Systems and methods related to the collection of biological fluids

Abstract

The present application relates to systems and methods related to the collection of biological fluids. At least one example is a polymer sleeve comprising: an elongate body defining a main passageway; an interior chamber defined within the main passageway; a first flange suspended within the interior chamber at a first location along the longitudinal central axis; and an aperture through the first flange, the aperture at least partially aligned with the longitudinal central axis.

Description

[0001] Cross Reference to Related Applications

[0002] Not applicable. TECHNICAL FIELD

[0003] The present application relates to systems and methods for the stimulation and collection of biological fluids, particularly semen. BACKGROUND

[0004] In recent years, there have been many advances in devices for the stimulation and collection of biological fluids, particularly semen. For example, The product by the brand is a device that assists in the stimulation and collection of semen via ejaculation. Many such products visually simulate a genital organ and also attempt to simulate the sensation of sexual intercourse.

[0005] Research has found that the prostate health of human males can be related to the frequency of ejaculation. Specifically, infrequent ejaculation can cause the prostate to swell, known as congestive prostatitis, and can also increase the risk of cancer in human males. Some medical resources suggest that an ejaculation frequency of three to four times per week ensures good prostate health and reduces the risk of cancer. One study found that men who ejaculate between 13 and 20 times per month have a 14% lower lifetime risk of prostate cancer, while men who ejaculate 21 or more times per month have a more than 33% lower lifetime risk of prostate cancer. Devices for the stimulation and collection of semen can assist in achieving a higher ejaculation rate in males.

[0006] In addition to the effects of ejaculation on prostate health, devices for the stimulation and collection of semen via ejaculation can also assist in reversing desensitization issues. That is, repeated manual stimulation of the penis, particularly without lubrication, can cause the penis to become desensitized. Desensitization in turn can cause erectile dysfunction during sexual intercourse. The use of a properly lubricated device specifically designed for the stimulation and collection of semen can help reverse desensitization issues and thus reduce the occurrence of erectile dysfunction associated with desensitization issues.

[0007] Given the positive health benefits, any improvements in devices for the stimulation and collection of semen would be beneficial. SUMMARY

[0008] One example is a system including a polymer sleeve. The polymer sleeve can include: an elongate body defining a first end, a second end opposite the first end, and a longitudinal central axis; a main passageway through the elongate body along the longitudinal central axis, the main passageway extending from the first end to the second end, and the main passageway defining a first aperture at the first end and a second aperture at the second end; an interior chamber defined within the main passageway between the first aperture and the second aperture; a first flange disposed within the interior chamber at a first location along the longitudinal central axis, the first flange defining an aperture at least partially aligned with the longitudinal central axis; a first strut extending from the first flange in a first radial direction relative to the longitudinal central axis, the first strut coupled to an interior surface of the interior chamber; a second strut extending from the first flange in a second radial direction relative to the longitudinal central axis, the second strut coupled to the interior surface of the interior chamber; and the first and second struts suspending the first flange within the interior chamber.

[0009] The example system can further include a first gap volume defined between the interior surface of the interior chamber, the first strut, and the second strut.

[0010] In the example system, the first radial direction and the second radial direction can form an angle of at least 90 degrees. In the example system, the first radial direction and the second radial direction can form an angle of 180 degrees.

[0011] The example system can further include a third strut extending from the first flange in a third radial direction relative to the longitudinal central axis, the third strut coupled to the interior surface of the interior chamber. In the example system, the first radial direction and the second radial direction form an angle of 120 degrees; and the second radial direction and the third radial direction form an angle of 120 degrees.

[0012] The example system can further include: a first gap volume defined between the interior surface of the interior chamber, the first strut, and the second strut; a second gap volume defined between the interior surface, the second strut, and the third strut; and a third gap volume defined between the interior surface, the third strut, and the first strut.

[0013] The example system can further include: a second flange disposed within the interior chamber at a second location along the longitudinal central axis; a third strut extending from the second flange in a third radial direction relative to the longitudinal central axis, the third strut coupled to the interior surface; a fourth strut extending from the second flange in a fourth radial direction relative to the longitudinal central axis, the fourth strut coupled to the interior surface; and the third and fourth struts suspending the second flange within the interior chamber.

[0014] The example system can further include a third strut extending from the first flange along a third radial direction relative to the longitudinal center axis, the third strut coupled to the inner surface; a second flange disposed within the interior chamber at a second location along the longitudinal center axis; a fourth strut extending from the second flange along a fourth radial direction relative to the longitudinal center axis, the fourth strut coupled to the inner surface; a fifth strut extending from the second flange along a fifth radial direction relative to the longitudinal center axis, the fifth strut coupled to the inner surface; and a sixth strut extending from the second flange along a sixth radial direction relative to the longitudinal center axis, the sixth strut coupled to the inner surface. The example system can further include that the first radial direction and the second radial direction can form an angle of 120 degrees; the second radial direction and the third radial direction can form an angle of 120 degrees; the fourth radial direction and the fifth radial direction can form an angle of 120 degrees; the fifth radial direction and the sixth radial direction can form an angle of 120 degrees; and the first radial direction and the third radial direction can form an angle of 60 degrees.

