Patent Grant
7083635
The present invention relates generally to apparatus and methods for sealing or closing passages through tissue, and more particularly to devices for sealing punctures or other openings communicating with body lumens, such as blood vessels, and to apparatus and methods for delivering such devices.
Catheterization and interventional procedures, such as angioplasty or stenting, generally are performed by inserting a hollow needle through a patient's skin and muscle tissue into the vascular system. A guide wire may then be passed through the needle lumen into the patient's blood vessel accessed by the needle. The needle may be removed, and an introducer sheath may be advanced over the guide wire into the vessel, e.g., in conjunction with or subsequent to a dilator. A catheter or other device may then be advanced through a lumen of the introducer sheath and over the guide wire into a position for performing a medical procedure. Thus, the introducer sheath may facilitate introduction of various devices into the vessel, while minimizing trauma to the vessel wall and/or minimizing blood loss during a procedure.
Upon completion of the procedure, the devices and introducer sheath may be removed, leaving a puncture site in the vessel wall. External pressure may be applied to the puncture site until clotting and wound sealing occur. This procedure, however, may be time consuming and expensive, requiring as much as an hour of a physician's or nurse's time. It is also uncomfortable for the patient, and requires that the patient 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 have been suggested for percutaneously sealing a vascular puncture by occluding the puncture site. For example, U.S. Pat. Nos. 5,192,302 and 5,122,974, issued to Kensey et al., describe the use of a biodegradable plug that may be delivered through an introducer sheath into a puncture site. When deployed, the plug may seal the vessel and provide hemostasis. Such devices, however, may be difficult to position properly with respect to the vessel, which may be particularly significant since it is generally undesirable to expose the plug material, e.g., collagen, within the bloodstream, where it may float downstream and risk causing an embolism.
Another technique has been suggested that involves percutaneously suturing the puncture site, such as that disclosed in U.S. Pat. No. 5,304,184, issued to Hathaway et al. Percutaneous suturing devices, however, may require significant skill by the user, and may be mechanically complex and expensive to manufacture.
Staples and surgical clips have also have been suggested for closing wounds or other openings in tissue. For example, U.S. Pat. Nos. 5,007,921 and 5,026,390, issued to Brown, disclose staples that may be used to close a wound or incision. In one embodiment, an “S” shaped staple is disclosed that includes barbs that may be engaged into tissue on either side of the wound. In another embodiment, a ring-shaped staple is disclosed that includes barbs that project from the ring. These staples, however, have a large cross-sectional profile and therefore may not be easy to deliver through a percutaneous site to close an opening in a vessel wall.
In addition, skin seals have been proposed that may be threaded into an opening in skin. For example, U.S. Pat. No. 5,645,565, issued to Rudd et al., discloses a surgical plug that may be screwed into a puncture to seal the puncture. The surgical plug includes an enlarged cap and a threaded shaft that extends from the cap. During an endoscopic procedure, the plug may be threaded into an opening through skin until the cap engages the surface of the skin. The plug is intended to seal the opening communicating with a body cavity to prevent insufflation fluid from leaking from the cavity. Such plugs, however, may only be used at the surface of the skin, and may not be introduced through tissue, for example, to seal an opening in the wall of a blood vessel or other subcutaneous region.
Accordingly, devices for sealing punctures or other passages through tissue, e.g., an opening into a blood vessel, would be considered useful.
The present invention is directed to apparatus and methods for sealing or closing passages through tissue, such as punctures communicating with blood vessels or other body lumens.
In accordance with one aspect of the present invention, an apparatus is provided for sealing a passage through tissue that includes an elongate guide member, a carrier member, and a plug member. The guide member includes a groove in an outer wall of the guide member that extends between proximal and distal portions of the guide member. The carrier member includes proximal and distal ends, and a first lumen extending between the proximal and distal ends.
A plug member, e.g., formed from bioabsorbable material, may be carried on the distal end of the carrier member. The plug member may be releasable from the distal end of the carrier member, e.g., by cooperating connectors, and/or an actuator, or may be substantially permanently attached to the carrier member. The plug member includes a second lumen extending therethrough that communicates with the first lumen, and may include a sealing member disposed in the second lumen for substantially sealing the second lumen from fluid flow therethrough. The plug member may include a substantially smooth outer surface, or may include a helical thread on its outer surface. Preferably, the plug member has a cross-section larger than a cross-section of the carrier member, e.g., to minimize dilation of a passage through which the carrier member is inserted.
