MEDICAL DEVICE DEPLOYMENT DEVICES AND ASSOCIATED SYSTEMS AND METHODS
CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims the benefit of U.S. Provisional Patent Application No. 63/315,904, filed on March 2, 2022, which is incorporated herein by reference in its entirety.
BACKGROUND
Various medical devices are commonly implanted into humans for many medical conditions, which often involve physiological structures that are in need of intervention. Numerous implantable devices have been developed for treating such conditions, such as guidewires, catheters, medical device delivery systems (e g., for stents, grafts, replacement valves, occlusive devices, etc.), and the like. For an aneurism, for example, a portion of a wall of a blood vessel can grow or otherwise form an outward recess. When such a recess is located, such that the blood flows into the recess under some pressure, the recess can continue to grow outwardly. Such outward growth can cause pressure on surrounding tissue, impede the functionality of the physiological structure where the recess has formed, and eventually rupture, thus causing a potential health risk or even death in the affected subject. Several of the aforementioned devices are commonly used to treat such conditions.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 A illustrates a view of an implant being delivered to a blood vessel in accordance with an example embodiment;
FIG. IB illustrates a view of an implant being delivered to a blood vessel in accordance with an example embodiment;
FIG. 1C illustrates a view of an implant being delivered to a blood vessel in accordance with an example embodiment;
FIG. 2A illustrates a view of an implant delivery device in accordance with an example embodiment;
FIG. 2B illustrates a view of an implant delivery device in accordance with an example embodiment; FIG. 3A illustrates a view of a braided wire proximal transverse opening in accordance with an example embodiment;
FIG. 3B illustrates a view of braided wire making a mechanical connection with an implant anchor in accordance with an example embodiment;
FIG. 3C illustrates a view of the proximal end of an implant loaded into an implant delivery device in accordance with an example embodiment;
FIG. 4A illustrates a view of an implant mechanically secured in an implant delivery device in accordance with an example embodiment;
FIG. 4B illustrates a view of an implant nearing release from an implant anchor device in accordance with an example embodiment;
FIG. 4C illustrates a view of an implant released from an implant anchor device in accordance with an example embodiment;
FIG. 5 illustrates a view of an implant delivery device in accordance with an example embodiment;
FIG. 6A illustrates a view of an implant delivery device having an undeployed implant being delivered to a blood vessel in accordance with an example embodiment; and
FIG. 6B illustrates a view of an implant delivery device having released an implant into a blood vessel in accordance with an example embodiment.
DESCRIPTTON OF EMBODIMENTS
Although the following detailed description contains many specifics for the purpose of illustration, a person of ordinary skill in the art will appreciate that many variations and alterations to the following details can be made and are considered included herein. Accordingly, the following embodiments are set forth without any loss of generality to, and without imposing limitations upon, any claims set forth. It is also to be understood that the terminology used herein is for describing particular embodiments only, and is not intended to be limiting. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. Also, the same reference numerals in appearing in different drawings represent the same element. Numbers provided in flow charts and processes are provided for clarity in illustrating steps and operations and do not necessarily indicate a particular order or sequence. Furthermore, the described features, structures, or characteristics can be combined in any suitable manner in one or more embodiments. In the following description, numerous specific details are provided, such as examples of layouts, materials components, etc., to provide a thorough understanding of various embodiments. One skilled in the relevant art will recognize, however, that such detailed embodiments do not limit the overall concepts articulated herein but are merely representative thereof. One skilled in the relevant art will also recognize that the technology can be practiced without one or more of the specific details, or with other methods, components, layouts, etc. In other instances, well-known structures, materials, or operations may not be shown or described in detail to avoid obscuring aspects of the disclosure.
