US20050261725A1 - Balloon occlusion device having a proximal valve - Google Patents

Abstract

A medical device for vessel occlusion, the medical device including an elongated body having a distal end portion, a proximal end portion, and a lumen disposed therethrough, an balloon disposed at the distal end portion of the elongated body, the balloon in fluid communication with the lumen. An opening defined at the proximal end portion of the elongated body, the opening being in fluid communication with the balloon via the lumen, and a valve body moveably disposed at the proximal end portion of the elongated body, the valve body movable between a closed position and an open position, the valve body configured to engage a surface of the elongated body, distal to the opening, to seal the opening when the valve body is in the closed position.

Description

CLAIM OF PRIORITY
• The present application claims priority under 35 U.S.C. § 119 to U.S. Provisional Application Ser. No. 60/212,187 filed on Jun. 16, 2000, entitled “Angioplasty Catheter”, the entirety of which is incorporated by reference herewith.
1. FIELD OF THE INVENTION
• The present invention relates to medical devices, specifically a medical device having a low profile valve for selectively inflating and deflating an inflatable balloon disposed upon the medical device, wherein the valve allows passage of interventional devices over the medical device during use.
2. BACKGROUND OF THE INVENTION
• In order to perform many vascular procedures a guidewire is initially inserted into the patient's vasculature. The guidewire is generally inserted into the patient through an incision created in the patient's femoral artery. After the guidewire has been placed within the patient's vasculature, other interventional devices such as catheters may be passed over the guidewire. As used herein, the term “interventional device” is intended to include, but not be limited to, any known device capable of being inserted within the human vasculature for diagnosis, treatment or inspection thereof. Additionally the terms “catheter” and “guidewire” as utilized herein are intended to be interchangeable when referring to the medical device in accordance with the present invention.
• One difficulty associated with this procedure however is that the guidewire must be held in place while the interventional device is passed over the guidewire. It is possible that the guidewire may become dislodged from the position where it was initially placed, therefore when a interventional device is advanced over the guidewire it may not be advanced to the desired position.
• A common medical procedure where it is desirable to place a guidewire and then advance interventional devices over the guidewire are angioplasty and/or bypass procedures. In an angioplasty procedure, the guidewire may be advanced up to or through a blockage in a patient's vessel, wherein a catheter containing a stent or other interventional device is then passed over the guidewire to the occluded area.
• A common procedure performed on occluded or narrowed vessels is to place an angioplasty catheter having a balloon disposed on one end within the occluded region and expanding the balloon, thereby expanding the vessel. The balloon catheter is typically formed of a flexible material wherein the catheter includes radiopaque markings thereon in order to properly place the balloon within the desired region. The balloon catheter is placed within the patient's vasculature through a percutaneous access site such as the femoral artery. The balloon catheter is placed within the patient's vasculature by tracking the catheter over a guidewire which has been placed first. The guidewire enables a user to more easily track the flexible catheter into a proper position, wherein the balloon may be inflated to expand the vessel and/or occlusion therein.
• Another commonly utilized cardiovascular procedure is stenting. Stenting is a procedure wherein a expanding device is placed within an obstructed vessel in order to hold open or expand the constricted vessel. Stenting procedures are carried out in a manner similar to the balloon angioplasty procedure described above. Many times both procedures will be performed wherein the vessel may be first expanded with a balloon catheter and subsequently a stent will be deployed thereafter to maintain the expanded diameter of the vessel.
• During stenting and/or balloon angioplasty procedures there is the risk that plaque or other debris may be dislodged from the inner walls of the vessel. The plaque may be in the form of small particles which may be carried within the patient's blood stream and may lead to other complications such as embolism if the particles become lodged into a branch vessel or artery and restrict or prevent blood flow to that vessel or artery.
• Therefore it is desirable to provide a device which may be utilized during a medical procedure such as those described above wherein the device may be utilized to prevent dislodged particles from flowing into a patient's blood stream and potentially causing further blockage or a stroke. It is also desirable to provide a device which may be utilized to temporarily occlude a vessel distal an area where a surgical procedure is to be performed thereby providing a contained area for the surgeon to operate within.
• One such device has been disclosed in U.S. Pat. No. 5,807,330 to Teitelbaum, the entirety of which is incorporated by reference herewith. However, there remains a desire for an improved low profile valve for the device of Teitelbaum.
• A further object of the present invention therefore is to provide a medical device having a low profile valve means disposed on the proximal end portion, wherein the valve may be selectively opened and closed thereby enabling the inflation and deflation of a balloon disposed at the distal end portion of the device. Furthermore, the valve provides a sufficiently low profile area wherein other interventional devices may be passed over the medical device to conduct surgical procedures within the patient's vasculature.
• A further object of the present invention is to provide an medical device wherein an balloon disposed upon the distal end portion of the device may be selectively inflated or deflated through a valve means wherein the inflation device is removable from the valve means.
