WO2022241671A1

WO2022241671A1 - Wire gripping device

Info

Publication number: WO2022241671A1
Application number: PCT/CN2021/094618
Authority: WO
Inventors: Xiaojing GUO; Yapeng XU; Shichang WEN; Zhi Li; Junmin Guo; Jiaqi RONG
Original assignee: Covidien Lp
Priority date: 2021-05-19
Filing date: 2021-05-19
Publication date: 2022-11-24
Also published as: EP4340922A1; CN117500556A

Abstract

In some examples, a medical device wire retainer includes a retainer body defining a blind hole and a slot, the slot extending from an outside surface of the wire retainer body to the blind hole. The blind hole is configured to receive an end of a medical device wire, and an axial length of the blind hole is less than an axial length of the wire retainer body. In some examples, a ratio of the axial length of the blind hole to a maximum cross-sectional dimension of the blind hole is greater than 20: 1, and one or more inner surfaces of the wire retainer body defining the blind hole are configured to grip the end of the medical device wire with a retention force in response to exertion of a radial compression force on one or more outer surfaces of the wire retainer body.

Description

WIRE GRIPPING DEVICE

TECHNICAL FIELD

The disclosure relates to medical devices.

BACKGROUND

Some medical devices include a wire, such as a delivery wire, a guidewire, or a push wire. During a medical procedure, a clinician may control movement of the wire, such as by applying a distal pushing force and/or a torqueing motion to a proximal portion of the wire to navigate a distal portion. The wire may be relatively thin and can also include a hydrophilic coating.

SUMMARY

The present disclosure describes a wire retainer including a blind hole configured to receive a medical device wire (e.g., a delivery wire, a guidewire, or a push wire) , and a slot extending from an outer surface of the wire retainer to the blind hole and extending axially for at least a portion of the axial length of the blind hole. When an end portion of the medical device wire is positioned in the blind hole, the wire retainer is configured to grip the end portion with a retention force upon exertion of a radial compression force on one or more outer surfaces of the wire retainer. For example, the wire retainer may be configured to mate with a clip, and the clip may be configured to exert the radial compression force on one or more outer surfaces of the wire retainer upon mating with the deliver wire retainer. In some examples, the wire retainer is configured to grip the end portion of the medical device wire with a retention force, e.g., when mated with the clip, that is enough to prevent unintentional release of the delivery wire from the wire retainer during shipping and storage.

In some examples, a medical device wire retainer includes a retainer body defining a blind hole and a slot, the slot extending from an outside surface of the wire retainer body to the blind hole, wherein the blind hole is configured to receive an end of a medical device wire, wherein an axial length of the blind hole is less than an axial length of the wire retainer body, wherein a ratio of the axial length of the blind hole to a maximum cross-sectional dimension of the blind hole is greater than 20: 1, wherein one or more inner surfaces of the wire retainer body defining the blind hole are configured to grip the end of the medical device wire with a retention force in response to exertion of a radial compression force on one or more outer surfaces of the wire retainer body.

In some examples, a medical device assembly includes a clip; and a retainer body defining a longitudinal axis and defining first and second ends on opposite sides of the wire retainer body, the wire retainer body defining a blind hole and a slot, wherein the slot extends from an outside surface of the wire retainer body to the blind hole, and wherein the blind hole extends along the longitudinal axis from the first end of the wire retainer body to location between the first and second ends, wherein the blind hole is configured to receive an end of a medical device wire, wherein a ratio of the axial length of the blind hole to a maximum cross-sectional dimension of the blind hole is greater than 20: 1, and wherein one or more inner surfaces of the wire retainer body defining the blind hole are configured to grip the end of the medical device wire with a retention force in response to mating of the wire retainer body with the clip.

In some examples, a method of forming a medical device wire retainer includes forming a blind hole and a slot in a retainer body, the slot extending from an outside surface of the wire retainer body to the blind hole, wherein the blind hole is configured to receive an end of a medical device wire, wherein an axial length of the blind hole is less than an axial length of the wire retainer body, wherein a ratio of the axial length of the blind hole to a maximum cross-sectional dimension of the blind hole is greater than 20: 1, and wherein one or more inner surfaces of the wire retainer body defining the blind hole are configured to grip the end of the medical device wire with a retention force in response to exertion of a radial compression force on one or more outer surfaces of the wire retainer body.

The details of one or more examples are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view illustrating an example medical device wire retainer.

FIG. 2 is a conceptual cross-sectional view of the example wire retainer of FIG. 1, the cross-section being taken through a central longitudinal axis of the wire retainer.

FIG. 3 is conceptual cross-sectional view of an example uncompressed wire retainer, the cross-section being taken along line B illustrated in FIG. 1.

FIG. 4 is a conceptual cross-sectional view of an example compressed wire retainer, the cross-section being taken along line B illustrated in FIG. 1.

FIG. 5 is a perspective view of an example wire retainer with a medical device wire inserted in a blind hole of the wire retainer and also illustrating the wire retainer mated with a clip.

FIG. 6 is a flow diagram of an example method of forming a wire retainer.