In this application, “compnses,” “comprising,” “containing” and “having” and the like can have the meaning ascribed to them in U.S. Patent law and can mean “includes,” “including,” and the like, and are generally interpreted to be open ended terms. The terms “consisting of’ or “consists of’ are closed terms, and include only the components, structures, steps, or the like specifically listed in conjunction with such terms, as well as that which is in accordance with U.S. Patent law. “Consisting essentially of’ or “consists essentially of’ have the meaning generally ascribed to them by U.S. Patent law. In particular, such terms are generally closed terms, with the exception of allowing inclusion of additional items, materials, components, steps, or elements, that do not materially affect the basic and novel characteristics or function of the item(s) used in connection therewith. For example, trace elements present in a composition, but not affecting the compositions nature or characteristics would be permissible if present under the “consisting essentially of’ language, even though not expressly recited in a list of items following such terminology. When using an open- ended term in this written description, like “comprising” or “including,” it is understood that direct support should be afforded also to “consisting essentially of’ language as well as “consisting of’ language as if stated explicitly and vice versa.
As used herein, the term “substantially” refers to the complete or nearly complete extent or degree of an action, characteristic, property, state, structure, item, or result. For example, an object that is “substantially” enclosed would mean that the object is either completely enclosed or nearly completely enclosed. The exact allowable degree of deviation from absolute completeness may in some cases depend on the specific context. However, generally speaking the nearness of completion will be so as to have the same overall result as if absolute and total completion were obtained. The use of “substantially” is equally applicable when used in a negative connotation to refer to the complete or near complete lack of an action, characteristic, property, state, structure, item, or result. For example, a composition that is “substantially free of’ particles would either completely lack particles, or so nearly completely lack particles that the effect would be the same as if it completely lacked particles. In other words, a composition that is “substantially free of’ an ingredient or element may still actually contain such item as long as there is no measurable effect thereof.
As used herein, the term “about” is used to provide flexibility to a given term, metric, value, range endpoint, or the like. The degree of flexibility for a particular variable can be readily determined by one skilled in the art. However, unless otherwise expressed, the term “about” generally provides flexibility of less than 1%, and in some cases less than 0.01%. It is to be understood that, even when the term “about” is used in the present specification in connection with a specific numerical value, support for the exact numerical value recited apart from the “about” terminology is also provided.
As used herein, a plurality of items, structural elements, compositional elements, and/or materials may be presented in a common list for convenience. However, these lists should be construed as though each member of the list is individually identified as a separate and unique member. Thus, no individual member of such list should be construed as a de facto equivalent of any other member of the same list solely based on their presentation in a common group without indications to the contrary.
Concentrations, amounts, and other numerical data may be expressed or presented herein in a range format. It is to be understood that such a range format is used merely for convenience and brevity and thus should be interpreted flexibly to include not only the numerical values explicitly recited as the limits of the range, but also to include all the individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly recited. As an illustration, a numerical range of “about 1 to about 5” should be interpreted to include not only the explicitly recited values of about 1 to about 5, but also include individual values and sub-ranges within the indicated range. Thus, included in this numerical range are individual values such as 2, 3, and 4 and sub-ranges such as from 1-3, from 2-4, and from 3-5, etc., as well as 1, 1.5, 2, 2.3, 3, 3.8, 4, 4.6, 5, and 5.1 individually.
This same principle applies to ranges reciting only one numerical value as a minimum or a maximum. Furthermore, such an interpretation should apply regardless of the breadth of the range or the characteristics being described.
Reference throughout this specification to “an example’" means that a particular feature, structure, or characteristic described in connection with the example is included in at least one embodiment. Thus, appearances of phrases including “an example” or “an embodiment” in various places throughout this specification are not necessarily all referring to the same example or embodiment.
The terms “first,” “second,” “third,” “fourth,” and the like in the description and in the claims, if any, are used for distinguishing between similar elements and not necessarily for describing a particular sequential or chronological order. It is to be understood that the terms so used are interchangeable under appropriate circumstances such that the embodiments described herein are, for example, capable of operation in sequences other than those illustrated or otherwise described herein. Similarly, if a method is described herein as comprising a series of steps, the order of such steps as presented herein is not necessarily the only order in which such steps may be performed, and certain of the stated steps may possibly be omitted and/or certain other steps not described herein may possibly be added to the method.