SUMMARY OF THE INVENTION
• In one aspect of the invention there is provided a medical device for vessel occlusion, the medical device including an elongated body having a distal end portion, a proximal end portion, and a lumen disposed therethrough. The medical device further includes an inflatable balloon disposed at the distal end portion of the elongated body, the balloon being in fluid communication with the lumen, and an opening defined at the proximal end portion of the elongated body, the opening being in fluid communication with the balloon via the lumen. A valve body is moveably disposed at the proximal end portion of the elongated body; the valve body being movable between a closed position and an open position. The valve body is configured to engage a surface of the elongated body, distal to the opening, to seal the opening when the valve body is in the closed position.
• In another aspect of the invention, there is provided a medical device for vessel occlusion. The medical device includes an elongated body having a distal end portion, a proximal end portion, and a lumen disposed therethrough. The medical device further includes an inflatable balloon disposed at the distal end portion of the elongated body, the balloon being in fluid communication with the lumen. An opening is defined at the proximal end portion of the elongated body, the opening being in fluid communication with the balloon via the lumen. A valve body is moveably disposed at the proximal end portion of the elongated body, the valve body being movable between a closed position and an open position. The valve body is configured to engage an outer surface of the elongated body to seal the opening when the valve body is in the closed position.
• In another aspect of the present invention there is provided a medical device for vessel occlusion, the medical device including an elongated body having a distal end portion, a proximal end portion, and a lumen disposed therethrough. The medical device further includes an inflatable balloon disposed at the distal end portion of the elongated body, the inflatable balloon being in fluid communication with the lumen. An opening is defined at the proximal end portion of the elongated body, the opening being in fluid communication with the balloon via the lumen. A valve body is moveably disposed at the proximal end portion of the elongated body, the valve body being movable between a closed position and an open position. The valve body is configured to engage an outer surface at the proximal end portion of the elongated body, distal to the opening, to seal the opening when the valve body is in the closed position. The valve body includes a side wall having a cavity defined therein to receive the proximal end portion of the elongated body, and an outer surface substantially flush with an outer surface of the distal end portion of the elongated body when in the closed position. At least one of the valve body and the elongated body has a projection extending therefrom for mating engagement with the other body to prevent inadvertent movement of the valve body at least when in the closed position.
DETAILED DESCRIPTION OF THE DRAWINGS
• The objects and advantages of the invention will become apparent from the following detailed description of preferred embodiments thereof in connection with the accompanying drawings in which like numerals designate like elements and in which:
• FIG. 1 is a side view of the medical device according to the present invention;
• FIG. 2 is a partial cross-sectional side view of one representative embodiment of the distal tip of the medical device according to the present invention;
• FIG. 2B is a partial cross-sectional side view of one representative embodiment of a removable distal tip according to the present invention;
• FIG. 3 is a partial cross-sectional side view of another representative embodiment of the distal tip of the medical device according to the present invention;
• FIG. 4 is a partial cross-sectional side view of yet another representative embodiment of the distal tip of the medical device according to the present invention;
• FIG. 5 is a partial cross-sectional side view of still another representative embodiment of the distal tip of the medical device according to the present invention;
• FIG. 6 is a partial cross-sectional side view of one representative embodiment of the proximal end portion of the medical device according to the present invention;
• FIG. 7 is a partial cross-sectional side view of another representative embodiment of the proximal end portion of the medical device according to the present invention;
• FIG. 8 is a partial cross-sectional side view of another representative alternative embodiment of the proximal end portion of the medical device according to the present invention;
• FIG. 9 is a cross-sectional side view of a representative embodiment of a valve body according to the present invention;
• FIG. 10 is a cross-sectional side view of a representative alternative embodiment of the valve body according to the present invention;
• FIG. 11 is a partial cross-sectional side view of a representative embodiment of the proximal end portion of the medical device according to the present invention illustrating the valve body disposed thereabout;
• FIG. 12 is a partial cross-sectional side view of the proximal end portion of the medical device according to the present invention showing the valve body in an opened position;
• FIG. 13 is a partial cross-sectional side view of an alternative representative embodiment of the proximal end portion of the medical device according to the present invention illustrating the valve body disposed thereabout;
• FIG. 14 is a partial cross-sectional side view of the alternative embodiment of the proximal end portion of the medical device according to the present invention showing the valve body in an opened position;
• FIG. 15 is a partial cross-sectional side view of another alternative embodiment of the proximal end portion of the medical device according to the present invention illustrating the valve body disposed thereabout;
• FIG. 16 is a partial cross-sectional side view of of the proximal end portion illustrating a plurality of apertures formed within the wall of the medical device;
• FIG. 17 is a partial cross-sectional side view of of the proximal end portion illustrating a skive formed within the wall of the medical device;
• FIG. 18 is a partial cross-sectional side view of an alternative embodiment of the proximal end portion of the medical device according to the present invention illustrating a plurality of elongated slots formed within the wall of the medical device;
