This application incorporates U.S. patent application, Ser. No. 11/427,297, entitled “Clip Applier and Methods of Use”, and filed Jun. 28, 2006 in its entirety.
The present invention relates generally to medical devices, and more particular to device, apparatus, and methods for managing access through tissue.
Catheterization and interventional procedures, such as angioplasty or stenting, generally are performed by inserting a hollow needle through a patient's skin and tissue into the vascular system. A guide wire may be advanced through the needle and into the patients blood vessel accessed by the needle. The needle is then removed, enabling an introducer sheath to be advanced over the guide wire into the vessel, e.g., in conjunction with or subsequent to a dilator.
A catheter or other device may then be advanced through a lumen of the introducer sheath and over the guide wire into a position for performing a medical procedure. Thus, the introducer sheath may facilitate introducing various devices into the vessel, while minimizing trauma to the vessel wall and/or minimizing blood loss during a procedure.
Upon completing the procedure, the devices and introducer sheath would be removed, leaving a puncture site in the vessel wall. Traditionally, external pressure would be applied to the puncture site until clotting and wound sealing occur; however, the patient must remain bedridden for a substantial period of time after clotting to ensure closure of the wound. This procedure, however, may be time consuming and expensive, requiring as much as an hour of a physician's or nurse's time. It is also uncomfortable for the patient, and requires that the patient remain immobilized in the operating room, catheter lab, or holding area. In addition, a risk of hematoma exists from bleeding before hemostasis occurs.
Various apparatus have been suggested for percutaneously sealing a vascular puncture by occluding the puncture site. For example, U.S. Pat. Nos. 5,192,302 and 5,222,974, issued to Kensey et al., describe the use of a biodegradable plug that may be delivered through an introducer sheath into a puncture site. Another technique has been suggested that involves percutaneously suturing the puncture site, such as that disclosed in U.S. Pat. No. 5,304,184, issued to Hathaway et al.
For many patients, the puncture location may be frequently accessed. Frequent access may result in structural changes that may limit access to that point over time. Accordingly, devices, apparatus, and methods for managing access through tissue would be considered useful.
An embodiment device for managing access through tissue is described. The device includes a body movable from a pre-deployed configuration towards a deployed configuration. The device includes a plurality of tissue engaging portions extending from the body. At least a portion of the tissue engaging portions are obtuse. At least two of the tissue engaging portions are separated by a first distance in the deployed configuration and a second distance in the pre-deployed configuration. The first distance is smaller than the second distance.
In some embodiments, the body further defines a plane. The body is disposed about a central axis extending substantially normal to the plane in the deployed configuration. The body is disposed out of the plane in the pre-deployed configuration. The tissue engaging portions are oriented generally towards the central axis in the deployed configuration. The tissue engaging portions are generally parallel to the central axis in the pre-deployed configuration.
At least one tissue engaging portion, in some embodiments, includes an obtuse tip portion. In further embodiments, the tissue engaging portions include an edge that is obtuse.
The body, in some embodiments, is biased towards the deployed configuration for biasing at least one of the tissue engaging portions towards another tissue engaging portion.
In some embodiments, at least a portion of a surface of the device includes a bioactive agent to reduce scar tissue response, structural tissue response, restenosis, thrombosis, or combinations thereof.
The first and second set of tissue engaging portions, in some embodiments, are disposed symmetrically alternatively about a central axis and such that each of the first set of tissue engaging portions is located adjacent to two of the second set of tissue engaging portions. In other embodiments, adjacent tissue engaging portions have a first curved region disposed between them.
In some embodiments, at least one of the tissue engaging portions includes a stop member disposed between a tip of the tissue engaging portion and the respective first curved region. In further embodiments, the stop member includes a blunt base that is substantially wider than the tissue engaging portion and the tissue engaging portions are obtuse from the blunt base to the tip.
In some embodiments, the plurality of tissue engaging elements include a first primary tissue engaging portion having a first length and a second primary tissue engaging portion having a second length. The first and second primary tissue engaging portions are disposed on opposing first curved regions and oriented towards one another in the deployed configuration. The first and second lengths cause the first and second primary tissue engaging portions to at least partially overlap one another in the deployed configuration.
An embodiment of a method for managing access through tissue is described. The method includes deploying a closure element to tissue adjacent a tissue opening to substantially close the opening following a first procedure. The opening in the tissue is selectively opened by advancing a distal end of a medical device through the deployed closure element as a part of or before a second procedure.
Another embodiment of a method for managing access to a body lumen is described. The method includes deploying a closure element to tissue adjacent a tissue opening to substantially close the opening following a first procedure. The closure element includes a body movable from a pre-deployed configuration towards a deployed configuration. The body includes a plurality of tissue engaging portions extending from the body. At least a portion of the tissue engaging portions are obtuse. At least two of the tissue engaging portions are separated by a first distance in the deployed configuration and a second distance in the pre-deployed configuration. The first distance is smaller than the second distance. The method includes locating the deployed closure element. The opening in the tissue is selectively opened by advancing a distal end of a medical device through the deployed closure element as a part of or before a second procedure. The distal end of the medical device is removed through the opening in the tissue and through the closure element thereby redeploying the closure element to the tissue adjacent the opening in the tissue to substantially close the opening.
In some embodiments, the tissue is skin. In other embodiments, the tissue is a wall of a body lumen.
The distal end of the medical device, in some embodiments, is removed through the opening in the tissue and through the closure element thereby redeploying the closure element to the tissue adjacent the opening in the tissue to substantially close the opening. In some embodiments, the medical device includes a cannula or other access device.
