Patent Grant
8348971
The present invention relates generally to apparatus and methods for sealing punctures in a body, and more particularly, to apparatus and methods for sealing a vascular puncture extending through tissue into a blood vessel, and to apparatus and methods for delivering a fast-dissolving sealing device into a puncture extending from a patient's skin to a blood vessel or other body lumen to provide temporary hemostasis.
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 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 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 a percutaneous puncture instead of using external pressure. For example, U.S. Pat. No. 5,108,421 issued to Fowler discloses a plug that may be delivered into a puncture through tissue. In one embodiment, a catheter is inserted through the puncture into the blood vessel. A balloon on the catheter is expanded and retracted until the balloon is disposed adjacent the puncture at the wall of the vessel. The plug may be advanced into the puncture until the plug contacts the balloon. Once the plug is positioned within the puncture, the balloon may be deflated and withdrawn, leaving the plug therein to expand and seal the puncture and/or to promote hemostasis.
Alternatively, U.S. Pat. No. 5,222,974 issued to Kensey et al. describes a system and method for sealing a percutaneous puncture in an artery. The system includes a sealing member including a resorbable plug, a rigid resorbable anchor member, and resorbable positioning member in the form of a filament. The disclosed sealing member is designed to resorb completely, e.g., within sixty to ninety (60-90) days.
U.S. Pat. No. 6,663,655 issued to Ginn et al. discloses a two-piece plug device for sealing a passage through tissue. The device includes a plug member and a sealing member disposed within a lumen of the plug member. The device is delivered into a puncture proximate to a vessel communicating with the puncture. The plug member and sealing member are made of a bioabsorbable material and may remain within the body until both components are absorbed.
U.S. Pat. No. 5,916,236 issued to Muijs Van de Moer et al. discloses an occlusion assembly that includes a flexible sheet attached to one end of a thread, and a retaining ring slidable along the thread towards the sheet. The sheet is folded, delivered via a sheath through a puncture into a blood vessel, and allowed to unfold within the vessel. The thread is pulled to direct the sheet against the wall of the vessel, whereupon the retaining ring is advanced down the thread to secure the sheet against the wall. The sheet, thread, and retaining ring are made of bioabsorbable material such that they disappear after a few weeks.
U.S. Pat. No. 4,890,612 issued to Kensey discloses a three-component closure device that includes a holding member or toggle, a filament, and a cylindrical plug made of bioabsorbable materials that is absorbed in approximately, forty five days, ninety days, and ten days, respectively. The closure device is delivered through a puncture into a blood vessel via a sheath, whereupon the filament is retracted to pull the toggle against the wall of the vessel with the plug within the puncture. The closure device remains in place until absorbed by the patient's body.
One of the disadvantages with these closure devices is that it may be difficult to position them properly with respect to the vessel, which may be significant since it is generally undesirable to expose collagen material to the bloodstream where it may float downstream and cause an embolism. In addition, these closure devices take a relatively long period of time to resorb and/or dissolve within the body (i.e., ten days or more). This is particularly undesirable for the portion of the device that is disposed within the blood vessel, because of the risk of a piece of the closure device breaking free and causing an embolism or other damage downstream of the puncture site.
Even when non-collagen materials are used for the portion of a closure device residing within a blood vessel, however, it may be desirable to minimize the amount of time the intravascular portion of the device is present within the vessel. Of course, if the device is absorbed too rapidly, it may adversely affect effective hemostasis of the puncture without risk of hematoma or other complications.
The present invention is directed to apparatus and methods for providing temporary or permanent hemostasis within a puncture extending through tissue, e.g., to a blood vessel or other body lumen, and/or to apparatus and methods for delivering a sealing device through a percutaneous puncture into a vessel or other body lumen that includes an intravascular component that is substantially absorbed during or shortly upon completing a procedure via the puncture.
In accordance with one embodiment, a device for sealing a puncture extending through tissue into a body lumen includes a filament or other elongate member, and a sealing member on a distal end of the elongate member formed from a bioabsorbable material that may be substantially absorbed by the body within not more than about twenty four (24) hours of exposure to an aqueous physiological environment, e.g., to blood or other fluid within the body lumen. In other embodiments, the sealing member may be substantially absorbed within not more than about twelve (12) hours, three (3) hours, one (1) hour, or even within not more than about thirty (30) minutes of exposure to an aqueous physiological environment within the body lumen. The retaining member may be formed from either a bioabsorbable or non-bioabsorbable material. Optionally, the device may also include extravascular sealing material deliverable within the puncture around the elongate member, e.g., a plug, a bolus of liquid sealing material, and the like.