DETAILED DESCRIPTION

The present disclosure describes a medical device wire retainer (also referred to herein as a “retainer” or a “wire retainer” ) defining a blind hole configured to receive a medical device wire (also referred to herein as a “wire” ) and a slot extending from an outside surface of the wire retainer to the blind hole and extending axially for at least a portion of the axial length of the hole. For example, the slot may extend the full length of the blind hole or only along part of an axial length of the blind hole, the axial lengths being measured in a direction parallel to a longitudinal (or “axial” ) axis of the wire retainer. The wire retainer is configured to grip an end of the medical device wire with a retention force upon exertion of a radial compression force on one or more outer surfaces of the wire retainer, e.g., to retain the end of the medical device wire during shipping and storage of the medical device including the wire. In some examples, a clip configured to engage an outer surface of the wire retainer is configured to apply the radial compression force on the wire retainer.

Example medical devices include guidewires, marker wires, delivery wires, embolization devices, embolectomy and/or thrombectomy devices, guide extension catheters including a push wire, and any other suitable medical device including a wire and/or another relatively thin elongated body. In some examples, a medical device may include any other suitable elongated element or shaft, such as a tube, hypotube, or catheter body, that is part of a medical device or used to facilitate a medical procedure. The elongated element can be, for example, configured to be introduced into a hollow anatomical structure of a patient (e.g., a blood vessel) . The wire may be relatively thin and can also include a hydrophilic coating, both of which may make it difficult to protect the end of the wire during shipping and delivery of the wire from its manufacturing and/or finishing location to a location where it is to be used.

Interventional medical devices used for vasculature embolization have a relatively long delivery wire on the order of several meters, e.g., 1.8 meters, 3 meters, 3.5 meters, 5 meters, 10 meters, or any suitable length for the desired procedure. A clinician may navigate an implant part of the interventional medical device to a treatment site (e.g., a lesion) through manipulation the delivery wire outside of the patient body. Interventional medical devices, as well as other types of medical devices, need effective and efficient means of packaging for protecting the wire during shipping, storage, and/or handling. During shipping, storage, or handling, a medical device stored in a medical device package may undergo various forces, e.g., vibrations, shaking, forces from being dropped, and the like.

In some packaging of medical devices including wires, the medical device wire is packaged in a hoop or other configuration with an end of the wire is inserted into a wire retainer. The wire retainer provides a retention force to the medical device wire to help ensure the whole medical device stays in the package during distribution. Retaining a medical device wire in the wire retainer can be relatively difficult because the medical device wire can be relatively thin, e.g., 500 micron diameter, and smooth, making gripping of the medical device wire by the wire retainer relatively challenging. Some retainers defines a hole open at only one end of the wire retainer, and an end of the medical device wire is introduced into the hole via the open end. The hole must have a relatively long axial length in order to get an adequate retention force on the medical device wire. The axial length of the hole, e.g., the depth of the hole, may be relatively long compared with its diameter, e.g., longer than 10 millimeters (mm) , and the wire retainer hole consequently may have a very high aspect ratio. Although the medical device wire and/or example wire retainers and holes defined by example wire retainers wire retainers, or any other example components, may be described herein as having a diameter, such articles and/or components may have a cross-sectional shape other than circular and “diameter” may be understood to be a “cross-sectional dimension” . For example, as used herein, “diameter” may refer to a cross-sectional dimension in a plane perpendicular to the axial length of the medical device wire and/or example wire retainers, e.g., perpendicular to a longitudinal axis L illustrated and described in FIGS. 1-2 below.

For example, the wire retainer may have 400 micron diameter and a 12 mm length for an aspect ratio, e.g., length to diameter ratio, of 30: 1. The manufacture of such a retainer including a small diameter, high aspect ratio retaining hole can be challenging, particularly for a blind hole. A blind hole may extend from one end of the wire retainer to a location within the wire retainer, e.g., between the longitudinal or axial ends of the wire retainer, and is not a through hole that extends from one of the wire retainer to the other end of the wire retainer. For example, it may be difficult and/or prohibitively costly to machine a core pin with the above dimensions for long-term manufacturing, e.g., such as for use with elastomer modeling and/or injection molding, because the core pin may frequently crack and/or break.

Additionally, it may be difficult to insert and withdraw a medical device wire from such a retainer. For example, the diameter of the hole may be substantially the same as the wire, or slightly less, such that the wire is press-fit into the hole and is retained with a desired retention force by virtue of inserting an adequate length of wire into the hole. In some examples, it may be difficult to align the wire with the hole for insertion because of the relatively small diameter (or other maximum cross-sectional dimension in the case of non-circular cross-section wires) . Additionally, inserting the wire into the hole may result in hard-taking, e.g., difficulty in advancing the wire within the hole which may cause the wire to bend, kink, and the like, and/or an inability to advance the wire an adequate axial and/or longitudinal distance into the hole and resulting in an inadequate retention force and increased chance of unintentional release of the delivery wire from the wire retainer during shipping and storage. In some examples, it may also be difficult to remove the wire from the wire retainer, e.g., there is no mechanism for reducing the retention force when it comes time to take the wire out of the wire retainer.

