Patent Application
20120330352
The present invention relates generally to apparatus and methods for sealing punctures in tissue, and more particularly, to apparatus and methods for sealing a puncture or hole in the wall of a heart, e.g., a puncture in the ventricular wall of the heart.
Apparatus and methods are known for accessing a patient's vasculature percutaneously, e.g., to perform a procedure within the vasculature, and for sealing the puncture that results after completing the procedure. For example, a hollow needle may be inserted through a patient's skin and overlying tissue into a blood vessel. A guide wire may be passed through the needle lumen into the blood vessel, whereupon the needle may be removed. An introducer, procedural, or femoral sheath may then be advanced over the guide wire into the vessel, e.g., in conjunction with or subsequent to one or more dilators. A catheter or other device may be advanced through the introducer sheath and over the guide wire into a position for performing a medical procedure. Thus, the introducer sheath may facilitate accessing and/or introducing various devices into the vessel, while minimizing trauma to the vessel wall and/or minimizing blood loss.
Upon completing the procedure, the device(s) and introducer sheath may be removed, leaving a puncture extending between the skin and the vessel wall. To seal the puncture, external pressure may be applied to the overlying tissue, e.g., manually and/or using sandbags, until hemostasis occurs. This procedure, however, may be time consuming and expensive, requiring as much as an hour of a medical professional's time. It is also uncomfortable for the patient, and may require the patient to remain immobilized in the operating room, catheter lab, or holding area. In addition, a risk of hematoma exists from bleeding before hemostasis occurs.
Various apparatus and methods have been suggested for sealing vascular punctures resulting from such procedures, such as those disclosed in U.S. Pat. Nos. 7,316,704, 7,331,979, 7,335,220, and 7,806,856, and U.S. Publication Nos. 2007/0231366, 2008/0082122, 2009/0088793, 2009/0254110, 2010/0168789, 2010/0274280, and 2010/0280546. The entire disclosures of these references are expressly incorporated by reference herein.
For example, the MATRIX™ product included two synthetic polyethylene glycol (“PEG”) polymer powders that were mixed with appropriate buffers and injected through a femoral sheath at an arteriotomy site, e.g., as disclosed in U.S. Pat. No. 7,316,704. The Mynx® Vascular Closure Device is another system for sealing vascular punctures, e.g., as disclosed in one or more of the references identified above, such as U.S. Pat. No. 7,335,220.
Accordingly, apparatus and methods for sealing a puncture through tissue would be useful.
The present invention is directed to apparatus and methods for sealing a puncture in tissue. More particularly, the present invention is directed to apparatus and methods for sealing a puncture in the wall of a heart, e.g., a puncture or hole in the ventricular wall of the heart.
In the continuing push toward minimally invasive medical procedures, treatments that formerly required open surgery are being performed by medical devices developed to treat target organs through small incisions that are more easily closed using sutures or other closure methods. Smaller incisions can potentially lead to fewer complications before and after the procedure.
For example, surgical procedures may be performed via an access hole in the ventricular wall of the heart. Typically, this approach is called a “transapical approach” since the device may be introduced through the apex of the left ventricle. However, similar surgical openings can be created for accessing other chambers of the heart as well as other organs of the body.
Conventional devices and methods for sealing vascular punctures may not be easily applicable to such openings through the wall of the heart. The openings involved are formed through a relative thick tissue body and may be substantially larger than conventional vascular punctures, e.g., in the femoral or other peripheral arteries of the body. Further, such openings may be more difficult to access than punctures through a patient's skin into an artery, since the heart must be accessed through an opening in the patient's chest, e.g., a sternotomy, thoracotomy, and the like.
In accordance with one embodiment, a method is provided for performing a medical procedure that includes providing access to a patient's heart; creating a passage through the myocardium of the heart into a chamber of the heart; introducing a distal end of an access sheath through the passage into the chamber of the heart; and performing one or more medical procedures via the access sheath. Upon completing the medical procedure(s), a sealant is introduced into the passage such that a distal end of the sealant is offset from the endocardial wall of the chamber by a predetermined offset distance, and the access sheath may be removed from the heart.
