The present disclosure pertains generally, but not by way of limitation, to orthopedic implants and methods of treatment. More particularly, the present disclosure relates to a tendon repair implant, such as one that is engineered for arthroscopic placement over or in the area of a full or partial thickness tear of the supraspinatus tendon of the shoulder or other tendon, and an associated delivery device.
With its complexity, range of motion and extensive use, a common soft tissue injury is damage to the rotator cuff or rotator cuff tendons. Damage to the rotator cuff is a potentially serious medical condition that may occur during hyperextension, from an acute traumatic tear or from overuse of the joint. Current procedures for treatment of a torn tendon include affixing a biocompatible implant over the torn tendon. There is an ongoing need to deliver and adequately position medical implants during an arthroscopic procedure in order to treat injuries to the rotator cuff, rotator cuff tendons, or other soft tissue or tendon injuries throughout a body.
This disclosure provides design, material, manufacturing method, and use alternatives for medical devices. An example implant delivery system includes a delivery shaft including a proximal portion and a distal portion, a frame coupled to the distal portion of the delivery shaft, the frame including a body portion and at least first and second arms, the first and second arms each having first ends attached to the body portion and second, free ends opposite the first ends, the first arm having a first tab disposed adjacent its free end, the second arm having a second tab disposed adjacent its free end, and the body portion having a third tab, wherein the first tab extends toward the free end of the first arm and the second tab extends toward the body portion, and wherein the first, second, and third tabs are all configured to be releasably attached to an implant.
Alternatively or additionally to any of the embodiments above, the first and second tabs include a sharp tip configured to extend at least partially through the implant.
Alternatively or additionally to any of the embodiments above, the body portion and first and second arms define a Y shape.
Alternatively or additionally to any of the embodiments above, the first and second arms each extend at an angle from the body portion such that when the third tab engages an edge of an implant, the free ends of the first and second arms are disposed adjacent opposing edges of the implant.
Alternatively or additionally to any of the embodiments above, the third tab extends toward the free ends of the first and second arms.
Alternatively or additionally to any of the embodiments above, the third tab is blunt and configured to engage an edge of the implant.
Alternatively or additionally to any of the embodiments above, the third tab includes a sharp tip configured to extend at least partially through the implant.
Alternatively or additionally to any of the embodiments above, the frame has a concave shape between the body portion and the free ends of the first and second arms.
Alternatively or additionally to any of the embodiments above, the frame has an upper surface and a lower surface, and the first and second tabs extend downward from the lower surface.
Alternatively or additionally to any of the embodiments above, the first and second arms are fixed to the body portion and have a fixed length.
Alternatively or additionally to any of the embodiments above, an entirety of the frame, including the body portion and first and second arms, is formed from a single, monolithic piece.
Alternatively or additionally to any of the embodiments above, the implant delivery system further comprises a tack member connected to the body portion.
Alternatively or additionally to any of the embodiments above, the frame is removably coupled to the delivery shaft, and configured to be detached from the delivery shaft in vivo.
Alternatively or additionally to any of the embodiments above, the implant delivery system further comprises a tether extending through a lumen of the delivery shaft, the tether fixedly attached to the frame such that the tether remains attached to the frame when the delivery shaft is detached from the frame.
Another implant delivery system includes a delivery shaft including a proximal portion and a distal portion, a frame coupled to the distal portion of the delivery shaft, the frame including a body portion and at least first and second arms extending from the body portion, the frame including a plurality of tabs configured to releasably engage an implant, the first and second arms each having free ends, the free end of the first arm defining a first tab, the free end of the second arm defining a second tab, and the body portion having a third tab, wherein the first, second, and third tabs are configured to engage at least one edge of the implant.
Alternatively or additionally to any of the embodiments above, the free ends of the first and second arms are bent such that when the first and second arms are disposed on an upper surface of a planar implant, the free ends of the first and second arms wrap around side edges of the implant forming first and second tabs that extend along a lower surface of the implant.
Alternatively or additionally to any of the embodiments above, the body portion and first and second arms define a Y shape.
Alternatively or additionally to any of the embodiments above, the first and second arms each extend at an angle from the body portion such that when the third tab engages the at least one edge of the implant, the free ends of the first and second arms are disposed adjacent the at least one edge at opposing edges of the implant.
Alternatively or additionally to any of the embodiments above, when the implant is a polygon and the third tab engages a first edge of the implant, the first and second tabs of the first and second arms are configured to engage second and third edges of the implant adjacent the first edge of the implant.
