Medical tools for interacting with lumens

Abstract

A medical lumen interaction tool and associated manufacturing methods are provided that includes an elongated core having a longitudinal axis, a body attached to the elongated core for interacting with a lumen, and one or more anchors connecting the body to the elongated core along the longitudinal axis of the elongated core to prevent relative movement between the elongated core and the body along the longitudinal axis.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS AND PRIORITY CLAIM

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 316,494, filed March 4, 2022, the entire contents of which are incorporated herein by reference.

[0002]

[0002] The present disclosure relates generally to medical tools, and more particularly, to medical tools for interacting with a lumen of a medical device and / or for interacting with an anatomical or artificial lumen. [Background technology]

[0003]

[0003] Some medical tools include an elongated core having one or more working bodies attached thereto for interacting with a lumen. Such medical tools may be configured to be inserted into and moved along a lumen of a medical device or an anatomical lumen. During use, the working body(s) should not become unintentionally detached from the elongated core. Summary of the Invention [Means for solving the problem]

[0004] In one aspect, the present disclosure describes a lumen cleaning tool for cleaning a lumen of a medical device. The lumen cleaning tool includes: an elongated core having a longitudinal axis, the elongated core being defined by wires twisted together; a wiper attached to an elongated core; and an anchor connecting the wiper to the elongated core along the longitudinal axis of the elongated core to prevent relative movement between the elongated core and the wiper along the longitudinal axis.

[0005]

[0005] The elongated core may include a tightly stranded section and a loosely stranded section having different axial positions along the elongated core. The loosely stranded section may define a gap between the wires twisted together. The wiper may be overmolded onto the loosely stranded section of the elongated core. The anchor may include a beam extending into the gap. The beam and wiper may have a monolithic construction.

[0006]

[0006] The gaps can define through passages for the beams to extend laterally through the elongated core.

[0007] The anchor may include a protrusion attached to the elongate core. The wiper may at least partially seal the protrusion.

[0007]

[0008] The protrusions and wipers may be made from different materials.

[0009] The protrusions may include bristles held between the wires twisted together.

[0010] The protrusions may be disc-shaped. The protrusions may occupy a space within a radially extending fin of the wiper.

[0008]

[0011] The wiper may include an overmolded body over the elongate core and over the protrusions. The protrusions may protrude outwardly from the overmolded body.

[0009]

[0012] The anchor may include a helical arrangement of bristles extending radially outwardly from an elongate core. The wiper may at least partially seal the helical arrangement of bristles.

[0010]

[0013] The lumen clearing tool may include a plurality of anchors connecting the wiper to the elongate core along the longitudinal axis of the elongate core. The plurality of anchors may be axially spaced apart along the longitudinal axis of the elongate core.

[0011]

[0014] The plurality of anchors can include a first anchor having a first radial dimension from a longitudinal axis of the elongate core and a second anchor having a second radial dimension from the longitudinal axis of the elongate core. The second radial dimension can be greater than the first radial dimension.

[0012]

[0015] The anchor may be crimped onto the elongate core. The anchor may be welded to the elongate core. The anchor may be overmolded onto the elongate core.

[0016] The anchor may include a tube having an inner bore. The elongated core may include a first portion within the inner bore of the tube. The elongated core may include a second portion exterior to the inner bore of the tube. The wiper may be overmolded onto the second portion of the elongated core and onto the tube.

[0013]

[0017] The longitudinal length of the tube may be greater than the longitudinal length of the first portion of the elongated core inside the tube.

[0018] The anchor may be made of polypropylene, and the wiper may be made of a thermoplastic elastomer.

[0014]

[0019] In another aspect, the present disclosure describes a medical lumen interaction tool for interacting with a lumen. The medical lumen interaction tool includes: an elongated core having a longitudinal axis; a body for interacting with the lumen, the body being attached to the elongate core; and one or more anchors connecting the body to the elongated core along a longitudinal axis of the elongated core to prevent relative movement between the elongated core and the body along the longitudinal axis, the one or more anchors comprising: a beam having a monolithic construction with the body and extending within a passageway formed through the elongated core; and A projection attached to the elongated core and at least partially sealed by the body. Includes one or both of the following:

[0015]

[0020] The one or more anchors may include a beam.

[0021] The elongate core may include wires twisted together, and the passageways may be defined by gaps between the wires.

[0016]

[0022] The elongate core may include a tightly twisted section and a loosely twisted section, and the passageway may be located within the loosely twisted section.

[0023] The body can be a first body. The medical lumen interaction tool can include a second body for interacting with the lumen. The second body can be attached to the elongated core and axially positioned within the tightly twisted section of the elongated core.

[0017]

[0024] The elongated core may include a helical coil, and the passageway may be defined by a gap defined between two turns of wire of the helical coil.

[0025] The helical coil can include a first section having a first pitch and a second section having a second pitch greater than the first pitch. The first section can be axially adjacent to the second section along the helical coil. The body can be attached to the helical coil and can be axially located within the second section of the helical coil.

[0018]

[0026] The first section of the helical coil and the second section of the helical coil may have substantially the same outer diameter.

[0027] The wire may be the only wire in the elongated core.

[0019]

[0028] The wire may have a polygonal cross-sectional profile.

[0029] The wire may have a circular cross-sectional profile.

[0030] One or more of the anchors may include a protrusion.

[0020]

[0031] The protrusions may include bristles.

[0032] The protrusion may have a helical shape.

[0033] The projections may include a helical arrangement of bristles extending radially outwardly from an elongate core.

[0021]

[0034] The protrusion may include a disc.

[0035] The protrusion may be ring-shaped.

[0036] The projection may include a tube having an inner bore. The elongated core may include a first portion within the inner bore of the tube. The elongated core may include a second portion exterior to the inner bore of the tube. The body may be overmolded onto the second portion of the elongated core and onto the tube.

[0022]

[0037] The longitudinal length of the tube may be greater than the longitudinal length of the first portion of the elongated core inside the tube.

[0038] The anchor may be made of polypropylene.

[0023]

[0039] The body may be made of a thermoplastic elastomer.

[0040] The elongated core may include a helical coil.

[0041] The helical coil can include a first section having a first outer diameter and a second section having a second outer diameter greater than the first outer diameter. The projection can include the second section.

[0024]

[0042] The helical coil can include a third section having a third outer diameter smaller than the second outer diameter of the second section. The second section can be axially located between the first section and the third section.

[0025]

[0043] The second section may have an axial span that is less than the axial span of the first section.

[0044] The elongated core may have only one wire defining a helical coil.

[0026]

[0045] The body may be overmolded onto the elongate core.

[0046] The body may be a wiper.

[0047] The body can be a lumen stabilizer.

[0027]

[0048] In a further aspect, the present disclosure describes a method of manufacturing a medical lumen interaction tool for interacting with a lumen, the method comprising: receiving an elongated core having a longitudinal axis; and coupling the lumen interaction body to the elongate core to prevent relative movement between the elongate core and the lumen interaction body along the longitudinal axis by performing one or both of the following: overmolding the lumen interacting body onto the elongate core using an overmolding material, the overmolding material defining a beam extending into a passageway formed through the elongate core; and The lumen interacting body is used to at least partially seal against the protrusion attached to the elongate core.

[0028]

[0049] Coupling the lumen interaction body with the elongate core can include overmolding the lumen interaction body onto the elongate core using an overmolding material. The overmolding material can define beams extending through passageways formed through the elongate core.

[0029]

[0050] The elongate core may include pairs of wires twisted together, and the passageway may be defined by a gap between the pairs of wires.

[0051] The elongate core may include a tightly twisted section and a loosely twisted section, and the passageway may be located within the loosely twisted section.

[0030]

[0052] Coupling the lumen interaction body with the elongate core can include at least partially sealing a protrusion attached to the elongate core with the lumen interaction body.

[0031]

[0053] At least partially sealing the protrusions attached to the elongate core with the lumen interacting body may include overmolding the lumen interacting body onto the elongate core and onto the protrusions.

[0032]

[0054] The protrusions may include bristles.

[0055] The method may include welding, crimping, or overmolding the projections onto the elongate core.

[0033]

[0056] The elongated core may include a helical coil.

[0057] The projection may comprise a tube having an inner bore. The method may include inserting an elongate core into the inner bore of the tube prior to at least partially sealing the tube with the lumen interaction body.

[0034]

[0058] The method can include overmolding a lumen interacting body onto the elongate core and onto a portion of the tube.

[0059] The method can include injecting an overmolding material between the elongated core and the inner bore of the tube.

[0035]

[0060] Further details of these and other aspects of the subject matter of the present application will become apparent from the detailed description and figures included below.

[0061] Reference is now made to the accompanying drawings, in which: [Brief description of the drawings]

[0036] [Figure 1]

[0062] 1 is a perspective view of an exemplary lumen cleaning tool for cleaning a lumen of a medical device. [Diagram 2]

[0063] FIG. 2 is a side elevational view of the tool of FIG. 1. [Diagram 3]

[0064] 2 is a side elevational view of the tool of FIG. 1 disposed within a lumen of a medical device and advanced within the lumen. [Figure 4]

[0065] FIG. 13 is a side elevational view of another exemplary lumen cleaning tool disposed within and propelled within a lumen of a medical device. [Diagram 5]

[0066] FIG. 5 is a side elevational view of a scrubber of the lumen cleaning tool of FIG. 4. [Figure 5A]

[0067] FIG. 6 is an enlarged view of the bristles of the scrubber of FIG. 5 in area A of FIG. 5. [Figure 6]

[0068] FIG. 13 is a side elevational view of another exemplary lumen cleaning tool. [Figure 7]

[0069] 1 is a flow diagram of a method for cleaning a lumen of a medical device. [Figure 8]

[0070] 1 is a flow diagram of a method of propelling a lumen cleaning tool along a lumen of a medical device using a pressure differential. [Figure 9]

[0071] 2 is a side view of the lumen cleaning tool of FIG. 1 disposed within a lumen of a medical device and propelled along the lumen using a pressure differential. [Figure 10]

[0072] 1 is a perspective view of another exemplary lumen cleaning tool for cleaning a lumen of a medical device. [Figure 11]

[0073] 11 is a side view of a portion of the lumen cleaning tool of FIG. 10 disposed within and propelled along a curved lumen of a medical device. [Figure 12]

[0074] 11 is a schematic diagram of an exemplary wiper of the lumen cleaning tool of FIG. 10 being released from a mold, the wiper being shown as transparent to show an elongated core disposed within the wiper. [Figure 13]

[0075] FIG. 11 is a side view of a portion of the elongate core of the lumen clearing tool of FIG. 10 shown in isolation. [Figure 14]

[0076] 14 is a schematic perspective view of a portion of the elongate core of FIG. 13 during manufacture of the elongate core. [Figure 15A]

[0077] 15 is a cross-sectional view of the lumen clearing tool of FIG. 12 taken along line 15-15 of FIG. 12. [Figure 15B]

[0078] 15 is a cross-sectional view of another exemplary lumen clearing tool of the type shown in FIG. 12 taken along line 15-15 of FIG. 12. [Figure 15C] 15 is a cross-sectional view of another exemplary lumen clearing tool of the type shown in FIG. 12 taken along line 15-15 of FIG. 12. [Figure 16]

[0079] FIG. 1 is a side view of another exemplary lumen cleaning tool for cleaning a lumen of a medical device, the wiper of the lumen cleaning tool is shown as transparent to show the elongated core with bristles attached to the elongated core connecting the wiper to the elongated core. [Figure 17]

[0080] FIG. 17 is a side view of the elongated core and bristles of the lumen cleaning tool of FIG. 16. [Figure 18]

