阅读说明：本技术 具有可扩张能力的导引器 (Introducer with expandable capability ) 是由 大卫·罗伯特·乌尔夫曼 马修·尼尔森·弗罗斯特 派特·斯皮特 托马斯·马丁·基廷 马丁·G· 于 2018-06-13 设计创作，主要内容包括：公开了一种示例导引器。示例性导引器套管包括具有第一层和第二层的管状部件和设置于管状部件的第一层和第二层之间的支架。支架包括外表面和内表面。附加地,支架被配置为从第一形态变化至第二扩张形态且在第二扩张形态,支架的外表面接触管状部件的第一层。(An example introducer is disclosed. An exemplary introducer sheath includes a tubular member having a first layer and a second layer and a stent disposed between the first layer and the second layer of the tubular member. The stent includes an outer surface and an inner surface. Additionally, the stent is configured to change from a first configuration to a second expanded configuration and in the second expanded configuration, an outer surface of the stent contacts the first layer of the tubular member.)

1. An introducer sheath, comprising:

a tubular member comprising a first layer and a second layer; and

a stent disposed between the first layer and the second layer of the tubular member, the stent comprising an outer surface and an inner surface;

wherein the stent is configured to transition from a first configuration to a second expanded configuration;

wherein in the second expanded configuration, the outer surface of the stent contacts the first layer of the tubular member.

2. The introducer of claim 1, wherein the stent is slidable relative to the first and second layers of the tubular member.

3. The introducer of any of claims 1-2, wherein the stent is designed to foreshorten, and wherein foreshortening the stent transforms the stent from the first configuration to the second, expanded configuration.

4. The introducer of any one of claims 1-3, wherein the stent includes a proximal end, and wherein shifting the proximal end in a distal direction shifts the stent from the first configuration to the second expanded configuration.

5. The introducer of any of claims 1-4, wherein the first layer of the tubular member is radially outward of the second layer of the tubular member.

6. The introducer of any of claims 1-5, wherein the first layer of the tubular member is continuous with the second layer of the tubular member.

7. The introducer of any of claims 1-6, wherein the second layer of the tubular member is folded back on itself to form the first layer of the tubular member.

8. The introducer of any one of claims 1-7, wherein the tubular member further comprises a cavity extending therein, and wherein the cavity is positioned radially inward of both the first layer and the second layer.

9. The introducer of any of claims 1-8, wherein the tubular member comprises a first length in a first configuration and a second length in the expanded configuration, and wherein the first length is substantially the same as the second length.

10. The introducer of any of claims 1-9, wherein the tubular member includes a first outer diameter in the first configuration and a second outer diameter in the expanded configuration, and wherein the first outer diameter is less than the second outer diameter.

11. An introducer sheath, comprising:

a tubular member having a first layer and a second layer;

an expandable member disposed between the first layer and the second layer;

wherein the tubular member is configured to transition between a first elongated configuration and a second expanded and shortened configuration;

wherein transforming the tubular member to the second state comprises expanding the expandable member.

12. The introducer of claim 11, wherein the expandable member is slidable relative to the first and second layers of the tubular member.

13. The introducer of any of claims 11-12, wherein the expandable member is designed to shorten, and wherein shortening the expandable member transitions the expandable member from the first configuration to the second expanded configuration.

14. The introducer of any of claims 11-13, wherein the first layer of the tubular member is radially outward of the second layer of the tubular member.

15. The introducer of any of claims 11-14, wherein the tubular member includes a proximal end, and wherein shifting the proximal end in a proximal direction shifts the stent from the first configuration to the second, expanded configuration.

Technical Field

The present disclosure relates generally to medical devices and, more particularly, to medical devices suitable for use in percutaneous medical procedures.

Background

In some instances, performing a percutaneous medical procedure may require inserting and/or manipulating a relatively large medical device through the vasculature of a patient. However, inserting a medical device into the vasculature can result in undesirable forces being applied to the vessel wall. For example, as the medical device penetrates the vasculature, undesirable contact may be made with one or more vessel walls. This intervention can result in injury to the blood vessel when the medical device is navigated into a calcified or diseased blood vessel. Thus, in some instances, the use of an introducer may assist in inserting a medical device into a vessel. Further, vessel damage resulting from forces applied to the vessel wall by the medical device may be mitigated by minimizing the size of the introducer used to access the vessel. Accordingly, it would be desirable to design an introducer with a reduced insertion profile, yet capable of expansion when necessary (e.g., during passage of a medical device therethrough).

