Patent Application
20180200041
The present embodiments relate generally to medical devices, and more particularly, to endografts used to treat a diseased vessel or region of vessels.
The functional vessels of human and animal bodies, such as blood vessels and ducts, occasionally weaken or even rupture. For example, the aortic wall can weaken, resulting in an aneurysm. Upon further exposure to hemodynamic forces, such an aneurysm can rupture. One study found that in Western European and Australian men who are between 60 and 75 years of age, aortic aneurysms greater than 29 mm in diameter are found in 6.9% of the population, and those greater than 40 mm are present in 1.8% of the population.
One surgical intervention for weakened, aneurysmal, or ruptured vessels involves the use of an endoluminal prosthesis such as a stent-graft or endograft. Such a prosthesis may provide some or all of the functionality of the original, healthy vessel and/or preserve any remaining vascular integrity by replacing a length of the existing vessel wall that spans the site of vessel failure. A prosthesis of this type can treat, for example, aneurysms of the aortic arch, thoracic aorta, abdominal aortic, iliac, or renal arteries. In cases of aortic pathologies such as dissection or aneurysm, it is often necessary to introduce an endograft to replace or exclude the affected portion of the anatomy. Although open repair to replace a portion of the vessel may be preferable in some cases, many patients are ineligible for open surgery due to secondary issues, and require the placement of an endograft for treatment.
A properly placed prosthesis excludes the diseased and/or aneurysmal portion of the vessel. For weakened or aneurysmal vessels, even a small leak (“endoleak”) in or around the prosthesis may lead to the pressurization of or flow (including retrograde flow) in the treated vessel which may aggravate the condition that the prosthesis was intended to treat. Over time, even a properly placed prosthesis may eventually have a reduced hemodynamic seal and incur endoleak in or around the prosthesis, for example, due to changes in anatomy or disease progression.
The disclosed embodiments relate to a graft material suitable for use in a medical procedure.
In one example, the graft material may have a plurality of circumferential threads and may achieve at least two unique physical states. Each thread may be constructed such that during a first state, the threads are taut, inexpansible, and have a first diameter. Each thread may also be constructed such that during a second state occurring after the first state, the threads are taut, inexpansible, and have a second diameter greater than the first diameter.
In another example, the first and second diameters may be predetermined.
In another example, at least one thread may be constructed from at least two fibers. The two fibers may be interwoven or intertwined. Each fiber may have a bioabsorption rate. The first fiber may be nonbioabsorbable, and the second fiber may be bioabsorbable. The first fiber may be inexpansible. In the second state having a greater diameter than the first state, the second fiber may be substantially bioabsorbed.
In a further example, at least one thread may further comprise a third fiber, wherein the first and third fibers are counterwoven around the second fiber. The third fiber may be nonbioabsorbable and inexpansible. Alternatively, the third fiber may be inexpansible and have a third bioabsorption rate greater than zero and different from the second bioabsorption rate of the second fiber.
In another example, the graft material may form at least one sealing zone of an endograft. In another example, one of the fibers may comprise texturized yarn.
In another example, the first fiber and second fiber may be interwoven (or intertwined) at a generally uniform interweave spacing. The difference in length between the second circumference and the first circumference may be proportional to the interweave spacing.
The methods and systems disclosed herein are nonlimiting and may be applied to other vasculature or anatomy. Other systems, methods, features and advantages of the invention will be, or will become, apparent to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, methods, features and advantages be within the scope of the invention, and be encompassed by the following claims.
The invention can be better understood with reference to the following drawings and description. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. Moreover, in the figures, like referenced numerals designate corresponding parts throughout the different views.
In the present application, the term “proximal” refers to a direction that is generally upstream to the direction of blood flow during a medical procedure, while the term “distal” refers to a direction that is generally downstream to the direction of blood flow during a medical procedure.
As used herein, the terms “bioabsorption,” “biodegradable,” and “bioabsorbable” mean a capacity to be taken in and made part of an existent whole, to be assimilated, or to be dissolved by an organism. Per the purposes of this disclosure, “bioabsorption,” “biodegradable,” “bioresorbable,” “bioerodable,” and “bioabsorbable” have the same meaning. It is to be understood that wherever the term “bioabsorbable” is used, including the claims, the terms “bioabsorption,” “bioresorbable,” “bioerodable,” and “biodegradable” can be substituted.
The embodiments described below are in connection with systems and methods for the introduction and deployment of an implantable medical device in a vessel, such as endovascular prostheses, but could also be used for deploying a range of implantable medical devices including, but not limited to, stents, occlusion devices and the like.