[0081] FIG. 1 is a side view of another exemplary lumen cleaning tool for cleaning a lumen of a medical device, where the wiper of the lumen cleaning tool is shown as transparent to show the elongated core with a ring-shaped anchor attached to the elongated core connecting the wiper to the elongated core. [Figure 19]

[0082] FIG. 20 is a side view of the elongated core and ring anchor of the lumen clearing tool of FIG. 18. [Figure 19A]

[0083] FIG. 20 is an enlarged side view of a ring anchor crimped onto the elongated core of FIG. 19. [Figure 19B]

[0084] FIG. 20 is an enlarged side view of a ring anchor welded to the elongated core of FIG. 19. [Figure 20]

[0085] FIG. 1 is a side view of a portion of another exemplary lumen cleaning tool for cleaning a lumen of a medical device, where the wiper of the lumen cleaning tool is shown as transparent to show the elongated core with an anchor welded to the elongated core connecting the wiper to the elongated core. [Figure 21]

[0086] FIG. 21 is a side view of the elongate core and anchor of the lumen clearing tool of FIG. 20. [Figure 22]

[0087] FIG. 1 is a side view of a portion of another exemplary lumen cleaning tool for cleaning a lumen of a medical device, where the wiper of the lumen cleaning tool is shown as transparent to show the elongated core with an anchor welded and crimped to the elongated core connecting the wiper to the elongated core. [Diagram 23]

[0088] FIG. 23 is a side view of the elongate core and anchor of the lumen clearing tool of FIG. 22. [Figure 24]

[0089] FIG. 1 is a side view of a portion of another exemplary lumen cleaning tool for cleaning a lumen of a medical device, where the wiper of the lumen cleaning tool is shown as transparent to show the elongated core with an anchor attached to the elongated core connecting the wiper to the elongated core. [Diagram 25]

[0090] FIG. 25 is a side view of the elongate core and anchor of the lumen clearing tool of FIG. 24. [Figure 26]

[0091] 1 is a perspective view of an exemplary lumen stabilization tool for stabilizing a lumen. [Figure 27]

[0092] FIG. 27 is a side view of a portion of the lumen stabilization tool of FIG. 26, in which the stabilizer of the lumen stabilization tool is shown as transparent to show the elongated core with bristles attached to the elongated core connecting the stabilizer to the elongated core. [Figure 28]

[0093] FIG. 27 is a side view of the elongated core and bristles of the lumen stabilization tool of FIG. 26. [Figure 29]

[0094] FIG. 13 is a side view of a portion of another exemplary luminal stabilization tool, where the stabilizer of the luminal stabilization tool is shown as transparent to show the elongated core including the exemplary helical coil. [Diagram 30]

[0095] FIG. 30 is a side view of the elongate core of the lumen stabilization tool of FIG. 29 shown in isolation. [Diagram 31]

[0096] FIG. 31 is an enlarged side view of a portion of material from the helical coil and stabilizer of FIG. 30. [Diagram 32]

[0097] FIG. 13 is a side view of a portion of another exemplary luminal stabilization tool, where the stabilizer of the luminal stabilization tool is shown as transparent to show an elongated core including another exemplary helical coil. [Diagram 33]

[0098] FIG. 33 is a side view of the elongate core of the lumen stabilization tool of FIG. 32 shown in isolation. [Diagram 34]

[0099] FIG. 13 is a side view of a portion of another exemplary luminal stabilization tool, where the stabilizer of the luminal stabilization tool is shown as transparent to show an elongated core including another exemplary helical coil. [Diagram 35]

[0100] FIG. 35 is a side view of the elongate core of the lumen stabilization tool of FIG. 34 shown in isolation. [Diagram 36]

[0101] 36A and 36B illustrate an exemplary two-shot overmolding process for manufacturing a lumen cleaning tool. [Figure 37A]

[0102] FIG. 1 is a perspective view of an exemplary anchor attached to an elongate core. [Figure 37B]

[0103] 37B is a side view of an exemplary lumen interaction tool including a lumen interaction body partially sealing the anchor of FIG. 37A. [Figure 37C]

[0104] 37C is a cross-sectional view of the lumen interaction tool of FIG. 37B taken along line 37C-37C of FIG. 37B. [Figure 38]

[0105] 1 is a side view of another exemplary lumen cleaning tool for cleaning a lumen of a medical device that includes a tube connecting a wiper to an elongate core. [Figure 39]

[0106] 39 is a schematic diagram of a portion of a lumen cleaning tool within region 39 of FIG. 38, showing a wiper overmolded onto a portion of the elongate core and onto a portion of the tube. [Diagram 40]

[0107] FIG. 39 is an enlarged view of a portion of the lumen clearing tool in region 40 of FIG. 38. [Diagram 41]

[0108] 1 is a flow diagram of a method of manufacturing a lumen interacting tool for interacting with a lumen. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0037]

[0109] Detailed Description

[0110] The following disclosure describes medical tools and associated methods for interacting with (e.g., cleaning, contacting, stabilizing) lumens of reusable medical (e.g., surgical) devices, such as, for example, endoscopes, and / or anatomical lumens, such as blood vessels of the gastrointestinal tract or cardiovascular system of a human or animal. In some embodiments, the medical tools described herein can include one or more actuating lumen-interacting bodies (e.g., lumen stabilizers, such as lumen wipers, implantable stents, stent-like devices, or other implants) attached to and coupled with an elongated core by one or more anchors. The anchor(s) can increase the holding force of the lumen-interacting body(s) on the elongated core to overcome frictional force(s) between the lumen-interacting body(s) and the lumen when the tool is inserted into and propelled inside the lumen.

[0038]

[0111] In some embodiments, the coupling may be provided by mechanical and / or adhesive locking between the lumen interaction body and the anchor. In other words, the movement of the lumen interaction body along the elongate core may be constrained by the anchor. For example, the coupling may be provided by the lumen interaction body and the anchor mating with one another such that the movements of the lumen interaction body and the anchor may be coordinated (e.g., synchronized). For example, the coupling may be provided by the lumen interaction body and the anchor being braided or interwoven with one another. In some embodiments, the coupling may be provided by an interconnection of one or more portions between the lumen interaction body and the anchor. In some embodiments, the coupling may be provided by a suitable (e.g., melt) bond between the lumen interaction body and the anchor.

[0039]

[0112] In some embodiments, the anchor(s) can prevent migration of the implantable luminal stabilization body within the lumen. The increased retention force of the lumen interacting body(s) on the elongate core can reduce the likelihood of the lumen interacting body(s) becoming unintentionally detached from the elongate core during use. In some embodiments, the increased retention force of the lumen interacting body(s) on the elongate core can reduce the likelihood of damaging the medical device being cleaned and promote patient safety when medical tools are used within an anatomical lumen.

[0040]

[0113] In some embodiments, the type and configuration of anchors used to couple the lumen interaction body(s) with the elongate core can also allow for flexibility of the medical tool, for example, allowing the medical tool to be inserted into and driven along a curved lumen. In the various tools shown in the accompanying drawings, the elongate core can be longer than the portion shown, and the tool can include additional elements attached to the elongate core.

[0041]

[0114] Aspects of the present disclosure, including various means for connecting the lumen interacting body(s) with the elongate core, may be applied to a variety of medical tools, including lumen cleaning tools, such as those described in U.S. Patent Publication No. 2021 / 0244266 (entitled TOOLS AND METHODS FOR CLEANING LUMENS OF MEDICAL DEVICES), which is incorporated herein by reference.

[0042]

[0115] The medical tool embodiments described herein include, by way of non-limiting example, different types of lumen interacting bodies, and the fastening and manufacturing methods described herein in relation to one type of lumen interacting body (e.g., lumen wipers) may be suitable for other types of lumen interacting bodies (e.g., lumen stabilizers).

[0043]

[0116] The term "attached" can include both direct attachment (where two elements contact one another) and indirect attachment (where at least one additional element is located between the two elements).

[0044]

[0117] As used herein, the term "substantially" may be applied to modify any quantitative expression, which may be permissibly varied without resulting in a change in the basic function to which the quantitative expression relates.

[0045]

[0118] Aspects of various embodiments are described through reference to the drawings.

[0119] 1 and 2 are perspective and side elevation views, respectively, of an exemplary lumen clearing tool 100 (hereinafter referred to as "tool 100"). Tool 100 can include an elongated core 10 (hereinafter referred to as "core 10"), one or more wipers 11, and one or more scrubbers 12. Core 10 can have a longitudinal axis LA and can have an axial length greater than the length of the portion of core 10 shown in FIG. 1. Wiper 11 and scrubber 12 can be attached to core 10. Wiper 11 can be axially located between two scrubbers 12 along the length of core 10. Core 10 can include wires, stranded wires, tubes, rods, catheters, or combinations thereof. Core 10 can be of unitary construction or can include multiple elements (e.g., axial sections) assembled together. Core 10 can be flexible, semi-rigid, or substantially rigid along its entire axial length. Core 10 can have a non-uniform flexibility that varies along its length. By way of example, the core 10 can include a flexible section followed by a rigid section. The exemplary core 10 shown in Figure 1 includes twisted (e.g., metal, stainless steel) wires (e.g., wire pairs).

[0046]

[0120] The core 10 can be of any length and thickness (e.g., diameter) that is suitable for the size and configuration of the lumen to be cleaned and that accommodates the desired number and configuration of wipers 11 and scrubbers 12 included in the tool 100. In some non-limiting embodiments, the core 10 can have a thickness (e.g., diameter) that is between 0.3 mm and 2.0 mm, and an axial length that is between 50 mm and 2500 mm.

[0047]

[0121] The wiper 11 and scrubber 12 may be mounted and positioned along the core 10 of the cleaning tool 100. The wiper 11 and scrubber 12 may be sized to allow contact (i.e., frictional engagement) with the wall(s) of the lumen to mechanically remove contaminants (e.g., debris, solids, liquids) inside the lumen. In other words, the outer diameter of the wiper 11 and scrubber 12 may be larger than the diameter of the lumen to provide an interference fit within the lumen, as shown in Figures 3, 4, and 9.

[0048]

[0122] The wiper 11 may include one or more (e.g., a set of) flexible disk-shaped squeegees 14 shown in FIG. 1, which may be made of a conformable thermoplastic material. For example, the squeegees 14 may be made of a suitable thermoplastic elastomer (TPE), thermoplastic rubber (TPR), thermoplastic polyurethane (TPU), and / or thermoplastic vulcanizate (TPV). The squeegees 14 may be flexible, radially extending fins distributed axially along the core 10. Alternatively or additionally, the wiper 11 may include one or more O-rings made of silicone or any other suitable material, one or more sponges made of a moisture-absorbing expanding material, and / or one or more inflatable balloons configured to maintain intimate contact with the wall(s) defining the lumen. The wiper 11 may be continuous along its length along the longitudinal axis LA of the core 10. Alternatively, wiper 11 may include multiple axial sections separated by axial gaps that expose core 10. In various embodiments, wiper 11 may be attached to core 10 by suitable means (e.g., adhesive) or may be overmolded onto core 10 using injection molding, for example, as described below.

[0049]

[0123] The dimensions of wiper 11 can be any length and thickness suitable for the size of the lumen to be cleaned. In some non-limiting embodiments, wiper 11 can have a thickness (e.g., diameter) that is between 1 mm and 15 mm and a length that is between 20 mm and 100 mm.

