US20160213357A1 - Closure device - Google Patents
Closure device Download PDFInfo
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- US20160213357A1 US20160213357A1 US15/005,780 US201615005780A US2016213357A1 US 20160213357 A1 US20160213357 A1 US 20160213357A1 US 201615005780 A US201615005780 A US 201615005780A US 2016213357 A1 US2016213357 A1 US 2016213357A1
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- Prior art keywords
- closure element
- proximal
- distal
- blood vessel
- closure
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Abstract
A closure device for closing an opening in tissue is provided. The closure device according the present invention includes a delivery system for deploying a closure element, wherein the closure element is movable between a delivery configuration and a deployed configuration to close an opening in tissue. The closure device of the present invention may further include a charge of hemostatic material.
Description
- This application is a continuation of U.S. patent application Ser. No. 12/608,773, filed Oct. 29, 2009 and entitled “CLOSURE DEVICE”, which claims the benefit of, and priority to, U.S. Provisional Patent Application Ser. No. 61/109,822, filed on Oct. 30, 2008 and entitled “CLOSURE DEVICE,” and Ser. No. 61/143,748, filed on Jan. 9, 2009 and entitled “CLOSURE DEVICE,” all of which are incorporated in their entireties herein by this reference.
- 1. The Field of the Invention
- The present disclosure relates generally to systems, devices, and methods for blocking an opening in body lumens. More particularly, the present disclosure relates to techniques for percutaneous closure of arterial and venous puncture sites, which are usually accessed through a tissue tract.
- 2. The Relevant Technology
- A number of diagnostic and interventional vascular procedures are now performed translumenally. A catheter is introduced to the vascular system at a convenient access location and guided through the vascular system to a target location using established techniques. Such procedures require vascular access, which is usually established during the well-known Seldinger technique. Vascular access is generally provided through an introducer sheath, which is positioned to extend from outside the patient body into the vascular lumen. When vascular access is no longer required, the introducer sheath is removed and bleeding at the puncture site stopped.
- One common approach for providing hemostasis (the cessation of bleeding) is to apply external force near and upstream from the puncture site, typically by manual compression. This approach suffers from a number of disadvantages. For example, the manual compression procedure is time consuming, frequently requiring one-half hour or more of compression before hemostasis is achieved. Additionally, such compression techniques rely on clot formation, which can be delayed until anticoagulants used in vascular therapy procedures (such as for heart attacks, stent deployment, non-optical PTCA results, and the like) wear off. The anticoagulants may take two to four hours to wear off, thereby increasing the time required before completion of the manual compression procedure.
- Further, the manual compression procedure is uncomfortable for the patient and frequently requires analgesics to be tolerable. Moreover, the application of excessive pressure can at times totally occlude the underlying blood vessel, resulting in ischemia and/or thrombosis. Following manual compression, the patient typically remains recumbent from four to as much as twelve hours or more under close observation to assure continued hemostasis. During this time, renewed bleeding may occur, resulting in blood loss through the tract, hematoma and/or pseudo-aneurysm formation, as well as arteriovenous fistula formation. These complications may require blood transfusion and/or surgical intervention.
- The incidence of complications from the manual compression procedure increases when the size of the introducer sheath grows larger, and/or when the patient is anticoagulated. The compression technique for arterial closure can be risky, and is expensive and onerous to the patient. Although the risk of complications can be reduced by using highly trained individuals, dedicating such personnel to this task is both expensive and inefficient. Nonetheless, as the number and efficacy of translumenally performed diagnostic and interventional vascular procedures increases, the number of patients requiring effective hemostasis for a vascular puncture continues to increase.
- To overcome the problems associated with manual compression, the use of bioabsorbable sealing bodies is one example approach that has been proposed. Generally, this example approach relies on the placement of a thrombogenic and bioabsorbable material, such as collagen, at the superficial arterial wall over the puncture site. While potentially effective, this approach suffers from a number of problems. For example, bioabsorbable sealing bodies may lack a solid mechanical attachment of the sealing body to the tissue. Due to the lack of a solid mechanical attachment, the sealing body can wander within the tissue tract or move out of the puncture site, thus causing late bleeds. Conversely, if the sealing body wanders and intrudes too far into the arterial lumen, due to the lack of a solid mechanical attachment, intravascular clots and/or collagen pieces with thrombus attached can form and embolize downstream, causing vascular occlusion.
- In addition to not having a solid mechanical attachment to the tissue, the sealing bodies may rely upon expandable materials to achieve hemostasis. Again, the expandable materials lack the security of a hard mechanical closure, thus potentially causing late bleeds and prolonging hemostasis.
- This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter. Embodiments of the present invention provide systems, methods, and devices for closing an opening in tissue. Embodiments of the invention can be configured to close an opening within a body lumen.
- In one example embodiment, a device for closing an opening in tissue includes a tubular body member having a wall thickness, a proximal end, and a distal end. The tubular body member of the device may include slits formed within the tubular member through the wall thickness. The slits are arranged above and below a waist portion located between the proximal end and distal end of the tubular body member.
- In another example embodiment, a device for closing an opening in a body lumen wall includes a tubular body element having a first portion, a second portion, and a waist portion located between the first portion and second portion. The first and second portions have a delivery configuration and a deployed configuration. When the first and second portions are in the delivery configuration they have a delivery cross-sectional dimension, and when the first and second portions are in a deployed configuration they have a deployed cross-sectional dimension. The deployed cross-sectional dimension is larger than the delivery cross-sectional dimension.
- Another example embodiment discloses a system for closing an opening in a body lumen. The system includes a closure element having a delivery configuration and a deployed configuration. The system further includes an actuator that is coupled to the closure element and operatively associated with a handle assembly. The handle assembly includes a rotatable handle element that may be inserted into a hub member such that when the handle element is rotated, the closure element changes from the delivery configuration to the deployed configuration.
- In another example embodiment, a method for closing an opening in a body lumen is disclosed. The method includes inserting a closure device into an opening in a body lumen wall, the closure device including a closure element and actuator. After inserting the closure device, a force is applied to the closure element by way of the actuator such that a first portion of the closure element changes from a delivery configuration to a deployed configuration. Next, a second force may be applied to the closure element by way of the actuator such that a second portion of the closure element changes from a delivery configuration to a deployed configuration.
- These and other advantages and features of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter.
