Left atrial appendage closure device with central support

Abstract

The implantable medical device comprises an expandable frame movable between a collapsed configuration for delivery, an expanded configuration for deployment, and an expanded configuration, the expandable frame comprising a first frame end and a second frame end, a distance between the first frame end and the second frame end while in the expanded configuration defining an expanded configuration end distance, and a distance between the first frame end and the second frame end while in the expanded configuration defining an expanded configuration end distance, a support member extending between the first frame end and the second frame end, the support member comprising a first end secured to the first frame end and a second end releasably securable to the second frame end, the adjustable support adapted to limit the expanded configuration end distance relative to the expanded configuration end distance.

Description

Technical Field

[0001] The present disclosure relates to medical devices, methods of manufacturing medical devices, and methods of using medical devices. More specifically, the present disclosure is directed to implantable medical devices having a central support that limits axial expansion.

Background Art

[0002] A wide variety of medical devices have been developed for medical use (e.g., for use when accessing a body cavity or interfering with body fluids or body structures within a body cavity). Some of these devices may include guidewires, catheters, pumps, motors, controllers, filters, grinders, needles, valves, and delivery devices and / or delivery systems used to deliver such devices. These devices are manufactured by any one of a variety of different manufacturing methods and can be used according to any one of a variety of methods. Known medical devices and medical methods each have specific advantages and disadvantages.

Summary of the Invention

[0003] The present disclosure provides alternatives for the design, materials, manufacturing methods, and use of medical devices. As an example, an implantable medical device includes an expandable frame that defines a body of the implantable medical device, the expandable frame being movable between a collapsed configuration for delivery and an expanded configuration for placement, the expandable frame including a first frame end and a second frame end, the expandable frame being axially extensible beyond the expanded configuration by an applied axial force. An adjustable support extends between the first frame end and the second frame end and is adapted to limit how far the expandable frame can axially extend beyond its expanded configuration.

[0004] Alternatively or additionally, the adjustable support may include a first end fixed to the first frame end and a second end releasably fixable to the second frame end. Alternatively or additionally, the adjustable support may comprise a member having a first end fixed to the first end of the frame.

[0005] Alternatively or additionally, this component may have a second end that can be removably secured to the second frame end. Alternatively or additionally, the adjustable support may further comprise a pin fixed to the second frame end, the member passing through this pin.

[0006] Alternatively or additionally, the adjustable support may further comprise a tapered collar fixed in position on the member, the tapered collar being adapted to be releasably secured to the pin to secure the second end of the member to the second end of the frame.

[0007] Alternatively or additionally, the member may include a suture wrapped around the first frame end and having a first free end and a second free end, each free end extending proximal beyond the second frame end.

[0008] Alternatively or additionally, the adjustable support may further comprise a ratchet element comprising a toothed lumen through which the first and second free ends of the suture pass, the toothed lumen being adapted to allow the ratchet element to slide in one direction relative to the suture but restrict movement in the opposite direction.

[0009] Alternatively or additionally, the adjustable support may further comprise a reversible suture fastener comprising: a suture fastener body defining a lumen through the suture fastener body; a first element slidably disposed within the lumen, the first element comprising a first element lumen, the member extending freely through the first element lumen; a second element slidably disposed within the lumen and engaged with the first element, the element member comprising a second element lumen, the member extending freely through the second element lumen; and an engaging element adapted to releasably engage with the first element, the engaging element comprising an engaging element lumen, the member extending freely through the engaging element lumen. The first and second elements are movable between a first position in which the member can move freely relative to the suture fastening body and a second position in which the member is constrained against movement relative to the suture fastening body.

[0010] Alternatively or additionally, the adjustable support may further comprise a suture fastener comprising a suture fastener body defining a lumen through which the fastener body penetrates, and the lumen housing a member so as to pass through the lumen; and a ratchet engaging with the member, the ratchet applying tension to the member.

[0011] Alternatively or additionally, the implantable medical device may include a LAAC (left atrial appendage closure) device. Alternatively or additionally, the expandable frame may be biased to become an expandable configuration.

[0012] As another example, an implantable medical device comprises an expandable frame defining the implantable medical device body, which is movable between a collapsed configuration for delivery, an expanded configuration for placement, and an inflated configuration. The expandable frame comprises a first frame end and a second frame end, the distance between the first frame end and the second frame end while within the expanded configuration defines the expanded configuration end distance, and the distance between the first frame end and the second frame end while in the inflated configuration defines the inflated configuration end distance. A support member extends between the first frame end and the second frame end, the support member comprising a first end fixed to the first frame end and a second end removably fixed to the second frame end, the adjustable support being adapted to limit the inflated configuration end distance relative to the expanded configuration end distance.