In an exemplary embodiment, the sealant may be introduced by inserting a tubular cartridge carrying the sealant into the access sheath, and withdrawing the cartridge and the access sheath to deploy the sealant within the passage, e.g., such that the distal end of the sealant is offset from the endocardial wall of the chamber by the predetermined offset distance, e.g., at least about two millimeters (2 mm).
For example, a positioning member may be introduced into the access sheath until a positioning element thereon is disposed within the chamber, the positioning element may be expanded within the chamber, and then the positioning member may be withdrawn until the expanded positioning element contacts the endocardial wall of the chamber adjacent the passage. The cartridge may then be inserted into the access sheath by advancing the cartridge over the positioning member. Optionally, the cartridge and the positioning member may include cooperating elements that limit advancement of the cartridge over the positioning member, e.g., such that the distal end of the sealant is offset by the predetermined offset distance.
Thereafter, the positioning element may be collapsed after deploying the sealant within the passage, and the positioning member may be withdrawn such that the collapsed positioning element passes through the sealant deployed within the passage.
In accordance with another embodiment, a method is provided for sealing a puncture through the wall of a patient's heart that includes introducing a positioning member into the puncture until a positioning element thereon is disposed within the chamber; expanding the positioning element within the chamber; and withdrawing the positioning member until the expanded positioning element contacts the endocardial wall of the chamber adjacent the passage. A cartridge carrying a solid sealant may be advanced over the positioning member, and the sealant may be deployed within the puncture, the sealant expanding upon exposure to fluid within the puncture to substantially seal the puncture.
In an exemplary embodiment, the cartridge may be advanced over the positioning member to position a distal end of the sealant spaced apart from the positioning element, thereby offsetting the sealant from the endocardial wall of the chamber by a predetermined offset distance. For example, the cartridge and the positioning member may include cooperating elements that limit advancement of the cartridge over the positioning member until the distal end of the sealant is offset by the predetermined offset distance.
In accordance with yet another embodiment, a method is provided for sealing a puncture through the wall of a patient's heart using an apparatus comprising an elongate positioning member carrying a cartridge, the cartridge carrying a sealant and a pusher member adjacent the sealant within a lumen of the cartridge. The method may include introducing a distal end of the positioning member into the puncture with the cartridge until a positioning element thereon is disposed within a chamber of the heart; expanding the positioning element within the chamber; and withdrawing the positioning member from the puncture until the expanded positioning element contacts an endocardial wall of the chamber adjacent the puncture. The cartridge may be advanced over the positioning member into the puncture until a distal end of the sealant is spaced apart from the positioning element, thereby offsetting the sealant from the chamber by a predetermined distance; and then the cartridge may be retracted to deploy the sealant within the puncture.
In accordance with still another embodiment, an apparatus is provided for sealing a puncture extending through the wall of a patient's heart that includes a cartridge comprising a proximal end, a distal end sized for insertion into a puncture, a lumen extending between the proximal and distal ends, and a distal opening in communication with the lumen; sealant disposed within the lumen, having a predetermined outer diameter before being deployed from the cartridge that is at least about two millimeters (2 mm); and an advancer or tamp member disposed within the lumen of the cartridge for deploying the sealant from the lumen out the distal opening when the cartridge is retracted from a puncture relative to the advancer member. In other embodiments, before being exposed to fluid, i.e., when provided in the cartridge before delivery, the sealant may have an outer diameter of at least about four millimeters (4 mm) or at least about six millimeters (6 mm), and a length between about five and thirty millimeters (5-30 mm), at least about two millimeters (2 mm), five millimeters (5 mm), ten millimeters (10 mm), and the like.