Referring to
An aneurysm 50 may form at almost any level of the aorta or other vessel, for example, in the descending aorta 16 distal to the renal arteries 40 and proximal to the iliac bifurcation 60. As shown, an endograft 100 may be implanted in the aorta 10 (here, descending aorta 16), such that blood flows through the endograft 100, avoiding the aneurysm 50. Use of an endograft 100 reduces pressure on the aneurysm 50 and can cause the aneurysm 50 to shrink in size. The endograft 100 may incorporate self-expanding stents. The shape, size, and position of the endograft 100 may also be modified through use of a balloon catheter.
The endograft 100 may comprise an expandable support structure 110 (not shown) and a graft material 120, including a tubular main body 140 having a proximal end 130 with a proximal opening 135, a distal end 150 with a distal bifurcation 154 and distal openings 155, and a lumen 160 extending therebetween. The proximal opening 135 and distal openings 155 may both provide fluid access to the lumen 160 of the main body 140. The main body 140 may be generally tubular in shape, and have either a uniform or varying diameter along its length.
The proximal end 130 may have a proximal sealing zone 132 where the graft material 120 is in contact with a vessel wall, here, the descending aorta 16 distal to the renal arteries 40 and proximal to the iliac bifurcation 60. The distal end 150 may have distal sealing zones 152 where the graft material 12.0 is in contact with the vessel walls, here, the right iliac artery 62 (shown on left) and left iliac artery 64 (shown on right) distal to the iliac bifurcation. The proximal and distal sealing zones 132 and 152, respectively, may form a hemodynamic seal with their respective vessel walls. The hemodynamic seal may prevent endoleak, retrograde blood flow, and blood flowing past (exerting pressure on) the aneurysm 50. This may also help maintain the hemodynamic seal over a longer period of time and over a range of conditions.
In another embodiment (not shown), the proximal end 130 may extend proximally such that the proximal sealing zone 132 is proximal to the renal arteries 40. To maintain blood flow to the renal arteries 40, the main body 140 may have one or more openings called fenestrations. Covered branch stents (or branch endografts) may extend through one or more fenestrations to cannulate the renal arteries 40. The branch stent may be deployed with the distal end within the renal arteries 40, the branch stent body passing through a fenestration in the endograft 100, and some proximal portion of the branch stent protruding into the lumen 160 of the endograft 100.
Referring to
Referring to
The circumferential threads 200 may comprise at least first and second fibers 210 and 220, respectively, having first and second bioabsorption rates 212 and 222 and first and second spring constants 214 and 224, respectively. As shown in
For example, the first and third fibers 210 and 230, respectively, may have first and third bioabsorption rates 212 and 232 of about zero, such that both are substantially nonbioabsorbable (nonbiodegradable). The first and third fibers 210 and 230, respectively, may have first and third spring constants 214 and 234 of about zero, such that both are substantially inelastic. The second fiber 220 may have a second bioabsorption rate 222 greater than zero, such that it may biodegrade over time after implantation. The second fiber 220 may either have a second spring constant 224 of about zero (substantially inelastic) or greater than zero (elastic).
After endograft 100 is deployed (post-implantation), any fibers exposed to the body and having an absorption rate greater than zero may biodegrade as molecules of the fiber are absorbed into the body over time. Continuing with the example from above, the second fiber 220 having a second bioabsorption rate 222 greater than zero may biodegrade over time while first and third fibers 210 and 230, respectively, having bioabsorption rates (212 and 232) of about zero do not biodegrade. As a result, the length of each thread will elongate from an initial length L0 and diameter D0 (
In one example, D0 may be about 36 mm, D2 may be 40-42 mm, and D1 may be any intervening diameter. Other sizes can be easily made to accommodate a patient's specific anatomy and anticipated changes in diameter.
The lengths L0 and L2 can be predetermined by precisely winding the first fiber 210 and third fiber 230 around the second fiber 220. The first fiber 210 and third fiber 230 may be counterwoven and have a generally uniform interweave spacing 250. The greater the frequency that first fiber 210 and third fiber 220 are wound around second fiber 220, the greater the difference between lengths L0 and L2 (and diameters D0 and D2). This is because each additional winding provides additional fiber length that will become available after the second fiber 220 biodegrades. The interweave spacing may be directly proportional to the change in length from L0 to L2. Additionally, since the first fiber 210 and third fiber 230 are substantially inelastic (and the second fiber 220 may also be substantially inelastic or inexpansible), the lengths L0 and L2 may be substantially inexpansible.