[0015] The example system can further include an outer covering of rigid material defining an interior volume, wherein the polymer sleeve is disposed at least partially within the outer covering.

[0016] Another example is a method of manufacturing a polymer sleeve, comprising: placing a lower mold assembly that structurally defines a negative of an insertion end of a polymer sleeve, and that defines a negative of a first portion of a main passageway of the polymer sleeve; assembling a disk assembly into a mating relationship that structurally defines a negative of an interior volume of the polymer sleeve, and that defines a negative of at least two struts and a first flange; stacking the disk assembly into a mating relationship with the lower mold assembly; coupling a stem component to the disk assembly, an outer surface of the stem component defining a negative of a main passageway from the interior volume to a discharge end of the polymer sleeve; closing an outer mold assembly around the disk assembly and the stem component, an inner surface of the outer mold assembly structurally defining a negative of an outer surface of the polymer sleeve; and injecting a polymer compound in a liquid state into the outer mold assembly.

[0017] In an example method, the assembling can further include abutting the lower disk component against the upper disk component. In an example method, the lower disk component and the upper disk component, when assembled, define a negative of the first strut at the first radial direction, the second strut at the second radial direction, and the third strut at the third radial direction.

[0018] In an example method, the assembling can further include abutting the lower disk component against the intermediate disk component, and abutting the intermediate disk component against the upward upper disk component; the lower disk component and the intermediate disk component defining a negative of the at least two struts and the first flange; and the intermediate disk component and the upper disk component defining a negative of the at least two struts and the second flange.

[0019] In an example method, the assembling can further include: abutting the lower disc component against the intermediate disc component, and abutting the intermediate disc component against the upward upper disc component; the lower disc component and the intermediate disc component defining a negative image of the three struts and the first flange; and the intermediate disc component and the upper disc component defining a negative image of the three struts and the second flange.

[0020] Another example is a mold system for manufacturing a polymer sleeve, the mold system comprising: a lower mold defining a mold surface and a post projecting upward from the mold surface along a longitudinal axis; a disc assembly configured to be stacked in a mating relationship with an upper end of the post, the disc assembly defining at least two channels into a first interior volume surrounding the longitudinal axis; and a stem configured to be coupled to an upper surface of the disc assembly and to extend along the longitudinal axis.

[0021] In an example mold assembly, the disc assembly can further include a lower disc component and an upper disc component, the lower and upper disc components defining three channels into the interior volume, the three channels extending along three distinct radial directions relative to the longitudinal axis.

[0022] In an example mold assembly, the disc assembly can further include: a lower disc component abutting an intermediate disc component, and the intermediate disc component abutting an upper disc component; the lower disc component and the intermediate disc component defining at least two channels into a first interior volume; and the intermediate disc component and the upper disc component defining at least two channels into a second interior volume, the second interior volume surrounding the longitudinal axis.

[0023] In an example mold assembly, the disc assembly can further include: a lower disc component abutting an intermediate disc component, and the intermediate disc component abutting an upper disc component; the lower disc component and the intermediate disc component defining at least two channels into a first interior volume; and the intermediate disc component and the upper disc component defining at least two channels into a second interior volume, the second interior volume surrounding the longitudinal axis. BRIEF DESCRIPTION OF DRAWINGS

[0024] To describe the example embodiments in detail, reference will now be made to the accompanying drawings, in which:

[0025] Figure 1 A perspective view of a system is shown in accordance with at least some embodiments;

[0026] Figure 2 A perspective view of a system is shown in accordance with at least some embodiments generally along Figure 1a cross-sectional perspective view taken along line 2-2;

[0027] Figure 3 a cross-sectional view of a polymer sleeve taken across a proximal volume as viewed toward a discharge end, according to at least some embodiments;

[0028] Figure 4 a perspective view of a mold system, according to at least some embodiments;

[0029] Figure 5 a perspective view of a lower disk component, according to at least some embodiments;

[0030] Figure 6 a bottom perspective view of a middle disk component, according to at least some embodiments;

[0031] Figure 7 a top perspective view of a middle disk component, according to at least some embodiments;

[0032] Figure 8 a bottom perspective view of an upper disk component, according to at least some embodiments; and

[0033] Figure 9 a method, according to at least some embodiments. DETAILED DESCRIPTION

[0034] DEFINITIONS

[0035] Various terminology is used to refer to particular system components. Different companies may refer to a component by different names — what is described herein as a component can also be referred to as having a different name. In the following discussion and in the claims, the terms "including" and "comprising" are used in an open-ended fashion, and thus should be interpreted to mean "including, but not limited to...." Also, the term "couple" is intended to mean either an indirect or direct connection. Thus, if a first device couples to a second device, that connection can be through a direct connection, or through an indirect connection via other devices and connections.

[0036] "About" in reference to a number (e.g., a length or width) will mean the stated number plus or minus ten percent (+ / - 10%) of the stated number.

[0037] DETAILED DESCRIPTION

[0038] The following discussion is directed to various embodiments of the application. While one or more of these embodiments can be preferred, no single embodiment should be interpreted as limiting the scope of the disclosure, including the claims, or as limiting the scope of the disclosure, including the claims, to only the embodiments described. Additionally, it should be understood that the description given herein is not the only way to implement the embodiments and that the described embodiments are merely examples of one way to implement the application.

