Patent Application
20240423664
The present disclosure generally relates to the field of medical devices. Delivery catheters and other therapy devices are often used to deliver medical devices, such as prosthetic heart valves, shunts, stents, or other devices, to locations inside the body that are not readily accessible by surgery or where access without invasive surgery is desirable. An access sheath can often be used to introduce a therapy device into the desired anatomy, such as the patient's vasculature or other anatomy. In some instances, the access sheath may include a relatively large diameter that can cause damage to the patient's tissue when the access sheath is inserted into the tissue. Further, in some instances, the therapy device can be damaged when pushed through the access sheath. For example, the access sheath can include a smaller inner diameter than the outer diameter of the therapy device, requiring a relatively high push force to move the therapy device through the access sheath. This can damage a fragile therapy device.
Described herein are methods and devices relating to an introducer comprising an elongate shaft configured to be received within an expandable access sheath. The introducer can have an expansion feature disposed on the elongate shaft. The expansion feature can include a larger outer diameter than an inner diameter of at least a portion of the expandable access sheath, including a distal end portion of the expandable access sheath. The expansion feature can be configured to dilate at least a portion of the expandable access sheath, including the distal end portion of the expandable access sheath, such as when the elongate shaft is translated distally within the expandable access sheath.
Described herein are methods and devices relating to expandable access sheaths. In some instances, a medical access system can comprise an expandable access sheath comprising a shaft having an expandable distal end portion. The medical access system can include a cord comprising a medial cord portion between first and second cord tail portions, the medical cord portion being configured to be disposed around a circumferential portion of the expandable distal end portion. The first and second cord tail portions can be configured to pass through a side shaft opening and comprise respective proximal portions for manipulation by an operator to transform the expandable distal end portion to an open and/or closed state. In some instances, an expandable access sheath can have a shaft comprising an expandable distal end portion with a plurality of pleats. Each pleat can comprise a pair of pleat portions configured to be attracted to one another to maintain the expandable distal end portion in a closed state. In some instances, each pleat portion can comprise magnetic material and/or electrostatic charges. In some instances, an expandable access sheath can have a shaft with an expandable distal end portion comprising a circumferential portion with a weakened joint. The circumferential portion can be configured to separate along the weakened joint to allow the expandable distal end portion to transform from a closed state to an open state. In some instances, an expandable access sheath can have a shaft with an expandable distal end portion comprising a weakened portion formed in a sidewall while the expandable distal end portion is in a closed state. The weakened portion can have a distal end spaced from a distal end of the shaft. At least a portion of the weakened portion can have an orientation at an angle relative to the distal end of the shaft. The expandable distal end portion can be configured to separate along the weakened portion.
Methods and structures disclosed herein for treating a patient also encompass analogous methods and structures performed on or placed on a simulated patient, which is useful, for example, for training; for demonstration; for procedure and/or device development; and the like. The simulated patient can be physical, virtual, or a combination of physical and virtual. A simulation can include a simulation of all or a portion of a patient, for example, an entire body, a portion of a body (e.g., thorax), a system (e.g., cardiovascular system), an organ (e.g., heart), or any combination thereof. Physical elements can be natural, including human or animal cadavers, or portions thereof; synthetic; or any combination of natural and synthetic. Virtual elements can be entirely in silica, or overlaid on one or more of the physical components. Virtual elements can be presented on any combination of screens, headsets, holographically, projected, loud speakers, headphones, pressure transducers, temperature transducers, or using any combination of suitable technologies.
For purposes of summarizing the disclosure, certain aspects, advantages and features have been described herein. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular example. Thus, the disclosed examples may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.
Various examples are depicted in the accompanying drawings for illustrative purposes and should in no way be interpreted as limiting the scope of the subject matter. In addition, various features of different disclosed examples can be combined to form additional examples, which are part of this disclosure. Throughout the drawings, reference numbers may be reused to indicate correspondence between reference elements. However, it should be understood that the use of similar reference numbers in connection with multiple drawings does not necessarily imply similarity between respective examples associated therewith. Furthermore, it should be understood that the features of the respective drawings are not necessarily drawn to scale, and the illustrated sizes thereof are presented for the purpose of illustration of various aspects thereof. For example, illustrated features may be relatively smaller/larger than as illustrated in some examples/configurations.
The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the subject matter.
Although certain examples are disclosed below, the subject matter extends beyond the specifically disclosed examples to other alternative examples and/or uses and to modifications and equivalents thereof. Thus, the scope of the claims that may arise here from is not limited by any of the particular examples described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding certain examples; however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures, systems, and/or devices described herein may be implemented as integrated components or as separate components. For purposes of comparing various examples, certain aspects and advantages of these examples are described. Not necessarily all such aspects or advantages are achieved by any particular example. Thus, for example, various examples may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.
Certain standard anatomical terms of location are used herein to refer to the anatomy of animals, and namely humans, with respect to the examples. Although certain spatially relative terms, such as “outer,” “inner,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” “top,” “bottom,” and similar terms, are often used herein to describe a spatial relationship of one device/element or anatomical structure to another device/element or anatomical structure, it is understood that these terms are used herein for ease of description to describe the positional relationship between element(s)/structures(s), as illustrated in the drawings. It should be understood that spatially relative terms are intended to encompass different orientations of the element(s)/structures(s), in use or operation, in addition to the orientations depicted in the drawings. For example, an element/structure described as “above” another element/structure may represent a position that is below or beside such other element/structure with respect to alternate orientations of the subject patient or element/structure, and vice-versa.
An access sheath can be used to introduce a medical instrument/device into a patient's anatomy (e.g., a catheter or other delivery device into the patient, including the femoral artery or other anatomy). In some cases, at least a portion of an access sheath, such as an expandable access sheath, can be designed to expand from an initial state having a first inner diameter (ID) to an expanded state having a second larger ID. For example, the access sheath can be introduced into the desired anatomy in the initial state with the smaller ID. Once the access sheath is positioned, a medical instrument, such as a catheter or other delivery device, can be inserted through the access sheath to reach a target site within the patient. For example, the catheter or other delivery device can be advanced through the access sheath positioned into the patient to position the catheter or other delivery device at the target site within the patient. The access sheath can expand to the larger ID to accommodate the catheter or other delivery device. In some instances, the catheter or other delivery device can be configured to carry a therapy device. In some instances, the therapy device can be carried by and/or preloaded within the catheter or other delivery device. This can reduce, minimize, or prevent damage to the patient's anatomy and/or the access sheath (e.g., avoid damaging the tissue of the patient with a sheath having a traumatic point (relatively large diameter), avoid the access sheath from folding inward on itself during insertion of the access sheath, etc.).
In some solutions, a relatively high push force is needed to push the delivery device, including a delivery device carrying a therapy device, through the access sheath and/or out of the distal end of the access sheath. The push force can refer to the amount of effort or force exerted axially on the delivery device and/or therapy device, such as to effect expansion of the access sheath radially, to allow the delivery device and/or therapy device to travel through the access sheath axially. The push force can refer to the amount of effort or force exerted axially on the delivery device and/or therapy device to distally advance the delivery device and/or therapy device through the access sheath. However, some delivery devices and/or therapy devices may not be able to withstand excessive push forces (e.g., due to the relatively fragile form of the delivery devices and/or therapy devices), resulting in damage to the delivery devices and/or therapy devices. Further, excessive push force can cause the delivery device and/or therapy device to abruptly eject from the access sheath, causing damage to the patient.
In some instances, the present disclosure describes devices, systems, and methods relating to introducers that include expansion features configured to dilate access sheaths in a manner that reduces, minimizes, or prevents damage to the patient's anatomy, and/or access sheaths and/or medical devices that are used therewith. For example, an access sheath, such as an expandable access sheath, can be inserted into the patient's anatomy with a collapsed or relatively small profile and/or form. After the access sheath is positioned within the desired anatomy, the introducer can be translated through the access sheath to expand and/or stretch the access sheath, thereby preparing the access sheath for a delivery device and/or therapy device. The introducer can include an expansion feature that has a larger diameter and/or dimension than an inner diameter/dimension of the access sheath, in at least some configurations of the expansion feature. The introducer can be removed from the access sheath and a delivery device and/or medical device can be inserted through the access sheath with minimal push force. As such, the introducer can be used to reduce, minimize, or prevent harm to the patient and/or avoid damage to the access sheath, delivery device and/or medical device.
In some instances, the present disclosure describes devices, systems, and methods relating to expandable access sheaths comprising an expandable distal end portion configured to be in an open state and a closed state. In some instances, a medical access system can comprise a cord having at least a portion configured to be disposed around a circumferential portion of an expandable distal end portion of an expandable access sheath, while the expandable distal end portion is in the closed state. Maintaining tension on the cord can facilitate maintaining the expandable distal end portion in the closed state. In some instances, an expandable access sheath can comprise an expandable distal end portion comprising a plurality of pairs of pleat portions, where pleat portions of each pair can be configured to be attracted to one another to maintain the expandable distal end portion in the closed state. In some instances, an expandable access sheath can comprise an expandable distal end portion comprising a circumferential portion with a weakened joint. The circumferential portion can break and/or separate along the weakened joint to allow transformation of the expandable distal end portion to the open state. In some instances, an expandable access sheath can have a shaft with an expandable distal end portion comprising one or more weakened portions formed in a sidewall such that the expandable distal end portion can separate along the weakened portions to transform from a closed state to an open state. A distal end of the weakened portion can be spaced from a distal end of the shaft. At least a portion of the weakened portion can have an orientation at an angle relative to the distal end of the shaft, including being perpendicular or substantially perpendicular to the distal end of the shaft. In some instances, the weakened portion can extend along a portion of the expandable distal end portion and be parallel or substantially parallel to a longitudinal axis of the shaft. In some instances, the one or more expandable access sheaths described herein can be used in combination with one or more introducers as described herein.
Methods and structures disclosed herein for treating a patient also encompass analogous methods and structures performed on or placed on a simulated patient, which is useful, for example, for training; for demonstration; for procedure and/or device development; and the like. The simulated patient can be physical, virtual, or a combination of physical and virtual. A simulation can include a simulation of all or a portion of a patient, for example, an entire body, a portion of a body (e.g., thorax), a system (e.g., cardiovascular system), an organ (e.g., heart), or any combination thereof. Physical elements can be natural, including human or animal cadavers, or portions thereof; synthetic; or any combination of natural and synthetic. Virtual elements can be entirely in silica, or overlaid on one or more of the physical components. Virtual elements can be presented on any combination of screens, headsets, holographically, projected, loud speakers, headphones, pressure transducers, temperature transducers, or using any combination of suitable technologies.
Any of the various systems, devices, apparatuses, etc. in this disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise sterilization of the associated system, device, apparatus, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).
The term “associated with” is used herein according to its broad and ordinary meaning. For example, where a first feature, element, component, device, or member is described as being “associated with” a second feature, element, component, device, or member, such description should be understood as indicating that the first feature, element, component, device, or member is physically coupled, attached, or connected to, integrated with, embedded at least partially within, or otherwise physically related to the second feature, element, component, device, or member, whether directly or indirectly.
In some cases, the introducer 102 is used in cooperation with the access sheath 104 to advance and/or insert the access sheath 104 into the desired anatomy. In some instances, the introducer 102 can be received by and/or preloaded within the access sheath 104, including while the access sheath 104 is advanced and/or inserted into the desired anatomy. For example, the introducer 102 and the access sheath 104 can be arranged in the configuration shown in
In examples, the introducer 102 and the access sheath 104 can be sized such that the devices, such as the introducer 102 and the access sheath 104, form a relatively tight fit to each other, which can provide support to each other and/or an atraumatic structure. For example, the inner diameter of the access sheath 104 and an outer diameter of the introducer 102 can be dimensioned to be relatively close or the same (e.g., within a threshold amount to each other). In a few non-limiting illustrative examples, an inner diameter of an unexpanded access sheath 104 can be about 6 French (F), about 8 French (F), about 10 French (F), about 12 French (F), or about 14 French (F), while an outer diameter of the introducer 102 can be about 6 French (F), about 8 French (F), about 10 French (F), 12 French (F), or about 14 French (F) and an outer diameter of the expansion feature 106 can be about 10 French (F), about 12 French (F), about 14 French (F) about 16 French (F), about 18 French (F), about 20 French (F), or about 22 French (F). However, any dimensions can be used. In some instances, the access sheath 104 can be sized with the smallest inner diameter and/or the most rigid structure at the distal end of the access sheath 104. The relatively tight fit of the introducer 102 and the access sheath 104 can assist in providing the access sheath 104 with additional structure and/or support when the access sheath 104 is advanced into the desired anatomy. Further, this fit can provide an atraumatic tip for the access sheath 104 (e.g., at the transition of the introducer 102 to the access sheath 104, such as when the introducer 102 is received by and/or preloaded within the access sheath 104, including when the introducer 102 and the access sheath 104 are coupled together).