Disclosure of Invention

The present disclosure provides designs, materials, methods of manufacture, and methods of use of medical devices. An exemplary introducer sheath includes a tubular member including first and second layers and a stent disposed between the first and second layers of the tubular member. The stent includes an outer surface and an inner surface. Additionally, the stent is configured to transition from a first configuration to a second expanded configuration and the outer surface of the stent contacts the first layer of the tubular member in the second expanded configuration.

Alternatively or additionally to any of the embodiments above, wherein the stent is slidable relative to the first and second layers of the tubular member.

Alternatively or additionally to any of the embodiments above, wherein the stent is designed to foreshorten, and wherein foreshortening the stent transitions the stent from the first configuration to the second, expanded configuration.

Alternatively or additionally to any of the embodiments above, wherein the stent includes a proximal end, and wherein shifting the proximal end in a distal direction shifts the stent from the first configuration to the second expanded configuration.

Alternatively or additionally to any of the embodiments above, wherein the first layer of the tubular member is radially outward of the second layer of the tubular member.

Alternatively or additionally to any of the embodiments above, wherein the first layer of the tubular member is continuous with the second layer of the tubular member.

Alternatively or additionally to any of the embodiments above, wherein the second layer of the tubular member is folded back on itself to form the first layer of the tubular member.

Alternatively or additionally to any of the embodiments above, wherein the tubular member further comprises a cavity extending therein, and wherein the cavity is positioned radially inward of the first layer and the second layer.

Alternatively or additionally to any of the embodiments above, wherein the tubular member comprises a first length in the first configuration and a second length in the expanded configuration, and wherein the first length is substantially the same as the second length.

Alternatively or additionally to any of the embodiments above, wherein the tubular member thereof comprises a first outer diameter in the first configuration and a second outer diameter in the expanded configuration, and wherein the first outer diameter is less than the second outer diameter.

Another introducer sheath includes:

a tubular member having a first layer and a second layer;

an expandable member disposed between the first layer and the second layer;

wherein the tubular member is configured to transition between a first elongated configuration and a second expanded and shortened configuration;

wherein transforming the tubular member to the second state comprises expanding the expandable member.

Alternatively or additionally to any of the embodiments above, wherein the expandable member is slidable relative to the first and second layers of the tubular member.

Alternatively or additionally to any of the embodiments above, wherein the expandable member is configured to shorten, and wherein shortening the expandable member transforms the expandable member from the first configuration to the second expanded configuration.

Alternatively or additionally to any of the embodiments above, wherein the first layer of the tubular member is radially outward of the second layer of the tubular member.

Alternatively or additionally to any of the embodiments above, wherein the tubular member includes a proximal end, and wherein shifting the proximal end in a proximal direction shifts the stent from the first configuration to the second expanded configuration.

Alternatively or additionally to any of the embodiments above, wherein the first layer of the tubular member is continuous with the second layer of the tubular member.

Alternatively or additionally to any of the embodiments above, wherein the second layer of the tubular member is folded back on itself to form the first layer of the tubular member.

Alternatively or additionally to any of the embodiments above, wherein the tubular member further comprises a cavity extending therein, and wherein the cavity is positioned radially inward of the first layer and the second layer.

A method of inserting a medical device into a body, comprising:

inserting an introducer cannula into a body lumen, the introducer cannula comprising:

a tubular member comprising a first layer and a second layer; and

a stent disposed between the first layer and the second layer of the tubular member, the stent comprising an outer surface and an inner surface;

advancing a medical device through the introducer sheath, wherein advancing the medical device through the introducer sheath shifts the tubular member between a first configuration and a second expanded configuration, and wherein shifting the tubular member to the second configuration comprises expanding the stent.

Alternatively or additionally to any of the embodiments above, wherein the stent is slidable relative to the first and second layers of the tubular member.

The above summary of some examples is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The figures and the detailed description that follow more particularly exemplify these examples.

Drawings

FIG. 1 is a plan view of an exemplary guide;

FIG. 2 is a cross-sectional view of the introducer shown in FIG. 1 taken along line 2-2;

FIG. 3 is a partial cross-sectional view of the introducer shown in FIG. 1;

FIG. 4 is a partial cross-sectional view of the introducer shown in FIG. 1 in an expanded configuration;

FIG. 5 is a cross-sectional view of the introducer shown in FIG. 4 taken along line 5-5;

FIG. 6 is a partial cross-sectional view of another exemplary guide;

FIG. 7 is a partial cross-sectional view of the introducer shown in FIG. 6 in an expanded configuration;

FIG. 8 is a cross-sectional view of the introducer shown in FIG. 7 taken along line 8-8;

while the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the disclosure to the particular examples described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.

DETAILED DESCRIPTION OF EMBODIMENT (S) OF INVENTION

For the following defined terms, these definitions shall apply, unless a different definition is given in the claims or elsewhere in the specification.