The terms “left,” “right,” “front,” “back,” “top,” “bottom,” “over,” “under,” and the like in the description and in the claims, if any, are used for descriptive purposes and not necessarily for describing permanent relative positions. It is to be understood that the terms so used are interchangeable under appropriate circumstances such that the embodiments described herein are, for example, capable of operation in other orientations than those illustrated or otherwise described herein.
As used herein, comparative terms such as “increased,” “decreased,” “better,” “worse,” “higher,” “lower,” “enhanced,” and the like refer to a property of a device, component, or activity that is measurably different from other devices, components, or activities in a surrounding or adj acent area, in a single device or in multiple comparable devices, in a group or class, in multiple groups or classes, or as compared to the known state of the art.
An initial overview of embodiments is provided below, and specific embodiments are then described in further detail. This initial summary is intended to aid readers in understanding the disclosure more quickly and is not intended to identify key or essential technological features, nor is it intended to limit the scope of the claimed subject matter.
The present disclosure provides a novel delivery device and delivery system to place a medical device into a subject at a location to provide medical treatment. For example, such locations can include, without limitation, a blood vessel, a duct, or any lumen into which a medical device can be inserted. One specific example of such a medical device can include an implant, which can be an expandable.
The delivery device is capable of substantially deploying and then retrieving an implant in situations where, for example, the implant needs to be removed or repositioned during placement. As is shown in FIG. 1A, a delivery device 100 positions an implant 102 in an undeployed configuration (i.e., an “undeployed implant”) in the lumen 104 of a blood vessel 106. The proximal end of the undeployed implant 102 is coupled to a pusher wire 110 and is held in the undeployed configuration by a delivery lumen of a sheath 108. A sheath can include a delivery catheter or other delivery tube, including any internal sheath, tube, or tubular structure having an inner confining surface. As the undeployed implant 102 exits the sheath 108, the implant begins to deploy. Exiting the sheath can include the sheath being withdrawn proximally to expose the undeployed implant and/or the undeployed implant being pushed distally from the inside of the sheath. FIG. IB shows a partially deployed implant 1 12 following partial exit from the sheath 108. Due to the sheath 108 being positioned over an undeployed portion 114 of the partially deployed implant 112, the implant is not fully deployed and can be pulled back into the sheath 108 by the pusher wire 110, either partially or fully back to an undeployed configuration. Once the sheath 108 is withdrawn sufficiently to fully deploy the expanded implant 112, as is shown in FIG. 1C, the expanded implant 112 can no longer be withdrawn into the sheath 108 by the pusher wire 110.
Example delivery devices according to the present disclosure include a novel attachment and release mechanism that secures an implant during delivery up to a nearly complete deployment, while maintaining the capacity to withdraw the implant back into the delivery device. Current delivery mechanisms generally utilize friction forces to hold implants in delivery devices during deployment. Once the friction forces are reduced to a point where the delivery mechanism can no longer maintain a grip on the implant, the implant is released. Furthermore, the point at which full deployment occurs with such mechanisms, such as friction pad delivery systems, for example, can vary depending on the inherently inconsistent friction forces applied by the delivery mechanism to a given implant. The present delivery devices, however, utilize a mechanical engagement to releasably secure an implant prior to and during deployment. Such mechanical attachment allows the implant to be deployed to a much greater extent compared to current delivery mechanisms, while maintaining the capacity to withdraw the implant back into the sheath. Additionally, the point of full deployment of an implant held by a mechanical attachment according to delivery devices of the present disclosure, however, is predictable and consistent, thus allowing a medical professional to reliably know the point at which deployment will occur.