[0050]

[0124] The scrubber 12 may include a twisted-in wire (e.g., bristle) brush attached to a core 10 as shown in FIG. 1. The scrubber 12 may include a twisted wire brush that includes bristles held in place by the twisted wire core 10 and extending radially therefrom. The bristles may be similarly distributed circumferentially around the core 10. To form a twisted wire brush, the bristles may be inserted between parallel wires, and the wires may then be twisted together to press (clamp) and hold the bristles between the wires. Other suitable methods of attaching bristles to different types of cores 10 may be used. Depending on the intended application, the density of the bristles and the surface area covered by the bristles may be varied by adjusting the number of bristles and / or by angling the bristles at a desired angle from the longitudinal axis LA.

[0051]

[0125] The bristles may be made of suitable materials (e.g., polyester, nylon, polypropylene) having suitable physical dimensions, flexibility, and other properties according to the intended application. In general, the dimensions of the scrubber 12 may be any length and thickness suitable for the size of the lumen to be cleaned. In some non-limiting embodiments, the scrubber 12 may have a thickness (e.g., diameter) that is between 1 mm and 15 mm and an axial length that is between 5 mm and 100 mm. The scrubber 12 may be continuous along its length along the longitudinal axis LA of the core 10. Alternatively, one or more scrubbers 12 may include multiple axial sections separated by axial gaps that expose the core 10.

[0052]

[0126] Alternatively or additionally, the scrubber 12 may include one or more abrasive sponges, molded brushes, abrasive fibers, or any other elements including scrubbing media. The scrubber 12 may be attached to and positioned along the core 10 of the tool 100 and may be sized to allow contact between the scrubber 12 and the wall(s) defining the lumen.

[0053]

[0127] The tool 100 may also incorporate other features (not shown), such as a size restrictor that prevents entry of the tool 100 into a lumen of a certain size or shape (e.g., smaller than normal) and / or a leader that allows easy entry of the tool 100 into the lumen.

[0054]

[0128] FIG. 3 is a side view of the tool 100 disposed within a lumen L of a medical device and propelled in a direction D within the lumen L. FIG. 3 shows an axial cross-sectional view of the lumen L to expose the tool 100 disposed therein. The lumen L can be, for example, a channel of a flexible or rigid endoscope. In operation, the tool 100 can be manually, semi-automatically, or automatically propelled within the lumen L such that the wiper 11 and the scrubber 12 can cooperatively evacuate contaminants from the lumen L. For example, the tool 100 can be manually pushed or pulled through the lumen L by manually pushing or pulling on the core 10. Alternatively or additionally, the tool 100 can be propelled through the lumen L by an actuator drivingly coupled to the tool 100 and / or by an axial pressure differential (e.g., positive or negative pressure) across the wiper 11, for example, as described further below.

[0055]

[0129] The tool 100 may include a wiper 11 disposed axially between the front scrubber 12F and the rear scrubber 12B with respect to a direction of movement D relative to the lumen L. As the tool 100 moves axially inside the lumen L in the direction D by pushing or pulling the tool 100 along the lumen L, the front scrubber 12F is disposed forward of the wiper 11 and scrapes and loosens contaminants from the wall(s) defining the lumen L. The wiper 11 then wipes (e.g., removes) the contaminants and moves them forward in the direction D of axial movement of the tool 100, eventually discharging the contaminants from the lumen L. However, the frictional engagement of the wiper 11 with the wall(s) defining the lumen L may, in some circumstances, leave a relatively thin biofilm on the wall(s) of the lumen L. Such biofilm may be difficult to remove in one or more subsequent decontamination steps. Additionally, the wall(s) defining lumen L may not be perfectly smooth. For example, lumen L may have surface imperfections such as scratches and voids. Wiper 11 may push some contaminants into these surface imperfections, making them increasingly difficult to remove in a subsequent decontamination step, such as rinsing / flushing with a cleaning-based solution.

[0056]

[0130] In some circumstances, the use of a post scrubber 12B propelled behind the wiper 11 along direction D can facilitate a subsequent decontamination step by scrubbing and loosening residual biofilm or other contaminants that may remain behind the wiper 11. Such scrubbing and loosening of contaminants behind the wiper 11 can increase the effectiveness of a subsequent rinsing / flushing step that may be included when cleaning or decontaminating the lumen L. Thus, the combination of scrubbers 12F, 12B and wipers 11 axially disposed between scrubbers 12F, 12B can, in some circumstances, perform a series of coordinated steps in a sequence that can enhance cleaning and similarly facilitate subsequent decontamination of the lumen L.

[0057]

[0131] In some embodiments, the scrubbers 12F, 12B can have substantially the same configuration. For example, the scrubbers 12F, 12B can have the same density of bristles and can also have bristles of the same cross-sectional thickness (e.g., diameter) and length. Alternatively, the scrubbers 12F, 12B can have different configurations, as described below.

[0058]

[0132] FIG. 4 is a side view of another exemplary lumen cleaning tool 200 (hereinafter referred to as "tool 200") disposed within a lumen L of a medical device and propelled within the lumen L along a direction D. FIG. 4 shows an axial cross-sectional view of the lumen L to expose the tool 200 disposed within the lumen L. The tool 200 can include a core 10, scrubbers 121, 122, and a wiper 11 disposed axially between the scrubbers 121 and 122. The scrubbers 121, 122 can be bristle brushes. In contrast to the tool 100, the scrubbers 121 and 122 of the tool 200 can have different configurations from each other. For example, the bristles in the front scrubber 121 and the rear scrubber 122 can have different cross-sectional thicknesses (e.g., diameters). For example, the rear scrubber 122 can have bristles of a smaller thickness than the bristles of the front scrubber 121. For example, the rear scrubber 122 may be a relatively fine bristle brush, while the front scrubber 121 may include a relatively coarse bristle brush.

[0059]

[0133] The front scrubber 121 may have bristles of greater thickness (i.e., coarser) that, during operation, more aggressively scrub contaminants loose from the wall(s) defining the lumen L ahead of the wiper 11. Meanwhile, the rear scrubber 122 may have bristles of lesser thickness (i.e., thinner) that may more favorably interact with thin scratches and small voids in the lumen walls. Thus, the lesser thickness bristles of the rear scrubber 122 may be better adapted to scrub contaminants loose from relatively small surface defects in the lumen wall(s) and may facilitate subsequent cleaning or decontamination steps.

[0060]

[0134] FIG. 5 is a side view of an exemplary rear scrubber 122 of the tool 200 shown in FIG. 4. FIG. 5A is an enlarged view of the bristles 131, 132 of the rear scrubber 122 in region A of FIG. 5. In some embodiments, the rear scrubber 122 can include a combination of bristles 131 of smaller thickness t and bristles 132 of larger thickness T that can cooperate together to provide a desired scrubbing action against the wall(s) defining the lumen L. The arrangement of the bristles 131, 132 in the rear scrubber 122 can be such that sections of thinner bristles 131 and thicker bristles 132 are alternately arranged along the core 10. Alternatively, the thinner bristles 131 and thicker bristles 132 can be randomly arranged or otherwise intermixed within the rear scrubber 122. The rear scrubber 122 can include bristles of two or more (e.g., three, four, or five) different thicknesses. The cross-sectional profile(s) of the bristles 131, 132 may be circular, oval, rectangular, or any other suitable shape. The bristles 131, 132 may be solid or hollow.

[0061]

[0135] During operation, to facilitate subsequent cleaning or decontamination of the lumen L, the thicker bristles 132 of the rear scrubber 122 can more aggressively scrub loosen biofilm that may be left behind by the wiper 11, and the thinner bristles 131 can help scrub contaminants that have become lodged within surface defects formed in the wall(s) of the lumen, freeing or loosening the contaminants.

[0062]

[0136] In various embodiments of the scrubbers described herein that include bristle brushes, an appropriate bristle thickness (e.g., diameter) and material may be selected based on the particular application and expected cleaning needs. For example, the bristles may be made from nylon or other suitable material(s). The bristles of the scrubbers described herein may be of uniform or non-uniform thickness. Examples of suitable bristle thicknesses (e.g., diameters) for some applications may be, for example, about 0.03 mm (0.001”), about 0.05 mm (0.002”), about 0.08 mm (0.003”), about 0.10 mm (0.004”), about 0.13 mm (0.005”), about 0.15 mm (0.006”), about 0.18 mm (0.007”), about 0.20 mm (0.008”), about 0.23 mm (0.009”), or about 0.25 mm (0.010”).

[0063]

[0137] 6 is a side view of another exemplary lumen cleaning tool 300 (hereafter referred to as "tool 300"). Tool 300 can have components previously described above in connection with tool 100. Like elements are identified using like reference numerals. In some embodiments, tool 300 can include multiple scrubbers 12 and multiple wipers 11. The scrubbers 12 and wipers 11 can be arranged one after the other along the core 10. Thus, as tool 300 is propelled through lumen L, the arrangement of scrubbers 12 and wipers 11 can perform alternating scraping and wiping operations against the wall(s) defining lumen L.

[0064]

[0138] 7 is a flow diagram of a method 2000 for cleaning a lumen L of a medical device. Method 2000 may be performed with a lumen cleaning tool described herein or with other lumen cleaning tools. Aspects or steps related to the lumen cleaning tools described herein may be incorporated into method 2000. Method 2000 includes: Advancing a tool 100, 200, or 300 along a direction D within a lumen L (block 1002); using the tool 100, 200, or 300 while propelling the tool 100, 200, or 300 along a direction D within the lumen L, such that in a single pass of the tool 100, 200, or 300 within the lumen L: Scraping the wall defining the lumen L (block 1004); After scrubbing the wall, the wall is wiped (block 1006); After wiping the wall, use may include scrubbing the wall (block 1008).

[0065]

[0139] In various embodiments of the method 2000, the tool 100, 200, or 300 may be passed through the lumen L one or more times to achieve a desired level of cleaning. However, the configuration of the tool 100, 200, or 300 may allow the initial scrubbing, wiping, and subsequent scrubbing actions to be performed in a single pass of the tool 100, 200, or 300 through the lumen L. The scrub-wipe-scrub sequence of operations performed in a single pass may be accomplished by the wiper 11 being disposed axially between the two scrubbers 12. Propulsion of the tool 100, 200, or 300 may be performed manually and / or using a pressure differential inside the lumen L, as further described below.

[0066]

[0140] After cleaning lumen L using tool 100, 200, or 300, lumen L may be decontaminated using one or more subsequent steps, such as rinsing / flushing with a cleaning solution.

[0067]

[0141] 8 is a flow diagram of a method 3000 of propelling a lumen cleaning tool along a lumen L of a medical device using a pressure differential. Method 3000 may be performed with a lumen cleaning tool described herein or with other lumen cleaning tools. Aspects or steps related to lumen cleaning tools described herein may be incorporated into method 3000. Aspects of method 3000 may be incorporated into method 2000. Method 3000 may be used in conjunction with a lumen cleaning tool that includes one or more scrubbers 12 and / or one or more wipers 11. Method 3000 includes: Inserting a tool 100, 200, or 300 into a lumen L (block 3002); Once the tool 100, 200, or 300 is disposed within the lumen L, This may include using a pressure differential within the lumen L to propel the tool 100, 200, or 300 along the lumen L (Block 3003).

[0068]

[0142] 9 is a side view of tool 100 disposed within lumen L of a medical device and propelled within lumen L using a pressure differential, according to method 3000. Wiper 11 can act as a piston such that tool 100 can be propelled along lumen L when positive or negative pressure is applied to one end of lumen L to maintain intimate contact with the wall(s) of lumen L. In other words, disc-shaped squeegee 14 can provide a substantially perfect circumferential seal within lumen L such that a sufficient axial pressure differential (e.g., ΔP=P1-P2) across wiper 11 urges and propels tool 100 along lumen L.