[0013] Alternatively, the implantable medical device may further comprise a pin fixed to a second frame end, a support member through which the pin passes, and a tapered collar fixed on the support member, the tapered collar being adapted to be releasably fixed to the pin to secure the second end of the support member to the second frame end.

[0014] Alternatively or additionally, the support member may include a suture wrapped around the first frame end and having a first free end and a second free end, each free end extending proximal beyond the second frame end.

[0015] Alternatively or additionally, the implantable medical device may further comprise a ratchet element comprising a toothed lumen through which the first and second free ends of the suture pass, the toothed lumen being adapted to allow the ratchet element to slide in one direction relative to the suture but restrict movement in the opposite direction.

[0016] Alternatively or additionally, the implantable medical device may further comprise a reversible suture fastener comprising: a suture fastener body defining a lumen through which the suture fastener body penetrates; a first element slidably disposed within the lumen, the first element comprising a first element lumen through which a suture extends freely; a second element slidably disposed within the lumen and engaged with the first element, the element member comprising a second element lumen through which a suture extends freely; and an engaging element adapted to be releasably engaged with the first element, the engaging element comprising an engaging element lumen through which the suture extends freely.

[0017] Alternatively or additionally, the implantable medical device may further comprise a suture holder comprising a suture holder body defining a lumen through which the suture passes, the lumen accommodating the suture so as to pass through the lumen, and a ratchet engaging with the suture, the ratchet maintaining tension on the suture.

[0018] As another example, a LAAC (left atrial appendage occlusion) device comprises an expandable frame defining the body of an implantable medical device, which is movable between a collapsed configuration for delivery, an expanded configuration for placement, and an inflated configuration. The expandable frame comprises a first frame end and a second frame end, the distance between the first and second frame ends while within the expanded configuration defines the expanded configuration end distance, and the distance between the first and second frame ends while in the inflated configuration defines the inflated configuration end distance. A support member extends between the first and second frame ends, and this support member comprises a first end fixed to the first frame end and a second end that can be removably fixed to the second frame end. An adjustable support is adapted to limit the inflated configuration end distance relative to the expanded configuration end distance.

[0019] Alternatively or additionally, an adjustable support may further comprise a pin fixed to a second frame end, the member passing through the pin, and a tapered collar fixed at a position on the member, the tapered collar being adapted to be releasably fixed to the pin to secure the second end of the member to the second frame end.

[0020] The above summaries of some embodiments are not intended to describe each embodiment of the disclosure or all implementations of the disclosure. The following drawings and detailed descriptions illustrate these embodiments more specifically. [Brief explanation of the drawing]

[0021] The present invention can be better understood by considering the following detailed description of various embodiments of the invention in conjunction with the accompanying drawings. [Figure 1] Figure 1 is a side view of an exemplary implantable medical device with an exemplary adjustable support. [Figure 2A] Figure 2A is a schematic example of relative sealing of an exemplary implantable medical device without an adjustable support. [Figure 2B] Figure 2B is a schematic example of relative sealing of the implantable medical device shown in Figure 1. [Figure 3A] Figure 3A is a side view of an exemplary implantable medical device lacking an adjustable support, shown in an inflatable configuration. [Figure 3B] Figure 3B is a side view of the exemplary implantable medical device shown in Figure 1, in an inflated configuration. [Figure 4A] Figure 4A is a side view of an exemplary implantable medical device with an exemplary adjustable support. [Figure 4B] Figure 4B is an enlarged side view of a portion of the exemplary regulating support shown in Figure 4A. [Figure 5A] Figure 5A is a cross-sectional view of an exemplary suture-fastening device that may be used with the exemplary implantable medical device of Figure 1, and is shown in an unlocked configuration in which the suture is not constrained against axial movement. [Figure 5B] FIG. 5B is a cross-sectional view of an exemplary suture retention device of FIG. 5A, shown in a locking configuration in which the suture is constrained against axial movement. [Figure 6] FIG. 6 is a cross-sectional view of an exemplary suture retention device that can be used with the exemplary implantable medical device of FIG. 1.

[0022] While this disclosure is not loath to accept various changes and alternative forms, specific examples thereof are shown by way of illustration in the drawings and are described in detail. It should be understood, however, that there is no intent to limit this disclosure to the particular embodiments described. On the contrary, it is intended to cover all modifications, equivalents, and alternative forms within the spirit and scope of this disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

[0023] For the terms defined below, these definitions apply unless a different definition is given in the claims or elsewhere in this specification. In this specification, all numerical values are assumed to be modified by the term "about" whether explicitly indicated or not. The term "about" typically refers to a range of numbers that a person of ordinary skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the term "about" may include numbers rounded to the nearest significant figure.

