CN114450054A - Hubs for medical devices - Google Patents

Abstract

A medical device, comprising: a first tube having a first tube cavity; a second tube having a second tube cavity, wherein the second tube is disposed around the first tube; and a hub comprising a first port, a second port, a first lumen extending from the first port and in fluid communication with the first tube lumen of the first tube, and a second lumen extending from the second port and in fluid communication with a lumen within the hub; wherein the hub is made of a material, and wherein the cavity is defined by the material of the hub and is in fluid communication with a space between the first tube and the second tube.

Description

hubs for medical devices

field

The field of the present application relates to hubs for medical devices, medical devices including such hubs, and methods of making hubs and medical devices.

background

Medical devices, such as stent delivery catheters or other types of catheters, may sometimes include a hub at their proximal end. In some cases, the hub may be a hub that includes a first port and a second port. Ports can be used to deliver substance(s) to a patient, and/or retrieve substance(s) from a patient.

Sometimes the catheter can be made by gluing the tube to the hub. However, using only glue to connect the tube to the hub poses a risk for stent transfer, as misalignment within the hub or variations in the size of the hub/tube may constrain or damage the stent when transferring the stent into the tube of the catheter bracket.

Furthermore, it is difficult to manufacture a catheter with multiple concentric tubes connected to corresponding ports of the hub. This is because the proximal end of the inner tube of the catheter needs to exit the proximal end of the outer tube of the catheter, while the outer tube of the catheter remains in fluid communication with its corresponding port at the hub. These features are difficult to achieve, especially with overmolding techniques.

This article describes new manufacturing techniques and tools for making hubs for multi-lumen catheters, as well as the resulting hubs and catheters made from this new technology and new tools.

Overview

According to some embodiments, a hub is provided having a first port and a second port. The first port extends to a first lumen in the hub, and the second port extends to a second lumen in the hub. The first cavity of the hub is in fluid communication with the first cavity of the first (inner) tube, and the second cavity of the hub is in fluid communication with the second cavity of the second (outer) tube concentrically surrounding the first tube fluid communication. The hub is overmolded onto the first tube, and the second tube is attached to the hub after the hub is fabricated. This has the advantage of providing a smooth transition from the first cavity of the hub to the inner surface of the first tube defining the first tube cavity. In some cases, the hub may be a portion of a stent delivery catheter. In this case, the first tube may be configured to deliver the stent(s). Because the overmolding techniques described herein provide a smooth transition between the first port and the inner surface of the cavity defining the first tube, when the stent(s) are transferred into the first tube, the ) bracket will not be damaged or restricted. The space between the second tube and the first tube can be used to deliver substances (eg, irrigation fluids, inflation fluids used to inflate the balloon at the distal end of the stent catheter, drugs, etc.) and/or retrieve substances (eg, Irrigation fluid from the patient, fluid retrieved from the balloon to retract the balloon, biological samples, etc.). In other cases, the conduits may be other types of conduits.

A medical device comprising: a first tube having a first lumen body; a second tube having a second lumen body, wherein the second tube is disposed around the first tube; and a hub including a first port , a second port, a first cavity extending from the first port and in fluid communication with the first tube cavity of the first tube, and a second cavity extending from the second port and with the hub A cavity within the member is in fluid communication; wherein the hub is made of a material, and wherein the cavity is defined by the material of the hub and is in fluid communication with the space between the first and second tubes.

Optionally, the lumen is provided around the first tube.

Optionally, the majority of the length of the cavity is located between the end of the second tube and the second cavity.

Optionally, a portion of the cavity extends proximally beyond the second cavity of the hub.

Optionally, the first cavity of the hub and the second cavity of the hub are defined by the material of the hub.

Optionally, the inner surface of the first cavity of the hub has a smooth transition relative to the inner wall of the first tube that defines the first tube cavity.

Optionally, the first tube has a length disposed within the hub.

Optionally, the medical device further includes a bushing disposed between the material of the first tube and the hub, wherein the hub is coupled to the first tube by the bushing.

Optionally, the material of the hub defines a space for receiving the second tube.

Optionally, the space has a cross-sectional dimension greater than that of the cavity.

Optionally, the hub is formed around a section of the first tube.

Optionally, the second tube is mechanically secured to the hub.

Optionally, the second tube is mechanically secured to the hub by adhesive.

Optionally, the first lumen of the first tube is sized to deliver the stent.

Optionally, the medical device further comprises a balloon, wherein the space between the first tube and the second tube is in fluid communication with the interior space of the balloon.

A mold system for manufacturing a medical device, comprising: a mold having a mold cavity for receiving material; a first core pin having a first core pin located in the mold cavity or configured for placement in the mold cavity a cavity-defining section; a second core pin having a second cavity-defining section located in the mold cavity or configured for placement in the mold cavity; and a spacer tool having a cavity that is dimensioned to accommodate the first tube when the first tube is in a fixed position relative to the mold, and wherein one end of the first tube is in contact with the first cavity of the first core pin when the first tube is in the fixed position relative to the mold body-defining segment engagement; and wherein the spacing tool includes a first segment configured for placement in a mold cavity of a mold, the first segment of the spacing tool having a first outer cross-sectional dimension greater than the outer cross-sectional dimension of the first tube.

Optionally, the first section of the spacing tool abuts the second cavity-defining section of the second core pin.

Optionally, one end of the first section of the spacing tool is located longitudinally at one end of the first cavity-defining section of the first core pin and one end of the second cavity-defining section of the second core pin between the departments.

Optionally, a region of the first tube is outside the spacing tool when the first tube is in a fixed position relative to the mold.

Optionally, the first section of the spacing tool is configured to define a cavity within the hub of the medical device to be formed, the cavity being circumferentially formed around a section of the first tube.

Optionally, the spacing tool further includes a second section having a second outer cross-sectional dimension greater than the first outer cross-sectional dimension of the first section.

Optionally, the second section of the spacing tool is configured to define a space for accommodating the second tube.

Optionally, the difference between the second outer cross-sectional dimension of the second section of the spacing tool and the first outer cross-sectional dimension of the first section of the spacing tool is greater than twice the wall thickness of the second tube.

Optionally, the mold includes a slot, and wherein the spacer tool further includes a third section configured to be placed in a slot of the mold, the slot configured to prevent lateral movement of the spacer tool relative to the mold.

Optionally, the spacing tool further includes an end section configured to prevent longitudinal movement of the spacing tool relative to the mold.