All numerical values herein are to be considered as modified by the term "about" unless expressly indicated otherwise. The term "about" generally refers to a range of numbers that one of ordinary skill in the art would consider equivalent to the recited value (e.g., having the same function or effect). In many instances, the term "about" may include numbers that are rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numbers subsumed within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and/or" unless the context clearly dictates otherwise.

It is noted that references in this specification to "an embodiment", "some embodiments", "other embodiments", etc., indicate that the embodiment described may include one or more particular features, structures, and/or characteristics. However, such references do not necessarily imply that all embodiments include the particular feature, structure, and/or characteristic. Additionally, when a particular feature, structure, and/or characteristic is described in connection with an embodiment, it is understood that unless explicitly stated to the contrary, such feature, structure, and/or characteristic may also be used in connection with other embodiments, whether or not explicitly described.

The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered identically. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

In some instances, performing a percutaneous medical procedure may require inserting and/or manipulating a relatively large medical device through a patient's vasculature. However, inserting a medical device into the vasculature can result in undesirable forces being applied to the vessel wall. For example, as the medical device penetrates the vasculature, undesirable contact may be made with one or more vessel walls. Such intervention may cause damage to the blood vessel when the medical device is navigated into a calcified or diseased blood vessel. Thus, in some instances, an introducer is utilized to assist in inserting the medical device into the vessel. Further, vessel damage resulting from forces applied to the vessel wall by the medical device may be mitigated by minimizing the size of the introducer used to access the vessel. Accordingly, it would be desirable to design an introducer with a reduced insertion profile, yet capable of expansion when necessary (e.g., during passage of a medical device therethrough). The following examples disclose intravascular medical devices that include an expandable introducer, whereby the introducer is designed to expand from a reduced profile, unexpanded configuration to an expanded configuration.

Fig. 1 illustrates an exemplary expandable introducer (e.g., delivery sheath, access sheath, etc.) 10. The introducer 10 may include a tubular member 14. The tubular member 14 may include a proximal region 16 and a distal region 18. The tubular member 14 may further include a lumen 35 extending therethrough (discussed in detail below). The tubular member 14 may be constructed from lubricious polymer fibers. For example, the tubular member 14 may be constructed from a composite of fluoropolymer (e.g., PVDF-HFP) fibers and silicone. This composition may have the advantage of making the tubular member 14 tough, thin, and lubricious.

Further, the introducer 10 may include a manifold 12. The proximal end region 16 of the tubular member may be attached to the manifold 12. Additionally, the manifold 12 may include a hemostatic valve or seal disposed therein. The hemostatic valve or seal may prevent blood or other bodily fluid(s) from flowing proximally through the lumen 35 of the tubular member 14. In at least some embodiments, the manifold 12 can include a port (not shown) in fluid communication with the cavity 35 of the tubular member 14.

In some examples, it may be desirable to add an end component 34 distal to any of the examples disclosed herein. The end member 34 may be designed with a low durometer material. In some examples, the low durometer material may give the tip component 34 the ability to expand (e.g., flex) radially outward as well as contract radially as various medical devices are advanced through the tip component 34. Further from this, the tip component 34 may include a tapered portion. For example, at the distal end of the introducer 10, the tip component 34 may taper from a first diameter to a second diameter. Although not intended to be limiting, in some examples, the tip component 34 may be shaped to look like a bovine nose. Additionally, the tip component 34 may comprise a radiopaque material. The radiopaque material may allow tip component 34 to be visible to a physician during a medical procedure. In some examples, the tip component 34 may be radially segmented and/or cut so that upon expansion, the tip component may be divided into multiple pieces. Although any of the embodiments described herein may include end components, this is not intended to be limiting. Rather, as shown in the figures, some examples described herein do not include end components.

Fig. 2 is a cross-sectional view of the introducer 10 along line 2-2 of fig. 1. As shown in fig. 2, in some examples, the tubular member 14 may include a second layer 22 and a first layer 20. In some examples, the second layer 22 of the tubular member 14 may be referred to as an inner layer. Similarly, in some examples, the first layer 20 of the tubular member 14 may be referred to as an outer layer. As can be appreciated from fig. 2, the first layer 20 is positioned radially outward (e.g., radially away) from the second layer 22. Fig. 2 also shows the cavity 35 described with reference to fig. 1. As shown in fig. 2, the cavity 35 may be placed radially inward of the second layer 22, the first layer 20, or both the second layer 22 and the first layer 20.