The present disclosure describes a wire retainer having a design that facilitates improved manufacturability and which is configured to apply a retention force to a medical device wire within a desired range during shipping, storage, and/or handling. In some examples, a wire retainer according to the present disclosure includes a mechanism for compressing and decompressing the blind hole. As such, the wire retainer may utilize, and be manufactured with, a larger diameter blind hole. As a result, the aspect ratio of the blind hole may be reduced, easing both manufacturability and use, e.g., enabling easier alignment, insertion, and withdrawal of the wire while still providing an adequate retention force on the medical device wire to prevent unintentional release of the delivery wire from the wire retainer during shipping, handling, and storage. Because the wire retainer defines a hole configured to receive the medical device wire that is larger in maximum cross-sectional dimension than the medical device wire, the wire retainer also exhibits improved ease of insertion and withdrawal of the delivery wire from the wire retainer compared to wire retainers that include smaller holes, e.g., holes that are close to the same size as the medical device wire. For example, the hole may have a circular cross-sectional shape with a diameter that is at least 5%larger than the diameter of a medical device wire with a circular cross-sectional shape, or the diameter of the hole may be at least 10%larger than the diameter of the medical device wire, or the hole may be at least 20%larger than the diameter of the medical device wire, or the hole may be at least 30%larger than the diameter of the medical device wire.

In some examples, a retaining assembly includes a clip and a retainer including a retainer body defining a blind hole configured to receive a medical device wire and further defining a slot open to the blind hole and extending along at least a portion of an axial length of the blind hold. The clip is configured to engage with an outer surface of the wire retainer to apply a radially compressive force (in a direction towards a central longitudinal axis of the wire retainer) to the wire retainer and cause the wire retainer to grip a medical device wire introduced in the blind hole. The slot enables a retainer body of the wire retainer to compress radially inward in response to the application of the radially compressive force and grip the medical device wire, while also closing the slot enough to help prevent the medical device wire from slipping out of the blind hole through the slot.

In some examples, an outer surface of the wire retainer body is configured to mate with a clip, e.g., an angle clip. For example, the shape of the wire retainer body may be adapted and/or configured to mate with an inner shape of the clip.

In some examples, the wire retainer body is compressed by the clip when mated and/or inserted into the clip. For example, the outer diameter and/or other maximum cross-sectional dimension (if not circular in cross-section) of the wire retainer body may be larger than the inner diameter and/or other maximum cross-sectional dimension of the clip such that the clip exerts a radial compression force on one or more outer surfaces of the wire retainer body, e.g., a radially inwards force. The wire retainer body slot may deform under the compression of clip, thereby reducing the volume of the blind hole and causing one or more inner surfaces of the wire retainer body defining the blind hole to contact and/or increase a radial compression force on the delivery wire, thereby gripping at least a portion of the delivery wire within the blind hole, e.g., with a retention force that resists axial movement of the delivery wire within the hole (in a direction along the central longitudinal axis of the wire retainer) . In some examples, the wire retainer body is formed of a material that is deformable and/or compressible and/or the structural configuration (e.g., the slot) alone enables the wire retainer body to deform.

In some examples, the configuration of the slot, e.g., the slot width, shape, surface structure, axial length, and the like, may be varied based on delivery wire dimensions and/or other attributes, e.g., such as delivery wire surface coatings. The slot is configured such that the medical device wire can be introduced into the blind hole via the slot, rather than via an opening to the blind hole at an end of the wire retainer body. For example, the slot width (W _SLOT illustrated in FIG. 1) may range from about 2 times the diameter of the medical device wire to about 10 times the diameter of the medical device wire, such as about 5 times to about 8 times the diameter of the medical device wire. In some examples, the retention force the wire retainer body is configured to apply to the medical device wire is varied and/or controlled via forming the wire retainer body with a predetermined slot width and/or axial length. For example, the axial length of the slot may be less than the axial length of the hole, and the retention force of the wire retainer body may be increased by increasing the axial length to allow an increase in surface area of the inner surfaces of the hole contacting and exerting a radial compression force on the delivery wire. In some examples, the axial length of the slot may range from about 10 times the diameter of the medical device wire to about 50 times the diameter of the medical device wire, such as about 20 times to about 35 times the diameter. In these examples as well as other examples described herein, “about” a value can mean within about 10%or within about 5%of the value.

The wire retainer body may be formed from any suitable material. In some examples, the wire retainer body is made of one or more of an elastomers, a polymer, a monomer, a silicone, a rubber, a thermoplastic urethane (TPU) , or any combination thereof. In some examples, the external shape of the wire retainer body may be cylindrical, cubic-shaped, a cuboid, tetrahedral-shaped, octahedral-shape, or any other suitable shape, e.g., that may mate with the clip. In some examples, the slot may be cuboid, an irregular shape, may include a texture on one or more surfaces, and may include a physical surface profile structure, e.g., such as ribs, and the like. Although a retainer body defining a blind hole that is circular in cross-section (and, therefore, defining a diameter) and a retainer body defining a curved outer surface are primarily referred to here, in other examples, the wire retainer body and blind hole can have any other suitable shape. The reference to diameters, circumferential distance, or other terms referring to circular or curved shapes is not intended to limit the description herein to retainer bodies and blind holes having specific shapes. The reference to diameters and circumferential distances can refer to other maximum cross-sectional dimensions and lengths, respectively.