[0024] The recitation of a numerical range by endpoints includes all numbers within that range (e.g., for 1 - 5, it 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 ordinarily employed in the sense including "and / or" unless the content clearly dictates otherwise.

[0025] The following detailed description should be read with reference to the drawings, where similar elements in different drawings are numbered the same. The drawings are not necessarily to scale and illustrate exemplary embodiments; they are not intended to limit the scope of the invention.

[0026] Various medical devices are intended to be implanted in a patient's body. In some cases, once an implantable medical device is implanted, or at least in the initial stages of implantation, it undergoes tag testing before the implantation is complete. It should be understood that in some cases, this tag testing may cause the implantable medical device to swell. In some cases, this may cause the implantable medical device to detach and move. In the case of implantable medical devices intended to seal to tissue, swelling that occurs during testing, such as tag testing, may cause a loss of seal to the tissue.

[0027] Figure 1 is a side view of an exemplary IMD (implantable medical device) 10. This exemplary IMD 10 can be adapted for use as a LAAC (left atrial appendage occlusion) device. An LAAC is used to seal the inside of the left atrial appendage from the rest of the patient's heart to reduce or eliminate the possibility of a thrombus becoming detached from the left atrial appendage.

[0028] The IMD10 includes an expandable frame 12 that is movable between a compressed configuration for delivery and an expanded configuration for placement (as shown in Figure 1). The expandable frame 12 may be configured to reach the expanded configuration by tension applied to it. In some examples, the expandable frame 12 may be biased to reach the expanded configuration.

[0029] In some cases, the IMD 10 may include a membrane (not shown) covering at least a portion of the expandable frame 12, which enables the IMD 10 to seal the left atrial appendage. The expandable frame 12 is formed from a number of individual frame struts 12a. In some cases, the individual frame struts 12a may be laser-cut, for example. Further details relating to the construction of the expandable frame 12 can be found in U.S. Patent Application Publication No. 2017 / 0224354 (incorporated herein by reference).

[0030] The IMD10 includes a first frame end 14 and a second frame end 16. In some examples, the first frame end 14 may be considered the distal frame end, and the second frame end 16 may be considered the proximal frame end 16. Distal and proximal are relative terms with respect to the final implantation direction of the IMD10. In some examples, if the IMD10 includes a membrane, this membrane may extend over the second frame end 16. In some cases, the second frame end 16 may be configured to allow attachment of the IMD10 to a delivery device for delivering the IMD10 to a suitable implantation site within the patient's body (e.g., in the patient's heart proximal to the left atrial appendage).

[0031] The IMD10 includes an adjustable support structure 18 which can be used, for example, to limit the expansion of the expandable frame 12 during tag testing. This adjustable support structure 18 may be adapted to limit how far the expandable frame 12 can axially extend before it becomes an inflated configuration beyond its expanded configuration. In some cases, the distance between a first frame end 14 and a second frame end 16 while the expandable frame 12 is in its expanded configuration defines the expanded configuration end distance. In some cases, the distance between the first frame end 14 and a second frame end 16 while the expandable frame 12 is in an inflated configuration defines the inflated configuration end distance. The adjustable support structure 18 may be adapted to limit the inflated configuration end distance relative to the expanded configuration end distance. The expanded configuration end distance may be in the range of 15 to 22 millimeters (mm) (for 20 mm devices and 40 mm devices, respectively). In some cases, the inflated configuration end distance may be in the range of 24 to 44 mm (for 20 mm devices and 40 mm devices, respectively).

[0032] In some cases, the adjustable support structure 18 includes an elongated member 20. The elongated member 20 may be flexible or rigid and may be formed from any suitable material. If the elongated member 20 is rigid, it may be made of metal or a rigid polymer. If the elongated member 20 is flexible, it may be made of a softer polymer. In some cases, the elongated member 20 may be sewing thread or suture thread. In some cases, the elongated member 20 may be suture thread wrapped around the first frame end 14, with a pair of free ends of the suture thread extending proximal to the second frame end 16.

[0033] The elongated member 20 has a first end 22 which can be fixed to the first frame end 14. The first end 22 may be tied to the first frame end 14, for example, or wrapped around the first frame end 14. In some cases, the first end 22 may be fixed to the first frame end 14 by adhesive. If the elongated member 20 is made of metal, the first end 22 of the elongated member 22 may be fixed to the first frame end 14 by welding or soldering. The first end 22 can be fixed to the first frame end 14 without hindering the ability of the expandable frame 12 to move between the delivery crush configuration and the placement expand configuration.