- To further clarify the above and other advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
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FIG. 1 is a cross-sectional view of the closure device in accordance with one embodiment of the present invention; -
FIG. 2A is a close-up cross-sectional view of an example embodiment of a closure device in accordance with the present invention; -
FIG. 2B is a close-up cross-sectional view of an example embodiment of a closure device in accordance with the present invention and further illustrating a locking mechanism formed therewith; -
FIG. 2C is a cross-section view of an example embodiment of a closure element in a deployed configuration; -
FIGS. 3 through 6 illustrate the use of an example closure device in accordance with the present invention; -
FIGS. 7A through 9B illustrate various embodiments of a closure element in accordance with the present invention; -
FIGS. 10 and 11 are cross-sectional views of an alternative embodiment of a closure device including a charge of a hemostatic material; -
FIG. 12 is a flow chart showing an example method of closing an opening in tissue in accordance with the present invention; -
FIG. 13A is an exploded illustration of a delivery system of one embodiment of the present invention; -
FIG. 13B is a top view of a portion of the delivery system ofFIG. 13A according to one embodiment of the present invention; -
FIG. 13C is another illustration of the delivery system ofFIG. 13A according to one embodiment of the present invention; -
FIG. 13D is a cross-section illustration of a portion of the delivery system ofFIG. 13A ; -
FIG. 13E is a further illustration of the delivery system ofFIG. 13A ; -
FIG. 13F is a yet further illustration of the delivery system ofFIG. 13A ; and -
FIG. 13G is a perspective illustration of the delivery system ofFIG. 13A in combination with an introducer sheath according to another embodiment of the present invention. - In accordance with the present invention there is provided a closure device configured to close an opening formed in tissue. The closure devices described herein may be formed of a bioabsorbable material or may be formed of a biocompatible material. It is further contemplated the closure device may be coated with a covering membrane and/or another biocompatible coating as will be described in greater detail below. In one embodiment, the closure device may be configured to be received within the lumen of a medical sheath, for example, in accessing the patient's femoral artery, the physician will typically utilize a 6 French sheath. The closure device may be configured to be received within the lumen of this 6 French sheath. However, it can be understood that embodiments of the closure device may be configured to be received within multiple sizes of sheaths and should not be limited to the example above.
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FIG. 1 illustrates one example embodiment of aclosure device 10. As shown inFIG. 1 theclosure device 10 may include anelongate member 12 that has aproximal end 14 and adistal end 16. Theelongate member 12 may also include apassage 18 that extends from theproximal end 14 towards thedistal end 16. Within thepassage 18 of theelongate member 12, aprotrusion 20 extends into thepassage 18, thus reducing the cross-sectional dimension of thepassage 18 at a location that is between theproximal end 14 and thedistal end 16 of theelongate member 12. Theclosure device 10 further includes anactuator 22 that extends through thepassage 18 of theelongate member 12. Aclosure element 100 extends beyond theelongate member 12 and may be coupled to theactuator 22. - In operation, the
closure device 10 may be inserted into abody lumen 30 as illustrated inFIG. 1 . In one embodiment, theelongate member 12 and theclosure element 100 pass through the proximalluminal wall 34 of thebody lumen 30. While within thebody lumen 30 theclosure element 100 is changed from a delivery configuration, as illustrated inFIG. 1 , to a deployed configuration as illustrated inFIG. 2C . While in the deployed configuration theclosure element 100 is able to block or otherwise close a puncture in the proximalluminal wall 34. - Referring back to
FIG. 1 , the structure of theclosure device 10 will be discussed in more detail. In particular, theclosure device 10 may have configurations and characteristics that vary from one embodiment to the next. For example, theelongate member 12 is one aspect of theclosure device 10 that may vary from one embodiment to the next. In particular, theelongate member 12 may have various geometric configurations. As illustrated inFIG. 1 , theelongate member 12 may have a substantially circular cross-sectional geometric configuration. In other embodiments, however, the cross-sectional configuration of theelongate member 12 may vary and take various other configurations such as oval, square, triangular or any other configuration or combination of configurations. - Along with the various cross-sectional configurations of the
elongate member 12, thepassage 18 may also have various cross-sectional configurations. The cross-sectional configuration of theelongate member 12 may or may not match the cross-sectional configuration of thepassage 18. Moreover, the cross-sectional configurations of theelongate member 12 and thepassage 18 may vary from the proximal end to the distal end of theelongate member 12. - Notwithstanding variations in the geometric configuration, the
elongate member 12 may be configured to retain theclosure element 100 at thedistal end 16 of theelongate member 12. In one example embodiment, illustrated inFIG. 1 , theelongate member 12 further includes aprotrusion 20 that protrudes inwardly into thepassage 18 such that theclosure element 100 is not permitted to pass theprotrusion 20. Theprotrusion 20, as illustrated inFIG. 1 , also may include a passage such that theactuator 22 may pass through theprotrusion section 20 and contact or couple to theclosure element 100. - In one example, and as illustrated in
FIG. 1 , theclosure element 100 is generally allowed to be inserted only about halfway into thepassage 18 of theelongate member 12 and thereafter is blocked from being inserted further into theelongate member 12 by theprotrusion 20. The location of theprotrusion 20 may vary from one embodiment to the next. In other example embodiments, theprotrusion 20 may be positioned more proximally within thepassage 18 of theelongate member 12, or alternatively, theprotrusion 20 may be positioned more distally within theelongate member 12. Thus, the position of theprotrusion 20 may allow theclosure element 100 to either be further inserted into the elongate member or have more of theclosure element 100 positioned outside theelongate member 12. - In addition to variations of the
protrusion 20 within thepassage 18 of theelongate member 12, thedistal end 16 of theelongate member 12 may also vary. For example and as illustrated inFIG. 1 , thedistal end 16 of theelongate member 12 may have a radius. This radius, for instance, may assist when inserting theelongate member 12 into a tissue tract and subsequently into thebody lumen 30 through the proximalluminal wall 34. In other example embodiments, thedistal end 16 of theelongate member 12 may have various other configurations. For example, they may have various ranges of radii as well as various other geometric configurations, for example, square, triangular, or rectangular. - In addition to the geometric configuration variations, the
elongate member 12 may also have various material characteristics. For example, in one embodiment theelongate member 12 may be formed of a rigid material such as a stainless steel or other biocompatible material that is rigid. Alternatively, theelongate member 12 may be formed of a flexible material such as those materials utilized to form catheter shafts, introducer sheaths, or other medical devices. Suitable materials include polyvinyl chloride (PVC), peak, PTFE, nylon, or any other similar materials. - As discussed, the