The access sheath 104 can be elastically and/or temporarily deformable and/or expandable or permanently deformable and/or expandable. In examples, an elastically and/or temporarily deformable and/or expandable access sheath can refer to an access sheath that seeks to maintain an initial inner diameter and/or dimension when an external force is removed. Whereas a permanently deformable and/or expandable access sheath can refer to an access sheath that seeks to maintain an expanded inner diameter and/or dimension until an external force is applied to the access sheath. In some cases, the access sheath 104 includes one or more permanently expandable portions and one or more temporarily and/or elastically expandable portions.
In examples herein, the introducer 102 is discussed in the context of expanding and/or stretching the access sheath 104. Such process can generally include changing one or more properties and/or characteristics of the access sheath 104. For example, when the access sheath 104 is implemented as a permanently expandable sheath, translation of the introducer 102 through the access sheath 104 can change the access sheath 104 from a collapsed and/or non-expanded state having a first inner diameter to an expanded state having a second larger inner diameter. Alternatively, when the access sheath 104 is implemented as a temporarily expandable sheath, translation of the introducer 102 through the access sheath 104 can cause an elasticity and/or stiffness characteristic and/or property of the access sheath 104 to change, such that the access sheath 104 is more malleable and/or deformable after the translation. This can occur in addition to the temporary expansion of a particular section of the access sheath 104 as the introducer 102 passes through the access sheath 104. For example, respective portions of the access sheath 104 can become more malleable and/or deformable after the introducer 102 is advanced through the lumen adjacent to the respective portions. In any case, the introducer 102 can be used to temporarily or permanently expand and/or stretch the access sheath 104, thereby preparing the access sheath 104 for advancement of a medical instrument. For example, a stretched and/or expanded access sheath can allow a medical instrument (which may have a relatively fragile structure) to be pushed and/or advanced through the access sheath and/or beyond the distal end of the access sheath with a relatively small push force, reducing, minimizing, or preventing harm to the patient, medical instrument, and/or access sheath.
Although various examples are illustrated and/or discussed herein in the context of cylindrical introducers and/or sheaths, the introducers and/or sheaths can be implemented in other forms.
The expansion feature 106 can allow an access sheath (not shown) to be expanded in phases. For example, if the introducer 102 is distally translated through an access sheath, the expansion feature 106 can incrementally expand the access sheath as the introducer 102 moves through the access sheath. By incrementally expanding and/or stretching the access sheath, the push and/or pull force that is needed to move the introducer 102 can be reduced (in comparison to other solutions), since the friction is greatest at the expansion feature 106, which may be short relative to the length of the access sheath 104 and/or introducer 102. In some cases, one or more dimensions of the expansion feature 106 can be designed to provide the desired push and/or pull force on the introducer 102 when axially moving the introducer 102 through access sheath. For example, an axial length of the expansion feature 106, an outer diameter of the expansion feature 106, a length of tapering at the beginning or end of the expansion feature 106, and/or other dimensions of the expansion feature 106 can be configured to satisfy the appropriate requirements.
The expansion feature 106 can be implemented in a variety of manners. Referring again to
In another example, the expansion feature 106 can be implemented with a balloon 106(B) attached to the elongate shaft of the introducer 102. In some instances, the balloon 106(B) can be disposed around the elongate shaft 220 of the introducer 102. The balloon 106(B) can be inflated and/or deflated with a fluid and/or gas via a tube/channel 214 that is connected to the balloon 106(B). For example, the tube/channel 214 can be in fluid communication with the balloon 106(B) such that fluid and/or gas can be delivered to or withdrawn from the balloon 106(B) for inflating or deflating the balloon 106(B), respectively. The balloon 106(B) can be implemented with a variety of materials to facilitate expansion and/or deflation. The balloon 106(B) is illustrated in a non-expanded form at 106(B)(1) and illustrated in an expanded form at 106(B)(2). In a non-expanded form, the balloon 106(B) can be relatively tight to the elongate shaft of the introducer 102 such that the balloon 106(B) has the same or substantially the same outer diameter as the elongate shaft. For example, the balloon 106(B) can assume a low profile while in the non-expanded form such that an outer diameter of the balloon 106(B) can be the same or similar to that of the elongate shaft 220.
In a further example, the expansion feature 106 can be implemented with a section 106(C) that includes a different type of material than the rest of and/or neighboring sections of, the elongate shaft of the introducer 102. For instance, the section 106(C) can be formed of a material that is more deformable, malleable, and/or compressible than an adjacent section of the introducer 102, including an adjacent portion of the elongate shaft 220. The section 106(C) can be formed of a softer material than an adjacent section. A pull wire/elongate movement member 216 can be coupled to a portion of the introducer 102, including a portion of the expansion feature 106, or a portion of the introducer 102 distal of the expansion feature 106, including a portion of the elongate shaft 220 distal of the section 106(C). In some instances, the pull wire/elongate movement member 216 can be attached to a distal side of the section 106(C). In some instances, the pull wire/elongate movement member 216 can be coupled to a portion of the introducer 102 distal of the section 106(C), including a distal end of the introducer 102. The pull wire/elongate movement member 216 can extend through the elongate shaft of the introducer 102, such as through the lumen 206 or a dedicated lumen. The pull wire 216 can be actuated/pulled proximally to deform the section 106(C) in a radially direction (e.g., expanding the section 106(C)). Although a different type of material is discussed in the context of the section 106(C), any of the implementations 106(A)-106(E) can include a different type of material than other portions of the introducer 102.
In yet another example, the expansion feature 106 is implemented with a braided/stent/mesh section 106(D) that is configured to radially expand when a force is exerted on the braided section 106(D). For instance, a pull wire/elongate movement member 218 can be coupled to a portion of the introducer 102, including a portion of the expansion feature 106, or a portion of the introducer 102 distal of the expansion feature 106. In some instances, the pull wire/elongate movement member 218 can be attached to a portion of the elongate shaft 220 distal of the braided section 106(D). In some instances, the pull wire/elongate movement member 216 can be attached to a distal side of the braided section 106(D). In some instances, the pull wire/elongate movement member 218 can be coupled to a portion of the introducer 102 distal of the braided section 106(D), including a or distal end of the introducer 102. The pull wire/elongate movement member 218 can extend through the elongate shaft of the introducer 102, such as through the lumen 206 or a dedicated lumen. The pull wire 218 can be actuated and/or pulled proximally to radially expand the braided section 106(D). In particular, the braided section 106(D) can be compressed using the pull wire 218 (e.g., in a similar manner as that discussed above for the ribs 106(A)) to cause the braided section 106(D) to enlarge the outer diameter and/or dimension of the braided section 106(D). The braided section 106(D) is illustrated in a non-expanded form at 106(D)(1) and illustrated in an expanded form at 106(D)(2). In a non-expanded form, the braided section 106(D) can include the same or substantially the same outer diameter as adjacent portions of the elongate shaft of the introducer 102. In some instances, the braided section 106(D), while in the non-expanded form, can include the same or substantially the same outer diameter as the rest of the elongate shaft of the introducer 102. The braided section 106(D) can be implemented with a mesh-like form using a variety of materials, such as a polymer, a metal, etc.
Although various examples are discussed in the context of using a pull wire to enable and/or actuate an expansion feature, a rigid elongate shaft can additionally, or alternatively, be implemented, such as by pushing and/or pulling the rigid elongate shaft to deform/form the expansion feature.
In an additional example, the expansion feature 106 can be implemented as a fixed feature 106(E) (sometimes referred to as “the fixed-form expansion feature 106(E)”) along the elongate shaft 220 of the introducer 102. For instance, the fixed expansion feature 106(E) can be formed by extruding a material onto or along with the manufacturing of the elongate shaft 220 of the introducer 102 (e.g., through a reflow or melt process), molding the elongate shaft 220 with the feature 106(E), attaching and/or fastening one or more elements to the elongate shaft 220 (e.g., using an adhesive, mechanical fastener, soldering material, or another fastening mechanism to attach a larger diameter shaft to the elongate shaft 220 of the introducer 102), or otherwise forming a fixed feature on the elongate shaft 220. The fixed expansion feature 106(E) can be a separate component from the elongate shaft 220 of the introducer 102 or integral with the elongate shaft 220. The fixed expansion feature 106(E) includes a first tapered section at a distal portion and a second tapered section at a proximal portion, wherein the tapered sections provide a smooth transition to the fixed expansion feature 106(E). However, the fixed expansion feature 106(E) can be implemented with a more abrupt transition to the elongate shaft. In some cases, the fixed expansion feature 106(E) is referred to as “a radially-protruding bump.”
The implementations 106(A)-106(D) (and other implementations discussed herein) can be referred to as active/articulable expansion features that can be selectively enabled/disabled, such as by actuating a pull wire, providing fluid and/or gas, etc. As such, these implementations can be independently controlled (e.g., separate from the movement of the introducer 102). An active expansion feature can be enabled/radially expanded while the expansion feature is positioned at a particular location, such as within a particular portion of an access sheath, extended out a distal end of an access sheath, etc. In contrast, the implementation 106(E) (and other implementations discussed herein) can be referred to as non-active, non-articulable, and/or fixed expansion feature that is generally fixed in the same form (e.g., is not activated by some form of manipulation and/or actuation).
The introducer 102 can include a variety of materials, such as a polymer, a metal, etc. In some examples, the expansion feature 106 includes a different type of material than the rest of the introducer 102. While in other examples, the expansion feature is implemented with the same type of material.
Although the introducer 102 is illustrated with a single expansion feature, the introducer 102 can include multiple expansion features. For example, the introducer 102 can include a first expansion feature positioned a distance from the distal end 202 and a second expansion feature positioned farther from the distal end 202. The first expansion feature can include a first outer diameter and/or dimension and the second expansion feature can include a second outer diameter and/or dimension, wherein the first outer diameter and/or dimension is smaller (or larger than) the second outer diameter and/or dimension. This can allow an access sheath to be expanded in phases.
The access sheath 104 can be implemented in a variety of forms. For example, as shown at 302 in
In the examples of
In examples, the tapered configuration of the access sheath 104, such as the elongate shaft 320, shown in
In some examples where the access sheath 104 is tapered, an introducer (e.g., an expansion introducer or non-expansion introducer) can be implemented with a tapered form to generally fit and/or match to the access sheath 104 when the introducer is positioned at a particular position relative to the access sheath 104, such as with a particular amount of the introducer extending beyond the distal end of the access sheath 104.
In this example, the inner diameter (ID) of the access sheath 104 may return to the same or substantially the same dimension as the initial inner diameter ID1 of the access sheath 104 (shown in
Referring to
In
Referring to
In examples, the distal end 306 of the access sheath 104 can be permanently or temporarily expanded to the inner diameter ID4 (as shown in
As shown in
In this example, the introducer hub 706 can be detachably coupled to a clip/locking member 708, which is configured to move axially within a space(s)/cavity 710 in the sheath hub 704. For example, the clip/locking member 708 can be translated proximally and distally within the space(s)/cavity 710. When the introducer hub 706 is coupled to the clip/locking member 708, the introducer hub 706 and the clip/locking member 708 can move together through the sheath hub 704 based on the axial constraints of the space(s)/cavity 710. For example, an arm 708(A) of the clip/locking member 708 can slide, such as translating proximally and/or distally, within the space(s)/cavity 710 between positions 710(A) and 710(B), while an arm 708(B) can slide, such as translating proximally and/or distally, within the space(s)/cavity 710 between positions 710(D) and 710(C).
The sheath hub 704 can be configured to release and/or unlatch the introducer hub 706 from the clip/locking member 708 when the clip/locking member 708 is positioned at a distal end of the space(s)/cavity 710. For example, the space(s)/cavity 710 can be tapered to pinch and/or move the arms 708(A) and 708(B) radially inward (e.g., closer together) as the clip/locking member 708 is distally moved to the positions 710(B) and 710(C). When the arms 708(A) and 708(B) are positioned at 710(B) and 710(C), respectively, portions/clip members 708(C) and 708(D) of the clip/locking member 708 can release the introducer hub 706 (e.g., open and/or move radially outward to detach from the introducer hub 706). For instance, the arm 708(A) can be actuated and/or leveraged to control motion of the portion 708(C), while the arm 708(B) can be actuated and/or leveraged to control motion of the portion 708(D).
The space(s)/cavity 710 can include stopping features (e.g., lips, ridges, designated cavities, and/or another locking feature) at the positions 710(B) and 710(C) to prevent the arms 708(A) and 708(B) from moving proximally once the stopping features are reached. That is, the arms 708(A) and 708(B) can be held/remain fixed at the positions 710(B) and 710(C) when such positions are reached. This can allow the introducer hub 706 to be released from the clip/locking member 708 and the introducer 102 to be pulled out of the access sheath 104.