• FIG. 19 is a partial cross-sectional side view of the alternative embodiment of the proximal end of the medical device according to the present invention illustrating a skive formed within the proximal end portion of the medical device;
• FIG. 20 is a partial side view of a representative alternative embodiment of the proximal end of the medical device according to the present invention;
• FIG. 21 is a cross-sectional end view of the alternative embodiment of the proximal end portion of the medical device shown inFIG. 20;
• FIG. 22 is a cross-sectional end view of the alternative embodiment of the proximal end portion of the medical device shown inFIG. 20;
• FIG. 23 is a partial side view of another representative alternative embodiment of the proximal end portion of the medical device according to the present invention;
• FIG. 24 is a partial cross-sectional side view of another representative alternative embodiment of the proximal end portion of the medical device according to the present invention;
• FIG. 25 is a partial cross-sectional side view of another representative alternative embodiment of the proximal end portion of the medical device according to the present invention;
• FIG. 26 is a partial cross-sectional top view of another representative alternative embodiment of the proximal end portion of the medical device according to the present invention;
• FIG. 27 is a partial cross-sectional side view an alternative embodiment of the valve body of the medical device according to the present invention;
• FIG. 28 is a partial cross-sectional top view of an alternative embodiment of the medical device according to the present invention;
• FIG. 29 is a partial cross-sectional side view of the alternative embodiment of the medical device as shown inFIG. 28;
• FIG. 30 is a cross-sectional end view taken about line A-A ofFIG. 29, of the alternative embodiment of the medical device ofFIG. 29;
• FIG. 31 is a partial side view of the valve body according toFIG. 28;
• FIG. 32 is a partial cross-sectional side view of the valve body ofFIG. 31 as disposed within the proximal end portion of the medical device ofFIG. 28; and
• FIG. 33 is a partial cross-sectional side view of an alternative embodiment of the proximal end portion and valve body in accordance with the present invention.
DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT
• In accordance with the present invention there is shown and described a medical device for vessel occlusion. The medical device includes an elongated body having a distal end portion, a proximal end portion, and a lumen disposed therethrough. A balloon is disposed at the distal end portion of the elongated body, the balloon being in fluid communication with the lumen. An opening is defined at the proximal end portion of the elongated body, the opening being in fluid communication with the balloon via the lumen. A valve is disposed at the proximal end portion of the elongated body, the valve including a valve body movable between a closed position and an open position. The valve body is configured to engage a surface of the elongated body, distal to the opening, to seal the opening when the valve body is in the closed position.
• Referring now toFIGS. 1, 2, and11, there is shown a representative embodiment of amedical device100 according to the present invention. Themedical device100 includes anelongated body105 having aproximal end portion104 and adistal end portion102 and at least onelumen101 disposed therethrough defining an inner cavity. Aninflatable balloon120 is disposed proximate thedistal end portion102, wherein the inner cavity of theballoon120 is in fluid communication with thelumen101 of themedical device100.
• If desired, at least oneradiopaque marker108 may be disposed at the distal end portion of theelongated body105 proximate theballoon120. Preferably, at least oneradiopaque marker108 is disposed within the distal end of the cavity defined by the balloon, and if desired, at least one proximalradiopaque marker106 is disposed within the proximal end of the cavity defined by the balloon. Themedical device100 also may include aflexible tip160. Theflexible tip160 may extend from thedistal end portion102 of themedical device100.
• In accordance with the present invention, themedical device100 includes at its proximal end portion104 avalve body150, wherein thevalve body150 is movable between a closed position and an open position; the valve body configured to engage a surface of the elongated body to seal the opening when the valve body is in the closed position. Themedical device100 will be described in greater detail below.
• Theelongated body105 of themedical device100 may be constructed of any suitable material including but not limited to polymide material, alloy materials, and metallic materials such as stainless steel hypodermic tubing which is available from MicroGroup® Inc., Medway, Md. Preferably theelongated body105 of themedical device100 is constructed of a nickel titanium alloy known as Nitinol. Materials such as these are available from various suppliers such as Memry Corp., Menlo Park, Calif. US. The above materials should not be considered limiting in any manner, it is contemplated that theelongated body105 may be constructed of any bio-compatible material. For example, the elongated body may be constructed of a polymer such as polymide tubing from HV Technologies, Inc. of Trenton, Ga. US. Theelongated body105 may be manufactured using well known techniques such as swaging, machining, grinding, electropolishing, EDM, heat forming, extruding, or by any other processes commonly used to shape and configure small metal or polymer components. Additionally, theelongated body105 may be constructed from polypropylene or urethane by an extrusion process using an extruder such as that available from Medical Extrusion Technologies, Inc. Murieta, Calif. US.
• Theelongated body105 may be further coated with any of a variety of materials to enhance performance if desired. For example possible coating materials include lubricious materials such as Teflon® available from DuPont De Nemours, Wilmington, Del. US, and hydrophobic materials such as silicone lubricant dispersion PN 4097, available from Applied Silicone Corp., Ventura, Calif. US, or a hydrophilic materials such as hydrogel available from Hydromer, Branchburg, N.J. US, or lubricious coatings such as those available from Hydro-Silk of Merritt Island, Fla., under the trade name TUA Systems.