[0039] Various embodiments are directed to systems and methods of manufacturing a polymer sleeve for collecting biological fluids, particularly semen. Various example systems are developed in the context of devices for use by human males, and thus the following description is based on a developmental context; however, the systems and methods can have other uses, such as veterinary (e.g., equine, canine), and thus the developmental context should not be viewed as limiting the scope of applicability of the devices.

[0040] Figure 1 A perspective view of a system 100 according to at least some embodiments is shown. In particular, the system 100 includes a polymer sleeve 102 disposed at least partially within an interior volume of an outer cover 104 of a rigid material, such as plastic. In Figure 1 In the view, only the insertion end 106 of the polymer sleeve 102 is visible, as the remainder of the polymer sleeve resides within the outer cover 104. The polymer sleeve 102 can be made of a low durometer grade of thermoplastic elastomer gel (TPE) or other material such as silicone, polyvinyl chloride (PVC), or elastomeric rubber. The system 100 can further include a cover or cap 108 that defines an inner diameter D2 that is slightly larger than an outer diameter Dl of the insertion end 106 of the polymer sleeve 102, such that the cap 108 can be collapsed over the insertion end 106 and coupled to the outer cover 104 when not in use. For example, the cap 108 can protect the insertion end 106 from damage when not in use. The system 100 can further include a second top cover or cap 110 coupled to the outer cover 104 opposite the cap 108. The cap 110 can serve as a controllable discharge mechanism during use in some cases and in conjunction with other features of the outer cover 104. The diameter Dl can be about 3.0 inches, and the diameter D2 can be slightly larger to accommodate the collapse over the insertion end 106.

[0041] The insertion end 106 of the example system 100 includes a main aperture 112 (only partially visible in Figure 1 which is discussed more below) that leads to a main passageway 114 aligned with a longitudinal center axis 118 of the polymer sleeve 102. In some cases, the main passageway 114 can be coaxial with the longitudinal center axis 118. In other cases, the main passageway 114 can be parallel to the longitudinal center axis 118 but slightly offset with respect to the longitudinal center axis.

[0042] Figure 2 A cross-sectional perspective view of system 100 is shown taken generally along line 2-2 Figure 1 Figure 1 A cross-sectional perspective view of system 100 is shown taken generally along line 2-2 Figure 2 A portion of outer cover 104 and polymer sleeve 102 is shown. Outer cover 104 defines an interior volume 200 and a longitudinal central axis 118. Polymer sleeve 102 is disposed, at least partially, within interior volume 200. In the example system shown, insertion end 106 resides at least partially outside of interior volume 200 of outer cover 104. Polymer sleeve 102 defines an elongate body 202 and a discharge end 204 opposite insertion end 106. In some example systems, overall length L is at least twice diameter Dl, in some cases about three times diameter Dl, and in particular cases about nine inches.

[0043] Main passageway 114 extends along longitudinal central axis 118 from insertion end 106 to discharge end 204. Figure 2 It is seen in the figures that main passageway 114 defines a main aperture 112 on insertion end 106. An inner lumen or interior chamber 206 is positioned along main passageway 114, and interior chamber 206 can be disposed at a wider end of polymer sleeve 102. In particular, in Figure 2 In the figures from left to right, main passageway 114 includes a first portion 208 extending from main aperture 112 to interior chamber 206. First portion 208 has a diameter D3, in some cases about 0.5 inches. First portion 208 is fluidly coupled to interior chamber 206 having a diameter D4. In some cases, diameter D4 is at least twice diameter D3, and in particular cases diameter D4 is about four times diameter D3. Interior chamber 206 defines an inner wall or inner surface 210. Main passageway 114 then includes a second portion 212 terminating from interior chamber 206 to discharge end 204. In some cases, second portion 212 is about the same diameter as first portion 208, but in any case, the diameter of second portion is less than diameter D4 of interior chamber 206. In some cases the inner surface of second portion 212 can be smooth, and in other cases the inner surface of second portion 212 can be textured to increase irritation. For example, second portion can include inwardly protruding features such as "rifling," various bosses or protrusions.

[0044] According to various embodiments, one or more suspended rings or flanges reside within interior chamber 206. In Figure 2 ​In the example system, there are two flanges – a proximal flange 214 and a distal flange 216. The proximal flange 214 is positioned at a first location relative to the longitudinal central axis 118, closer to the insertion end 106. The distal flange 216 is positioned at a second location relative to the longitudinal central axis 118, closer to the discharge end 204. Conceptually, the proximal flange 214 and the distal flange 216 divide the internal chamber 206 into a proximal volume 218, an intermediate volume 220, and a distal volume 222. Although two flanges 214 and 216 are shown, one or more flanges may be implemented (e.g., only one flange, exactly three flanges), and therefore, showing a system with two flanges should not be considered a limitation.

