Patent Grant
10967556
The present invention relates to medical devices; more particularly, this invention relates to processes for uniformly crimping and deploying a medical device, such as a polymeric scaffold, to and from, respectively, a delivery balloon.
Radially expandable endoprostheses are artificial devices adapted to be implanted in an anatomical lumen. An “anatomical lumen” refers to a cavity, or duct, of a tubular organ such as a blood vessel, urinary tract, and bile duct. Stents are examples of endoprostheses that are generally cylindrical in shape and function to hold open and sometimes expand a segment of an anatomical lumen. Stents are often used in the treatment of atherosclerotic stenosis in blood vessels. “Stenosis” refers to a narrowing or constriction of the diameter of a bodily passage or orifice. In such treatments, stents reinforce the walls of the blood vessel and prevent restenosis following angioplasty in the vascular system. “Restenosis” refers to the reoccurrence of stenosis in a blood vessel or heart valve after it has been treated (as by balloon angioplasty, stenting, or valvuloplasty) with apparent success.
The treatment of a diseased site or lesion with a stent involves both delivery and deployment of the stent. “Delivery” refers to introducing and transporting the stent through an anatomical lumen to a desired treatment site, such as a lesion. “Deployment” corresponds to expansion of the stent within the lumen at the treatment region. Delivery and deployment of a stent are accomplished by positioning the stent about one end of a catheter, inserting the end of the catheter through the skin into the anatomical lumen, advancing the catheter in the anatomical lumen to a desired treatment location, expanding the stent at the treatment location, and removing the catheter from the lumen.
The stent must be able to satisfy a number of basic, functional requirements. The stent (or scaffold) must be capable of sustaining radial compressive forces as it supports walls of a vessel. Therefore, a stent must possess adequate radial strength. After deployment, the stent must adequately maintain its size and shape throughout its service life despite the various forces that may come to bear on it. In particular, the stent must adequately maintain a vessel at a prescribed diameter for a desired treatment time despite these forces. The treatment time may correspond to the time required for the vessel walls to remodel, after which the stent is no longer needed.
Scaffolds may be made from a biodegradable, bioabsorbable, bioresorbable, or bioerodable polymer. The terms biodegradable, bioabsorbable, bioresorbable, biosoluble or bioerodable refer to the property of a material or stent to degrade, absorb, resorb, or erode away from an implant site. Scaffolds may also be constructed of bioerodible metals and alloys. The scaffold, as opposed to a durable metal stent, is intended to remain in the body for only a limited period of time. In many treatment applications, the presence of a stent in a body may be necessary for a limited period of time until its intended function of, for example, maintaining vascular patency and/or drug delivery is accomplished. Moreover, it has been shown that biodegradable scaffolds allow for improved healing of the anatomical lumen as compared to metal stents, which may lead to a reduced incidence of late stage thrombosis. In these cases, there is a desire to treat a vessel using a polymer scaffold, in particular a bioabsorbable or bioresorbable polymer scaffold, as opposed to a metal stent, so that the prosthesis's presence in the vessel is temporary.
Polymeric materials considered for use as a polymeric scaffold, e.g. poly(L-lactide) (“PLLA”), poly(D-lactide) (“PDLA”), poly(D,L-lactide-co-glycolide), poly(D-lactide-co-glycolide) or poly(L-lactide-co-D-lactide) with less than 10% D-lactide, poly(L-lactide-co-caprolactone), poly(caprolactone), PLLA/PDLA stereo complex, and blends of the aforementioned polymers may be described, through comparison with a metallic material used to form a stent, in some of the following ways. Polymeric materials typically possess a lower strength to volume ratio compared to metals, which means more material is needed to provide an equivalent mechanical property. Therefore, struts must be made thicker and wider to have the required strength for a stent to support lumen walls at a desired radius. The scaffold made from such polymers also tends to be brittle or have limited fracture toughness. The anisotropic and rate-dependent inelastic properties (i.e., strength/stiffness of the material varies depending upon the rate at which the material is deformed, in addition to the temperature, degree of hydration, thermal history) inherent in the material, only compound this complexity in working with a polymer, particularly, bioresorbable polymers such as PLLA or PLGA.