actuator 22 may extend through theelongate member 12. Theactuator 22 is another aspect of theclosure device 10 that may vary from one embodiment to the next. As shown inFIG. 1 , theactuator 22 extends through thepassage 18 of theelongate member 12 and couples to or attaches to theclosure element 100. One way in which theactuator 22 may vary is the cross-sectional geometric configuration of the actuator.FIG. 1 illustrates anactuator 22 that has a substantially circular cross-sectional configuration. In other example embodiments, the cross-sectional geometric configuration of theactuator 22 may vary and include configurations such as square, triangular, rectangular or any other geometric configuration. In one example embodiment, the geometric configuration of theactuator 22 may be configured to match the cross-sectional geometric configuration of thepassage 18 within theelongate member 12. - Another way in which the
actuator 22 may vary is the material from which theactuator 22 is made. For example, theactuator 22 may be made from a rigid material such as stainless steel or other biocompatible materials that are rigid. Alternatively, theactuator 22 may be formed of a flexible material, for example, if theelongate member 12 is made from a flexible material. Examples offlexible actuator 22 materials include polyvinyl chloride (PVC), peak, PTFE, nylon, or similar materials. Generally, theactuator 22 material may be made from any material that is able to have enough strength and structural properties to change theclosure element 100 from a delivery configuration, as shown inFIG. 2A , to a deployed configuration, as shown inFIG. 2C . - Another way in which the
actuator 22 may vary is the way in which it connects to or attaches to theclosure element 100.FIG. 2B illustrates a cross-sectional view of theclosure element 100 that shows one example of connecting theactuator 22 to theclosure element 100. For example,actuator 22 may include acoupler element 24 that is configured to couple to thedistal end 106 of theclosure element 100. In one example embodiment, and as illustrated inFIG. 2B , thecoupler element 24 includes a section that has a larger cross-sectional dimension than theactuator 22. In this example, thecoupler element 24 may interface with thedistal end 106 of theclosure element 100 such that thecoupler element 24 is held by the material of the closure element 100 (e.g., theclosure element 100 material surrounds thecoupler element 24. In other example embodiments, the coupler element may simply attach to or couple to thedistal end 106 of theclosure element 100 by an adhesive or other bonding means. - In addition to the
coupler element 24, theactuator 22 may also include a lockingelement 26, as illustrated inFIG. 2B . The lockingelement 26 may vary from one embodiment to the next. For example, and as illustrated inFIG. 2B , the lockingelement 26 has a triangular configuration, however, in other example embodiments the geometric configuration of the locking element may take various forms such as square, rectangular, oval, circular or any other configuration. - In particular, the geometric configuration of the locking
element 26 is configured such that the lockingelement 26 and theproximal end 104 of theclosure element 100 cooperate to lock theclosure element 100 in the deployed configuration. For example, and as illustrated inFIGS. 2B and 2C , the lockingelement 26 may be pulled through theproximal end 104 of theclosure element 100. Once pulled through theproximal end 104 of theclosure element 100, the lockingelement 26 and/or theproximal end 104 of theclosure element 100 may be configured such that the lockingelement 26, in combination with theproximal end 104 of theclosure element 100, restricts the actuator from moving distally with respect to theclosure element 100. In other words the lockingelement 26 may be configured to facilitate removal of the lockingelement 26 from within theclosure element 100, but after removal from theclosure element 100, the lockingelement 26 may not be allowed to re-enter theclosure element 100. - Notwithstanding the various configurations and characteristics of both the
elongate member 12 and theactuator 22, theclosure element 100 may be configured to be operatively associated with theelongate member 12 and theactuator 22 in order to be delivered and deployed in an opening within a body lumen. Continuing now withFIGS. 2A, 2B, and 2C , theclosure element 100 will be discussed in more detail. As illustrated inFIG. 2A , theclosure element 100 may include abody member 102 that has aproximal end 104 and adistal end 106. Thebody member 102 may also include awaist portion 108 that separates a plurality ofproximal slits 110 from a plurality ofdistal slits 112. Moreover, theclosure element 100 may have a delivery configuration, as illustrated inFIG. 2A , and a deployed configuration, as illustrated inFIG. 2C . - As with other aspects of the
closure device 10, theclosure element 100 may vary from one embodiment to the next. One way in which theclosure element 100 may vary is the cross-sectional configuration of theclosure element 100body member 102. For example, and as illustrated inFIG. 2A , thebody member 102 may have a generally cylindrical cross-sectional configuration. In other example embodiments, the cross-sectional configuration of thebody member 102 may take various forms such as square, rectangular, triangular or any other cross-sectional configuration. - Another way in which the
closure element 100 may vary is the geometric dimensions of theproximal slits 110 and/ordistal slits 112. For example, the geometric configuration of the upper andlower slits FIG. 2A , may be a generally rectangular configuration. However, in other example embodiments the geometric configuration of theproximal slits 110 and/or thedistal slits 112 may take various other geometric configurations such as more square, triangular, oval or any other configuration or combination configurations. The slits may be formed within the wall of thebody member 102 using known manufacturing techniques such as cutting, laser cutting, water jet cutting. Alternatively, the slits may be integrally formed within thebody member 102 during manufacturing such as through the use of injection molding. - Furthermore, and as illustrated in the example embodiment in
FIG. 2A , theproximal slits 110 may have substantially the same configuration and dimensions as thedistal slits 112. In other example embodiments, however, the proximal slits may have a different geometric configuration and/or dimension compared to thedistal slits 112. For example, in one embodiment, theproximal slits 110 may have a different length and width as thedistal slits 112, or theproximal slits 110 may have a different geometric configuration relative to thedistal slits 112. - In addition to variations between the
proximal slits 110 and thedistal slits 112, the geometric configuration and the dimensions of theproximal slits 110 and/ordistal slits 112 may vary from one slit to the next. For instance, theupper slits 110 may have a variety of different sized and configured slits that make up the plurality ofupper slits 110. Similarly, thelower slits 112 may be made up of a variety of different sized and configured individual slits. - Another way in which the