• Theelongated body105 may have any suitable cross-sectional shape, including elliptical, polygon, or prismatic, although a circular cross-section generally is preferred. The cross-sectional dimension generally is between about 0.01 millimeters to about 1.0 millimeters, preferably between about 0.10 millimeters and about 0.50 millimeters, most preferably between about 0.250 millimeters and about 0.450 millimeters. Furthermore themedical device100 may have an overall length between about 180 centimeters and 400 centimeters, preferably between about 250 centimeters and about 350 centimeters, more preferably the medical device has a length between about 290 centimeters and about 310 centimeters, and most preferably about 300 centimeters.
• Referring now toFIG. 2 there is shown a partial cross-sectional side view of thedistal end portion102 of themedical device100. As shown inFIG. 2, aflexible tip160 may extend from thedistal end portion102 of theelongated body105. A variety of distal tip configurations are known an used in the art, each generally capable of performing particular functions. For example, and as embodied herein, theflexible tip160 is constructed of a solidinner core wire162 of type 304 stainless steel, wherein thesolid core162 is wrapped with abio-compatible wire164. Examples of abio-compatible wire164 which may be utilized include stainless steel, Nitinol, Titanium, Platinum, Iridium, and similar bio-compatible materials. In a preferred embodiment thebio-compatible wire164 is platinum wire. Platinum wire is preferably used because platinum wire is visible under fluoroscopy thereby enabling a surgeon to locate theflexible tip160 within a patient's body in use. By utilizing a solidinner core162 for theflexible tip160, the distal tip may include a pre-formed curve169 as shown inFIG. 2. The pre-formed curve169 in addition to ablunt tip167 form an atramatic tip thereby allowing themedical device100 to be inserted within a patient's vasculature. The pre-formed curve169 ensures that theblunt tip167 does not pierce the vessel/artery or organ through which themedical device100 is being advanced. It shall be understood that the pre-formed curve169 remains sufficiently pliable and elastic whereby an interventional device may be advanced over the outer diameter of themedical device100 such that the pre-formed curve169 will straighten and allow the medical device to pass over. Such tip designs are well known in the art.
• As shown inFIG. 2, theproximal end166 of theflexible tip160 as embodied herein is adapted to be received within thelumen101 of themedical device100. Theproximal end166 of theflexible tip160 may be secured within thelumen101 through the use of a bio-compatible adhesive, such as Locktite® 4014, or through mechanical fastening methods such as soldering or a friction fit. In a preferred embodiment, thedistal end portion102 of theelongated body105 is deformed about the diameter of thedistal end166 of theflexible tip160, thereby forming a fluid tight seal between thelumen101 and theflexible tip160.
• In accordance with another embodiment of the invention, referring now toFIG. 2B there is shown an alternative embodiment of theflexible tip160 as described above. As shown inFIG. 2B, theflexible tip160 may be constructed in the same or similar manner as that described above, wherein like reference numerals have been utilized to denote similar features. Theflexible tip160 ofFIG. 2B further includes aproximal end166, wherein theproximal end166 is adapted to be detachably received within thelumen101 of theelongated body105. In use, it is desirable to pre-prime themedical device100, that is to remove as much air as possible from thelumen101 as well as thechamber123 defined by theballoon120. Typically this is done by drawing a vacuum within thelumen101 andchamber123 and allowing a bio-compatible fluid such as saline or contrast to fill thelumen101 andchamber123 of themedical device100. Although most air is removed from the system, removal of 100% of the air typically may not be possible. By constructing themedical device100 with a removable tip as shown inFIGS. 2B and 4, a bio-compatible fluid may be flushed distally through thelumen101 and thechamber123 thereby forcing air out of these spaces. After the air has been forced through themedical device100, theflexible tip160 is attached to thedistal end portion102 of theelongated body105, wherein themedical device100 is ready for use.
• As previously noted, an inflatable balloon is provided at the distal end portion of the medical device of the present invention. Theballoon120 may be constructed of any suitable, flexible bio-compatible materials depending upon the intended function of themedical device100. The balloon may be inelastic, if desired, although generally elastic materials are preferred. Examples of materials of which theballoon120 may be formed are urethane, polyvinyl chloride, silicone or other similar materials which have good elastomeric properties. Preferably theballoon120 is constructed of C-Flex, which is available from Consolidated Polymer Technologies, Inc. of Largo, Fla., USA. The C-Flex material allows for the formation of a balloon having very specific durometers, thereby enabling the balloon to be specifically tuned to be responsive to a pre-determined force. For example, if a pressure of one atmosphere or about 14 psi is available to be applied to a balloon and it is desirable to inflate the balloon from a first diameter of 0.90 millimeters to a second diameter of about 6 millimeters, the durometer of the C-Flex may be adjusted thereby allowing for a balloon to be formed which will expand from the first diameter to the second desired diameter in response to the applied force.
