US20040122349A1 - Closure device with textured surface - Google Patents

Abstract

A closure device closes an opening in a body cavity. The closure device includes a closure member that has an external, tissue-engaging surface formed with tissue engaging surface irregularities. An elongate member is disconnectably connected to the closure member.

Description

BACKGROUND OF THE INVENTION
• The present invention relates to closing openings in a vessel or other body cavity. More specifically, the present invention relates to a closure device that quickly closes openings in body tissue by engaging the adventitia closely adjacent the wall of the body cavity.[0001]
• There are a wide variety of procedures which require gaining internal access to blood vessels or other body cavities. Many such procedures also require the insertion of treatment devices into the blood vessel or body cavity. Many of these procedures utilize accessible arteries as entry points for the treatment devices. For example, some such arteries include the femoral artery or subclavian artery. There are also a wide variety of procedures which gain access to other body cavities in a minimally invasive fashion.[0002]
• One problem which must be addressed during these procedures is how to seal or close the opening in the blood vessel or other body cavity once the treatment procedure has been completed. Some prior techniques include simply applying pressure to the opening until it seals itself sufficiently that the pressure may be released. However, this technique often requires that pressure must be consistently applied for an undesirable amount of time after the procedure. Similarly, this type of technique can require a patient's hospitalization to be extended until the treating physician is certain that the closure is complete.[0003]
• Other techniques have involved suturing the wall of the vessel or body cavity itself. This has typically required the physician to peel back a rather large portion of the tissue surrounding the puncture in order to gain sufficient access to the blood vessel or body cavity that it may be sutured adequately. This can be an undesirably time consuming procedure, and it can result in significant discomfort to the patient.[0004]
• Still other techniques have involved the insertion of embolic materials adjacent the puncture. Of course, this carries with it its own difficulties. For instances, it is desirable that the embolic material not be placed within a blood vessel or body cavity because this can result in an embolus forming within the blood vessel or body cavity. Similarly, however, it is desirable that the embolic material not be located to far proximal of the puncture because this can result in the blood vessel or body cavity bleeding into the interstitial space proximal of the opening in the blood vessel or body cavity, but distal to the embolic material.[0005]
• Similarly, when entry is gained into the lumen of the blood vessel by puncturing the blood vessel, the vessel may not have been punctured in a direction entirely orthogonal to the longitudinal axis of the blood vessel. Instead, the blood vessel may be punctured in a “side stick” fashion in which case the puncture is made in an off-center position. In such punctures, it is difficult to locate the outer wall of the blood vessel as well.[0006]
SUMMARY OF THE INVENTION
• A closure device closes an opening in a body cavity. The closure device includes a closure member that has an external, tissue-engaging surface formed with tissue engaging surface irregularities. An elongate member is disconnectably connected to the closure member.[0007]
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a side view of a portion of a blood vessel with an opening therein.[0008]
• FIGS.[0009]2A-2C illustrate one embodiment of closing the opening in the vessel shown in FIG. 1.
• FIG. 3 illustrates another embodiment for delivering a closure device.[0010]
• FIGS.[0011]4A-4C illustrate another embodiment for closing the opening shown in FIG. 1.
• FIG. 5 illustrates another embodiment of a closure device.[0012]
• FIGS.[0013]6A-6F illustrate the operation of the closure device shown in FIG. 5.
• FIG. 7 illustrates a closure plug in accordance with one embodiment of the present invention.[0014]
• FIGS.[0015]8A-8C illustrate the formation of another closure plug in accordance with one embodiment of the present invention.
• FIGS. 9A and 9B illustrate a closure operation using the closure plug shown in FIGS.[0016]8A-8C.
• FIGS.[0017]10A-10D illustrate a closure device in accordance with another embodiment of the present invention.
DETAILED DESCRIPTION OF THE ILLUSTRATIVE EMBODIMENTS