As will be described in greater detail below, fig. 2 illustrates that introducer 20 may include a space 28 (e.g., a gap, void (void), etc.) between second layer 22 and first layer 20. In other words, the space 28 may be defined as a void of material extending between the outer surface 26 (as shown in fig. 2) of the second layer 22 and the inner surface 29 (as shown in fig. 2) of the first layer 20.

Further, fig. 2 shows that, in some examples, the introducer 10 may include an expandable member 24 (e.g., a stent) disposed within the space 28 (as described above). The expandable member 24 may include an inner surface 30 and an outer surface 32. As shown in fig. 2, the inner surface 30 and/or the outer surface 32 of the expandable member 24 may not contact the outer surface 26 of the second layer 22 and/or the inner surface 29 of the first layer 20. However, this is not intended to be limiting. Rather, in some examples, the inner surface 30 and/or the outer surface 32 of the expandable member 24 may not contact the outer surface 26 of the second layer 22 and/or the inner surface 29 of the first layer 20. In some examples, the tubular member 14 may be sized such that its diameter is smaller than the stent diameter when fully compressed.

In some examples, the expandable member 24 may be a self-expanding stent. Examples of self-expanding stents may include expandable frames having one or more filaments combined to form a rigid and/or semi-rigid stent structure. For example, the stent filaments may be braided, wound, interwoven, braided, knitted, etc., to form an expandable framework.

The expandable member 24 in the examples disclosed herein may be constructed from a variety of materials. For example, the expandable member 24 may be constructed from a metal (e.g., nitinol). In some examples, the expandable member 24 may be constructed from a polymeric material (e.g., PET). In still other examples, the expandable member 24 may be constructed from a combination of metal and polymer materials. Additionally, the expandable member 24 may include a bioabsorbable and/or biodegradable material

FIG. 3 shows a partial cross-sectional view of the introducer 10, including a second layer22. A first layer 20, and a space 28 disposed between the second layer 22 and the first layer 20. It will be appreciated that fig. 3 may show the introducer 10 in an unexpanded (e.g., compressed) configuration. The introducer 10 in the compressed configuration may be compressible in an axial direction, more compliant, and more radially compliant than in the expanded configuration (described below). It is further understood that in the unexpanded configuration, the introducer 10 may include an outer diameter labeled "D1" in fig. 3. Additionally, FIG. 3 illustrates that the tubular member 14 may have an L-shape, labeled "L" in the unexpanded configuration₁"length of the film.

Fig. 3 illustrates that, in at least some examples, a proximal end region of the tubular member can be coupled (e.g., attached, affixed, disposed therealong, etc.) to a portion of the manifold 12 (described above and shown in fig. 1). For example, fig. 3 shows that, in some examples, the tubular member may be coupled to the manifold at one or more fixation points 38. Additionally, fig. 3 shows that, in some examples, the proximal end region 16 of the tubular member may include the proximal ends of both the first layer 20 and the second layer 22 of the tubular member 14.

Although fig. 3 shows the proximal end region 16 of the tubular member (including the proximal ends of both the first layer 20 and the second layer 22 of the tubular member 14) attached to the manifold 12 at the fixation points 38, this is not intended to be limiting. Rather, it is contemplated that in some instances, the proximal end region 16 of the tubular member may be disposed, attached, affixed, etc. to any portion of the manifold 13. For example, it is contemplated that a portion of the proximal end region 16 of the tubular member may extend into the manifold 12. Other examples contemplate that the tubular member 14 and the manifold 12 may be coupled together via an auxiliary component (e.g., a ferrule, a coupling component, etc.).

As described above, with reference to fig. 1, the introducer 10 may include a tip component 34 disposed along the distal region 18 of the tubular member 14. However, fig. 3 illustrates another example in which the distal tip 34 of the introducer 10 may be formed from a tubular member. In particular, fig. 3 illustrates that, in at least one example contemplated herein, the second layer 22 of tube members "folds back" on itself to form the first layer 20 of the tubular member 14. In other words, the tubular member 14 may be characterized as a "lay-over tube," whereby the first and second layers 20, 22 may be formed from a single tube that may be laid over itself to form the inner and outer layers. As can be seen in fig. 3, the distal end 34 of the tubular member 14 described above (and as shown in fig. 3) can include a curved portion whereby the second layer 22 "transitions" to the first layer 20.

FIG. 3 also shows the expandable member 24 disposed in the space 28 between the second layer 22 and the first layer 20 of the tubular member 14. It will be appreciated that in at least some examples, the expandable member 24 is slidably disposed between the second layer 22 and the first layer 20. In other words, in at least some examples, the expandable member 24 can slide (e.g., move, switch, etc.) relative to the second layer 22 and/or the first layer 20.