The wire retainer body may be formed using any suitable technique. In some examples, the wire retainer body may be formed via injection molding, modelling or any other suitable method.

In some examples, the wire retainer assemblies described herein may provide a benefit of retaining a delivery wire with an adequate retention force over a wide range of delivery wire diameters. In some examples, the hole-and-slot design of the wire retainer body may provide the benefit of decreased manufacturing complexity and cost and increased manufacturing reliability. For example, the hole-and-slot design of the wire retainer body may be made via modelling and/or injection molding via one-piece tooling instead of a floating core pin for making a blind hole.

FIGS. 1 and 2 are different views of an example medical device wire retainer 100, and are described together. FIG. 1 is a perspective view illustrating an example medical device wire retainer 100. FIG. 2 is a conceptual cross-sectional view of wire retainer 100, the cross-section being taken through a central longitudinal axis L of wire retainer 100.

Wire retainer 100 includes a retainer body 102 defining a slot 108, a blind hole 110, and an end surface 114 defining the entrance to blind hole 110. In some examples wire retainer 100 optionally includes a head portion 104 and a channel structure 106. In the example shown, retainer body 102 defines blind hole 110 through end surface 114 and extending in the longitudinal direction along longitudinal axis L. In some examples, retainer body 102 may optionally define taper 112 at the entrance of blind hole 110 in end surface 114 and extending generally in the longitudinal direction.

Wire retainer 100 is illustrated in an unclipped and/or release position, e.g., without radial compression of blind hole 110. Wire retainer 100 may be formed from any suitable material, such as, but not limited to, a polymer, an elastomer, a silicone, a rubber, or a thermoplastic polyurethane (TPU) . In some examples, wire retainer 100 may be made of a metal or any suitable material for providing structure for wire retainer 100, e.g., to define blind hole 110, slot 108, and to retain at least a portion of a medical device wire. In some examples, wire retainer 100 is be made of a compressible material, and in some examples wire retainer 100 is made of a rigid material that is configured to compress blind hole 110 in response to exertion of a radial compression force on one or more outer surfaces of retainer body 102 by virtue of slot 108 being a mechanical relief of retainer body 102.

Retainer body 102 has any suitable shape. In some examples, retainer body 102 is substantially cylindrical and has a substantially circular (e.g., circular or nearly circular to the extent permitted by manufacturing tolerances) cross-sectional shape, the cross-section being taken in a direction perpendicular to longitudinal axis L. Other cross-sectional shapes may also be used, e.g., elliptical, rectangular, irregular, etc. For example, retainer body 102 may be cubic, cuboid, tetrahedral, octahedral, or any suitable shape.

Head portion 104 may be at one or both ends of retainer body 102 and may have any suitable shape. In the example shown, head portion 104 is substantially cylindrical and has a substantially circular cross-sectional shape with a larger diameter than that of the other parts of retainer body 102. In some examples, head portion 104 may be integrally formed with and/or separate from and mechanically attached to retainer body 102. Head portion 104 may be configured to function as a stop for wire retainer 100 when wire retainer 100 is mated with a clip, e.g., as illustrated and described below with reference to FIG. 5. In some examples, wire retainer 100 may not include head portion 104, or head portion 104 may have substantially the same cross-sectional diameter as retainer body 102. For ease of description, head portion 104 is referred to herein as being part of retainer body 102.

Channel structure 106 may be configured to mate with a channel of a clip, e.g., as illustrated and described below with reference to FIG. 5. Channel structure 106 may be any size or shape suitable for mating with a clip. In the example shown, channel structure 106 extends radially from an outer surface of retainer body 102 along a portion of the axial length AL _R of retainer body 102 and extends in the circumferential direction about retainer body 102 for a portion of the circumference of retainer body 102.

Blind hole 110 extends for a portion of the axial length AL _R of retainer body 102 and is configured to receive an end portion, including an end, of a medical device wire. In the example shown, blind hole 110 extends for a portion of the axial length AL _R of retainer body 102, and terminates within retainer body 102, and is configured to receive an end of a medical device wire. Retainer body 102 extends from end 102A to end 102B, such that ends 102A, 102B are on opposite sides of retainer body 102. Blind hole 110 is not a through hole that extends from end 102A to end 102B, but, rather, extends from end 102A to a location between ends 102A, 102B. Blind hole 110 can be accessed via an opening at end 102A or via slot 108.

Blind hole 110 may have any suitable axial length AL _BH, measured along longitudinal axis L, for retaining a medical device wire, e.g., to grip the wire with a threshold level of retaining force to retain the wire within blind hole 110 during shipping, handling, and storage of the medical device wire when the medical device wire may be subjected to vibrations, shaking, forces from being dropped, thermal expansion and shrinking of the medical device wire, and the like. In general, the inner surfaces of retainer body 102 define blind hole 110 and are configured to contact and grip the end of the medical device wire.