Alternatively or additionally to any of the embodiments above, when the implant is circular and has an outer edge, and the third tab engages a first location on the outer edge, the first and second tabs of the first and second arms are configured to engage second and third locations on the outer edge of the implant spaced apart from the first location.
An example implant assembly includes a one-piece planar implant, and a delivery system including an outer shaft including a proximal end, a distal end, and a lumen extending therebetween, an inner shaft slidably disposed within the lumen of the outer shaft, and a frame fixedly attached to a distal end of the inner shaft and configured to be releasably attached to the implant, the frame including a body portion and at least first and second arms extending from the body portion, each of the first and second arms having a free end configured to penetrate the implant when inserted through the implant in a first direction, and to resist withdrawal from the implant when pulled in a second direction opposite the first direction, wherein the first and second arms are woven into and out of the implant.
Alternatively or additionally to any of the embodiments above, the free ends of the first and second arms each include a sharp distal tip and a flared region proximal of the sharp distal tip.
Alternatively or additionally to any of the embodiments above, the frame, including the body portion and first and second arms, is formed from as a single, monolithic piece.
Alternatively or additionally to any of the embodiments above, the frame defines a single concave arc between the body portion and the free ends of the first and second arms.
Alternatively or additionally to any of the embodiments above, the first and second arms are fixed to the body portion and have a fixed length.
Alternatively or additionally to any of the embodiments above, the body portion and first and second arms define a Y shape.
The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The Figures, and Detailed Description, which follow, more particularly exemplify these embodiments.
The disclosure may be more completely understood in consideration of the following detailed description in connection with the accompanying drawings, in which:
While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.
For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.
All numeric values are herein assumed to be modified by the term “about”, whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the terms “about” may include numbers that are rounded to the nearest significant figure.
The recitation of numerical ranges by endpoints includes all numbers within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).
As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
It is noted that references in the specification to “an embodiment”, “some embodiments”, “other embodiments”, etc., indicate that the embodiment described may include one or more particular features, structures, and/or characteristics. However, such recitations do not necessarily mean that all embodiments include the particular features, structures, and/or characteristics. Additionally, when particular features, structures, and/or characteristics are described in connection with one embodiment, it should be understood that such features, structures, and/or characteristics may also be used connection with other embodiments whether or not explicitly described unless clearly stated to the contrary.
The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the disclosure.
Rotator cuff surgeries are most frequently performed arthroscopically through various portals outside the shoulder. In order to successfully complete the repairs, the surgeons require appropriately sized medical devices that fit through the skin portals created. An accepted treatment for rotator cuff tears includes reattaching the torn tendon to the humeral head using sutures. Additionally, in treating rotator cuff tears, an accepted practice may also include the placement of a scaffold or planar implant over the repaired tendon to mechanically reinforce the repaired tendon. In order to fix the implant to the native tendon, a delivery device including a sheath may be used to shield the implant from the soft tissue during insertion into the joint. Once inside the joint space, the implant may be deployed from the sheath. Sufficient control of the implant is needed for manipulation inside the joint space. Additionally, a secure yet releasable connection between the delivery device and the implant is needed to successfully complete the procedure.
It is noted that although the disclosure below is in reference to treatment of a tendon of the shoulder joint, it is contemplated and within the understanding of this disclosure that the implants, delivery devices, and uses thereof, are also applicable to other body joints, such as the hip, knee, and elbow, as well as other regions of the body.
In
In some instances, delivery of an implant 12 (e.g., a sheet-like, one-piece planar implant) to a target site of a patient may require a physician to create an incision in the patient sufficient to access the target implant site. After creating this “access site,” the physician may insert an implant delivery system through the access site and position the distal end of the implant delivery system adjacent the target implant site. The physician may then manipulate the implant delivery system to deploy an implant out of a delivery sheath or otherwise deploy the implant adjacent the target implant site.
For example,
Delivery shaft 44 may include a proximal portion (not shown) extending out of the proximal portion of delivery sheath 42 and/or otherwise manipulatable relative to delivery sheath 42 by a user. Additionally, in some examples the proximal portion of delivery shaft 44 and/or or delivery sheath 42 may be coupled to a handle member (not shown). The handle member may be utilized to manipulate delivery shaft 44. For example, the handle member may be utilized to impart a rotational and/or longitudinal force to delivery shaft 44.