Additionally, fig. 3 shows that in some examples, the proximal end 36 of the expandable member 24 may extend into a portion of the manifold 12. FIG. 3 also shows that the expandable member 24 may extend into the manifold a distance marked "X"₁". As will be discussed in more detail below, in some examples, the proximal end 36 of the expandable member 24 may be configured to change in a proximal-to-distal direction. In other words, the proximal end 36 of the expandable member 24 may not be fixed relative to the manifold 12 and may move relative thereto.

FIG. 3 also shows that the distal end 42 of the expandable member 24 can be positioned adjacent the distal end of the tubular member 14. As shown in FIG. 3, the distal end 42 of the expandable member 24 may extend into the space 28 such that the distal end 42 of the expandable member 24 is adjacent the distal end of the tubular member 14. In some examples, the distal end 42 of the expandable member 24 may abut (e.g., contact, touch, etc.) the tubular member 14.

Fig. 4 shows the introducer 10 described in fig. 3 in an expanded configuration. It will be further appreciated that in the expanded configuration, the introducer 10 may include a lumen labeled "D" in FIG. 4₂"outer diameter. Diameter D₂May be larger than the unexpanded diameter D shown in fig. 3₁. E.g. diameter D₂Specific unexpanded diameter D₁About 1 to 10 times, or more than, the unexpanded diameter D₁About 1 to 5 times the relative unexpanded diameter D₁About 1 to 2.5 times. These are merely examples, and other expansion ratios are contemplated. For example, in some instances, the expansion ratio may be adjusted up or down based on the design of the expandable member, as will be described further belowAs described in detail.

Fig. 4 also illustrates that, in some examples, the tubular member 14 may be expanded via outward, radial expansion of the expandable member 24. In other words, expanding the expandable member 24 radially outward may cause the outer surface 32 (shown in fig. 1 and 4) of the expandable member 24 to contact the inner surface 29 (shown in fig. 1 and 4) of the first layer 20, thereby expanding the tubular member 14 radially outward. For example, fig. 4 shows an outer surface 32 (shown in fig. 1 and 4) of the expandable member 24 contacting an inner surface 29 (shown in fig. 1 and 4) of the first layer 20. However, fig. 4 also illustrates that the inner surface of the expandable member 24 (shown in fig. 1 and 4) may not contact the outer surface 26 of the second layer 22 of the tubular member (shown in fig. 1 and 4). Thus, in some examples, there will still be a gap 28 between the inner surface 30 of the expandable member 24 and the outer surface 26 of the second layer 22. However, this is not intended to be limiting. Rather, in some examples, the inner surface 30 of the expandable member 24 may contact the outer surface 26 of the second layer 22 once the expandable member 24 is expanded.

Fig. 4 also shows that, in some examples, the tubular member 14 may be designed to expand radially outward while its length remains constant. For example, it will be appreciated that if the proximal end region 16 of the tubular member 14 is fixed relative to the manifold 12 (e.g., at the fixation points 38) and the tubular member 14 is prevented from elongating along its longitudinal axis (e.g., by utilizing a particular material or structural design), as shown and described with reference to FIG. 3, radial expansion of the expandable member 24 may be translated into radial expansion of the tubular member 14 without longitudinally elongating the tubular member. For example, FIG. 4 shows the tubular member in the expanded configuration having a length "L₂". In some examples, the length L of the tubular member in the unexpanded configuration₁(as shown in FIG. 3) is capable of interacting with the length L of the tubular member in the expanded configuration₂(as shown in fig. 4).

FIG. 4 also illustrates the expansion of the expandable member 24 radially outward. As shown in fig. 4 and described above, the proximal end 26 of the expandable member 24 may extend into the manifold 12 and move relative to the manifold 12. It will be further appreciated that, therefore, the manifold 12 may be designed to allow the proximal end 36 of the expandable member 24 to be deformed in the proximal-to-distal directionAnd (as indicated by the arrows in fig. 4). In other words, it can be appreciated that the manifold 12 can be designed with one or more components (not shown for clarity) that can exert a force on the proximal end 36 of the expandable member 24 such that the proximal end 36 of the expandable member 24 can be varied in a proximal-to-distal direction (as shown by the arrows in fig. 4). For example, FIG. 3 shows the proximal end 36 of the expandable member 24 extending a distance, labeled "X", into the manifold 12₁"(in an unexpanded configuration), while FIG. 4 shows the proximal end 36 of the expandable member 24 extending into the manifold 12 a distance, designated as" X2 "(in an expanded configuration), wherein the distance" X "is₁Greater than distance X₂". Further, as described above, in some examples (such as shown in fig. 3 and 4), the distal end 42 of the expandable member 24 may remain fixed via an elongated tubular member (which, as described above) that is designed to oppose the longitudinal direction. Thus, it can be appreciated that if the proximal end 36 of the expandable member 24 changes in the proximal-to-distal direction while the distal end 42 of the expandable member remains fixed, the expandable member 24 (and, therefore, the tubular member 14) can expand radially outward, as described above.