In some embodiments, the closure element includes a radiopaque marker. In further embodiments, the method includes locating the deployed closure element using the radiopaque marker. In other embodiments, the method includes locating the deployed closure element using skin marking.
In further embodiments, the closure element includes a body movable from a pre-deployed configuration towards a deployed configuration and a plurality of tissue engaging portions extending from the body. At least a portion of the tissue engaging portions are obtuse. At least two of the tissue engaging portions are separated by a first distance in the deployed configuration and a second distance in the pre-deployed configuration. The first distance is smaller than the second distance.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and are intended to provide further explanation of the invention claimed.
The accompanying Figures, which are incorporated in and constitute part of this specification, are included to illustrate and provide a further understanding of the method and system of the invention. Together with the description, the Figures serve to explain the principles of the invention.
In order to describe the manner in which the above-recited and other advantages and features of the invention can be obtained, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. Understanding that these drawings depict only typical embodiments of the invention and are not therefore to be considered to be limiting of its scope, the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings.
It should be noted that the figures are not drawn to scale and that elements of similar structures or functions are generally represented by like reference numerals for illustrative purposes throughout the figures. It also should be noted that the figures are only intended to facilitate the description of embodiments of the present invention.
The embodiments described herein extend to methods, systems, and apparatus for managing access through tissue. Some of the apparatuses of the present invention are configured to deliver a device for managing access through tissue into an opening formed in and/or adjacent to tissue.
One of the challenges of cannulation of vessels may include the need to achieve hemostasis post procedure. For many patients, this access may be frequent, with the potential for complications of vascular access, such as structural changes that may limit access to that point over time. For example, a hemodialysis patient may require vascular access up to six times per week. By having a device that could allow access through tissue and repeatedly provide hemostasis post access, some of these issues may be resolved. Furthermore, the ability to visualize the device with X-ray, may increase access at that site and provide a reduction in complications.
In order to reduce the risk of infection at or near the opening, silver and/or alloys of silver may be used. The silver and/or alloys of silver may be incorporated into at least a portion of the closure element and/or components of the locator and/or carrier assemblies. For example, at least a portion of the closure element and/or components of the locator and/or carrier assemblies may include silver and/or alloys of silver as a component of a coating over and/or a mixture with their respective materials. The use of silver and/or silver alloys may reduce the risk of infection because silver and silver alloys are generally known to possess antimicrobial properties.
These results, whether individually or collectively, can be achieved, according to one embodiment of the present invention, by employing methods, systems, and/or apparatus as shown in the figures and described in detail below.
Turning now to the drawings,
The device 10 for managing access through tissue may include a plurality of tissue engaging portions 13 extending from the body 12. The tissue engaging portions 13 may include edges 28 and/or tip portions 18. Portions of the tissue engaging portions 13 may include edges 28 and/or tip portions 18 that are sharp and/or obtuse. In some embodiments, the tissue engaging portions 13 may not have edges such that they are generally rounded.
In the present embodiment, the tip portions 18 may be obtuse to facilitate engaging the tissue. In some embodiments where the tip portion 18 is obtuse, the tip portion 18 may not substantially penetrate the tissue, but rather may engage the tissue to manage access through the tissue. For example, if the device 10 for managing access through tissue were used with an opening in a body lumen, the tip portions 18 may not penetrate through the tissue into the body lumen, but rather may engage the tissue near the opening (although in some embodiments, the tip portions 18 may partially penetrate the tissue). Engaging tissue may include using frictional forces and/or other forces to manipulate the tissue. For example, in an embodiment where the tissue engaging portions 13 have tip portions 18 that are obtuse, the tip portions 18 may engage the tissue such that, as the device 10 moves back toward the deployed configuration, the tissue is pulled closed. In other embodiments, the tip portion 18 may substantially penetrate the tissue. In further embodiments, the tip portions 18 of primary tissue engaging portions (not shown) may substantially penetrate the tissue while the tip portions 18 of secondary tissue engaging portions (not shown) may not substantially penetrate the tissue. Other configurations of the tissue engaging portions 13 and their tip portions 18 may be used.
In the present embodiment, the body 12 may include a plurality of looped or curved elements 30 that may be connected to one another to form the body 12. Each looped element 30 may include an inner or first curved region 32 and an outer or second curved region 34. The first and second curved regions 32, 34 may be out of phase with one another and/or may be connected alternately to one another, thereby defining an endless sinusoidal pattern. Alternatively, other generally zigzag patterns may be provided that repeat periodically, e.g., saw tooth or square tooth patterns (not shown), instead of a sinusoidal pattern, thereby defining inner and outer regions that may alternate about the body 12.
The plurality of tissue engaging portions 13 may be biased to extend towards one another. In the present embodiment, the tissue engaging portions 13 may be biased generally inwardly into the space bounded by the inner periphery 36. In other configurations, the tissue engaging portions 13 may be biased toward the central axis 24 the central axis 24. In other embodiments, at least two of the tissue engaging portions 13 may be biased to extend towards each other.
In the present embodiment, the tissue engaging portions 13 may be disposed on the first curved regions 32 and/or oriented toward the central axis 24 when the device 10 is in the deployed configuration. The tissue engaging portions 13 may be provided in pairs opposite from one another, as in the present embodiment. The tissue engaging portions 13 may be provided symmetrically with respect to the central axis 24 or may not be provided symmetrically.