Scaffolds and stents traditionally fall into two general categories—balloon expanded and self-expanding. The later type expands (at least partially) to a deployed or expanded state within a vessel when a radial restraint is removed, while the former relies on an externally-applied force to configure it from a crimped or stowed state to the deployed or expanded state.
Self-expanding stents are designed to expand significantly when a radial restraint is removed such that a balloon is often not needed to deploy the stent. Self-expanding stents do not undergo, or undergo relatively no plastic or inelastic deformation when stowed in a sheath or expanded within a lumen (with or without an assisting balloon). Balloon expanded stents or scaffolds, by contrast, undergo a significant plastic or inelastic deformation when both crimped and later deployed by a balloon.
In the case of a balloon expandable stent, the stent is mounted about a balloon portion of a balloon catheter. The stent is compressed or crimped onto the balloon. Crimping may be achieved by use of an iris or sliding-wedge types, or other types of crimping mechanisms. A significant amount of plastic or inelastic deformation occurs both when the balloon expandable stent or scaffold is crimped and later deployed by a balloon. At the treatment site within the lumen, the stent is expanded by inflating the balloon. The expanded state is achieved and maintained, substantially, if not entirely by an irreversible or inelastic strain at the crowns of the stent or scaffold caused by the balloon expansion. Self-expanding stents or scaffolds, by contrast, achieve and maintain their expanded state in the vessel by an elastic, radially outward force.
A film-headed crimper has been used to crimp stents to balloons. Referring to
The dispensed sheets of non-stick material are used to avoid buildup of coating material on the crimper blades for stents coated with a therapeutic agent. The sheets 125a, 124a are replaced by a new sheet after each crimping sequence. By advancing a clean sheet after each crimp, accumulation of contaminating coating material from previously crimped stents is avoided. By using replaceable sheets, stents having different drug coatings can be crimped using the same crimping assembly without risk of contamination or buildup of coating material from prior stent crimping.
There is a continuing need to improve upon methods for crimping a medical device and, in particular, a polymer scaffold to a delivery balloon in order to improve upon the uniformity of deployment of a polymer scaffold from the balloon, to increase the retention force between scaffold and balloon, and to obtain a minimal crossing profile for delivery of the scaffold to a target site.
The invention provides methods for crimping a balloon-expanded scaffold to a balloon catheter. According to one embodiment the inventive methods disclosed herein are used to improve upon a crimping process for a thin-walled scaffold. The process may alternatively be used to improve-upon a crimp process used to crimp scaffolds that have thicker walls.
Referring to the case of a thin-walled scaffold, it has been realized through testing a need to modify aspects of a crimping process that did not pose significant problems when a higher wall thickness scaffold was crimped using the same process. An example of a scaffold having a higher wall thickness is described in US 2010/0004735. It has been found that when a significant reduction in wall thickness is made (e.g., from 158 microns or about 160 microns wall thickness down to 100 microns wall thickness or less) prior methods of crimping have proven unsatisfactory. Those prior methods of crimping produced high numbers of twisted, cracked or fractured struts when applied to thin-walled scaffolds.
According to the invention, it has been determined that modifications to a crimping process may better ensure that all four of the following objectives are met:
According to the embodiments, a polymer scaffold is crimped to a balloon of a balloon catheter using a crimping device and a crimping barrier or protective sheet, such as a polymer material and hereinafter referred to as a polymer material. The polymer material is disposed between the surfaces of the scaffold and faces of crimper blades that bear down on the scaffold during crimping. In a preferred embodiment the polymer material are sheets provided with a film-headed crimping device. According to this embodiment, the scaffold is crimped down in intermittent fashion. Between one or more crimping stages the polymer sheets are adjusted to remove slack or excess accumulated sheet material. After this re-setting of the polymer sheets the scaffold diameter is reduced down further, which may be followed subsequently by another re-setting of the polymer sheets, as necessary or desired. The number of re-sets of the polymer sheets will in general depend on the degree of diameter reduction during crimping, and more specifically will depend upon the crimping results, type of scaffold being crimped and material of the scaffold.