In examples, the length of the space(s)/cavity 710 and/or length of the clip/locking member 708 can be correlated to the length of the introducer 102 and/or access sheath 104 and/or a position of the expansion feature 106 on the introducer 102, such that the expansion feature 106 of the introducer 102 extends beyond the distal end 306 of the access sheath 104 when the clip/locking member 708 is positioned at the distal end of the space(s)/cavity 710 (e.g., the positions 710(B) and 710(C)). As such, the introducer hub 706 can disengage from the clip/locking member 708 when the introducer 102 is translated distally within the access sheath 104 by more than a threshold distance. The threshold distance can be associated with and/or correlated to the length of the introducer 102, the length of the access sheath 104, a position of the expansion feature 106 (e.g., relative to the proximal and/or distal end of the introducer 102, relative to the introducer hub 706, etc.), the length of the space(s)/cavity 710, and/or length of the clip/locking member 708.
In the example of
Although a particular structure is illustrated for the locking mechanism 702, the locking mechanism 702 can be implemented in a variety of other manners. For example, the locking mechanism can be implemented as a cinch mechanism, such as a Tuohy Borst, collet, set screw, cam, and/or another element in the sheath hub 704 and/or the introducer hub 706.
At block 804, the process 800 includes advancing an access sheath into the anatomy. For example, as shown in images 904A and 904B, a distal portion of the access sheath 104 can be advanced and/or inserted into the blood vessel 901. The access sheath 104 can be coupled to an introducer 102/903 and advanced into the blood vessel 901 with the introducer 102/903 disposed therein. The introducer 102/903 can provide an atraumatic edge/point for inserting the access sheath 104 into the blood vessel 901. The access sheath 104 can be advanced into the patient such that at least the distal end of the access sheath 104 is located within the blood vessel 901. This can create a port and/or access point into the blood vessel 901 (e.g., for a therapy/delivery device to access the blood vessel 901), as discussed in further detail below.
In one example, as shown in image 904A, the access sheath 104 can be advanced with a non-expansion type introducer 903, which is free from an expansion feature. For example, the introducer 903 can include a straight or tapered form introducer that is generally not configured to expand the access sheath 104. Here, the introducer 903 can be inserted into the access sheath 104 outside the patient, such that the distal end portion of the introducer 903 extends beyond the distal end of the access sheath 104 (in the configuration shown in the image 904A). The combined/coupled introducer 903 and the access sheath 104 can then be inserted into the blood vessel 901. In some cases, the introducer 903 is used with the access sheath 104 to insert the distal end of the access sheath 104 into the blood vessel 901, the introducer 903 is removed from the access sheath 104, and an expansion-feature introducer is advanced through the access sheath 104 to expand the access sheath 104.
In another example, as shown in image 904B, the access sheath 104 can be advanced into the anatomy with the introducer 102 that includes an expansion feature. For example, the introducer 102 can be inserted into the access sheath 104 outside the patient, such that the distal end portion of the introducer 102 extends beyond the distal end of the access sheath 104 (in the configuration shown in the image 904B). The combined/coupled introducer 102 and the access sheath 104 can then be inserted into the blood vessel 901, so that at least the distal end of the access sheath 104 is disposed in the blood vessel 901.
In one example, as shown in image 906A, the introducer 102 is implemented with a fixed and/or non-active expansion feature. The access sheath 104 is expanded by inserting and/or advancing the introducer 102 farther into the access sheath 104. This can expand at least a distal end portion of the access sheath 104 and/or other portions of the access sheath 104. Although discussed in the context of advancing the introducer 102 with the fixed expansion feature, the introducer 102 can alternatively, or additionally, be retracted through the access sheath 104.
In another example, as shown in image 906B, the introducer is implemented with an active and/or articulable expansion feature, wherein the expansion feature is enabled to expand a portion of the access sheath 104. In the illustrated example, the introducer 102 is translated distally such that the expansion feature extends beyond the distal end of the access sheath 104. The expansion feature is then enabled and/or activated on the introducer 102, such as by pulling a pull wire proximally to expand the expansion feature. The introducer 102 can then be retracted through the access sheath 104 to expand the access sheath 104. In other examples, the expansion feature is enabled while the expansion feature is located within the access sheath 104. Here, the introducer 102 can then be translated proximally and/or distally to expand the access sheath 104.
At block 810, the process 800 includes advancing a medical instrument through the access sheath. For example, as shown in image 910, a medical instrument 911 can be advanced through the access sheath 104 once the introducer 102 has been removed from the access sheath 104. The medical instrument 911 can include a delivery catheter and/or any other type of delivery/therapy device may be used in a medical procedure. In examples, the medical instrument 911 is navigated through the blood vessel 901 and/or other anatomy along the wire/guidewire 712 to reach a target location/anatomical feature.
In some illustrations, the process 800 is performed to deliver a prosthetic device to a target location, perform a therapy at the target location, and so on. For instance, the access sheath 104 can be inserted into an artery or vein to provide an access point for a delivery catheter or other therapy device to enter into the artery or vein. The access sheath 104 can be introduced into the artery or vein with a relatively small profile and/or diameter to prevent damage to the patient and/or access sheath 104. The introducer 102 can be then used to dilate and/or expand the access sheath 104. The introducer 102 can then be removed and a medical instrument can be inserted through the access sheath 104 and through the artery or vein to a target location to deploy a medical device, perform a therapy at the target location, etc. This can allow the access sheath 104 to be introduced into the artery or vein in a relatively small form and the access sheath 104 to be expanded when needed to provide larger access for the medical instrument. This can reduce, minimize, or prevent damage to the patient's tissue and/or reduce or minimize the push force needed to push the therapy device through the access sheath 104. Further, in some cases where the access sheath 104 is elastically expandable, the access sheath 104 can retract back to a smaller inner diameter once the expansion feature of the introducer 102, medical instrument, and/or other device passes through the access sheath 104. This can provide greater blood flow through the artery or vein during the procedure, since the access sheath 104 is only temporarily larger during device insertion.
Medical access sheaths comprising expandable distal end portions are often used in minimally invasive procedures to facilitate delivery of medical devices. A medical access sheath comprising an expandable distal end portion can be inserted into a vessel, lumen and/or chamber prior to advancement therethrough of a delivery catheter and/or medical device. The expandable distal end portion can be kept in a closed and/or folded state while being advanced through an anatomical pathway. The expandable distal end portion of the sheath can subsequently assume an open and/or expanded state to allow passing of the delivery catheter and/or medical device through the expandable distal end portion.
Referring to
As described herein, the expandable distal end portion 1114 of the shaft 1110 can be configured to be in the open state and the closed state. While the expandable distal end portion 1114 is in the closed state, a medial portion 1140 of the cord 1104 can be configured to be positioned around a circumferential portion of the expandable distal end portion 1114. Remaining portions of the cord 1104 can extend from around the circumferential portion through the side shaft opening 1118 on the shaft 1110 and into the shaft delivery lumen 1116. For example, the cord 1104 can comprise a first cord tail portion 1142 and a second cord tail portion 1144. The medial cord portion 1140 can be between the first and second cord tail portions 1142, 1144. In some instances, while the expandable distal end portion 1114 is in the closed state, the medial cord portion 1140 can be configured to be disposed around a circumferential portion of the expandable distal end portion 1114. The medial cord portion 1140 can be disposed around a circumferential portion of the expandable distal end portion 1114 that is externally oriented such the first and second cord tail portions 1142, 1144 can pass from an external surface 1126 of the shaft 1110 through the side shaft opening 1118 into the shaft delivery lumen 1116. The first and second cord tail portions 1142, 1144 can be configured to extend through the side shaft opening 1118 on the expandable distal end portion 1114 of the shaft 1110, into the shaft delivery lumen 1116 and extend proximally along at least a portion of the shaft delivery lumen 1116 such that an operator can manipulate a proximal portion 1146, 1148 of each of the first and second cord tail portions 1142, 1144. Corresponding portions of the first and second cord tail portions 1142, 1144 can be disposed along the portion of the shaft delivery lumen 1116 proximal of the side shaft opening 1118. In some instances, corresponding portions of the first and second cord tail portions 1142, 1144 can be disposed through at least a portion of the hub delivery lumen 1156. The first and second cord tail portions 1142, 1144 can extend proximally from the shaft delivery lumen 1116 into the hub delivery lumen 1156, and along at least a portion of the hub delivery lumen 1156. In some instances, the proximal portions 1146, 1148 of the first and second cord tail portions 1142, 1144 can be coupled to and/or secured to the hub 1150 while the expandable distal end portion 1114 is in the closed state or the open state. Securing the proximal portions 1146, 1148 of the first and second cord tail portions 1142, 1144 to the hub 1150 can facilitate maintaining the expandable distal end portion 1114 in the closed state or the open state.
The medial portion 1140 of the cord 1104 can be disposed around a circumferential portion of the expandable distal end portion 1114 proximal of the distal end 1122 of the shaft 1110. In some instances, the circumferential portion can be at about a medial portion along a longitudinal dimension of the expandable distal end portion 1114. In some instances, the longitudinal dimension can be parallel or substantially parallel to a longitudinal axis of the shaft 1110. Alternatively, the longitudinal dimension can be a longitudinal dimension along an externally oriented surface of the expandable distal end portion 1114. For example, the longitudinal dimension can extend between a proximal end 1130 and a distal end 1128 of the expandable distal end portion 1114. The distal end 1128 of the expandable distal end portion 1114 can be the distal end 1122 of the shaft 1110. The circumferential portion can be at about midway between the proximal end 1128 and the distal end 1130 of the expandable distal end portion 1114. The circumferential portion can be at a position on the expandable distal end portion 1114 that facilitates maintaining the expandable distal end portion 1114 in the closed state while the cord 1104 is tensioned.
In some instances, at least a portion of the medical access sheath 1102, including at least a portion of the shaft 1110, can be inserted into an anatomical vessel and/or lumen and advanced along an anatomical pathway while the expandable distal end portion 1114 is in the closed state. In some instances, while the shaft 1110 is advanced to a target site, tension can be maintained in the cord 1104 to facilitate maintaining the expandable distal end portion 1114 in the closed state. In some instances, the proximal portions 1146, 1148 of the first and second cord tail portions 1142, 1144 can be secured to the hub 1150 to maintain desired tension on the cord 1104, including tensioning of the first and second cord tail portions 1142, 1144 such that the expandable distal end portion 1114 remains in the closed state.
The expandable distal end portion 1114 can expand and/or unfold to transform the expandable distal end portion 1114 to the open state. In some examples, the expandable distal end portion 1114 can comprise a plurality of folds and/or pleats. The expandable distal end portion 1114 can comprise a folded configuration in the closed state. The plurality of folds and/or pleats can unfold such that the expandable distal end portion 1114 can assume the open state.
Referring to
The cord 1104 can remain while the introducer 1160 is advanced to its desired position. The first and second cord tail portions 1142, 1144 can remain in the shaft delivery lumen 1116. In some instances, while the expandable distal end portion 1114 is in the open state, proximal portions 1146, 1148 of the first and second cord tail portions 1142, 1144 can be secured to the hub 1150. The cord 1104 can be tensioned to facilitate transforming the expandable distal end portion 1114 to the closed state from the open state. For example, an operator can pull on the cord 1104, such as proximal portions 1146, 1148 of the first and second cord tail portions 1142, 1144, to facilitate folding of the expandable distal end portion 1114 so as to transform the expandable distal end portion 1114 from the open state to the closed state. In some instances, the expandable distal end portion 1114 can be transformed to the closed state before the medical access sheath is retracted. The expandable distal end portion 1114 can be maintained in the closed state while the medical access sheath 1102 is retracted and withdrawn. For example, after the expandable distal end portion 1114 assumes the closed state, the cord 1104 can be kept in a tensioned state to facilitate maintaining the expandable distal end portion 1114 in the closed state.
The medical access sheath 1202 can have one or more features of the medical access sheath 1102. For example, the expandable access sheath 1202 can comprise a hub 1250. The shaft 1210 can be disposed distally of the hub 1250. A proximal portion 1212 of the shaft 1210 can be associated with a distal end 1254 of the hub 1250, for example being coupled to the distal end 1254 of the hub 1250. The shaft 1210 can extend distally from the hub 1250, for example from the distal end 1254 of the hub 1250. The expandable access sheath 1202 can comprise a sheath delivery lumen 1206 extending therethrough and configured to allow advancement therethrough of a medical device and/or delivery catheter configured to carry the medical device. The sheath delivery lumen 1206 can comprise a hub delivery lumen 1256 extending through the hub 1250, and a shaft delivery lumen 1216 extending through the shaft 1210 and in fluid communication with and/or be coaxial with the hub delivery lumen 1256.