• FIG. 1 is a side view of a portion of a[0018]blood vessel10. While the present invention can be used with substantially any body cavity, a blood vessel is described herein for exemplary purposes only.Blood vessel10 has alumen12 defined by ablood vessel wall14.Blood vessel wall14 is shown as having anopening16 therein.Opening16 can be an opening which was made, for example, in order to perform a treatment procedure during which access tolumen12 is needed. FIG. 1 also illustrates an access tract or opening20 which was made when opening16 was made invessel10.
• Vessel[0019]wall14 is formed of media having an endothelium inner layer. The media is generally smooth muscular tissue. As is known, the media is surrounded byadventitia18 which includes fibrous collagen.
• FIG. 1A illustrates a closure apparatus in accordance with one embodiment of the present invention. FIG. 1A shows that[0020]closure apparatus22 includes anelongate delivery member24 and aclosure plug26.Elongate member24 is, illustratively, a catheter or wire having a hollow distal tip. Closureplug26 is made of a plugging material, such as collagen, or another suitable material, which has aproximal end28 and distal surface irregularities (or hooks)30.Hooks30 illustratively comprise annular rings or discrete hooks disposed about the exterior surface ofclosure plug26. Thehooks30 can form a regular pattern or be randomly located.Hooks30 are illustratively oriented such that they are atraumatic when traveling in one direction, such as the direction indicated byarrow32, and such that they grasp or grip surfaces which they engage when traveling in the opposite direction. In one embodiment, thehooks30 face proximally so they only grip when traveling proximally. In another embodiment,hooks30 are oriented randomly and are covered or encapsulated when traveling distally and are exposed when in a desired position or when moved proximally, so they only grip when traveling proximally.
• The[0021]proximal end28 ofplug26 is illustratively disconnectably connected to the distal end ofelongate member24. In one illustrative embodiment,proximal end28 ofplug26 is frictionally engaged within the distal hollow opening inelongate member24. In another embodiment, plug26 is attached through a disconnectable adhesive to the distal end ofelongate member24. In yet another embodiment, an active actuation mechanism can be used to disconnectplug26 fromelongate member24, or a frangible or other disconnectable connection can be used.
• [0022]Plug26 is illustratively formed of collagen or any other suitable plugging, biocompatible or bioabsorable material. Similarly, it may require rigidity, in some embodiments, during deployment. Therefore, if it is formed of collagen, it can illustratively be coated, using any suitable coating technique, by a coating which imparts rigidity for an initial 30-90 seconds, or so. However, after that time, the rigidity will illustratively give way to allow fluid to swellplug26. One such coating may be, for example, hydroxypropycelluouse, which is a water soluble polymer with favorable biocompatabiltiy properties.
• FIGS.[0023]2A-2C illustrate the use of closure plug26 in closingopening16 invessel10. As shown in FIG. 2A,closure apparatus22 is first inserted, in a distal direction shown byarrow34, throughaccess tract20. Because hooks orridges30 are atraumatic when traveling in the distal direction shown byarrow34, plug26 andelongate member24 slide easily throughtract20. Once inside thelumen12 ofvessel10,elongate member24 is retracted in the proximal direction opposite that ofarrow34. This is better illustrated in FIG. 2B.
• FIG. 2B shows that hooks[0024]30, when retracted in the proximal direction shown byarrow36, do not engage the relatively smooth media which formswall14 ofvessel10. However, when hooks30encounter adventitia18, they immediately become securely lodged intract20. In the embodiment shown, thehooks30 become snagged and entangled inadventitia18. However, other means of becoming securely lodged are contemplated as well, such as frictionally engagement of the surface irregularity and not simply entanglement. Becauseadventitia18 lies immediately proximal ofmedia14, plug26 becomes entangled, in place, immediately proximal ofopening16. This placement is highly desired.
• FIG. 2C illustrates that[0025]elongate member24 is further withdrawn in the proximal direction shown byarrow36. However, because thehooks30 ofplug26 have become securely entangled in the strong fibrous collagen inadventitia18, the frictional engagement (or other disconectable engagement) betweenplug26 and the distal end ofelongate member24 comes loose, such thatplug26 is disengaged fromelongate member24. This leavesplug26 in place, where it became entangled, just proximal of opening16 inmedia14 ofvessel10.Elongate member24 is then simply withdrawn throughtract20.