Optionally, the mold includes a first slot for retaining the first core pin and a second slot for retaining the second core pin.

Optionally, the first slot is configured to prevent lateral movement of the first core pin relative to the mold, and the second slot is configured to prevent lateral movement of the second core pin relative to the mold.

Optionally, the first core pin includes a first intermediate section, and the first slot is configured to retain the first intermediate section of the first core pin; and wherein the second core pin includes a second intermediate section, and the first core pin includes a second intermediate section. The two grooves are configured to retain the second intermediate section of the second core pin.

Optionally, the first core pin includes a first end section configured to prevent longitudinal movement of the first core pin relative to the mold, and the second core pin includes a second end section, The second end section is configured to prevent longitudinal movement of the second core pin relative to the mold.

A method of manufacturing a medical device comprising: maintaining a spacer tool by a slot of a mold, the mold having a mold cavity; and receiving a portion of a first tube by the cavity in the spacer tool when the first tube is in a fixed position relative to the mold ; wherein when the first tube is in a fixed position relative to the mould, an area of the first tube is within the mould cavity and outside the spacer tool, and an end of the first tube is in contact with the first cavity of the first core pin One end of the defined section is engaged; wherein the spacer tool includes a first section that is positioned in the mold cavity when the spacer tool is retained by the groove of the mold, the first section of the spacer tool being configured to define the space to be forming a cavity within the hub, the cavity being circumferentially formed around a section of the first tube, wherein the section of the first tube is distinct from the region of the first tube; and wherein the method further comprises receiving by the mold cavity Material.

Optionally, the method further includes retaining the first core pin by the mold, wherein the first core pin is configured to define a first cavity to be formed in the hub.

Optionally, the method further includes preventing longitudinal movement of the first core pin relative to the mold.

Optionally, the method further includes retaining the second core pin by the mold.

Optionally, the method further includes preventing longitudinal movement of the second core pin relative to the mold.

Optionally, the second core pin is configured to define a second cavity to be formed in the hub.

Optionally, after the hub is fabricated, the second cavity is in fluid communication with the cavity.

Optionally, the method further comprises subjecting the material to a curing process to obtain a cured material for the hub.

Optionally, the cured material is in contact with the region of the first tube and forms a space around the section of the first tube.

Optionally, the region of the first tube includes a liner coupled to the wall of the first tube.

Optionally, the method further includes defining, by the spacing tool, a space to be formed in the hub, wherein the space is sized to accommodate the second tube.

Optionally, the space defined by the spacing means has a cross-sectional dimension greater than the cross-sectional dimension of the cavity.

Optionally, the method further includes receiving the second tube from the space in the hub after the hub is fabricated.

Optionally, the method further includes attaching the second tube to the hub using an adhesive.

Other and additional aspects and features will become apparent upon reading the following detailed description.

Description of drawings

The drawings illustrate the design and use of embodiments, wherein similar elements are designated by the same reference numerals. The drawings are not necessarily to scale. For a better understanding of how the above and other advantages and objects are obtained, a more specific description of embodiments will be presented, which are illustrated in the accompanying drawings. These drawings depict only exemplary embodiments, and therefore should not be considered as limiting the scope of the claims.

1 illustrates a perspective view of a mold system for manufacturing a hub, in particular a mold system having a mold, two core pins, and a spacer tool, according to some embodiments.

FIG. 2 shows a real view of the mold of FIG. 1 .

FIG. 3 shows the spacing tool of FIG. 1 .

FIG. 4 shows an interior portion of a hub manufactured using the mold system of FIG. 1 .

Figure 5 shows a hub manufactured using the die system of Figure 1, particularly showing the position of the spacer tool prior to its removal from the hub.

FIG. 6 shows a hub manufactured using the mold system of FIG. 1 , particularly showing the spacer tool being removed from the hub.

Figure 7 shows a hub manufactured using the mould system of Figure 1, in particular showing the second tube attached to the hub after the spacing tool has been removed from the hub.

FIG. 8 illustrates a method of manufacturing a medical device using the mold system of FIG. 1 .

Detailed Description

Various embodiments are described below with reference to the accompanying drawings. It should be noted that the drawings are not to scale and that elements of similar structure or function are represented by the same reference numerals throughout the drawings. It should also be noted that the drawings are only intended to facilitate the description of the embodiments. They are not intended to be exhaustive descriptions of the invention nor to limit the scope of the invention. Furthermore, the illustrated embodiments need not have all of the aspects or advantages illustrated. An aspect or advantage described in connection with a particular embodiment is not necessarily limited to that embodiment, but may be practiced in any other embodiment, even if not so shown, or if not so explicitly described.

1-2 illustrate perspective and real views, respectively, of a mold system 100 for manufacturing a hub for a catheter, according to some embodiments. Mold system 100 includes mold 102 , first core pin 112 , second core pin 114 , and spacer tool 120 .

The mold 102 includes a first slot 132 configured to receive a section of the first core pin 112 , a second slot 134 configured to receive a section of the second core pin 114 , and a second slot 134 configured to receive the spacing tool 120 . The third slot 136 of the segment. The mold 102 also includes a mold cavity 138 that defines the shape of the hub to be formed from the mold 102 . Thus, the mold cavity 138 has a shape corresponding to the shape of the hub to be manufactured. As shown, the mold 102 also includes a delivery channel 140 configured to deliver material into the mold cavity 138 of the mold 102 to manufacture the hub of the catheter.

The first core pin 112 is configured to occupy a space in the mold cavity 138 that will become the first cavity of the hub to be formed, and the second core pin 114 is configured to occupy a space in the mold cavity 138 that is the space will be the second cavity of the hub to be formed. As used in this specification, the term "core pin" refers to any object capable of occupying a space in mold cavity 138 such that material in mold cavity 138 can flow around the object to create a desired shape or configuration. The term "core pin" is not limited to objects having any particular shape, and is certainly not limited to objects having a pin configuration. The first core pin 112 includes an end section 150 , an intermediate section 152 and a cavity defining section 154 . Similarly, the second core pin 114 includes an end section 160 , an intermediate section 162 and a cavity defining section 164 .