The guide member is slidable into the first and second lumens such that edges of the groove substantially engage walls of the first and second lumens to define a bleed back lumen.
In accordance with another aspect of the present invention, a method is provided for sealing a passage through tissue communicating with a body lumen, e.g., a puncture communicating with a blood vessel. The passage may be used to access the body lumen, e.g., to perform an endovascular procedure within the patient's body. Upon completion of the procedure, any instruments received through the passage may be removed, although an introducer sheath and/or guidewire may remain in place through the passage into the vessel.
An elongate member including a groove extending between its proximal and distal portions may be inserted into the passage, e.g., through the introducer sheath or over the guidewire, until the distal portion enters the body lumen. The introducer sheath may be removed (if used), and a plug member disposed on a carrier member may be advanced over the elongate member with the elongate member received in a lumen of the plug member such that the groove and the lumen together define a bleed back lumen. The plug member may include an external thread, and consequently the carrier member may be rotated to thread the plug member into the passage.
When the plug member enters the body lumen, fluid from the body lumen may enter the bleed back lumen to identify the location of the body lumen with respect to the plug member. In one embodiment, a first fluid flow rate through the groove may be detected when the distal portion of the elongate member initially enters the body lumen (before insertion of the plug member and carrier member), and a second greater fluid flow rate through the bleed back lumen may be detected when the plug member begins to enter the body lumen.
The plug member may be released from the carrier member within the passage, and the carrier member and/or guide member may be removed from the plug member. The plug member may include a sealing member for sealing the lumen upon removal of the guide member. Preferably, the plug member is formed at least partially from bioabsorbable material, and is left within the passage until it is absorbed by the tissue.
In accordance with yet another aspect of the present invention, an apparatus is provided for sealing a passage through tissue communicating with a body lumen. The apparatus includes a plug member including a distal end and a proximal end. The plug member may include a tapered portion terminating in the distal end, and a helical thread pattern on an outer surface of the plug member. The plug member may also include a lumen extending from the proximal end to a location proximal to the distal end.
The plug member may be continuously tapered from the proximal end to the distal end, preferably having a frustoconical shape, defining substantially blunt distal end. The lumen may communicate with a distal port that may be disposed on the distal end or offset proximally from the distal end by a predetermined distance.
The apparatus may also include a carrier member or handle device including proximal and distal ends, the plug member being coupled to the distal end of the carrier member. The carrier member may include a lumen extending between the proximal and distal ends that communicates with the lumen in the plug member. The plug member may be formed from bioabsorbable material, and/or may be releasable from the distal end of the carrier member, similar to the embodiment described above.
Other objects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.
Turning now to the drawings,
The plug member 12 is a substantially rigid body, preferably having a generally cylindrical shape, including a proximal end 20, a distal end 22, and an outer surface 30. The plug member 12 includes a lumen 24 that extends between a proximal opening 26 and a distal opening or port 28.
The plug member 12 may be formed from a biocompatible material, e.g., a plastic, such as polyethylene or polyester. Preferably, the plug member 12 is formed at least partially (and more preferably entirely) from bioabsorbable material, such as collagen, polyglycolic acids (PGA's), polyactides (PLA's), and the like, that may be at least partially absorbed by the patient's body over time. Alternatively, the plug member 12 may be a semi-rigid or flexible body or may have a substantially flexible distal tip (not shown), e.g., to facilitate atraumatic insertion of the plug member 12 into the passage. In addition or alternatively, the plug member 12 may be tapered along its length, and/or the distal end 22 may be rebound to facilitate advancement of the plug member 12 into a passage through tissue.
Preferably, the plug member 12 has a length of not more than about ten millimeters (10 mm), and more preferably about one and ten millimeters (1–10 mm). The plug member 12 also preferably has a diameter of between about one and twenty millimeters (1–20 mm). In addition, the length and diameter may have a ratio that is not more than about two-to-one.
In one embodiment, shown in
Returning to
In addition or alternatively, the plug member 12 may include a cavity (not shown) in the distal end 22. A material (also not shown) may be provided in the cavity, such as extra-cellular matrix material, e.g., intestinal, stomach, or bladder submucosa, collagen, an infection-resistant material, and the like, that may promote hemostasis and/or healing of the tissue. Alternatively, such material may be otherwise detachably secured to the distal end 22 of the plug member 12, either within a cavity or across the distal end 22 without a cavity. For example, the material may be secured using a biodegradable adhesive or a mechanical fastener, such as one or more clips (not shown).