The cord 1204 can comprise a medial portion 1240 configured to be disposed around a circumferential portion of the expandable distal end portion 1214. The cord 1204 can comprise a first and a second cord tail portion 1242, 1244, the medial cord portion 1240 being between the first and second cord tail portions 1242, 1244. The first and second cord tail portions 1242, 1244 can pass from around the circumferential portion through a side shaft opening 1218 of a wall portion 1220 of the shaft 1210 and into the shaft delivery lumen 1216, extend proximally from the side shaft opening 1218 along the shaft delivery lumen 1216 to facilitate manipulation of the cord 1204 by an operator. While the expandable distal end portion 1214 is in the closed state, proximal portions 1246, 1248 of the first and second cord tail portions 1242, 1244 can be secured to the expandable access sheath 1202, including the hub 1250 to maintain tension in the cord 1204. In some instances, the first and second cord tail portions 1242, 1244 can comprise portions, including proximal portions 1246, 1248, disposed proximally of a proximal end 1252 of the hub 1250, such as to facilitate securing the first and second cord tail portions 1242, 1244 to the hub 1250 and/or manipulation by the operator. Tension in the cord 1204 can be relaxed to allow transformation of the expandable distal end portion 1214 from the closed state to the open state.
Referring to
It will be understood that although the shafts of
In some instances, an introducer can be preloaded within an expandable access sheath. For example, at least a portion of the introducer can be disposed within the expandable access sheath while the expandable access sheath is advanced along an anatomical pathway to a target location.
Referring to
The introducer 1360 can comprise the central lumen 1372 extending along at least a portion thereof. For example, the central lumen 1372 can extend from a proximal end 1366 to a distal portion 1364 of the introducer 1360. The first and the second side introducer opening 1370a, 1370b can be on the distal portion 1364 of the introducer 1360. The side introducer openings 1370a, 1370b can extend through a wall portion 1374 of the introducer 1360 such that the side introducer openings 1370a, 1370b are in fluid communication with the central lumen 1372. While the expandable distal end portion 1314 is in the closed state, at least a portion of the introducer 1360 can be configured to be slidably received within the shaft delivery lumen 1316 such that the side introducer openings 1370a, 1370b can be configured to be within the shaft delivery lumen 1316. In some instances, the side introducer openings 1370a, 1370b and the side shaft openings 1318a, 1318b can be aligned with one another while the expandable distal end portion 1314 is in the closed state, such as while the introducer 1360 is preloaded within the within the expandable access sheath 1302. For example, the first side shaft opening 1318a can be aligned with the first side introducer opening 1370a, and the second side shaft opening 1318b can be aligned with the second side introducer opening 1370b.
The cord 1304 can comprise a medial portion 1340 between a first and second cord tail portion 1342, 1344. The medial cord portion 1340 can be configured to be disposed around the circumferential portion of the expandable distal end portion 1314 while the expandable distal end portion 1314 is in the closed state. Remaining portions of the cord 1304 can pass from around the circumferential portion through the side shaft openings 1318a, 1318b and the side introducer openings 1370a, 1370b, into the central lumen 1372 and extend proximally from the side introducer openings 1370a, 1370b along the central lumen 1372 to facilitate manipulation of the cord 1304 by an operator. The first cord tail portion 1342 can be disposed through the first side shaft opening 1318a and the first side introducer opening 1370a. The second cord tail portion 1344 can be disposed through the second side shaft opening 1318b and the second side introducer opening 1370b. Respective portions of the first and second cord tail portions 1342, 1344 can be disposed along at least a portion of the central lumen 1372 of the introducer 1360. The cord 1304 can be tensioned to facilitate maintaining the expandable distal end portion 1314 in the closed state. Tension in the cord 1304 can be relaxed to allow transformation of the expandable distal end portion 1314 from the closed state to the open state. Proximal portions 1346, 1348 of the first and second cord tail portions 1342, 1344 can extend proximally from a proximal end 1366 of the introducer 1360 to facilitate manipulation thereof by an operator. For example, a proximal portion 1362 of the introducer 1360 can be disposed proximally of a proximal end 1352 of the hub 1350 and proximal portions 1346, 1348 of the first and second cord tail portions 1342, 1344 can be disposed proximally of the proximal end 1366 of the introducer 1360.
The circumferential portion around which the medial cord portion 1340 is disposed can be at a position that facilitates maintaining the expandable distal end portion 1314 in the closed state while the cord 1304 is tensioned. In some instances, the position of the circumferential portion can be at about a medial portion along a longitudinal dimension of the expandable distal end portion 1314. In some instances, the longitudinal dimension can be parallel or substantially parallel to a longitudinal axis of the shaft 1310. Alternatively, the longitudinal dimension can be a longitudinal dimension along an externally oriented surface of the expandable distal end portion 1314. For example, the longitudinal dimension can extend between a proximal end 1330 and a distal end 1328 of the expandable distal end portion 1314. The distal end 1330 of the expandable distal end portion 1314 can be the distal end 1322 of the shaft 1310. The circumferential portion can be at about midway between the proximal end 1330 and the distal end 1328 of the expandable distal end portion 1314.
In some instances, the introducer 1360 can be translated distally relative to the expandable access sheath 1302 to open the expandable distal portion 1314. For example, advancing the distal portion 1364 of the introducer 1360 through the distal opening 1324 and disposing the distal portion 1364 distally of the distal end 1322 of the shaft 1310 can cause the expandable distal end portion 1314 to expand and/or unfold. Referring to
The medical access system 1400 can comprise one or more other features of the medical access system 1300 described with reference to
The cord 1404 can comprise a medial portion 1440 between a first and second cord tail portion 1442, 1444. The medial cord portion 1440 can be configured to be disposed around the circumferential portion of the expandable distal end portion 1414 while the expandable distal end portion 1414 is in the closed state. The first cord tail portion 1442 can pass from around the circumferential portion through the first side shaft opening 1418a and the first side introducer opening 1470a into the central lumen 1472. The second cord tail portion 1444 can pass from around the circumferential portion through the second side shaft opening 1418b and the second side introducer opening 1470b into the central lumen 1472. Respective portions of the first and second cord tail portions 1442, 1444 can be disposed along at least a portion of the central lumen 1472 of the introducer 1460. Proximal portions 1446, 1448 of the first and second cord tail portions 1442, 1444 can extend proximally from a proximal end 1466 of the introducer 1460 to facilitate manipulation thereof by an operator. For example, a proximal portion 1462 of the introducer 1460 can be disposed proximally of a proximal end 1452 of the hub 1450 and proximal portions 1446, 1448 of the first and second cord tail portions 1442, 1444 can be disposed proximally of the proximal end 1466 of the introducer 1460.
Referring to
It will be understood that although the shafts of
In block 1504, the process can involve inserting at least a portion of the shaft into a bodily lumen while the expandable distal end portion is in a closed state. While the expandable distal end portion is in the closed state, the medial cord portion can be disposed around a circumferential portion of the expandable distal end portion. The first and second cord tail portions can extend through a respective one of the first and second side shaft openings. For example, corresponding portions of the first and second cord tail portions can be disposed within the shaft delivery lumen.
In block 1506, the process can involve maintaining tension in the cord. The tension on the cord can be maintained so as to maintain the expandable distal end portion in the closed state. In some instances, the expandable distal end portion can be maintained in the closed state while the expandable distal end portion is advanced along an anatomical pathway to a target site.
In block 1508, the process can involve reducing the tension on the cord to allow the expandable distal end portion to assume an open state. For example, reducing tension on the cord can allow the expandable distal end portion to expand and/or unfold such that a portion of at least one of the first and second cord tail portions can be positioned over the circumferential portion of the expandable distal end portion.
In some instances, the cord can be removed after the expandable distal end portion assumes the open state. In some instances, the cord can be removed to facilitate allowing the expandable distal end portion to assume the open state. In some instances, the process can involve passing the medial cord portion and then the second tail cord portion through the first and second side shaft openings and into the shaft delivery lumen, as the first tail cord portion is translated proximally to remove the cord and allow the expandable distal end portion to assume the open state. In some instances, the process can involve passing the medial cord portion and then the first tail cord portion through the first and second side shaft openings and into the shaft delivery lumen as the second tail cord portion is translated proximally to remove the cord and allow the expandable distal end portion to assume the open state.
In some instances, an introducer can be provided that is at least partially received in the shaft delivery lumen of the shaft. The introducer can comprise a central lumen extending therethrough. A first side introducer opening and second side introducer opening can be on a portion of the introducer, including on a distal portion of the introducer. The first and second side introducer openings can be in fluid communication with the central lumen. In some instances, while the expandable distal end portion is advanced to a target site, the introducer can be preloaded within the expandable access sheath. For example, at least a portion of the introducer can be received within the shaft delivery lumen. A portion of the distal portion of the introducer, including a distal end of the introducer, can be disposed distally of a distal end of the shaft while the introducer is preloaded within the delivery lumen of the expandable access sheath. The first and second side introducer openings can be disposed within the shaft delivery lumen. For example, the first and second cord tail portions can extend through a respective one of the first and second side shaft openings and then a respective one of the first and second side introducer openings. Corresponding portions of the first and second cord tail portions can extend along the central lumen of the introducer. For example, corresponding portions of the first and second cord tail portions can be disposed with the portion of the central lumen proximal of the first and second side introducer openings.
In some instances, the introducer can be translated proximally relative to the expandable access sheath to withdraw the introducer from within the delivery lumen of the expandable access sheath. For example, the introducer can be translated proximally relative to the expandable access sheath to withdraw the introducer from within the shaft delivery lumen. The introducer can be further translated proximally relative to the expandable access sheath to withdraw the introducer from within the hub delivery lumen. While the introducer is translated proximally, the first and second side introducer openings can slide proximally along at least a portion of the first and second cord tail portions extending through the delivery lumen of the expandable access sheath, such as the shaft delivery lumen and/or hub delivery lumen. The cord can remain in place while the introducer is withdrawn from the expandable access sheath. For example, the medial cord portion can remain around the circumferential portion of the expandable distal end portion while the introducer is translated proximally.
In some instances, the cord can be removed from the expandable access sheath before the introducer is withdrawn. In some instances, the cord can be removed from the expandable access sheath to facilitate transformation of the expandable distal end portion to the open state. For example, the process can involve passing the medial cord portion and then the second tail cord portion through the first and second side shaft openings and the first and second side introducer openings and the central lumen as the first tail cord portion is translated proximally to remove the cord and allow the expandable distal end portion to assume the open state. Alternatively, the process can involve passing the medial cord portion and then the first tail cord portion through the first and second side shaft openings and the first and second side introducer openings and the central lumen as the second tail cord portion is translated proximally to remove the cord and allow the expandable distal end portion to assume the open state.
In some instances, a position of the cord can be secured to facilitate maintaining the expandable distal end portion in the open state or the closed state. Proximal portions of the cord can be secured to a portion of the expandable access sheath. In some instances, the process can involve securing a proximal portion of the first tail cord portion and a proximal portion of the second tail cord portion to the hub of the expandable access sheath to maintain the expandable distal end portion in the closed state or the open state.
In some instances, leaving the cord in place after the expandable distal end portion assumes the open state can facilitate transformation of the expandable distal end portion back to the closed state before withdrawing the shaft from the patient. In some instances, the process can involve tensioning the cord to transform the expandable distal end portion of the shaft from the open state to the closed state. Tensioning the cord can cause a force to be exerted upon the circumferential portion of the expandable distal end portion, such as by the medial cord portion. Force exerted on the circumferential portion of the expandable distal end portion can lead to a reduction in a lateral cross-sectional size of a corresponding portion of the expandable distal end portion. For example, force exerted on the circumferential portion of the expandable distal end portion can cause the expandable distal end portion can transform back to the closed state. In some instances, the process can involve translating the shaft proximally to withdraw the shaft from the bodily lumen, such as after the expandable distal end portion assumes the closed state.
In some instances, at least a portion of a medical device can be advanced through the delivery lumen of the expandable access sheath. The medical device can be carried on and/or within a delivery catheter. For example, at least a portion of a delivery catheter configured to receive the medical device can be advanced through the shaft delivery lumen. In some instances, the delivery catheter can be first advanced through the shaft delivery lumen. The medical device can subsequently be deployed from the delivery catheter. For example, at least a portion of the medical device can be advanced through the delivery catheter to be deployed from the delivery catheter.