The intermediate section 152 of the first core pin 112 is configured (eg, sized and/or shaped to fit) within the slot 132 of the mold 102 during use. The middle section 152 of the first core pin 112 abuts the surface of the first slot 132 , preventing lateral movement of the first core pin 112 relative to the first slot 132 . Similarly, the intermediate section 162 of the second core pin 114 is configured (eg, sized and/or shaped to fit) within the slot 134 of the mold 102 during use. The middle section 162 of the second core pin 114 abuts the surface of the second slot 134 , preventing lateral movement of the second core pin 114 relative to the second slot 134 .

The end section 150 of the first core pin 112 is configured to prevent longitudinal (along the axis of the first core pin 112 ) movement of the first core pin 112 relative to the mold 102 . In particular, the cross-sectional dimension of the end section 150 of the core pin 112 is larger than the dimension of the first slot 132 . This allows the end section 150 of the first core pin 112 to abut against the outer surface of the mold 102 while the end section 150 of the first core pin 112 is received within the opening 156 of the mold 102 . Similarly, the end section 160 of the second core pin 114 is configured to prevent longitudinal (along the axis of the second core pin 114 ) movement of the second core pin 114 relative to the mold 102 . In particular, the cross-sectional dimension of the end section 160 of the second core pin 114 is larger than the dimension of the second slot 134 . This allows the end section 160 of the second core pin 114 to abut against the outer surface of the mold 102 while the end section 160 of the second core pin 114 is received within the opening 166 of the mold 102 .

As shown in FIGS. 1-2 , when the middle section 152 of the first core pin 112 is placed in the first groove 132 of the mold 102 , the middle section 152 of the first core pin 112 will Cavity defining section 154 is placed away from the inner surface of mold cavity 138 . This creates a separation between the cavity-defining section 154 of the first core pin 112 and the inner surface of the mold cavity 138 . Thus, when material is delivered into the mold cavity 138, the material will flow around the cavity-defining section 154 of the first core pin 112 to create the first cavity of the hub. Similarly, when the middle section 162 of the second core pin 114 is placed in the second slot 134 of the mold 102 , the middle section 162 of the second core pin 114 defines the cavity of the second core pin 114 to the section 164 Placed away from the inner surface of the mold cavity 138 . This creates a separation between the cavity-defining section 164 of the second core pin 114 and the inner surface of the mold cavity 138 . Thus, when material is delivered into the mold cavity 138, the material will flow around the cavity-defining section 164 of the second core pin 114 to create the second cavity of the hub.

In other embodiments, the first core pin 112 may not include the end section 150 and the second core pin 114 may not include the end section 160 . Alternatively, for example, the intermediate section 152 of the first core pin 112 may have a tapered profile to prevent longitudinal movement of the first core pin 112 relative to the mold 102 . Similarly, in other embodiments, the intermediate section 162 of the second core pin 114 may have a tapered profile to prevent longitudinal movement of the second core pin 114 relative to the mold 102 .

In further embodiments, the first core pin 112 and the second core pin 114 may be fabricated as sections of the mold 102 . In this case, the first core pin 112, the second core pin 114 and the mold 102 have a unitary configuration. The cavity-defining section 154 of the first core pin 112 and the cavity-defining section 164 of the second core pin 114 are located in the mold cavity 138 of the mold 102 .

FIG. 3 shows a spacing tool 120 in accordance with some embodiments. The spacing tool 120 includes a first end 200 , a second end 202 , and a body 210 extending between the first end 200 and the second end 202 . The spacing tool 120 also includes a cavity 212 in the body 210 that extends from the first end 200 to the second end 202 . The body 210 of the spacing tool 120 has three sections 230 , 232 , 234 and one end section 236 . The first section 230 has a first outer cross-sectional dimension, the second section 232 has a second outer cross-sectional dimension, and the third section 234 has a third outer cross-sectional dimension. In the illustrated embodiment, the third outer cross-sectional dimension of the third section 234 is larger than the second outer cross-sectional dimension of the second section 232, and the second outer cross-sectional dimension of the second section 232 is larger than the first outer cross-sectional dimension A first outer cross-sectional dimension of segment 230 . Furthermore, in the illustrated embodiment, the first section 230, the second section 232, and the third section 234 each have a circular cross-section. Thus, the first outer cross-sectional dimension, the second outer cross-sectional dimension and the third outer cross-sectional dimension are the first outer diameter, the second outer diameter and the third outer diameter, respectively. In other embodiments, the first section 230, the second section 232, or the third section 234 may have other cross-sectional shapes.

As shown in FIGS. 1-4 , the cavity 212 of the spacing tool 120 is sized to receive the first tube 300 to which the hub is overmolded. The cavity 212 has a uniform cross-section along the entire length of the body 210 of the spacing tool 120 . Furthermore, the first section 230 of the spacing tool 120 has an outer cross-sectional dimension that is greater than the outer cross-sectional dimension of the first tube 300 . This configuration allows a cavity (hub cavity) to be formed in the hub, wherein the cavity is in fluid communication with the space between the exterior of the inner first tube 300 and also with the second port of the hub to be manufactured. The second section 232 of the spacing tool 120 has an outer cross-sectional dimension that corresponds to the outer cross-sectional dimension of the second tube that concentrically surrounds the first tube 300 after the hub has been overmolded onto the first tube 300 . Tube 300 set. As shown in FIGS. 1-2, the third section 234 of the spacer tool 120 is sized to be placed in the third slot 136 of the mold. In particular, the third section 234 of the spacing tool 120 abuts the surface of the third groove 136 . This configuration prevents lateral movement of the spacer tool 120 relative to the mold 102 .

The end section 236 of the spacer tool 120 is configured to prevent longitudinal movement of the spacer tool 120 relative to the mold 102 (along the longitudinal axis of the spacer tool 120). In particular, the cross-sectional dimension of the end section 236 of the spacing tool 120 is larger than the dimension of the third slot 136 . This allows the end section 236 of the spacer tool 120 to abut against the outer surface of the mold 102 while the end section 236 of the spacer tool 120 is received within the opening 158 of the mold 102 (shown in FIGS. 1-2 ).

In other embodiments, the spacing tool 120 may not include the end section 236 . For example, the third section 234 of the spacer tool 120 may alternatively have a tapered profile to prevent longitudinal movement of the spacer tool 120 relative to the mold 102 .