In an alternative embodiment the polymer material are sheaths placed over the scaffold. According to this embodiment a sheath having a first size is placed over the scaffold. The scaffold diameter is then reduced down by a crimping device. After the scaffold is partially reduced in diameter, the first sheath is replaced by a second, smaller sheath, matching the reduced diameter of the scaffold. The first sheath is replaced by the second, smaller sheath to avoid interference with the crimping process.
In addition to the aforementioned re-set of polymer material during crimping, in some embodiments a crimping process further includes modifying balloon pressurization during crimping to control distribution of balloon material supporting the scaffold. The objective is to maintain a distribution of small folds of balloon material supporting the scaffold during crimping, both when the crimp head is applying pressure to the scaffold and when the aperture is opened to allow for resetting of polymer material. In order to achieve this objective, balloon pressurization adjustment may be needed between times when the crimp blades apply pressure to the scaffold and when the aperture is open.
When balloon material supporting the scaffold inner diameter is distributed predominately as small folds (as opposed to a mixture of small and large folds) the scaffold expands more uniformly when the balloon is inflated. Balloon material formed into mostly or predominately small folds when the scaffold is compressed into it during crimping will subsequently expand out (when inflated) with relatively even radial outward pressure imposed on the scaffold. This relatively even radial outward pressure produces the desired uniformity of expansion.
If instead the scaffold is compressed down onto a balloon with its material formed into a combination of large and small folds, the balloon material when inflated will not apply uniform radial pressure on the scaffold. This is because areas of the balloon with small folds will expand out more quickly than areas with large folds. As a result, one area or region of the scaffold will expand more quickly than another area. An example of this non-uniform expansion is shown in
If a relatively low balloon pressurization is used during crimping, no balloon pressure adjustments may be needed when crimp blades are removed to reset polymer material. However, if a sufficiently high balloon pressurization is used for crimping, the scaffold may expand outwardly when the crimp blades are withdrawn (a net radial outward force exists on the scaffold when equilibrating radial inward force of crimp blades is removed). It may therefore be desirable to reduce balloon pressure before the crimp blades are removed, so that the scaffold diameter is maintained while the polymer material is reset.
For embodiments where a thin-walled scaffold is crimped, balloon pressure preferably is maintained at a very high level (e.g. near or exceeding a rated burst pressure for the balloon) when the blades are compressing the scaffold (high balloon pressure helps to support scaffold and prevent such events as flipping or twisting of struts from occurring during the diameter reduction). For these embodiments balloon pressure is reduced significantly to avoid expansion of the scaffold when blade pressure is removed. At the same time, a significant amount of balloon pressure must be maintained to ensure that small folds are maintained. It has been found that if the pressure is reduced too much, large folds can form when resetting the polymer material. As explained above, the presence of large folds produces non-uniform expansion of the scaffold. The disclosure provides pressure values to use during resetting of polymer material, relative to or independent of the balloon pressure used when the crimp blades are bearing down on the scaffold.
Although this disclosure primarily refers to the crimping of a scaffold, the scope of the invention is not limited to scaffolds. The disclosure also applies to the crimping of a stent.
According to the various aspects of the invention, there is a medical device, method for crimping, or method for assembly of a medical device comprising such a medical device having one or more, or any combination of the following things (1) through (21):
All publications and patent applications mentioned in the present specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. To the extent there are any inconsistent usages of words and/or phrases between an incorporated publication or patent and the present specification, these words and/or phrases will have a meaning that is consistent with the manner in which they are used in the present specification.
In the description like reference numbers appearing in the drawings and description designate corresponding or like elements among the different views.