[0069]

[0143] 9, a sufficient difference between pressure P1 and pressure P2 (i.e., P1>P2) can result in movement of tool 100 along lumen L. For example, application of a positive pressure P1 behind wiper 11 (e.g., using a source of pressurized air or water) can be used to push tool 100 in direction D along lumen L. Alternatively or additionally, application of a negative pressure P2 in front of wiper 11 (e.g., using a vacuum pump) can be used to pull tool 100 in direction D along lumen L.

[0070]

[0144] The pressure differential may be applied by a pressurized fluid (e.g., gas and / or liquid) including air and / or water. For example, water pressurized to about 40 psi may be used to apply a pressure differential along lumen L to urge tool 100 in direction D. In some situations, using a pressure differential to urge tool 100 along lumen L may be less time consuming and easier than manually pulling or pushing tool 100 through lumen L. The use of pressurized fluid to urge tool 100 may also provide further rinsing of lumen L, facilitating further removal of contaminants therefrom.

[0071]

[0145] FIG. 10 is a perspective view of another exemplary lumen cleaning tool 400 (hereinafter referred to as "tool 400") for cleaning a lumen L (shown in FIG. 11) of a medical device. Tool 400 can have the components described above in connection with other tools described herein. Tool 400 can include a wiper 411 and a scrubber 412 attached to an elongated core 410 (hereinafter referred to as "core 410") and disposed at different axial locations along the core 410. Core 410 can have a longitudinal axis LA. Scrubber 412 can be a bristle brush as described above. Wiper 411 can include a base 416 and one or more squeegees 414 in the form of disc-shaped fins extending radially outward from base 416. Squeegees 414 can be axially spaced apart along longitudinal axis LA. Squeegees 414 can all have the same size and shape. Alternatively, the wiper 411 may include a different size and / or shape squeegee 414. As described below, the wiper 411 may be coupled to the core 410 along the longitudinal axis LA of the core 410 using one or more anchors that prevent relative movement between the core 410 and the wiper 411 along the longitudinal axis LA.

[0072]

[0146] 11 is a side view of a portion of the tool 400 of FIG. 10 disposed within a curved lumen L of a medical device and driven in a direction D along the lumen L. In some embodiments, the tool 400 can be sufficiently flexible (compliant) to accommodate a desired bend radius R of the lumen L. The type(s) and configuration(s) of the anchor(s) used to couple the wiper 411 with the core 410 can be selected, for example, such that the flexibility of the tool 400 allows the tool 400 to be inserted into and driven through the curved lumen L. As the tool 400 is driven through the lumen L, the squeegee 414 of the wiper 11 can deform while contacting and frictionally engaging the wall(s) of the lumen L. The frictional engagement between the wiper 411 and the lumen L may require that the attachment of the wiper 411 to the core 410 be capable of withstanding an appropriate axial force between the wiper 411 and the lumen L to prevent inadvertent removal of the wiper 411 from the core 410. Approaches for providing coupling between various types of lumen interaction bodies and elongate cores are described below.

[0073]

[0147] FIG. 12 is a schematic illustration of an exemplary wiper 411 of the tool 400 of FIG. 10 released from mold portions 418A, 418B, where the wiper 411 is shown as transparent to show the core 410 disposed therein. In some embodiments, the wiper 411 (or other type of lumen interacting body) may be formed by injection molding (e.g., overmolding) onto the elongated core 10. However, it is understood that other methods of forming the wiper 411 (or other type of lumen interacting body) and mounting onto the core 410 may be used. For example, the wiper 411 may be made from a relatively soft material that allows the wiper 411 to deform and slide along the core 410, and may be pulled or pushed over an anchor to engage (e.g., at least partially seal) an anchor attached to the core 410. In some embodiments, the wiper 411 may be formed using, for example, a dipping process, a potting process, or 3D printing. In some embodiments, the wipers 411 may be pre-molded into a shape configured to interlock with the anchors and then assembled onto the core 410 in one or more pieces.

[0074]

[0148] With reference to FIG. 12, overmolding is an injection molding process in which one material of the wiper 411, such as, for example, TPE, is molded onto a different material of the core 410. The overmolded material of the wiper 411 can form an adhesive bond with the core 410. The bond between the wiper 411 and the core 410 can be enhanced by one or more anchors that connect the wiper 411 with the core 410. Such anchors can include one or more beams 420 of overmolded material that extend into a passage 422 formed through the core 410. In the embodiment shown in FIG. 12, the core 410 can be defined by metal wires (e.g., a pair) that are twisted (intertwined) together. The core 410 can include a first tightly twisted section 410A, a loosely twisted section 410B, and a second tightly twisted section 410C. The sections 410A, 410B, and 410C can have different axial positions along the core 410. For example, the loosely twisted section 410B can be axially disposed between the first tightly twisted section 410A and the second tightly twisted section 410C. The loosely twisted section 410B can define one or more gaps G (shown in FIGS. 15A-15C ) between the wires twisted together, and such gaps G can define respective passages 422 extending radially through the core 410.

[0075]

[0149] During the overmolding process, the mold parts 418A, 418B (e.g., halves) may be closed together on the core 410 extending into a cavity defined by the mold parts 418A, 418B that defines the outer geometry of the wiper 411. With the mold parts 418A, 418B closed together, overmolding material, for example in the form of a liquid resin heated above its glass transition temperature, may be injected through the sprue 419 into the cavity defined by the mold parts 418A, 418B. The overmolding material may fill the passages 422, thereby defining beams 420 that extend radially through the core 410 and connect the wiper 411 with the core 410. After filling the mold cavity defining the shape of the wiper 411, and similarly after the overmolding material has cooled and solidified, the mold sections 418A, 418B may be opened to release the core 410 and the wiper 411 from the mold sections 418A, 418B.

[0076]

[0150] 13 is a side view of a portion of the core 410 of the tool 400 of FIG. 10 shown in isolation. A loosely twisted section 410B axially disposed between a tightly twisted section 410A and a second tightly twisted section 410C can define one or more through passages 422 extending radially through the core 410. Although FIG. 13 shows the core 410 made from wires twisted together, it is understood that the core 410 can have a different configuration, such as a single wire, a tube, a rod, or a catheter, having one or more passages 422 extending partially or completely therethrough (e.g., drilled) to receive overmolding material and define one or more respective beams 420.

[0077]

[0151] Fig. 14 is a schematic perspective view of a portion of the core 410 of Fig. 13 during the manufacture of the core 410. During stranding of the metal wires of the core 410 as indicated by arrows T, one or more pins 424 or other suitable spacers may be inserted between the wires to form the passages 422 in the loosely stranded section 410B, and then removed from the core 410 to define the respective passages 422. Another approach to producing the loosely stranded section 410B may be to tightly strand the metal wires of the core 410 without using pins 424, and then partially untwist a portion of the core 410 to define the loosely stranded section 410B including the passages 422.

[0078]

[0152] FIG. 15A is a cross-sectional view of the tool 400 of FIG. 12 taken along line 15-15 of FIG. 12. The wires of the elongated core 10 may be disposed within a base 416 of the wiper 411 (or of another type of lumen interaction body). The wires may be fully or partially sealed by the base 416 of the wiper 411. Gaps G between the wires define through passages 422 extending laterally through the core 410 and are filled with an overmolding material to define beams 420. In some embodiments, such gap(s) G may have a dimension of at least 0.25 mm. In some embodiments, the gap(s) G may have a dimension between 1 mm and 2 mm. In some embodiments, the gap(s) G may have a dimension between 1 mm and 8 mm. In some embodiments, the gap(s) G may have a dimension between 6 mm and 8 mm.

[0079]

[0153] The beams 420 may be made of the same overmolding material as the wipers 411 and may be connected at opposing ends of the base 416. In other words, the beams 420 may interconnect portions of the wipers 411 disposed on opposing sides of the core 410. Thus, the beams 420 and the wipers 411 may have a monolithic configuration. It is understood that overmolding of the beams 420 may be used with other types of overmolded lumen interacting bodies as well, such as, for example, lumen stabilizers.

[0080]

[0154] 15B and 15C are cross-sectional views of other lumen cleaning tools 414', 414'' of the type shown in FIG. 12 taken along line 15-15 of FIG. 12. As shown in FIG. 15B, in some embodiments, the wires of the elongated core 10 can be disposed within the base 416' of the wiper 411', spaced apart by a gap G', and can be flush with the radially outer surface of the base 416'. As shown in FIG. 15C, in some embodiments, the wires of the elongated core 10 can be disposed within the base 416'' of the wiper 411'', spaced apart by a gap G'', and can protrude from the radially outer surface of the base 416''.

[0081]

[0155] FIG. 16 is a side view of another exemplary lumen cleaning tool 500 (hereinafter referred to as "tool 500") for cleaning the lumen L (shown in FIG. 11) of a medical device. FIG. 17 is a side view of an elongated core 510 (hereinafter referred to as "core 510") and bristles 530 of the tool 500. The tool 500 can have the components described above in connection with other tools described herein. With reference to FIGS. 16 and 17, the tool 500 can include a wiper 511 and / or one or more other lumen interacting bodies attached to the core 510 and disposed at different axial location(s) along the core 510. The wiper 511 can include a base 516 and one or more squeegees 514 in the form of disc-shaped fins extending radially outward from the base 516. The wiper 511 may be coupled to the core 510 along the longitudinal axis LA of the core 510 using one or more fibrous anchors in the form of one or more bristles 530 that prevent relative movement between the core 510 and the wiper 511 along the longitudinal axis LA.

[0082]

[0156] The wiper 511 is shown as transparent to show the core 510 with the bristles 530 attached to and at least partially sealed by the wiper 511. The bristles 530 can be attached to the core 510 and serve as protrusions connecting the wiper 511 with the core 510. The bristles 530 can be inserted between wires which can then be twisted together to press (clamp) and hold the bristles 530 between the wires when the core 510 is manufactured. Other suitable methods of attaching the bristles 530 to the core 510 can be used. The wiper 511 can be overmolded onto the core 510 and the bristles 530 such that the bristles 530 can be at least partially sealed by the overmolding material of the wiper 511. The bristles 530 can be made of a suitable polymer.

[0083]

[0157] In some embodiments, the bristles 530 can be relatively short so as not to protrude radially outward from the base 516. For example, the bristles 530 can remain hidden inside the wiper 511 and not interfere with the function of the wiper 511. For example, with respect to the longitudinal axis LA, the bristles 530 can have a radial dimension that is equal to or less than the radial dimension of the base 516. In some embodiments, the bristles 530 can extend radially outward (i.e., protrude) from the core 510 and can be arranged to define a helical arrangement extending along the longitudinal axis LA. The helical arrangement of the bristles 530 can extend along the longitudinal axis LA, for example, an amount that covers at least a majority of the axial span of the wiper 511. It is understood that other types of anchor(s) defining a helical shape may be attached (e.g., glued, welded, crimped, soldered, brazed, molded, or frictionally engaged) to core 510 to connect wiper 511 with core 510.

[0084]

[0158] FIG. 18 is a side view of another exemplary lumen cleaning tool 600 (hereinafter referred to as "tool 600") for cleaning the lumen L (shown in FIG. 11) of a medical device. FIG. 19 is a side view of an elongated core 610 (hereinafter referred to as "core 610") and a ring-shaped anchor 634 of the tool 600. The tool 600 can have the components described above in connection with other tools described herein. With reference to FIGS. 18 and 19, the tool 600 can include a wiper 611 and / or one or more other lumen interacting bodies attached to the core 610 and disposed at different axial location(s) along the core 610. The wiper 611 can include a base 616 and one or more squeegees 614 in the form of disc-shaped fins extending radially outward from the base 616. The wiper 611 may be coupled to the core 610 along the longitudinal axis LA of the core 610 using one or more ring-shaped anchors 634 attached to the core 610 that prevent relative movement between the core 610 and the wiper 611 along the longitudinal axis LA.