In one embodiment, the apparatus also includes an elongate positioning member having an expandable element on a distal end thereof, the positioning member sized for passing through the lumen of the cartridge and the sealant. For example, the cartridge, with the sealant and advancer member therein, may be provided initially in a proximal position on the positioning member, the cartridge being advanceable along the positioning member to a distal position wherein the sealant is disposed adjacent the positioning element. Optionally, the cartridge and the positioning member may include cooperating elements that limit advancement of the cartridge over the positioning member until the distal end of the sealant is offset by a predetermined offset distance, e.g., at least about two millimeters (2 mm).
Other aspects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.
It will be appreciated that the exemplary apparatus shown in the drawings are not necessarily drawn to scale, with emphasis instead being placed on illustrating the various aspects and features of the illustrated embodiments.
Turning to the drawings,
As shown, the cartridge 16 includes an elongate tubular member 20 carrying the sealant 2 therein, an advancer tube or member 30 adjacent the sealant 2 within the tubular member 20, and a handle or hub 23 coupled to the tubular member 20. Generally, as best seen in
The advancer member 30 may be an elongate tubular body sized to be slidably received within the lumen 26 of the tubular member 20, although the advancer member 30 may abut or otherwise interact with the hub 23 of the cartridge 16, e.g., such that the advancer member 30 is advanced distally when the cartridge 16 is advanced. A distal end 34 of the advancer member 30 may terminate in a substantially blunt distal tip proximal to the tubular member distal end 24, which may facilitate contacting and/or otherwise maintaining the sealant 2 within a puncture, e.g., when the tubular member 20 is retracted during use, as described further below.
The advancer member 30 may be substantially rigid, semi-rigid, and/or substantially flexible, e.g., having sufficient column strength to allow proximal movement of the tubular member 20 relative to the sealant 2 without buckling the advancer member 30 and/or to allow the distal end 34 of the advancer member 30 to be advanced to compress the sealant 2 within a puncture, e.g., by pushing from the proximal end 32, as described further below. The advancer member 30 may also include a lumen (not shown) extending between the proximal and distal ends 32, 34, e.g., to accommodate the positioning member 14, a flowable sealing compound, and/or fluid (not shown).
Optionally, the advancer member 30 may include one or more elements (not shown), e.g., on the proximal end, for interacting with one or more cooperating elements (also not shown) on the positioning member 14, e.g., to limit movement of the advancer member 30 relative to the positioning member 14. For example, the cooperating elements may interact to limit advancement of the advancer member 30 and/or the entire cartridge 16, e.g., to limit advancement of the sealant 2 to a predetermined offset distance relative to a positioning element 46 on the positioning member 14, as described further below.
As shown in phantom, the sealant 2 may be disposed within the lumen 26 of the tubular member 20 proximate to the distal end 24, e.g., immediately adjacent a distal tip 25 thereof or offset a predetermined distance from the distal tip 25, e.g., between about one and ten millimeters (1-10 mm) or between about one and five millimeters (1-5 mm). The lumen 26 may be sized such that the tubular member 20 and sealant 2 are slidable relative to one another, e.g., to allow the tubular member 20 to be retracted proximally relative to the sealant 2 and/or advancer member 30, as described further below.
With continued reference to
For example, as shown in
Alternatively, the positioning element may be biased to an enlarged condition, but may be compressed to a contracted condition, e.g., by an overlying sleeve or other constraint (not shown). The constraint may be removed to expose the positioning element, allowing the expandable element to automatically expand to the enlarged condition. Additional information on expandable structures that may be provided on the positioning member 14 may be found in U.S. Pat. Nos. 6,238,412, 6,635,068, and 6,890.343, and in co-pending application Ser. No. 10/975,205, filed Oct. 27, 2004. The entire disclosures of these references are expressly incorporated herein by reference.
With additional reference to
As shown in
Optionally, the cartridge 16 and/or positioning member 14 may include cooperating features that limit distal movement of the cartridge 16 relative to the positioning member 14. For example, the hub 23 of the cartridge 16 may include a pocket and the positioning member 14 may include a detent or other feature (both not shown) that may be received within the pocket when the cartridge 16 is advanced to a distal position. In addition or alternatively, the positioning member 14 and/or advancer member 30 may include one or more elements that engage when the cartridge 16 reaches a predetermined location when advanced along the positioning member 14, e.g., to limit subsequent distal and/or proximal movement of the advancer member 30 relative to the positioning member 14, e.g., when the tubular member 20 is subsequently refracted, similar to embodiments disclosed in the references incorporated by reference herein.