• As embodied herein, specifically with reference toFIGS. 1 and 2, theballoon120 may be radially disposed at thedistal end portion102 of theelongated body105, wherein theballoon120 is in fluid communication with thelumen101 of theelongated body105 through at least oneaperture107 formed within the wall of theelongated body105. Theaperture107 may be formed having a generally cylindrical geometry or the aperture may be formed as an elongated slit within the wall of theelongated body105. Furthermore, it is contemplated that theaperture107 may be embodied having many different geometric shapes and the examples above and those which are shown in the Figures are merely exemplary.
• Alternatively, theballoon120 may be disposed asymmetrically upon only a portion of the outer wall circumference if desired. Furthermore, if desired, the proximal end of theballoon120 may be disposed about the extreme distal end of theelongated body105 as shown inFIG. 3, and as further depicted by U.S. Pat. No. 5,807,330, to George P. Teitelbaum, entitled “Angioplasty Catheter,” the entirety of which is hereby incorporated by reference.
• As shown inFIG. 3, thedistal end121 of theballoon120 may be attached to asupport member180, wherein thesupport member180 may be disposed within thelumen101 of theelongated body105. Thesupport member180 may extend beyond thedistal end121 of theballoon120, such that thedistal end182 of thesupport member180 functions in the manner as described above with reference to theflexible tip160. Inflation of theballoon120 as shown inFIG. 3 is accomplished through thedistal end portion102 andlumen101 of theelongated body105.
• As embodied inFIGS. 4 and 5, theballoon120 may be disposed about aballoon support member140, wherein theballoon support member140 is adapted to be received within thelumen101 of theelongated body105 as shown, or about the outer surface of theelongated body105. Theballoon120 as shown inFIGS. 4 and 5 is similar to that shown and described above with reference toFIGS. 1-3, wherein like numerals designate similar features. As shown inFIGS. 4 and 5, thechamber123 of the balloon is in fluid communication with thelumen101 through anaperture107′ formed in theballoon support member140, wherein the balloon support member may be constructed of the same material as that of theelongated body105. Alternatively, the balloon support member may be constructed of any one of the materials described above with reference to theelongated body105 and theballoon120.
• Theballoon120 may be integrally formed onto theelongated body105 adjacent to thedistal end portion102 of theelongated body105 through dip forming, spray forming, extrusion, heat forming, or similar manufacturing processes. Preferably theballoon120 is formed independent of theelongated body105 by employing one of or a plurality of the processes above and then fixedly attached to theelongated body105. Prior to affixing theballoon120 to theelongated body105, any coating applied to theelongated body105 in the area where theballoon120 is to be affixed is first removed if necessary. Theballoon120 is then positioned adjacent thedistal end portion102 such that theproximal end124 and thedistal end122 of theballoon120 extend beyond theapertures107 formed in theelongated body105. Theballoon120 may be fixedly attached to the elongated body with a bio-compatible adhesive such as Loctite® 4014. Heat shrinktubing125 may be disposed about theproximal end124 and thedistal end122 of the balloon to further affix theballoon121 to theelongated body105.
• As shown inFIGS. 2-5, adistal marker band108 and aproximal marker band106 may be disposed about the distal and proximal ends of theballoon120, wherein themarker bands106/108 may be constructed of a bio-compatible material such as stainless steel, titanium, silver, platinum, gold, radiopaque plastics, or similar materials which may be readily viewed under fluoroscopy. Preferably themarker bands106/108 are formed of gold. Themarker bands106/108 may be separate pieces which are fixedly attached to the diameter of the elongated body utilizing mechanical methods or adhesives. Preferably, the marker bands are integrally formed upon the diameter of the elongated body through the use of spray coating, electroplating or similar methods which will deposit the marker band material upon the elongated body. It shall be understood that additional marker bands may be disposed upon theelongated body105 at any distance along thedistal portion102.
• Abio-compatible adhesive112 may be applied to the edges of theheat shrink tubing125 as shown inFIGS. 2-5 in order to provide a smooth transition surface between theheat shrink tubing125 and the outer diameter of theelongated body105. An example of a bio-compatible adhesive which may be utilize is Loctite® 3311, an ultra-violet cured adhesive.
• It shall be understood that theballoon120 may be disposed about theelongated body105 at any distance along thedistal end portion102 of theelongated body105, so long as the balloon is sealingly disposed in fluid communication with thelumen101 of theelongated body105.
• As previously noted, and in accordance with the present invention the medical device also has a valve including a valve body configured to be moveably disposed at the proximal end portion of the elongated body. The valve body is movable between a closed position and an open position, wherein the valve body is configured to engage a surface of the elongated body, to seal the opening when the valve body is in the closed position.
• The valve body may be configured to be movable in either an axial or radial direction. In a preferred embodiment, the valve body can be moved axially between a sealed position and an opened position, and moved radially to engage or disengage a locking mechanism disposed upon the proximal end portion of the medical device.