During the manufacture of a hub using the mold system 100 , the first core pin 112 and the second core pin 114 are first placed in their operating positions relative to the mold 102 , as shown in FIG. 1 . Additionally, the first tube 300 is inserted into the cavity 212 of the spacing tool 120 and the first tube 300 is extended through the spacing tool 120 . As shown in FIG. 1 , the spacing tool 120 with the first tube 300 is placed in the operating position relative to the mold 102 . In the illustrated embodiment, the cavity-defining section 154 of the first core pin 112 has an end sized to be inserted into the end 302 of the first tube 300 . This configuration allows the hub material to flow around the cavity-defining section 154 and up to the edge around the end opening at the end 302 of the first tube 300 , relative to the flow around the end opening of the first tube 300 . Edges produce smooth transitions. Furthermore, as shown in FIGS. 1-3 , the first end 200 of the spacing tool 120 does not extend all the way to the first core pin 112 , leaving an exposed area 420 of the first tube 300 . The exposed area 420 allows the hub material delivered into the mold cavity 138 to contact the first tube 300 to be overmolded onto the first tube 300 . As can be seen in FIGS. 1-2 , the first end 200 of the spacing tool 120 extends beyond the end of the second core pin 114 . This allows a cavity to be created in the hub such that it is in fluid communication with the cavity of the port created by the second core pin 114 . This aspect will be further described with reference to FIG. 4 .

Next, the material used to form the hub is delivered into the mold cavity 138 of the mold 102 via the channel 140 of the mold 120 . The hub material will flow around the cavity-defining section 154 of the first core pin 112 , the cavity-defining section 164 of the second core pin 114 , the exposed area 420 of the first tube 300 , and the spacing tool 120 . After the hub material has cured, the mold 102 , the first and second core pins 112 , 114 , and the spacing tool 120 are then removed from the resulting hub that has been overmolded onto the first tube 300 .

Referring now to Figure 4, the interior of the hub 400 is shown as it has been fabricated. As shown, the hub 400 includes a first port 410 having a first cavity 411 that is segmented by the cavity of the first core pin 112 (which has been removed from the formed hub 400 ) 154 limited. The hub 400 also includes a second port 412 having a second cavity 413 defined by the cavity-defining section 164 of the second core pin 114 (which has been removed from the formed hub 400).

Furthermore, as shown in FIG. 4 , because the first tube 300 has exposed areas 420 that are not covered by the spacing tool 120 during the molding process, the material 402 of the hub 400 can flow around the exposed areas 420 and interact with the first tube 300 The exposed area 420 contacts. This allows the hub 400 to be overmolded onto the exposed area 420 of the first tube, thereby attaching the hub 400 to the exposed area 420 of the first tube 300 .

In some embodiments, the exposed area 420 of the first tube 300 may optionally include a bushing coupled to the outer surface of the wall of the first tube 300 . The liner may protect the walls of the first tube 300 from damage by heat generated during the molding process, such as heat from hot materials surrounding the first tube 300 .

In the illustrated embodiment shown in FIG. 4 , the transition between the cavity 411 and the inner surface of the first tube 300 has a smooth transition. This allows substances such as stents to be delivered from the lumen 411 into the first tube 300 without obstruction or restriction. In some cases, the first tube 300 can be used to deliver the stent distally into the patient. In other cases, the first tube 300 may be used to proximally deliver a stent (eg, a stent removed from a patient) into the lumen 411 .

FIG. 4 also shows a cavity 430 formed in the hub 400 . The cavity 430 surrounds a section of the first tube 300 and is in fluid communication with the cavity 413 of the second port 412 . The cavity 430 is defined by the hub material 402 that flows around the first section 230 of the spacing tool 120 during the molding process. After the hub 400 is formed, the spacing tool 120 is removed, leaving a cavity 430 around a section of the first tube 300 with the walls of the cavity spaced from the first tube 300 . The longitudinal length of cavity 430 in hub 400 corresponds to (eg, is equal to) the length of first section 230 of spacing tool 120 .

As discussed, the first end 200 of the spacing tool 120 extends beyond the end of the second core pin 114 during the molding process. This allows a cavity to be created in the hub such that the cavity is in fluid communication with the cavity of the port created by the second core pin 114 . This aspect can be seen in Figure 4, which shows cavity 430 in hub 400 extending slightly beyond cavity 413 (which is defined by second core pin 114 during the molding process). Because the first section 230 of the spacing tool 120 (defining the cavity 430 ) stops at position A, which is beyond the end of the second core pin 114 , the resulting cavity 430 and the resulting cavity 413 are in fluid communication with each other.

As shown in FIG. 4 , the formed hub 400 also includes a space 440 that serves as a tube receiving section for receiving the second tube 450 . The space 440 is larger than the cavity 430 because the space 440 is defined by the second section 232 of the spacing tool 120, which has an outer cross-sectional dimension that is larger than the outer cross-sectional dimension of the first section 230 (which defines the cavity 430). Specifically, during the molding process, the hub material 402 flows around the second segment 232 of the spacing tool 120 , which occupies an area that will become the space 440 . The hub material 402 also flows around the first segment 230 of the spacer tool 120 , which occupies the space that will become the cavity 430 . Because the second section 232 of the spacing tool 120 is larger than the first section 230 , the space 440 for receiving the second tube 450 is also larger than the cavity 430 . As shown, the second tube 450 is then inserted into the space 440 after the hub 400 is formed. The second tube 450 may be mechanically attached to the hub 400 using an adhesive (eg, glue, epoxy, etc.) or a mechanical connector. The second tube 450 is disposed concentrically around the first tube 300, and the inner surface of the second tube 450 and the outer surface of the first tube 300 define a space.

When a substance is delivered distally via the second port 412 using the hub 400 , the substance is delivered through the second port 412 of the hub 400 and through the cavity 413 . Substances are delivered into the cavity 430 defined by the hub material 402 . The substance then enters the space 440 between the first tube 300 and the second tube 450 from within the cavity 430 .

When the hub 400 is used to deliver the substance proximally via the second port 412 , the substance travels proximally through the space 440 between the first tube 300 and the second tube 450 . The substance then enters cavity 430 defined by hub material 402 and travels into cavity 413 . The substance then exits the second port 412 .