In some examples, axial length AL _BH of blind hole 110 may be at least 1 mm, at least 5 mm, at least 10 mm, or any suitable length less than the entire length of wire retainer 100. In some examples, blind hole 110 may have a circular cross-sectional shape, although in general blind hole 110 may have any cross-sectional shape. For example, blind hole 110 may have a circular, an elliptical, a rectangular, or an irregular cross-sectional shape. In some examples, blind hole 110 retains the same diameter, or an equivalent dimension such as a maximum or minimum cross-sectional extent when not a circular cross-sectional shape, for its entire length. In other examples, surfaces of retainer body 102 defining blind hole 110 include taper 112 for a portion of the length of blind hole 110. As a result, blind hole 110 may be referred to as tapering along at least a portion of its length. For example, blind hole 110 may include a taper along at least a portion of its length and/or taper 112 along a first portion of its length and second taper along a second portion of its length. In some examples, blind hole 110 may have a diameter and/or equivalent diameter of less than 2 mm, 1 mm, 500 microns, 250 microns, 100 microns, or any suitable diameter for retaining a medical device wire. In some examples, the aspect ratio of blind hole 110 may be 2: 1, 10: 1, 30: 1, 50: 1, or any suitable aspect ratio for inserting, retaining, and removing a medical device wire.

Retainer body 102 defining blind hole 110 may include textured, treated, coated, etc., surfaces. For example, one or more surfaces of retainer body 102 defining blind hole 110 may have a texture/coating which may increase friction with a medical device wire which may help retain a medical device wire by increasing the retention force on the wire for a given radial compression force applied to retainer body 102 and the medical device wire.

Slot 108 extends for a portion of the axial length AL _R of retainer body 102. In the example shown, slot 108 extends for a portion of the axial length AL _R of retainer body 102 and terminates somewhere along retainer body 102 prior to end 102B. Slot 108 extends radially from an outer surface of the wire retainer body 102 and/or head portion 104 to blind hole 110 and extends axially for at least a portion of the axial length AL _BH of the blind hole. Slot 108 is configured to enable blind hole 110 to compress, e.g., reduce in volume such that one or more inner surfaces of retainer body 102 defining blind hole 110 contact and grip the medical device wire inserted within blind hole 110 with a retention force, in response to a radial compression force on one or more outer surfaces of retainer body 102. In some examples, slot 108 is a mechanical relief that enables retainer body 102 (and head portion 104) , to reduce in diameter in response to exertion of a radial compression force on one or more outer surfaces of retainer body 102, thereby compressing blind hole 110 such that one or more inner surfaces of retainer body 102 to contact and grip the medical device wire inserted within blind hole 110 with a retention force, and/or to increase the grip and retention force.

In some examples, the axial length AL _SLOT of slot 108 is less than or equal to the axial length AL _BH of blind hole 110, and the retention force on the medical device wire is proportional to the axial length AL _SLOT of slot 108. Slot 108 defines a slot width measured in a direction orthogonal to longitudinal axis L. For example, in the case of a curvilinear outer surface, the slot width of slot 108 may be a circumferential length. In some examples, the slot width is less than a cross-sectional dimension of blind hole 110, such as a diameter of blind hole 110. In some examples, retainer body 102 is configured to compress and reduce the slot width of slot 108 in response to a radial compression force on one or more outer surfaces of retainer body 102. In other examples, the slot width may be greater than or equal to a cross-sectional dimension of blind hole 110, and retainer body 102 is configured to compress and reduce the slot width of slot 108 in response to a radial compression force on one or more outer surfaces of retainer body 102. In some examples, slot 108 has a cuboid shape, a texture of one or more surfaces of the wire retainer body defining the slot, or retainer body 102 includes ribs on or formed from one or more surfaces of the wire retainer body defining the slot.

In general, surfaces of retainer body 102 defining slot 108 may have any shape and/or surface texture and/or profile suitable for retainer body 102 to compress blind hole 110 in response to exertion of a radial compression force on one or more outer surfaces of retainer body 102.

Taper 112 is configured to aid alignment and insertion of the medical device wire into blind hole 110. For example, taper 112 may ease alignment difficulty by providing a relatively large opening at retainer body end 102A into which the medical device wire can be inserted; the size of the opening at retainer body end 102A is larger than the diameter defined by more distal portions of blind hole 110. The medical device wire may be guided into the smaller diameter portions of blind hole 110 by contact with the surface of taper 112 as the wire is distally advanced into blind hole 110. Taper 112 extends for a portion of the axial length of head portion 104 and/or retainer body 102. In some examples, taper 112 is defined by a first, larger diameter (e.g., measured in a direction perpendicular to longitudinal axis L) at the axial/longitudinal position of end surface 114 and a second, smaller diameter at an axial position towards the end 102B of retainer body 102. The taper 112 may be linear, parabolic, hyperbolic, or any suitable shape.