The expandable access sheath 1600 can comprise a sheath delivery lumen 1602 extending therethrough and configured to allow advancement of a medical device and/or delivery catheter configured to carry the medical device through the sheath delivery lumen 1602. The expandable access sheath 1600 can comprise a hub 1640 associated with a proximal portion 1612 of the shaft 1610. The proximal portion 1612 of the shaft 1610 can be coupled to the distal end 1644 of the hub 1640. The shaft 1610 can extend distally from the hub 1640, including from the distal end 1644 of the hub 1640. The shaft 1610 can comprise a shaft delivery lumen 1616 extending therethrough. The shaft delivery lumen 1616 can be in communication with and/or be coaxial with the hub delivery lumen 1646. The hub 1640 can comprise a hub delivery lumen 1646 extending therethrough, from a proximal end 1642 to a distal end 1644 thereof. The sheath delivery lumen 1602 can comprise the shaft delivery lumen 1616 and the hub delivery lumen 1646.
At least a portion of a medical instrument can be advanced through the sheath delivery lumen 1602 to facilitate transformation of the expandable distal end portion 1614 to the open state. Referring to
In some instances, the introducer 1660 can be configured to be preloaded within the expandable access sheath 1600. For example, at least a portion of the introducer 1660 can be disposed within the sheath delivery lumen 1602 while at least a portion of the shaft 1610 is advanced along an anatomical pathway to a target position. In some instances, a portion of the introducer 1660 can be disposed distally of a distal end 1618 of the shaft 1610 while the shaft 1610 is advanced to its target position. A portion of the introducer 1660 can be extending through a distal opening 1620 at the distal end 1618 of the shaft 1610. At least a portion of the distal portion 1664 of the introducer 1660, such as a distal end 1668 of the introducer 1660 can initially be distal of the distal end 1618 of the shaft 1610. In some instances, the introducer 1660 can be subsequently advanced distally relative to the expandable access sheath 1600 to facilitate pushing apart the plurality of pleats 1630. For example, after the shaft 1610 is at a desired position within the anatomical pathway, the introducer 1660 can be subsequently advanced distally relative to the expandable access sheath 1600 to facilitate unfolding of the expandable distal end portion 1614 to the open state.
Referring to
Referring to
In block 1904, the process can involve inserting the expandable distal end portion into a bodily vessel and/or lumen. At least a portion of the shaft can be advanced along an anatomical pathway.
In block 1906, the process can involve advancing at least a portion of a medical instrument through the shaft delivery lumen and out of the distal end opening of the shaft. For example, at least a portion of an introducer can be advanced through the shaft delivery lumen and out of the distal end opening such that a distal portion of the introducer can be disposed distally of the distal end opening.
In block 1908, the process can involve pushing apart the pair of pleat portions of the plurality of pleats as a portion of the medical instrument is advanced through the expandable distal end portion such that the expandable distal end portion can assume an open state. The pair of pleat portions configured to be oriented toward and attracted to one another while the plurality of pleats is in the folded configuration can be pushed apart as the portion of the medical instrument is advanced through a corresponding portion of the shaft delivery lumen extending through the expandable distal end portion to allow the expandable distal end portion to assume the open state. Advancing the portion of the medical instrument through the portion of the shaft delivery lumen extending through the expandable distal end portion can result in pushing apart of the plurality of pairs of pleat portions of the plurality of pleats. For example, advancing a portion of an introducer through the shaft delivery lumen, including disposing a distal portion of the introducer distally of the distal end opening, can result in pushing apart the plurality of pleats. Causing the circumferential portion of the expandable distal end portion to assume an opened state can comprise causing the plurality of pleats of the expandable distal end to unfold.
In some instances, advancing at least a portion of the medical instrument through the shaft delivery lumen can comprise advancing at least a portion of a medical device through the delivery lumen of the shaft. The medical device can be carried on and/or within a delivery catheter. For example, at least a portion of a delivery catheter configured to receive the medical device can be advanced through the shaft delivery lumen. In some instances, the delivery catheter can be first advanced through the shaft delivery lumen. The medical device can subsequently be deployed from the delivery catheter. For example, at least a portion of the medical device can be advanced through the delivery catheter for deployment from the delivery catheter.
As described herein, in some instances, pleat portions can comprise magnetic material. For example, pushing apart the pair of pleat portions can comprise pushing apart a pair of pleat portions each comprising magnetic material embedded therein. In some instances, the pleat portions can comprise electrostatic charges. For example, pushing apart the pair of pleat portions can comprise pushing apart a pair of pleat portions each comprising a surface portion having electrical charges thereon.
The expandable access sheath 2000 can comprise a sheath delivery lumen 2002 extending therethrough and configured to allow advancement of a medical device and/or delivery catheter configured to carry the medical device through the expandable access sheath 2000. The expandable access sheath 2000 can comprise a shaft 2010 and a hub 2040. The shaft 2010 can comprise a proximal portion 2012 associated with the hub 2040, such as a distal end 2044 of the hub 2040. The proximal portion 2012 can be coupled to the distal end 2044 of the hub 2040. The shaft can extend distally from the hub 2040, including from the distal end 2044 of the hub 2040. The shaft 2010 can comprise a shaft delivery lumen 2016 and the hub 2040 can comprise a hub delivery lumen 2046 extending from a proximal end 2042 to a distal end 2044 of the hub 2040. The sheath delivery lumen 2002 can comprise the shaft delivery lumen 2016 and the hub delivery lumen 2046. The shaft delivery lumen 2016 can be in communication with and/or be coaxial with the hub delivery lumen 2046.
The expandable distal end portion 2014 can comprise circumferential portion 2030 with the weakened joint 2032. The weakened joint 2032 can be integrated with and/or coupled to the circumferential portion 2030. In some instances, the circumferential portion 2030 and/or the weakened joint 2032 can be integrated with the expandable distal end portion 2014, including being embedded within and/or as a part of a wall portion of the expandable distal end portion 2014. For example, the circumferential portion 2030 can form a part of the side wall of the expandable distal end portion 2014. Alternatively, the circumferential portion 2030 can be disposed over an externally oriented surface of the expandable distal end portion 2014. For example, the circumferential portion 2030 can be disposed over and coupled to an externally oriented surface of a wall portion of the expandable distal end portion 2014.
The circumferential portion 2030 can be disposed around a circumferential portion proximal of a distal end 2018 of the shaft 2010. The position of the circumferential portion 2030 on the expandable distal end portion 2014 can be at or around a medial point along a longitudinal dimension of the expandable distal end portion 2014. In some instances, the longitudinal dimension can be parallel or substantially parallel to a longitudinal axis of the shaft 2010. In some instances, the longitudinal dimension can be a longitudinal dimension along an externally oriented surface of the expandable distal end portion 2014. For example, the longitudinal dimension along the externally oriented surface of the expandable distal end portion 2014 can extend from a proximal end 2024 to a distal end 2022 of the expandable distal end portion 2014. The position of the circumferential portion 2030 can be selected to facilitate maintaining the expandable distal end portion 2014 in the closed state.
Although the circumferential portion 2030 is shown as extending along only a portion of the expandable distal end portion 2014, it will be understood that the circumferential portion 2030 can have a length the same or similar to that of the expandable distal end portion 2014. In some instances, the circumferential portion 2030 can comprise an elastic material. In some instances, the circumferential portion 2030 can be elastic. For example, the circumferential portion 2030 with the weakened joint 2032 can be an elastic ring comprising a weakened joint. The elastic ring can be configured to stretch, such as radially stretch, and separate along the weakened joint to allow the expandable distal end portion 2014 to assume the open state. In some instances, an elastic circumferential portion can extend along an entire length of the expandable distal end portion 2014. For example, an elastic circumferential portion can comprise a ring configuration, extending along only a portion of the expandable distal end portion, while the expandable distal end portion is in the closed state, such as shown in
In some instances, the circumferential portion 2030 can comprise an inelastic material. In some instances, the circumferential portion 2030 can comprise a metallic material configured to separate along the weakened joint 2032. In some instances, the circumferential portion 2030 with the weakened joint 2032 can comprise a metal ring comprising a weakened joint. The metal ring can be configured to separate along the weakened joint to allow the expandable distal end portion 2014 to assume the open state.
In some instances, a medical instrument can be advanced through the expandable distal end portion 2014 to facilitate transformation of the expandable distal end portion 2014 from the closed state to the open state. Referring to
As described herein, in some instances, the circumferential portion 2030 can comprise metal. Advancing at least a portion of an introducer 2060 through the shaft delivery lumen 2016 can cause an expandable distal portion comprising the metallic material to deform. Deformation of the metallic circumferential portion can lead to separation and/or breakage of the metallic circumferential portion along the weakened joint. The circumferential portion 2030 can be a metal ring member comprising a weakened joint that is associated with the expandable distal end portion 2014. In some instances, the metal ring can be an integral part of the expandable distal end portion 2014. In some instances, the metal ring can be coupled to an external surface portion of the expandable distal end portion 2014. Radial force exerted upon the expandable distal end portion 2014 by portions of the introducer 2060 as the introducer 2060 is advanced through the expandable distal end portion 2014 can result in deformation of the metal ring member and subsequent breakage and/or separation along the weakened joint of the metal ring. An elastic circumferential portion can be stretched as the introducer 2060 is advanced through the corresponding portion of the shaft delivery lumen 2016 extending through the expandable distal end portion 2014. Stretching of the elastic circumferential portion can lead to its breakage and/or separation along the weakened joint.
In some instances, the introducer 2060 can be configured to be preloaded within the expandable access sheath 2000. For example, at least a portion of the introducer 2060 can be disposed within the sheath delivery lumen 2002 while at least a portion of the shaft 2010 is advanced along an anatomical pathway to a target position. In some instances, a portion of the introducer 2060 can be disposed distally of a distal end 2018 of the shaft 2010 while the shaft 2010 is advanced to its target position, including at least a portion of the distal portion 2064 of the introducer 2060, such as a distal end 2068 of the introducer 2060.
In block 2104, the process can involve inserting the expandable distal end portion into a bodily vessel and/or lumen. At least a portion of the shaft can be advanced along an anatomical pathway.
In block 2106, the process can involve advancing at least a portion of a medical instrument through the shaft delivery lumen and out of the distal end opening of the shaft. In some instances, the medical instrument can comprise an introducer. For example, at least a portion of an introducer can be advanced through the shaft delivery lumen and out of the distal end opening such that a distal portion of the introducer can be disposed distally of the distal end opening.
In block 2108, the process can involve causing the circumferential portion of the expandable distal end portion to separate along the weakened joint such that the expandable distal end portion can assume an opened state as a portion of the medical instrument is advanced through the expandable distal end portion. For example, pushing the portion of the medical instrument through a corresponding portion of the shaft delivery lumen extending through the expandable distal end portion can cause the circumferential portion to stretch radially and separate along the weakened joint. Separation of the circumferential portion along the weakened joint can allow the expandable distal end portion to expand and/or unfold.
In some instances, the circumferential portion can comprise a metal. For example, the circumferential portion can comprise a metallic material. In some instances, causing the circumferential portion of the expandable distal end portion to separate along the weakened joint can comprise causing a metallic circumferential portion to separate along the weakened joint. In some instances, the circumferential portion can comprise an elastic material. For example, the circumferential portion can comprise an elastic circumferential portion. In some instances, causing the circumferential portion of the expandable distal end portion to separate along the weakened joint can comprise causing an elastic circumferential portion to separate along the weakened joint.
In some instances, the expandable distal end portion can be in a folded configuration while in the closed state. Causing the expandable distal end portion to assume an opened state can comprise causing the expandable distal end portion to unfold. In some instances, the expandable distal end portion can comprise a plurality of pleats configured to be in a folded configuration while the expandable distal end portion is in the closed state. For example, causing the circumferential portion of the expandable distal end portion to assume an opened state can comprise causing the expandable distal end to unfold a plurality of pleats.
In some instances, advancing at least a portion of the medical instrument through the shaft delivery lumen can comprise advancing at least a portion of a medical device through the delivery lumen of the shaft. The medical device can be carried on and/or within a delivery catheter. For example, at least a portion of a delivery catheter configured to receive the medical device can be advanced through the shaft delivery lumen. In some instances, the delivery catheter can be first advanced through the shaft delivery lumen. The medical device can subsequently be deployed from the delivery catheter. For example, at least a portion of the medical device can be advanced through the delivery catheter to be deployed from the delivery catheter.
At least a portion of the weakened portion 2240 can have an orientation that is at an angle relative to a distal end 2218 of the shaft 2210. The distal end 2218 of the shaft 2210 can be a distal end of the expandable distal end portion 2214. In some instances, the weakened portion 2240 can be parallel or substantially parallel to a longitudinal axis of the shaft 2210. In some instances, the weakened portion 2240 can have an orientation that is perpendicular or substantially perpendicular to a portion of the distal end 2218. For example, the weakened portion 2240 can be perpendicular or substantially perpendicular to a portion of the distal end 2218 adjacent to and/or closest to the weakened portion 2240.