In the illustrated embodiment, the inner cross-sectional dimension of the second tube 450 is greater than the outer cross-sectional dimension of the first tube 300 , thereby creating a space between the first tube 300 and the second tube 450 . In some cases, the inner cross-sectional dimension of the second tube 450 may be equal to the cross-sectional dimension of the cavity 430 . This can be achieved by making the inner cross-sectional dimensions of the second tube 450 and the outer cross-sectional dimensions of the first section 230 of the spacing tool 120 (which define the cavity 430 ) equal to each other. In other cases, the inner cross-sectional dimension of the second tube 450 may be greater than the cross-sectional dimension of the cavity 430 . This has the advantage of ensuring that material delivered from the second port 412 (travel in the distal direction) into the lumen 430 travels unobstructed or unrestricted into the space between the first tube 300 and the second tube 450 . In other cases, the inner cross-sectional dimension of the second tube 450 may be smaller than the cross-sectional dimension of the cavity 430 . This has the advantage of ensuring that substances delivered from the space between the first tube 300 and the second tube 450 (travelling in the proximal direction) can travel into the lumen 430 without obstruction or restriction.

The space 440 between the first tube 300 and the second tube 450 may be used to deliver substances (eg, irrigation fluids, medications, etc.) from the port 412 to the patient. Additionally or alternatively, the space 440 between the first tube 300 and the second tube 450 may be used to remove substances (eg, irrigation fluids, biological samples, etc.) from the patient. Additionally, in some embodiments, the space 440 between the first tube 300 and the second tube 450 may be used to deliver inflation fluid to inflate a balloon at the distal end of the medical device (which includes the hub 400), and/or Or remove inflation fluid from the balloon to retract the balloon.

Figure 5 shows the formed hub 400 with the mold 102 and core pins 112, 114 removed. However, the spacing tool 120 has not been removed. The respective positions of the first section 230 , the second section 232 and the third section 234 of the spacing tool 120 can be seen in relation to the hub 400 . For clarity, the end section 236 of the spacing tool 120 is not shown. Also shown are a first cavity 411 and a second cavity 413 formed within the hub 400 . The first cavity 411 in the hub 400 is in fluid communication with the first tube 300 . The second cavity 413 terminates in the outer surface of the first section 230 of the spacing tool 120 .

FIG. 6 shows the hub 400 of FIG. 5, particularly showing the spacing tool 120 being removed.

Figure 7 shows the hub 400 of Figure 5, in particular showing the second tube 450 attached to the hub 400 after the spacing tool 120 has been completely removed. Also shown is the cavity (hub cavity) 430 previously occupied by the first section 230 of the spacing tool 120 . Cavity 430 is in fluid communication with second cavity 413 in hub 400 and is defined by material 402 of hub 400 . The cavity 430 is also in fluid communication with the space 440 of FIG. 4 , which is defined between the outer surface of the first tube 300 and the inner surface of the second tube 450 . As shown, the end 700 of the second tube 450 cannot extend into the cavity 430 . This is because the cavity 430 formed by the first section 230 of the spacing tool 120 has a smaller cross-sectional dimension than the space formed by the second section 232 of the spacing tool 120 (which now receives the second tube 450).

The hub forming techniques described herein can be used to form any hub for any catheter. For example, the techniques described above can be used to form a Y-shaped hub that includes two proximal ports that communicate at the hub with two corresponding lumen bodies of the tube of the catheter. In other embodiments, the techniques described above may be used to form hubs having more than two ports and two hub cavities in fluid communication with more than two catheter tube lumens, respectively. For example, in other embodiments, the spacing tool 120 may include additional section(s) configured to define tube(s) for the additional tube(s) surrounding the inner first tube 300 receiving space. In this case, the mold system 100 may include respective additional core pin(s) for defining respective hub cavity(s) that will be in fluid communication with the tube receiving space(s).

As shown in the above embodiments, the mold system 100 and techniques for forming a hub using the mold system 100 are advantageous because they allow the hub to be easily formed while providing the hub with two ports and two corresponding hub cavities , these hub cavities are in fluid communication with the corresponding tubes (tubes of the catheter). The resulting hub is also advantageous because the hub has a smooth transition between the inner wall of the tube and the inner surface of the hub cavity.

FIG. 8 shows a method 800 of manufacturing a medical device. As used in this specification, the term "medical device" may refer to one or more components of a device for medical use, or a finished manufactured device itself. For example, the medical device may be a hub, a component of a catheter having a hub and one or more tubes attached to the hub, or the catheter itself. Method 800 includes maintaining a spacer tool by a slot of a mold, the mold having a mold cavity (item 802). The method 800 also includes receiving a portion of the first tube by the cavity in the spacer tool when the first tube is in the fixed position relative to the mold, wherein when the first tube is in the fixed position relative to the mold, an area of the first tube is in the fixed position relative to the mold. inside the mold cavity and outside the spacer tool, and one end of the first tube engages one end of the first cavity-defining section of the first core pin, wherein the spacer tool includes the first section, when the spacer tool When retained by the groove of the mold, the first section is located in the mold cavity, the first section of the spacer tool is configured to define a cavity within the hub to be formed, the cavity circumferentially surrounding a section of the first tube is formed, and wherein the section of the first tube is distinct from the region of the first tube (item 804). Method 800 also includes receiving material from the mold cavity (item 806).

Optionally, method 800 further includes retaining, by the mold, the first core pin, wherein the first core pin is configured to define a first cavity to be formed in the hub.

Optionally, method 800 further includes preventing longitudinal movement of the first core pin relative to the mold.

Optionally, method 800 further includes retaining the second core pin by the mold.

Optionally, method 800 further includes preventing longitudinal movement of the second core pin relative to the mold.

Optionally, in method 800, the second core pin is configured to define a second cavity to be formed in the hub.

Optionally, in method 800, after the hub is fabricated, the second cavity is in fluid communication with the cavity.

Optionally, method 800 further includes subjecting the material to a curing process to obtain a cured material for the hub.

Optionally, in method 800, the cured material is brought into contact with the region of the first tube and a space is formed around the section of the first tube.

Optionally, in method 800, the region of the first tube includes a liner coupled to the wall of the first tube.

Optionally, method 800 further includes defining, by the spacing tool, a space to be formed in the hub, wherein the space is sized to accommodate the second tube.

Optionally, in method 800, the space defined by the spacer tool has a cross-sectional dimension that is greater than the cross-sectional dimension of the cavity.

Optionally, the method 800 further includes receiving the second tube from the space in the hub after the hub is fabricated.

Optionally, method 800 further includes attaching the second tube to the hub using an adhesive.

The following items are exemplary features of the embodiments described herein. Each item may be an embodiment itself or may be part of an embodiment. One or more of the items described below may be combined with other item(s) in an embodiment.