• FIG. 3 illustrates another embodiment for deploying[0026]plug26. Instead of simply advancingelongate member24 and plug26 throughtract20, as shown in FIG. 2A,elongate member24 and plug26 are advanced distally intolumen12 ofvessel10 through an introducer sheath, such assheath40.Sheath40 may be a sheath specially formed to be used withapparatus22, or it can simply be the introducer sheath which was used in performing the treatment which required the formation ofaccess tract20. In any case, once plug26 is in place withinlumen12,introducer sheath40 is withdrawn proximally and the operation is completed as shown with respect to FIGS.2B-2C.
• FIGS.[0027]4A-4C illustrate yet another embodiment in which plug26 is used to close opening16 invessel10. In the embodiment shown in FIGS.4A-4C, instead ofelongate member24 being used to deployplug26, a core wire or other flexible wire orthread42 is used. In this embodiment, plug26 is advanced to withinlumen12 ofvessel10 through a delivery catheter (or through an introducer) designated asitem44 in FIG. 4A or it is advanced using a separate pusher, such as a catheter, not shown. In any case, once plug26 is inserted withinlumen12 ofvessel10, the items used for delivering it, other thanelongate wire42, are withdrawn proximally.
• FIG. 4B shows that[0028]wire42 is then withdrawn proximally in the direction indicated byarrow46. This causes proximal movement ofplug26, through theopening16 defined bymedia14. This also causes hooks orridges30 to engage adventitia18 and become entangled therein.
• In one embodiment,[0029]wire42 is connected to the distal end ofplug26 by a frangible connection which can simply be broken when enough force is applied to the connection point. Therefore, as shown in FIG. 4C, once plug26 becomes entangled inadventitia14, and proximally directed force is applied towire42, the connection point between the proximal end ofplug26 andwire42 is broken, leavingplug26 in place. Again, plug26 is placed just proximal of themedia14 which defines opening16 invessel10.Wire42 is then simply withdrawn proximally throughtract20.
• FIG. 5 illustrates another embodiment of a[0030]closure apparatus50 in accordance with one embodiment of the present invention.Apparatus50 includes adelivery sheath52, aclosure sheath54, and awire array56 which is disposed on a cone shapedseal member58.Elongate members52 and54 illustratively extend proximally all the way to a proximal region accessible by a user.Wire array56 includes a plurality ofindividual wires60, each of which have ahook62 on its distal end. Thewires60 inwire array56 extend proximally in either awire bundle70, or they are connected to asingle wire70 which extends proximally.Hooks62, like hooks orridges30 shown in the above Figures, are oriented such that, as they are advanced in the direction shown byarrow64, they are atraumatic. However, when withdrawn in the opposite direction, they hook or snag some tissues.Hooks62 can be formed of conventional hooks used with hook and loop fabric (one embodiment which is sold under the trade name VELCRO), or they can be other desired hooks as well.
• FIGS.[0031]6A-6F illustrate one embodiment in whichapparatus50 is used for closingopening60 invessel10.
• FIG. 6A shows[0032]vessel10 with anintroducer sheath80 inserted through opening16 invessel10. FIG. 6A also shows thatdelivery sheath52 has been advanced distally relative towire array56 such that thedistal end82 ofdelivery sheath52 is in engagement withhooks62. In this position,delivery sheath52 is advanced distally relative tointroducer sheath80 until the distal tip ofapparatus50 is withinlumen12 ofvessel10 as shown in FIG. 6A.
• FIG. 6B shows[0033]apparatus50 in the same position as that shown in FIG. 6A, except thatintroducer sheath80 has been withdrawn proximally. It can be seen that the sides of opening16, onceintroducer sheath80 is withdrawn, close in arounddelivery sheath52.
• FIG. 6C shows that, in a next step,[0034]apparatus50 is withdrawn proximally. In one embodiment,wire70 is simply withdrawn proximally. This causes hooks62 to withdrawdelivery sheath52 andelongate member54 in the proximal direction as well.Hooks62 readily pass through the generally smooth mediatissue forming opening16. However, once they encounter adventitia18, they become firmly entangled therein, as shown in FIG. 6C. The treating physician can easily tell thatapparatus50 is in this position because the resistance to further proximal movement ofwire70 becomes significant.
• [0035]Closure sheath54 is than advanced proximally overwire70,wire array56, andwires60, in the direction shown byarrow84. This causes flexible cone-shape seal58, andwires60, to collapse inwardly pullinghooks62 together. FIG. 6D showsclosure sheath54 advanced all the way proximally relative towire70, such that hooks62 are pulled closely adjacent to one another at the distal end ofclosure sheath54.Seal58 is shown collapsed withinclosure sheath52.