As shown in
In the same manner that the difference between L0 and L2 can be predetermined by precisely winding the first and third fibers 210 and 230 around the second fiber 220, D0 and D2 can be similarly predetermined since circumferential thread length is directly proportional to diameter (circumference=π*diameter). Thus, the initial diameter D0 and final diameter D2 can be predetermined by controlling frequency of the fiber windings.
Other factors that may affect the difference of D0 and D2 include the diameter of second fiber 220, and the spacing of the windings (windings per unit length) of 230 and 210 around the second fiber 220. The difference between D0 and D2 may increase for larger diameters of second fiber 220 and for greater numbers of windings per unit length of first fiber 210 and third fiber 230. Another factor that may affect the difference between D0 and D2 is the exact woven textile of the graft material 120. A more rigid graft material 120 may reduce the flexibility of the graft material at the sealing zones.
In general, the diameter of the first fiber 210 and third fiber 230 may be between 33% and 200% the diameter of the second fiber 220. However, these ranges are not absolute, and may be between 1% and 1000% of the second fiber 220.
The rate of change in diameter can be predetermined by controlling the bioabsorption rate 222 of the second fiber 220. In essence, the higher the bioabsorption rate 222, the faster the diameter will increase from D0 to D2. Another factor that may affect the rate of change in diameter is the spacing of the windings, which may also affect the bioabsorption rate 222 of the second fiber 220. For example, if the first fiber 210 and third fiber 230 are counterwoven tightly (increased windings per unit length) around the second fiber 220, the surface area of the second fiber 220 actually exposed to blood (or other fluids) may be reduced, thereby reducing the actual bioabsorption rate 222. This may be further affected by the material and construction of the fibers themselves (e.g., hydrophobic vs. hydrophilic). Thus, the optimal spacing of the first and third fibers 210 and 230 around the co-axial core second fiber 220 may require empirical testing for the given material(s) used to construct the threads.
The selection of material for second fiber 220 may produce graft materials 120 with varying mechanical properties at the sealing zones. For example, a polycaprolactone or a co-polymer of polycaprolactone may provide higher elasticity of second fiber 220 (or other components of the graft material 120), while other materials such as Polylactide, Polyglycolide, or a co-polymer thereof, may provide lower elasticity of second fiber 220 (or other components of the graft material 120).
The expandable support structure 110 provides a constant expansion force throughout the endograft body 140, including the proximal sealing zone 132 and distal sealing zones 152. Thus, as the fibers biodegrade, the threads gradually elongate, and the diameter at the sealing zones gradually increase because the graft material is subject to radially outward tension via the expandable support structure 110.
The support structure 110 of the endograft 100 may have any suitable stent pattern known in the art. The support structure 110 may be self-expanding or may expand under external pressures, for example from an inflatable balloon at the tip of a balloon catheter. One example of a stent pattern is the Z-stent or Gianturco stent design. Each Z-stent may include a series of substantially straight segments or struts interconnected by a series of bent segments or bends. The bent segments may include acute bends or apices. The Z-stents are arranged in a zigzag configuration in which the straight segments are set at angles relative to one another and are connected by the bent segments. Alternative stents may include, for example, annular or helical stents. The stents mentioned herein may be made from standard medical grade stainless steel. Other stents may be made from nitinol or other shape-memory materials.
The graft material 120 may be connected to the one or more support structures 110 (not shown) by known methods, for example biocompatible stitching. The graft material 120 for the main endograft body 140 (excluding the proximal and distal sealing zones 132 and 152, respectively) may be fabricated from any at least substantially biocompatible material including such materials as polyester fabrics, polytetrafluoroethylene (PTFE), expanded PTFE, and other synthetic materials known to those of skill in the art. In some embodiments in accordance with the technology, the graft material 120 may also include drug-eluting coatings or implants. These materials may also be used in fabricating the non-biodegradable fibers used at the sealing zones (e,g., first fiber 210, third fiber 230, etc.).