• The valve body when in a closed position is preferably flush with the outer diameter of theelongated body105. By providing such a low profile valve body, interventional devices may be easily passed over the medical device. In an alternative embodiment, it is contemplated that the valve body may have a diameter greater than that of theelongated body105, so long as the outer diameter of the valve body is not so large as to inhibit the passage of interventional devices thereover.
• Referring now toFIG. 9, there is shown a preferred embodiment of thevalve body150 in accordance with one aspect of the present invention. Thevalve body150 includes aproximal end portion154 and adistal end portion152, and acavity156 formed therebetween. Thedistal end portion152 of the valve body is adapted to sealingly engage the outer diameter of the elongated body as shown inFIG. 11.
• Thecavity156 of thevalve body150 may further include a pliable coating to aid in the sealing of the valve body to theelongated body105. The coating may be silicone, urethane, TFE. In a preferred embodiment the pliable coating is a parylene coating. Thevalve body150 may be constructed of a bio-compatible material such as titanium, stainless steel, polyurethane, polyvinyl chloride, Nitinol, or similar materials, wherein the valve body further has a closedproximal end portion154, such as aplug158 disposed within thelumen151 of thevalve body150. Theplug158 may be formed of the materials listed above. In a preferred embodiment theplug158 may be formed of solder, wherein a solder, such as that described above may be utilized to form theplug158.
• Referring now toFIG. 10 there is shown another embodiment of thevalve body150 in accordance with the present invention. Thevalve body150 shown in FIG.10 may further include abeveled section156, wherein thebeveled section156 may be formed at an angle β between about 0 and about 90 degrees, preferably between about 30 and about 60 degrees, more preferably thebevel156 is formed having an angle of about 45 degrees. Thebevel156 is adapted to receive thestep117, as shown inFIG. 11, wherein the step may be formed adjacent theproximal end portion104 of theelongated body105, wherein thebevel156 and step117 form a fluid tight seal between thevalve body150 and theelongated body105.
• In accordance with the present invention, referring now toFIGS. 6, 9, and11 there are shown partial cross-sectional side views of a first representative embodiment of themedical device100. Theproximal end portion104 of themedical device100 is shown inFIGS. 6, 9, and11.FIGS. 9 and 11 illustrate a first representative embodiment of thevalve body150, wherein as shown inFIG. 11, thevalve body150 can be disposed about theproximal end portion104 of theelongated body105. Thevalve body150 includes an elongated body having aproximal end portion154 and adistal end portion152, wherein thedistal end portion152 is adapted to sealingly receive theelongated body105 of themedical device100, and the proximal end portion has a closed orblind end158. As embodied herein, thevalve body150 therefore is moved axially between an open position and a closed position as described in greater detail below.
• The valve body may be constructed of any suitable bio-compatible material such as titanium, Nitinol, polymide, and other bio-compatible plastics. In a preferred embodiment the valve body is constructed of a stainless steel tube, wherein theproximal end154 of the tube is sealed with aplug158. Theplug158 may be constructed of a bio-compatible material such as titanium, Nitinol, stainless steel, nylon, delrin, and other similar materials. In a preferred embodiment theplug158 is constructed of solder available from Kester of Des Plains, Ill., wherein the solder is preferably lead-free. It is further contemplated that the valve body may be constructed of a unitary body wherein the valve body may be injection molded and being constructed of plastics or metals.
• Thevalve body150 defines acavity151 therein to receive the outer diameter of theelongated body105. If cylindrical in shape, the valve body may have an inner diameter between about 0.10 millimeters and about 2.0 millimeters, preferably between about 0.25 millimeters and about 1.0 millimeters and most preferably between about 0.300 millimeters and about 0.500 millimeters. The valve body further has a wall thickness between about 0.001 millimeters and about 0.10 millimeters, preferably between about 0.025 millimeters and about 0.05 millimeters, most preferably between about. 0.03 millimeters and about 0.04 millimeters.
• In accordance with the present invention, theelongated body105 of the medical device may include a reduced cross-sectional dimension at theproximal end portion104 to enhance sealing properties and to create a low profile valve configuration, as shown inFIGS. 6 and 11. For example, with a circular cross-sectional profile, astep117 provides a transition between the reduceddiameter area115 and the diameter of theelongated body105. Thestep117 may be formed by grinding, molding, swaging, extruding, or other known techniques, and may be configured at any of a variety of angles, although the preferred angle α is between about 0 and about 90 degrees, preferably between about 30 and about 60 degrees and more preferably the angle is about 45 degrees. In this manner, the outer surface of the valve body is substantially flush with the outer surface of theelongated body105 distal to thestep117. It is further contemplated that thestep117 may be formed having a convex or concave radius (not shown). That is instead of being formed as a linear transition between the two diameters, thestep117 may form a gradual radius between the two diameters, the gradual radius embodied as either convex, concave or a combination thereof.