In another embodiment, a device for sealing a puncture extending through tissue to a body lumen includes a filament or other elongate member formed from a first material, a sealing member formed from a second bioabsorbable material on a distal end of the elongate member, and extravascular sealing material formed from a third bioabsorbable material, the extravascular material being deliverable into the puncture around the elongate member. In one embodiment, the second bioabsorbable material may be absorbed at a faster rate compared to the third bioabsorbable material when exposed to an aqueous physiological environment, e.g., to blood or other fluid from the body lumen. Optionally, the first material is also bioabsorbable, e.g., at a slower rate compared to the second bioabsorbable material when exposed to an aqueous physiological environment.
In yet another embodiment, a method for sealing a puncture extending from a patient's skin through tissue to a body lumen includes delivering a sealing member into the body lumen, the sealing member formed from bioabsorbable material, retracting the sealing member against a wall of the body lumen, e.g., using a filament or other retaining member secured to the sealing member, to substantially seal the puncture from the body lumen. The sealing member may remain within the body lumen until it is substantially absorbed, e.g., within not more than about twenty-four hours of exposure to an aqueous physiological environment inside the blood vessel.
In one embodiment, the retaining member may be withdrawn from the puncture after the sealing member is absorbed, e.g., if the retaining member is formed from a non-bioabsorbable material. Alternatively, the retaining member may also be bioabsorbable, and may remain within the puncture until absorbed by the patient's body.
Optionally, sealing material, e.g., a plug and/or a single or multiple liquid sealing material, may be delivered into the puncture, e.g., around the retaining member, to further enhance hemostasis within the puncture. The sealing material may also be bioabsorbable, e.g., over a relatively longer time than the sealing member disposed within the body lumen.
Other aspects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.
Turning to the drawings,
The closure device 2 generally includes a filament or other retaining member 12 including a proximal end 12a and a distal end 12b, and a bioabsorbable sealing member 10 on the distal end 12b. The filament 12 may be a solid or hollow elongate body, e.g., a suture, string, wire, tube, and the like, e.g., having a diameter, thickness, or other cross-sectional dimension of not more than about 0.90 mm. In one embodiment, the filament 12 may be a bioabsorbable suture, e.g., made from poly(glycolic-co-lactic) acid, poly (glycolic acid), and the like. In this embodiment, the retaining member 12 may be made from material that may be absorbed over a longer period of time compared to the sealing member 10. For example, the filament 12 may be absorbed over a period of at least about twenty-four (24) hours after exposure to an aqueous environment, and may take as long as days, weeks, or even months to absorb completely. Alternatively, the filament 12 may be formed from a biocompatible, nonbioabsorbable material, such as nylon, Teflon, catgut, silk, polypropylene, and the like.
The filament 12 may be substantially flexible, i.e., having little or no column strength. Alternatively, the filament 12 may have sufficient column strength such that the distal end 12b carrying the sealing member 10 may be advanced distally, e.g., from the delivery sheath 20, by pushing on the proximal end 12a of the filament 12, as described further below. The filament 12 should have sufficient strength in tension to allow the sealing member 10 to be pulled through a puncture against a wall of a blood vessel or other body lumen, e.g., to substantially seal the puncture from the vessel without the filament 12 breaking and/or separating from the sealing member 10.
Optionally, particularly if the filament 12 is not bioabsorbable, an exterior surface of the filament 12 may include a lubricious coating or other material, for example, to facilitate withdrawing the filament 12 through a puncture, e.g., after the puncture has been at least partially filled with sealing material around the filament 12, as explained further below.
As shown, the sealing member 10 is affixed to the distal end 12b of the filament 12 at a fixation or toggle location 16, e.g., at or near the center or midpoint of the sealing member 10. The filament 12 may be at least partially embedded within the sealing member 10 at the fixation location 16 and/or may extend at least partially around to secure the sealing member 10 to the distal end 12b. For example, the distal end 12b may include a loop (not shown) that may be secured around a portion of the sealing member 10 and/or may extend through one or more openings (also not shown) through the sealing member 10. In addition or alternatively, an adhesive or other material (not shown) may be used to attach the distal end 12b to the sealing member 10.
The sealing member 10 may be a body generally defining a plane, i.e., having a thickness or other minor dimension that is substantially smaller than its width, diameter, or other major dimension. For example, as shown, the sealing member 10 may be generally disk-shaped, having a circular, square, polygonal, or other shape generally within a plane and defining upper and lower surfaces 10a, 10b. The generally upper and lower surfaces 10a, 10b may be substantially planar, concave and/or convex (not shown).
The sealing member 10 may be formed from a rapidly absorbing, biocompatible material. As used herein, “rapidly absorbing” means material that is absorbed by any physical process (e.g., dissolving, melting, or the like) within a relatively short period of time, e.g., not more than about twenty four (24) hours, e.g., upon exposure to an aqueous physiological environment. An example of an aqueous physiological environment is a location within a patient's body exposed to blood or other bodily fluids, such as an interior of a blood vessel or other organ.