Additionally, it will be further appreciated that in the expanded configuration shown in fig. 4, the expandable member 24, and thus the tubular member 14, may provide a balance of structure and lubrication to translate the medical device through the lumen 35 of the introducer 10. For example, the tubular member 14 may provide surface texturing, lubrication, etc. to reduce friction of the medical device translating through the lumen 35 of the introducer 10, while the expandable member 24 provides sufficient radial support (e.g., hoop strength) against the vessel wall to allow the medical device to translate efficiently therethrough.

It is contemplated that, for at least some of the examples disclosed herein, the specific design characteristics of the expandable assembly 24 may control the minimum and maximum expansion ratios of the introducer 10. For example, the expandable assembly 24 may be "tuned" and optimized for the particular needs and intended use of the introducer cannula 10. For example, the expandable assembly 24 may be designed to be made of a particular material with particular thickness, length, and diameter dimensions that alter the expansion characteristics of the introducer sheath.

Further, the tubular member 14 may be designed to match the design of the expandable assembly 24. For example, the tubular member 14 may provide a balance between allowing the expandable member 24 to freely expand to a desired diameter while also limiting expansion of the expandable member 24 to an undesired diameter. Additionally, it is contemplated that in some examples, the action of the tubular member 14 against the expandable member 24 causes the introducer cannula 10 to become a more rigid structure. In other words, when the expandable member 24 expands radially outward (via shortening of the expandable member 24, as described above), it eventually contacts the inner surface of the tubular member 14, whereby the tubular member 14 begins to expand while also resisting further expansion of the tubular member 24. The tubular member 14 exhibits a stiffer introducer 10 against expansion (e.g., the combination of the tubular member 14 and the expandable member 24 becomes stiffer). The more rigid introducer 10 is less likely to deform (buckle) when a medical device is passed therethrough. In some examples, the interaction between the tubular member 14 and the expandable member 24 provides a limit to the extent to which the expandable member 24 is allowed to expand, which may provide a degree of protection against damage to the vessel wall. It is contemplated that the interaction between the tubular member 14 and the expandable member 24 described above may be applied to any of the introducer examples disclosed herein.

Fig. 3 and 4 are schematic illustrations of an exemplary introducer sheath changing from an unexpanded position to an expanded configuration. The particular design of the components relative thereto is not intended to be limiting. For example, it is contemplated that the manifold 12 and its components are designed in various ways to attach to the tubular member 14 and provide force to the proximal end 36 of the expandable member 24. Further, additional configurations, designs, and engagements of the tubular member 14 and the expandable member 24 with the proximal region of the manifold 12 are contemplated. It will be appreciated that a variety of different manifold configurations may allow the tubular member 14 and the expandable member 24 to function as described herein.

Fig. 5 is a cross-sectional view of the introducer 10 taken along line 5-5 of fig. 4. FIG. 5 illustrates the tubular member 14 including the second layer 22, the first layer 20, and the expandable member 24 disposed in the space 28 between the second layer 22 and the first layer 20. It will be appreciated that FIG. 5 may illustrate the expanded configurationAn introducer 10. It will be further appreciated that in the expanded configuration, the introducer 10 may include the structure designated as "D" in FIG. 5₂"outer diameter. As discussed above, FIG. 5 shows the outer surface 32 of the expandable member 24 contacting the inner surface 29 of the first layer 20. However, FIG. 5 also illustrates that the inner surface 30 of the expandable member 24 may not contact the outer surface 26 of the second layer 22 of the tubular member. Thus, in some examples, there may still be a gap 28 between the inner surface 30 of the expandable member 24 and the outer surface 26 of the second layer 22.

Fig. 6 and 7 illustrate another exemplary expandable introducer cannula 110. The expandable introducer cannula 110 may be similar in form and function to the other exemplary introducer cannulas described herein. For example, the introducer sheath 110 (and its components) may be similar in form and function to the introducer 10 described herein.

Fig. 6 shows introducer cannula 110 including tubular member 114. The tubular member 114 may include a second layer 122, a first layer 120, and an expandable member 124 positioned within the gap 128. Additionally, fig. 6 illustrates that the proximal end 136 of the expandable member 124 may be coupled (e.g., attached, fastened, secured, etc.) to a remote region of the manifold 112 at a fixation point 138. Additionally, FIG. 6 is a cross-sectional view illustrating that the tubular member 14 may have an L-shape illustrated in the unexpanded configuration₃"length of the film.