Returning to
Preferably, the carrier member 14 is substantially rigid tubular member, formed from a biocompatible material, e.g., plastic, such as polyethylene or polyester, or metal, such as stainless steel. The carrier member 14 preferably has a cross-section that is substantially smaller than a cross-section of the plug member 12, e.g., to minimize dilation of a passage into which the apparatus 10 is inserted. In the preferred embodiment shown, the carrier member 14 may include a lateral proximal portion 52 through which the lumen 40 extends and communicates with a proximal port 54. The proximal port 54 may be connected to a valve or other device (not shown) for facilitating visual observation of fluid exiting the proximal port 54, as will be appreciated by those skilled in the art.
At least one of the plug member 12 and the distal end 36 of the carrier member 14 includes a connector. Preferably, the plug member 12 and the distal end 36 of the carrier member 14 include cooperating connectors (not shown) for releasably securing the plug member 12 to the carrier member 14, as described in application Ser. No. 09/738,431, incorporated above. Preferably, the cooperating connectors substantially couple the plug member 12 to the carrier member 14 such that the plug member 12 cannot move independently of the carrier member 14, e.g., such that the plug member 12 may be rotated only by rotating the carrier member 14.
Preferably, the handle 42 includes an actuator 43 that may be activated to release the connector(s) securing the plug member 12 to the distal end 36 of the carrier member 14. For example, the actuator 43 may include a button coupled to a control rod or wire (not shown) that extends through the carrier member 14 to the distal end 36. Upon depression of the button, the control rod may be moved, thereby disengaging the connector on the carrier member 14 from the plug member 12 or a mating connector (not shown) on the plug member 12. In another alternative, the distal end 36 of the carrier member 14 and the plug member 12 may include mating threads (not shown) such that the carrier member 14 may be rotated with respect to the plug member 12 to release the plug member 12. In this embodiment, the mating threads should wind helically in the same direction as the thread pattern 18 on the plug member 12 to ensure that the plug member 12 is not released prematurely from the carrier member 14.
The guide member 16 is an elongate member, e.g., formed from flexible or semi-rigid material, having a proximal end 44 and a substantially atraumatic and/or flexible distal tip 46, e.g., having a size for insertion into a passage through tissue into a blood vessel or other body lumen (not shown). An elongate groove 48 defined by opposing edges 49 is provided in an external surface 50 that extends from the proximal end 44 to the distal tip 46. Alternatively, the groove 48 may terminate before to the distal tip 46, e.g., a predetermined distance proximal to the distal tip 46 (not shown).
The guide member 16 has a size and shape for slidable insertion through the lumen 48 of the carrier member 14 and through the lumen 24 of the plug member 12. During use, the guide member 16 may be inserted through the carrier member 14 such that the distal tip 46 of the guide member 16 extends beyond the distal end 22 of the plug member 12, as shown in
Preferably, as shown in
In alternative embodiments, shown in
Turning to
Upon completion of the procedure, any instruments, such as an introducer sheath (not shown), may be removed from the vessel 90 and puncture 92. If a guidewire 102 is used during the procedure, the guidewire 102 may be removed before delivering the plug member 12. Alternatively, however, the guidewire 102 may be used to guide the plug member 12 into position, as described below. In a further alternative, an introducer sheath (not shown), such as that used to previously introduce instruments into the vessel 90 may be left in place, and the guidewire 102 may removed.
Initially, the guide member 16 is introduced into the puncture 92, for example, by inserting the distal tip 46 of the guide member 16 into the puncture 92 and advancing the distal tip 46 until it enters the vessel 90, as shown in
As the distal tip 36 enters the vessel 90 (e.g., over the guidewire 102 or through an introducer sheath), capillary action may cause a relatively small amount of blood, represented by v1, to travel proximally along the groove 48 to the proximal end 44 of the guide member 16. Because the groove 48 does not provide a substantially enclosed lumen, however, much (and preferably most) of the blood entering the puncture 92 may be dispersed within subcutaneous tissue, e.g., adjacent to the wall 98 of the vessel 90, as represented by v2, and not travel to the proximal end 44 of the guide member 16. If a guidewire and/or an introducer sheath is used to direct the guide member 16 into the vessel 90, they may be removed once the distal tip 36 is positioned within the vessel 90.