[0085]

[0159] The wiper 611 is shown as transparent to show the core 610 having a ring anchor 634 attached to and at least partially sealed by the wiper 611. The ring anchor 634 can serve as a protrusion that is attached to the core 610 and connects the wiper 611 with the core 610. The wiper 611 can be overmolded onto the core 610 and the ring anchor 634 such that the ring anchor 634 can be at least partially sealed by the overmolding material of the wiper 611. In embodiments in which multiple ring anchors 634 are used, the ring anchors 634 can be configured and spaced apart to allow some flexibility of the tool 600 to accommodate the curved lumen L. For example, the ring anchors 634 can be selected to have a relatively short axial length and similarly spaced apart to avoid interference with one another as the core 610 bends to accommodate the desired bend radius R (shown in FIG. 11 ). For example, relative to the longitudinal axis LA, the ring anchor 634 can have a radial dimension that is equal to or less than the radial dimension of the base 616 such that it does not protrude radially outward from the base 616. For example, the ring anchor 634 can remain hidden within the wiper 611 and not interfere with the function of the wiper 611.

[0086]

[0160] 19A is a close-up side view of an exemplary metal ring anchor 634A attached to the core 610 by crimping. During assembly, the core 610 can be inserted through a central opening of the ring anchor(s) 634A, and the ring anchor(s) 634A can be slid along the core 610 to its desired axial location. The ring anchor(s) 634A can then be plastically deformed (e.g., crimped) onto the core 610.

[0087]

[0161] 19B is a close-up side view of an exemplary metal ring anchor 634B attached to the core 610 by welding via weld W. During assembly, the core 610 can be inserted through a central opening of the ring anchor(s) 634B, and the ring anchor(s) 634B can be slid along the core 610 to its desired axial location. The ring anchor(s) 634A can then be laser welded onto the core 610.

[0088]

[0162] FIG. 20 is a side view of a portion of another exemplary lumen cleaning tool for cleaning the lumen L (shown in FIG. 11 ) of a medical device. FIG. 21 is a side view of an elongated core 710 (hereafter referred to as “core 710”), a ring anchor 734, and a disc-shaped anchor 736. With reference to FIG. 21 , the ring anchor 734 and the disc-shaped anchor 736 may each be welded to the core 710 via a weld W. The tool of FIG. 20 may include the components described above in connection with the other tools described herein. With reference to FIGS. 20 and 21 , the wiper 711 may include a base 716 and one or more squeegees 714 in the form of disc-shaped fins extending radially outward from the base 716. The wiper 711 may be coupled to the core 710 along the longitudinal axis LA of the core 710 using one or more ring-shaped anchors 734 and disc-shaped anchors 736 attached to the core 710 that prevent relative movement between the core 710 and the wiper 711 along the longitudinal axis LA.

[0089]

[0163] The wiper 711 is shown as transparent to show in dashed lines the core 710 having a ring anchor 734 and a disc anchor 736 attached to and at least partially sealed by the wiper 711. The ring anchor 734 and disc anchor 736 are attached to the core 710 and can serve as protrusions connecting the wiper 711 with the core 710. The wiper 711 can be overmolded onto the core 710, the ring anchor 734, and the disc anchor 736 such that the ring anchor 734 and disc anchor 736 can be at least partially sealed by the overmolding material of the wiper 711. In embodiments in which multiple ring anchors 734 and disc anchors 736 are used, the ring anchors 734 and disc anchors 736 can be configured and spaced apart to allow some flexibility of the tool 700 to accommodate the curved lumen L.

[0090]

[0164] Relative to the longitudinal axis LA, the ring-shaped anchor(s) 734 can have a radial dimension that is equal to or less than the radial dimension of the base 716 so as not to protrude radially outward from the base 716. The ring-shaped anchor(s) 734 can be axially located between adjacent squeegees 714. The disk-shaped anchor(s) 736 can have a radial dimension that is greater than the dimension of the ring-shaped anchor(s) 734. The disk-shaped anchor(s) 736 can have a radial dimension that is greater than the radial dimension of the base 716. The disk-shaped anchor 736 can be axially located in line with the squeegee 714, for example, and can occupy a space within a radially extending fin of the wiper 711. In some embodiments, the disk-shaped anchor 736 can be made from a harder material than the overmolding material of the wiper 711, and thus can serve to stiffen the squeegee 714 or otherwise affect the rigidity or other mechanical properties of the wiper 711. For example, the disc-shaped anchor 736 or other anchors can modify the mechanical properties of the relatively soft wiper 711 (or other lumen interacting member) to adjust stiffness, flexibility, or malleability as may be desirable for a particular application, while the relatively soft wiper 711 can provide an atraumatic engagement with the lumen L. In some embodiments, the ring-shaped anchor(s) 734 and the disc-shaped anchor(s) 736 can be disposed alternatingly along the core 710.

[0091]

[0165] FIG. 22 is a side view of a portion of another exemplary lumen cleaning tool for cleaning the lumen L (shown in FIG. 11) of a medical device. FIG. 23 is a side view of an elongated core 810 (hereafter referred to as "core 810"), a ring anchor 834, and a disc-shaped anchor 836. In contrast to the tool shown in FIGS. 20 and 21, the ring anchor(s) 734 may be crimped onto the core 810, and the disc-shaped anchor(s) 836 may be welded to the core 810 via a weld W. The tool of FIG. 22 may include the components described above in connection with other tools described herein. With reference to FIGS. 22 and 23, the wiper 811 may include a base 816 and one or more squeegees 814 in the form of disc-shaped fins extending radially outward from the base 816. The wiper 811 may be coupled to the core 810 along the longitudinal axis LA of the core 810 using one or more ring-shaped anchors 834 and disc-shaped anchors 836 attached to the core 810 that prevent relative movement between the core 810 and the wiper 811 along the longitudinal axis LA. The wiper 811 is shown as transparent to show in dashed lines the core 810 with the ring-shaped anchors 834 and disc-shaped anchors 836 attached to the core 810 and at least partially sealed by the wiper 811.

[0092]

[0166] FIG. 24 is a side view of a portion of another exemplary lumen cleaning tool for cleaning the lumen L (shown in FIG. 11 ) of a medical device. FIG. 25 is a side view of an elongated core 910 (hereafter referred to as “core 910”), a ring-shaped anchor 934, and a disc-shaped anchor 936. In contrast to the tool shown in FIGS. 20 and 21 , the disc-shaped anchor(s) 936 can extend radially outward beyond the overmolding material of the wiper 911. In other words, the disc-shaped anchor 936 can define a protrusion that protrudes from the overmolded body of the wiper 911. For example, the disc-shaped anchor 936 can directly interact with the lumen L during use. The tool of FIG. 24 can include the components described above in connection with other tools described herein. With reference to FIGS. 24 and 25 , the wiper 911 can include a base 916 and one or more squeegees 914 in the form of disc-shaped fins extending radially outward from the base 916. The wiper 911 may be coupled to the core 910 along the longitudinal axis LA of the core 910 using one or more ring-shaped anchors 934 and disc-shaped anchors 936 attached to the core 910 that prevent relative movement between the core 910 and the wiper 911 along the longitudinal axis LA. The wiper 911 is shown as transparent to show the core 910 with the ring-shaped anchors 934 in dashed lines and the disc-shaped anchors 936 attached to the core 910 and at least partially sealed by the wiper 911 in solid lines.

[0093]

[0167] FIG. 26 is a perspective view of an exemplary lumen stabilization tool 1000 (hereinafter referred to as “tool 1000”) for stabilizing an anatomical or artificial lumen. Tool 1000 can include one or more lumen stabilizers 1038 (hereinafter referred to as singular) and / or other types of lumen interacting body(s) attached to an elongated core 1010 (hereinafter referred to as “core 1010”) and disposed at different axial locations along the core 1010. Core 1010 can have a longitudinal axis LA. Lumen stabilizer 1038 can have an umbrella-like structure suitable for holding a lumen open without completely occluding the lumen so that fluid flow can be permitted along the lumen. Lumen stabilizer 1038 can include a base 1016 and one or more arms 1014 extending radially outward from base 1016. Each arm can include a proximal end attached to the base 1016 and a distal free end located radially outward of the base 1016 and the core 1010. The lumen stabilizer 1038 can be coupled to the core 1010 along the longitudinal axis LA of the core 1010 using one or more anchors that prevent relative movement between the core 1010 and the lumen stabilizer 1038 along the longitudinal axis LA.

[0094]

[0168] FIG. 27 is a side view of a portion of the tool 1000, with the lumen stabilizer 1038 shown as transparent to show the core 1010 with the bristles 1030 attached thereto. FIG. 28 is a side view of the core 1010 and the bristles 1030. As explained above in connection with FIGS. 16 and 17, the bristles 1030 can serve as protrusions attached to the core 1010 to couple the lumen stabilizer 1038 with the core 1010. The bristles 1030 can be inserted between the wires of the core 1010, which can then be twisted together to press (clamp) and hold the bristles 1030 between the wires 1010 when the core 1010 is manufactured. The lumen stabilizer 1038 can be overmolded onto the core 1010 and the bristles 1030 such that the bristles 1030 can be at least partially sealed by the overmolding material of the lumen stabilizer 1038. The bristles 1030 may be dimensioned to remain concealed within the lumen stabilizer 1038. In some embodiments, the bristles 1030 may extend (i.e., protrude) radially outward from the core 1010 and may be arranged to define a helical arrangement extending along the longitudinal axis LA. The helical arrangement of the bristles 1030 may extend along the longitudinal axis LA an amount that covers at least a majority of the axial span of the lumen stabilizer 1038, for example.

[0095]

[0169] FIG. 29 is a side view of a portion of another exemplary lumen stabilization tool 1100 (hereinafter referred to as “tool 1100”) for stabilizing an anatomical or artificial lumen. Tool 1100 can include one or more lumen stabilizers 1138 (hereinafter referred to as singular) and / or other types of lumen interacting body(s) attached to an elongated core 1110 (hereinafter referred to as “core 1110”) and disposed at different axial locations along the core 1110. Core 1110 can have a longitudinal axis LA. Lumen stabilizer 1138 is shown as transparent to show core 1110 extending through lumen stabilizer 1138. Lumen stabilizer 1138 can have an umbrella-like structure suitable for holding a lumen open without completely occluding the lumen. Lumen stabilizer 1138 can include a base 1116 and one or more arms 1114 extending radially outward from base 1116. The lumen stabilizer 1138 may be coupled to the core 1110 along the longitudinal axis LA of the core 1110 using one or more anchors that prevent relative movement between the core 1110 and the lumen stabilizer 1138 along the longitudinal axis LA, thereby preventing undesirable movement of the lumen stabilizer 1138.

[0096]

[0170] FIG. 30 is a side view of the core 1110 of the tool 1100 of FIG. 29 shown in isolation. The core 1110 can include a helical coil made from only one (i.e., only one) wire or from multiple wires to facilitate torque transmission by the core 1110. For example, the helical coil can be made from one or more metal or polymer wires, as shown in FIG. 30. The helical coil can include a first section 1110A having a first pitch p1 and a second section 1110B having a second pitch p2 that is greater than the first pitch p1 such that p2>p1. The helical coil can include a third section 1110C having a third pitch p3. The second pitch p2 can be greater than the third pitch p3 such that p2>p3, as shown in FIG. 30. In some embodiments, the first pitch p1 and the third pitch p3 can be substantially the same. In some embodiments, the second pitch p2 can be at least 10% greater than the first pitch p1 or the third pitch p3. In some embodiments, the second pitch p2 can be between 10% and 100% greater than the first pitch p1 or the third pitch p3.