[0045] See also Figure 2 Specifically, see proximal flange 214. Example proximal flange 214 is in the form of a ring or toroidal surface. More precisely, example proximal flange 214 is in the form of a ring. However, any shape suitable for suspension within the internal chamber 206 can be used, such as a toroidal surface with a square cross-section. Example proximal flange 214 has a thickness of approximately 0.75 inches measured parallel to the longitudinal central axis 118. Example proximal flange 214 is suspended within the internal chamber 206 by means of multiple supports, struts, or pillars. Figure 2 In instance system 100, three pillars are associated with proximal flange 214, but... Figure 2 Only two are visible in the cross-sectional view. Specifically, the first strut 224 is shown in the cross-section. Strut 224 extends from the proximal flange 214 along a first radial direction relative to the longitudinal central axis 118. Strut 224 is coupled to the inner surface of the internal chamber 206. The second strut 226 is also present. Figure 2 As can be seen in the cross-sectional perspective view. Support 226 extends from the proximal flange 214 along a second radial direction relative to the longitudinal central axis 118. Support 226 is also coupled to the inner surface of the internal chamber 206. In the example system, a third support will also be associated with the proximal flange 214, but this third support is not visible due to the cross-sectional view. All supports of the proximal flange 214 (e.g., supports 224 and 226) reside at the same longitudinal location along the longitudinal central axis 118, but each support extends in a different radial direction relative to the longitudinal central axis 118.

[0046] Referring now to the distal flange 216. The distal flange 216 is in the form of a ring or toroidal surface. More precisely, the distal flange 216 is in the form of a ring. However, any shape suitable for suspension within the internal chamber 206 can be used, such as a toroidal surface with a square cross-section. Furthermore, the proximal flange 214 and the distal flange 216 do not necessarily need to match. Example: The distal flange 216 has a thickness of approximately 0.75 inches measured parallel to the longitudinal central axis 118, but the distal flange 216 and the proximal flange 214 do not necessarily have the same thickness. Example: The distal flange 216 is suspended in the internal chamber 206 by means of multiple supports, struts, or pillars. Figure 2 In instance system 100, three pillars are associated with the distal flange 216. Figure 2 In the cross-sectional view, two of the three struts associated with the distal flange 216 are visible. Specifically, the first strut 228 is shown in the cross-section. Strut 228 extends from the distal flange 216 along a third radial direction relative to the longitudinal central axis 118. Strut 228 is coupled to the inner surface of the internal chamber 206. The second strut 230 is also present. Figure 3 As can be seen in the cross-sectional view. The strut 230 extends from the distal flange 216 in a fourth radial direction relative to the longitudinal central axis 118. The strut 230 is also coupled to the inner surface of the internal chamber 206. In the example system, a third strut will also be associated with the distal flange 216, but the third strut is not visible due to the cross-sectional view.

[0047] Each of the supports (e.g., 224, 226, 228, and 230) extends in a radial direction different from the radial direction of other supports associated with a particular flange. Furthermore, in example system 100, between the flanges, each support extends in a different radial direction. However, between the flanges, and given the offset between the flanges along the longitudinal central axis 118, the supports may extend in approximately the same radial direction without adversely affecting the casting or molding of the polymer sleeve 102 or its use.

[0048] Figure 3 The diagram shows a cross-sectional view of the polymer sleeve 102, taken across the proximal volume 218, viewed towards the discharge end 204 according to at least some embodiments. Specifically, Figure 3 The outer wall 300 of the polymer sleeve 102 is visible, and the inner surface of the outer wall 300 defines the inner surface 302 of the internal chamber 206. Figure 3 In the view, the proximal flange 214 is shown suspended within the internal chamber 206. The proximal flange 214 is suspended within the internal chamber 206 by struts 224, 226, and 304. Figure 3 In the view, the longitudinal center axis 118 is perpendicular to the page plane and is therefore shown as a single point. Figure 3Three example radials extending from the longitudinal central axis 118 are further illustrated in three distinct radial directions. These radials are aligned with three example struts 224, 226, and 304. More specifically, each strut extends radially relative to the longitudinal central axis 118 and is coupled to a corresponding portion of the inner surface 302. Consider strut 224, which extends from the proximal flange 214 to the inner surface 302 of the inner chamber 206 along a radial direction indicated by radial line 308. Strut 226 extends from the proximal flange 214 to the inner surface 302 along a radial direction indicated by radial line 310. Strut 304 extends from the proximal flange 214 to the inner chamber 206 along a radial direction indicated by radial line 312. In the example embodiment, radial lines 308 and 310, and thus the directions in which struts 224 and 226 extend, form an angle of at least 90 degrees, and an angle α of approximately 120 degrees as illustrated. Radial lines 310 and 312, and therefore the directions in which supports 226 and 304 extend, form an angle of at least 90 degrees, and an angle β of approximately 120 degrees as shown. Finally, radial lines 312 and 308, and therefore the directions in which supports 304 and 224 extend, form an angle of at least 90 degrees, and an angle θ of approximately 120 degrees as shown. In instances where exactly two supports are present, the directions in which the supports extend may form an angle of 180 degrees.

