Left atrial appendage closure device having central support - Patents.com

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] FIELD OF THE DISCLOSURE The present disclosure relates to medical devices, methods of making and using medical devices. More particularly, the present disclosure is directed to implantable medical devices having a central support that limits axial expansion. [Background technology]

[0002] A wide variety of medical devices have been developed for medical use (e.g., for use in accessing body cavities or interfering with bodily fluids or 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 systems used to deliver such devices. These devices may be manufactured by any one of a variety of different manufacturing methods and used according to any one of a variety of different methods. Each of the known medical devices and methods has certain advantages and disadvantages. Summary of the Invention

[0003] The present disclosure provides alternatives for the design, materials, manufacturing methods, and use of medical devices. By way of 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 deployment, the expandable frame including a first frame end and a second frame end, the expandable frame being axially extendable 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 be axially extended beyond its expanded configuration.

[0004] Alternatively or additionally, the adjustable support may have a first end secured to the first frame end and a second end releasably securable to the second frame end. Alternatively or additionally, the adjustable support may comprise a member having a first end secured to the first frame end.

[0005] Alternatively or additionally, the member may have a second end releasably securable to the second frame end. Alternatively or additionally, the adjustable support may further comprise a pin fixed to the second frame end, said member passing through said pin.

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

[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 proximally beyond the second frame end.

[0008] Alternatively or additionally, the adjustable support may further comprise a ratcheting element having a toothed lumen through which the first and second free ends of the suture extend, the toothed lumen adapted to allow the ratcheting element to slide relative to the suture in one direction but be restricted from movement in the opposite direction.

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

[0010] Alternatively or additionally, the adjustable support may further comprise a suture clasp comprising a suture clasp body defining a lumen therethrough that accommodates the member for passage therethrough, and a ratchet engaging the member, the ratchet applying tension to the member.

[0011] Alternatively or additionally, the implantable medical device comprises a LAAC (Left Atrial Appendage Closure) device. Alternatively or additionally, the expandable frame may be biased into the expanded configuration.

[0012] As another example, an implantable medical device includes an expandable frame defining an implantable medical device body, the expandable frame being movable between a collapsed configuration for delivery, an expanded configuration for deployment, and an expanded configuration. The expandable frame includes 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 defines an expanded configuration end distance, and a distance between the first frame end and the second frame end while in the expanded configuration defines an expanded configuration end distance. A support member extends between the first frame end and the second frame end, the support member having 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.

[0013] Alternatively or additionally, the implantable medical device may further comprise a pin fixed to the second frame end, through which the support member passes, and a tapered collar fixed in position on the support member, the tapered collar adapted to be releasably secured 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 proximally beyond the second frame end.

[0015] Alternatively or additionally, the implantable medical device may further comprise a ratcheting element having a toothed lumen through which the first and second free ends of the suture extend, the toothed lumen adapted to allow the ratcheting element to slide relative to the suture in one direction but be restricted from moving in the opposite direction.

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

[0017] Alternatively or additionally, the implantable medical device may further comprise a suture clasp comprising a suture clasp body defining a lumen therethrough that accommodates the suture passing therethrough, and a ratchet that engages the suture, the ratchet maintaining tension on the suture.

[0018] As another example, a LAAC (left atrial appendage occlusion) device includes an expandable frame defining a body of an implantable medical device, the expandable frame being movable between a collapsed configuration for delivery, an expanded configuration for deployment, and an expanded configuration. The expandable frame includes a first frame end and a second frame end, the distance between the first frame end and the second frame end while in the expanded configuration defines an expanded configuration end distance, and the distance between the first frame end and the second frame end while in the expanded configuration defines an expanded configuration end distance. A support member extends between the first frame end and the second frame end, the support member having a first end secured to the first frame end and a second end releasably securable to the second frame end. The adjustable support is adapted to limit the expanded configuration end distance relative to the expanded configuration end distance.

[0019] Alternatively or additionally, the adjustable support may further comprise a pin secured to the second frame end, through which the member passes, and a tapered collar fixed in position on the member, the tapered collar adapted to be releasably secured to the pin to secure the second end of the member relative to the second frame end.