In addition, delivery shaft 44 may include a distal portion 50 extending out of the distal end 48 of delivery sheath 42. Further, delivery shaft 44 may include a lumen extending therein. The lumen of delivery shaft 44 may extend along a portion or the entire length of delivery shaft 44 (e.g., from distal portion 50 to the proximal portion of delivery shaft 44).
Delivery system 40 may further include a frame 46 coupled to the distal portion 50 of the delivery shaft 44. In some examples, the frame 46 may be fixedly mounted to the delivery shaft 44. As shown in
When initially positioning the frame 46 and implant 12 adjacent a target site, a clinician may orient the frame 46 and implant 12 (for example, via a handle member attached to a proximal portion of the delivery shaft 44) such that the proximal portion 52 may be adjacent (e.g., overlaid) on a portion of the humerus (e.g., on the bone), while the distal portion 54 of the frame 46 and implant 12 may overlay the tendon 24.
As described above, delivery of implant delivery system 40 may include the insertion of delivery sheath 42 through an access site (e.g., incision) and advancement to a target site. After positioning the distal end 48 of delivery sheath 42 proximate the target site, a clinician may deploy the frame 46 in combination with the implant 12 out of the lumen located within and along the distal end 48 of the delivery sheath 42, such as by retracting delivery sheath 42 relative to delivery shaft 44 and frame 46, and positioning implant 12 and frame 46 over the target site.
Prior to deployment, the frame 46 and implant 12 combination may be contained (e.g., housed) within the lumen of delivery sheath 42 for subsequent deployment distally out distal opening of delivery sheath 42. As will be described in greater detail below, the combination of frame 46 and implant 12 may wrap and/or fold upon itself such that it may be positioned within the lumen of the delivery sheath 42. Alternatively, frame 46 and implant 12 may wrap and/or fold around implant delivery shaft 44 while disposed within delivery sheath 42. For example, frame 46 may be formed of a flexible material, such as a flexible polymer or metal material, capable of undergoing elastic deformation to collapse frame 46 for placement within the lumen of the delivery sheath 42.
As shown in
In some examples (such as that shown in
The frame 46 may include a plurality of attachment members configured to releasably couple with the implant 12. The first arm 60 may have a first tab 70 disposed adjacent its free end 62, the second arm 64 may have a second tab 72 disposed adjacent its free end 66, and the body portion 56 having a third tab 74. In some instances, first arm 60 may include a plurality of first tabs 70 arranged along a length of the first arm 60 and/or second arm 64 may include a plurality of second arms 72 arranged along a length of the second arm 64. In some examples, the first, second, and third tabs 70, 72, 74 may include barbs or projections having a sharp tip configured to pierce and extend at least partially through the implant 12. In some instances the first, second and/or third tab 70, 72, 74 may extend entirely through the implant 12 to be exposed on a lower surface of the implant 12. However, in other instances the first, second and/or third tab 70, 72, 74 may extend only partially through the thickness of the implant 12, and thus not be exposed on the lower surface of the implant 12.
In the example illustrated in
In the example shown in
In some instances, one or more of the first, second, and third tabs 70, 72, 74 may be made of a superelastic and/or shape memory material, such as nitinol, configured to provide a secure grip on the implant 12 during delivery, but to be pulled free of the implant 12 without damaging the implant 12 as a withdrawal force is applied to frame 46. While a single tab is shown on each of the first and second arms 60, 64, it is contemplated that two or more tabs may be disposed on each arm. When multiple tabs are present on a single arm, the tabs may extend in the same direction or they may extend in opposite directions. In other words, in some instances, the first arm 60 may include one or more tabs having a free end (e.g., pointed end) extending toward the proximal end of the implant 12 and one or more tabs having a free end (e.g., pointed end) extending toward the distal end of the implant 12. Likewise, the second arm 64 may include one or more tabs having a free end (e.g., pointed end) extending toward the proximal end of the implant 12 and one or more tabs having a free end (e.g., pointed end) extending toward the distal end of the implant 12.