[0097]

[0171] The first section 1110A can be axially adjacent to the second section 1110B along the longitudinal axis LA of the helical coil. The second section 1110B can be axially adjacent to the third section 1110C along the longitudinal axis LA of the helical coil. The second section 1110B can be located between the first section 1110A and the third section 1110C along the longitudinal axis LA of the helical coil. In some embodiments, the core 1110 can have a substantially uniform diameter along the longitudinal axis LA such that the first diameter D1, the second diameter D2, and the third diameter D3 can be substantially the same. As shown in FIG. 30 by way of example, the wire defining the helical coil can have a polygonal (e.g., square, rectangular, quadrilateral, hexagonal) cross-sectional profile. A lumen stabilizer 1138 (or wiper or another lumen interacting device) may be attached to the helical coil and secured to the second section 1110C of the core 1110, as described below.

[0098]

[0172] FIG. 31 is an enlarged side view of a portion of the second section 1110B of the core 1110, where the lumen stabilizer 1138 is overmolded onto the second section 1110B such that the core 1110 can be at least partially sealed by the overmolding material. The helical coil can be disposed within the base 1116 of the lumen stabilizer 1138. Gaps GP defined between adjacent wire turns can define respective through passages 1122 extending laterally through the core 1110 and are filled by the overmolding material to define respective beams 1120. In some embodiments, such gap(s) GP can have a dimension of at least 0.25 mm. In some embodiments, the gap(s) G can have a dimension between 1 mm and 2 mm. In some embodiments, the gap(s) G can have a dimension between 1 mm and 8 mm. In some embodiments, the gap(s) G can have a dimension between 6 mm and 8 mm. The beams 1120 may be made of the same overmolding material as the lumen stabilizers 1138 and may be connected at opposing ends of the base 1116. In other words, the beams 1120 may each interconnect portions of the lumen stabilizers 1138 disposed on opposing sides of the core 1110. Thus, the beams 1120 and the base 1116 may have a monolithic construction.

[0099]

[0173] 32 is a side view of a portion of another exemplary lumen stabilization tool 1200 (hereinafter referred to as "tool 1200") for stabilizing an anatomical or artificial lumen. Tool 1200 can include one or more lumen stabilizers 1238 (hereinafter referred to as singular) and / or other types of lumen interacting body(s) attached to an elongated core 1210 (hereinafter referred to as "core 1210") and disposed at different axial locations along the core 1210. Core 1210 can have a longitudinal axis LA. Lumen stabilizer 1238 is shown as transparent to show core 1110 extending through lumen stabilizer 1238. Lumen stabilizer 1238 can include a base 1216 and one or more arms 1214 extending radially outward from base 1216. The lumen stabilizer 1238 may be coupled to the core 1210 along the longitudinal axis LA of the core 1210 using one or more anchors that prevent relative movement between the core 1210 and the lumen stabilizer 1238 along the longitudinal axis LA.

[0100]

[0174] FIG. 33 is a side view of the core 1210 of the tool 1200 of FIG. 32 shown in isolation. The core 1210 can include a helical coil made from only one (i.e., only one) wire or from multiple wires to facilitate torque transmission by the core 1210. As shown in FIG. 33, the wire defining the helical coil can have a circular cross-sectional profile. However, the wire can alternatively have an elliptical, semicircular, rectangular, or polygonal cross-sectional profile. The wire can have a cross-sectional profile that includes a combination of straight / flat and curved / round segments. The wire can have a uniform or non-uniform cross-sectional profile along its length. For example, the wire can vary in size and / or shape along its length. The helical coil can include a first section 1210A having a first pitch p1 and a second section 1210B having a second pitch p2 greater than the first pitch p1 such that p2>p1. The helical coil may include a third section 1210C having a third pitch p3. The second pitch p2 may be greater than the third pitch p3 such that p2>p3. In some embodiments, the first pitch p1 and the third pitch p3 may be substantially the same. In some embodiments, the second pitch p2 may be at least 10% greater than the first pitch p1 or the third pitch p3. In some embodiments, the second pitch p2 may be between 10% and 100% greater than the first pitch p1 or the third pitch p3.

[0101]

[0175] In some embodiments, the core 1210 can have a substantially uniform diameter along the longitudinal axis LA such that the first diameter D1, the second diameter D2, and the third diameter D3 can be substantially the same. A lumen stabilizer 1238 (or wiper or another lumen interacting device) can be attached to the helical coil and secured to the second section 1210C of the core 1210 in substantially the same manner as shown in FIG.

[0102]

[0176] 34 is a side view of a portion of another exemplary lumen stabilization tool 1300 (hereinafter referred to as "tool 1300") for stabilizing an anatomical or artificial lumen. Tool 1300 is attached to an elongated core 1310 (hereinafter referred to as "core 1310") and may include one or more lumen stabilizers 1338 (hereinafter referred to as singular) and / or other types of lumen interacting body(s) disposed at different axial locations along core 1310. Core 1310 may have a longitudinal axis LA. Lumen stabilizer 1338 is shown as transparent to show core 1310 extending through lumen stabilizer 1338. Lumen stabilizer 1338 may include a base 1316 and one or more arms 1314 extending radially outward from base 1316. The lumen stabilizer 1338 may be coupled to the core 1310 along the longitudinal axis LA of the core 1310 using one or more anchors that prevent relative movement between the core 1310 and the lumen stabilizer 1338 along the longitudinal axis LA.

[0103]

[0177] FIG. 35 is a side view of the core 1310 of the tool 1300 of FIG. 32 shown in isolation. The core 1310 can include a helical coil made from only one (i.e., only one) wire or from multiple wires to facilitate torque transmission by the core 1310. The helical coil can include a first section 1310A having a first outer diameter D1 and a second section 1310B having a second outer diameter D2 larger than the first outer diameter D1 such that D2>D1. The helical coil can include a third section 1310C having a third outer diameter D3. The second outer diameter D2 can be larger than the third outer diameter D3 such that D2>D3. In some embodiments, the first outer diameter D1 and the third outer diameter D3 can be substantially the same. The first outer diameter D1 and the third outer diameter D3 can define a nominal outer diameter of the core 1310. The second section 1310B can have an increased outer diameter D2 relative to the nominal diameter of the core 1310. In some embodiments, the second outer diameter D2 can be at least 10% larger than the first outer diameter D1 or the third outer diameter D3. In some embodiments, the second outer diameter D2 can be between 10% and 100% larger than the first outer diameter D1 or the third outer diameter D3. The second section 1310B can be axially located between the first section 1310A and the third section 1310B.

[0104]

[0178] The lumen stabilizer 1338 (or wiper or another lumen interacting device) may be coupled to the helical coil and secured to the second section 1310C of increased outer diameter D2 of the core 1310. In other words, the second section 1310C may define a protrusion attached to the core 1310 for coupling the lumen stabilizer 1338 with the core 1310. In some embodiments, the lumen stabilizer 1338 may be overmolded onto the core 1310 and seal the core 1310. In some embodiments, the core 1310 may include one or more sections of increased diameter that serve as protrusions for coupling the lumen stabilizer 1338 with the core 1310. In some embodiments, the second section 1310B may have an axial span L2 that is less than the axial span L1 of the first section 1310A. The second section 1310B can have an axial span L2 that is less than the axial span L3 of the third section 1310C.

[0105]

[0179] 36A and 36B show schematic diagrams of an exemplary two-shot overmolding method for manufacturing an exemplary lumen cleaning tool 1400 (hereinafter referred to as "tool 1400") for cleaning a lumen L (shown in FIG. 11) of a medical device, or for manufacturing another type of lumen interacting tool. Tool 1400 can include an elongated core 1410 (hereinafter referred to as "core 1410"), which can include stranded metal wires, one or more anchors 1434 (hereinafter referred to as singular), and one or more wipers 1411 (hereinafter referred to as singular). Tool 1400 can have the components described above in connection with other tools described herein. Tool 1400 can include one or more other lumen interacting bodies (e.g., lumen stabilizers) attached to core 1410 and disposed at different axial location(s) along core 1410. The wiper 1411 may include a base 1416 and one or more squeegees 1414 in the form of disc-shaped fins extending radially outward from the base 1416. The wiper 1411 may be attached to the core 1410 and coupled to the core 1410 along the longitudinal axis LA of the core 1410 using anchors 1434 that prevent relative movement between the core 1410 and the wiper 1411 along the longitudinal axis LA.

[0106]

[0180] Both the anchor 1434 and the wiper 1411 may be produced by overmolding using different overmolding materials that provide suitable melt adhesion between the two. In some embodiments, the anchor 1434 and the wiper 1411 may be produced using a two-shot overmolding process in which one material is injection molded onto a previously injection molded substrate. For example, referring to FIG. 36A, the anchor 1434 may be first overmolded onto the core 1410 using a first overmolding material. The mold portions 1418A, 1418B (e.g., halves) may be brought together and sealed to the core 1410 extending into a cavity defined by the mold portions 1418A, 1418B that defines the outer geometry of the anchor 1434. With the mold sections 1418A, 1418B in close proximity, a first overmolding material, for example in the form of a liquid resin heated above its glass transition temperature, can be injected through the sprue 1419A into the cavity defined by the mold sections 1418A, 1418B. The first overmolding material can fill the cavity, thereby forming anchors 1434 extending radially outward from the core 1410. After filling the mold cavity and cooling the first overmolding material, the mold sections 1418A, 1418B can be opened to release the core 1410 and anchors 1434 from the mold sections 1418A, 1418B.

[0107]

[0181] 36B, the wiper 1411 may then be overmolded onto the anchor 1434 and core 1410 using a second overmolding material that is different from the first overmolding material. In other words, the anchor 1434 and core 1410 may serve as a substrate onto which the wiper 1411 may be overmolded. The wiper 1411 is shown as being transparent to show the core 1410 with the anchor 1434 attached to and at least partially sealed by the wiper 1411. The mold portions 1418C, 1418D (e.g., halves) may be attached and sealed to the core 1410 extending into a cavity defined by the mold portions 1418C, 1418D that define the outer geometry of the wiper 1411. With the mold sections 1418C, 1418D in close proximity, a second overmolding material, for example in the form of a liquid resin heated above its glass transition temperature, can be injected through the sprue 1419C into the cavity defined by the mold sections 1418C, 1418D. The second overmolding material can fill the cavity, thereby defining the wiper 1411 that seals the anchor 1434. After filling the mold cavity and cooling the first overmolding material, the mold sections 1418C, 1418D can be opened to release the core 1410 and the wiper 1411 from the mold sections 1418C, 1418D.

[0108]

[0182] The first overmolding material of the anchor(s) 1434 can be of a different type than the second overmolding material that is subsequently used to form the wiper 1411. For example, the first overmolding material can be harder than the second overmolding material. For example, the first overmolding material can provide better adhesion to the core 1410 compared to the second overmolding material, and therefore can help impede movement of the wiper 1411 along the core 1410 during use of the tool 1400. By way of example, the first overmolding material can be polypropylene (PP) and the second overmolding material can be a TPE that can adhere relatively well to PP. Thus, the anchor(s) 1434 can serve as an interlock in the form of a protrusion that impedes movement of the wiper 1411 along the core 1410. Alternatively or additionally, the anchor(s) 1434 can prevent movement of the wiper 1411 by (eg, melt) adhesion between the first and second overmolding materials.

[0109]

[0183] 36A and 36B is merely exemplary, and it will be understood that other methods may be used to form the anchor(s) 1434 and / or the wiper 1411. For example, the anchor(s) 1434 could instead be deposited by brushing, dipping, plating, or other methods prior to overmolding the wiper 1411.