• In one embodiment, the proximal end of[0036]closure sheath54 is illustratively provided with a snap lock fitting. Therefore, whenclosure sheath54 is advanced a sufficient distance distally such that hooks62 are substantially closed and in the position shown in FIG. 6D, the snap lock engages so the user can readily tell this. Of course, any other relative measurement device can be used to indicate that thesheath54 is in the position shown in FIG. 6D as well.
• FIG. 6E shows that a plurality of closure plugs[0037]86 have been delivered to the closure site. One embodiment of a plurality of generally disc shaped closure plugs86 is shown in FIG. 7. The disc shaped plugs86 are illustratively, arranged generally coaxially and have acentral lumen88 defined therethrough. The plugs can be formed of collagen, absorbable gel, or any other material or substance suitable for closingopening16. FIG. 6E shows that plugs86 are illustratively mounted overclosure sheath54 and advanced distally thereover by advancing asecond delivery sheath90.Sheath90 has a distal end which is sized to engage the most proximal of disc-shaped plugs86. The disc-shapedplugs86 are advanced throughdelivery sheath52 by advancingdelivery sheath90 overclosure sheath54.Plugs86 are advanced to the position shown in FIG. 6E, just proximal ofopening16.
• Next,[0038]wire array56 is removed. This is better illustrated with respect to FIG. 6F. FIG. 6F shows thatclosure sheath54 is advanced further distally until it deforms hooks62 until they reside within the distal end ofclosure sheath54. Once in that position,wires70 andclosure sheath54 are withdrawn proximally, to the position shown in FIG. 6F relative tosecond delivery sheath90. At anytime during this process, and after delivery ofplugs86, thefirst delivery sheath52 can be withdrawn proximally.
• [0039]Delivery sheath90 can then be used to tampplugs86 firmly in place. Then, the entire system is withdrawn proximally, in any desired order.
• FIGS.[0040]8A-8C illustrate another embodiment of aplug92 which can be formed and used in accordance with the system shown in FIGS.6A-6F.Plug92 is formed of a sheet ofmaterial94 having a generally centrally locatedaperture96 therein.Sheet94 can be substantially any shape, but is shown in a generally circular shape for the sake of simplicity.Sheet94 is illustratively formed of a vascular occluding material such as that in the QuickSeal Arterial Closure System from Sub-Q, Inc. of San Clamente, Calif.Sheets94 are illustratively pliable material which can be bent and folded. Therefore,sheets94 are folded or twisted to a fully collapsed shape having a generally central lumen extending therethrough, as shown in FIGS. 8B and 8C. Instead of loading disc-shapedplugs86 overclosure sheath54, plugs94 are loaded thereover.
• FIGS. 9A and 9B illustrate delivery of a[0041]plug94 using the apparatus shown in FIGS.6A-6F.Plug94 is advanced overclosure sheath54 usingsheath90.Delivery sheath52 is then withdrawn proximally, andclosure sheath54 is advanced distally to retrieve hooks62. Then,closure sheath54 is withdrawn proximally andsheath90 is advanced distally to tamp inplace plug94. This is shown in FIG. 9B. Of course, a plurality ofplugs94 can be loaded ontoclosure sheath54 and delivered bysheath90, either one at a time, or multiple plugs at a single time, as desired.
• FIGS.[0042]10A-10D illustrate another embodiment of a closure device in accordance with the present invention. In FIG. 10A,delivery sheath52 is shown inserted within thelumen12 ofvessel10. A small bolus of inert gas, such as CO₂, is then injected intovessel10 through sheath52 (which can be attached to a source of the inert gas). This forms adry field100 of the inert gas within thelumen12 ofvessel10. Distal pressure onvessel10 may be used in order to better hold thegas bolus100 in place.
• FIG. 10B shows that a[0043]delivery apparatus102 is then inserted throughsheath52 intolumen12 ofvessel10.Delivery apparatus102 includes anelongate delivery sheath104 anelongate delivery member106, and liquid swellable plug or plugs108.Plugs108 are inserted throughsheath52 until swellable plugs108 are within thelumen12 and reside at the distal end ofsheath52. This can be ensured by proximal markings onsheaths52 and104, or using any other desired mechanism or method. Because swellable plugs108 are within a dry field formed bybolus100, they do not begin to swell or to occlude.
• FIG. 10C shows that[0044]sheath52, along withswellable plugs108, are then withdrawn proximally. As soon assheath52 and plugs108 are withdrawn proximally to a point outside ofvessel10, thegas bolus100 escapes fromvessel10. This produces a visual and audio feedback indicating thatsheath52 and plugs108 have just clearedvessel10.Sheath52 is then withdrawn further proximally. Once thegas bolus100 has vented, blood from withinvessel10 engages and wets swellable plugs108. Sheaths52 and104 and delivery member (or wire)106, are then withdrawn proximally as shown by FIG. 10B, leavingplugs108 in place in the desired position.
• Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.[0045]