[0020] 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 that follow more particularly exemplify these embodiments. [Brief description of the drawings]

[0021] The present invention may be more fully understood from consideration of the following detailed description of various embodiments of the invention in conjunction with the accompanying drawings. [Figure 1] FIG. 1 is a side view of an exemplary implantable medical device including an exemplary adaptive support. [Figure 2A] FIG. 2A is a schematic illustration of the relative sealing of an exemplary implantable medical device without an adjustable support. [Figure 2B] FIG. 2B is a schematic illustration of the relative sealing of the exemplary implantable medical device of FIG. [Figure 3A] FIG. 3A is a side view of an exemplary implantable medical device lacking an adjustable support and shown in an expanded configuration. [Figure 3B] FIG. 3B is a side view of the exemplary implantable medical device of FIG. 1, shown in an expanded configuration. [Figure 4A] FIG. 4A is a side view of an exemplary implantable medical device with an exemplary adjustable support. [Figure 4B] FIG. 4B is an enlarged side view of a portion of the exemplary adjustable support of FIG. 4A. [Figure 5A] FIG. 5A is a cross-sectional view of an exemplary suture clasp device that may be used with the exemplary implantable medical device of FIG. 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 the exemplary suture clasp device of FIG. 5A shown in a locked configuration in which the suture is restrained against axial movement. [Figure 6] 6 is a cross-sectional view of an exemplary suture clasp device that may be used with the exemplary implantable medical device of FIG.

[0022] While the disclosure is open to various modifications and alternative forms, specific examples thereof have been shown by way of example in the drawings and will be described in detail. It is to be understood, however, that there is no intention 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. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or anywhere in this specification. All numerical values ​​herein, whether explicitly stated or not, are assumed to be modified by the term "about." The term "about" generally refers to a range of numbers that one 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 that are rounded to the nearest significant figure.

[0024] The recitation of numerical ranges by endpoints includes all numbers within that range (eg, 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 ordinarily employed in its sense including "and / or" unless the content clearly dictates otherwise.

[0025] 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 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 goes through the initial stages of being implanted, the implantable medical device goes through a tag test before the implantation is complete. It should be understood that in some cases, this tag test may cause the implantable medical device to expand. In some cases, this may cause the implantable medical device to become dislodged and migrate. In the case of an implantable medical device that is intended to seal against tissue, the expansion that occurs during testing, such as tag testing, may cause it to lose its seal against tissue.

[0027] 1 is a side view of an exemplary IMD (implantable medical device) 10. The exemplary IMD 10 may be adapted for use as a LAAC (left atrial appendage occlusion) device. The LAAC is used to seal off the inside of the left atrial appendage from the rest of the patient's heart to reduce or eliminate the possibility of a blood clot becoming dislodged from the left atrial appendage.

[0028] The IMD 10 comprises an expandable frame 12 that is movable between a collapsed configuration for delivery and an expanded configuration for deployment (as shown in FIG. 1 ). The expandable frame 12 can be configured to reach the expanded configuration by tension applied to the expandable frame 12. In some examples, the expandable frame 12 can be biased into the expanded configuration.

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

[0030] The IMD 10 includes a first frame end 14 and a second frame end 16. In some instances, the first frame end 14 may be considered to be a distal frame end and the second frame end 16 may be considered to be a proximal frame end 16, where distal and proximal are relative terms with reference to the final implantation orientation of the IMD 10. In some instances, if the IMD 10 includes a membrane, the 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 IMD 10 to a delivery device for delivering the IMD 10 to an appropriate implantation location within a patient (e.g., within the patient's heart proximal to the left atrial appendage).

[0031] The IMD 10 includes an adjustable support structure 18 that may be used to limit the expansion of the expandable frame 12, for example, during tag testing. The adjustable support structure 18 may be adapted to limit how far the expandable frame 12 can extend axially beyond its expanded configuration to the expanded configuration. In some cases, the distance between the first frame end 14 and the second frame end 16 while the expandable frame 12 is in the expanded configuration defines the expanded configuration end distance. In some cases, the distance between the first frame end 14 and the second frame end 16 while the expandable frame 12 is in the expanded configuration defines the expanded configuration end distance. The adjustable support 18 may be adapted to limit the expanded configuration end distance relative to the expanded configuration end distance. The expanded configuration end distance may range from 15 to 22 millimeters (mm) (for 20 mm devices and for 40 mm devices, respectively). In some cases, the expanded configuration end distance may range from 24 to 44 mm (for 20 mm devices and for 40 mm devices, respectively).