As stated above, it is contemplated in the examples discussed herein that frame 46 may be able to be detached from implant 12 upon securement of the implant 12 at a treatment site. For example, frame 46 may be configured to detach from implant 12 after implant 12 has been affixed to a target site in the body, such as with staples and/or sutures. Therefore, it can be appreciated that in some examples disclosed herein, frame 46 may be temporarily attached to implant 12. For example, frame 46 may be coupled, affixed or attached to implant 12 while positioned within delivery sheath 42, deployed out of delivery sheath 42 and maneuvered into position relative to a target site. Once positioned at the target site (e.g., along the tendon and/or humeral head), implant 12 may be securely affixed to the target site, such as stapled and/or sutured to bone and/or tendon tissue at the target site. However, once implant 12 has been securely affixed to the target site, frame 46 may be pulled away (e.g., detached) from implant 12 and removed from the body. The first and second tabs 70, 72 may be configured to be detached or disengaged from implant 12 upon application of a threshold level of force. For example, the second tab 72 shown in
As discussed above, in some instances, a physician may insert implant delivery system 40 (including a delivery sheath 42, delivery shaft 44, frame 46 and implant 12) through an incision and position the distal end of the implant delivery system 40 adjacent a target implant site (e.g., torn tendon). Once adjacent the target site, the physician may manipulate the implant delivery shaft 44 to advance the implant (while attached to the detachable frame 46) out of the delivery sheath 42 adjacent the target implant site. For example, the physician may retract delivery sheath 42 proximally relative to delivery shaft 44 and frame 46 and/or may advance delivery shaft 44 and frame 46 distally relative to delivery sheath 42.
However, when positioned in the delivery sheath 42 (e.g., prior to deployment) the frame 46 and implant 12 may be wrapped around the delivery shaft 44 in a convex configuration. Therefore, frame 46 and implant 12 may shift from a first convex configuration (while wrapped tightly around delivery shaft 44 within the lumen of delivery sheath 42) to a second concave configuration when advanced (e.g., deployed) out of delivery sheath 42.
In other words, frame 46 and implant 12 may be attached to the delivery shaft 44 when positioned within the lumen of the delivery sheath 42. In one example, when positioned within the delivery sheath 42, the frame 46 and implant 12 may wrap, or extend around, the delivery shaft 44. The position of the frame 46 and implant 12 may be in a convex, or rolled up configuration with respect to the distal portion 50 of the delivery shaft 44. As the frame 46 and implant 12 are deployed out of the distal end of the delivery sheath 42, the frame 46 and implant 12 may “shift” from a convex configuration to a concave configuration (as viewed with respect to the distal portion 50 of delivery shaft 44). Additionally,
In some instances, the configuration of frame 46 shown in
As briefly described above, any of the implant delivery systems described herein may include a tack member 94 designed to anchor the delivery system in place prior to a clinician affixing implant 12 to the bone and/or tendon. As shown in
In some examples, frame 46 and implant 12 may be positioned within delivery sheath 42 (depicted as dashed line) as shown in
Additionally,
In other examples, tack member 94 may translate (e.g., slide, move, etc.) along a longitudinal axis within a lumen (not shown) of first connection member 90 of connection assembly 88. For example,
In some instances, once tack member 94 has been anchored into a target site (e.g., humeral head 16) it may be desirable to remove the delivery shaft 44 to make room for additional instruments to be advanced adjacent the target site.
In some instances, delivery system 40 may include a tether 96 coupled to frame 46. For example,
Further, it can be appreciated that tether 96 may remain attached to frame 46 (e.g., via first connection member 90) and extend to a location exterior of the patient through insertion site (i.e., incision) with delivery shaft 44 detached from frame 46 and removed from insertion site (i.e., incision) while additional instruments are advanced through the insertion site and to the target site. For example,
As discussed above, in some instances, implant 12 may be affixed to a target site after which the frame 46 may be detached (and removed) from both implant 12 and the target site. For example, in some instances, implant 12 may be attached to a target site via one or more bone and/or tendon staples. The staples may be applied to the target site via a stapling instrument (e.g., medical instrument 98).
Further, in some instances, it may be beneficial to affix implant 12 to the bone portion of the target site (e.g., humeral head 16) prior to affixing the implant to the tendon portion 24 of the target site. For example, it may be beneficial for a clinician to orient and/or position the frame 46 and implant 12 in the location/arrangement shown in
It can be further appreciated that because the examples disclosed herein allow for the removal of the delivery sheath 42 and delivery shaft 44 prior to insertion of the stapling instrument, sufficient room exists to manipulate the stapling instrument in order to accurately place the staples along the proximal portion 52 of the implant 12 adjacent the humeral head 16. Further, as discussed above, the frame 46 is shaped to allow access to fastening regions 15 (shown in
Additionally, as discussed above, the tack member 94 may anchor the frame 46 and implant 12 in place (e.g., to the bone 16), thereby allowing a clinician to remove the delivery shaft 44 without fear that the frame/implant 46/12 combination will change position prior to the insertion of staples into the implant 12.