The weakened portion 2240 can extend along a portion of the expandable distal end portion 2214. In some instances, the weakened portion 2240 does not extend to the distal end 2218 of the shaft 2210. For example, a distal end 2244 of the weakened portion 2240 can be at a distance from and/or be spaced from the distal end 2218 of the shaft 2210. In some instances, the distal end 2244 of the weakened portion 2240 can be at least about 1 millimeter (mm) from the distal end 2218 of the shaft 2210. Having the distal end 2244 of the weakened portion 2240 not be at the distal end 2218 of the shaft 2210 can avoid or reduce premature opening of the expandable distal end portion 2214, while facilitating opening of the expandable distal end portion 2214 after the shaft 2210 is desirably positioned. In some instances, the distal end 2244 of the weakened portion 2240 can be between about 1 millimeter (mm) to about 2 millimeter (mm), including about 1 millimeter (mm) to about 1.5 millimeter (mm), from the distal end 2218 of the shaft 2210. A proximal end 2242 of the weakened portion 2240 can be at or distal of a proximal end 2216 of the expandable distal end portion 2214. In some instances, a length of the weakened portion can be selected to provide an expandable distal end portion with desired column strength and/or ability to maintain the closed state for navigation through anatomical pathways, while facilitating transformation of the expandable distal end portion to the open state.
As shown in
In some instances, the expandable distal end portion 2214 can comprise a polymeric material. In some instances, the sidewall 2230 of the expandable distal end portion 2214 can be formed using a polymeric material. For example, while in the closed state, the expandable distal end portion 2214 can assume a tapered profile. A lateral dimension, such as a diameter, of the expandable distal end portion 2214 can decrease along a dimension of the shaft 2210 extending distally along the longitudinal axis toward the distal end 2218 of the shaft 2210. The lateral dimension can be perpendicular or substantially perpendicular to the longitudinal axis of the shaft 2210. The polymeric sidewall can assume the tapered profile, for example forming the tapered expandable distal end portion 2214 while the expandable distal end portion 2214 is in the closed state. The weakened portion 2240, such as the pre-formed slit, can extend through the polymeric material. The polymeric sidewall of the expandable distal end portion 2214 can separate along the weakened portion 2240 to allow the expandable distal end portion 2214 to assume the open state.
In some instances, the expandable distal end portion 2214 can comprise polyethylene, including low density polyethylene (LDPE) and/or ultrahigh molecular weight polyethylene (UHMWPE). In some instances, the expandable distal end portion 2214 can comprise both low density polyethylene (LDPE) and ultrahigh molecular weight polyethylene (UHMWPE), including one or more layers of low-density polyethylene (LDPE) and/or ultrahigh molecular weight polyethylene (UHMWPE). For example, the weakened portion 2240 can be formed through a plurality of polymer layers of the sidewall 2230, including a plurality of layers of low-density polyethylene (LDPE) and/or ultrahigh molecular weight polyethylene (UHMWPE).
In the alternative or in combination, a weakened portion can comprise an indentation along a sidewall of a shaft that does not extend through the entire thickness of the sidewall. In the alternative or in combination, a weakened portion can comprise a perforated portion, including for example, a perforated line. For example, at least a portion of an indentation and/or perforated portion can extend along a line, including a linear or substantially linear line, at an angle relative to a distal end of the shaft. The indentation and/or perforated portion can extend along a line that is parallel or substantially parallel to a longitudinal axis of the shaft. In some instances, an expandable distal end portion can comprise a plurality of weakened portions. In some instances, the plurality of weakened portions can be evenly distributed circumferentially around a sidewall of the expandable distal end portion. For example, a plurality of pre-formed slits, indentations and/or perforated portions can be at respective positions on the sidewall forming the expandable distal end portion, including at respective positions evenly distributed around the circumference of the expandable distal end portion.
The expandable access sheath 2200 can comprise a hub 2250. The shaft 2210 can extend distally from the hub 2250, and can be associated with a distal end 2254 of the hub 2250. For example, a proximal portion 2212 of the shaft 2210 can be coupled to the distal end 2254 of the hub 2250. The hub 2250 can comprise a hub delivery lumen 2256 extending through the hub 2250. The hub delivery lumen 2256 can be in fluid communication with and/or be coaxial with a shaft delivery lumen 2222 extending through the shaft 2210. A sheath delivery lumen 2206 extending through the expandable access sheath 2200 can comprise the hub delivery lumen 2256 and the shaft delivery lumen 2222. The sheath delivery lumen 2206 can be configured to allow advancement therethrough of a medical device and/or delivery catheter configured to carry the medical device.
In some instances, a medical instrument, such as an introducer can be preloaded through the expandable access sheath 2200 to facilitate navigation of the expandable access sheath 2200 through tortuous anatomical pathways.
In some instances, at least a portion of a medical instrument can be advanced through the expandable distal end portion 2214 to cause the expandable distal end portion 2214 to separate along the weakened portion 2240.
Alternatively, a second introducer is not used and a first introducer used for navigating the shaft 2210 to the target location can comprise a dilation feature configured to cause the expandable distal end portion 2214 to separate along the weakened portion 2240. For example, after the expandable access sheath 2200 is desirably positioned, the first introducer can be advanced relative to the expandable access sheath 2200 to the sidewall of the expandable distal end portion 2214 can rip, tear and/or split along the weakened portion 2240.
In some instances, the weakened portion 2340 does not extend to the distal end 2318 of the shaft 2310. For example, a distal end 2344 of the weakened portion 2340 can be at a distance from and/or be spaced from the distal end 2318 of the shaft 2310, including from the intermediate portion 2384. In some instances, the distal end 2344 of the weakened portion 2340 can be at least about 1 millimeter (mm) from the distal end 2318 of the shaft 2310, including between about 1 millimeter (mm) to about 2millimeter (mm), including about 1 millimeter (mm) to about 1.5 millimeter (mm), from the distal end 2318 of the shaft 2310, such as from the intermediate portion 2384 of the distal end 2318. A proximal end 2342 of the weakened portion 2340 can be at or distal of a proximal end 2316 of the expandable distal end portion 2314.
In some instances, the weakened portion can be a perforated portion, including a perforated line formed a portion of the sidewall 2330 of the shaft 2310. At least a portion of the perforated portion can be oriented at an angle relative to the distal end 2318 of the shaft 2310, including a portion of the distal end 2318 closest to the perforated portion. In some instances, the weakened portion 2340 can be a perforated portion, including a perforated line, through a portion of the sidewall 2330. At least a portion of the perforated portion can extend along a line, including a linear or substantially linear line, having an orientation that is at an angle relative to the distal end 2318 of the shaft 2310. In some instances, the perforated portion can extend along a line that is parallel or substantially parallel to the longitudinal axis of the shaft 2310. A distal end of the perforated portion can be about 1 millimeter (mm) to about 2 millimeter (mm), including about 1 millimeter (mm) to about 1.5 millimeter (mm), from the distal end 2318 of the shaft 2310.
In the alternative or in combination, a weakened portion can comprise an indentation along the sidewall of a shaft that does not extend through the entire thickness of the sidewall and/or a pre-formed slit. The indentation and/or pre-formed slit can be between adjacent segments of ellipses at a distal end of the shaft. For example, at least a portion of an indentation and/or pre-formed slit can extend along a line, including a linear or substantially linear line, at an angle relative to a distal end of the shaft and between two adjacent segments of ellipses. The indentation and/or pre-formed slit can extend along a line that is parallel or substantially parallel to a longitudinal axis of the shaft.
In some instances, the distal end 2318 can form a plurality of segments of circles. For example, the first segment of the ellipse 2380 can be a first segment of a circle and the second segment of the ellipse 2382 can be a second segment of a circle. The weakened portion 2340 can be between the two adjacent segments of circles. The distal end 2344 of the weakened portion 2340 can be a distance from and/or spaced from a portion of the distal end 2318, such as the intermediate portion 2384, between the first segment of the circle and the second segment of the circle.
Although
Referring to
The weakened portion 2440 can be formed in the sidewall between the first pleat 2480 and the second pleat 2482. The weakened portion 2440 can have an orientation that is at an angle relative to the distal end 2418 of the shaft 2410, including being parallel or substantially parallel to a longitudinal axis of the shaft 2410. A distal end 2444 of the weakened portion 2440 can be at a distance and/or spaced from the distal end 2418 of the shaft 2410. In some instances, the distal end 2444 of the weakened portion 2440 can be at least about 1 millimeter (mm) from the distal end 2418 of the shaft 2410, including between about 1 millimeter (mm) to about 2 millimeter (mm), including about 1 millimeter (mm) to about 1.5 millimeter (mm), from the distal end 2418 of the shaft 2410. A proximal end 2442 of the weakened portion 2440 can be at or distal of a proximal end 2416 of the expandable distal end portion 2414.
In some instances, the weakened portion 2440 can comprise a pre-formed slit through a portion of the sidewall 2430 of the shaft 2410. At least a portion of the pre-formed slit can be oriented at an angle relative to the distal end 2418 of the shaft 2410, including a portion of the distal end 2418 closest to the pre-formed slit. In some instances, the weakened portion 2440 can be a pre-formed slit through a portion of the sidewall 2430. At least a portion of the pre-formed slit can extend along a line, including a linear or substantially linear line, having an orientation that is at an angle relative to the distal end 2418 of the shaft 2410 and/or being parallel or substantially parallel to the longitudinal axis of the shaft 2410. A distal end of the pre-formed slit can be about 1millimeter (mm) to about 2 millimeter (mm), including about 1 millimeter (mm) to about 1.5 millimeter (mm), from the distal end 2418 of the shaft 2410.
Referring to
In the alternative or in combination, a weakened portion can comprise an indentation along a sidewall of a shaft that does not extend through the entire thickness of the sidewall, including an indentation that extends a long a line, such as a linear or substantially linear line, at an angle relative to a distal end of the shaft. In the alternative or in combination, a weakened portion can comprise a perforated portion, including for example, a perforated line, such as a linear or substantially linear line, at an angle relative to a distal end of the shaft. The indentation and/or perforated portion can comprise at least a portion that extends along a line that is parallel or substantially parallel to a longitudinal axis of the shaft. In some instances, an expandable distal end portion can comprise a plurality of weakened portions. In some instances, the plurality of weakened portions can be at respective positions around the circumference of the expandable distal end portion that are not folded while the expandable distal end portion is closed. For example, the plurality of weakened portions can be at respective positions that are not part of a fold and/or a pleat. The plurality of weakened portions can be evenly distributed circumferentially around a sidewall of the expandable distal end portion and be on portions of the sidewall that are between adjacent pleats. For example, a plurality of pre-formed slits, indentations and/or perforated portions can be at respective positions on the sidewall forming the expandable distal end portion, including at respective positions evenly distributed around the circumference of the expandable distal end portion, that are between adjacent pleats.
In some instances, the expandable access sheaths 2300, 2400 described with reference to
In some instances, causing the expandable distal end portion to separate along the weakened portion can comprise causing the expandable distal end portion to separate along a weakened line, including a weakened line having an orientation that is parallel or substantially parallel to a longitudinal axis of the shaft. In some instances, causing the expandable distal end portion to separate along the weakened portion can comprise causing a perforated portion, including a perforated line, on the sidewall of the expandable distal end portion to separate. In some instances, causing the expandable distal end portion to separate along the weakened portion can comprise causing a preformed slit on the sidewall of the expandable distal end portion to separate. In some instances, causing the expandable distal end portion to separate along the weakened portion can comprise causing the expandable distal end portion to separate along a plurality of weakened portions, including a plurality of weakened portions evenly distributed around a circumference of the expandable distal end portion.
In some instances, at least a portion of the distal end of the shaft can form a plurality of segments of ellipses. Causing the expandable distal end portion to separate along the weakened portion can comprise causing the expandable distal end portion to separate along a weakened portion between two adjacent segments of ellipses, including two adjacent segments of circles.
In some instances, the expandable distal end portion can comprise a plurality of pleats. The weakened portion can be on an unfolded sidewall portion of the expandable distal end portion while the expandable distal end portion is in the closed state. The process can involve causing the plurality of pleats of the expandable distal end portion to unfold as a portion of the medical instrument is advanced through a corresponding portion of the shaft delivery lumen. In some instances, causing the distal end portion to separate along the weakened portion can comprise causing the expandable distal end portion to separate along the weakened portion on the unfolded sidewall portion.
In some instances, advancing at least a portion of a medical instrument through a shaft delivery lumen comprises pushing a portion of the medical instrument against the sidewall of the expandable distal end portion to cause separation of the sidewall along the weakened portion. In some instances, pushing the portion of the medical instrument against the sidewall of the expandable distal end portion can comprise engaging a distal end portion of the medical instrument with the sidewall of the shaft to cause separation of the sidewall along the weakened portion.
Provided below is a list of examples, each of which may include aspects of any of the other examples disclosed herein. Furthermore, aspects of any example described above may be implemented in any of the numbered examples provided below.