In addition or alternatively, one or more markers may be provided on the apparatus 10, e.g., to identify when components are located at one or more desired positions or otherwise to facilitate use of the apparatus 10. For example, the positioning member 14 may include one or more markers (not shown) at predetermined locations on the elongate member 40. Such markers may provide visual confirmation when the cartridge 16 has been advanced to a desired distal position, e.g., when the marker(s) emerge from the hub 23 as the cartridge 16 is advanced over the positioning member 14. In addition or alternatively, the advancer member 30 may include one or more markers thereon (also not shown), which may be visible when the cartridge 16 is advanced to a distal position and then the tubular member 20 is retracted to expose the sealant 2. These markers may also provide visual guides to inform the user when the advancer member 30 is manipulated, e.g., advanced into a puncture to compress the sealant 2 therein, as described further below.
The apparatus 10 may be assembled using conventional manufacturing methods and/or using methods disclosed in the references incorporated by reference herein. The components of the cartridge 16, the tubular body 20, advancer tube 30, and hub 23 may be formed using conventional methods, e.g., extruding, molding, and the like. For example, the hub 23 may be formed from a plurality of molded shells that may be attached together and to which the proximal end 22 of the tubular body 20 may be attached. In the exemplary embodiment shown, the cartridge 16 includes a single tubular body 20 attached to the hub 23. In an alternative embodiment, the cartridge 16 may include inner and outer cartridge assemblies, including inner and outer tubular bodies (not shown) attached to the hub 23, e.g., similar to embodiments disclosed in the references incorporated by reference herein.
The advancer member 30 may include a section of tubing with a thermoformed tapered tip. Once the tubular body 20 (or bodies) is assembled to the hub 23, the advancer member 30 may be inserted into the lumen 26 of the tubular body 20 (e.g., into the inner cartridge tubing if inner and outer cartridge tubular bodies are provided).
To provide the hub 48 of the positioning member 14, a hub barrel (not shown), stopcock 48b, and extension line 48c may be assembled, similar to embodiments disclosed in the references incorporated by reference herein. One end of the extension line 48c may be bonded or otherwise attached to the stopcock 48b, and the other end of the extension line 48c may be bonded or otherwise attached into a side port of the hub barrel. To complete the positioning member 14, locking features (not shown) may be bonded onto the tubular body 40, e.g., spaced a predetermined distance from the proximal end 42.
The proximal leg of the balloon 46 may be bonded to the distal end 44 of the tubular body 40. The cartridge 16, hub barrel 48 and a core wire with tension plunger (not shown) are all then assembled with the tubular body 40, e.g., similar to embodiments in the references incorporated by reference herein. The core wire may then be bonded into the distal leg of the balloon 46. The hub barrel may be bonded to the proximal end 42 of the tubular body 40 and captured within the halves of a handle shell to provide the hub 48, as shown in
Finally, the sealant 2 may be loaded into the assembled apparatus 10. For example, a rolled sealant 2 may be coaxially mounted over the tubular body 40 from the distal end 44 and positioned inside the tubular member 20 of the cartridge 16, e.g., adjacent the distal end 24 and the advancer member 30 therein.