Additionally, as shown in
In the deployed configuration, shown in
The distances d1, d2 may vary before deployment, pre-deployment, and/or when providing access through the tissue post deployment. In the present embodiment, before being deployed in tissue, the device 10 for managing access through tissue may be substantially in the pre-deployed configuration such that two tissue engaging portions 13 may be separated by about the second distance d2. When deployed in tissue, the device 10 may be substantially in the deployed configuration such that the two tissue engaging portions 13 may be separated by about the first distance d1. When providing access to the tissue after being deployed in tissue, the device 10 may be moved from substantially the deployed configuration substantially toward and/or to the pre-deployed configuration.
As shown in
In the present embodiment, the tissue engaging portions 13 may be oriented substantially parallel to the central axis 24 in the pre-deployed configuration, as shown in
The tissue engaging portions 13 and/or body 12 may be biased to move from the pre-deployed configuration towards the deployed configuration of
The looped elements 30 may distribute stresses in the device 10 for managing access through tissue as it is moved between the deployed and pre-deployed configurations, thereby generally minimizing localized stresses that may otherwise plastically deform, break, and/or otherwise damage the device 10 during delivery. In addition, when the device 10 is in the pre-deployed configuration, the looped elements 30 may be movable between a compressed state, such as that shown in
With the device 10 in the pre-deployed configuration, the looped elements 30 may be circumferentially and/or radially compressed to the compressed state until the device 10 defines a first diameter or circumference 26a, such as that shown in
Tissue engaging portions 113 with sharp tip portions 118, i.e. tissue engaging portions 113a, 113e, may more easily penetrate tissue compared to a tissue engaging portion 113 with an obtuse tip portion 118, i.e. tissue engaging portions 113b, 113c, 113d, 113f. Tissue engaging portions 113 with sharp edges 128, i.e. tissue engaging portions 113a, 113b, may more easily cut and/or damage the surrounding tissue if the device 10 moves after the device 10 is deployed compared to a tissue engaging portion 113 with an obtuse edge 128, i.e. tissue engaging portions 113c, 113d, 113e, 113f. For example, if a deployed device 10 that includes a tissue engaging portion 113 with at least one sharp edge 128 is moved while deployed, the device 10 may more easily cut and/or damage the surrounding tissue. While a deployed device 10 that includes a tissue engaging portion 128 with all obtuse edges 128 is moved while deployed, the device 10 may less easily cut and/or damage the surrounding tissue.
Unlike the previous embodiment, the device 210 for managing access through tissue of the present embodiment may include only one pair of primary tissue engaging portions 214. The primary tissue engaging portions 214 may have a length l1, although alternatively each of the primary tissue engaging portions 214 may have a different length than one another.
Although the length, l1, is illustrated as extending from a curved region 232, 234, beyond the central axis 224, it may be possible for the length, l1, to be less than this distance, such as a length defined from a curved region 232, 234 to the central axis 224 or a length defined from a curved region 232, 234 toward, but not passing the central axis 224. The primary tissue engaging portions 214 may be disposed in one or more opposing pairs, e.g., on opposing first curved regions 232, and may be oriented towards and/or across the central axis 224 in the planar configuration. In the deployed configuration, the primary tissue engaging portions 214 may be sufficiently long such that the primary tissue engaging portions 214 at least partially overlap one another, i.e., extend across the central axis 224 towards an opposing tissue engaging portion 214. Therefore, the tip portions 218 of the primary tissue engaging portions 214 may extend past the central axis 224 and/or the primary tissue engaging portions 214 in each pair may lie substantially parallel to each other when the device 210 for managing access through tissue is in the deployed configuration. Each of the primary tissue engaging portions 214 may include a variety of tip portions 218 and/or edges 228 as described in connection with
In the deployed configuration, shown in
The distances d1, d2 may vary before deployment, pre-deployment, and/or when providing access through the tissue post deployment. In the present embodiment, before being deployed in tissue, the device 210 for managing access through tissue may be substantially in the pre-deployed configuration such that the two primary tissue engaging portions 214 may be separated by about the second distance d2. When deployed in tissue, the device 210 may be substantially in the deployed configuration such that the two primary tissue engaging portions 214 may be separated by about the first distance d1. When providing access to the tissue after being deployed in tissue, the device 210 may be moved from the substantially deployed configuration substantially toward and/or to the pre-deployed configuration.
As shown in
The primary tissue engaging portions 214 and/or body 212 may be biased to move from the pre-deployed configuration towards the deployed configuration of
The primary tissue engaging portions 214 of the present embodiment may include the tip portions 218 and/or edges 228 described in connection with
The device 310 for managing access through tissue of the present embodiment may include a plurality of primary tissue engaging portions 314 and a plurality of secondary tissue engaging portions 316. Each of the primary and secondary tissue engaging portions 314, 316 may include a variety of tip portions 318 and/or edges 328 as described in connection with
The primary tissue engaging portions 314 may be similar to the primary tissue engaging portions 214 of the previous embodiment. However, each of the secondary tissue engaging portions 316 may be disposed on a first or inner curved region 332, e.g., such that one or more secondary tissue engaging portions 316 may be provided between opposing pairs of primary tissue engaging portions 314. Each of the secondary tissue engaging portions 316 may have a length l2 that is substantially less than the length, l1, of the primary tissue engaging portions 314.