Example 1: An introducer comprising an elongate shaft configured to be received within an access sheath, the elongate shaft including a distal end and a proximal end, and a fixed-form expansion feature disposed on the elongate shaft between the distal end and the proximal end, the fixed-form expansion feature including a larger outer diameter than the distal end of the elongate shaft and configured to dilate at least a distal end portion of the access sheath when the elongate shaft is translated distally within the access sheath.
Example 2: The introducer of any example herein, in particular example 1, wherein the elongate shaft includes a tapered portion between the distal end of the elongate shaft and the fixed-form expansion feature, the tapered portion tapering toward the distal end of the elongate shaft.
Example 3: The introducer of any example herein, in particular example 1 or 2, further comprising: an introducer hub coupled to the elongate shaft and configured to selectively engage with a sheath hub, the introducer hub being configured to disengage from the sheath hub when the introducer is translated distally.
Example 4: The introducer of any example herein, in particular example 3, wherein the introducer hub is configured to disengage from the sheath hub when the introducer is translated distally by more than a threshold distance, the threshold distance being associated with at least one of a position of the fixed-form expansion feature on the elongate shaft or a length of the access sheath.
Example 5: The introducer of any of any example herein, in particular examples 1-4, wherein an outer diameter of the fixed-form expansion feature is larger than an inner diameter of a distal end of the access sheath in a pre-dilated state.
Example 6: The introducer of any example herein, in particular examples 1-5, wherein the elongate shaft includes a lumen to receive a guidewire.
Example 7: An access system comprising an expandable access sheath including a lumen, and an introducer configured to axially move within the lumen of the expandable access sheath, the introducer including a fixed expansion feature on a distal section of the introducer, the fixed expansion feature including a larger outer diameter than an inner diameter of at least a portion of the expandable access sheath in a non-expanded state, the introducer being configured to radially expand the expandable access sheath when the introducer is translated within the expandable access sheath.
Example 8: The access system of any example herein, in particular example 7, further comprising a sheath hub coupled to the expandable access sheath, and an introducer hub coupled to the introducer and configured to selectively engage with the sheath hub, the introducer hub being configured to disengage from the sheath hub when the introducer is moved distally.
Example 9: The access system of any example herein, in particular examples 7-8, further comprising a locking mechanism coupled to at least one of the expandable access sheath or the introducer, the locking mechanism being configured to prevent removal of the introducer from the expandable access sheath until the fixed expansion feature is moved distally beyond a distal end of the expandable access sheath.
Example 10: The access system of any example herein, in particular examples 7-9, wherein the expandable access sheath is tapered such that a distal end of the expandable access sheath has a smaller diameter than a proximal end of the expandable access sheath.
Example 11: The access system of any example herein, in particular examples 7-10, wherein the expandable access sheath is permanently expandable.
Example 12: The access system of any example herein, in particular examples 7-11, wherein the expandable access sheath is elastically expandable.
Example 13: The access system of any example herein, in particular examples 7-12, wherein the introducer includes a tapered portion between a distal end of the introducer and the fixed expansion feature, the tapered portion tapering toward the distal end of the introducer.
Example 14: A method of accessing an anatomical feature, the method comprising advancing an access sheath into a patient anatomy, the access sheath including a lumen, distally translating a first introducer through the lumen to cause an expansion feature on the first introducer to radially expand at least a distal end of the access sheath, the expansion feature including a fixed form, removing the first introducer from the lumen of the access sheath, and advancing a medical instrument through the lumen of the access sheath.
Example 15: The method of any example herein, in particular example 14, wherein the advancing the access sheath into the patient anatomy includes inserting a second introducer into the access sheath such that at least a distal end portion of the second introducer extends beyond the distal end of the access sheath and advancing the access sheath with the second introducer disposed therein into the patient anatomy.
Example 16: The method of any example herein, in particular example 15, further comprising upon advancing the access sheath with the second introducer disposed therein into the patient anatomy, and removing the second introducer from the access sheath.
Example 17: The method of any example herein, in particular examples 14-16, wherein the distally translating the first introducer includes distally translating the first introducer by at least a threshold distance to disable a locking mechanism and allow the first introducer to be removed from the access sheath.
Example 18: The method of any example herein, in particular examples 14-17, wherein the advancing the access sheath into the patient anatomy includes inserting the first introducer into the lumen in the access sheath such that a distal end of the first introducer extends beyond the distal end of the access sheath and advancing the access sheath with the first introducer disposed therein into the patient anatomy.
Example 19: The method of any example herein, in particular examples 14-18, wherein the first introducer includes a tapered portion between a distal end of the first introducer and the expansion feature, the tapered portion tapering toward the distal end of the first introducer.
Example 20: The method of any example herein, in particular examples 14-19, wherein the access sheath is permanently expandable.
Example 21: The method of any example herein, in particular examples 14-20, wherein the access sheath is temporarily expandable.
The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (e.g., with body parts, heart, tissue, etc. being simulated).
Example 22: A medical access system comprising an expandable access sheath, the expandable access sheath comprising a hub, and a shaft extending distally from the hub, the shaft having an expandable distal end portion configured to be in an open state and a closed state and a side shaft opening on the expandable distal end portion in fluid communication with a shaft delivery lumen extending through the shaft. The medical access system can include a cord comprising a first cord tail portion configured to pass through the side shaft opening, a second cord tail portion configured to pass through the side shaft opening, and a medial cord portion between the first and second cord tail portions, the medial cord portion being configured to be disposed around a circumferential portion of the expandable distal end portion when the expandable distal end portion is in the closed state.
Example 23: The system of any example herein, in particular example 22, wherein the side shaft opening comprises a first side shaft opening and a second side shaft opening, and the first and the second cord tail portions are configured to extend through a respective one of the first and second side shaft openings and extend proximally along a portion of the shaft delivery lumen.
Example 24: The system of any example herein, in particular example 22 or 23, wherein the cord is configured to be removed from the expandable access sheath to allow the expandable distal end portion to assume the open state.
Example 25: The system of any example herein, in particular example 22, further comprising an introducer, the introducer comprising a central lumen extending through at least a portion of the introducer, and a side introducer opening on a distal portion thereof, the side introducer opening in fluid communication with the central lumen, and while the expandable distal end portion is in the closed state, at least a portion of the introducer being configured to be slidably received within the shaft delivery lumen, and the side introducer opening being configured to be within the shaft delivery lumen, and the first and second cord tail portions being configured to extend through the side shaft opening and the side introducer opening and along at least a portion of the central lumen of the introducer.
Example 26: The system of any example herein, in particular example 25, wherein, while the expandable distal end portion is in the closed state, the side shaft opening is configured to be aligned with the side introducer opening.
Example 27: The system of any example herein, in particular example 25 or 26, wherein the side shaft opening comprises a first side shaft opening and a second side shaft opening, the side introducer opening comprises a first side introducer opening and a second side introducer opening, and the first and the second cord tail portions are configured to extend through a respective one of the first and second side shaft openings and a respective one of the first and second side introducer openings.
Example 28: The system of any example herein, in particular examples 25-27, wherein the introducer is configured to be translated proximally relative to the expandable access sheath to withdraw the introducer from within the shaft delivery lumen, and the first and second side introducer openings are configured to slide proximally along at least a portion of the first and second cord tail portions extending through the shaft delivery lumen as the introducer is translated proximally.
Example 29: The system of any example herein, in particular examples 25-27, wherein the cord is configured to be removed from around the expandable access sheath and the central lumen of the introducer while the at least a portion of the introducer is received within the shaft delivery lumen to allow the expandable distal end portion to assume the open state.
Example 30: The system of any example herein, in particular examples 22-29, wherein a portion of at least one of the first tail cord portion and the second tail cord portion is configured to be positioned around a portion of the circumferential portion of the expandable distal end portion to allow the expandable distal end portion to transform to the open state from the closed state.
Example 31: The system of any example herein, in particular examples 22-30, wherein a proximal portion of the first tail cord portion and a proximal portion of the second tail cord portion are configured to be secured to the hub of the expandable access sheath to maintain the expandable distal end portion in the closed state or the open state.
Example 32: An expandable access sheath comprising a hub, and a shaft extending distally from the hub, the shaft comprising an expandable distal end portion and the expandable distal end portion comprising a plurality of pleats. The plurality of pleats can be configured to be in a folded configuration while the expandable distal end portion is in a closed state, each of the plurality of pleats comprising a pair of pleat portions configured to be oriented toward one another in the folded configuration, the pair of pleat portions being configured to be attracted to one another to maintain the folded configuration, and an unfolded configuration while the expandable distal end portion is in an open state.
Example 33: The sheath of any example herein, in particular example 32, wherein a respective pleat portion of each pair of pleat portions comprises magnetic material having opposite magnetic poles.
Example 34: The sheath of any example herein, in particular example 33, wherein the respective pleat portion of each pair of pleat portions comprises magnetic material having the opposite magnetic poles embedded therein.
Example 35: The sheath of any example herein, in particular example 32, wherein a surface portion of a respective pleat portion of each pair of pleat portions comprises opposite electrostatic charges.
Example 36: The sheath of any example herein, in particular example 35, wherein the surface portion of the respective pleat portion comprises a plurality of positively charged electrical particles or a plurality of negatively charged electrical particles.
Example 37: The sheath of any example herein, in particular examples 32-36, wherein the expandable access sheath is configured to receive an introducer and advancing a distal portion of the introducer through the expandable distal end portion is configured to push apart the plurality of pleats to allow the expandable distal end portion to assume an open state.
Example 38: An expandable access sheath comprising a hub, and a shaft extending distally from the hub, the shaft comprising an expandable distal end portion and the expandable distal end portion comprising a circumferential portion having a weakened joint. The circumferential portion, while the expandable distal end portion is in a closed state, can be configured to be circumferentially disposed around a portion of the expandable distal end portion, and configured to separate along the weakened joint to allow the expandable distal end portion to assume an open state.
Example 39: The sheath of any example herein, in particular example 38, wherein the circumferential portion comprises a metal ring comprising the weakened joint, and the metal ring is configured to separate along the weakened joint to allow the expandable distal end portion to assume the open state.
Example 40: The sheath of any example herein, in particular example 38, wherein the circumferential portion comprises an elastic ring comprising a weakened joint, and the elastic ring is configured to stretch and separate along the weakened joint to allow the expandable distal end portion to assume the open state.
Example 41: The sheath of any example herein, in particular examples 38-40, wherein the expandable distal end portion comprises a plurality of pleats and wherein the plurality of pleats are configured to be in a folded configuration while the expandable distal end portion is in the closed state, and the plurality of pleats are configured to be in an unfolded configuration while the expandable distal end portion is in the open state.
Example 42: A method of delivering a medical device, the method comprising providing a medical access system. The medical access system can comprise an expandable access sheath comprising a shaft extending distally from a hub, the shaft having an expandable distal end portion, and a first and a second side shaft opening on the expandable distal end portion in fluid communication with a shaft delivery lumen extending through the shaft. The medical access system can comprise a cord comprising a first cord tail portion, a second cord tail portion, and a medial cord portion between the first and second cord tail portions. The method can include inserting the expandable distal end portion into a bodily lumen while the expandable distal end portion is in a closed state, the medial cord portion being disposed around a circumferential portion of the expandable distal end portion, and the first and second cord tail portions extending through a respective one of the first and second side shaft openings; and reducing the tension on the cord to position a portion of at least one of the first and second cord tail portions over the circumferential portion of the expandable distal end portion to allow the expandable distal end portion to assume an open state.
Example 43: The method of any example herein, in particular example 42, further comprising one of passing the medial cord portion and then the second tail cord portion through the first and second side shaft openings and the delivery lumen as the first tail cord portion is translated proximally to remove the cord and allow the expandable distal end portion to assume the open state; and passing the circumferential cord portion and then the first tail cord portion through the first and second side shaft openings and the shaft delivery lumen as the second tail cord portion is translated proximally to remove the cord and allow the expandable distal end portion to assume the open state.
Example 44: The method of any example herein, in particular example 42, further comprising providing an introducer at least partially received in the shaft delivery lumen, the introducer comprising a central lumen extending through at least a portion thereof, and a first and a second side introducer opening in fluid communication with the central lumen and disposed within the shaft delivery lumen, and the first and second cord tail portions extending through a respective one of the first and second side shaft openings and a respective one of the first and second side introducer openings.
Example 45: The method of any example herein, in particular example 44, further comprising translating the introducer proximally relative to the expandable access sheath to withdraw the introducer from within the shaft delivery lumen, the first and second side introducer openings sliding proximally along at least a portion of the first and second cord tail portions.
Example 46: The method of any example herein, in particular example 44, further comprising one of passing the medial cord portion and then the second tail cord portion through the first and second side introducer openings and the central lumen as the first tail cord portion is translated proximally to remove the cord and allow the expandable distal end portion to assume the open state; and passing the medial cord portion and then the first tail cord portion through the first and second side introducer openings and the central lumen as the second tail cord portion is translated proximally to remove the cord and allow the expandable distal end portion to assume the open state.