In other embodiments, the sealing member 10 may be substantially absorbed within about twelve (12) hours of exposure to an aqueous physiological environment, within about three (3) hours, about one (1) hour, or even less than about thirty (30) minutes of exposure to an aqueous physiological environment. In this regard, the intravascular aspect of the closure device 2, namely, the sealing member 10, may be substantially absorbed before the patient becomes ambulatory, i.e., during or immediately following a procedure performed via the puncture. Thus, the amount of time that the sealing member 10 remains intact within the patient's body may be minimized compared to known closure devices that may be absorbed by a patient's body over days, weeks, or months.
Exemplary materials for the sealing member 10 may include carbohydrate (sugar) or salt-based materials, e.g., that rapidly dissolve in the presence of an aqueous environment, e.g., blood or other bodily fluids. In addition or alternatively, the sealing member 10 may be formed from a material that rapidly melts due to the increased temperature within a patient's body, e.g., when exposed to temperatures of about thirty seven degrees Celsius (37° C.) or more.
In one embodiment, the sealing member 10 may be pre-formed into a shape that prevents the sealing member 10 from being pulled easily through an arteriotomy or other opening through a wall of a blood vessel or other body lumen into a puncture (not shown). Further, the shape of the sealing member 10 may aid in substantially sealing such a puncture from the vessel, e.g., to provide temporary hemostasis. Optionally, the sealing member 10 may include structural features (e.g., structural reinforcement elements, shaped sealing surfaces, and the like, not shown) that may aid in preventing the sealing member 10 from being dislodged through an arteriotomy or other opening once deployed.
The sealing member 10 may be substantially rigid, i.e., fixed in a shape, such as an elongate foot, plate, sheet, a generally disk-shape, or other configuration. Alternatively, the sealing member 10 may be semi-rigid, i.e., such that the shape of the sealing member 10 may conform at least partially to contacted anatomy, e.g., assuming a curved shape conforming to a wall of a vessel or other body lumen when directed against the wall.
In a further alternative, the sealing member 10 may be substantially flexible, i.e., capable of being deformed into a contracted condition, e.g., to facilitate loading within the delivery sheath 20, and expandable into an enlarged condition, e.g., a generally disk-shaped configuration, when deployed from the delivery sheath 20 and/or when free from outside stresses. For example, the sealing member 10 may be rolled into a generally tubular shape to facilitate loading into the delivery sheath 20, may be compressed or deflected into a lower profile contracted condition, and the like.
With continued reference to
The pusher member 30 may be an elongate member, e.g., a plunger, catheter, and the like, including a proximal end 32, and a distal end 34 having a size for slidable insertion into and/or movement within the lumen 26 of the delivery sheath 20. The distal end 34 of the pusher member 30 may be substantially blunt or otherwise shaped to facilitate contacting and/or pushing the sealing member 10 within the delivery sheath 20, as described further below. The pusher member 30 may be substantially rigid, semi-rigid, and/or substantially flexible, having sufficient column strength to allow movement of the delivery sheath 20 relative to the sealing member 10 without buckling. The pusher member 30 may also include a lumen 36 extending between the proximal end and the distal end 34, e.g., to accommodate the filament 12 of the closure device 2 and/or a guidewire (not shown) therethrough.
Optionally, as shown in
In one embodiment, the plunger assembly 48 may include a pair of plungers 50 that are coupled to one another yet are received in respective syringes 42. Thus, both plungers 50 may be manually depressed substantially simultaneously to deliver the components in the syringes 42 out together. Alternatively, an auto-injection device may be provided for delivering the components from the syringes 42, such as that disclosed in co-pending application Ser. No. 10/806,952, filed Mar. 22, 2004, the entire disclosure of which is expressly incorporated herein by reference.
In one embodiment, a liquid precursor polymer compound is provided in each syringe 42 of the syringe assembly 40 that, when mixed together, may be activated to form a hydrogel, such as a poly(ethylene glycol)-based (PEG) multiple component hydrogel. Additional information on hydrogels and systems for delivering them are disclosed in U.S. Pat. Nos. 6,152,943, 6,165,201, 6,179,862, 6,514,534, 6,379,373, and 6,703,047, and in co-pending application Ser. No. 09/776,120 filed Feb. 2, 2001, Ser. No. 10/010,715 filed Nov. 9, 2001 published as U.S. patent Application Publication No. 2003-0012734 A1, and Ser. No. 10/068,807 filed Feb. 5, 2002 published as U.S. patent Application Publication No. 2002-0114775 A1. The disclosures of these references and any others cited therein are expressly incorporated by reference herein.