[0110]

[0184] FIG. 37A is a perspective view of another exemplary anchor 1534 formed by overmolding as shown in FIG. 36A or by another method. The anchor 1534 can have any suitable shape and can have a relatively smooth outer surface for adhering to a second material of a lumen interaction body, such as wiper 1511 (shown in FIG. 37B), which can at least partially seal the anchor 1534. Alternatively, the anchor 1534 can define one or more features that enhance grip between the anchor 1534 and the wiper 1511. Such features can include surface textures, ribs, circumferential and / or longitudinal grooves 1550, protrusions, recesses, voids, or other surface irregularities that can promote melt adhesion by increasing the contact surface area between the first material of the anchor 1534 and the second material of the wiper 1511.

[0111]

[0185] FIG. 37B is a side view of an exemplary lumen interaction tool 1500 including a lumen interaction body such as wiper 1511 overmolded or otherwise deposited onto anchor 1534 of FIG. 37A. Wiper 1511 can include a base 1516 and a squeegee 1514 extending radially outward from base 1516. In some embodiments, tool 1500 can be manufactured using a two-shot overmolding process shown in FIGS. 36A and 36B. Anchor 1534 can include a protrusion, shown in dashed lines, that is only partially sealed by base 1516 of wiper 1511. In other embodiments, anchor 1534 can be completely sealed by base 1516.

[0112]

[0186] FIG. 37C is a cross-sectional view of the tool 1500 taken along line 37C-37C of FIG. 37B. The overmolding material of the wiper 1511 can occupy the grooves 1550 and provide a suitable melt bond with the material of the anchor 1534. Additionally, the cooperating geometries of the anchor 1534 and the wiper 1511 can mate with one another to similarly provide a mechanical interlock between the anchor 1534 and the wiper 1511. As shown in FIG. 37C, the anchor 1534 may be only partially sealed by the base 1516 of the wiper 1511 such that the portion of the anchor 1534 between the grooves 1550 may be exposed to the exterior of the tool 1500. In some embodiments, the radially outer surface of the base 1516 that is angularly aligned with one or more grooves 1550 can be flush with the radially outer surface of the anchor 1534 between the grooves 1550. In various embodiments, the outer diameter of anchor 1534 can be smaller, larger, or substantially the same as the outer diameter of base 1516. In some embodiments, the methods and configurations of anchors and lumen interaction devices described herein can facilitate the manufacture of different types of lumen interaction tools for different types and sizes of lumens.

[0113]

[0187] FIG. 38 is a side view of another exemplary lumen cleaning tool 1600 (hereinafter referred to as “tool 1600”) for cleaning the lumen L (shown in FIG. 11) of a medical device. Tool 1600 can have the components described above in connection with other tools described herein. Tool 1600 can include a wiper 1611 and a scrubber 1612 attached to an elongated core 1610 (hereinafter referred to as “core 1610”) and disposed at different axial locations along the core 1610. Core 1610 can have a longitudinal axis LA and can include a stranded metal wire or other type of core 1610. Scrubber 1612 can be bristle brass. Wiper 1611 can include a base 1616 and one or more squeegees 1614 in the form of disc-shaped fins extending radially outward from base 1616. The wiper 1611 may be coupled to the core 1610 along the longitudinal axis LA of the core 1610 using one or more anchors, such as a tube 1642 and / or other type(s) of anchor. The tube 1642 may be a catheter and may have an inner bore 1644. The tube 1642 may be attached to the core 1610 and likewise the wiper 1611 such that longitudinal movement of the tool 1600 along the longitudinal axis LA may be driven, for example, by pushing or pulling the tube 1642.

[0114]

[0188] Figure 39 is a schematic diagram of a portion of the tool 1600 within region 39 of Figure 38, showing the wiper 1611 overmolded onto the core 1610 and onto a portion of the tube 1642. The portion of the core 1610 and the portion of the tube 1642 sealed by the wiper 1611 are shown in dashed lines in Figure 39. Prior to the overmolding process, the portion of the core 1610 may be partially inserted into the inner bore 1644 of the tube 1642. The portion of the tube 1642 and the core 1610 onto which the wiper 1611 is overmolded are then inserted into the cavity defined by mold portions 1618A, 1618B. With the mold sections 1618A, 1618B (e.g., halves) closed and sealed against the core 1610 on one side and against the tube 1642 on the other side, an overmolding material, for example in the form of a liquid resin heated above its glass transition temperature, can be injected into the cavity defined by the mold sections 1618A, 1618B through the sprue 1619. The overmolding material can fill the cavity, thereby forming a wiper 1611 that seals a portion of the tube 1642 and also a portion of the core 1610 disposed outside the tube 1642. For example, the base 1616 of the wiper 1611 can axially overlap a portion of the tube 1642. In other words, the open end 1646 of the tube 1642 can be disposed between axially opposed ends of the wiper 1611. After filling the mold cavity and cooling the overmolding material, the mold sections 1618A, 1618B may be opened to release the core 1610, wiper 1611, and tube 1642 from the mold sections 1618A, 1618B.

[0115]

[0189] FIG. 40 is an enlarged view of a portion of the tool 1600 in region 40 of FIG. 38. In some embodiments, the tube 1642 may be made of PP and the wiper 1611 may be made of TPE. In some embodiments, the wiper 1611 and the tube 1642 may be bonded together by a melt bond achieved by an overmolding process. For example, overmolding TPE onto PP may provide adequate melt bonding in some situations. For example, the adhesion of the wiper 1611 onto the tube 1642 over the axial span L4 may be better than the adhesion of the wiper 1611 onto the core 1610 over the axial span L5 (shown in FIGS. 38 and 40).

[0116]

[0190] Instead of or in addition to bonding the wiper 1611 to the exterior surface of the tube 1642, the portion of the core 1610 received inside the inner bore 1644 may be attached to the tube 1642 by any suitable means. In some embodiments, some interstitial space(s) 1648 defined between the core 1610 and the surface of the inner bore 1644 may be filled by overmolding material during the overmolding process. The presence of the overmolding material in the interstitial space(s) 1648 may help fasten the core 1610 to the tube 1642, for example, by melt bonding between the overmolding material and the surface of the inner bore 1644 and the core 1610. Alternatively or additionally, the portion of the core 1610 inside the inner bore 1644 may be attached to the tube 1642, for example, by gluing, heat staking, ultrasonic welding, and / or by deformation of the wire of the core 1610.

[0117]

[0191] The portion of the core 1610 disposed within the inner bore 1644 may only extend partially along the tube 1642. The length of the core 1610 within the inner bore 1644 may be selected based on the attachment desired between the core 1610 and the inner bore 1644. Thus, as shown in FIG. 40 , the longitudinal length of the tube 1642 along the longitudinal axis LA may be longer than the longitudinal length of the portion of the core 1610 that is received within the inner bore 1644 of the tube 1642.

[0118]

[0192] In various embodiments, the tube 1642 can be attached to the wiper 1611 and / or the core 1610 to impede longitudinal movement of the wiper 1611 relative to the core 1610. The presence of the end 1646 of the tube 1642 within the interior of the wiper 1611 can result in the tube 1642 defining a protrusion that serves as a mechanical interlock to impede movement of the wiper 1611 along the core 1610, particularly when the tool 1600 is actuated along the longitudinal axis LA by pushing the tube 1642 toward the left in FIG.

[0119]

[0193] 41 is a flow diagram of a method 4000 of manufacturing a lumen interacting tool for interacting with a lumen (e.g., cleaning, stabilizing a lumen). Method 4000 may be used to manufacture tools described herein or other lumen interacting tools. Method 4000 may include elements of tools described herein. Method 4000 may include operations or steps described herein and / or other operations or steps. In various embodiments, method 4000 includes: Receiving an elongated core having a longitudinal axis (Block 4002); and coupling the lumen interaction body to the elongate core to prevent relative movement between the elongate core and the lumen interaction body (Block 4004).

[0120]

[0194] In some embodiments, coupling the lumen interacting body (e.g., wiper, lumen stabilizer) with the elongate core can include overmolding the lumen interacting body onto the elongate core using an overmolding material. The overmolding material can define one or more beams extending into respective passages formed through the elongate core. Alternatively or additionally, coupling the lumen interacting body with the elongate core can include at least partially sealing a protrusion attached to the elongate core with the lumen interacting body.

[0121]

[0195] In some embodiments, the method 4000 can include overmolding the protrusions onto the elongate core.

[0196] In some embodiments, the protrusion can include a tube 1642 having an inner bore 1644, and the method 4000 can include inserting the core 1610 into the inner bore 1644 of the tube 1642 before at least partially sealing the protrusion with a lumen interacting body (e.g., wiper 1611). In some embodiments, at least partially sealing the protrusion with a lumen interacting body can include overmolding the lumen interacting body over the elongated core and the protrusion. In some embodiments, overmolding the lumen interacting body over the elongated core and the protrusion can include injecting an overmolding material between the elongated core and the inner bore 1644 of the tube 1642.

[0122]

[0197] The above description is meant to be merely exemplary, and those skilled in the art will recognize that modifications may be made to the described embodiments without departing from the scope of the disclosed invention. For example, aspects of the present disclosure may be used with lumen interaction bodies having various configurations and features. The lumen interaction body may include one or more outwardly projecting ribs, wings, arms, umbrella-like features, squeegees, fins, disks, O-rings, piston rings, and / or other protrusions for interacting with the lumen L. In some embodiments, the lumen interaction body may have a star-like shape when viewed along the longitudinal axis LA. The lumen interaction body may have a different shape than shown herein and may be axially symmetric, axially asymmetric, cylindrical, conical, frusto-conical, elliptical, spherical, and / or combinations thereof about the longitudinal axis LA.

[0123]

[0198] The luminal interaction body may be made of any suitable material(s), such as, for example, TPE, TPR, TPU, TPV, silicone, elastomeric polymers such as ethylene vinyl acetate (EVA), polyisoprene, urethane, UV curable silicone polymers sold under the trade name KRATON, silicone rubber, fluoropolymers, low density polyethylene (LDPE) and high density polyethylene (HDPE), polyetheretherketone (PEEK), etc. The luminal interaction body may be made of a suitable flexible material that may have, for example, a relatively low tear resistance. The luminal interaction body may be porous or non-porous. In some embodiments, the luminal interaction body may have a Shore A hardness between 20 and 80. In some embodiments, the luminal interaction body may have a Shore A hardness greater than 80.

[0124]

[0199] In some embodiments, the lumen interaction body may be made from a relatively soft material that allows it to slide along the elongate core and be pushed or pulled over the anchor to engage (e.g., at least partially seal) the anchor. In some embodiments, the lumen interaction body may be threaded up to the anchor. In some embodiments, the lumen interaction body may be formed using, for example, an overmolding process, a dipping process, a potting process, or 3D printing. In some embodiments, the lumen interaction body may be pre-molded into a shape configured to couple with the anchor(s) and then assembled onto the elongate core as one or more pieces.

[0125]

[0200] Various types and shapes of anchors can be used to connect the lumen interaction body with the elongate core. The anchors can have different shapes than those shown herein and can be axially symmetric, axially asymmetric, cylindrical, conical, frustoconical, elliptical, spherical, and / or combinations thereof about the longitudinal axis LA. The anchors can be made of suitable metal or polymer (e.g., PP, PEEK) materials. In some embodiments, the material of the anchors can be harder than or the same hardness as the material of the lumen interaction body. In some embodiments, suitable anchors can be discrete elements that are separate from the elongate core, attached to the elongate core using, for example, glue, epoxy, welding, crimping, clamping (between wires of the elongate core), brazing, soldering, friction fit, and threading. In some embodiments, suitable anchors can be deposited on the elongate core using, for example, overmolding, 3D printing, brushing, dipping, or dispensing. In some embodiments, the anchors can be integrally formed with the elongate core (having a monolithic configuration). For example, the anchor may include irregularities such as loose twists, spiral sections, wavy sections, flattened sections, helical windings, or combinations thereof formed within an elongate core.

