, and the connector can then be pulled off the plastic conical Christmas tree piece. [0060] This motion is tricky because, as shown in Figs. 10A, 10B, and IOC, the silicone/rubber material tends to be quite stiff and difficult to manipulate into the collar shape. [0061] Alternatively, sometimes it is not possible to create this “collar” with stiffer silicone materials. A thumb can be used to try and slide the silicone more distally on the Christmas tree piece. Again, the user will work circumferentially around the proximal end of the silicone piece, scooting it a little distal, moving over, scooting that edge a little more distal, etc. until the silicone has edged its way up the Christmas tree and is now over a more narrow portion of that plastic cone. At this point, there should be less friction between the Christmas tree and the silicone piece, and the silicone piece should be able to be pulled off.

[0062] Both of these motions inevitably do not go terribly smoothly and could result in frustration and sore fingers.

[0063] Attempts to simply pull the silicone/rubber piece off the Christmas tree without manipulating the position of the silicone first are usually unsuccessful; there is enough of the two surfaces in contact with each other to create adequate friction and keep the pieces connected.

[0064] There are a number of tools that can be utilized to disassemble CBI tubing (in its conventional manufactured state). [0065] A Kelly forceps or towel clamp can be used to either a) grip the proximal end and pull/invert this into the collar shape mentioned above or b) wedge itself in between the Christmas tree and the silicone to stretch out that silicone piece and allow for removal.

[0066] A scalpel can be used to incise the silicone tubing at the proximal edge over the Christmas tree, and then once that tubing is split it can be easily peeled off the Christmas tree.

[0067] The outer sheath of a syringe can also be used to help apply force to the silicone piece. A syringe can first be pulled apart and the outer sheath kept (piston set aside). One of the two “wings” that rest against the back of a user’s fingers while injecting will be the portion of the outer sheath that is in contact with the silicone. The syringe is positioned so the wing is up against the proximal edge of the silicone and then the user pulls down on the syringe in a trajectory parallel to the length of the silicone piece, so that the outer sheath applies pressure to the proximal edge of the silicone and forces it distally. The syringe can be moved circumferentially as needed and the same motion applied to help free the silicone piece.

[0068] Scissors can also be used to either split the silicone piece at the proximal end, or split the whole silicone tube starting at the distal end and working back towards the Christmas tree. The difficulty of removing the silicone connector comes with a few downsides.

[0069] First and most importantly, it causes delays in patient care (more time is spent in the operating room or emergency room trying to disassemble this tubing) or adds on enough time to existing scheduled OR cases that surgeons’ productivity gets limited and fewer patients undergo needed surgery that day. The delays are not tremendous (<10 minutes), but these increments of time add up when urologists do 6-10 endoscopic cases a day or the emergency room is trying to move along patients who have been in the waiting room for hours. Ten minutes multiplied by several cases equals enough time to schedule another short outpatient case and get one more patient a needed procedure.

[0070] Data from the 2021 AUA (American Urological Association) Census reports

49.7% of currently practicing urologists are age 55 or older. In a time when the U.S. population is continuing to increase and a near-majority of urologists are in the latter half of their careers, it is imperative to minimize inefficiencies within the operating room and enable practicing urologists to deliver care to as many patients as feasible.

[0071] Secondly, using tools to disassemble CBI tubing uses extra hospital supplies that cost almost as much as the tubing itself. This is wasteful and could be fixed with a simple modification.

[0072] Thirdly, using sharp tools to disassemble CBI tubing can result in injury to the surgeon or healthcare worker. There are scenarios where a surgeon finishes an operation and then places a patient on continuous bladder irrigation before leaving the operating room. As previously discussed, urologists often have wet/slippery hands as endoscopic procedures employ irrigation fluid and lubricant jelly. It is common for users to accidentally poke themselves with scissors or other surgical tools when attempting to remove this flexible connector piece. This is a sharps/occupational hazard, and if there is other bodily fluid/blood on the field this also presents potential for accidental transmission of bloodbome pathogens to healthcare workers.

[0073] Lastly, physicians themselves find the tubing extraordinarily frustrating to work with.