Additionally, fig. 6 shows that, in some examples, the proximal end 137 of the tubular member 114 may extend into a portion of the manifold 112. For example, FIG. 6 shows that a portion of the first layer 120 of the tubular member 114 may extend a distance, labeled "X", into the manifold 112₃". As will be described in detail below, in some examples, the proximal end 137 of the tubular member 114 may be configured to change in a distal-to-proximal direction. In other words, the proximal end 137 of the tubular member 114 may not be fixed relative to the manifold 112 and may move relative to the manifold.

FIG. 6 also shows that the distal end 142 of the expandable member 124 can be positioned adjacent to the distal end of the tubular member 114. As shown in fig. 6, the distal end 142 of the expandable member 124 can extend within the space 128 such that it is adjacent the distal end of the tubular member 114. In some examples, the distal end 142 of the expandable member 124 may abut (e.g., contact, touch, etc.) the tubular member 114.

Fig. 7 shows the introducer 110 shown in fig. 6 in an expanded configuration. It will be further appreciated that in the expanded configuration, introducer 110 may include a "D" illustrated in fig. 6₄"outer diameter. Diameter D₄May be larger than the unexpanded diameter D shown in fig. 6₃. E.g. diameter D₄Comparable unexpanded diameter D₃About 1 to 10 times, or more than, the unexpanded diameter D₃About 1 to 5 times, or greater than, the unexpanded diameter D₃About 1 to 2.5 times. These are examples only, and other ratios are contemplated. For example, in some instances, the expansion ratio may be adjusted up or down based on the design of the expandable member, as will be described in detail below.

Fig. 7 also shows that in some examples, the tubular member 114 can be expanded via outward, radial expansion of the expandable member 124. In other words, expanding the expandable member 124 radially outward may cause the outer surface 132 of the expandable member 124 to contact the inner surface 129 of the first layer 120, thereby expanding the tubular member 114 radially outward. For example, fig. 7 shows the outer surface 132 of the expandable member 124 contacting the inner surface 129 of the first layer 120. However, FIG. 7 also illustrates that the inner surface 130 of the expandable member 124 may not contact the outer surface 126 of the second layer 122. Thus, in some examples, there may still be a gap 128 between the inner surface 130 of the expandable member 124 and the outer surface 126 of the second layer 122. However, this is not intended to be limiting. Rather, in some examples, the inner surface 130 of the expandable member 124 may contact the outer surface 126 of the second layer 122 once the expandable member 124 is expanded.

Fig. 7 also shows that the tubular member 114 can be designed to expand radially outward while shortening its length. For example, it can be appreciated that if the proximal end 136 of the expandable member 124 is fixed relative to the manifold 112 (e.g., at the fixation point 138) and the tubular member 114 is shortened along its longitudinal axis, the expandable member 124 can be simultaneously shortened and radially outwardly expanded (which can also radially outwardly expand the tubular member 114). For example, FIG. 7 also illustrates the length of the tubular member 114 in the expanded configuration as "L₄". In some examples, the length of the tubular member 114 in the unexpanded configuration (shown in fig. 6)L₃May be greater than the length L of the tubular member 114 in the expanded configuration (shown in fig. 7)₄。

Fig. 7 also illustrates the radially outward expansion of the expandable member 124. As shown in fig. 7 and described above, the proximal end 137 of the tubular member 114 (e.g., the proximal end 137 of the first layer 120) can extend into the manifold 112 and can move relative to the manifold 112. It will be further appreciated that, therefore, the manifold 112 may be designed to allow the proximal end 137 of the tubular member 114 to change in a distal-to-proximal direction (as indicated by the arrows in FIG. 7). In other words, it can be appreciated that the manifold 112 can be designed with one or more components (not shown for purposes of clarity) that can "pull" at least a portion of the proximal end 137 of the tubular member 114 such that the proximal end 137 of the tubular member 114 can change in a distal-to-proximal direction (as shown by the arrows in fig. 7). Further, as described above, the proximal end 136 of the expandable member 124 may be held stationary via the manifold 112. Thus, it can be appreciated that as the proximal end 137 of the tubular member 114 is changed in the distal-to-proximal direction (thereby shortening the tubular member 114) while the proximal end 136 of the expandable member 124 remains fixed, the expandable member 124 (and, therefore, the tubular member 114) can be shortened and expanded radially outward simultaneously.