FIG. 2 shows an example of a delivery device capable of deploying and retrieving an implant. FIG. 2A shows a delivery device 200 having a spacer 202, a pusher wire 204, and a distal guide 205. In some examples, either the spacer 202 or the spacer 202 and the distal guide 205 are a continuous extension of the pusher wire 203. In other examples, either the distal guide 205 or the distal guide and the spacer 202 are separate components from the pusher wire 204, either of the same material or different materials. An implant anchor 206 is positioned between the spacer 202 and the distal guide 205, which is configured to couple to the proximal end of an implant (not shown). A sheath 208 initially encloses the spacer 202, the distal guide 204, and the implant anchor 206 prior to deployment of the implant. When the implant is enclosed by the sheath 108, the implant is compressed into an undeployed state. As the sheath 208 moves in a direction shown by arrow 210, the implant begins to deploy as it is released from the confinement of the sheath 208. The implant does not fully deploy until the sheath 208 has been sufficiently withdrawn to allow implant anchor 206 to release the proximal end of the implant. Prior to reaching this “point of no return,” the implant can be pulled back into the sheath 208. FIG. 2B shows an example of a device showing the withdrawn sheath 208 with the spacer 202, the distal guide 205, and the implant anchor 206, exposed to a greater extent than what would be required to fully deploy the implant for clarity. FIG. 2B also shows a pusher coupling 212 to couple to the spacer 202 to the pusher wire 204.
In some examples, one or more components of a delivery device can be made from a radiopaque material to allow the delivery device to be imaged during the implant procedure. Such real time visualization allows the medical professional to guide the delivery device through the blood vessel to a target location. Furthermore, once reaching the target location, the implant can be more accurately positioned as a result of such visualization.
In some examples, implants can be made from braided wires, as is described more fully below. In other examples, implants can be made using a cutting process, such as laser cutting to form laser-cut implants. In both cases, a series of transverse openings is formed in the sides of the implant, as can be seen in FIGs. 1A-1C. When the implant is in a compressed or a partially deployed state, the implant anchor engages one or more transverse openings to form a mechanical attachment or engagement that secures the implant to the delivery device and allows retraction of the implant into the sheath up to the point of full deployment.
Various implant anchor designs can be utilized to form a mechanical attachment with transverse openings of an implant. In one example, an implant anchor includes a proximal transverse edge that is structurally configured to mechanically engage a distal-facing region or edge of a proximal transverse opening when an implant is in an undeployed configuration. FIG. 3A shows an example of a proximal termination 302 of a braided wire implant where bundles of wires 304 converge, thus forming a transverse opening 306 having a distal-facing region 308, in this case at a proximal end of the implant. As such, a plurality of transverse openings can thus be formed around the periphery of the proximal end of the implant. FIG. 3B shows an example of an implant anchor 310 having a proximal transverse edge 312, in this case a proximal-facing proximal transverse edge. The proximal transverse edge 312 mechanically engages engaging an opening 306, in this case two openings 306, formed by two pairs of braided wire bundles 304 as they merge into two proximal terminations 302. While in a compressed or partially deployed state, the overlying sheath (not shown ) maintains the mechanical attachment between the proximal transverse edge 312 of the implant anchor 310 and the distal-facing region 308 of the transverse opening 306 by limiting the radial movement of the distal-facing region 308 of the transverse opening 306 away from the transverse edge 312, which would release the mechanical attachment. Once the sheath is sufficiently withdrawn to allow the distal-facing region 308 of the transverse opening 306 to expand or move radially from the transverse edge 312, the implant is released from the implant anchor 310 and allowed to fully deploy. It is noted that, while FIGs. 3A and 3B show the implant anchor mechanically attaching to the openings at the proximal terminations of the implant, any location along the implant capable of receiving and forming a mechanical attachment with the implant anchor can be similarly utilized and is considered to be within the present scope.
FIG. 3B shows an example of an implant anchor 310 coupled to a distal guide 314. The implant anchor 310 is shown protruding from a sheath 316, with a plurality of braided wire bundles 304 from an implant surrounding the implant anchor 310. The braided wire bundles 304 couple together proximally to form transverse openings (not shown), at least one of which is held in a mechanically locked configuration with the implant anchor 310 by an inner wall of the sheath 316, thus maintaining the implant compressed into an undeployed state. When the braided wire bundles 304 are released from the confinement of the sheath 316, the implant is allowed to expand, transverse opening and the implant anchor 310 are released from the mechanically locked configuration, and the implant is released from the implant anchor 310. FIG. 3C shows an isometric view of an example of an implant anchor 310 and a distal guide 314 protruding from a sheath 316, with a plurality of braided wire bundles 304 from an implant surrounding the implant anchor 310.