[0074] Proposed modifications/designs and mechanics of flexible connector removal:

[0075] Outlined below are potential modifications to CBI tubing to introduce a frangible component and allow for more convenient disassembly as well as explanations of how each modified silicone connector is removed.

[0076] 1. Scoring at 9 o'clock and 3 o'clock [0077] As shown in Figs. 11 A - 1 IF, this exemplary design uses two linear scorings within the silicone (for example, at 9 o'clock and 3 o'clock positions) that overlies the plastic conical piece. The set of scorings functionally make two pull tabs that can be peeled away from one another in opposite directions (almost like a banana, illustrated with arrows in Fig.

1 IB). When the user wishes to remove the connector, the user can wedge a thumb under one half of the scored tubing to create leverage/further split the tubing and then grip the tubing/peel away one half from the other until the connector is sufficiently loosened and falls off the conical plastic "Christmas tree."

[0078] Perforations would be just within the portion of the silicone piece overlying the Christmas tree. They would be longitudinal along the axis of the silicone connector and positioned on opposite sides of the silicone connector from each other (as indicated by the arrows in Fig. 1 IF).

[0079] 2. L-shaped perforation

[0080] This exemplary design, as shown in Figs. 12A - 12F introduces an L-shaped perforation (outlined with black markings to better illustrate cuts) into the portion of the silicone connector that overlies the plastic conical "Christmas tree." The user can wedge a thumb under the perforation until a little tab is raised. This tab can be re-gripped and pulled in an outward trajectory (shown by arrows in Figs. 12C and 12D) until the silicone tubing is loosened and the whole connector is able to be pulled off of the conical plastic piece.

[0081] 3. Parallel scoring to create an embedded pull tab

[0082] This exemplary design, as shown in Figs. 13A-13D, incorporates a set of two parallel scorings within the silicone connector piece (portion overlying plastic conical piece). These perforations are illustrated with black markings in the figures to better show the cuts. The user can wedge a thumb under the skinny piece of silicone that is bookended by the two scorings until this piece is freed up/flipped up and has become a pull tab. The user can then regrip the pull tab and pull this towards the narrowed end of the plastic conical piece (trajectory shown with arrow in Fig. 13D) until the silicone connector is loosened and able to be pulled off the plastic conical "Christmas tree." [0083] 4. Pre-cut pull tabs

[0084] This exemplary design, as shown in Fig. 14A, has a few subtypes and variations, but the shared idea is that the silicone connector piece tubing can be cut post production on a bevel or with other shapes/cutouts that will create some asymmetry in the amount of silicone that overlies the plastic conical "Christmas tree." This overhang/longer piece of silicone overlying the Christmas tree can function as a pull tab. The user can directly grip the longer end of the silicone and pull it in an outward trajectory until the silicone piece has become less adherent to the plastic conical piece and the silicone connector is able to be removed. Alternatively, the user can wedge a thumb underneath this tab to create leverage and push/slide the silicone piece more distally down the conical plastic piece until the silicone piece has become sufficiently loosened and can be pulled off the Christmas tree (see arrows in Figs. 14E and 14G).

[0085] The drawings in Figs. 14B and 14G demonstrate this disassembly motion with the beveled cut (model B) but all four designs utilize the same motions/steps.

[0086] Incorporating a frangible element into the silicone extrusion and curing manufacturing process:

[0087] The basic manufacturing processes of silicone tubing do not have to be changed but should be understood to add changes to the post-processing. Silicone tubing is created by the extrusion of long tubing all at once through a mandrel that creates the cylindrical shape of the tubing. This tubing is then rolled into larger rolls that can be cured at very high temperatures to solidify the shape completely. The rolls that are cured can then be cut to a specific shape using a variety of methods, with the most popular being a machine that can cut tubing at specific lengths using certain timings. These machines can be programmed at certain timings to create either longer or shorter lengths of silicone tubing at the client's request. This post-processing method is the one that is considered to be changed to create a novel silicone tubing product.

[0088] The exemplary change to the conventional manufacturing process would be simply to introduce a secondary cutting blade to the timed cutting apparatus to cut the silicone tubing at, for example, a 45-degree angle. This would increase the complexity of the cutting machine timing by requiring two different timing components in the cutting process.