[0049] See also Figure 2 The proximal flange 214 has the same thickness as the strut, and thus the combination of the strut and the proximal flange 214 forms multiple gap volumes. Specifically, strut 224, strut 226, inner surface 302, and proximal flange 214 define gap volume 314. Strut 226, strut 304, inner surface 302, and proximal flange 214 define another gap volume 316. Strut 304, strut 224, inner surface 302, and proximal flange 214 define yet another gap volume 318. During use of system 100, and specifically during insertion, the proximal flange 214 will tend to move along the longitudinal central axis 118 toward the discharge end 204. Figure 3 Displacement. Gap volumes 314, 316, and 318 allow the discharged air to move proximally during insertion. Similarly, during withdrawal, the proximal flange 214 will tend to move proximally. Gap volumes 314, 316, and 318 allow the discharged air to move distally during withdrawal.

[0050] Because it is used to form Figure 2 The location of the "cut" in the view, where the proximal flange 214 is visible, and is therefore the subject of the discussion. However, an additional flange may exist (e.g., the distal flange 216). Figure 2Each additional flange will also have its associated two or more struts, which have radial offsets based on the number of struts (e.g., two struts with a 180-degree offset, three struts with a 120-degree offset, and four struts with a 90-degree offset). Furthermore, each flange will define multiple gap volumes between the struts (e.g., two struts and two gap volumes, three struts and three gap volumes, four struts and four gap volumes). Moreover, in embodiments where more than one flange is present, the flanges need not have the same number of struts. All such variations are contemplated in the specification.

[0051] The proximal flange 214 defines a perforation or aperture 306. According to at least some embodiments, the aperture 306 defines an inner diameter. In some cases, the inner diameter of the aperture 306 is related to the diameter D3 of the main aperture 112. Figure 2 Approximately the same. In other cases, the inner diameter of orifice 306 may be approximately twice the diameter D3. In any case, the inner diameter of orifice 306 is designed and constructed such that during insertion, the diameter expands slightly to provide an area with increased inward circumferential pressure on the penis. In one example, each flange has an orifice having the same inner diameter. In other cases, the inner diameter of each flange may vary based on the longitudinal position of the flange along the longitudinal central axis 118. For example, the inner diameter of orifice 306 of proximal flange 214 may be smaller than that of distal flange 216 ( Figure 4 The inner diameter of the polymer sleeve is determined by the following method: (1) the inner diameter of the polymer sleeve, and vice versa. The instruction manual now turns to an example method for manufacturing the polymer sleeve.

[0052] Figure 4 A perspective view of a mold system 400 according to at least some embodiments is shown. Specifically, Figure 4 An outer mold assembly 402 is shown, comprising a first mold component 404 and a second mold component 406. Each mold component 404 and 406 defines an inner surface, but... Figure 1 In the view, only the inner surface 408 of the mold component 406 is visible. The inner surface 408 of the mold component 406 extends from the insertion end 106 ( Figure 2 Then it crosses over to the emission end 204 ( Figure 1 ) Forming polymer sleeve 102 ( Figure 1 Half of the negative image of the outer surface of the polymer sleeve 102 is formed by the inner surface of the mold component 404 from just after the insertion end 106 to the discharge end 204.

[0053] The mold system 400 further includes a lower mold assembly 410 positioned in operative relation to the inner surface defined by the outer mold assembly 402. The lower mold assembly 410 structurally defines a negative image of the outer portion of the insertion end 106 of the polymer sleeve 102, and thus forms a basin-shaped volume 412. In some cases, and as shown, the basin-shaped volume 412 may define only the main aperture 112 (…). Figure 2 However, in other cases, the lower mold assembly may form a negative image of the anatomical structure (e.g., female genitalia) to be formed on the insertion end 106. The lower mold assembly 410 also defines a rod or post 414 that defines the first portion 208 of the main passage 114 in the completed polymer sleeve 102. Figure 2 The disc assembly 416 is stacked on top of the upper end of the rod 414, and the disc assembly 416, together with the flanges and the pillars of each flange, defines a negative image of the internal cavity. In other words, during the injection molding process, the disc assembly 416 resides within a volume such that no polymeric material can fill and / or occupy the volume, and the locations where the polymeric material is not filled or resided form internal cavities, gap volumes, and pores through the flanges. The rod member 418 is coupled to and / or stacked on top of the disc assembly 416. The outer surface of the rod member 418 defines a second portion 212 of the main passage 114 through the polymer sleeve 102. Figure 1 The negative image of the inner surface of the main passage 114. In the example shown, the rod member 418 has a negative image of the features that will be produced in the second portion 212 of the main passage 114, but in other cases the second portion 212 may be smooth.

[0054] In some example systems, the various mold assemblies, including the lower mold assembly 410, the disc assembly 416, and the rod component 418, may be cast or ground from a metal material such as aluminum. However, other materials (e.g., high-density plastics) may also be used.