The pellet or sealant 2 may have an “as delivered” diameter ranging from much smaller than the inner diameter of the tubular member 20 to substantially the same as the inside diameter of the tubular member 20, e.g., between about one and ten millimeters (1-10 mm), at least about two millimeters (2 mm), at least about four millimeters (4 mm), at least about six millimeters (6 mm), or at least about eight millimeters (8 mm). The length of the “as delivered” sealant 2 may range from about two millimeters (2 mm) to as long as the predicted thickness of the myocardial wall, e.g., between about five and thirty millimeters (5-30 mm). Typically, the length may be designed shorter than the predicted thickness of the myocardial wall such that, after deployment, the tract on the proximal and distal ends of the sealant s may recover to a much smaller diameter than the sealant 2 and even recover to the point of achieving casual closure of the tract, e.g., as shown in
The configuration of the sealant 2 within the diameters and lengths described herein may range from 100% freeze-dried polymeric material to 100% unreacted precursors of polymeric material, e.g., similar to the sealants disclosed in application Ser. No. 13/354,278, filed Jan. 19, 2012, the entire disclosure of which is expressly incorporated by reference herein. The purpose of the freeze-dried sections may be to swell with fluids to create a mechanical barrier to blood flow, while the purpose of the unreacted precursors may be to cross-link in-situ and mechanically adhere to the walls of the tract, as well as to swell and provide a mechanical barrier to blood flow, effectively anchoring the sealant 2 in place against the blood pressure within the chamber.
For example, in one embodiment, the sealant 2 may include a rolled freeze-dried sheet of polymeric material, e.g., a hydrogel material, coated on either the entire or partial outside surface with a layer of unreacted precursors. In an alternative embodiment, the sealant 2 may include a rolled freeze-dried sheet of polymeric material with a proximal and/or distal segment of unreacted precursors attached to one or both ends of the polymeric material. In further alternatives, the sealant 2 may include segments of alternating rolled freeze-dried sheet and solid unreacted precursors and/or a rolled, freeze-dried sheet with spaced bands of unreacted precursor coatings on the outside. Alternatively, in any of the embodiments herein, the “rolled, freeze-dried sheet” may be replaced with a formed cylindrical piece of freeze-dried polymer.
Additional exemplary embodiments of pellets and/or sealants that may be used are disclosed in U.S. Pat. Nos. 7,316,704, 7,331,979, 7,335,220, and 7,806,856, in U.S. Publication Nos. 2007/0231366, 2008/0082122, 2009/0088793, 2009/0254110, 2010/0168789, 2010/0274280, and 2010/0280546, and in co-pending application Ser. Nos. 13/105,822, filed May 11, 2011, and 61/434,412, filed Jan. 19, 2011. The entire disclosures of these references are expressly incorporated by reference herein.
Turning to
In an exemplary method, the puncture 92 may be created using known procedures, e.g., using a needle, guide wire, one or more dilators, and the like (not shown). A distal end 84 of an introducer sheath 80 may be advanced through the puncture 92 into the left ventricle 96, e.g., over a guide wire (not shown) placed through the puncture 92 into the left ventricle 96. As shown, the introducer sheath 80 may include a proximal end 82 coupled to a hub 81 opposite the distal end 84. The introducer sheath 80 may have sufficient length to extend from within the heart 90 to outside the patient's body, e.g., via an access port, thoracotomy, sternotomy, and the like (not shown), e.g., between about ten and forty centimeters (10-40 cm).
The introducer sheath 80 may provide access into the left ventricle 96 for one or more instruments (not shown), e.g., to allow one or more diagnostic and/or interventional procedures to be performed within or via the left ventricle 96. Upon completing the procedure(s), any such instrument(s) may be removed, leaving the introducer sheath 80 extending through the puncture 92 into the left ventricle 96.
With reference to
Still referring to
After expanding the positioning element 46, the positioning member 40 may be at least partially withdrawn until the positioning element 46 contacts the endocardial wall of the left ventricle 96, e.g., to provide temporary hemostasis and substantially seal the left ventricle 96 from the puncture 92. In an exemplary method, this may involve a two-step process (although it may be completed in a single substantially continuous action). First, with the positioning element 46 expanded within the left ventricle 96 beyond the distal end 84 of the introducer sheath 80, the positioning member 14 may be withdrawn until the positioning element 46 contacts the distal end 84 of the introducer sheath 80, which may provide a first tactile feedback to the user (i.e., that the positioning element 46 has contacted the introducer sheath 80, e.g., based upon the increased weight and/or resistance to proximal movement). The positioning member 14 may be withdrawn further until the positioning element 46 contacts the endocardial wall of the left ventricle 96 and resists further withdrawal, thereby providing a second tactile feedback. The introducer sheath 80 may be pulled proximally by the positioning element 46 as the positioning member 14 is withdrawn, e.g., until the distal end 84 of the introducer sheath 80 is withdrawn into the puncture 92.