For purposes of this disclosure, the following terms and definitions apply:
The terms “about,” “approximately,” “generally,” or “substantially” mean 30%, 20%, 15%, 10%, 5%, 4%, 3%, 2%, 1.5%, 1%, between 1-2%, 1-3%, 1-5%, or 0.5%-5% less or more than a stated value, a range or each endpoint of a stated range, or a one-sigma, two-sigma, three-sigma variation from a stated mean or expected value (Gaussian distribution). For example, d1 about d2 means d1 is 30%, 20%, 15%, 10%, 5%, 4%, 3%, 2%, 1.5%, 1%, 0% or between 1-2%, 1-3%, 1-5%, or 0.5%-5% different from d2. If d1 is a mean value, then d2 is about d1 means d2 is within a one-sigma, two-sigma, or three-sigma variance or standard deviation from d1.
It is understood that any numerical value, range, or either range endpoint (including, e.g., “approximately none”, “about none”, “about all”, etc.) preceded by the word “about,” “approximately,” “generally,” or “substantially” in this disclosure also describes or discloses the same numerical value, range, or either range endpoint not preceded by the word “about,” “approximately,” “generally,” or “substantially.”
The “glass transition temperature,” TG, is the temperature at which the amorphous domains of a polymer change from a brittle vitreous state to a solid deformable or ductile state at atmospheric pressure. This application defines TG and methods to find TG, or TG-low (the lower end of a TG range) for a polymer in the same way as in US20160081824.
A “stent” can mean a permanent, durable or non-degrading structure, usually comprised of a non-degrading metal or metal alloy structure, generally speaking, while a “scaffold” can mean a temporary structure comprising a bioresorbable or biodegradable polymer, metal, alloy or combination thereof and capable of radially supporting a vessel for a limited period of time, e.g., 3, 6 or 12 months following implantation. It is understood, however, that the art sometimes uses the term “stent” when referring to either type of structure and visa-versa.
“Inflated diameter” or “expanded diameter” refers to the inner diameter or the outer diameter the scaffold attains when its supporting balloon is inflated to expand the scaffold from its crimped configuration to implant the scaffold within a vessel. The inflated diameter may refer to a post-dilation balloon diameter which is beyond the nominal diameter, or nominal inflated diameter for the balloon (e.g., a 6.5 mm balloon has a nominal diameter of 6.5 mm or when inflated to its nominal inflated diameter has a diameter of 6.5 mm). The scaffold diameter, after attaining its inflated or expanded diameter by balloon pressure, will to some degree decrease in diameter due to recoil effects related primarily to, any or all of, the manner in which the scaffold was fabricated and processed, the scaffold material and the scaffold design. When reference is made to a fully inflated diameter of a balloon, it refers to balloon pressurization corresponding to the nominal inflated diameter or greater than the nominal inflated diameter. Balloon pressure may be given in pressure units (e.g., psi or N/m2) or relative to standard atmospheric (abbreviated as “atm”). One atm corresponds to about 14.7 psi or 101325 Pascal or N/m2. Typical balloon inflation pressure tables for balloon catheters have nominal or fully inflated pressures of about between 6-8 atm and have rated burst pressures of about 16 atm.
When reference is made to a diameter it shall mean the inner diameter or the outer diameter, unless stated or implied otherwise given the context of the description.
“Post-dilation diameter” (PDD) of a scaffold refers to the inner diameter of the scaffold after being increased to its expanded diameter and the balloon removed from the patient's vasculature. The PDD accounts for the effects of recoil. For example, an acute PDD refers to the scaffold diameter that accounts for an acute recoil in the scaffold.