The biodegradable fibers used in the threads comprising the plurality of circumferential threads 200 used at the proximal and distal sealing zones 132 and 152, respectively, may be fabricated from any at least substantially biocompatible and biodegradable material including such materials as polyhydroxyalkanoate, polyalpha-hydroxy acid) such as polylactide (PLA) [including poly-L-lactide (PLLA), poly-D-lactide (PDLA)], polyglycolide (PGA), polydioxanone, polycaprolactone, polygluconate, polylactic acid-polyethylene oxide copolymers, poly(hydroxybutyrate), polyanhydride, polyphosphoester, poly(amino acids), and/or related copolymers thereof, each of which have a characteristic degradation rate in the body. For example, PGA and polydioxanone are relatively fast-bioabsorbing materials (weeks to months) and PLA and polycaprolactone are relatively slow-bioabsorbing material (months to years). Other synthetic materials known to those of skill in the art may also be utilized. In some embodiments in accordance with the technology, the biodegradable fibers may also include drug-eluting coatings or implants.
In some examples, relatively slow bioabsorbing materials may be preferable. For example, in patients where the predicted rate of expansion of the vessel is on the order of months to years, materials and fabrications that biodegrade at a similar rate may be utilized so as to maintain the hemodynamic seal over the same time period. Additionally, this may allow tissue ingrowth into the newly created space where the bioabsorbable materials have biodegraded, thereby maintaining the fluid-tight seal at the sealing zone and preventing the graft material from leaking or sweating.
In one example, the bioabsorption may occur over the course of 2-6 months. In another example, the bioabsorption may occur over the course of 6-12 months. In another example, the bioabsorption may occur over the course of 1-5 years.
As shown in
As shown in
As discussed above with respect to
In other examples not shown here, additional fibers may be incorporated into the threads comprising the plurality of circumferential threads 200. For example, a fourth or fifth fiber may be added, each having any of the properties described above with respect to bioabsorption and elasticity (expansibility).
In another example, at least one of the fibers (e.g., first fiber 210 and/or third fiber 230) may be elastic, and as a result, the graft material 120 forming at least one of the proximal or distal sealing zones 132 and 152, respectively, may be elastic and/or expansible so as to accommodate further radial expansion.
In another example, at least two of the fibers (e.g., second fiber 220 and third fiber 230) may have bioabsorption rates greater than zero and that are different from one another. Thus, the threads may have a first predetermined length L0 (with corresponding first predetermined diameter D0 at the respective sealing zone) upon initial deployment/implantation. As the fiber with faster bioabsorption rate biodegrades, the threads may have an intermediate length L1 (with corresponding diameter D1), and after it completely biodegrades, a second predetermined length L2 (with corresponding second predetermined diameter D2 at the respective sealing zone). As the fiber with the slower bioabsorption rate biodegrades, the threads may have an second intermediate length L3, and after it completely biodegrades, a third predetermined length L4 (with corresponding third predetermined diameter D4 at the respective sealing zone) If any of the fibers are inelastic, then the predetermined lengths and diameters may also be inexpansible, whereas elastic fibers may result in expansible lengths and diameters. Additional predetermined lengths (e.g., fourth predetermined length and diameter) can be accommodated via additional fibers having appropriate windings and bioabsorption rates.
In another example, one or more of the fibers (e.g., first fiber 210 and/or second fiber 220) may be formed from a texturized yarn, for example, having a wave-like pattern that may straighten and elongate given appropriate pressure and space to expand. Thus, the threads may have a first predetermined length (and corresponding first predetermined diameter at the respective sealing zone). After the texturized yarn elongates to full length, the threads may have a second predetermined length (and corresponding second predetermined diameter at the respective sealing zone).
The controlled expansion of select portions of an endograft 100 may have several advantages and uses in different patient populations.
First, it may be useful in patients where the aneurysm disease state is predicted to progress towards one or more of the proximal or distal sealing zones 132 and 152, reducing the integrity of the hemodynamic seal. Using such an embodiment may reduce the frequency of follow up procedures which might otherwise be required to repair or replace the endograft 100 when the hemodynamic seal fails (resulting in possible endoleak, retrograde blood flow, etc.). The controlled expansion may result in a hemodynamic seal being maintained even where the aneurysm progresses and the diameter of the vessel at the sealing zone increases. This maintains the fluid-tight seal even as the vessel expands over time, which may not have been possible if the graft material 120 had simply been “oversized.” Oversizing the graft material 120 would likely have resulted in folds in the graft material 120, reduced patency with the vessel wall, and a corresponding reduced integrity of the hemodynamic seal.
Second, it may be useful in patients whose bodies that are growing, for example, children or adolescents, where the diameter of certain vessels may grow at predictable rates. Using such an embodiment may reduce the frequency of follow up procedures which might otherwise be required as the patient's cardiac anatomy matures and grows. In such an embodiment, the plurality of circumferential threads 200 comprising first and second fibers 210 and 220, respectively, may be used throughout the construction of the endograft 100, thereby allowing the entire endograft 100 to expand over time, not just the sealing zones 132 and 152 as described in certain examples above.