Item 1: A medical device comprising: a first tube having a first lumen body; a second tube having a second lumen body, wherein the second tube is disposed around the first tube; and a hub comprising a first port, a second port, a first cavity extending from the first port and in fluid communication with the first tube cavity of the first tube, and a second cavity extending from the second port and is in fluid communication with a cavity within the hub; wherein the hub is made of material, and wherein the cavity is defined by the material of the hub, and is in fluid communication with the space between the first tube and the second tube.

Item 2: In the medical device, a cavity (hub cavity) is provided around the first tube.

Item 3: In the medical device, a majority of the length of the lumen is located between the end of the second tube and the second lumen (which is in fluid communication with the second port of the hub).

Item 4: In the medical device, a portion of the cavity (hub cavity) extends proximally beyond the second cavity of the hub.

Item 5: In the medical device, the first cavity of the hub and the second cavity of the hub are defined by a material of the hub.

Item 6: In the medical device, the inner surface of the first lumen of the hub has a smooth transition relative to the inner wall of the first tube that defines the first lumen.

Item 7: In the medical device, the first tube has a length disposed within the hub.

Item 8: The medical device further includes a bushing disposed between the material of the first tube and the hub, wherein the hub is coupled to the first tube via the bushing.

Item 9: In the medical device, the material of the hub defines a space for receiving the second tube.

Item 10: In a medical device, the space has a cross-sectional dimension that is greater than the cross-sectional dimension of the cavity (hub cavity).

Item 11: In the medical device, a hub is formed around a section of the first tube.

Item 12: In the medical device, the second tube is mechanically secured to the hub.

Item 13: In the medical device, the second tube is mechanically secured to the hub by an adhesive.

Item 14: In the medical device, the first lumen of the first tube is sized to deliver the stent.

Item 15: The medical device further comprises a balloon, wherein the space between the first tube and the second tube is in fluid communication with the interior space of the balloon.

Item 16: A mold system for manufacturing a medical device, comprising: a mold having a mold cavity for receiving a material; a first core pin having or being configured for placement in the mold cavity a first cavity-defining section of The cavity is sized to accommodate the first tube when the first tube is in a fixed position relative to the mold, and wherein one end of the first tube is in contact with the first core pin when the first tube is in the fixed position relative to the mold and wherein the spacer tool includes a first section configured for placement in a mold cavity of a mold, the first section of the spacer tool having a first The outer cross-sectional dimension is greater than the outer cross-sectional dimension of the first tube.

Item 17: In the mold system, the first section of the spacer tool abuts the second cavity-defining section of the second core pin.

Item 18: In the mold system, one end of the first section of the spacer tool is located longitudinally at one end of the first cavity-defining section of the first core pin and the second cavity-defining area of the second core pin between one end of the segment.

Item 19: In the mold system, a region of the first tube is outside the spacing tool when the first tube is in a fixed position relative to the mold.

Item 20: In the mold system, the first section of the spacing tool is configured to define a cavity within a hub of a medical device to be formed, the cavity being formed circumferentially around a section of the first tube.

Item 21: In the mold system, the spacer tool further includes a second section having a second outer cross-sectional dimension that is greater than the first outer cross-sectional dimension of the first section.

Item 22: In the mold system, the second section of the spacer tool is configured to define a space for receiving the second tube.

Item 23: In the die system, the difference between the second outer cross-sectional dimension of the second section of the spacer tool and the first outer cross-sectional dimension of the first section of the spacer tool is greater than two times the wall thickness of the second tube. times.

Item 24: In the mold system, the mold includes a slot, and wherein the spacer tool further includes a third section configured to be placed in a slot of the mold, the slot configured to prevent the spacer tool from being transverse to the mold sports.

Item 25: In the mold system, the spacer tool further includes an end section configured to prevent longitudinal movement of the spacer tool relative to the mold.

Item 26: In the mold system, the mold includes a first slot for retaining a first core pin and a second slot for retaining a second core pin.

Item 27: In the mold system, the first slot is configured to prevent lateral movement of the first core pin relative to the mold, and the second slot is configured to prevent lateral movement of the second core pin relative to the mold.

Item 28: In the mold system, the first core pin includes a first intermediate section, and the first slot is configured to retain the first intermediate section of the first core pin; and wherein the second core pin includes a second intermediate section , and the second slot is configured to retain the second intermediate section of the second core pin.

Item 29: In the mold system, the first core pin includes a first end section configured to prevent longitudinal movement of the first core pin relative to the mold, and the second core pin includes a second end The second end section is configured to prevent longitudinal movement of the second core pin relative to the mold.

Item 30: A method of manufacturing a medical device, comprising: retaining a spacer tool by a slot of a mold, the mold having a mold cavity; and receiving a first tube by a cavity in the spacer tool when the first tube is in a fixed position relative to the mold A portion of a tube; wherein when the first tube is in a fixed position relative to the mold, an area of the first tube is within the mold cavity and outside the spacer tool, and an end of the first tube is in contact with the first pin of the first core pin. One end of a cavity-defining section is engaged; wherein the spacer tool includes a first section that is positioned in the mold cavity when the spacer tool is retained by the groove of the mold, the first section of the spacer tool being configured to defining a cavity within the hub to be formed, the cavity being circumferentially formed around a section of the first tube, wherein the section of the first tube is different from the region of the first tube; and wherein the method further comprises forming the cavity by the mold The cavity receives material.

Item 31: The method further includes retaining the first core pin by the mold, wherein the first core pin is configured to define a first cavity to be formed in the hub.

Item 32: The method further includes preventing longitudinal movement of the first core pin relative to the mold.

Item 33: The method further includes retaining the second core pin by the mold.

Item 34: The method further includes preventing longitudinal movement of the second core pin relative to the mold.

Item 35: In the method, the second core pin is configured to define a second cavity to be formed in the hub.

Item 36: In the method, after the hub is fabricated, the second cavity is in fluid communication with the cavity.

Item 37: The method further includes subjecting the material to a curing process to obtain a cured material for the hub.

Item 38: In the method, the cured material contacts the region of the first tube and forms a space around the section of the first tube.

Item 39: In the method, the region of the first tube includes a liner coupled to a wall of the first tube.

Item 40: The method further includes defining, by the spacing tool, a space to be formed in the hub, wherein the space is sized to accommodate the second tube.

Item 41: In the method, the space defined by the spacing means has a cross-sectional dimension that is greater than a cross-sectional dimension of the cavity.