Although the length, l1, is illustrated as extending from a curved region 332, 334, beyond the central axis 324, it may be possible for the length, l1, to be less than this distance, such as a length defined from a curved region 332, 334 to the central axis 324 or a length defined from a curved region 332, 334 toward, but not passing the central axis 324. A secondary tissue engaging portion 316 may be disposed on either side of each primary tissue engaging portion 314, in the present embodiment. For example, the device 310 for managing access through tissue may include first and second primary tissue engaging portions 314. Each of the first and second primary tissue engaging portions 314 may include a secondary tissue engaging portion 316 on either side of it. Thus, the device 310 may include a total of two primary tissue engaging portions 314 and four secondary tissue engaging portions 316. The secondary tissue engaging portions 316, in the present embodiment, may be disposed substantially symmetrically about the central axis 324. The tissue engaging portions 314, 316 may be provided on every other first curved regions 332. For example, a first curved region 332 having neither a primary tissue engaging portion 314 nor a secondary tissue engaging portion 316 may separate each adjacent tissue engaging portion, e.g., between two adjacent secondary tissue engaging portions 316, or between a secondary tissue engaging portion 316 and a primary tissue engaging portion 314. The primary and secondary tissue engaging portions 314, 316 may also include other orientations and arrangements.
The device 310 may be moved from the deployed configuration of
The tissue engaging portions 314, 316 may be biased towards one another and/or towards the central axis 324, i.e., due to the bias of the device 310 towards the deployed configuration of
In the deployed configuration, shown in
The distances d1, d2 may vary before deployment, pre-deployment, and/or when providing access through the tissue post deployment. In the present embodiment, before being deployed in tissue, the device 310 for managing access through tissue may be substantially in the pre-deployed configuration such that the two primary tissue engaging portions 314 may be separated by about the second distance d2. When deployed in tissue, the device 310 may be substantially in the deployed configuration such that the two primary tissue engaging portions 314 may be separated by about the first distance d1. When providing access to the tissue after being deployed in tissue, the device 310 may be moved from the substantially deployed configuration substantially toward and/or to the pre-deployed configuration.
The looped elements 330 may be expandable between a compressed state, as shown in
The precursor 310e can then be polished using one or more polishing processes such as electropolishing, tumbling, sand blasting, sanding, or other polishing processes. In some embodiments, polishing may be done as a final step after the device 10 for managing access through tissue is formed. Forming of a precursor 310e in this manner may not require working to tolerances as close as those which would be required if the device 10 was to be manufactured in its final configuration shown in
The tissue engaging portions 13 may be formed or given a shape, e.g., pointed, rounded, edged, chamfered, etc., while the device 10 is in the precursor state. For example, the tip portions 18 and/or edges 28 (shown in
Heat setting and quenching are typically essential to successful practice of the invention with superelastic alloys. As explained in more detail in U.S. Pat. No. 4,665,906, a superelastic alloy such as nickel-titanium generally exists in two states, the austenitic state and the martensitic state. Such alloys will initially be in the austenitic state, e.g., when the precursor 310e is formed. However, when the precursor 310e is inverted to take the shape of the final device 310, the stress experienced by the alloy during the inversion will cause the alloy to be partially or wholly converted to the martensitic state. Such a martensitic state is commonly referred to as stress-induced martensite. Such martensite structure generally has the property of superelasticity and the inverted precursor would typically revert to its original shape if not held in the inverted configuration.
Since, if the inverted precursor 310e were left in the martensitic state, it would want to elastically revert to its original uninverted state, it must be converted back to austenite. Thus, heating and quenching are generally required to convert the inverted precursor 310e from the martensitic state to the austenitic state such that the device 310 for managing access through tissue is stable in its deployed configuration as shown in
The times and temperatures for heat setting of superelastic alloys of various compositions may be determined from existing literature or may be determined empirically without any difficulty. The devices 10 are typically small in size and the heating and quenching may be done with any conventional heating and quenching equipment. For example, once inverted, the inverted precursor 310e may be held in that configuration and placed in a fixture that will hold it in the inverted configuration during heat setting.
When devices 10 are manufactured according to this process, the space between the tissue engaging portions 13 may actually be substantially eliminated, i.e., after inverting the precursor, the tissue engaging portions 13 may be in contact with each other, in either a side-by-side or an over-and-under relationship. The number, length, and spacing of the tissue engaging portions may be varied according to the desires of the manufacturer. Furthermore, while use of a planar precursor is a convenience in manufacturing, planar precursors may not be required. For example, the precursor 310e could be bent along a diameter or major or minor axis of the precursor 310e and could be heat set in such a bent configuration. Alternatively, the device 910, in generally planar embodiments, may have the tissue engaging portions 913 extending at an acute angle to the plane defined by the body 912 as shown in
Still further, the device 310 for managing access through tissue need not be fabricated from a single material, e.g., the tissue engaging portions 13 may be manufactured from a different material than the body 312. In such cases, a portion of the device 310 such as the tissue engaging portions 314, 316 may be bioabsorbable if the final device 310 is capable of elastic recovery after being deformed. Forming a precursor 310e may permit the production of devices 10 with tissue engaging portions 13 that are longer by about 30 to 40% or more than those that could be made with prior direct cutting methods, because there is typically no limit on the length of the tissue engaging portion 13 that may be formed on the precursor 310e. Thus, after the precursor 310e is inverted, the tissue engaging portions 314, 316 may overlap the body 312.
In some embodiments, the devices 10 may include a bioactive agent. The bioactive agent may be associated with a base coat and/or top coat and/or incorporated or otherwise applied to a supporting structure of the device 10.
The bioactive agent may have any therapeutic effect. Examples of suitable therapeutic properties may include anti-proliferative, anti-inflammatory, antissue engaging portionoplastic, antiplatelet, anti-coagulant, anti-fibrin, antithrombonic, antimitotic, antibiotic, antiallergic, antioxidant properties, and/or other therapeutic properties.