FIG. 4A shows a delivery device 400 mechanically coupled to a wire-braided implant 401. The delivery device includes a spacer 402 coupled between an implant anchor 406 and a pusher coupling 412. The pusher coupling 412 provides an engagement between the spacer 402 and a pusher wire 414. The implant 401 includes a plurality of braided wire bundles 450 that form multiple transverse openings 454 as they converge into multiple proximal terminations 452. When the implant 401 is in an undeployed state, as is shown in FIG. 4A, the implant anchor 406 engages one or more transverse openings 454 to form a mechanical attachment that secures the implant 401 to the delivery device 400. The implant 401 is prevented from deploying by an overlying sheath 416 that limits radial movement of the braided wire bundles 450 away from the spacer 402. As such, the implant 401 is secured to the delivery device 400 by the mechanical engagement between the transverse openings 454 and the implant anchor 406 until the proximal end of the implant 401, in this case the proximal terminations 452, is released from the sheath 416.
FIG. 4B shows the sheath 416 pulled back (or the pusher wire 414 moved forward, or both) to expose a distal portion of the proximal terminations 452. At this point the transverse openings 454 remain mechanically engaged with the implant anchor 406, thus maintaining the capacity for the implant 401 to be fully or partially withdrawn into the sheath 416. This capacity is maintained until the proximal end 453 of the implant 401 has been exposed from the sheath 416 to a degree that allows the proximal terminations 452 sufficient radial movement such that the transverse openings 454 disengage from the implant anchor 406. Depending on the distance of the openings 454 from the proximal terminations 452, disengagement can occur as the proximal terminations 452 are released from the sheath 416 or prior to the release of the proximal terminations 452 from the sheath 416.
FIG. 4C shows the release of the implant 401 from the implant anchor 406 of the delivery device 400 and into the fully deployed state. As the sheath 416 releases the proximal terminations 452, the body of the implant 401 expands radially away from the implant anchor 406, thus breaking the mechanical attachment therewith.
In one example, the proximal transverse edge of the implant anchor is structurally configured to mechanically disengage from the proximal transverse opening when the delivery lumen is withdrawn to fully expose a proximal end of the implant. In another example, the proximal transverse edge of the implant anchor is structurally configured to mechanically disengage from the proximal transverse opening when the delivery lumen is withdrawn to expose a proximal end of the implant sufficiently to allow the proximal transverse opening to lift off of the proximal transverse edge between the implant anchor and the delivery lumen.
The implant can thus be deployed to a significant extent while retaining the capacity to withdraw the implant back into the sheath. In one example, the proximal transverse edge of the implant anchor and the delivery lumen are structurally configured to maintain the capacity to withdraw the implant into the delivery lumen when the implant is at least 70% deployed. In another example, the proximal transverse edge of the implant anchor and the delivery lumen are structurally configured to maintain the capacity to withdraw the implant into the delivery lumen when the implant is at least 80% deployed. In a further example, the proximal transverse edge of the implant anchor and the delivery lumen are structurally configured to maintain the capacity to withdraw the implant into the delivery lumen when the implant is at least 90% deployed.
It is noted that the presently described mechanical attachment functions according to passive release, whereby the withdrawal of the sheath releases the mechanical engagement by allowing the openings of the braided wire bundles to expand away from the implant anchor. It is additionally noted that the implant device expansion can include self-expansion or expansion by other mechanical mechanisms, such as balloon assisted expansion. The implant anchor can be formed into a variety of shapes and sizes and can attach to one or more openings in the implant, including two or more openings.
FIG. 5 shows one example cross section of a delivery device including a spacer 502 a distal guide 504. An implant anchor 506 is positioned between the spacer 502 and the distal guide 504, which is configured to couple to the proximal end of an implant (not shown). A pusher coupling 512 provides an attachment point 504 between the spacer 502 and a pusher wire 510.