The plug member 12 may then be advanced over the guide member 16 into the puncture 92, as shown in
Preferably, the lumens 24, 40 in the plug member 12 and/or the carrier member 14 have a cross-section, e.g., diameter, similar to that of the guide member 16 such that the groove 48 and the lumens 24, 40 define a bleed back lumen 51, as described above. Thus, as the plug member 12 is advanced over the guide member 16, the bleed back lumen 51 is also advanced distally.
If the plug member 12 includes a thread pattern 18 (as shown in
One advantage of providing an external thread on the plug member 12 is that the thread pattern 18 may facilitate advancement of the plug member 12 through layers of tissue (not shown) towards the vessel 90. For example, the tissue 96 may include one or more intermediate layers of fascia or other tissue structures disposed between layers of fat (also not shown). The fascia layer may be relatively thin, yet resilient and tough, and therefore it may be difficult to advance a device axially through the layer without deflecting the layer towards the vessel 90.
When the plug member 12 is advanced through the wall 98 of the vessel 90, as shown in
If desired, the carrier member 14 may then be withdrawn partially to move the plug member 12 to a predetermined deployment depth, e.g., offset proximally from the wall 98 of the vessel 90. For example, bleed back may occur when the plug member 12 is within or in close proximity to the vessel 90, as shown in
Once the desired deployment location is attained, the plug member 12 may be released from the carrier member 14, e.g., by depressing actuator 43. The guide member 16 may be withdrawn from the plug member 12 and carrier member 14 either before or after releasing the plug member 12. The sealing member 32 preferably substantially seals the lumen 24 within the plug member 12 thereafter to prevent fluid within the vessel 90 from passing therethrough to leak from the puncture 92.
For example, as explained above, the sealing member 32 may include a material that expands when exposed to fluid. As the guide member 16 is withdrawn, fluid, e.g., blood, may flow proximally through the lumen 24 in the plug member 12, e.g., until it encounters the sealing member 32. Although a relatively small amount of fluid may pass beyond the sealing member 32, the sealing member 32 may expand relatively quickly due to the fluid contact until it substantially seals the lumen 24. Alternatively, the sealing member 32 may be a valve that may automatically open to accommodate the guide member 16, but may automatically close upon withdrawal of the guide member 16. In a further alternative, the sealing member 32 may be manually actuated by the user.
Finally, as shown in
Turning to
In addition, the plug member 112 includes a lumen 124 that extends between a proximal opening 126 and a distal opening 128 generally parallel to a longitudinal axis 138. An inner lip 125 is provided within the lumen 124, e.g., adjacent the distal end 122 of the plug member 112, which may be a continuous annular ridge or a plurality of tabs.
A sealing member 132 is disposed within the lumen 124 in an open position (shown in
The handle device 114 includes an outer carrier tube 134, and an inner delivery tube 136, the inner tube 136 being coaxially and/or slidably disposed within the outer tube 134. The handle device 114 may include a handle and/or actuator (not shown) on a proximal end of the handle device 114 for manipulating the handle device 114 and/or for controlling movement of the inner tube 136 relative to the outer tube 134. A distal end 140 of the outer tube 134 may be received in an annular recess 127 to couple the plug member 112 to the handle device 114. The distal end 140 may frictionally engage a wall of the recess 127, e.g., providing a desired resistance to removing the distal end 140 from the recess 127. In addition or alternatively, the distal end 140 and/or the plug member 112 may include one or more detects or connectors (not shown), similar to the embodiment described above.
A distal end 142 of the inner tube 136 preferably has a size for being slidably received within the lumen 124 and substantially abutting the sealing member 132. The inner tube 136 preferably includes a lumen 144 that communicates with the lumen 124. Thus, the lumens 144, 124 may provide a lumen for receiving a guide member (not shown), such as that shown and described in connection with
Use of the apparatus 110 proceeds similar to the previous embodiment, except that the sealing member 132 is manually activated, rather than being activated automatically upon fluid contact. The apparatus 110 is assembled by inserting the distal end 140 of the outer tube 134 into the recess 127 and the distal end 142 of the inner tube 136 into the lumen 124, as shown in
The plug member 112 is inserted into the passage over the guide member until the distal end 122 of the plug member 112 enters the vessel. As the plug member 112 enters the vessel, a bleed back lumen defined by a groove (not shown) in the guide member and the wall of the lumen 124 becomes exposed to the interior of the vessel, causing fluid to flow into the bleed back lumen to a proximal outlet port or other bleed back indicator (not shown) on the handle device 114.