Item 42: The method further includes receiving a second tube from the space in the hub after the hub is fabricated.

Item 43: The method further includes attaching the second tube to the hub using an adhesive.

Claims (58)

1. A medical device comprising: a first tube having a first tube cavity; a second tube having a second lumen body, wherein the second tube is disposed around the first tube; and a hub including a first port, a second port, a first cavity and a second cavity, the first cavity extending from the first port and communicating with the first lumen of the first tube body in fluid communication, the second cavity extending from the second port and in fluid communication with the cavity in the hub, wherein the hub is made of a material, and wherein the cavity is defined by the material of the hub and is in fluid communication with the space between the first tube and the second tube. 2. The medical device of claim 1, wherein the lumen is disposed around the first tube. 3. The medical device of claim 1 or 2, wherein a majority of the length of the lumen is located between the end of the second tube and the second lumen. 4. The medical device of claim 1 or 2, wherein a portion of the lumen extends proximally beyond the second lumen of the hub. 5. The medical device of any one of claims 1-4, wherein the first cavity of the hub and the second cavity of the hub are formed from the material of the hub limited. 6. The medical device of any one of claims 1-5, wherein an inner surface of the first lumen of the hub defines the first lumen relative to that of the first tube The inner wall has a smooth transition. 7. The medical device of any of claims 1-6, wherein the first tube has a length disposed within the hub. 8. The medical device of any of claims 1-6, wherein the hub is formed around a portion of the first tube. 9. The medical device of any one of claims 1-8, further comprising a bushing disposed between the material of the first tube and the hub, wherein The hub is coupled to the first tube via the bushing. 10. The medical device of any of claims 1-9, wherein the material of the hub defines a space for receiving the second tube. 11. The medical device of claim 9, wherein the space has a cross-sectional dimension that is greater than a cross-sectional dimension of the lumen. 12. The medical device of any of claims 1-11, wherein the second tube is mechanically secured to the hub. 13. The medical device of any one of claims 1-12, further comprising an inflatable balloon, wherein the space between the first tube and the second tube The inner region of the balloon is in fluid communication. 14. A medical device comprising: a first tube having a first tube cavity; a second tube having a second lumen body, wherein the second tube is disposed around the first tube; and a hub including a first port, a second port, a first cavity and a second cavity, the first cavity extending from the first port and communicating with the first lumen of the first tube body in fluid communication, the second cavity extending from the second port and in fluid communication with the cavity in the hub, wherein the hub is made of a material, and wherein the cavity is defined by the material of the hub and is in fluid communication with the space between the first tube and the second tube, wherein the cavity is disposed around the first tube, and wherein the first cavity of the hub and the second cavity of the hub are defined by the material of the hub. 15. The medical device of claim 14, wherein the inner surface of the first lumen of the hub has a smooth transition with respect to the inner wall of the first tube that defines the first lumen. 16. The medical device of claim 14 or 15, wherein the first tube has a length disposed within the hub. 17. The medical device of any one of claims 14-16, further comprising a bushing disposed between the material of the first tube and the hub, wherein The hub is coupled to the first tube via the bushing, and wherein the material of the hub defines a space for receiving the second tube, and wherein the space has a cross-sectional dimension of larger than the cross-sectional dimension of the cavity. 18. The medical device of any of claims 14-17, wherein the second tube is mechanically secured to the hub by an adhesive. 19. The medical device of any one of claims 14-18, further comprising an inflatable balloon, wherein the space between the first tube and the second tube The inner region of the balloon is in fluid communication. 20. A mold system for manufacturing a medical device, comprising: a mold having a mold cavity for receiving material; a first core pin having a first cavity-defining section located in the mold cavity or configured for placement in the mold cavity; a second core pin having a second cavity-defining section located in the mold cavity or configured for placement in the mold cavity; and a spacer tool having a cavity sized to receive the first tube when the first tube is in a fixed position relative to the mold, wherein one end of the first tube engages a first cavity-defining section of the first core pin when the first tube is in the fixed position relative to the mold, and wherein the spacer tool includes a first section configured for placement in a mold cavity of the mold, the first section of the spacer tool having a first outer cross-section The size is greater than the outer cross-sectional size of the first tube. 21. The mold system of claim 20, wherein the first section of the spacer tool abuts the second cavity-defining section of the second core pin. 22. The mould system of claim 20 or 21, wherein one end of the first section of the spacer tool is located longitudinally in the first cavity-defining section of the first core pin between one end of the second core pin and one end of the second cavity-defining section of the second core pin. 23. The mold system of any one of claims 20-22, wherein when the first tube is in the fixed position relative to the mold, a region of the first tube is at the spacing outside the tool. 24. The mold system of any one of claims 20-23, wherein the first section of the spacing tool is configured to define a cavity within a hub of the medical device to be formed, the The cavity is formed circumferentially around a section of the first tube. 25. The mold system of any of claims 20-24, wherein the spacer tool further comprises a second section having a second outer cross-sectional dimension greater than the first The first outer cross-sectional dimension of the segment. 26. The mold system of claim 25, wherein the second section of the spacing tool is configured to define a space for receiving a second tube. 27. The mold system of claim 26, wherein the second outer cross-sectional dimension of the second section of the spacer tool and the first section of the first section of the spacer tool The difference between an outer cross-sectional dimension is greater than twice the wall thickness of the second tube. 28. The mold system of claim 25, wherein the mold includes a slot, and wherein the spacer tool further includes a third section configured for placement in the mold of the slot, the slot is configured to prevent lateral movement of the spacer tool relative to the die. 29. The mold system of claim 28, wherein the spacer tool further comprises an end section configured to prevent longitudinal movement of the spacer tool relative to the mold. 30. The mold system of any one of claims 20-29, wherein the mold includes a first slot for retaining the first core pin and a second slot for retaining the second core pin groove. 31. The mold system of claim 30, wherein the first groove is configured to prevent lateral movement of the first core pin relative to the mold, and the second groove is configured to prevent the first core pin from moving laterally relative to the mold. The two core pins move laterally relative to the mold. 32. The mold system of claim 30, wherein the first core pin includes a first intermediate section and the first slot is configured to retain the first intermediate section of the first core pin paragraph; and wherein the second core pin includes a second intermediate section, and the second slot is configured to retain the second intermediate section of the second core pin. 33. The mold system of any of claims 20-29, wherein the first core pin includes a first end section configured to prevent the first A core pin moves longitudinally relative to the mold, and the second core pin includes a second end section configured to prevent longitudinal movement of the second core pin relative to the mold . 