A “before-crimp diameter” means an outer diameter (OD) of a tube from which the scaffold was made (e.g., the scaffold is cut from a dip coated, injection molded, extruded, radially expanded, die drawn, and/or annealed tube) or the scaffold before it is crimped to a balloon. Similarly, a “crimped diameter” means the OD of the scaffold when crimped to a balloon. The “before-crimp diameter” can be about 2 to 2.5, 2 to 2.3, 2.3, 2, 2.5, 3.0 times greater than the crimped diameter and about 0.9, 1.0, 1.1, 1.3 and about 1-1.5 times higher than an expanded diameter, the nominal balloon diameter, or post-dilation diameter. Crimping, for purposes of this disclosure, means a diameter reduction of a scaffold characterized by a significant plastic deformation, i.e., more than 10%, or more than 50% of the diameter reduction is attributed to plastic deformation, such as at a crown in the case of a stent or scaffold that has an undulating ring pattern, e.g.,
A “crimping stage” or “stage” of a crimping process refers to a period of time when the jaws of a crimping device are held fixed, or the aperture of the crimp head is held at a constant diameter. The duration of the stage may be called a dwell period. Dwell periods can range from 1 sec to 25 sec, for initial stages prior to a final dwell. After the final crimped diameter is reached the dwell may be between 50 sec and 300 sec. The aperture of a crimping device is reduced from a first diameter to a second diameter when the crimping device moves from a first stage to a second stage, respectively. The aperture reduction sizes—e.g., from a first diameter or aperture size to second diameter or aperture size—are, for purposes of this disclosure, understood as being the same as the actual outer diameter of the scaffold within the aperture when the scaffold is being reduced in size by the crimper crimp. It is understood, however, that a programmed aperture size may not be exactly the same as the outer diameter of the crimped scaffold size, especially when a scaffold is being crimped to very small diameters.
A material “comprising” or “comprises” poly(L-lactide) or PLLA includes, but is not limited to, a PLLA polymer, a blend or mixture including PLLA and another polymer, and a copolymer of PLLA and another polymer. Thus, a strut comprising PLLA means the strut may be made from a material including any of a PLLA polymer, a blend or mixture including PLLA and another polymer, and a copolymer of PLLA and another polymer.
When reference is made to a direction perpendicular to, or parallel with/to axis A-A (e.g., as shown in
Wherever the same element numbering is used for more than one drawing it is understood the same description first used for the element in a first drawing applies to embodiments described in later drawings, unless noted otherwise.
The dimension of thickness (e.g., wall, strut, ring or link thickness) refers to a dimension measured perpendicular to both of axes A-A and B-B. The dimension of width is measured in the plane defined by axes A-A and B-B; more specifically, the width is the cross-sectional width from one side to another side of a contiguous structure; thus, link 334 can have a constant link width. Moreover, it is understood that the so-called plane of axes A-A and B-B is technically not a plane since it describes surfaces of a tubular structure having central lumen axis parallel with axis A-A. Axis B-B therefore may alternatively be thought of as the angular component if the scaffold locations were being described using a cylindrical coordinate system (i.e., axis A-A is Z axis and location of a luminal/abluminal surface of a crown, link, ring, etc. is found by the angular coordinate and radial coordinate constant).
A “thin wall thickness,” “thin-walled scaffold,” “thin-wall” refers to a strut, ring, link, or bar arm made from a polymer and having a wall thickness less than 125 microns. The polymer can comprise poly(L-lactide).
A “crimping temperature” according to the disclosure means a temperature above ambient and slightly less than, or about equal to the glass transition temperature (TG) for a polymer of the scaffold, e.g., poly(L-lactide). In a preferred embodiment the crimping temperature is between TG and 15 degrees less than TG, or between TG and 10 degrees, or 5 degrees less than TG. In other embodiments the crimping temperature is achieved by heating the scaffold to a temperature at least 20 degrees below TG and preferably to a temperature at least 15 degrees below TG.