The inner tube 136 may then be advanced distally relative to the outer tube 134, thereby engaging the sealing member 132 and forcing it distally against the inner lip 125. Because of its inherent flexibility and/or because of its coil shape, the sealing member 132 may compress and/or become crushed, wedging the sealing member 132 within the lumen 124 and sealing the lumen 124 from fluid flow therethrough, as shown in
The plug member 112 may be released from the handle device 114, e.g., by withdrawing the outer tube 136 and/or by releasing connectors securing the plug member 112 to the distal end 140 of the outer tube 134. The handle device 114 may then be withdrawn form the passage, leaving the plug member 112 in place, similar to the embodiment described above.
Turning to
In addition, the plug member 212 includes a lumen 224, and may include a sealing member 232 disposed within the lumen 224, similar to the embodiments described above. The lumen 224 communicates with a distal port 228 that is located on or adjacent the distal end 222 of the plug member 212.
A helical thread pattern 218 extends along an outer surface 230 of the plug member 212 at least partially between the proximal and distal ends 220, 222. Alternatively, the outer surface 230 may be substantially smooth or may include gripping elements for allowing distal advancement but preventing proximal withdrawal of the plug member 212 from within a passage through tissue, similar to the embodiments described above.
The handle device 214 is an elongate member having a proximal end 234, a distal end 236, and a lumen 240 extending therebetween. Preferably, the plug member 212 and the handle device 214 include cooperating elements (not shown) for coupling the plug member 212 to the handle device 214, i.e., to prevent rotation of the plug member 212 relative to the handle device 214. For example, cooperating connectors (not shown) may be provided for releasably securing the plug member 212 to the distal end 236 of the handle device 214, similar to the embodiment described above. If the plug member 212 has an internal sealing member (not shown), the handle device 214 may include an internal member, e.g., inner tube (also not shown), for wedging or otherwise activating the sealing member.
Turning to
As shown in
As shown in
The plug member 212 may then be released from the handle device 214, e.g., by activating an actuator (not shown, see
Alternatively, after bleed back indicates that the distal end 22 is located within the vessel 90, rotation of the handle device 214 may be reversed, i.e., in a second direction opposite the first direction, to withdraw the plug member 212 a predetermined distance relative to the vessel 90. Once the desired deployment location is attained, the plug member 212 may be released from the handle device 214. The handle device 214 may be withdrawn, leaving the plug member 212 in place to substantially seal the passage 92.
As fluid flows through the lumen 224, the sealing member 232 may expand to substantially seal the lumen 224 to prevent further fluid within the vessel 90 from passing therethrough to leak from the puncture 92. Alternatively, the lumen 224 may be sufficiently small that the sealing member 232 may be eliminated, and may seal as hemostasis occurs. In a further alternative, the sealing member 132 may be manually wedged or otherwise closed to seal the lumen 124.
If the plug member 212 is bioabsorbable, it may remain within the puncture 92 as the tissue heals, thereby allowing the wall 98 of the vessel 90 and tissue 96 surrounding the passage 92 to at least partially heal before the plug member 112 is absorbed. Alternatively, the plug member 212 may be retrieved once the tissue between the plug member 212 and the vessel 90 has substantially healed.
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.
This application is a continuation of application Ser. No. 09/931,676, filed Aug. 15, 2001 now U.S. Pat. No. 6,623,509, which is a continuation-in-part of application Ser. No. 09/866,548, filed May 25, 2001 now U.S. Pat. No. 6,663,655, which is a continuation-in-part of application Ser. No. 09/738,431, filed Dec. 14, 2000 now U.S. Pat. No. 6,846,319, the disclosures of which are expressly incorporated herein by reference.
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| Number | Date | Country | |
|---|---|---|---|
| 20030195560 A1 | Oct 2003 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 09931676 | Aug 2001 | US |
| Child | 10423133 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 09866548 | May 2001 | US |
| Child | 09931676 | US | |
| Parent | 09738431 | Dec 2000 | US |
| Child | 09866548 | US |