It should be noted that although the above description discloses shortening the tubular member 114 by pulling the proximal end of the first layer 120 in a proximal-to-distal direction, this is not intended to be limiting. Rather, a similar result can be achieved by pulling the proximal end of the second layer 122 in a proximal-to-distal direction. Still other examples may shorten both the tubular member and the expandable member 124 by pulling both the first layer 120 and the second layer 122 in a proximal-to-distal direction.

Fig. 8 illustrates a cross-sectional view of introducer 110 taken along line 8-8 of fig. 7. FIG. 8 illustrates a tubular member 114 including a second layer 122, a first layer 120, and an expandable member 124 disposed in a space 128 between the second layer 122 and the first layer 120. It will be appreciated that fig. 8 may show introducer 110 in an expanded configuration. It will be further appreciated that in the expanded configuration, introducer 110 may include a portion labeled "D" in FIG. 8₄"outer diameter. As described above, FIG. 8 shows the expandable member 124 in contact with the inner surface 129 of the first layer 120. However,FIG. 8 also illustrates that the inner surface 130 of the expandable member 124 may not contact the outer surface 126 of the second layer 122 of the tubular member 114. Thus, in some examples, there is still a gap 128 between the inner surface 130 of the expandable member 124 and the outer surface 126 of the second layer 122.

In some examples, the introducer 10 and/or 110 may be made of a material such as a metal, metal alloy, polymer, ceramic, metal polymer composite, or other suitable material. Some examples of suitable materials may include metallic materials such as stainless steel (e.g., 304v stainless steel or 316L stainless steel), nitinol (e.g., nitinol, such as superelastic or linear elastic nitinol), nichrome, cobalt alloy, nickel, titanium, platinum, or alternatively, polymeric materials such as high performance polymers or other suitable materials, and the like. The word nickel titanium compound (nitinol) was created by a group of researchers at the Naval Ordinance Laboratory (NOL), the first to observe the shape memory behavior of this material. The word nickel titanium compound (nitinol) is an acronym that includes the chemical notation of nickel (Ni), titanium (Ti), and the acronym designating the Naval Ordinance Laboratory (NOL).

In some examples, introducer 10 and/or introducer 110 may be made of materials such as, for example, polymeric materials, ceramics, metals, metal alloys, metal-polymer composites, and the like. Examples of suitable polymers may include polyurethanes, polyetheresters, such as available from DSM engineering plastics, Inc

Polyesters, such as those available from DuPont

Polyesters, linear low density polyethylenes, such as

Polyesters, polyamides, such as those available from Bayer AG

Or

Polyesters, elastomeric polyamides, polyamide/ether blocks, polyether block amides, such as PEBA, under the trade name PEBA

Silicone, polyethylene, Marlex high density polyethylene, Polyetheretherketone (PEEK), Polyimide (PI) and Polyetherimide (PEI), Liquid Crystal Polymer (LCP), alone or in mixture with other materials. In some examples, suitable polymeric materials may have a yield strain of at least 20%, at least 30%, at least 40%, at least 50%, or more. In some examples, the sleeve, membrane, and/or plurality of corrugations may be made of a material having a low coefficient of friction. The sleeve, membrane, and/or plurality of corrugations may be formed from a fluoropolymer, such as Polytetrafluoroethylene (PTFE) or Fluorinated Ethylene Propylene (FEP).

Portions of introducer 10 or introducer 110 may be made of, may be doped with, may include a layer, or may otherwise include a radiopaque material. Radiopaque materials are understood to be materials that are capable of producing relatively bright images on fluoroscopy, or another imaging technique such as X-ray in a medical procedure. This relatively bright image helps the device user to determine its location. For example, one or more of the components described above (i.e., the cannula, membrane, medical device, etc.) may include or be formed from a radiopaque material. Suitable materials may include, but are not limited to, bismuth subcarbonate, iodine, gold, platinum, palladium, tantalum, tungsten, or tungsten alloys, and the like.

It should be understood that while the above discussion has focused on percutaneous medical procedures within a patient's vasculature, other examples or methods according to the invention may be adapted and configured for use with other portions of a patient's anatomy. For example, devices and methods according to the present invention may be adapted for use in the alimentary or gastrointestinal tract, such as in the mouth, throat, small and large intestines, colon, rectum, and the like. For another example, the apparatus and methods may be adapted and configured for use within a respiratory tract, such as in the mouth, nose, throat, bronchial passages, nasal passages, lungs, and so forth. Similarly, the devices and methods described herein with respect to percutaneous placement may be used in other types of surgical procedures as appropriate. For example, in some examples, the device may be provided in a non-percutaneous procedure. The device and method according to the invention may also be adapted and configured for other uses in the anatomy.

It should be understood that the present invention, in many respects, is illustrative only. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the invention. The scope of the invention is, of course, defined in the language in which the appended claims are expressed.