[0034] The elongated member 20 extends through the inside of the expandable frame 12 to the second end 24 and beyond the second frame end 16, as shown in the figure. In some cases, the adjustable support structure 18 includes a pin 26 that can be fixed to the second frame end 16, and the elongated member 20 passes through a lumen formed within this pin 26. In some examples, the pin 26 is radiopaque to enhance visibility during imaging procedures.

[0035] In some examples, the adjustable support structure 18 includes a tapered collar 28 that can be fixed to an elongated member 20. This tapered collar 28 may be configured to attach to a pin 26 in order to fix the elongated member 20 to the pin 26, and therefore to the second frame end 16. In some cases, the tapered collar 28 itself may be radiopaque, in addition to or instead of the pin 26 being radiopaque. It should be understood that the relative position of the collar 28 on the elongated member 20 determines whether and to what extent the expandable frame 12 can expand when the second frame end 16 is subjected to tension, for example, during a tag test.

[0036] Figures 2A and 2B provide a graphical comparison between the sealing ability of IMD10 without an adjustable structure, such as the adjustable structure 18 (Figure 2A), during tag testing and the sealing ability of IMD10 with the adjustable support structure 18 (Figure 2B) during tag testing. In Figure 2A, the outer circle 30 schematically shows the outer edge of the tissue to which the IMD10 has been transplanted. The inner circle 32 schematically shows the outer edge of IMD10 without a central support. In this example, 94.9% of the outer circle 30 is filled with IMD10. In Figure 2B, the inner circle 34 schematically shows the outer edge of IMD10 with a central support. In this example, 97.3% of the outer circle 30 is occupied by IMD10.

[0037] Figure 3A shows IMD10' during a tag test. IMD10' lacks a central support and, as shown in the figure, significantly expanded due to the tension applied during the tag test. It should be understood that axial expansion of IMD10' reduces its diameter, as shown in the figure. In contrast, Figure 3B shows IMD10 during a tag test. Thanks to the adjustable support structure 18, it can be seen that the degree of expansion of IMD10 is significantly reduced compared to Figure 3A.

[0038] Figure 4A is a schematic diagram of an exemplary IMD40 which may be considered an example of IMD10. The IMD40 comprises an expandable frame 41 which is movable between a crushed configuration for delivery and an expanded configuration (shown) for placement. The expandable frame 41 extends between a first frame end 40a and a second frame end 40b. In some cases, the first frame end 40a may be considered the distal frame end and the second frame end 40b may be considered the proximal frame end.

[0039] The IMD40 includes an adjustable support structure 42, which can be used, for example, with the IMD10. The adjustable support structure 42 includes an elongated member 44 extending through the IMD40, which may be attached to a first frame end 40a and (in the illustrated orientation) extends downward through a second frame end 40b. In some cases, the elongated member 44 may be, for example, a suture. This elongated member 44 passes through a ratchet element 46, which is better shown in Figure 4B.

[0040] The ratchet element 46 includes a ratchet lumen 48 that passes through the ratchet element 46 axially. The ratchet lumen 48 has numerous ratchet teeth 50 that are sized to engage with an elongated member 44. In some cases, the ratchet lumen 48 and ratchet teeth 50 are sized such that the elongated member 44 can be pulled down through the ratchet element 46, thereby securing the elongated member 44, but cannot be moved in the opposite direction, loosening the elongated member 44.

[0041] Figures 5A and 5B are cross-sectional views of an exemplary suture fastening device 52 that may be used with the exemplary IMD 10 of Figure 1. Figure 5A shows an unlocked configuration in which the suture 54 is not constrained against axial movement, while Figure 5B shows a locked configuration in which the suture 54 is constrained against axial movement. The suture fastening device 52 comprises a body 56 which defines a body lumen 58 that penetrates the body 56. The suture fastening device 52 comprises a first element 60 which is slidably positioned within the body lumen 58. The first element 56 comprises a first element lumen 62 through which the suture 54 extends freely.

[0042] The suture fastening device 52 includes a second element 64 slidably positioned within a main body lumen 58. The second element 64 engages with the first element 60 and includes a second element lumen 66 through which the suture 54 extends freely. The suture fastening device 52 also includes an engaging element 68 adapted to engage releasably with the first element 60. The engaging element 68 includes an engaging element lumen 70 through which the suture 54 extends freely. In some cases, the engaging element 68 includes teeth 72 which interact with a toothed surface 74 formed within the suture fastening body 56.