[0055] The molding process may involve stacking disk assemblies 416 on rods 414 in the lower mold assembly 410, and coupling rod members 418 to the top of disk assemblies 416. An outer mold assembly 402 closes around the respective assemblies and holds them in place in some manner. A polymeric material in liquid form is injected via an injection port into a volume defined by an inner surface 408, for example, via an injection orifice 420. The liquid polymeric material fills the volume defined by the inner surface 408, thereby expelling air and allowing the polymeric material to cure. Once cured, the outer mold assembly 402 reopens, the rod members 418 are withdrawn from the main passage, and the disk assembly 416 separates into individual disk members (discussed more further below), each disk member being separated via a main orifice 112 ( Figure 2 ) or via emission end 204 ( Figure 5Removal. The polymer sleeve 102 can be trimmed to remove the polymer material cured within the injection orifice, as well as any mold seams or marks formed by the joints of the external mold assembly. In some cases, the manufactured polymer sleeve 102 may be treated with a compound to reduce surface tension (e.g., by coating with talc). The specification now turns to a more detailed description of the example disc assembly 416.

[0056] Figure 2 A perspective view of a lower disk component according to at least some embodiments is shown. Specifically, the lower disk component 500 defines an outer surface 502 and an upper mold surface. In one example, the outer surface 502 defines a negative image of a portion of an internal cavity 206, and in another example, the outer surface 502 defines a proximal volume 218. Figure 3 ) and interstitial volumes 314, 316 and 318 ( Figure 3 At least a portion of each of the following. Example lower disc component 500 defines three channels 504A, 504B, and 504C. Channels 504 extend from the outer surface 502 to the central region 508. Lower disc component 500 also defines a protrusion or hill 510, which may be centered within the mold surface.

[0057] Channels 504A, 504B, and 504C are negative images of the portions of the struts that suspend and support the proximal flange 214. The central region 508 is a negative image of a portion of the proximal flange 214, and in the example, is a torus with a square or rectangular cross-section. Hill 510 is a hole 306 (…). Figure 5 At least a portion of the negative image of the material. During the injection molding process, the polymeric material, in liquid form, is forced into the channel 504 and the central region 508. Once cured, the polymeric material thus forms pillars 224, 226, and 304 and a proximal flange 214. It is thus clear that pillars 224, 226, and 304 and the proximal flange 214 are not individual components assembled into a system; in fact, the pillars and flange are formed simultaneously and are therefore integrated components. Therefore, the pillars and flange can be referred to as pillar components and flange components.

[0058] See also Figure 6 In some cases, a specific rotational alignment is used between the lower disk component 500 and the intermediate disk component, and therefore the lower disk component 500 may have one or more features that aid in the alignment process. For example, the lower disk component 500 has an alignment feature 514 defined in the hillock 510. Example alignment feature 514 is an aperture defining a triangular cross-section, but other cross-sectional shapes (e.g., square, rectangular, hexagonal) may be used. The corresponding feature of the intermediate disk component (discussed more further below) has a shape that overlaps with the example alignment feature, thus ensuring proper rotational alignment. Other alignment features may be used equivalently. The description now turns to the intermediate disk component.

[0059] Figure 7 A bottom perspective view of an intermediate disk component according to at least some embodiments is shown. Specifically, the intermediate disk component 600 defines an outer surface 602 and two mold surfaces—a lower mold surface defined on the lower surface shown, and an upper surface (not visible, but...) Figure 3 The upper mold surface is defined by the outer surface 602. Example: The outer surface 602 defines clearance volumes 314, 316, and 316 (…). Figure 2 Part of the middle volume 220 () Figure 2 ), and the distal flange 216 of the instance ( Figure 5 The negative image of the portion of the associated gap volume.

[0060] During the formation of disk assembly 416, intermediate disk component 600 is configured to stack on and abut against lower disk component 500. Intermediate disk component 600 defines lower channels 604A, 604B, and 604C. Lower channels 604A, 604B, and 604C correspond to lower disk component 500 (…). Figure 2 Channels 504A, 504B, and 504C. The lower channel 604 is a negative image of the portion (e.g., the distal portion) of the struts 224, 226, and 305 that suspend and support the proximal flange 214. Therefore, the combination of the intermediate disk component 600 and the lower disk component 500 defines the formation for the proximal flange 214 (…). Figure 3 The channels for the supports 224, 226 and 304. However, in other cases, the lower surface of the intermediate disc component 600 may be flat, and thus only the upper surface of the channels forming the supports for the proximal flange 214 is defined.

[0061] The intermediate disk component 600 further defines a central region 608 on its lower surface. The central region 608 is a negative image of a portion of the proximal flange 214, and in some instances is a torus having a square or rectangular cross-section. The intermediate disk component 600 further defines a protrusion or hillock 610 on its lower surface, the hillock 610 being centered within the mold surface. The hillock 610 is a pore 306 ( Figure 6 At least a portion of the negative image of the central disk component 600. During the injection molding process, the polymeric material, in liquid form, is forced into the channel 604 and the central region 608. Once cured, the polymeric material thus forms the pillars 224, 226, and 304 and the proximal flange 214. However, in other cases, the lower surface of the central disk component 600 may be flat, and thus only the upper surface of the proximal flange 214 is defined.