[0032] In some cases, the adjustable support structure 18 includes an elongate member 20. The elongate member 20 may be flexible or rigid and may be formed from any suitable material, for example. If the elongate member 20 is rigid, the elongate member 20 may be metallic or a rigid polymer. If the elongate member 20 is flexible, the elongate member 20 may be formed from a softer polymer. In some cases, the elongate member 20 may be a sewing thread or suture. In some cases, the elongate member 20 may be a suture wrapped around the first frame end 14 with a pair of free ends of the suture each extending proximally beyond the second frame end 16.

[0033] The elongated member 20 has a first end 22 that may be secured to the first frame end 14. The first end 22 may be tied to or wrapped around the first frame end 14, for example. In some cases, the first end 22 may be adhesively secured to the first frame end 14. If the elongated member 20 is made of metal, the first end 22 of the elongated member 22 may be welded or soldered to the first frame end 14. The first end 22 may be secured to the first frame end 14 without interfering with the ability of the expandable frame 12 to move between a collapsed configuration for delivery and an expanded configuration for deployment.

[0034] The elongated members 20 extend through the interior of the expandable frame 12 to a second end 24 and, as shown, beyond the second frame end 16. In some cases, the adjustable support structure 18 includes a pin 26 that may be secured to the second frame end 16, and the elongated members 20 extend through a lumen formed within the pin 26. In some instances, the pin 26 is radiopaque to enhance visibility during imaging procedures.

[0035] In some examples, the adjustable support structure 18 comprises a tapered collar 28 that may be secured to the elongated member 20. The tapered collar 28 may be configured to attach to the pin 26 to secure the elongated member 20 to the pin 26, and thus 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 appreciated that the relative position of the collar 28 on the elongated member 20 determines whether and to what extent the expandable frame 12 may expand when the second frame end 16 is subjected to tension, such as during a tag test.

[0036] 2A and 2B provide a graphical comparison between the sealing ability of an IMD 10 lacking an adjustable structure, such as adjustable structure 18 (FIG. 2A) and an IMD 10 having an adjustable support structure 18 (FIG. 2B) during tag testing. In FIG. 2A, outer circle 30 generally indicates the outer edge of the tissue into which the IMD 10 is implanted. Inner circle 32 generally indicates the outer edge of the IMD 10 lacking a central support. In this example, 94.9% of the outer circle 30 is filled by the IMD 10. In FIG. 2B, inner circle 34 generally indicates the outer edge of the IMD 10 with a central support. In this example, 97.3% of the outer circle 30 is filled by the IMD 10.

[0037] FIG. 3A shows the IMD 10' during tag testing. The IMD 10' lacks a central support and, as shown, expanded significantly due to the applied tension during tag testing. It should be understood that expanding the IMD 10' axially reduces the diameter of the IMD 10', as shown. In contrast, FIG. 3B shows the IMD 10 during tag testing. By virtue of including the adjustable support structure 18, it can be seen that the adjustable support structure 18 significantly reduces the degree of expansion of the IMD 10, as compared to FIG. 3A.

[0038] 4A is a schematic diagram of an exemplary IMD 40, which may be considered an example of IMD 10. IMD 40 comprises an expandable frame 41 that is movable between a collapsed configuration for delivery and an expanded configuration for deployment (as shown). Expandable frame 41 extends between a first frame end 40a and a second frame end 40b. In some cases, first frame end 40a may be considered to be the distal frame end and second frame end 40b may be considered to be the proximal frame end.

[0039] The IMD 40 includes an adjustable support structure 42 that may be used with, for example, the IMD 10. The adjustable support structure 42 includes an elongated member 44 that extends through the IMD 40, may be attached to the first frame end 40a, and extends (in the orientation shown) downwardly through the second frame end 40b. In some cases, the elongated member 44 may be a suture, for example. The elongated member 44 passes through a ratcheting element 46, better shown in FIG. 4B.