[0043] The first element 60 and the second element 64 are movable between a first position (shown in Figure 5A) in which the suture 54 can move freely relative to the suture fastening body 56, and a second position (shown in Figure 5B) in which the suture 54 is constrained against movement relative to the suture fastening body 56. As shown in Figure 5B, the suture 54 is trapped between the second element 64 and the side wall of the main body lumen 58.

[0044] Figure 6 is a cross-sectional view of an exemplary suture fastening device 76 that may be used with the exemplary IMD 10 of Figure 1. The suture fastening device 76 comprises a suture fastening body 78 that defines a lumen 80 passing through the suture fastening body 78. The lumen 80 is fitted to accommodate a suture 54 passing through the lumen 80. A ratchet 82 is fitted to engage with the suture 54. Slack can be removed from the suture 54 by rotating the ratchet 82.

[0045] The devices described herein, as well as their various components, may be manufactured according to any essential and appropriate manufacturing techniques (such as molding, casting, machining, or any other appropriate techniques). Furthermore, the various structures may include materials generally associated with medical devices (e.g., metals, alloys, polymers, metal-polymer composites, ceramics, combinations thereof, or any other appropriate materials). Such materials may also include transparent or translucent materials to aid in visualization during treatment. Some examples of suitable metals and alloys include stainless steel (e.g., 304V, 304L, and 316LV stainless steel); mild steel; nickel-titanium alloys (e.g., linear elastic and / or superelastic Nitinol); other nickel alloys (e.g., 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®, and other HASTELLOY® alloys, etc.)); nickel-copper alloys (MONEL® 400, NICKELVAC® 400, NICORROS®) This may include nickel-cobalt-chromium-molybdenum alloys (such as UNS:N04400, e.g., UNS:R30035, e.g., MP35-N(trademark)); nickel-molybdenum alloys (such as UNS:N10665, e.g., HASTELLOY(registered trademark) ALLOY B2(registered trademark)); other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten alloys or tungsten alloys: and similar; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (such as UNS:R30003, e.g., ELGILOY(registered trademark), PHYNOX(registered trademark)); platinum-reinforced stainless steel; combinations thereof; and similar; or any other suitable material.

[0046] Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylenetetrafluoroethylene (ETFE), fluoroethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethane, polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers such as HYTREL® available from DuPont), and polyamides (e.g., DURETHAN® or Elf available from Bayer). Available from Atochem: CRISTAMID®, polyamide elastomers, block polyamides / ethers, polyether block amides (PEBA, commercially available under the trademark PEBAX®, for example), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low-density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly-p-phenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (e.g., EMS American This may include perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy, polyvinylidene chloride (PVdC), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations thereof, copolymers, polymer / metal composites, etc. (such as GRILAMID® available from Grilon).

[0047] It should be understood that this disclosure is, in many respects, merely illustrative. Modifications may be made in detail, particularly in shape, size, and sequence of steps, without exceeding the scope of this disclosure. This may include, to an appropriate degree, the use of any feature of one exemplary embodiment used in other embodiments. The scope of the invention is, of course, determined by the language in which the appended claims are expressed.

Claims

1. A medical device that can be implanted, An expandable frame defining the body of the implantable medical device, which is movable between a delivery crush configuration and a placement expansion configuration, and includes a first frame end and a second frame end, and is axially extendable beyond the expansion configuration by an applied axial force, An adjustable support adapted to limit how far the expandable frame can extend axially beyond its expandable configuration, the adjustable support comprising a member having a first end fixed to the first frame end and a second end that can be removably fixed to the second frame end, Equipped with, The adjustable support is The suture fastening body defines a lumen through which the suture fastening body penetrates, A first element slidably disposed within the lumen, A second element is slidably disposed within the lumen and engages with the first element, A reversible suture fastener comprising: an engaging element adapted to releasably engage with the first element, The invention further comprises a reversible suture fastener in which the first and second elements are movable between a first position in which the member can move freely relative to the suture fastener body and a second position in which the member is constrained against movement relative to the suture fastener body. Implantable medical devices.

2. The implantable medical device according to claim 1, wherein the member is wrapped around the first frame end and includes a suture having a first free end and a second free end, each free end extending proximal beyond the second frame end.

3. The implantable medical device according to claim 1, wherein the first element comprises a first element lumen, and the member extends freely through the first element lumen.

4. The implantable medical device according to claim 1, wherein the second element comprises a second element lumen, and the member extends freely through the second element lumen.

5. The implantable medical device according to claim 1, wherein the engaging element comprises an engaging element lumen, and the member extends freely through the engaging element lumen.

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