Example 47: The method of any example herein, in particular examples 42-46, further comprising securing a proximal portion of the first tail cord portion and a proximal portion of the second tail cord portion to the hub of the expandable access sheath to maintain the expandable distal end portion in the closed state or the open state.
Example 48: The method of any example herein, in particular examples 42-47, further comprising tensioning the cord to transform the expandable distal end portion of the shaft from the open state to the closed state, and translating the expandable distal end portion proximally to withdraw the shaft from the bodily lumen.
The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (e.g., with body parts, heart, tissue, etc. being simulated).
Example 49: A method of delivering a medical device, the method comprising providing an expandable access sheath, the expandable access sheath comprising a shaft having an expandable distal end portion in a closed state, and a distal end opening in fluid communication with a shaft delivery lumen extending therethrough, the expandable distal end portion comprising a plurality of pleats in a folded configuration while in the closed state, each of the plurality of pleats comprising a pair of pleat portions configured to be oriented toward and attracted to one another while the pleats are in the folded configuration. The method can include inserting the expandable distal end portion into a bodily lumen, advancing at least a portion of a medical instrument through the shaft delivery lumen of the shaft and out of the distal end opening, and pushing apart the pair of pleat portions configured to be oriented toward and attracted to one another while the pleats are in the folded configuration as a portion of the medical instrument is advanced through a corresponding portion of the delivery lumen to allow the expandable distal end portion to assume an open state.
Example 50: The method of any example herein, in particular example 49, wherein pushing apart the pair of pleat portions comprises pushing apart a pair of pleat portions each comprising magnetic material embedded therein.
Example 51: The method of any example herein, in particular example 49, wherein pushing apart the pair of pleat portions comprises pushing apart a pair of pleat portions each comprising a surface portion having electrostatic charges thereon.
Example 52: The method of any example herein, in particular examples 49-51, wherein advancing the at least a portion of the medical instrument comprises advancing the at least a portion of an introducer through the shaft delivery lumen.
Example 53: The method of any example herein, in particular examples 49-51, wherein advancing the at least a portion of the medical instrument comprises advancing at least a portion of a medical device through the shaft delivery lumen.
Example 54: The method of any example herein, in particular examples 49-53, wherein causing the circumferential portion of the expandable distal end portion to assume an opened state comprises causing the plurality of pleats of the expandable distal end to unfold.
The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (e.g., with body parts, heart, tissue, etc. being simulated).
Example 55: A method of delivering a medical device, the method comprising providing an expandable access sheath, the expandable access sheath comprising a shaft having an expandable distal end portion in a closed state, and a distal end opening in fluid communication with a shaft delivery lumen extending therethrough, and a circumferential portion comprising a weakened joint, the circumferential portion being disposed around a portion of the expandable distal end portion. The method can include inserting the expandable distal end portion into a bodily lumen, advancing at least a portion of a medical instrument through the delivery lumen of the shaft and out of the distal end opening, and causing the circumferential portion of the expandable distal end portion to separate along the weakened joint and assume an opened state as a portion of the medical instrument is advanced through a corresponding portion of the delivery lumen extending through the expandable distal end portion.
Example 56: The method of any example herein, in particular example 55, wherein causing the circumferential portion of the expandable distal end portion to separate along the weakened joint comprises causing a metallic circumferential portion to separate along the weakened joint.
Example 57: The method of any example herein, in particular example 55, wherein causing the circumferential portion of the expandable distal end portion to separate along the weakened joint comprises causing an elastic circumferential portion to separate along the weakened joint.
Example 58: The method of any example herein, in particular examples 55-57, wherein advancing the at least a portion of the medical instrument comprises advancing the at least a portion of an introducer through the shaft delivery lumen.
Example 59: The method of any example herein, in particular examples 55-57, wherein advancing the at least a portion of the medical instrument comprises advancing at least a portion of a medical device through the shaft delivery lumen.
Example 60: The method of any example herein, in particular examples 55-59, wherein causing the circumferential portion of the expandable distal end portion to assume an opened state comprises causing the expandable distal end to unfold a plurality of pleats.
The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (e.g., with body parts, heart, tissue, etc. being simulated).
Example 61: An expandable access sheath comprising a hub and a shaft extending distally from the hub, the shaft comprising an expandable distal end portion configurable in a closed state in which a sidewall of the expandable distal end portion includes a weakened portion having a distal end spaced from a distal end of the shaft and at least a portion of the weakened portion having an orientation at an angle relative to the distal end of the shaft. The expandable distal end portion can be configured to separate along the weakened portion to provide the expandable distal end portion in an open state.
Example 62: The sheath of any example herein, in particular example 61, wherein the weakened portion comprises at least a portion having an orientation parallel to a longitudinal axis of the shaft.
Example 63: The sheath of any example herein, in particular example 61 or 62, wherein the weakened portion comprises a weakened line.
Example 64: The sheath of any example herein, in particular examples 61 to 63, wherein the weakened portion comprises a perforated portion of the sidewall of the expandable distal end portion.
Example 65: The sheath of any example herein, in particular example 64, wherein the perforated portion is a perforated line.
Example 66: The sheath of any example herein, in particular examples 61 to 65, wherein the weakened portion comprises a preformed slit formed through the sidewall of the expandable distal end portion.
Example 67: The sheath of any example herein, in particular examples 61 to 66, wherein the expandable distal end portion comprises a plurality of weakened portions evenly distributed circumferentially around the sidewall of the expandable distal end portion.
Example 68: The sheath of any example herein, in particular examples 61 to 67, wherein the distal end of the weakened portion is about 1 millimeter (mm) to about 1.5 millimeters (mm) from the distal end of the shaft.
Example 69: The sheath of any example herein, in particular examples 61 to 68, wherein at least a portion of the distal end of the shaft forms a plurality of segments of ellipses, and the weakened portion is between two adjacent segments of ellipses.
Example 70: The sheath of any example herein, in particular example 69, wherein the distal end of the shaft forms a plurality of segments of circles, and the weakened portion is between two adjacent segments of circles.
Example 71: The sheath of any example herein, in particular examples 61 to 70, wherein the expandable distal end portion comprises a plurality of pleats configured to be in a folded configuration while the expandable distal end portion is in the closed state, and wherein the weakened portion is on an unfolded sidewall portion while the expandable distal end portion is in the closed state.
Example 72: A method of delivering a medical device, the method comprising providing an expandable access sheath having a shaft, the shaft comprising an expandable distal end portion configurable in a closed state in which a sidewall of the expandable distal end portion includes a weakened portion having a distal end spaced from a distal end of the shaft and at least a portion of the weakened portion having an orientation at an angle relative to the distal end of the shaft. The method can include inserting the expandable distal end portion into a bodily lumen, advancing at least a portion of a medical instrument through a shaft delivery lumen of the shaft and out of a distal end opening of the shaft, and causing the expandable distal end portion to separate along the weakened portion of the sidewall as a portion of the medical instrument is advanced through a corresponding portion of the shaft delivery lumen to allow the expandable distal end portion to assume an open state.
Example 73: The method of any example herein, in particular example 72, wherein causing the expandable distal end portion to separate along the weakened portion comprises causing a perforated line on the sidewall of the expandable distal end portion to separate.
Example 74: The method of any example herein, in particular example 72 or 73, wherein causing the expandable distal end portion to separate along the weakened portion comprises causing a preformed slit on the sidewall of the expandable distal end portion to separate.
Example 75: The method of any example herein, in particular examples 72 to 74, wherein causing the expandable distal end portion to separate along the weakened portion comprises causing the expandable distal end portion to separate along a plurality of weakened portions evenly distributed around a circumference of the expandable distal end portion.
Example 76: The method of any example herein, in particular examples 72 to 75, wherein at least a portion of the distal end of the shaft forms a plurality of segments of ellipses, and the causing the expandable distal end portion to separate along the weakened portion comprises causing the expandable distal end portion to separate along a weakened portion between two adjacent segments of ellipses.
Example 77: The method of any example herein, in particular examples 72 to 76, further comprising causing a plurality of pleats of the expandable distal end portion to unfold as a portion of the medical instrument is advanced through a corresponding portion of the shaft delivery lumen.
Example 78: The method of any example herein, in particular example 77, wherein causing the distal end portion to separate along the weakened portion comprises causing the expandable distal end portion to separate along a weakened portion on an unfolded sidewall portion of the expandable distal end portion while the expandable distal end portion is in the closed state.
Example 79: The method of any example herein, in particular examples 72 to 78, wherein advancing at least a portion of a medical instrument through a shaft delivery lumen comprises pushing a portion of the medical instrument against the sidewall of the shaft to cause separation of the sidewall along the weakened portion.
Example 80: The method of any example herein, in particular example 79, wherein pushing the portion of the medical instrument against the sidewall of the shaft comprises engaging a distal end portion of the medical instrument with the sidewall of the shaft to cause separation of the sidewall along the weakened portion.
The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (e.g., with body parts, heart, tissue, etc. being simulated).
Depending on the example, certain acts, events, or functions of any of the processes or algorithms described herein can be performed in a different sequence, may be added, merged, or left out altogether. Thus, in certain examples, not all described acts or events are necessary for the practice of the processes.
Conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is intended in its ordinary sense and is generally intended to convey that certain examples include, while other examples do not include, certain features, elements and/or steps. Thus, such conditional language is not generally intended to imply that features, elements and/or steps are in any way required for one or more examples or that one or more examples necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and/or steps are included or are to be performed in any particular example. The terms “comprising,” “including,” “having,” and the like are synonymous, are used in their ordinary sense, and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Conjunctive language such as the phrase “at least one of X, Y and Z,” unless specifically stated otherwise, is understood with the context as used in general to convey that an item, term, element, etc. may be either X, Y or Z. Thus, such conjunctive language is not generally intended to imply that certain examples require at least one of X, at least one of Y and at least one of Z to each be present.
It should be appreciated that in the above description of examples, various features are sometimes grouped together in a single example, Figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than are expressly recited in that claim. Moreover, any components, features, or steps illustrated and/or described in a particular example herein can be applied to or used with any other example(s). Further, no component, feature, step, or group of components, features, or steps are necessary or indispensable for each example. Thus, it is intended that the scope of the subject matter herein disclosed and claimed below should not be limited by the particular examples described above, but should be determined only by a fair reading of the claims that follow.
It should be understood that certain ordinal terms (e.g., “first” or “second”) may be provided for ease of reference and do not necessarily imply physical characteristics or ordering. Therefore, as used herein, an ordinal term (e.g., “first,” “second,” “third,” etc.) used to modify an element, such as a structure, a component, an operation, etc., does not necessarily indicate priority or order of the element with respect to any other element, but rather may generally distinguish the element from another element having a similar or identical name (but for use of the ordinal term). In addition, as used herein, indefinite articles (“a” and “an”) may indicate “one or more” rather than “one.” Further, an operation performed “based on” a condition or event may also be performed based on one or more other conditions or events not explicitly recited.
Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which examples belong. It be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and not be interpreted in an idealized or overly formal sense unless expressly so defined herein.
The spatially relative terms “outer,” “inner,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” and similar terms, may be used herein for ease of description to describe the relations between one element or component and another element or component as illustrated in the drawings. It be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation, in addition to the orientation depicted in the drawings. For example, in the case where a device shown in the drawing is turned over, the device positioned “below” or “beneath” another device may be placed “above” another device. Accordingly, the illustrative term “below” may include both the lower and upper positions. The device may also be oriented in the other direction, and thus the spatially relative terms may be interpreted differently depending on the orientations.
Unless otherwise expressly stated, comparative and/or quantitative terms, such as “less,” “more,” “greater,” and the like, are intended to encompass the concepts of equality. For example, “less” can mean not only “less” in the strictest mathematical sense, but also, “less than or equal to.”
This application is a continuation of International Patent Application No. PCT/US2023/014574, filed Mar. 6, 2023, entitled “INTRODUCER WITH DILATION FEATURE AND EXPANDABLE ACCESS SHEATHS,” which claims the benefit of U.S. Provisional Patent Application No. 63/335,696, filed Apr. 27, 2022, entitled “INTRODUCER WITH DILATION FEATURE AND EXPANDABLE ACCESS SHEATHS,” and U.S. Provisional Patent Application No. 63/317,508, filed Mar. 7, 2022, entitled “INTRODUCER WITH DILATION FEATURE,” the disclosures of each of which are hereby expressly incorporated by reference herein in their entireties for all purposes.
| Number | Date | Country | |
|---|---|---|---|
| 63335696 | Apr 2022 | US | |
| 63317508 | Mar 2022 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2023/014574 | Mar 2023 | WO |
| Child | 18821639 | US |