Examples of suitable bioactive agents include synthetic inorganic and organic compounds, proteins and peptides, polysaccharides and other sugars, lipids, DNA and RNA nucleic acid sequences, antisense oligonucleotides, antibodies, receptor ligands, enzymes, adhesion peptides, blood clot agents, including streptokinase and tissue plasminogen activator, antigens, hormones, growth factors, ribozymes, retroviral vectors, anti-proliferative agents including rapamycin (sirolimus), 40-O-(2-hydroxyethyl)rapamycin (everolimus), 40-O-(3-hydroxypropyl)rapamycin, 40-O-(2-hydroxyethyoxy)ethylrapamycin, 40-O-tetrazolylrapamycin (zotarolimus, ABT-578), paclitaxel, docetaxel, methotrexate, azathioprine, vincristissue engaging portion, vinblastissue engaging portion, fluorouracil, doxorubicin hydrochloride, mitomycin, antiplatelet compounds, anticoagulants, antifibrin, antithrombins including sodium heparin, low molecular weight heparins, heparinoids, hirudin, argatroban, forskolin, vapiprost, prostacyclin, prostacyclin analogues, dextran, D-phe-pro-arg-chloromethylketone (synthetic antithrombin), dipyridamole, glycoprotein IIb/IIIa platelet membrane receptor antagonist antibody, recombinant hirudin, thrombin inhibitors including Angiomax ä, calcium channel blockers including nifedipine, colchicine, fibroblast growth factor (FGF) antagonists, fish oil (omega 3-fatty acid), histamine antagonists, lovastatin, monoclonal antibodies, nitroprusside, phosphodiesterase inhibitors, prostaglandin inhibitors, suramin, serotonin blockers, steroids, thioprotease inhibitors, triazolopyrimidine, nitric oxide or nitric oxide donors, super oxide dismutases, super oxide dismutase mimetic, estradiol, anticancer agents, dietary supplements including vitamins, anti-inflammatory agents including aspirin, tacrolimus, dexamethasone and clobetasol, cytostatic substances including angiopeptin, angiotensin converting enzyme inhibitors including captopril, cilazapril or lisinopril, antiallergic agents such as permirolast potassium, alpha-interferon, bioactive RGD, and genetically engineered epithelial cells. Other bioactive agents, which are currently available or that may be developed in the future for use with medical devices, may likewise be used and all are within the scope of this invention.
For example, a bioactive agent may be used to reduce scar tissue response when the device 10 is deployed in tissue. Reducing scar tissue response, structural tissue response, restenosis, and/or thrombosis may facilitate access to the tissue after the device 10 is deployed. For example, if a device did not use a beneficial agent to reduce scar tissue response, structural tissue response, restenosis, and/or thrombosis after deployment, these and/or other tissue responses may hinder future access to the tissue.
After a device 10 for managing access through tissue is deployed, it may be desirable to provide access through the deployed device 10. Locating a deployed device 10 may be necessary to provide future access through the device 10. Radiopaque markers, skin marking and/or other location techniques may be used to facilitate location of a deployed device 10.
Any of the devices of the present invention may include one or more radiopaque markers or other markers visible using external imaging, such as fluoroscopy. For example, using the device 310 of
Alternatively, a device 10 may be partially coated with radiopaque material by using masking techniques. For example, the entire device 10 may first be coated with radiopaque material. The device 10 may then be masked at locations where the radiopaque coating is desired. For example, the looped elements 30 of the device 10 may be left unmasked during this process if it is desired to leave the looped elements 30 uncoated by radiopaque material. This may be desirable, e.g., to prevent radiopaque material from adversely affecting the flexibility of the body 12. The device 10 may then be treated to remove the radiopaque material from the unmasked areas, in this example, the body 12. The masking may then be removed using conventional processes, leaving the rest of the device 10 coated with radiopaque material.
In some embodiments, silver and/or alloys of silver may be incorporated into at least a portion of the device 10. For example, silver and/or alloys of silver may be included as a component of a mixture that may be incorporated into the material of the device 10. In embodiments where the device 10 is formed from a sheet of material, the sheet of material may include silver and/or alloys of silver as a component of the material. In embodiments where the device 10 is formed from a wire as described in U.S. Pat. No. 6,719,777, the wire may include silver and/or alloys of silver as a component of the wire.
In other embodiments, at least a portion of the device 10 may include a coating that includes silver and/or alloys of silver as a component of the coating. For example, a coating of silver and/or alloys of silver may be applied to a portion of the surface of the device 10. Coatings may be applied using various coating methods. Coating methods may include physical vapor deposition, chemical vapor deposition, ion beam assisted deposition, electroplating and/or other coating methods. Physical vapor deposition may include sputter deposition and/or other physical vapor deposition methods.
Turning to
As described in connection with
Turning to
The device 410 may also include stop members 406 on one or more of the tissue engaging portions 414, 416, e.g., adjacent the respective first curved region 432. Each stop member 406 may be blunt-shaped. For example, the stop members 406 may be shaped generally triangularly with an apex 407 of the stop member 406 extending from the first curved region 432, and the tissue engaging portion 414, 416 extending from a wide or blunt base 407 of the stop member 406. During use, the blunt bases 407 may limit penetration of the respective tissue engaging portions 414, 416 into tissue by reducing an effective length of the respective tissue engaging portion 414, 416. For example, when the tissue engaging portions 414, 416 are driven into tissue, the tissue engaging portions 414, 416 may penetrate the tissue until the blunt bases 407 contact the tissue, whereupon the tissue engaging portions 414, 416 may be prevented from penetrating further into the tissue. Stop members 406 may be used in other embodiments to decrease the amount of the tissue engaging portion 414, 416 that penetrates and/or engages surrounding tissue.