[0062] See also Figure 5In some cases, a specific rotational alignment is used between the lower disk component 500 and the intermediate disk component 600, and therefore the intermediate disk component 600 may also have one or more features that aid in the alignment process. For example, the lower mold surface of the intermediate disk component 600 has an alignment feature 614 associated with the hill 610. Example alignment feature 614 is a protrusion defining a triangular cross-section, but other cross-sectional shapes may be used. Example alignment feature 614 is designed and constructed to fold into the lower disk component 500 (…). Figure 7 Alignment feature 514 is used in the alignment feature. Other alignment features can be used equivalently. The instruction manual now turns to the upper mold surface of the intermediate disk component 600.

[0063] Figure 7 A top perspective view of an intermediate disk component according to at least some embodiments is shown. Again, the intermediate disk component 600 defines an upper mold surface. The upper mold surface of the intermediate disk component 600 defines three channels 704A, 704B, and 704C. Channels 704 extend from the outer surface 602 to a central region 708. The upper surface of the intermediate disk component 600 also defines a protrusion or hillock 710, which may be centered within the upper mold surface.

[0064] Channels 704A, 704B, and 704C are negative images of portions of the struts (e.g., struts 228 and 230) that suspend and support the distal flange 216. The central region 708 is a negative image of a portion of the distal flange 216, and in some instances is a torus with a square or rectangular cross-section. Hillock 710 is a negative image of at least a portion of the aperture passing through the distal flange 216. During the injection molding process, a polymeric material in liquid form is forced into channels 704 and the central region 708. Once cured, the polymeric material thus forms the struts (e.g., struts 228 and 230) and the distal flange 216. Thus, the struts and the distal flange 216 are not individual components assembled into a system; in fact, the struts and the distal flange are formed simultaneously and are therefore integrated components. Therefore, the struts and the flange can also be referred to as strut components and flange components.

[0065] See also Figure 8 In some cases, the intermediate disk component 600 is used for specific rotational alignment with the upper component, and therefore the upper mold surface of the intermediate disk component 600 may have one or more features that aid the alignment process. For example, the upper mold surface of the intermediate disk component 600 has an alignment feature 714 defined in a hill 710. The example alignment feature 714 is an aperture defining a triangular cross-section, but other cross-sectional shapes may be used. The corresponding feature of the upper disk component (discussed more further below) has a shape that overlaps into the example alignment feature, thus ensuring proper rotational alignment. Other alignment features may be used equivalently. The description now turns to the upper disk component.

[0066] Figure 2 A bottom perspective view of an upper disc component according to at least some embodiments is shown. Specifically, the upper disc component 800 defines an outer surface 802 and a lower mold surface. Example: The outer surface 802 defines the gap volume between the supports of the distal flange 216 and the distal volume 222 (…). Figure 5 A negative image of a portion of ).

[0067] During the formation of the disk assembly, the upper disk component 800 is configured to stack on top of the intermediate disk component 600 and abut against the upper surface of the intermediate disk component 600. The upper disk component 800 defines channels 804A, 804B, and 804C. Channels 804A, 804B, and 804C correspond to the intermediate disk component 600 (see [link to documentation]). Figure 2 Channels 704A, 704B, and 704C are on the upper mold surface of the intermediate disk component 600. Channel 804 is a negative image of the portion (e.g., the distal portion) of the struts (e.g., struts 228 and 230) that suspend and support the distal flange 216. Therefore, the combination of the upper mold surface of the intermediate disk component 600 and the upper disk component 800 defines the formation for the distal flange 216. Figure 8 The upper disk component 800 may have a lower surface that is flat and thus only defines the upper surface of the channel forming the support for the distal flange 216.

[0068] The upper disc component 800 further defines a central region 808 on the lower mold surface. The central region 808 is a negative image of a portion of the distal flange 216, and in some cases is a torus having a square or rectangular cross-section. The upper disc component 800 further defines a protrusion or hillock 810 on the lower mold surface, which may be centered within the mold surface. The hillock 810 is a negative image of at least a portion of the aperture through the distal flange 216. During the injection molding process, a polymeric material in liquid form is forced into the channel 804 and the central region 808. Once cured, the polymeric material thus forms pillars (e.g., pillars 228 and 230) and the distal flange 216. However, in other cases, the lower surface of the upper flange component 800 may be flat, and thus only define the upper surfaces of the pillars and the proximal flange 214.

[0069] See also Figure 4In some cases, a specific rotational alignment is used between the intermediate disk component 600 and the upper disk component 800, and therefore the upper disk component 800 may also have one or more features that aid in the alignment process. For example, the lower surface of the upper disk component 800 has an alignment feature 814 defined on a hill 810. Example alignment feature 814 is a protrusion defining a triangular cross-section, but other cross-sectional shapes may be used. Example alignment feature 814 is designed and constructed to overlap with alignment feature 714 on the upper surface of the intermediate disk component 600. Other equivalent alignment features may be used.

[0070] Return to Figure 2 In an exemplary embodiment, the disk assembly 416 includes a lower disk component 500, an intermediate disk component 600, and an upper disk component 800. Specifically, the disk assembly 416 can be assembled by mating the lower disk component 500 against the intermediate disk component 600 and the intermediate disk component 600 against the upper disk component 800, wherein all three disk components are coaxially aligned. In one example, the lower disk component 500 and the intermediate disk component 600 define at least two pillars and a proximal flange 214. Figure 9 The lower disk component 500 and the middle disk component 600 define a negative image of the proximal flange 214, and the middle disk component 600 and the upper disk component 800 define a negative image of the distal flange 216. In a particular example, the lower disk component 500 and the middle disk component 600 define a negative image of the proximal flange 214, and the middle disk component 600 and the upper disk component 800 define a negative image of the distal flange 216.