Claims (41)

What is claimed is:

1. A closure device for closing an opening in a body cavity, comprising:

a closure member having an external, tissue engaging surface formed with fibrous tissue engaging surface irregularities; and

an elongate member disconnectably connected to the closure member.

2. The closure device ofclaim 1 wherein the surface irregularities are in a non-grasping orientation relative to movement of the closure member in a first direction.

3. The closure device ofclaim 2 wherein the surface irregularities are in a grasping orientation relative to movement of the closure member in a second direction, opposite the first direction.

4. The closure device ofclaim 3 wherein the surface irregularities are on a distal portion of the closure member.

5. The closure device ofclaim 4 wherein the elongate member is disconnectably connected to a proximal portion of the closure member.

6. The closure device ofclaim 5 wherein the elongate member is frictionally connected to the closure member.

7. The closure device ofclaim 5 wherein the elongate member is connected to the closure member with a frangible mechanical connection.

8. The closure device ofclaim 1 wherein the elongate member includes a hollow distal end sized to receive a portion of the closure member therein.

9. The closure device ofclaim 1 wherein the elongate member comprises a catheter.

10. The closure device ofclaim 1 wherein the elongate member comprises a wire.

11. The closure device ofclaim 3 wherein the surface irregularities comprise proximally facing hook portions.

12. The closure device ofclaim 11 wherein the hook portions comprise ridges extending about the surface of the closure member.

13. The closure device ofclaim 1 wherein the closure member comprises a substantially rigid material during delivery.

14. The closure device ofclaim 13 wherein the closure member comprises a swellable material.

15. The closure device ofclaim 14 wherein the swellable material is coated with a soluble coating that imparts rigidity prior to dissolution.

16. The closure device ofclaim 14 wherein the swellable material comprises collagen.

17. The closure device ofclaim 1 wherein the opening has fibrous tissue located proximally thereof and wherein the surface irregularities engage and become entangled in the fibrous tissue as the collapsible member is moved proximally relative thereto.

18. The closure device ofclaim 17 wherein the opening is defined by relatively smooth tissue and wherein the surface irregularities pass the relatively smooth tissue without becoming entangled therein when the closure member is moved proximal relative thereto.

19. A method for closing an opening in a body cavity having fluid therein, comprising:

establishing a dry field in the body cavity adjacent the opening;

inserting a liquid swellable material into the dry field;

withdrawing the liquid swellable material from the body cavity through the opening until the liquid swellable material engage fibrous tissue proximal of the opening; and

implanting the liquid swellable material outside the body cavity to close the opening.

20. A method ofclaim 19 and further comprising:

removing the dry field from the body cavity so liquid from the body cavity contacts and swells the swellable material.