In general, the retention force of wire retainer 100 is proportional to a radial compression force applied on one or more outer surfaces of retainer body 102, the axial length AL _SLOT of slot 108, and the axial length of medical device wire retained within wire retainer 100. For example, an increase of a radial compression force applied on one or more outer surfaces of retainer body 102 causes an increase in the grip force and/or retention force on a medical device wire positioned in blind hole 110. In some examples, the retention force may increase with increasing axial length AL _SLOT of slot 108 at least to the extent that the axial length AL _SLOT of slot 108 is at least the axial length AL _BH of blind hole 110. Additionally, the retention force may increase with increasing length of medical device wire being inserted into blind hole 110, at least to the extent of the axial length AL _BH of blind hole 110, e.g., by virtue of contacting and gripping a greater surface area of the medical device wire. In some examples, wire retainer 100 may be configured to retain the medical device wire with a retention force in a range from 5 gram-force to 1000 gram-force, 10 gram-force to 750 gram-force, or 20 gram-force to 500 gram-force.

FIG. 3 is conceptual cross-sectional view of an example uncompressed wire retainer 100, the cross-section being taken along line B illustrated in FIG. 1. In the example shown, a medical device wire 302 is inserted into blind hole 110. As shown in FIG. 3, medical device wire 302 has a diameter D _W that is less than the diameter D _BH of blind hole 110, and may be inserted and removed with reduced and/or minimal resistance force from one or more inner surfaces of blind hole 110, e.g., as compared with when compressed. Although described above with reference to diameters, medical device wire 302 and blind hole 110 may not have a circular cross-section, and their respective “diameters” may be rather be cross-sectional dimensions and D _W and D _BH may be the maximum cross-sectional dimension of medical device wire 302 and blind hole 110, respectively. FIG. 3 also illustrates the asymmetric configuration of retainer 102 due to the presence of slot 108.

FIG. 4 is a conceptual cross-sectional view of an example compressed wire retainer 100, the cross-section being taken along line B illustrated in FIG. 1. In the example shown, the size, volume, diameter, and/or cross-sectional dimension of blind hole 110 has been reduced via compression of retainer body 102, e.g., in response to the exertion of a radial compression force on one or more outer surfaces of retainer body 102. The radial compression force causes retainer body 102 to compress and reduce the circumferential width of slot 108, which in turn reduces the cross-sectional dimension of blind hole 110. For example, the maximum cross-sectional dimension of blind hole 110 may be reduced from D _BH to D _COMP. The reduction in the size, volume, diameter, and/or cross-sectional dimension of blind hole 110 causes one or more

inner surfaces

304, 306 of retainer body 102 defining blind hole 110 to contact and grip medical device wire 302 with a retention force, e.g., via friction between

inner surfaces

304, 306 and a surface of medical device wire 302.

The retention force resists movement of medical device wire 302 in the longitudinal direction within blind hole 110, e.g., in the direction generally parallel to the axial length AL _R of wire retainer 100, and is proportional to the frictional force between

inner surfaces

304, 306 and the surface of medical device wire 302 and the area of contact between

inner surfaces

304, 306 and a surface of medical device wire 302. For example, the frictional force between

inner surfaces

304, 306 and a surface of medical device wire 302 is proportional to the normal force applied pushing the two surfaces together, e.g., a radial compression force at

inner surfaces

304, 306 and the surface of medical device wire 302 resulting from a radial compression force exerted on one or more outer surfaces of retainer body 102. Increasing the radial compression force increases the frictional force and the retention force resisting movement of medical device wire 302 within blind hole 110. Similarly, increasing the surface area of contact between

inner surfaces

304, 306 and the surface of medical device wire 302 increases the retention force, e.g., the amount of force needed to move medical device wire 302 within blind hole 110 (when compressed) increases with increasing contact area, such as from a longer axial length of medical device wire 302 being inserted within blind hole 110.

The retention force of wire retainer 100 may also be determined and/or controlled via the axial length AL _BH of blind hole 110. For example, increasing the axial length AL _BH of blind hole 110 increases the retention force via an increase in the surface contact area between inner surface 304 and the surface of medical device wire 302, to the extent that a greater axial length of medical device wire 302 is inserted into the longer blind hole 110 and the axial length AL _SLOT of slot 108 increases as well.

The retention force of wire retainer 100 may also be determined and/or controlled via the slot width W _SLOT of slot 108. For example, a larger slot circumferential width W _SLOT may enable greater compression of blind hole 110 and one or both of a larger surface contact area between inner surface 304 and the surface of medical device wire 302 and a larger normal force, e.g., radial compression force. For example, a smaller slot width W _SLOT may limit the compression of blind hole 110 via the two surfaces of slot 108 defined by the longitudinal and radial directions coming into contact, e.g., the circumferential width of slot 108 is compressed to zero. In some examples, the slot width may range from about 2 times the diameter of the medical device wire to about 20 times the diameter of the medical device wire, from about 3 times the diameter of the medical device wire to about 10 times the diameter of the medical device wire, or from about 5 times the diameter of the medical device wire to about 8 times the diameter of the medical device wire.