FIGs. 6A and 6B show the placement and delivery of an implant 601 from a delivery device 600 into a lumen of a blood vessel 612. The delivery device 600 includes a spacer 602 coupled between an implant anchor 606 and a pusher coupling 614, which is in turn coupled to a pusher wire 604. As is shown in FIG. 6A, the delivery device 600 is passed through the lumen of the blood vessel 612 with the implant 601 in an undeployed configuration to a desired position. As is shown in FIG. 6B, the sheath 608 of the delivery device 600 is pulled back distally (or the implant pushed distally, or both) to allow the implant 601 to expand radially away from spacer 602 as it is exposed. Once the proximal end of the implant 601, in this example the proximal terminations 620, is sufficiently exposed, the proximal end of the implant 601 is allowed to immediately expand away from the implant anchor 606, which releases the implant 601 from the delivery device 600.
The delivery devices of the present disclosure can be made from various materials, as is known to those of ordinary skill in the art. For example, pushers, pusher couplings, spacers, implant anchors, and the like can be made from any physiologically compatible material that has appropriate material characteristics to perform delivery and deployment of an implant as outlined herein. Nonlimiting examples of such materials can include nitinol materials, stainless steel, platinum, titanium, iridium, etc., including alloys and mixtures thereof.
Radiopaque materials used in the presently disclosed devices can be any biologically compatible material capable of being incorporated therein. Nonlimiting examples of radiopaque materials can include tantalum, tungsten, bismuth, gold, titanium, platinum, palladium, rhodium, iridium, tin, and mixtures, blends, composites, and alloys thereof. Implants can include a variety of stents and other medical devices, such as vascular stent grafts, endovascular embolization devices, flow diverters, flow disrupters, erodible drug delivery devices, to name a few, which can be made from a variety of materials known to those of ordinary skill in the art. For example, an implant can be made from laser cut materials, polymeric materials, fabric materials, braided wire materials, and the like. In one example, an implant is made from bundles of wires braided together. In another example of the present disclosure, an implant can be made from mixed materials, or in other words, a combination of two or more laser cut materials, polymeric materials, wire materials, braided wire materials, and the like, including any other materials known to those skilled in the art that can be beneficially used in the presently disclosed devices.
Furthermore, wire used to create wire bundles can be any physiologically compatible shape memory alloy capable of forming an implant device as per the present disclosure. Nonlimiting examples of shape memory alloys can include Ag- Cd, Au-Cd, Co-Ni-Al, Co-Ni-Ga, Cu-Al-Be-X (where X is Zr, B, Cr, or Gd), Cu-Al- Ni, Cu-Al-Ni-Hf, Cu-Sn, Cu-Zn, Cu-Zn-X (where X is Si, Al, or Sn), Fe-Mn-Si, Fe- Pt, Mn-Cu, Ni-Fe-Ga, Ni-Ti, Ni-Ti-Hf, Ni-Ti-Pd, Ni-Mn-Ga, Ti-Cr or Ti-Nb, including combinations thereof. In another example, the wire can include a drawn filled tubing wire. While any combination of useful wire materials is contemplated, in one example the outer tube can be made of a nickel/titanium alloy and the inner core material can be a radiopaque material.
In one specific nonlimiting example, a metal alloy of nickel and titanium (Nitinol®) can be used as wires used to create the braided wire. Nitinol alloys are named according to the weight percentage of nickel in the alloy. For example, Nitinol 50, Nitinol 55, and Nitinol 60 include weight percentages of nickel in the alloy of 50%, 55%, and 60%, respectively. Any alloy of Nitinol can be used in the wire bundles that can be used to make an implant according to the present disclosure. Furthermore, the diameter of the Nitinol wire (or any other shape memory alloy wire) can be from about 0.008 inches to about 0.0005 inches in diameter in one example, from about 0.005 inches to about 0.0009 inches in diameter in another example, and from about 0.002 inches to about 0.0015 inches in diameter, without limitation.