21. A method ofclaim 20 wherein establishing a dry field comprises:

introducing an inert gas into the body cavity to establish a bolus of the gas adjacent the opening.

22. The method ofclaim 21 wherein introducing an inert gas comprises:

introducing a sheath into the body cavity through the opening; and

introducing the gas through the sheath.

23. The method ofclaim 22 wherein inserting a swellable material comprises:

inserting the swellable material with an elongate member through the sheath.

24. The method ofclaim 23 wherein removing the dry field comprises:

withdrawing the liquid swellable material and the sheath from the opening such that the gas vents from the body cavity through the opening.

25. A method of closing an opening in a body cavity, comprising:

advancing fibrous tissue engaging members distally through the opening into the body cavity;

withdrawing the fibrous tissue engaging members proximally through the opening to an engagement region where the fibrous tissue engaging members engage fibrous tissue proximal of the opening; and

placing a closure member at the engagement region.

26. The method ofclaim 25 wherein placing the closure member comprises:

advancing a swellable material to the engagement region; and

releasing the swellable material.

27. The method ofclaim 25 wherein the fibrous tissue engaging members are connected to an elongate member and wherein advancing the swellable material comprises:

advancing the swellable material over the elongate member to the engagement region.

28. The method ofclaim 27 wherein the swellable material comprises a plurality of disc shaped pieces having an aperture therein and wherein advancing the swellable material over the elongate member comprises:

advancing the swellable material over the elongate member such that the aperture receives the elongate member.

29. The method ofclaim 27 wherein the swellable material comprises a sheet of swellable material and wherein advancing the swellable material over the elongate member comprises:

folding the sheet to form a generally cylindrical member having an aperture defined therethrough;

advancing the folded sheet over the elongate member such that the aperture receives the elongate member.

30. The method ofclaim 27 wherein the fibrous tissue engaging members comprise hooks, and further comprising:

prior to advancing the swellable material, moving the hooks toward one another to reduce a size of the opening.

31. The method ofclaim 30 wherein the hooks are supported in a spread configuration by a collapsible member and wherein moving the hooks comprises:

sliding a closing sheath over the collapsible member to collapse the collapsible member.

32. The method ofclaim 31 and further comprising:

after advancing the swellable material, advancing the closure sheath distally to receive the hooks therein; and

withdrawing the hooks in the closure sheath proximally.

33. A closure apparatus for closing an opening in a body cavity, comprising:

a plurality of fibrous tissue engaging members coupled to a proximally extending elongate member, the fibrous tissue engaging members being movable between an expanded position and a collapsed position;

a closure sheath sized to receive the elongate member and slidable thereover to move the fibrous tissue engaging members from the expanded position to the collapsed position;

a delivery sheath sized to receive the closure sheath and having a distal end sized to engage the fibrous tissue engaging members when in the expanded position; and

a closure member having an aperture defined therein sized to receive the closure sheath.

34. The closure apparatus ofclaim 33 wherein the closure member comprises:

a generally disc shaped member having the aperture defined therein.

35. The closure apparatus ofclaim 34 wherein the generally disc shaped member comprises:

a plurality of disc shaped pieces each having an aperture defined therein and being arranged in a generally coaxial orientation.

36. The closure apparatus ofclaim 33 wherein the closure member comprises:

a sheet of pliable, swellable material folded into a generally tubular shape having the aperture defined therethrough.

37. The closure apparatus ofclaim 33 wherein the closure member comprises:

a plurality of sheets of pliable, swellable material, each folded into a generally tubular shape having the aperture defined therethrough.

38. The closure apparatus ofclaim 37 wherein the plurality of sheets are disposed over the closure sheath in a generally coaxial arrangement.

39. The closure apparatus ofclaim 33 wherein the fibrous tissue engaging members comprise:

a plurality of hook-shaped members.

40. The closure apparatus ofclaim 39 wherein the plurality of hook-shaped members are oriented to be proximally facing hook-shaped members.

41. The closure apparatus ofclaim 40 wherein the proximally facing hook-shaped members are sufficiently resilient to deform to be received within the closure sheath upon distal advancement of the closure sheath distally beyond the proximally facing hook-shaped members.

Images