[0040] The ratcheting element 46 includes a ratchet lumen 48 that extends axially through the ratcheting element 46. The ratchet lumen 48 includes a number of ratchet teeth 50 that are sized to engage the 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 ratcheting element 46, thereby securing the elongated member 44, but the elongated member 44 cannot be moved in the opposite direction to loosen the elongated member 44.

[0041] 5A and 5B are cross-sectional views of an exemplary suture clasp device 52 that may be used with the exemplary IMD 10 of FIG. 1. FIG. 5A illustrates an unlocked configuration in which the suture 54 is not constrained against axial movement, while FIG. 5B illustrates a locked configuration in which the suture 54 is constrained against axial movement. The suture clasp device 52 includes a body 56 defining a body lumen 58 therethrough. The suture clasp device 52 includes a first element 60 slidably disposed within the body lumen 58. The first element 56 includes a first element lumen 62 through which the suture 54 extends freely.

[0042] The suture clasp device 52 includes a second element 64 slidably disposed within the body lumen 58. The second element 64 is engaged to the first element 60 and includes a second element lumen 66 through which the suture 54 extends freely. The suture clasp device 52 includes an engaging element 68 adapted to releasably engage 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 that interact with a toothed surface 74 formed in the suture clasp body 56.

[0043] The first element 60 and the second element 64 are movable between a first position (shown in FIG. 5A ) in which the suture 54 is free to move relative to the suture clasp body 56, and a second position (shown in FIG. 5B ) in which the suture 54 is restrained against movement relative to the suture clasp body 56. As shown in FIG. 5B , the suture 54 is captured between the second element 64 and the sidewall of the body lumen 58.

[0044] Figure 6 is a cross-sectional view of an exemplary suture clasp device 76 that may be used with the exemplary IMD 10 of Figure 1. The suture clasp device 76 includes a suture clasp body 78 defining a lumen 80 therethrough. The lumen 80 is adapted to receive the suture 54 therethrough. A ratchet 82 is adapted to engage the suture 54. Slack may 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 suitable manufacturing technique (such as molding, casting, machining, etc., or any other suitable technique). Additionally, the various structures may include materials commonly associated with medical devices (e.g., metals, alloys, polymers, metal-polymer composites, ceramics, combinations thereof, etc., or any other suitable materials). Such materials may also include transparent or translucent materials to aid in visualization during procedures. Some examples of suitable metals and alloys are stainless steels (such as 304V, 304L, and 316LV stainless steel); mild steel; nickel-titanium alloys (such as linear elastic and / or superelastic 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, etc.), nickel-copper alloys (MONEL® 400, NICKELVAC® 400, NICORROS® 10 ... 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035, such as MP35-N™), 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 alloys or tungsten alloys; and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, such as ELGILOY®, PHYNOX®, etc.); platinum strengthened stainless steels; combinations thereof; and the like; or any other suitable material.

[0046] Some examples of suitable polymers are polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethanes, polypropylene (PP), polyvinyl chloride (PVC), polyetheresters (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), polyamides (e.g., DURETHAN® or Elf® available from Bayer), and the like. CRISTAMID® available from Atochem), polyamide elastomers, block polyamide / ethers, polyether block amides (PEBA, commercially available, for example, under the trade name PEBAX®), ethylene vinyl acetate copolymers (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), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (e.g., EMS American Such materials may include polyimide, polystyrene, polyvinylidene chloride (PVdC), polycarbonate, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer / metal composites, and the like.

[0047] It will be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in the shape, size, and sequence of steps, without exceeding the scope of the disclosure. This may include using, to an appropriate extent, any feature of one exemplary embodiment used in another embodiment. The scope of the invention will, of course, be determined by the language in which the appended claims are expressed.

Claims

1. 1. An implantable medical device, comprising: an expandable frame defining a body of the implantable medical device, the expandable frame being movable between a collapsed configuration for delivery and an expanded configuration for deployment, the expandable frame including a first frame end and a second frame end, the expandable frame being axially extendable beyond the expanded configuration by an applied axial force; an adjustable support extending between the first frame end and the second frame end, the adjustable support adapted to limit how far the expandable frame can extend axially beyond its expanded configuration; An implantable medical device comprising:

2. The implantable medical device of claim 1 , wherein the adjustable support comprises a first end secured to the first frame end and a second end releasably securable to the second frame end.