• If desired, theproximal end portion104 of theelongated body105 may have a closed or blind end, such as by providing aplug103 disposed to seal thelumen101 as shown inFIG. 6. The plug may be constructed of a bio-compatible material such as titanium, stainless steel, Nitinol, delrin, nylon, or similar materials. Theplug103 embodied herein is affixed within thelumen101 of the elongated body with a bio-compatible adhesive which will adhere to theplug103 and the inner wall of thelumen101. In a preferred embodiment, theplug103 is formed of solder such as that described above with regard to thevalve body150. Alternatively, theplug103 is not necessary because thedistal end152 of thevalve body150 sealingly contacts the outer diameter of theelongated body105 thereby creating hemostasis within themedical device100. It shall be understood that if theplug103 is not disposed within thelumen101 of theelongated body105, thevalve body150 must include theplug158 in order to form a fluid tight seal within theelongated body105.
• Referring now toFIGS. 11 and 12 there is shown themedical device100 in accordance with one aspect of the present invention in use. As shown inFIG. 11, thevalve body150 is disposed upon theproximal end portion104 of theelongated body105, wherein the valve body is in a closed position. Thedistal end152 of the valve body forms a fluid tight seal with thestep117 of theelongated body105. The fluid tight seal may be formed through an interference fit between thedistal tip152 of the valve body and thestep117 or altertnatively, as described herein the inner diameter of the valve body may include a parylene coating for enhanced sealing properties. Referring now toFIG. 12 there is shown thevalve body150 in an open configuration. Wherein, when thevalve body150 is in an open configuration, inflation fluid may be introduced into thelumen101 of theelongated body105 thereby inflating theballoon120 of thedistal tip portion102. Inflation fluid may be introduced in a manner such as that disclosed by Teitlebaum, U.S. Pat. No. 5,807,330. Alternatively, inflation fluid may be withdrawn from thelumen101, thereby deflating theballoon120. As shown inFIGS. 11 and 12, thevalve body150 may be selectively opened and closed in order to control the inflation and deflation of theballoon120. To move the valve body between an opened and closed position as shown an axial force or a radial force or a combination thereof may be applied to either or both thevalve body150 or theelongated body105. Additionally, thevalve body150 only need be moved between about 0.005 inches and about 1.0 inches, preferably between about 0.02 inches and about 0.75 inches, most preferably between about 0.05 inches and about 0.25 inches.
• Another alternative embodiment in accordance with the present invention is illustrated inFIG. 33, wherein there is shown amedical device100 having avalve body150 disposed upon theproximal end portion104 of the elongated body, wherein theplug158′ of the valve body forms a fluid tight seal with the veryproximal end137 of theelongated body105. Theplug158′ may further include a pliable coating as those described above in order to effectuate a better seal with theproximal end137 of theelongated body105. Furthermore, frictional interference between thechamber156 of the valve body and the outer diameter of theelongated body150 act to retain thevalve body150 upon theproximal end portion104 of theelongated body105. It shall be understood that themedical device100 embodied and described with reference toFIG. 33 may be adapted to include any other feature described herein in relation to other embodiments of themedical device100.
• Referring now to FIGS.7,13-14,18, and19 there is shown an alternative representative embodiment of the reduced diameter area according to the present invention. As shown in FIGS.7,13-14,18, and19, the reduced diameter area may include a plurality of steps, wherein thefirst step117 transitions the outer diameter of theelongated body105 to a first reduceddiameter section115 as described above. Asecond step118 may be disposed proximal to thefirst step117, wherein thesecond step118 provides a transition between the first reduceddiameter portion115 and a second reduceddiameter portion116.
• Thesecond step118 may be formed at an angle between about 0 and about 90 degrees, preferably between about 30 and about 60 degrees, more preferably between about 40 and about 50 degrees.
• As shown inFIGS. 13 and 14, thesecond step118 can provide improved inflation and deflation of the balloon when thevalve sleeve150 is moved proximally into an opened position. This is because, as the valve body is moved from a closed position to an opened position, thevalve body150 does not have to be moved past theopenings113 formed in the wall of theelongated body105. That is, once thedistal end152 of thevalve body150 passes proximal thesecond step118 as shown inFIG. 14, a fluid flow path is formed between the second reduced diameter portion and thecavity151 of thevalve body150. Indeed, by providing such a flow path, the extreme proximal end of the elongated body as shown inFIGS. 13 and 14, can be used to define an opening for inflation of the balloon such that additional openings need not be provided in the wall of theelongated body105.