proximal slits 110 anddistal slits 112 may vary is the alignment configuration between theproximal slits 110 with respect to thedistal slits 112. For example, as illustrated inFIG. 2A , theproximal slits 110 may be substantially aligned with thedistal slits 112. However, in other example embodiments, theproximal slits 110 may be positioned such that the proximal slits are misaligned with thedistal slits 112. In the same respect, the number ofproximal slits 110 compared to the number ofdistal slits 112 may vary from one embodiment to the next. As shown inFIG. 2A , there are an equal number ofproximal slits 110 relative to the number ofdistal slits 112. In other examples, however, theclosure element 100 may have moreproximal slits 110 compared todistal slits 112. For example, a closure element may be configured such that there are six distal slits equally spaced around thebody member 102 of theclosure element 100, while there are only fourproximal slits 110 positioned and equally spaced around thebody member 102 of theclosure element 100. - As can be understood, the spacing between each individual slit may also vary from one embodiment to the next, as well as from one slit to the next. For example, and as previously mentioned, the upper and/or
lower slits body member 102. Alternatively, the slits may be positioned around thebody member 102 such that the spacing between slits varies. - The distance between the
proximal slits 110 and thedistal slits 112 is another aspect of theclosure element 100 that may vary from one embodiment to the next. In one example embodiment, the distance between theproximal slits 110 and thedistal slits 112 is a distance that would be approximately equal to the width of a body lumen wall. For example, the distance between the upper and distal slits may be equal to the width of theproximal lumen wall 34, illustrated inFIG. 1 . In this manner, theclosure element 100, when in the deployed configuration, would assist in blocking an opening within theproximal lumen wall 34. -
FIG. 2B illustrates various other aspects of theclosure element 100 that may vary from one embodiment to the next. For example,FIG. 2B illustrates that theclosure element 100 may include anaperture 105 located on theproximal end 104 of thebody member 102. In one embodiment, theproximal end 104 of thebody member 102 of theclosure element 100 may be made of material that is flexible such that the lockingelement 26 of the actuator may be pulled in a proximal direction through theaperture 105 located on theproximal end 104 of theclosure element 100. Moreover, theproximal end 104 of thebody member 102 may have a geometric and/or material configuration that allows the lockingelement 26 or similar feature of the actuator to pass through in one direction (i.e. the proximal direction) but not pass through in the opposite direction (i.e. the distal direction). - For example, the
proximal end 104 may be configured with a plurality of cuts that are arranged in a generally circular pattern around theaperture 105 such that each cut extends away from the aperture along a radius line. The cuts may be formed at an angle such that the material on theproximal end 104 between the cuts are allowed to flex in a direction that would allow the lockingelement 26 to pass through theaperture 105 of theclosure element 100. However, once the lockingelement 26 has passed through theaperture 105, theproximal end 104 material between the cuts is not permitted to flex to allow the lockingelement 26 to again pass through theaperture 105. In other words, the material at theproximal end 104 of theclosure element 100 may only flex in one direction and thus resist movement of the lockingelement 26 in the distal direction after the lockingelement 26 has passed through theaperture 105. - The locking
element 26, along with the configuration of theclosure element 100 assist to change theclosure element 100 from a delivery configuration, shown inFIGS. 1 and 2A , to a deployed configuration shown inFIG. 2C . In one embodiment, theactuator 22 cooperates with theclosure element 100 to collapse thebody member 102 of the closure element such that theproximal slits 110 and thedistal slits 112 allow the portions of thebody member 102 between theproximal slits 110 anddistal slits 112 to collapse and flex radially outwardly. Moreover, when in the deployed configuration, theactuator 22, with the lockingelement 26 and thecoupler element 24 may cooperate with theclosure element 100 such that thebody member 102 of theclosure element 100 may be changed into, and held locked in, the deployed configuration. Specifically, the lockingelement 26 cooperates with thecoupler element 24 such that thebody member 102 of theclosure element 100 is held in place in the deployed configuration between the lockingelement 26 and thecoupler element 24. - The deployed configuration of the
closure element 100 may have various configurations. For example, in one embodiment, the deployed configuration of theclosure element 100 may provide a clamping force upon the body lumen wall, thus holding theclosure element 100 in place within the opening in the body lumen. Additional characteristics and configurations of theclosure element 100 in the deployed configuration will be discussed with respect toFIGS. 6 through 9B . - Another way in which the
closure element 100 may vary is the type of material used to make theclosure element 100. In one embodiment theclosure element 100 is manufactured from a bioabsorbable, bioresorbable, bioerodible, and/or biodegradable material. Examples of suitable materials for use are metals, metal alloys, polymers or combinations thereof that decompose or biodegrade in a biological environment such as within a body lumen. For example, and not by limitation, suitable bioabsorbable materials may include magnesium, zinc, silicon, lithium, zinc titanium, magnesium lithium, polyglocic acid (PGA), polyhydroxybutyric acid, polyL-Lactic acid (PLLA), polydilactidel glycolide acid, polydilactid acid, PolyDL Lactide-co-gycolide, Polylactic acid, Polylicolic acid, Polyhydroxyalkanoates or derivatives thereof and any combination thereof. - In addition to the various types of materials that may be used to manufacture the
closure element 100, theclosure element 100 may include additional material properties that may be useful. For example, theclosure element 100 may be covered with a flexible membrane to aid in sealing the opening. The flexible membrane may be formed of a flexible bio-compatible or bioabsorbable material such as any of those that were described above. Moreover, theclosure element 100 may further include a beneficial agent either disposed thereon as a coating or integrally formed within the absorbable material wherein the beneficial agent would be configured to aid in healing and/or reduce the potential for infection. - Moreover, material properties may be included in the
closure element 100 to help a user place theclosure element 100. For example, theclosure component 100 may further include a radiopaque marker or radiopaque coating in order to aid the user in positioning theclosure element 100 within the puncture site of the body lumen. The radiopaque marker may be formed within the wall of thebody member 102 in the form of a rivet. Alternatively, a radiopaque coating may be disposed on thebody member 102 as a thin coating of radiopaque metal such as gold, tantalum, alydium, platinum, uridium or similar metals. - Referring now to
FIGS. 3 through 6 , the operation of theclosure device 10 will be explained in more detail. Initially, theclosure device 10 is inserted in a tissue tract and disposed through an opening or puncture within a body lumen. For example and as shown inFIG. 1 , theclosure device 10 may be disposed through theproximal lumen wall 34 of thebody lumen 30. After disposing theclosure device 10 through the opening in theproximal lumen wall 34 theclosure element 100 may be changed from a delivery configuration to a deployed configuration. - In one embodiment, the process of changing the
closure element 10 from a delivery configuration to a deployed configuration begins with positioning theclosure element 100 within theelongate member 12 such that thedistal slits 112 are located outside of theelongate member 12 and theproximal slits 110 are located within theelongate member 12. In one example, this position of theclosure element 100 may correspond to theprotrusion 20 located within theelongate member 12 as discussed above and as illustrated inFIG. 3 . - With the