The retention force of wire retainer 100 may also be determined and/or controlled via the axial length AL _SLOT of slot 108. If the axial length AL _SLOT of slot 108 is decreased to be less than the axial length AL _BH of blind hole 110, then the retention force may decrease in proportion to the decrease of the axial length AL _SLOT of slot 108. For example, slot 108 may enable blind hole 110 to compress, and decreasing the axial length AL _SLOT of slot 108 decreases the axial length AL _BH of blind hole 110 that may compress upon the exertion of the radial compression force, e.g., thereby decreasing the surface contact area between inner surface 304 and the surface of medical device wire 302. In some examples, the axial length of the slot may range from about 5 times the diameter of the medical device wire to about 75 times the diameter of the medical device wire, or from about 10 times the diameter of the medical device wire to about 50 times the diameter of the medical device wire, or from about 20 times the diameter of the medical device wire to about 35 times the diameter of the medical device wire.

FIG. 5 is a perspective view of an example wire retainer 100 with an example medical device wire 302 inserted in blind hole 110 and also illustrating wire retainer 100 mated with a clip 402. Clip 402 is configured to engage with an outer surface of retainer body 102 to apply a radially compressive force (in a direction towards a central longitudinal axis L of retainer body 102) to retainer body 102 to decrease slot width W _SLOT of slot 108 and cause inner surface 304 of retainer body 102 defining blind hole 110 to grip medical device wire 302 and help retain medical device wire 302 in blind hole 110.

In the example shown, clip 402 includes a plurality of clip slots 404 configured to mate with and hold a respective wire retainer 100. In some examples, one or more of clip slots 404 include a channel 406 configured to receive channel structure 106 of wire retainer 100, e.g., which may prevent wire retainer 100 from rotating with clip slot 404. In other examples, clip 402 can be configured to engage with only one wire retainer 100. In some examples, clip 402 may be an angle clip.

In some examples, each clip slot 404 may have an inner shape that is configured to engage with, e.g., mate with the outer shape of wire retainer 100, e.g., retainer body 102. For example, clip slot 404 may have a cubic, cuboid, tetrahedral, octahedral, or any suitable shape for mating with and exerting a radial compression force on one or more outer surfaces of retainer body 102. In the example shown, clip slots 404 have a shape configured to mate with the substantially cylindrical shape of retainer body 102 and exert a radial compression force on retainer body 102, e.g., the inner diameter of clip slots 404 may be less than the outer diameter of retainer body 102. In the example shown, the shape of channels 406 have a shape configured to mate with channel structure 106.

In some examples, the inner diameter and/or dimension of clip slots 404 may be undersized, e.g., less than the outer diameter and/or dimension of retainer body 102, and may exert a radial compression force on one or more outer surfaces of retainer body 102 when wire retainer 100 is mated with clip 402 within a clip slot 404.

In the example shown, the axial length of each clip slot 404 is less than the axial length of retainer body 102 and is sized such that head portion 104 may function as a stop for wire retainer 100, e.g., so as to prevent wire retainer 100 from moving axially in at least one longitudinal direction. In some examples, channel structure 106 and head portion 104 may be configured to rotationally and axially position wire retainer 100 within clip slot 404 via mating with channel 406, e.g., with slot 108 in a particular rotational position relative to channel 406 and with the axial length of slot 108 in a particular position with respect to the axial length of clip slot 404, e.g., so as to compress retainer along at least a portion of the axial length AL _SLOT of slot 108 to result in a particular retention for or a particular range of retention force. For example, if wire retainer 100 is mated with channel 406 with a gap between an edge of clip 402 and head portion 106, clip 402 and/or channel 406 may apply radial compression along an axial length AL _R of retainer body 102 that at least partially does not include slot 108 thereby compressing a different (e.g., reduced) axial length AL _SLOT of slot 108 resulting in a different (e.g., less) retention force. In other examples, the axial position of wire retainer 100 within channel 406 does not matter and the same retention force and/or range of retention force may result for different axial and/or rotational positions of wire retainer 100 mated with clip 402 within clip slot 404, e.g., a retainer body 102 made of a relatively rigid material.

FIG. 6 is a flow diagram of an example method of forming a wire. While FIG. 8 is described with reference to wire retainer 100, in other examples, the method can be used with other similar wire retainers.

A user may machine a one-piece tool and/or mold (602) . For example, a user may use any type of machining, such as precision machining, to form a tool and/or mold. The one-piece tool may be configured to form wire retainer 100 without the use of additional fixed elements, such as a core pin, to create the void for blind hole 110 during molding. In some examples, because wire retainer 100 may be made with a blind hole 110 with a cross-sectional dimension larger than a medical device wire that blind hole 110 is configured to receive, the aspect ratio of tooling used to form blind hole 110 is reduced which reduces manufacturing complexity and/or difficulty, e.g., such tooling may be less susceptible to breaking and/or cracking. Additionally, because wire retainer 100 is made with a slot, tooling used to form blind hole 110 may be attached and/or integral with the tooling used to form wire retainer 100 (e.g., one-piece tooling) . Blind hole 110 may be made with a cross-sectional dimension comparatively larger than a medical device wire that blind hole 110 is configured to receive because wire retainer 100 is configured to compress the cross-sectional dimension of blind hole 110, e.g., radially inwards, because of slot 108.