3. The implantable medical device of claim 1 or claim 2, wherein the adjustable support comprises a member having a first end fixed to the first frame end and a second end releasably securable to the second frame end.

4. The implantable medical device of claim 3 , wherein the adjustable support further comprises a pin secured to the second frame end, the member passing through the pin.

5. The implantable medical device of claim 3 , wherein the adjustable support further comprises a tapered collar fixed in position on the member, the tapered collar adapted to be releasably secured to the pin to secure the second end of the member to the second frame end.

6. The implantable medical device of claim 4 , wherein the member comprises a suture wrapped around the first frame end and having a first free end and a second free end, each free end extending proximally beyond the second frame end.

7. The implantable medical device of claim 6, wherein the adjustable support further comprises a ratcheting element having a toothed lumen through which the first and second free ends of the suture extend, the toothed lumen being adapted to allow the ratcheting element to slide relative to the suture in one direction but limit movement in the opposite direction.

8. The adjustable support further comprises a reversible suture clasp, the suture clasp comprising: a suture clasp body defining a lumen therethrough; a first element slidably disposed within the lumen, the first element having 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 second element having a second element lumen through which the element extends freely; an engagement element adapted to releasably engage the first element, the engagement element including an engagement element lumen, the member extending freely through the engagement element lumen; the first and second elements being movable between a first position in which the members are free to move relative to the suture clasp body and a second position in which the members are constrained against movement relative to the suture clasp body; The implantable medical device of claim 3 .

9. The adjustable support further comprises a suture clasp, the suture clasp comprising: a suture clasp body defining a lumen therethrough, the lumen accommodating the member therethrough; a ratchet engaging the member; the ratchet applying tension to the member; A suture clasp comprising: The implantable medical device of claim 3 .

10. 1. An implantable medical device, comprising: an expandable frame defining a body of the implantable medical device, the expandable frame movable between a collapsed configuration for delivery, an expanded configuration for deployment, and an inflated configuration; the expandable frame includes 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 an expanded configuration end distance, and the distance between the first frame end and the second frame end while in an inflated configuration defines an expanded configuration end distance; a support member extending between the first frame end and the second frame end, the support member having 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 inflated configuration end distance relative to the extended configuration end distance; An implantable medical device comprising:

11. a pin secured to the second frame end, the support member passing through the pin; and a tapered collar fixed in position on the support member, the tapered collar adapted to be releasably secured to the pin to secure the second end of the support member to the second frame end; and The implantable medical device of claim 10, further comprising:

12. The implantable medical device of claim 10, further comprising a ratcheting element having a toothed lumen through which the first free end and the second free end of the suture pass, the toothed lumen adapted to allow the ratcheting element to slide relative to the suture in one direction but be limited in movement in the opposite direction.

13. The reversible suture clasp further comprises: a suture clasp body defining a lumen therethrough; a first element slidably disposed within the lumen, the first element having a first element lumen, the suture extending freely through the first element lumen; a second element slidably disposed within the lumen and engaged to the first element, the element member including a second element lumen and the suture extending freely through the second element lumen; an engaging element adapted to releasably engage the first element, the engaging element including an engaging element lumen, the suture extending freely through the engaging element lumen; the first and second elements being movable between a first position in which the suture is free to move relative to the suture clasp body and a second position in which the suture is constrained against movement relative to the suture clasp body; The implantable medical device of claim 10 .

14. The suture clasp further comprises: a suture clasp body defining a lumen therethrough, said lumen accommodating said suture therethrough; a ratchet that engages the suture; Rotating the ratchet to apply tension to the suture; The implantable medical device of claim 10 .

15. 1. A LAAC (left atrial appendage closure) device, comprising: an expandable frame defining a body of the implantable medical device, the expandable frame movable between a collapsed configuration for delivery, an expanded configuration for deployment, and an inflated configuration; the expandable frame includes 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 an expanded configuration end distance, and the distance between the first frame end and the second frame end while in the expanded configuration defines an expanded configuration end distance; a support member extending between the first frame end and the second frame end, the support member having 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 inflated configuration end distance relative to the extended configuration end distance; A LAAC (left atrial appendage closure) device comprising:

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