distal slits 112 positioned outside of theelongate member 12, theactuator 22 may be moved in the proximal direction (as indicated by the arrow inFIG. 3 ) such that the portions of thebody member 102 located in-between thedistal slits 112 are forced to collapse, bend, and/or buckle and extend in an outward direction as shown inFIG. 3 . In particular, theactuator 22 may pull thedistal end 106 of theclosure element 100 in a proximal direction by way of thecoupler element 24 that is coupled to thedistal end 106 of theclosure element 100. Thedistal slits 112 may weaken thebody member 102 such that upon experiencing the force associated with pulling thedistal end 106 of theclosure element 100 in the proximal direction, the portions of thebody member 102 in-between thedistal slits 112 collapse, the collapsing portions of thebody member 102 extending out from theclosure element 100. On the other hand, because theproximal slits 110 are positioned within and stabilized by theelongate member 12, the portions of thebody member 102 in-between theproximal slits 110 may not collapse. - Once the portions of the
body member 102 in-between thedistal slits 112 have collapsed, theclosure device 10 may be moved in the proximal direction such that the deployed lower section of theclosure element 100 is generally in contact with the inside portion of theproximal lumen wall 34, as illustrated inFIG. 4 . At this position, the deployed section of theclosure element 100 is within thebody lumen 30, thewaist portion 108 of theclosure element 100 extends through the opening in theproximal lumen wall 34, and theproximal slits 110 are located outside thebody lumen 30. - When in this position, the
elongate member 12 may be moved in a proximal direction relative to theclosure element 100 such as to reveal or release theproximal slits 110 from theelongate member 12. In one example embodiment, theactuator 22 is held in substantially a constant position, while theelongate member 12 is pulled or otherwise moved in a proximal direction with respect to theclosure element 100. Moreover, thedistal end 16 of theelongate member 12 may be configured with a bias that applies a radially compressive force on theclosure element 100. Thus, once the closure element is released from theelongate member 12, the user may sense the release and/or feel that the resistance to the movement of theelongate member 12 has changed indicating that theproximal slits 110 have been released from theelongate member 12. - At this point the
proximal slits 110 are now in position for the proximal portion of theclosure element 100 to be deployed. As illustrated inFIG. 5 , the proximal portion of theclosure element 100 is deployed by having the portions of thebody member 102 in-between theproximal slits 110 collapse such that the portions of thebody member 102 in-between theproximal slits 110 extend radially outwardly as illustrated inFIG. 5 . In order to deploy the upper portion of theclosure element 100, theactuator 22 may be moved in a proximal direction (as illustrated by the arrow inFIG. 5 ) thus applying a force to theclosure element 100 that causes the portions of thebody member 102 in-between theproximal slits 110 to collapse and extend outwardly. - Moreover, and as illustrated in
FIG. 5 , during or after the deployment of the proximal portion of theclosure element 100, the lockingelement 26 located on theactuator 22 may be pulled through theaperture 105 in theproximal end 104 of theclosure element 100. The lockingelement 26 is then allowed to rest or push on theproximal end 104 of theclosure element 100 such that the closure element is held in the deployed configuration between the lockingelement 26 and thecoupler element 24 of the actuator. -
FIG. 6 shows a close-up view of a deployedclosure element 100 within an opening of abody lumen 30. As shown inFIG. 6 , theproximal slits 110 anddistal slits 112 have allowed the proximal and distal portions of thebody member 102 to collapse, and thus the portions of thebody member 102 in-between the slits have extended outwardly such that theproximal lumen wall 34 is located between the collapsed proximal portion and the collapsed distal portion of theclosure element 100. Thewaist portion 108 of thebody member 102 may be located at least partially within the opening in theproximal lumen wall 34 of thebody lumen 30. -
FIG. 6 further illustrates that the deployedclosure element 100 may be held in a deployed configuration by thecoupler element 24 and the lockingelement 26. In particular, the lockingelement 26 cooperates with thecoupler element 24 such that theclosure element 100 is squeezed or otherwise restricted between thecoupler element 24 and the lockingelement 26. In this way, the portions of thebody member 102 that have collapsed are held in the collapsed or deployed configuration and are not permitted to return to the pre-collapsed or delivery configuration. - Once the
closure element 100 is locked in the deployed configuration, theactuator 22 portion proximal to the lockingelement 26 may be severed or cut using a secondary cutting device or, alternatively, theactuator 22 may be configured such that upon application of another proximal force a weakened portion of theactuator 22 allows the actuator to break free at a location on theactuator 22 that is proximal to the lockingelement 26. The severedactuator 22 and theelongate member 12 are then removed from the tissue tract leaving the deployedclosure element 100 within the puncture or opening within thebody lumen 30. -
FIGS. 7A through 8B illustrate various additional example embodiments of theclosure element 100. For example,FIG. 7A illustrates aclosure element 100 that includes abody member 102 with aproximal end 104 and adistal end 106. Thebody member 102 hasproximal slits 110 anddistal slits 112 formed within thebody member 102 of theclosure element 100. Theproximal slits 110 and thedistal slits 112 may have various arrangements and alignments with respect to one another. The arrangement and alignment of theproximal slits 110 and thedistal slits 112 may affect the deployed configuration of theclosure element 100. Thus, theproximal slits 110 and thedistal slits 112 may have almost any arrangement and alignment configurations that subsequently determine the deployed configuration of theclosure element 100. - For example, and as illustrated in
FIGS. 7A through 7B , theclosure element 100 may take various forms. In particular, theexample closure element 100, illustrated inFIG. 7A , includesproximal slits 110 that are offset from thedistal slits 112. In other words, theproximal slits 110 are not vertically aligned with thedistal slits 112. This example offset arrangement of the proximal anddistal slits closure element 100 having a deployed configuration as illustrated inFIG. 7B . - Specifically, when in the deployed configuration, the
closure element 100 hasupper extensions 114 andlower extensions 116. As illustrated inFIG. 7B , theupper extensions 114 may be offset from thelower extensions 116 such that theupper extensions 114 andlower extensions 116 alternate as viewed from thedistal end 106 of theclosure element 100. In other example embodiments, theupper extensions 114 andlower extensions 116 may be configured such to have any pattern of alignment or arrangement with respect to one another or with respect to other portions of theclosure element 100 depending on the alignment or arrangement of theproximal slits 110 with respect to thedistal slits 112. -
FIG. 8A shows another alternative embodiment of theclosure element 100 that varies the configuration of theproximal slits 110 and thelower slits 112 to produce another example of the deployed configuration of theclosure element 100. As illustrated inFIG. 8A , theclosure element 100 has abody member 102 that has aproximal end 104 anddistal end 106 and also includes awaist portion 108. Thewaist portion 108 is positioned betweenproximal slits 110 anddistal slits 112. In this example embodiment, the proximal anddistal slits FIG. 8A . The curvedproximal slits 110 and curveddistal slits 112 produce curved upper andlower extensions closure element 100 is changed into the deployed configuration. Moreover, and as illustrated inFIG. 8B , the curved upper andlower extensions FIG. 7A , the curved upper andlower extensions - In addition to the two embodiments of the