Once the implant 12 has been sufficiently affixed to the target site, the clinician may detach the frame 46 from the implant 12 (within the body) and remove it from the body via the insertion site. For example,
The implant 12 shown in
The frame 146, coupled to the implant 12, may be secured to a delivery system 40 including a delivery shaft 44, as described above. The free ends 162, 166 and tab 174 combine to securely hold the implant 12 during delivery, yet allow for the frame 146 to be pulled free of the implant 12 after the implant 12 has been stapled or otherwise secured within the body.
Another example frame 246 for delivering the implant 12 is illustrated in
The frame 246 illustrated in
In the undeployed state, frame 246 may be configured to fit within the delivery sheath 242. Accordingly, in such an example, each arm 260, 264 may deform in a manner to allow insertion of the frame 246 and attached implant 12 into delivery sheath 242. Accordingly, the frame 246 may generally be flexible, and in the example of
Although
The implant delivery system 400 may include an active retention mechanism to retain implant 12. The active retention mechanism may require manipulation by a user to retain and/or release implant 12. In some examples, the active retention mechanism may include a frame 446 releasably connected to delivery shaft 444. In some examples, frame 446 may be fixed to the distal end 445 of delivery shaft 444 and extend substantially parallel to the delivery shaft 444. In other examples, frame 446 may be fixed to first beam 480, frame 446 may be incorporated with first beam 480, or frame 446 may be positioned between first and second beams 480. When implant 12 is disposed between first and second beams 480, frame 446 may engage implant 12. In other examples, the implant delivery system 400 does not include the first and second beams 480. Instead, frame 446 alone may releasably engage the implant 12.
The frame 446 may be similar to frame 246 described above, with first and second arms 460, 466 having sharp distal tips 470, 472 configured to penetrate implant 12 when inserted in a first direction and to resist withdrawal from implant 12 when pulled in a second direction opposite the first direction. The arms may be woven into and out of implant 12 as shown in
In implant delivery system 400, once implant 12 is moved out of delivery sheath 442, implant 12 may extend generally parallel to the longitudinal axis of the delivery shaft 444, as illustrated in
In the undeployed state, frame 46, 146, 246, 346, 446 may be configured to fit within delivery sheath 42, 242, 442. Accordingly, in such an example, each arm of frame 46, 146, 246, 346, 446 may deform in a manner to allow insertion of frame 46, 146, 246, 346, 446 into delivery sheath 42, 242, 442. Accordingly, frame 46, 146, 246, 346, 446 may generally be flexible, and each arm of frame 46, 146, 246, 346, 446 may bend, twist, fold, wrap or otherwise deform in order for frame 46, 146, 246, 346, 446 with attached implant 12 to fit within delivery sheath 42, 242, 442.
In at least some examples, the frame 46, 146, 246, 346, 446 is made of a material that may deform elastically into one or more shapes in order to fit within the confines of delivery sheath 42, 242, 442. Some suitable example materials include metals and metal alloys including stainless steel, such as 304V, 304L, and 316LV stainless steel; mild steel; nickel-titanium alloy such as linear-elastic and/or super-elastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like); platinum enriched stainless steel; titanium; combinations thereof; and the like; or any other suitable material.
As alluded to above, within the family of commercially available nickel-titanium or nitinol alloys, is a category designated “linear elastic” or “non-super-elastic” which, although may be similar in chemistry to conventional shape memory and super elastic varieties, may exhibit distinct and useful mechanical properties. Linear elastic and/or non-super-elastic nitinol may be distinguished from super elastic nitinol in that the linear elastic and/or non-super-elastic nitinol does not display a substantial “superelastic plateau” or “flag region” in its stress/strain curve like super elastic nitinol does. Instead, in the linear elastic and/or non-super-elastic nitinol, as recoverable strain increases, the stress continues to increase in a substantially linear, or a somewhat, but not necessarily entirely linear relationship until plastic deformation begins or at least in a relationship that is more linear that the super elastic plateau and/or flag region that may be seen with super elastic nitinol. Thus, for the purposes of this disclosure linear elastic and/or non-super-elastic nitinol may also be termed “substantially” linear elastic and/or non-super-elastic nitinol.