Each of the tissue engaging portions 414, 416 may include a variety of tip portions 418 and/or edges 428 as described in connection with
The tissue engaging portions 414, 416 and/or body 412 may be biased to move from the pre-deployed configuration towards the deployed configuration of
As shown in
In the deployed configuration, shown in
The tissue engaging portions 513 may define an angle with respect to the axis 524, as shown in
In the access configuration, the tissue engaging portions 516 may be separated by a third distance, i.e. d3. In the present embodiment, the first and third distances d1, d3 may be measured from a tip portion 518 of the tissue engaging portions 513. In other embodiments, the first and third distances d1, d3 may be measured from another portion of the tissue engaging portions 513, for example from the base (not shown) of the tissue engaging portions 513. The first distance d1, in the present embodiment, may be smaller than the third distance d3, such that the distance d1 in the deployed configuration may be smaller than the distance d3 in the access configuration.
The access configuration shown in
The body 512 may be sufficiently flexible such that the device 510 may assume a generally circular or elliptical shape, as shown in
The tissue engaging portions 513 may be biased from the pre-deployed and/or access configurations towards one another, i.e., towards the deployed configuration of
In addition, the expandable elements 520 may be expandable from a compressed state, shown in
Using the manufacturing processes generally described in connection with
The precursor 610 may be reconfigured by imposing a radially inwardly directed force on body 612 such that precursor 610 may take a smaller planar shape such as one of those shown in
After reconfiguring the precursor 610, the reconfigured precursor 610 may be heat set and quenched as described above to complete the manufacture of the device 610 for managing access through tissue.
Devices 10 of still other configurations can be manufactured in the manner of device 710 for managing access through tissue by starting with a differently shaped precursor such as precursor 710a shown in
Although the lengths, l1, are illustrated in
It has been found that NITINOL® sheet is typically stronger in one direction than in others, which may be the result of crystal orientation in the NITINOL®. The device precursors 310e, 610, 710 may be formed such that the primary tissue engaging portions 214 are aligned with the strongest orientation of the NITINOL®. It has been found, as shown in
Although the length, l1, is illustrated as extending from a curved region (not shown), beyond the central axis (not shown), it may be possible for the length, l1, to be less than this distance, such as a length defined from a curved region to the central axis or a length defined from a curved region toward, but not passing the central axis.
The devices 10 for managing access through tissue of the present invention may have primary or secondary tissue engaging portions 214, 216 that may have the same or different lengths and the tissue engaging portions 13 may be straight and/or curved. For example, radially opposed tissue engaging portions 13 may have one tissue engaging portion at “12 o'clock” which is longer than the opposing tissue engaging portion at “6 o'clock.” Exemplary configurations of device 910, 1010 for managing access through tissue precursors with primary tissue engaging portions of different length are shown in
In the present embodiment, the tissue engaging regions 1313 may be disposed in opposing sets along an axis of symmetry (not shown) extending between looped regions 1331, defining a substantially planar deployed configuration. The tissue engaging portions 1313 may be directed substantially transversely, in a pre-deployed configuration (not shown), with respect to a plane defined by the deployed configuration. The tissue engaging portions 1313 may be biased to return towards the deployed configuration. Furthermore, the device 1310 may include edges (not shown) as described in connection with
In an alternative embodiment, shown in
Referring now to
Upon removal of the introducer sheath, the device 1610 may resiliently return to the deployed configuration, illustrated in
As depicted in
In
Turning to
The device 1810 may be moveable between a deployed configuration, which is substantially planar in the present embodiment, such as that shown in
In the present embodiment, the expandable elements 1820 may generally be hollow diamond shaped elements, including curved inner regions 1832 oriented towards the central axis 1824 of the body 1812 when the device 1810 is in the deployed configuration. The expandable elements 1820 may serve multiple purposes. One purpose may include biasing the device 1810, e.g., allowing the device 1810 to at least partially expand resiliently. For example, when the device 1810 is deflected into the pre-deployed configuration (not shown), the expandable elements 1820 may allow the tissue engaging portions 1813 to be moved away from the central axis 1824 and/or one radially outwardly or otherwise expanded to engage a larger area of tissue.
As the tissue engaging portions 1813 are expanded, the expandable elements 1820 may deform to become wider (along a dimension extending generally between the adjacent tissue engaging portions 1813) and shorter (along a dimension extending generally parallel to the tissue engaging portions 1813). Once a force causing the tissue engaging portions 1813 to expand is removed, the expandable elements 1820 may resiliently try to return towards their original shape, thereby pulling the tissue engaging portions 1813 substantially closer towards one another towards the deployed configuration.
In addition, the curved inner regions 1832 of the expandable elements 1820 may provide stops limiting penetration of the tissue engaging portions 1813 into tissue, similar to the stop members described above. For example, when the device 1810 is in the pre-deployed configuration and the expandable elements 1820 are expanded, the curved inner regions 1832 may be become more oblique, possibly becoming generally linear. Thus, in embodiments where the tissue engaging portions 1813 penetrate the tissue, the curved inner regions 1832 may limit penetration of the tissue engaging portions 1813.
Finally, after the device 1810 is deployed, e.g., the tissue engaging portions 1813 have penetrated and/or engaged the tissue, the curved inner regions 1832 may return towards the deployed configuration, and may pinch or otherwise engage tissue between the inner curved regions 1832 and the adjacent tissue engaging portions 1813. Thus, contracting the expandable elements 1820 may enhance the ability of the device 1810 to seal a puncture site, e.g., by pulling engaged tissue inwardly towards the central axis 1824 of the device 1810.