[0126]

[0201] In some embodiments, the anchors can be integrally formed with the lumen interaction body (have a monolithic configuration) and can engage the elongate core by extending into a passageway or other cavity formed in the elongate core. In various embodiments, one or more axially spaced anchors can be used to couple the lumen interaction body with the elongate core. In situations where multiple anchors are used with one lumen interaction body, the anchors can all be of the same shape, size, or configuration. Alternatively, anchors of different shapes, sizes, or configurations can be used with the same lumen interaction body. In some embodiments, the anchor(s) can be integrally formed with the elongate core (have a monolithic configuration).

[0127]

[0202] Various types of elongate cores can be used in the tools described herein. In various embodiments, the elongate core can include twisted (intertwined) wires, single wires, polymer and / or carbon filaments, tubes, rods, closed wound springs, multifilamentary wire twists, stranded wires, and / or combinations thereof.

[0128]

[0203] This disclosure is intended to cover and encompass all appropriate modifications in the art. Modifications that fall within the scope of the present invention will become apparent to those skilled in the art in view of the present disclosure, and such modifications are intended to fall within the scope of the appended claims. Similarly, the scope of the claims should not be limited by the preferred embodiments set forth in the examples, but should be given the broadest interpretation consistent with the description as a whole.

Claims

1. 1. A lumen cleaning tool for cleaning a lumen of a medical device, comprising: an elongated core having a longitudinal axis, the elongated core being defined by wires twisted together; a wiper attached to the elongated core; an anchor connecting the wiper to the elongate core along the longitudinal axis of the elongate core to prevent relative movement between the elongate core and the wiper along the longitudinal axis.

2. the elongated core includes tightly twisted and loosely twisted sections having different axial positions along the elongated core; the loosely stranded section defines gaps between the wires stranded together; the wiper is overmolded onto the loosely stranded section of the elongated core; the anchor includes a beam extending into the gap; The lumen cleaning tool of claim 1 , wherein the beam and the wiper have a monolithic construction.

3. The lumen cleaning tool of claim 2 , wherein the gap defines a through passage for the beam to extend laterally through the elongate core.

4. the anchor includes a protrusion attached to the elongate core; The lumen cleaning tool of claim 1 , wherein the wiper at least partially seals against the protrusion.

5. The lumen cleaning tool of claim 4 , wherein the protrusion and the wiper are made from different materials.

6. A lumen cleaning tool according to claim 4 or claim 5, wherein the protrusions include bristles held between the wires twisted together.

7. The lumen cleaning tool of claim 4 , wherein the protrusion is disc-shaped.

8. 8. A lumen cleaning tool according to any one of claims 4 to 7, wherein the protrusions occupy spaces within radially extending fins of the wiper.

9. the wiper includes an overmolded body over the elongated core and over the protrusions; The lumen cleaning tool of claim 4 , wherein the protrusion projects outwardly from the overmolded body.

10. the anchor includes a helical arrangement of bristles extending radially outward from the elongate core; The lumen cleaning tool of claim 1 , wherein the wiper at least partially seals the helical arrangement of bristles.

11. 11. The lumen cleaning tool of claim 1, comprising a plurality of anchors connecting the wiper to the elongate core along the longitudinal axis of the elongate core, the plurality of anchors being axially spaced apart along the longitudinal axis of the elongate core.

12. the plurality of anchors includes a first anchor having a first radial dimension from the longitudinal axis of the elongate core and a second anchor having a second radial dimension from the longitudinal axis of the elongate core; The lumen cleaning tool of claim 11 , wherein the second radial dimension is greater than the first radial dimension.

13. The lumen cleaning tool of claim 1 , wherein the anchor is crimped onto the elongate core.

14. The lumen cleaning tool of claim 1 , wherein the anchor is welded to the elongated core.

15. The lumen cleaning tool of claim 1 , wherein the anchor is overmolded onto the elongate core.

16. The anchor includes a tube having an internal bore; the elongated core includes a first portion within the inner bore of the tube; the elongated core includes a second portion exterior to the inner bore of the tube; The lumen cleaning tool of claim 1 , wherein the wiper is overmolded onto the second portion of the elongate core and onto the tube.

17. 17. The lumen cleaning tool of claim 16, wherein a longitudinal length of the tube is greater than a longitudinal length of the first portion of the elongate core inside the tube.

18. 18. The lumen cleaning tool of any one of claims 15 to 17, wherein the anchor is made of polypropylene.

19. The lumen cleaning tool of claim 18 , wherein the wiper is made from a thermoplastic elastomer.

20. 1. A medical lumen interaction tool for interacting with a lumen, comprising: an elongated core having a longitudinal axis; a body for interacting with the lumen, the body being attached to the elongate core; one or more anchors connecting the body to the elongated core along the longitudinal axis of the elongated core to prevent relative movement between the elongated core and the body along the longitudinal axis, the one or more anchors comprising: a beam having a monolithic construction with the body and extending within a passageway formed through the elongated core; and a projection attached to the elongated core and at least partially sealed by the body A medical luminal interaction tool comprising one or both of the above.

21. The medical lumen interaction tool of claim 20 , wherein the one or more anchors include the beam.

22. the elongated core includes wires twisted together; 22. The medical lumen interaction tool of claim 21, wherein the passageways are defined by gaps between the wires.

23. the elongated core includes tightly twisted sections and loosely twisted sections; 23. The medical lumen interaction tool of claim 22, wherein the passageway is located within the loosely stranded section.

24. the body is a first body, the medical lumen interaction tool includes a second body for interacting with the lumen; 24. The medical lumen interaction tool of claim 23, wherein the second body is attached to the elongate core and axially located within the tightly twisted section of the elongate core.

25. the elongated core includes a helical coil; 22. The medical lumen interaction tool of claim 21, wherein the passage is defined by a gap defined between two turns of wire of the helical coil.

26. the helical coil includes a first section having a first pitch and a second section having a second pitch greater than the first pitch, the first section axially adjacent the second section along the helical coil; 26. The medical lumen interaction tool of claim 25, wherein the body is attached to the helical coil and axially located within the second section of the helical coil.

27. 27. The medical lumen interaction tool of claim 26, wherein the first section of the helical coil and the second section of the helical coil have substantially the same outer diameter.

28. 28. The medical lumen interaction tool of any one of claims 25 to 27, wherein the wire is the only wire in the elongate core.

29. 29. The medical lumen interaction tool of any one of claims 25 to 28, wherein the wire has a polygonal cross-sectional profile.

30. 29. The medical lumen interaction tool of any one of claims 25 to 28, wherein the wire has a circular cross-sectional profile.

31. The medical lumen interaction tool of claim 20 , wherein the one or more anchors include the protrusions.

32. 32. The medical lumen interaction tool of claim 31, wherein the protrusion and the body are made of different materials.

33. 33. The medical lumen interaction tool of claim 31 or claim 32, wherein the protrusions include bristles.

34. 34. The medical lumen interaction tool of any one of claims 31 to 33, wherein the protrusion has a helical shape.

35. 35. The medical lumen interaction tool of claim 34, wherein the protrusions include a helical arrangement of bristles extending radially outward from the elongate core.

36. 33. The medical lumen interaction tool of claim 31 or claim 32, wherein the protrusion comprises a disc.

37. 33. The medical lumen interaction tool of claim 31 or claim 32, wherein the protrusion is ring-shaped.

38. the projection includes a tube having an internal bore; the elongated core includes a first portion within the inner bore of the tube; the elongated core includes a second portion exterior to the inner bore of the tube; 33. The medical lumen interaction tool of claim 31 or claim 32, wherein the body is overmolded onto the second portion of the elongate core and onto the tube.

39. 40. The medical lumen interaction tool of claim 38, wherein a longitudinal length of the tube is greater than a longitudinal length of the first portion of the elongate core inside the tube.

40. 40. The medical lumen interaction tool of any one of claims 31 to 39, wherein the protrusions are made of polypropylene.

41. 41. The medical lumen interaction tool of any one of claims 20 to 40, wherein the body is made of a thermoplastic elastomer.

42. 32. The medical lumen interaction tool of claim 31, wherein the elongated core comprises a helical coil.

43. the helical coil includes a first section having a first outer diameter and a second section having a second outer diameter greater than the first outer diameter; 43. The medical lumen interaction tool of claim 42, wherein the protrusion comprises the second section.

44. the helical coil includes a third section having a third outer diameter smaller than the second outer diameter of the second section; 44. The medical lumen interaction tool of claim 43, wherein the second section is axially located between the first section and the third section.

45. 45. The medical lumen interaction tool of claim 43 or claim 44, wherein the second section has an axial span that is less than an axial span of the first section.

46. 46. ​​The medical lumen interaction tool of any one of claims 42 to 45, wherein the elongate core has only one wire defining the helical coil.

47. 47. The medical lumen interaction tool of any one of claims 20 to 46, wherein the body is overmolded onto the elongate core.

48. 48. The medical lumen interaction tool of any one of claims 20 to 47, wherein the body is a wiper.

49. 48. The medical lumen interaction tool of any one of claims 20 to 47, wherein the body is a lumen stabilizer.

50. 1. A method of manufacturing a medical lumen interaction tool for interacting with a lumen, comprising: receiving an elongated core having a longitudinal axis; and coupling the lumen interaction body with the elongate core to prevent relative movement between the elongate core and the lumen interaction body along the longitudinal axis by performing one or both of the following: overmolding the lumen interaction body onto the elongate core using an overmolding material, the overmolding material defining a beam extending into a passageway formed through the elongate core; and and at least partially sealing a protrusion attached to said elongate core with said lumen interaction body.

51. 51. The method of claim 50, wherein the step of coupling the lumen interaction body with the elongate core includes overmolding the lumen interaction body onto the elongate core using an overmolding material, the overmolding material defining the beam extending through the passageway formed through the elongate core.

52. the elongated core includes pairs of wires twisted together; 52. The method of claim 51, wherein the passage is defined by a gap between the pair of wires.

53. the elongated core includes tightly twisted sections and loosely twisted sections; 53. The method of claim 52, wherein the passageway is located within the loosely stranded section.

54. 51. The method of claim 50, wherein coupling the lumen interaction body with the elongate core comprises at least partially sealing the protrusion attached to the elongate core with the lumen interaction body.

55. 55. The method of claim 54, wherein at least partially sealing the protrusions attached to the elongate core with the lumen interaction body comprises overmolding the lumen interaction body onto the elongate core and onto the protrusions.

56. 56. The method of claim 54 or claim 55, wherein the protrusions include bristles.

57. 56. A method according to claim 54 or claim 55, comprising welding, crimping or overmolding the projections onto the elongate core.

58. 56. The method of any one of claims 50, 51, 54, and 55, wherein the elongated core comprises a helical coil.

59. the projection includes a tube having an internal bore; 51. The method of claim 50, wherein the method includes inserting the elongate core into the inner bore of the tube prior to at least partially sealing the tube with the lumen interaction body.

60. 60. The method of claim 59, comprising overmolding the lumen interacting body onto the elongate core and onto a portion of the tube.

61. 61. The method of claim 60, comprising injecting an overmolding material between the elongated core and the inner bore of the tube.

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