closure element 100, illustrated inFIG. 7A throughFIG. 8B , the upper anddistal slits upper extensions 114 and/orlower extensions 116. Moreover, there can be any combination between theproximal slits 110 and thedistal slits 112. For example, the proximal slits may take on a more rectangular configuration, as shown inFIG. 7A , and thedistal slits 112 may take on a curved configuration as shown in 8A. Thus, the deployed configuration of theclosure element 100 may haveupper extensions 114 that are rectangular, as shown in 7B, andlower extensions 116 that are curved, as shown inFIG. 8B . - Although
FIGS. 7A through 8B addresses various example configurations of theclosure element 100 that have proximal anddistal slits closure element 100 may be configured to not contain any slits. For example,FIGS. 9A and 9B show an example embodiment of aclosure element 100 that does not include any proximal or distal slits; however, theclosure element 100 is still able to collapse such to form the deployed configuration of theclosure element 100. In particular, the sidewall of theclosure element 100, as illustrated inFIG. 9B , may includeindentations 118 or other areas within the wall that create natural weaknesses or breaking points. Theindentations 118 within theclosure element wall 120 may be configured such that when a compressive force is applied from theactuator 22, theclosure element 100 collapses around the weakened portions of theindentation 118. - The
indentations 118, shown inFIG. 9B , may vary from one embodiment to the next. For example, the number of indentations that are located on thesidewall 120 of theclosure element 100 may vary. In one example embodiment illustrated inFIG. 9B , thesidewall 120 of theclosure element 100 includes twoindentations 118. Eachindentation 118 would produce extensions when the closure device is changed to the deployed configuration, thus two extensions (for example an upper and lower extension) would be made from the example embodiment shown inFIG. 9B . However, in other example embodiments, more or less indentations may be used in order to create various or multiple sections of that collapse to form a barrier within an opening of a body lumen. -
FIGS. 10 and 11 show another optional embodiment of aclosure device 200. As illustrated inFIG. 10 ,closure device 200 may include anelongate member 12 that has apassage 18 extending through from a proximal end to a distal end. Theelongate member 12 may be configured to accept and retain aclosure element 100. The closure element may include aproximal end 104, adistal end 106, and awaist portion 108 that is located between theproximal end 104 and thedistal end 106. In one embodiment, theclosure element 100 may containproximal slits 110 anddistal slits 112, as previously discussed.Closure device 200 further includes anactuator 22 that is connected to theclosure element 100. Theactuator 22 is associated with asecond actuator 40. Located within thepassage 18 within theelongate member 12 may be ahemostatic agent 50. - In one example embodiment of the
closure device 200, thesecond actuator 40 has a slightly larger cross-sectional dimension than the cross-sectional dimension of theactuator 22. In this way a space is located in thepassage 18 between theelongate member 12 and theactuator 22 such that ahemostatic agent 50 may be placed next to theactuator 22. Moreover, thesecond actuator 40 may be configured and sized appropriately such that the clearance between thesecond actuator 40 and theelongate member 12 through thepassage 18 is minimal, allowing thesecond actuator 40 to press or move thehemostatic agent 50 through thepassage 18 of theelongate member 12. - As shown in
FIG. 11 , the basic operation of theclosure device 200 may be similar to the basic operation previously discussed withclosure device 10. However, in this embodiment after theclosure element 100 is secured in the deployed configuration about theproximal lumen wall 34, thesecond actuator 40 will then be positioned to press thehemostatic agent 50 out of theelongate member 12. Specifically, once theclosure element 100 is in the deployed configuration, theelongate member 12 may be moved in the proximal direction and thesecond actuator 40 may be pressed in the distal direction such that thehemostatic agent 50 is forced out of theelongate member 12 and onto the surface of the deployedclosure element 100, and thus the hemostatic agent may be deposited onto the portion of theproximal lumen wall 34 that is in the general area of the deployedclosure element 100. - The
hemostatic agent 50 may be any material configured to aid in the healing of the body lumen wall as well as to cause the cessation of bleeding. Moreover, thehemostatic agent 50 may contain any material or agent that may be used to avoid infection. Suitable hemostatic materials for any of the embodiments described above may include chitosan, collagen, thrombin, PEG or other biocompatible materials. In one embodiment, chitosan may be utilized. The chitosan hemostatic composition may provide a strong clotting action to seal a hole, puncture, incision, or any other bleeding site to promote enhanced healing of the bleeding site and reduce opportunities for infection. Additionally, the chitosan hemostatic composition can be configured to swell in the presence of blood to form a hemostatic barrier that covers or otherwise plugs the bleeding site. - Chitosan is a polycationic polymer derived from chitin, which can also be used as described herein. Chitosan has a positive charge from primary amine groups that can interact with the negative charge of the lipids present on cell surfaces, such as blood cells. This electrostatic interaction has been identified as an aspect of the hemostatic properties of chitosan. Dry chitosan compositions can have increased hemostatic properties by increasing surface area, and thereby the contact area with blood. Processing methods, such as freeze drying, puffing, foaming, sponging, ballooning, combinations thereof, or the like, can be used to provide a porous, open cellular, or closed cellular structure with increased surface area. In addition to chitosan and/or chitin, other polymers having N-acetylglucosamines and N-glucosamines, such as poly-beta-1→4-N-acetylglucosamines with or without one or more monosaccharides being deacetylated and poly-beta-1→4-N-glucosamines, and derivatives thereof.
- The chitosan or other similar polymer used in various embodiments of the present invention may be purified to facilitate use in a medical device and or used within the body of a subject. This may include being purified to remove proteins, other organic or inorganic contaminants. Such purification and processing of chitosan is well known in the art. Accordingly, the chitosan or other similar polymer can be considered to be biocompatible, immunoneutral, and/or generally recognized as safe for use with or within a subject, such as a human or other animal.
- Once the
hemostatic agent 50 has been deployed next to the deployedclosure element 100, theelongate member 12 along with the associatedactuator 22 andsecond actuator 40 may be removed from the patient. - The closure device discussed with the various example embodiments of the present invention may include various other configurations. For example, any configuration of the closure device that includes a closure element that is able to anchor on the inside surface of the body lumen wall as well as on the outside surface of the body lumen wall (i.e. sandwich the wall of the body lumen between two closure elements or two closure element portions) may be used with the closure device contemplated with the present invention.