Turning to
Turning now to
The tissue engaging portions 2013 may be curved or arcuately shaped and may include tip portions 2018 that may extend toward the central axis 2024 when the device 2010 is in a deployed configuration. The curves of the tissue engaging portions 2013 may all be in phase with one another such that the tissue engaging portions 2013 spiral about the central axis 2024. This may allow a length of the tissue engaging portions 2013 to be maximized for a given diameter of the body 2012.
For example, the tissue engaging portions 2013 may have a length that is greater than a radius of the body 2012 without the tip portions 2018 of the tissue engaging portions 2013 touching one another. Thus, due to the arcuate shape of each tissue engaging portion 2013, the tissue engaging portions 2013 of device 2010 may be generally longer than the straight tissue engaging portions of the previous devices having comparable diameters. The tissue engaging portions 2013 may, therefore, penetrate deeper into and/or apply pressure to tissue than the tissue engaging portions of the other devices.
The body 2012 and/or the tissue engaging portions 2013 of device 2010 may be deflected until the tissue engaging portions 2013 extend transversely with respect to the deployed configuration, thereby defining a pre-deployed configuration (not shown), which may be transverse in the present embodiments. In the pre-deployed configuration, the tissue engaging portions 2013 may be oriented substantially parallel to the central axis 2024. Additionally, the tissue engaging portions 2013 and/or body 2012 may be biased to move from the pre-deployed configuration towards the deployed configuration. The device 2010 may be delivered in substantially the same manner as will be described with respect to other devices of the present invention.
Turning to
The tissue engaging portions 2113 may be deflected from a deployed configuration, shown in
The expandable elements 2120 may have a generally arcuate shape that may be expandable from a first width to a second wider width (not shown), behaving similarly to the diamond-shaped cells of the embodiment shown in
Turning to
The expandable elements 2220 may be substantially enclosed loops that may at least partially open from a compressed state (shown in
Turning to
In a further embodiment of a device 2410 for managing access through tissue according to the present invention, shown in
Turning to
The device 2510 for managing access through tissue is shown in a deployed configuration. In the present embodiment, the tissue engaging portions 2513 may be disposed radially outward in a substantially planar configuration in the deployed configuration. The tissue engaging portions 2513 may be deflected such that they extend from the body 2512 in a pre-deployed configuration. In the present embodiment, the tissue engaging portions 2513 may be deflected such that they extend from the body 2512 substantially transversely with respect the plane defined by the sheet (similar to
The tissue engaging portions 2513 may be biased from the pre-deployed configuration away from one another, i.e., towards the deployed configuration. Thus, with the tissue engaging portions 2513 in the pre-deployed configuration, the tip portions 2518 may penetrate into and/or be engaged with tissue. When the device 2510 for managing access through tissue is released, e.g., from within a delivery device (not shown), the tissue engaging portions 2513 may be biased to return to the deployed configuration, thereby securing the tissue with respect to the device 2510 for managing access through tissue.
In addition, the device 2510 for managing access through tissue may include expandable elements 2520 that may be expandable from a compressed state to an expanded state (similar to
The devices 10 for managing access through tissue of the present invention may be delivered using various apparatus and methods. An exemplary apparatus 2600 suitable for delivering a device 10 of the present invention is shown in
The apparatus 2600 may include an introducer sheath 2652 and/or a housing or carrier assembly 2654 slidably disposed on the sheath 2652. The sheath 2652 may include a substantially flexible or semi-rigid tubular body 2658 including a lumen 2660 extending between its proximal and distal ends 2662, 2664. In some embodiments, the distal end 2664 may have a size and/or shape configured to facilitate insertion into a blood vessel, e.g., having a tapered tip for facilitating substantially atraumatic introduction through the passage and at least partially into the vessel. In other embodiments, the distal end 2664 may have other sizes and/or shapes. The lumen 2660 may have a size and/or shape for inserting one or more devices therethrough. In the present embodiment, the lumen 2660 may be configured to receive one or more medical devices, such as a catheter, guide wire, and/or other medical devices (not shown). The sheath 2652 may include one or more seals (not shown), such as a hemostatic valve, within the lumen 2660 at or near the proximal end 2662 that may provide a fluid-tight seal, while yet accommodating the insertion of one or more devices into the lumen 2660 without fluid passing proximally from the sheath 2652.
Optionally, the sheath 2652 may include a side port 2666 that may communicate with the lumen 2660, for example, to deliver fluids into the lumen 2660. Alternatively, or in addition, the side port 2666 may be used to provide a “bleed back” indicator.
The apparatus 2600 may also include a mechanical locator or obturator 2700 that may be part of an actuator assembly (not shown) that may be attachable to the proximal end of the sheath 2652. Alternatively, the mechanical locator or obturator 2700 may be a separate device that is insertable into the lumen 2660, e.g., through the actuator assembly. Generally, the obturator 2700 may be an elongate member including a distal tip 2714 and a distal portion 2716. The distal tip 2714 may be substantially soft and/or flexible such that the distal tip 2714 may substantially atraumatically enter tissue. The distal portion 2716 generally includes one or more wings or other expandable elements 2718 for providing tactile feedback, as described further below.
The carrier assembly 2654 may be slidably disposed on an exterior of the sheath 2652. The carrier assembly 2654 may be configured for releasably carrying a device 10 for managing access through tissue (shown in phantom), which may incorporate elements of the various embodiments of the devices described herein. The carrier assembly 2654 may be substantially permanently attached to the sheath 2652 and/or may be actuated from the proximal end 2662 of the sheath 2652, for example, by the actuator assembly (not shown), to advance the device 10 distally during deployment. Alternatively, the device 10 may be carried by an actuator assembly.