“Re-set of the polymer material within the aperture” as indicated in the crimping steps in
The term “first pressure” or “P1” shall refer to a balloon pressurization while the scaffold is reduced in diameter size using a crimp head, and/or during a dwell period or when the aperture size is maintained at a constant diameter and restraining outward recoil of the scaffold. P1 can range from between about 3 or 4 atm and up to about a rated burst pressure for the balloon. Preferably P1 is between about 200 psi and 250 psi, or between about 13 atm and 17 atm. In other embodiments P1 is higher than P2, or at least twice the pressure of P2. In a preferred embodiment the scaffold is a thin-walled scaffold and P1 is between about 200 psi and 250 psi, between about 13 atm and 17 atm, or about a rated burst pressure for the balloon in order to provide additional support for scaffold struts as the scaffold rings are being deformed by crimper blades. In other embodiments P1 can range from between about 4 atm and 13 atm.
The term “second pressure” or “P2” shall refer to a balloon pressurization during a reset of the polymer material, and/or when crimp blade pressure is withdrawn or not restraining outward recoil of the scaffold. P2 can be above 1 atm, from above 1 atm to 3 atm, up to about 3 or 4 atm, more than 4 atm and less than P1, or about 50% of a nominal inflation pressure for the balloon.
An effective crimping process for a scaffold must at least satisfy each of the following objectives:
As previously reported in US20140096357 a scaffold is not as resilient as a stent made from metal, which is highly ductile. Satisfying all of the above needs is therefore more challenging for a polymer scaffold, especially a thin-walled scaffold that can fracture more easily during crimping or balloon expansion and is more susceptible to twisting, flipping or overlap during crimping.
According to the disclosure there is a crimping process that includes steps where polymer material is re-set or replaced in the crimp head in order to minimize any interference between the compressing-down of the scaffold struts by crimper blades and the polymer material. The polymer material is used to protect the surface or the scaffold, or coating disposed over a scaffold (or stent). However, as the scaffold is crimped further down and its diameter decreases, the polymer material surrounding the scaffold when it had the larger diameter becomes excessive, resulting in folds, roll-up, slackening or loss of tension. Although a crimping mechanism may include a tensioning portion that applies a tensioning force as the aperture decreases (as a means to take-up excess slack in the polymer material) due to the presence of the blades in close proximity, or in contact with surfaces of the scaffold struts the tensioning force cannot remove material from near the scaffold. To address this problem a crimp aperture is opened and sheet material re-set (or replaced, in case of using sheaths).
Re-setting or removal of the excessive polymer material after diameter reductions (by withdrawing the blades or increasing the aperture size, in order to allow the outside tensioning to pull the polymer material away from the scaffold surface) was found to make a significant difference in the quality of crimp and production yields. It was found through testing and experimentation that a re-set or removal of excessive polymer sheet material (or in the alternative embodiment replacing a first sheath with a second, smaller sheath) at critical times (as explained below), following a diameter reduction, can prevent the polymer material from significantly interfering with the desired folding of ring struts about crowns in subsequent diameter reduction steps.
As discussed earlier in reference to
In some embodiments balloon material is complementary to spaces between struts when a length of a small fold is about a space between struts of the scaffold, such as a balloon fold length is about equal to the distance from a first strut to a third strut, and there is a second strut between the first strut and the third strut, or in the example of
Crimping Processes I and II may use one or two balloons. The two balloons referred to in the figures and below discussion are called “Balloon A” and “Balloon B.” The Balloon A refers to the balloon of the balloon catheter of the finished product. The Balloon B refers to a temporary or sacrificial balloon, or balloon catheter that is used during the initial stages then replaced by the Balloon A at the time of a final alignment check, as explained below. Practice of the Process I or Process II using Balloon B (later replaced by Balloon A) is desirable when the starting inner diameter size of the scaffold is larger than, or the same size as the diameter of the Balloon A when Balloon A is inflated to its nominal inflation diameter, or when Balloon A is inflated beyond this size.