[0089] The automated silicone tube cutter has timing intervals that allow for a certain length of tube to be cut. These timings can be adjusted for the desired length. In larger operations, these cutting machines are custom made to cut longer lengths of tubing for different industries. The desired shape of the silicone tube requires a cut to be made along the length of the tubing at, for example, a 45 degree angle with one of the angles remaining at 90 degrees.

[0090] The exemplary changes to be made to the automation of the cutting machine are a secondary blade setup and timing adjustment for two blades. These two blades need to be cutting at alternating times and most automation setups are only for one blade. A custom setup would need to be introduced to the post-processing line of silicone tubing in order to execute large amounts of these custom silicone tube shapes. An automation expert in this space may be required to custom build and execute the double blade setup.

[0091] Manufacturing modifications for some exemplary designs:

[0092] The explanation below illustrates how to potentially build the models/modifications proposed above as part of a high-volume and high-speed manufacturing process.

[0093] The original cutting process for a silicone tubing is shown in Fig. 15, which is a representation of the original setup for standard cutting machines. A blade (a) comes down on the silicone tubing (b) that has been cured and is being unrolled. This blade is timed to come down on the tubing that is being pushed past the blade at a regular rate. This method of cutting tubing is quick and efficient for high volume tubing manufacturing.

[0094] Fig. 16 shows the outcome of this process with the silicone tubing (b) being cut to a certain length.

[0095] Fig. 17 is the representation of the double blade cutting process that is going to be introduced. The first blade (a) is set to cut, for example, at a 90 degree angle while the second blade (c) is set at, for example, a 45 degree angle. The silicone tubing (b) runs its regular path through the unrolling machine. The difference is the timing between each blade. The second blade (c) cuts the tubing at, for example, a 45-degree angle and the machine pushes the silicone tubing forward.

[0096] Fig. 18 shows the next cut on the tubing. The first blade (a) then cuts the tubing at a later time than the second blade (d), creating the desired shape of silicone tubing (c). The second blade (d) is retracted during the first blade cut, preparing for the next rotation of cuts.

[0097] Fig. 19 shows the whole rotation of cuts represented in full. The desired shape

(a) has been cut and the first blade (c) is retracted while the second blade (e) makes the final cut. Since this operation requires two parts of the silicone tubing (a)-(b) to be cut in one rotation of cuts, the alternating blades need to be timed separately. With these blades being timed correctly, a steady stream of correctly cut pieces (a)-(b) can be achieved in automation.

[0098] The operation of creating the secondary shapes listed in the precut tab section above is similar to that of cutting profile B outlined here.

[0099] The speed of operations could be increased with a setup similar to that shown in Fig. 20. In Fig. 20, a blade shaped to the profile cut (e) is attached to a plate (b) that is configured to be hydraulically operated up and down. With the regular silicone tubing inserted into the holding plate (c), the plate attached with blades would be able to lower onto the silicone tubing cutting it to the desired profile (e). This process requires manual or automated insertion of regular cut silicone tubing into the holding blocks.

[00100] Fig. 21 demonstrates different blade profiles (a) that result in cut profile D (b).

[00101] Similarly, Fig. 22 shows how straight slits can be cut into the silicone tubing with the same blade setup as profiles C and D. This system of having profiles on a plate that moves up and down to cut the silicone tubing is used in the industry currently where be more intricate cuts need to be made. The same can be applied to the medical space.

[00102] While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and are herein described in detail. It should be understood, however, that the description herein of specific embodiments is not intended to limit the invention to the particular forms disclosed. [00103] The foregoing detailed description has set forth various example implementations of the devices and/or processes via the use of diagrams, schematics, and examples. Insofar as such diagrams, schematics, and examples contain one or more functions and/or operations, each function and/or operation within such diagrams or examples can be implemented, individually and/or collectively, by a wide range of structures. While certain example implementations have been described, these implementations have been presented by way of example only and are not intended to limit the scope of the protection. Indeed, the novel methods and apparatuses described herein may be embodied in a variety of other forms. Furthermore, various omissions, substitutions and changes in the form of the devices and systems described herein may be made without departing from the spirit of the protection. The accompanying claims and their equivalents are intended to cover such forms or modifications as would fall within the scope and spirit of the protection.