Turning to
As shown in
The passage 2692, and consequently the sheath 2652, may be oriented at an angle “alpha” with respect to the vessel 2690, thereby facilitating introducing devices through the lumen 2660 of the sheath 2652 into the vessel 2690 with minimal risk of damage to the vessel 2690. One or more devices, such as a guide wire, a catheter, and the like (not shown), may be inserted through the sheath 2652 and advanced to a desired location within the patient's body. In the present example, the devices may be used to perform a first therapeutic or diagnostic procedure, such as angioplasty, atherectomy, stent implantation, and/or other procedure, within the patient's vasculature. In other examples, other procedures may be performed.
After the first procedure is complete, any devices used during the procedure may be removed from the sheath 2652, and the obturator 2700 may be inserted into the lumen 2660. For example, the obturator 2700 may be part of an actuator assembly (not shown), and may be advanced through the lumen when the actuator assembly is attached to the proximal end of the sheath 2652. Alternatively, the actuator assembly and obturator 2700 may be coupled separately to the sheath 2652.
When the obturator 2700 is fully inserted within the sheath 2652, the distal portion 2716 of the obturator 2700 may extend beyond the distal end 2664 of the sheath 2652. In an alternative embodiment, the obturator 2700 may be attached to an exterior surface (not shown) of the sheath 2652, for example, along a track, e.g., including cooperating slots, grooves, and the like (not shown) in the sheath 2652 and obturator 2700.
Turning to
As shown in
Generally, the device 10 may be carried by the carrier assembly 2654 before the first procedure. The device 10 may be constrained in its pre-deployed configuration on the carrier assembly 2654, and the carrier assembly 2654 may be provided on and/or adjacent to the proximal end of the sheath 2652. Because the tissue engaging portions, which may include primary and secondary tissue engaging portions 314, 316 may be biased towards one another, the tissue engaging portions 314, 316 may slidably contact an inner surface (not shown) of the carrier assembly 2654 or an outer surface of the sheath 2652, thereby constraining the device 10 in its pre-deployed configuration.
Turning to
As the device 10 is deployed from the carrier assembly 2654, the device 10 may be expanded to an enlarged diameter, as described, for example, in connection with
Alternatively, the device 10 may include expandable looped elements and/or spring elements (not shown), such as those described above, that may facilitate expanding the device 10 as it is deployed from the carrier assembly 2654 and/or the sheath 2652. For example, the looped elements of the device 10 may be compressed when the device 10 is loaded into the carrier assembly 2654, e.g., thereby allowing a relatively smaller profile carrier assembly 2654 to be used. The device 10 may automatically expand upon deployment from the carrier assembly 2654 to engage a larger region of tissue surrounding the opening, such as an arteriotomy 2691 in the wall 2698 of the vessel 2690 (see
Once the device 10 is deployed entirely or otherwise released from the sheath 2652, the device 10 may resiliently move towards its deployed configuration, such as the substantially planar configuration shown in
During delivery of the device 10, radiopaque markers (not shown) on the device 10, the carrier assembly 2654, and/or the expandable members 2718 may be monitored, e.g., using fluoroscopy, to facilitate observing and/or positioning the apparatus 2600. Thus, a relative position of the device 10 with respect to the expandable elements 2718, and consequently to the wall 2698 of the vessel 2690, may be ascertained before the device 10 is deployed from the carrier assembly 2654. Markings may also assist in locating a deployed device 10.
Turning to
This predetermined rotational orientation may substantially minimize the possibility of the primary tissue engaging portions 314 contacting and/or damaging the expandable elements 2718. For example, with particular reference to
The primary tissue engaging portions 314 may be oriented such that the primary tissue engaging portions 314 pierce and/or engage the wall 2698 of the vessel 2690 on either side of the arteriotomy 2691, as shown. With the expandable elements 2718 crisscrossing diagonally, risk of contact with the primary tissue engaging portions may be substantially reduced. Thus, in some embodiments, the primary tissue engaging portions 314 may be sufficiently long to extend entirely through the wall 2698 of the vessel 2690 while avoiding the expandable elements 2718.
The expandable elements 2718 may then be collapsed and/or withdrawn into the distal end 2664 of the sheath 2652. As the device 10 is released entirely from the sheath 2652, the primary tissue engaging portions 314 may partially overlap, as shown in
In addition, if the device 10 includes secondary tissue engaging portions 316 (such as those shown in
Once the device 10 is successfully deployed into the wall 2698 of the vessel 2690, e.g., on either side of an arteriotomy 2691, the apparatus 2600 may be withdrawn from the passage 2692. The entire apparatus 2600 may be removed in one step, or alternatively, the obturator 2700 may first be withdrawn from the sheath 2652 before withdrawing the sheath 2652, thereby leaving the device 10 in place to close the arteriotomy 2691 and/or seal the passage 2692.
In the deployed configuration, the device 10 for managing access through tissue may substantially close and/or seal the incision, puncture, or other passage 2692 that extends from a patient's skin 2694, through intervening tissue 2696, and into a wall 2698 of a vessel 2690 or other body lumen; engage tissue in other procedures, e.g., to connect tissue segments together or otherwise to secure tissue structures with respect to one another (i.e. attach an anastomosis during a bypass procedure); and/or close an aperture (i.e. a puncture, cut, tear, and/or other aperture) on the surface of the patient's skin 2694. After the device 10 is deployed, it may be desirable to perform a second procedure. The location of the second procedure may be through the device 10. For example, it may be desirable to provide access through the tissue and through the device 10 for performing a second therapeutic or diagnostic procedure.
To perform the second procedure, as shown in
To perform the second procedure, as shown in
The invention is susceptible to various modifications and alternative means, and specific examples thereof have been shown by way of example in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular devices or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the claims.
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