In some cases, linear elastic and/or non-super-elastic nitinol may also be distinguishable from super elastic nitinol in that linear elastic and/or non-super-elastic nitinol may accept up to about 2-5% strain while remaining substantially elastic (e.g., before plastically deforming) whereas super elastic nitinol may accept up to about 8% strain before plastically deforming. Both of these materials can be distinguished from other linear elastic materials such as stainless steel (that can also can be distinguished based on its composition), which may accept only about 0.2 to 0.44 percent strain before plastically deforming.
In some examples, the linear elastic and/or non-super-elastic nickel-titanium alloy is an alloy that does not show any martensite/austenite phase changes that are detectable by differential scanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA) analysis over a large temperature range. For example, in some embodiments, there may be no martensite/austenite phase changes detectable by DSC and DMTA analysis in the range of about −60 degrees Celsius (° C.) to about 120° C. in the linear elastic and/or non-super-elastic nickel-titanium alloy. The mechanical bending properties of such material may therefore be generally inert to the effect of temperature over this very broad range of temperature. In some embodiments, the mechanical bending properties of the linear elastic and/or non-super-elastic nickel-titanium alloy at ambient or room temperature are substantially the same as the mechanical properties at body temperature, for example, in that they do not display a super-elastic plateau and/or flag region. In other words, across a broad temperature range, the linear elastic and/or non-super-elastic nickel-titanium alloy maintains its linear elastic and/or non-super-elastic characteristics and/or properties.
In some examples, the linear elastic and/or non-super-elastic nickel-titanium alloy may be in the range of about 50 to about 60 weight percent nickel, with the remainder being essentially titanium. In some embodiments, the composition is in the range of about 54 to about 57 weight percent nickel. One example of a suitable nickel-titanium alloy is FHP-NT alloy commercially available from Furukawa Techno Material Co. of Kanagawa, Japan. Some examples of nickel titanium alloys are disclosed in U.S. Pat. Nos. 5,238,004 and 6,508,803, which are incorporated herein by reference. Other suitable materials may include ULTANIUM™ (available from Neo-Metrics) and GUM METAL™ (available from Toyota). In some other embodiments, a superelastic alloy, for example a superelastic nitinol can be used to achieve desired properties.
In other examples, implant positioning component may be constructed of one or more of the above described materials configured as an inlay. For instance, the frame 46, 146, 246, 346, 446 may comprise a metal structure encased in one or more other materials, such as a plastic or silicone material. The plastic or silicone material may be molded either completely or partly over the metal structure. Such hybrid-material structures may reduce the manufacturing cost of producing frame 46, 146, 246, 346, 446 or provide frame 46, 146, 246, 346, 446 with physical properties unable to be achieved by using only metal.
In the above examples, implant 12 may comprise one or multiple of a number of different materials without deviating from the spirit and scope of the present disclosure. In some examples, implant 12 may comprise a plurality of fibers. The fibers may be interlinked with one another. When this is the case, implant 12 may comprise a plurality of apertures comprising the interstitial spaces between fibers. Various processes may be used to interlink the fibers with one another. Examples of processes that may be suitable in some applications including weaving, knitting, and braiding. In some embodiments, implant 12 may comprise a laminate including multiple layers of film with each layer of film defining a plurality of micro-machined or formed holes. Implant 12 may also comprise a reconstituted collagen material having a porous structure. Additionally, implant 12 may also comprise a plurality of electro-spun nanofiber filaments forming a composite sheet. Additionally, implant 12 may comprise a synthetic sponge material that defines a plurality of pores. Implant 12 may also comprise a reticulated foam material. Implant 12 may be circular, oval, oblong, square, rectangular, triangular, or any other shape configured to suit the target anatomy.
It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the disclosure. This may include, to the extent that it is appropriate, the use of any of the features of one example embodiment being used in other embodiments. The disclosure's scope is, of course, defined in the language in which the appended claims are expressed.
This application is a continuation of International Application No. PCT/US2021/043668, filed Jul. 29, 2021, titled MEDICAL IMPLANT DELIVERY SYSTEM, which claims the benefit of and priority to U.S. Provisional Patent Application Ser. No. 63/060,466, filed on Aug. 3, 2020, titled MEDICAL IMPLANT DELIVERY SYSTEM, the disclosures of which are incorporated herein by reference.
Number | Date | Country | |
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63060466 | Aug 2020 | US |
Number | Date | Country | |
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Parent | PCT/US2021/043668 | Jul 2021 | US |
Child | 18096339 | US |