34. A mold system for manufacturing a medical device, comprising: a mold having a mold cavity for receiving material; a first core pin having a first cavity-defining section located in the mold cavity or configured for placement in the mold cavity; a second core pin having a second cavity-defining section located in the mold cavity or configured for placement in the mold cavity; and a spacer tool having a cavity sized to accommodate the first tube when the first tube is in a fixed position relative to the mold, wherein the first tube is in a fixed position relative to the mold In the fixed position, one end of the first tube engages the first cavity-defining section of the first core pin, wherein the spacer tool includes a first section configured for placement in a mold cavity of the mold, the first section of the spacer tool having a first outer cross-section a dimension greater than an outer cross-sectional dimension of the first tube, wherein the first section of the spacing tool abuts the second cavity-defining section of the second core pin, and wherein one end of the first section of the spacing tool is longitudinally located at one end of the first cavity-defining section of the first core pin and the first end of the second core pin The two cavities define between one end of the segment. 35. The mold system of claim 34, wherein an area of the first tube is outside the spacing tool when the first tube is in the fixed position relative to the mold, and wherein, The first section of the spacing tool is configured to define a cavity within a hub of a medical device to be formed, the cavity being circumferentially formed around a section of the first tube. 36. The mold system of claim 34 or 35, wherein the spacer tool further comprises a second section having a second outer cross-sectional dimension greater than all of the first section the first outer cross-sectional dimension, wherein the second section of the spacing tool is configured to define a space for receiving a second tube, and wherein the second section of the spacing tool The difference between the second outer cross-sectional dimension and the first outer cross-sectional dimension of the first section of the spacing tool is greater than twice the wall thickness of the second tube. 37. The mold system of any of claims 34-36, wherein the mold includes a first slot for retaining the first core pin and a second slot for retaining the second core pin a slot, wherein the first slot is configured to prevent lateral movement of the first core pin relative to the mold, and the second slot is configured to prevent lateral movement of the second core pin relative to the mold. 38. The mold system of claim 37, wherein the first core pin includes a first intermediate section and the first slot is configured to retain the first intermediate section of the first core pin paragraph; and wherein the second core pin includes a second intermediate section, and the second slot is configured to retain the second intermediate section of the second core pin. 39. The mold system of claim 34, wherein the first core pin includes a first end section configured to prevent the first core pin from relative to the The mold moves longitudinally, and the second core pin includes a second end section configured to prevent longitudinal movement of the second core pin relative to the mold. 40. A method of manufacturing a medical device, the method comprising: the spacer tool is held by the grooves of the mold, the mold having a mold cavity; A portion of the first tube is received by a cavity in the spacing tool when the first tube is in the fixed position relative to the mold, wherein the first tube is in the fixed position relative to the mold , an area of the first tube is within the mold cavity and outside the spacer tool, and an end of the first tube defines one of the segments with the first cavity of the first core pin end engagement, the spacer tool includes a first section located in the mold cavity when the spacer tool is retained by the groove of the mold, the first section of the spacer tool A section is configured to define a cavity within the hub to be formed, the cavity being formed circumferentially around a section of the first tube, wherein the section of the first tube is different from the first tube said area of the tube; and Material is received by the mold cavity. 41. The method of claim 1, further comprising retaining the first core pin by the mold, wherein the first core pin is configured to define a first core pin to be formed in the hub cavity. 42. The method of claim 41, further comprising retaining a second core pin by the mold. 43. The method of claim 42, further comprising preventing longitudinal movement of the second core pin relative to the mold. 44. The method of claim 42, wherein the second core pin is configured to define a second cavity to be formed in the hub. 45. The method of claim 44, wherein the second cavity is in fluid communication with the cavity after the hub is fabricated. 46. The method of any of claims 40-45, further comprising preventing longitudinal movement of the first core pin relative to the mold. 47. The method of any of claims 40-46, further comprising subjecting the material to a curing process to obtain a cured material for the hub. 48. The method of claim 47, wherein the cured material contacts the region of the first tube and forms a space around the section of the first tube. 49. The method of claim 48, wherein the region of the first tube includes a liner coupled to a wall of the first tube. 50. The method of any of claims 40-49, further comprising using the spacing tool to define a space to be formed in the hub, wherein the space is sized to accommodate Second tube. 51. The method of claim 50, wherein the space defined by the spacing means has a cross-sectional dimension that is greater than the cross-sectional dimension of the cavity. 52. The method of claim 50, further comprising receiving the second tube from the space in the hub after the hub is fabricated. 53. The method of claim 50, further comprising attaching the second tube to the hub using an adhesive. 54. A method of manufacturing a medical device, the method comprising: the spacer tool is held by the grooves of the mold, the mold having a mold cavity; A portion of the first tube is received by a cavity in the spacing tool when the first tube is in the fixed position relative to the mold, wherein the first tube is in the fixed position relative to the mold , an area of the first tube is within the mold cavity and outside the spacer tool, and an end of the first tube defines one of the segments with the first cavity of the first core pin end engagement, the spacer tool includes a first section located in the mold cavity when the spacer tool is retained by the groove of the mold, the first section of the spacer tool A section is configured to define a cavity within the hub to be formed, the cavity being formed circumferentially around a section of the first tube, wherein the section of the first tube is different from the first tube said area of the tube; receiving material from the mold cavity; and A space to be formed in the hub is defined by the spacing tool, wherein the space is sized to accommodate the second tube, and the space has a cross-sectional dimension greater than that of the cavity. 55. The method of claim 54, further comprising receiving the second tube from the space in the hub after the hub is fabricated, and attaching the second tube with an adhesive A second tube is attached to the hub. 56. The method of claim 54 or 55, further comprising: holding the first core pin by the mold, wherein the first core pin is configured to define a first cavity to be formed in the hub, and a second core pin held by the die, The second core pin is prevented from moving longitudinally relative to the mold. 57. The method of claim 56, wherein the second core pin is configured to define a second cavity to be formed in the hub, and wherein after the hub is fabricated, the The second cavity is in fluid communication with the cavity. 58. The method of any one of claims 54-57, further comprising subjecting the material to a curing process to obtain a cured material for the hub, wherein the cured material is associated with the The area of the first tube contacts and forms a space around the section of the first tube.

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