In a preferred embodiment of a crimping process a film-headed crimper is used to crimp the scaffold to the balloon catheter. For a film-headed crimper, polymer material in the form polymer sheets dispensed from a pair of rolls (
Referring to
Pre-Crimp Procedure:
The scaffold is placed on Balloon A (or Balloon B if two balloons will be used). The balloon is inflated to its nominal diameter or post-dilation diameter (greater than nominal diameter size) or, more generally, the balloon is fully inflated so that its size is at least equal to or exceeds the inner diameter of the scaffold in order to support the scaffold during the initial crimping steps. The scaffold is aligned with proximal and distal markers on the balloon (not necessary if Balloon B is used). The crimper head, scaffold and/or balloon may also be deionized to remove static charge buildup that can cause the scaffold to shift out of alignment with balloon markers during crimping. Static charge buildup has been found to not only cause misalignment between the scaffold and balloon, but also cause irregular crimping of the scaffold (metal stents typically do not have static charge buildup because the balloon is in sliding contact with a metal, as opposed to a polymer surface). The scaffold is then inserted into the crimper head while the balloon remains fully inflated.
Stage I:
The scaffold supported on the fully inflated balloon is within the crimp head. The temperature for crimping or crimping temperature is set during this stage, as is the starting iris or aperture size corresponding to the input outer diameter of the scaffold (e.g. 3.5 mm). In a preferred embodiment blades of an iris or sliding wedge crimping device are heated to achieve the desired crimping temperature (alternatively a heated liquid or gas may be used). After the scaffold reaches the crimping temperature, the iris of the crimper closes to reduce the scaffold inner diameter (ID) to less than the outer diameter (OD) of the fully inflated balloon and while the balloon has pressure P1.
Stage II:
The crimper jaws are held at a fixed diameter for a dwell period and while the balloon has pressure P1. At the conclusion of this dwell period the scaffold and balloon are removed from the crimping device. The balloon may have a pressure of P2 when removed from the crimping device.
Verify Alignment/Replace Balloon:
Removal after Stage II may be skipped if there is no need to check or verify final alignment with balloon markers, or if Balloon A is used for Stages I and II. In the illustrated embodiment the scaffold supported on the balloon is removed from the crimping device to verify that the scaffold is located between the balloon markers (when Balloon A used for Stages I and II), or Balloon B is replaced with Balloon A and the scaffold aligned with the balloon markers.
Referring now to
Stage III:
After the scaffold and inflated Balloon A are returned to the crimper, the iris diameter is set at a slightly higher diameter than the scaffold diameter at the conclusion of Stage II (to account for recoil). The iris or aperture size is held constant for a time period sufficient to bring scaffold temperature back to crimping temperature.
After the crimping temperature is reached, the scaffold diameter is reduced down while the balloon has pressure P1. The balloon has pressure P1 for the diameter reduction following Stage III.
Stage IV:
The crimp aperture is held constant for a dwell period after scaffold diameter is reduced from the Stage III diameter and the balloon has pressure P1. Following Stage IV the polymer sheets of the film headed crimper are re-set to remove excess sheet material from within the aperture when the scaffold diameter was reduced from the Stage III diameter to the Stage IV diameter, or when the diameter was reduced from the initial diameter to the Stage IV diameter. The balloon has pressure P2 when the polymer material is reset.
Balloon pressurization in the crimping process helps ensure, or improves scaffold retention on the balloon, in addition to helping promote uniform expansion of the balloon. Balloon pressure may be relieved after 50%-75% of a final crimp dwell period is complete. Typically 75-250 psi is applied when reducing the scaffold diameter (or stent diameter) and during dwell periods, or more preferably pressure between about 200-250 psi, between about 200-280 psi, and between about 200-300 psi when crimping a thin-walled scaffold. The pressure is selected to achieve the lowest possible crossing profile, ensure sufficient retention and provide radial support for the scaffold struts when rings are being folded by the crimper blades.