Third, the controlled bioabsorption may facilitate tissue ingrowth into the endograft 100. Over time, endothelial-like cells may adhere to the endograft 100, resulting in tissue ingrowth. The rate of tissue ingrowth may depend on multiple variables, including graft material, pore size, and thread weave pattern. The bioabsorption rate of the fibers that may biodegrade (e.g., bioabsorption rate 222 of second fiber 220) may be tailored to approximate the tissue ingrowth rate. By doing so, the graft material 120 at the sealing zones 132 and 152 may retain sufficient thickness, porosity, and structural integrity.
In use, endograft 100 may be deployed intravascularly, for example in the descending aorta 16 distal to the renal arteries 40. The delivery system containing the graft may be tracked from a distal approach (e.g., transfemoral) and guided to the descending aorta 16 distal to the renal arteries 40. The main body 140 of the endograft 100 may be deployed by retraction of an outer sheath (not shown). The endograft 100 may employ diameter reduction ties (not shown) to prevent full deployment at this stage. After cannulation of any branch vessels (if applicable), if diameter reduction ties are in place, they may be removed to fully deploy the endograft 100. After deployment, any wires and catheters may be removed from the system.
Upon the initial deployment, the graft material may be fully expanded to a first configuration. The plurality of circumferential threads 200 at the proximal and distal sealing zones 132 and 152, respectively, may have an initial predetermined circumference corresponding to the initial diameters D0 and thread lengths L0. Over time, one or more biodegradable fibers within each thread (e.g., second fiber 220) may partially biodegrade, resulting in a thinner biodegradable fiber(s) that is still intact. As a result, other fibers inter-woven with the at least one biodegradable fiber may elongate and straighten, resulting a longer thread length L1 and corresponding diameter D1 at the respective sealing zone(s). After more time, the one or more biodegradable fibers within each thread may completely biodegrade, whereby the remaining fibers may further straighten and elongate. The thread length may increase to a second predetermined length L2 and the diameter may increase to predetermined diameter D2 at the respective sealing zone(s). If additional biodegradable fibers are utilized in the fabrication of the threads, additional time may result in the further elongation of threads to L3 and L4 and increase in diameter at the respective sealing zones to D3 and D4.
Each predetermined thread length (and corresponding predetermined diameter and/or circumference) may be referred to as a “state.” For example, the first state may correspond to predetermined thread length. L0 and predetermined diameter D0, and the second state may correspond to predetermined thread length L2 and predetermined diameter D2. As discussed herein, the length of each circumferential thread may increase (e.g., L0 to L1 to L2) and the corresponding diameter at the respective sealing zone may also increase (e.g., D0 to D1 to D2) with a corresponding increase in circumference (e.g., C0 to C1 to C2, not shown).
It should be understood that the circumference (and by association the length of circumferential threads) is generally equivalent to the diameter multiplied by pi. However, anatomical variations and other factors such as materials and fabrication technique may result in some variation. For example, variation in the vessel walls and/or progression of an uneven aneurysm may result in the cross-section of the vessel at the respective sealing zone not being a perfect circle. Thus, herein the diameter may be referenced and discussed for illustrative purposes, it should be understood that any predetermined diameter (e.g., D0 to D1 to D2) implies a predetermined circumference (e.g., C0 to C1 to C2, not shown).
The embodiments described herein provide non-limiting examples of endografts that are suitable for treating an array of medical conditions, and may be especially suited for treating an aortic aneurysm within the descending aorta 16. Various additional modular components may be provided for the endograft 100, for example, additional fenestrations, branching, and branch stents may be utilized.
While references to treatment of an aneurysm at or near the descending aorta 16 may be explained as one example, it will be appreciated that endograft 100 can be positioned at other bodily locations to treat aneurysms or other conditions, using the system and methods described herein.
While various embodiments of the invention have been described, the invention is not to be restricted except in light of the attached claims and their equivalents. Moreover, the advantages described herein are not necessarily the only advantages of the invention and it is not necessarily expected that every embodiment of the invention will achieve all of the advantages described.
The present application claims priority to U.S. provisional patent application No. 62/447,677 filed on Jan. 18, 2017, the entirety of which is incorporated by reference herein.
| Number | Date | Country | |
|---|---|---|---|
| 62447677 | Jan 2017 | US |