Proximal tension may be applied and/or maintained on the positioning member 14 to hold the positioning element 46 against the wall of the left ventricle 96, e.g., to substantially seal the puncture 92 from the left ventricle 96 and/or prevent further removal of the positioning member 14. The proximal tension may be maintained manually or using a tensioner device (not shown) to provide temporary hemostasis, e.g., during the subsequent steps. Exemplary tension devices are disclosed in U.S. Publication No. 2004/0267308, incorporated by reference elsewhere herein.
Turning to
Alternatively, the cartridge 16 may be advanced into the introducer sheath 80 until the distal end 24 contacts the expanded positioning element 46, which may provide tactile feedback that the cartridge 16 has been advanced sufficiently, or the sealant 2 is otherwise positioned within the puncture 92.
Thereafter, as shown in
As the tubular member 20 is retracted, the advancer member 30 may prevent substantial proximal movement of the sealant 2, thereby exposing the sealant 2 within the puncture 92, as shown in
When the sealant 2 is exposed within the puncture 92, the sealant 2 may be exposed to blood and/or other body fluids within the puncture 92. This exposure may cause the sealant 2 to absorb fluid and activate to provide hemostasis, as described further elsewhere herein. Optionally, once the sealant 2 is exposed within the puncture 92, the advancer member 30 may be advanced to compress or tamp the sealant 2 (not shown), e.g., against the positioning element 46. In this option, the advancer member 30 may include one or more markers (not shown), e.g., on or adjacent the proximal end 32, and the advancer member 30 may be advanced into the puncture 92 a desired distance, which may be confirmed by monitoring the markers. In addition or alternatively, the positioning member 14 may include a second feature (not shown) over which the advancer member 30 may pass when advanced a predetermined distance. The second feature may provide an audible confirmation that the advancer member 30 has been advanced the predetermined distance (in addition or instead of the visible confirmation provided by the markers 33).
Once the sealant 2 has been exposed for sufficient time and/or tamped by the advancer member 30, the positioning element 46 may be collapsed, as shown in
Once the positioning member 14 is completely removed, the advancer member 30 may be removed from the puncture 92, leaving the sealant 2 within the puncture 92, as shown in
Optionally, after or before removing the positioning member 14, liquid hydrogel or other sealing compound, or other material may be delivered into the puncture 92, e.g., above and/or around the sealant 2, to assist in achieving hemostasis. For example, solutions may be delivered including pH buffers and/or other compounds to activate a cross-linking reaction on all or part of the sealant, as described in different embodiments elsewhere herein and in the references incorporated by reference herein. Such material may be delivered via the lumen 36 of the advancer member 30 and/or by introducing another delivery device (not shown) into the puncture 92, e.g., after removing the advancer member 30.
The delivery device may be designed to deliver such solutions and/or materials to the internal and/or external surface of the sealant 2 causing the sealant 2 to swell. The sealant 2 and/or solutions may include formulations to activate a cross-linking reaction on all or part of the sealant, as described elsewhere herein.
It will be appreciated that elements or components shown with any embodiment herein are merely exemplary for the specific embodiment and may be used on or in combination with other embodiments disclosed herein.
While the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents and alternatives falling within the scope of the appended claims.
The present application claims benefit of co-pending U.S. provisional application Ser. No. 61/501,135, filed Jun. 24, 2011, the entire disclosure of which is expressly incorporated by reference herein.
| Number | Date | Country | |
|---|---|---|---|
| 61501135 | Jun 2011 | US |