Stages V-VIII:
These stages follow a similar process as in Stages III-IV: perform a dwell at each of the stages with a diameter reduction between the stages while the balloon has a pressure P1. After the dwell period, the aperture is fully opened and the excess polymer sheet material removed from the aperture while the balloon has a pressure P2. In total there are three illustrated re-sets of the polymer material in the example of
Optional Stages/Final Crimp:
Following the re-set (immediately after Stage VIII) there may be a number of additional, optional stages. At the conclusion of these stages there is a final pressurization of the balloon at the final crimp diameter and with balloon pressure P1. The pressurization may be a leak check. After this final step the scaffold is fully crimped to the balloon catheter, removed from the crimp head and placed within a constraining sheath.
According to one embodiment, a re-set of the polymer material should be employed whenever the space between struts is large enough to receive sheet material (near final crimp diameters spaces between struts may be too small for sheet material) and there has been a sufficient percentage of diameter reduction to cause material between the blades and scaffold surface to build up. This period of diameter reduction and resulting crimp size will be referred to as a critical crimping period.
The number of re-sets cannot be excessive because then the crimp process becomes too time consuming. Thus, it is not believed feasible or cost-effective to implement a re-set whenever the scaffold is reduced in diameter. A balance is needed. Re-set points within critical crimping periods should be chosen so that production yield is favorable but crimp time does not become overly burdensome.
Based on extensive testing of different scaffold types, critical crimp periods may employ one or more re-set of polymer material within the aperture (“re-set”) according to one or more of the following rules:
A ring 312, e.g., ring 312b, can be sinusoidal meaning the curvature of the ring along axis B-B is best described by a sine wave where the wavelength of the sine wave is equal to the distance between adjacent crests 311a of the ring. The ring can have a constant width at both crowns 307, 309 and 310 and struts 330, which connect a crown to an adjacent crown.
There are three crown types present in each inner ring 312b through 312e: U-crown, Y-crown and W-crown. Outermost rings have only the Y-crown or W-crown type, and the U-crown type. A crest or peak 311a (or trough or valley 311b) may correspond to a U-crown, Y-crown or W-crown. For the outermost ring 312a there is only a U-crown and W-crown type. For the outermost ring 312f there is only a U-crown and Y-crown type. A marker link 20 adjoins rings by forming a W-crown with the first ring (e.g., ring 312e) and a Y-crown with the second ring (e.g. ring 312f).
A link 334 connects to ring 312f at a Y-crown 310. A “Y-crown” refers to a crown where the angle extending between a strut 330 of a ring 312 and the link 334 is an obtuse angle (greater than 90 degrees). A link 334 connects to ring 312a at a W-crown 309. A “W-crown” refers to a crown where the angle extending between the strut 330 and the link 334 is an acute angle (less than 90 degrees). A U-crown 307 is a crown that does not have a link connected to it. Marker link 20 connects to a ring at a W-crown 314 and a Y-crown 316.
For the scaffold 300 there are 6 crests or peaks 311a and 6 troughs or valleys 311b for each ring 312. A crest 311a is always followed by a valley 311b. Ring 312b has 12 crowns: 3 are W-crowns 309, 3 are Y-crowns 310 and 6 are U-crowns 307.
A crimped diameter enforced on scaffold 300 (using, e.g., Process I or Process II) may be expressed in terms of a theoretical minimum crimped diameter where struts that converge at the same crown are in contact with each other when the scaffold is fully crimped, i.e., when the scaffold is removed from the crimping device, or when placed within a restraining sheath soon after crimping. The equation for the theoretical minimum crimped diameter (D-min) under these conditions is shown below
D-min=(1/π)×[(n×strut_width)+(m×link_width)]+2*t
Where
Hence, for scaffold 300 in
The above description of illustrated embodiments of the invention, including what is described in the Abstract, is not intended to be exhaustive or to limit the invention to the precise forms disclosed. While specific embodiments of, and examples for, the invention are described herein for illustrative purposes, various modifications are possible within the scope of the invention, as those skilled in the relevant art will recognize.
These modifications can be made to the invention in light of the above detailed description. The terms used in claims should not be construed to limit the invention to the specific embodiments disclosed in the specification.
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