[0071] ​ A method according to at least some embodiments is illustrated. Specifically, the method begins (box 900) and includes: placing a lower mold assembly, the lower mold assembly structurally defining a negative image of an insertion end of a polymer sleeve and a negative image of a first portion of a main passageway of the polymer sleeve (box 902); assembling a disc assembly in a mating relationship, the disc assembly structurally defining a negative image of an internal volume of the polymer sleeve and a negative image of at least two pillars and a first flange (box 904); stacking the disc assemblies in a mating relationship with the lower mold assembly (box 906); coupling a rod member to the disc assembly, the outer surface of the rod member defining a negative image of a main passageway from the internal volume to an outlet end of the polymer sleeve (box 908); closing an outer mold assembly around the disc assembly and the rod member, the inner surface of the outer mold assembly structurally defining a negative image of an outer surface of the polymer sleeve (box 910); and injecting a liquid polymer compound into the outer mold assembly (box 912). The method then ends (box 914).

[0072] The foregoing discussion is intended to illustrate the principles and various embodiments of the invention. Once fully understanding the above disclosure, many variations and modifications will become apparent to those skilled in the art. For example, although referred to as discharge end 204, in some cases the system may be designed and configured to be inserted from either direction, and therefore reference to discharge end 204 should not be construed as limiting operability to discharge only. As another example, the flange may be a triangular or cubic shape, its corners abutting the inner surface of the internal volume and thus defining the support. It is intended that the appended claims be construed as covering all such variations and modifications.

Claims

1. A system comprising a polymer sleeve, the polymer sleeve comprising: An elongated body, which defines a first end, a second end opposite to the first end, and a longitudinal central axis; A main passage that passes through the elongated body along the longitudinal central axis, the main passage extending from the first end to the second end, and the main passage defining a first aperture on the first end and a second aperture on the second end; An internal chamber is defined within the main passage between the first pore and the second pore; A first flange is disposed at a first position within the internal cavity along the longitudinal central axis, the first flange defining an aperture at least partially aligned with the longitudinal central axis; A first support column extends from the first flange in a first radial direction relative to the longitudinal central axis, and the first support column is coupled to the inner surface of the internal chamber; A second support extends from the first flange in a second radial direction relative to the longitudinal central axis, and the second support is coupled to the inner surface of the internal chamber; as well as The first and second pillars suspend the first flange within the internal cavity.

2. The system of claim 1, further comprising a first gap volume defined between the inner surface of the internal chamber, the first support, and the second support.

3. The system of claim 1, wherein the first radial direction and the second radial direction form an angle of at least 90 degrees.

4. The system of claim 3, wherein the first radial direction and the second radial direction form an angle of 180 degrees.

5. The system of claim 1, further comprising a third support extending from the first flange in a third radial direction relative to the longitudinal central axis, the third support being coupled to the inner surface of the internal chamber.

6. The system according to claim 5, Wherein the first radial direction and the second radial direction form an angle of 120 degrees; and The second radial direction and the third radial direction form an angle of 120 degrees.

7. The system according to claim 5, further comprising: A first gap volume is defined between the inner surface of the internal chamber, the first support, and the second support; The second gap volume is defined between the inner surface, the second pillar, and the third pillar; as well as A third gap volume is defined between the inner surface, the third pillar, and the first pillar.

8. The system according to claim 1, further comprising: The second flange is positioned at a second location within the internal cavity along the longitudinal central axis. A third support extends from the second flange in a third radial direction relative to the longitudinal central axis, and the third support is coupled to the inner surface; A fourth support, extending from the second flange in a fourth radial direction relative to the longitudinal central axis, is coupled to the inner surface; and The third and fourth pillars suspend the second flange within the internal cavity.

9. The system according to claim 1, further comprising: A third support extends from the first flange in a third radial direction relative to the longitudinal central axis, and the third support is coupled to the inner surface; The second flange is positioned at a second location within the internal cavity along the longitudinal central axis. A fourth support column extends from the second flange in a fourth radial direction relative to the longitudinal central axis, and the fourth support column is coupled to the inner surface; A fifth support column extends from the second flange in a fifth radial direction relative to the longitudinal central axis, and the fifth support column is coupled to the inner surface; as well as A sixth support, which extends from the second flange in a sixth radial direction relative to the longitudinal central axis, is coupled to the inner surface.

10. The system of claim 9, further comprising: The first radial direction and the second radial direction form an angle of 120 degrees; The second radial direction and the third radial direction form an angle of 120 degrees; The fourth radial direction and the fifth radial direction form an angle of 120 degrees; The fifth radial direction and the sixth radial direction form an angle of 120 degrees; and The first radial direction and the third radial direction form an angle of 60 degrees.

11. The system of claim 1, further comprising an outer cladding of rigid material defining an internal volume, wherein the polymer sleeve is at least partially disposed within the outer cladding.

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