- Accordingly, the previous figures and the corresponding text provide a number of different components and systems that may be used to close an opening in a body lumen. In addition to the foregoing, other example embodiments may also be described in terms of flowcharts comprising one or more acts in a method for accomplishing a particular result. For example,
FIG. 12 illustrates amethod 600 of closing an opening in tissue. The acts ofmethod 600 are discussed more fully below with respect to the disclosures ofFIGS. 1 through 11 . - For example,
FIG. 12 shows that a method in accordance with an example implementation of the invention may include inserting 602 a closure device into an opening in a body lumen wall. Inserting a closure device may involve inserting a closure device into an opening formed in tissue, the closure device including a delivery tube, an actuator, and a closure element, the closure element defined by a body having a proximal portion, a distal portion and a waist. For example, as shown inFIG. 3 , theclosure element 100 may be inserted through theproximal lumen wall 34. - After the closure device is inserted into an opening, a force may be applied 604 to the actuator to move a first portion of a closure element from a first configuration to a second configuration. Applying a force may involve applying a force to the actuator to move the distal portion of the closure element from a first configuration toward a second configuration, wherein in the second configuration, portions of the closure element protrude from the body. For example, as shown in
FIG. 3 , theactuator 22 may be moved in a proximal direction (as indicated by the arrow) such that the portions of thebody member 102 located in-between thedistal slits 112 are forced to collapse, bend, and/or buckle and extend in an outward direction thus causing the distal portion of theclosure element 100 to change from a delivery configuration to a deployed configuration. - Next, a second force may be applied 606 to an actuator to move a second portion of the closure element from a first configuration towards a second configuration. Applying a second force may involve applying a second force to the actuator to move the proximal portion of the closure element from a first configuration toward a second configuration. For example, and as illustrated in
FIG. 5 , theactuator 22 may be moved in a proximal direction, thus causing the portions of thebody member 102 in-between theproximal slits 110 to collapse and extend outwardly. -
FIGS. 13A through 13G illustrate an example embodiment of a closure device that uses ahandle assembly 400. In particular,FIG. 13A illustrates a closure device that includes ahandle assembly 400 that has ahandle element 402 and ahub member 404. Thehandle element 402 has aproximal end 406, adistal end 408, agrip portion 410, and anextended portion 412.Projections 414 may extend from theextended portion 412. Moreover, thehandle element 402 includes aport 416 through which anactuator 22 may extend. - The
handle element 402 is operatively associated with ahub member 404. Thehub member 404 includes ahub body 418 that has aproximal end 420 and adistal end 422. Achannel 424 is formed within thehub body 418 of thehub member 404, thechannel 424 configured to cooperate with theprojections 414 located on thehandle element 402. Anelongate member 12 may be connected to thehub member 404. Theelongate member 12 may be configured such that anactuator 22 may extend through theelongate member 12. Attached to a distal end of theactuator 22 is aclosure element 100, as illustrated inFIG. 13A . - Briefly, in operation, the
handle assembly 400 assists a user in deploying theclosure element 100 within an opening in a body lumen. For example, after theclosure element 100 is positioned appropriately within the opening in the body lumen, as discussed above, the user may turn thehandle element 402, which in turn assists to deploy theclosure element 100. Specifically, thehandle element 402 may be coupled to theactuator 22 such that as thehandle element 402 is rotated, the actuator applies a force upon theclosure element 100 that causes theclosure element 100 to change from a delivery configuration to a deployed configuration, as discussed above. - The
handle assembly 400, shown inFIG. 13A , may vary from one embodiment to the next. For example, thehandle element 402 is one example aspect of thehandle assembly 400 that may vary.FIG. 13B shows a bottom view of thehandle element 402. The bottom view of thehandle element 402 illustrates thegrip portion 410, theextended portion 412, and theprojections 414 that extend from or project out from theextended portion 412. Moreover,FIG. 13B illustrates theport 416 through which theactuator 22 may extend. - The geometric configuration is one way in which the
handle element 402 may vary. As illustrated inFIG. 13B , the geometric configuration of thehandle element 402 may have a substantially circular cross-sectional configuration. However, in other example embodiments, the cross-sectional configuration of the handle element including the extendedportion 412 and thegrip portion 410 may have various other geometric configurations such as square, rectangle, triangle or any other configuration or combination of configurations. - Moreover, and as shown in
FIGS. 13A and 13D , thehandle element 402 may include aset screw 428. Theset screw 428 may be positioned in thegrip portion 410 such that a set screw may be used to secure the position of theactuator 22.FIG. 13D illustrates how theset screw 428 may be positioned such to enter from the side of thegrip portion 410 and into theport 416, and thus, secure theactuator 22. - Another way in which the
handle element 402 may vary is the characteristics of theprojections 414. As shown inFIG. 13D , theprojections 414 may be made from a different piece of material than theextended portion 412. In alternate embodiments, theprojections 414 may be manufactured out of the same piece of material as theextended portion 412. - Not only can the manufacture method vary with respect to the
projections 414, but the location of theprojections 414 on theextended portion 412 may vary from one embodiment to the next. As illustrated inFIGS. 13A and 13D , theprojections 414 may be located on thedistal end 408 of thehandle element 402. However, in alternative embodiments, theprojections 414 may be located at various other locations or almost any location on theextended portion 412. - Another aspect of the
handle element 402 that may vary from one embodiment to the next is thegrip portion 410. Thegrip portion 410 may be sized such that a human finger or a human hand would be able to easily turn and twist thegrip portion 410. In order to help with the twisting of thehandle element 402, thegrip portion 410 may include a friction provider such as a piece of rubber or a pattern within the sidewall of the grip portion to aid in helping a human hand grip thegrip portion 410 and turn thehandle element 402. - In addition to various geometric characteristics, the
handle element 402 may vary in material composition. For example, in one example embodiment thehandle element 402 may be made from a metal such as stainless steel. Other materials may be used to make thehandle element 402 such as plastics, ceramics or any other material that would have structurally suitable properties. - Just as the
handle element 402 may vary from one embodiment to the next, so too may thehub member 404. For example, the cross-sectional configuration of thehub member 404 may vary from one embodiment to the next. The hub member, as illustrated inFIG. 13A , has a substantially circular cross-sectional geometric configuration. Alternatively, in other example embodiments, thehub member 404 may have a cross-sectional geometric configuration that is square, rectangular, hexagonal, or any other configuration or combination of configurations. - Notwithstanding the cross-sectional configuration of the
hub member 404, the way in which thechannel 424 is located throughout thehub member 404 may vary. For example, and as illustrated inFIG. 13A , thechannel 424 is configured such that thehandle element 402 is allowed to rotate one full turn within thehub member 404. Alternatively, thechannel 424 may be configured to allow more or less rotation of thehandle element 402. In one example embodiment, thechannel 424 may only allow for a half turn of thehandle element 402. Alternatively, in other embodiments of the invention, thechannel 424 may allow for multiple rotations of thehandle element 402. - In addition to the number of rotations in which the
channel 424 allows thehandle element 402 to make, thechannel 424 may also be configured with various pathways. For example, and as illustrated inFIG. 13A , the pathway of thechannel 424 is relatively smooth from the bottom portion of thechannel 424 around to the top portion of thechannel 424. However, in alternative embodiments, thechannel 424 may have step sections such that theprojections 414 on thehandle element 402 move within the channel at various steps from one depth to the next. In another example embodiment, thechannel 424 may direct thehandle element 402 to move with a combination of relatively smooth movements and stepped movements. - The operation of the
handle assembly 400 will be discussed in further detail with reference toFIGS. 13C through 13G . Thehandle element 402 is inserted within a receivingarea 426 located within thehub member 404, as illustrated inFIG. 13D . Theprojections 414 located on theextended portion 412 of thehandle element 402 interact with thechannel 424 on thehub member 404 such that as thehandle element 402 is turned, the position of the handle element relative to thehub member 404 changes. - For example, and as illustrated in