A user may form wire retainer via molding (604) . For example, the user may use the one-piece tool and/or to form wire retainer 100 via injection molding, blow molding, rotation molding, and the like.

Various examples of the disclosure have been described. Any combination of the described systems, operations, or functions is contemplated. These and other examples are within the scope of the following claims.

Claims

A medical device wire retainer comprising:

a retainer body defining a blind hole and a slot, the slot extending from an outside surface of the wire retainer body to the blind hole,

wherein the blind hole is configured to receive an end of a medical device wire,

wherein an axial length of the blind hole is less than an axial length of the wire retainer body,

wherein a ratio of the axial length of the blind hole to a maximum cross-sectional dimension of the blind hole is greater than 20: 1,

wherein one or more inner surfaces of the wire retainer body defining the blind hole are configured to grip the end of the medical device wire with a retention force in response to exertion of a radial compression force on one or more outer surfaces of the wire retainer body.
The medical device wire retainer of claim 1, wherein the retention force is about 20 gram-force to about 500 gram-force.
The medical device wire retainer of any one of claims 1 or 2, wherein the retention force is proportional to the radial compression force on the one or more outer surfaces of the wire retainer body.
The medical device wire retainer of any one of claims 1–3, wherein an axial length of the slot is less than or equal to the axial length of the blind hole, and wherein the retention force is proportional to the axial length of the slot.
The medical device wire retainer of any one of claims 1–4, wherein the maximum cross-sectional dimension of the blind hole is less than or equal to 1 millimeter.
The medical device wire retainer of any one of claims 1–5, wherein the axial length of the blind hole is greater than or equal to 5 millimeters.
The medical device wire retainer of any one of claims 1–6, wherein a circumferential width of the slot is less than the maximum cross-sectional dimension of the blind hole, and wherein in response to the radial compression force on one or more outer surfaces of the wire retainer body, the wire retainer body is configured to compress and reduce the circumferential width of the slot.
The medical device wire retainer of any one of claims 1–7, wherein the wire retainer body is deformable.
The medical device wire retainer of any one of claims 1–8, wherein the wire retainer body is comprises at least one of a polymer, an elastomer, a silicone, a rubber, or a thermoplastic polyurethane (TPU) .
The medical device wire retainer of any one of claims 1–9, wherein the wire retainer body is at least one of cylindrical, cubic, cuboid, tetrahedral, or octahedral.
The medical device wire retainer of any one of claims 1–10, wherein the one or more inner surfaces of the wire retainer body defining the blind hole are textured or define ribs, the texture or ribs being configured to increase friction with the medical device wire when the medical device wire is introduced in the blind hole.
The medical device wire retainer of any one of claims 1–11, wherein a cross-sectional shape of the blind hole is at least one of a circular shape, an elliptical shape, a rectangular shape, or an irregular shape.
The medical device wire retainer of any one of claims 1–12, wherein the one or more inner surfaces define a taper for at least a portion of the axial length of the blind hole.
The medical device wire retainer of any one of claims 1–13, wherein retainer body is formed via injection molding via one-piece tooling.
An assembly comprising:

the medical device wire retainer of any one of claims 1–14; and

a clip configured to mate with the wire retainer body, wherein the clip is configured to exert the radial compression force on the one or more outer surfaces of the wire retainer body upon mating with the clip.
The assembly of claim 15, further comprising the medical device wire.
A medical device assembly comprising:

a clip; and

a retainer body defining a longitudinal axis and defining first and second ends on opposite sides of the wire retainer body, the wire retainer body defining a blind hole and a slot, wherein the slot extends from an outside surface of the wire retainer body to the blind hole, and wherein the blind hole extends along the longitudinal axis from the first end of the wire retainer body to location between the first and second ends,

wherein the blind hole is configured to receive an end of a medical device wire,

wherein a ratio of the axial length of the blind hole to a maximum cross-sectional dimension of the blind hole is greater than 20: 1, and

wherein one or more inner surfaces of the wire retainer body defining the blind hole are configured to grip the end of the medical device wire with a retention force in response to mating of the wire retainer body with the clip.
The medical device assembly of claim 17, wherein the retention force is about 20 gram-force to about 500 gram-force.
The medical device assembly of any one of claims 17 or 18, further comprising a clip configured to mate with the wire retainer body, wherein the clip is configured to exert the radial compression force on the one or more outer surfaces of the wire retainer body upon mating with the clip.
A method of forming a medical device wire retainer, the method comprising:

forming a blind hole and a slot in a retainer body, the slot extending from an outside surface of the wire retainer body to the blind hole,

wherein the blind hole is configured to receive an end of a medical device wire,

wherein an axial length of the blind hole is less than an axial length of the wire retainer body,

wherein a ratio of the axial length of the blind hole to a maximum cross-sectional dimension of the blind hole is greater than 20: 1, and

wherein one or more inner surfaces of the wire retainer body defining the blind hole are configured to grip the end of the medical device wire with a retention force in response to exertion of a radial compression force on one or more outer surfaces of the wire retainer body.