As shown in
The sealing material 99 may be formed from other bioabsorbable and/or biocompatible material. Similar to the filament 12, the sealing material 99 may be absorbed over a longer period of time compared to the sealing member 10. In exemplary embodiments, the sealing material 99 may be absorbed over a period of time of not less than about twenty-four (24) hours after exposure to an aqueous environment, e.g., in not less than about seven to fourteen (7-14) days.
For example, the sealing material 99 may be formed from biologic-based material, such as collagen, fibrin, carboxymethylcellulose, oxidized cellulose, alginates, gelatin, or other protein-based material, and/or synthetic materials, such as polyglycolic acids (PGA's), polyactides (PLA's), and the like. The sealing material 99 may be formed into a discernable structure such as a plug, and the like.
Turning to
In an exemplary method, the puncture 90 may be created using known procedures, e.g., using a needle, guidewire, one or more dilators, and the like (not shown). An introducer sheath (also not shown) may be advanced through the puncture 90 into the vessel 94, e.g., to provide access into the vessel 90 for one or more instruments, and/or allow one or more diagnostic and/or interventional procedures to be performed via the vessel 90, as is known in the art. Upon completing the procedure(s) via the vessel 94, any instruments and/or the introducer sheath (not shown) may be removed from the puncture 90.
Turning to
Turning to
Alternatively, if the filament 12 is pushable from the proximal end 12a (i.e., having sufficient column strength), the proximal end 12a of the filament 12 may be directed distally into the delivery sheath 20 to advance the distal end 12b and the sealing member 10 out of the delivery sheath 20 into the vessel 94. In this alternative, it may be possible to eliminate the pusher member 30 completely. In addition, the delivery sheath 20 may include a lubricious coating or other material (not shown) to facilitate sliding the sealing member 10 out of the distal end 24 of the delivery sheath 20.
Turning to
Turning to
Turning to
Optionally, external pressure may be applied to the patient's skin 92 above the puncture 90 to further enhance hemostasis. In addition or alternatively, the proximal end 12a of the filament 12 may be secured relative to the patient, e.g., by taping, strapping, adhering, or otherwise securing the proximal end 12a to the patient's skin 92 adjacent the puncture 90 at 58, as shown in
Alternatively, as shown in
Optionally, the delivery sheath 20 may be withdrawn proximally as the sealing material 99 is delivered, e.g., to fill the puncture 90. Alternatively, the delivery sheath 20 may not include a side port, and a separate injection sheath (not shown) may be used to deliver the sealing material 99. In this alternative, the delivery sheath 20 may be removed after delivering the sealing member 10, and the injection sheath may be advanced over the filament 12 into the puncture 90 to deliver the sealing material, similar to the methods described elsewhere herein.
In another alternative, injection of the hydrogel precursor mixture into the lumen 26 of the delivery sheath 20 may be used to force the sealing member 10 out of the lumen 20, i.e., to initially deploy the sealing member 10 into the vessel 94. After the sealing member 10 has been ejected from the delivery sheath 20 into the vessel 94 in this manner, further hydrogel precursor mixture delivery may be discontinued, until the sealing member 10 is retracted against the wall of the vessel 94.
In further alternatives, the pusher member 30 may be used to deliver the sealing material 99 into the puncture, e.g., via lumen 36, similar to the methods described above.
Once the sealing member 10 has been deployed within the vessel 94, the sealing member 10 may begin to be absorbed rapidly, e.g., due to exposure to blood within the vessel 94. As explained above, the sealing member 10 may dissolve within not more than about twenty-four (24) hours after deployment. In one embodiment, the filament 12 may also be formed from bioabsorbable material, although the filament material may be absorbed over a longer period of time, e.g., greater than about twenty-four (24) hours after exposure within the patient's body. Similarly, the extravascular sealing material 99 may also be bioabsorbable, e.g., at a rate substantially slower than the sealing member 10.
In an alternative embodiment of the invention, if the filament is not bioabsorbable, the filament 12 may be removed, e.g., by pulling the filament 12 out of the patient's body after sufficient time for the sealing member 10 to dissolve. For example, the proximal end 12a may be released, if secured to the patient's skin 92, and pulled through the extravascular sealing material 99 and out of the puncture 90. Thus, the filament 12 may remain until hemostasis has been substantially established and/or after the sealing member 10 has been substantially absorbed. In this regard, the filament 12 may be removed at the time of patient ambulation, e.g., before discharge from the medical facility, or even subsequently during a follow-up visit. In this embodiment, the filament 12 may have a sufficiently small diameter or other cross-section so that the small tract resulting from its removal does not bleed or otherwise leak substantially. Any bleeding or leaking may be managed, e.g., by compression for a short period of time or a compressive bandage (not shown).
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 spirit and scope of the appended claims.
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