FIG. 13C , thehandle element 402 is located towards the distal end of thehub member 404. When thehandle element 402 is rotated, theprojections 414 follow thechannels 424 such that thehandle element 402 moves in the proximal direction with respect to thehub member 404, as illustrated in more detail inFIGS. 13E and 13F . Moreover, if theactuator 22 is secured to thehandle element 402 by way of theset screw 428, then as thehandle element 402 moves in the proximal direction with respect tohub member 404, thehandle element 402 also pulls theactuator 22 in the proximal direction. Thus, as thehandle element 402 is rotated, theactuator 22 is pulled in a proximal direction and theclosure element 100 may be deployed, as previously described with relation toFIGS. 3 through 6 . - In one specific embodiment, the
closure element 100 with thehandle assembly 400 cooperates with anintroducer sheath 500, as illustrated inFIG. 13G . Theintroducer sheath 500 may include an introducerelongate member 502. Theelongate member 12 and theclosure element 100 are passed through theintroducer sheath 500 and extend through the introducerelongate member 502 such that theclosure element 100 protrudes from the distal end of the introducerelongate member 502. In one example embodiment, theclosure element 100 has the distal slits protruding from the introducerelongate member 502. - In operation, the
introducer sheath 500 may already be positioned such that the introducerelongate member 502 is located at least partially within the body lumen or extended through an opening in a body lumen wall. Theclosure element 100, along with theelongate member 12, may then be introduced into theintroducer sheath 500 and positioned within the opening in the body lumen. With the closure device located within theintroducer sheath 500, thehandle element 402 may be rotated such that theactuator 22 is pulled in the proximal direction and the lower or distal region of theclosure element 100 changes from a delivery configuration to a deployed configuration, as shown inFIG. 13E . - After the first portion of the closure element has been deployed, the
introducer sheath 500 and the introducerelongate member 502 may be moved in the proximal direction such as to uncover theproximal slits 110. At this point, thehandle element 402 may be again twisted or rotated such that theactuator 22 is moved or pulled in the proximal direction, thus deploying the upper portion of theclosure element 100, as shown inFIG. 13F . - The amount of rotation that may be needed to deploy the
closure element 100 or change theclosure element 100 from a delivery configuration to a deployed configuration may vary. In one example embodiment, thehandle element 402 may be turned one half of a turn to deploy the first portion of theclosure element 100 and then turned another half of a turn to deploy the second portion of theclosure element 100. However, in other example embodiments it is understood that larger or smaller rotation may be used to deploy theclosure element 100. - Once the
closure element 100 is deployed and in place within the body lumen wall, the remainder of the closure device and the introducer sheath can be removed in a similar manner as described with respect toFIGS. 3-6 . - The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope. It shall be further understood that although the present invention has been described in relation to vessel closure, it is contemplated that the closure component of the present invention may be utilized to close other openings in the body such as PFO openings, or openings formed in organs such as the stomach for certain surgical procedures.
Claims (21)
1.-25. (canceled)
26. A method of closing an opening in a blood vessel, the method comprising:
positioning a closure element through the opening in the blood vessel and within a lumen of a tubular member, the tubular member applying a radial compressive force to the closure element;
following expanding of a distal portion of the closure element from a pre-deployed configuration to a deployed configuration, engaging an inside portion of the blood vessel with the distal portion of the closure element; and
following engaging the inside portion of the blood vessel with the closure element through proximal movement of the closure element and deployment of a proximal portion of the closure element from a pre-deployed configuration to a deployed configuration, engaging a proximal portion of the closure element with an outside portion of the blood vessel.
27. The method of claim 26 , further comprising releasing the closure element from an elongate member releasably connected to the closure element.
28. The method of claim 27 , wherein releasing the closure element comprises cutting the elongate member.
29. The method of claim 27 , wherein releasing the closure element comprises applying a force to a weakened portion to break the elongate member.
30. The method of claim 27 , wherein the closure element is made from bioabsorbable, bioerodible, biodegradable, and/or bioresorbable material.
31. The method of claim 26 , further comprising positioning the closure element at a predetermined depth within the tubular member with at least a portion of the closure element extending beyond a distal end of the tubular member.
32. The method of claim 26 , wherein the closure element has a curved distal end in cross section.
33. A method of closing an opening in tissue of a blood vessel, the method comprising:
positioning a closure element within a lumen of a tubular member and within the blood vessel, the tubular member having a bias and applying a radial compressive force to the closure element, a portion of the closure element extending distally beyond a distal end of the tubular member in a pre-deployed configuration of a distal portion of the closure element;
following expanding of the distal portion of the closure element from the pre-deployed configuration to a deployed configuration, withdrawing the closure element proximally to engage an inside portion of the blood vessel with the distal portion of the closure device;
following contacting the inside portion of the blood vessel with the closure element, deploying a proximal portion of the closure element from a pre-deployed configuration to a deployed configuration;
engaging the proximal portion of the closure element with an outside portion of the blood vessel; and
releasing the closure element from an elongate member releasably connected to the closure element.
34. The method of claim 33 , wherein expanding of the distal portion of the closure element comprises proximally withdrawing the elongate member to at least partially move the portion of the closure element which is distal an intermediate portion of the closure element towards the intermediate portion.
35. The method of claim 33 , wherein deploying the proximal portion of the closure element comprises proximally withdrawing the elongate member to at least partially move the portion of the closure element which is distal the intermediate portion of the closure element towards a proximal portion of the closure element.
36. The method of claim 35 , further comprising locking the proximal portion in the deployed configuration.
37. The method of claim 33 , wherein engaging the proximal portion of the closure element with the outside portion of the blood vessel applies a clamping force upon the blood vessel.
38. The method of claim 33 , further comprising positioning a hemostatic agent proximal the proximal portion.
39. The method of claim 33 , further comprising deploying a hemostatic material on or adjacent to the opening in the tissue.
40. A method of closing an opening in a blood vessel, the method comprising:
positioning a closure element within the blood vessel and at least partially extending from a distal end of a tubular member, the tubular member having a bias and applying a radial compressive force to the closure element;
reconfiguring a distal, tissue engaging portion of the closure element from a pre-deployed configuration to a deployed configuration;
withdrawing the closure element proximally to engage an inside portion of the blood vessel with the distal, tissue engaging portion, a portion of the distal;
following contacting the inside portion of the blood vessel with the closure element, deploying a proximal portion of the closure element from a pre-deployed configuration to a deployed configuration;
engaging the proximal portion of the closure element with an outside portion of the blood vessel; and
releasing the closure element from an elongate member releasably connected to the closure element.
41. The method of claim 40 , further comprising locking a position of the distal portion.
42. The method of claim 40 , further comprising locking a position of the proximal portion.
43. The method of claim 40 , wherein a portion of the closure element to which the elongate member extends through is positioned proximal the proximal portion engaging with the outside portion of the blood vessel.
44. The method of claim 40 , wherein the elongate member extends through a portion of the closure element.
45. The method of claim 40 , further comprising compressively restraining the proximal portion of the closure device within the tubular member.
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Also Published As
Publication number | Publication date |
---|---|
US20100114156A1 (en) | 2010-05-06 |
US8657852B2 (en) | 2014-02-25 |
US9241696B2 (en) | 2016-01-26 |
US8398676B2 (en) | 2013-03-19 |
US20130190810A1 (en) | 2013-07-25 |
WO2010062693A2 (en) | 2010-06-03 |
WO2010062693A3 (en) | 2010-07-29 |
US20100114159A1 (en) | 2010-05-06 |
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Legal Events
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