• Referring now toFIGS. 8 and 15 there is shown yet another alternative embodiment of theproximal end portion104 of themedical device100 in accordance with the present invention. As shown inFIGS. 8 and 15, theproximal end portion104 of themedical device100 may include taperedsection515, which can be formed by known techniques, such as grinding, milling, EDM, laser cutting, or swagging. The embodiment herein defines a constant angle of between about 0 and about 45 degrees, preferably between about 0 and about 10 degrees, more preferably between about 0.5 and about 3 degrees. As shown inFIG. 15 avalve body150 is disposed about the taperedsection515, wherein thedistal end152 of the valve body contacts the outer surface of theelongated body105 thereby sealing theopenings113 when in a closed position. Thevalve body150 may be moved axially, whereby an annular space is created about thedistal end152 of thevalve body150 and the tapering outer diameter of theelongated body105, thereby allowing for fluid to flow from the annular space into thelumen101 and thechamber123 of the balloon.
• In accordance with the present invention an opening is provided at theproximal end portion104 of theelongated body105, the opening being in fluid communication with theballoon120 via thelumen101 of theelongated body105, wherein the opening may be embodied in a variety of configurations. As previously noted, the opening may be defined as the extreme proximal end of the elongated body. Alternatively, and as embodied herein, the opening may include at least oneopening113 disposed through the wall of theelongated body105 at theproximal end portion104 thereof. Preferably, and when theproximal end portion104 is provided with an area of reduced cross-section, the opening is located within the reduceddiameter area115 of theproximal end portion104 of theelongated body105.
• In accordance with the present invention, theopening113 may be formed in a variety of manners, some of which are illustrated inFIGS. 6-8, and11-32. As shown inFIGS. 6-8 and11-32, a plurality of openings may be formed through the wall of the reduceddiameter sections115 and116, wherein the openings are disposed along theproximal end portion104 of theelongated body105. Theopenings113 may be formed within the wall of the elongated body utilizing manufacturing processes such as laser drilling, EDM, drilling, milling, electrochemical milling, and other similar procedures that will produce an opening through the wall of theelongated body105.
• Referring now toFIGS. 16 and 18, there is shown a first alternative embodiment of theopening213 in accordance with the present invention, wherein like numerals denote similar features as described above with reference to themedical device100 of the present invention. Theopening213 may be embodied in the form of at least one axially extending slit formed within the wall of the reduceddiameter portion115 or second reduceddiameter portion116.
• Referring now toFIGS. 17, 19, and29 there is shown a second alternative embodiment of theopening313 in accordance with the present invention. Theopening313 may be embodied as a skive within the wall of thereduce diameter portion115 or second reduceddiameter portion116. The skive may be formed within the wall of theelongated body105 by passing a grinding wheel over the portion of the elongated body where theskive313 is to be formed.
• In accordance with the invention, there are provided additional alternative embodiments in accordance with the medical device of the present invention. As previously discussed, the medical device includes a proximal end portion and a valve body disposed thereon, wherein the valve body is movable between an open position and a closed position, in a closed position the valve body sealingly engages the outer wall of the elongated body. In an open position the valve body allows for the inflation or deflation of the balloon as previously discussed.
• Referring now toFIG. 24, theelongated body105 and thevalve body450 includes each of the elements described above and illustrated inFIG. 11. Additionally, theelongated body105 includes aslot413 formed within the wall of theelongated body105 wherein theslot413 is axially aligned with theelongated body105. Theslot413 may be formed partially into the outer wall, such as by a groove or dimple, or extend entirely through the wall of theelongated body105 as an opening. Thevalve body450 is disposed about theproximal end portion104 of theelongated body105 in the manner as described above. Thevalve body450 may further include aprotrusion455 extending into the cavity456 of the valve body. Theprotrusion455 is slidably received within theslot413 of theelongated body105. Theprotrusion455 therefore may retain thevalve body450 upon theproximal end104 of theelongated body105, and limit the proximal movement of the valve body. Theprotrusion455 also may further provide tactile feedback to a user indicating whether the valve body is in an opened or closed configuration. The protrusion may be formed as a separate body attached to thevalve body450, or the protrusion may be formed integral with thevalve body450. Alternatively, the reduced diameter section may include a protrusion, either integrally formed therewith or fixedly attached thereto and the valve body may include a slot or groove adapted to receive the protrusion of the reduced diameter section.
• Referring now toFIGS. 20-22, there is shown an alternative embodiment of thevalve body550 and reduceddiameter portion515. The reduceddiameter portion515 further includes agroove519, formed in the wall of theelongated body105. Thegroove519 may be formed in the wall of the elongated body by machining, grinding, EDM milling, or similar manufacturing processes. Alternatively, thegroove519 may be formed by deforming the wall of the elongated body as shown inFIG. 30. Thevalve body550 includes apin555 or similar protrusion extending into thecavity556. When thevalve body550 is disposed about thereduce diameter portion515, thepin555 is received within thegroove519, wherein thegroove519 guides thepin555 during translation of thevalve body550 between an opened position and a closed position. Thegroove519 may be axially aligned with thelumen101 of theelongated body105 as shown inFIGS. 20-22, or extend helically to induce rotational movement of the valve body during displacement. Alternatively, thegroove519′ may be both axially and radially aligned with thelumen101 of theelongated body105 as shown inFIG. 23. By having agroove519′ that is both axially and radially aligned requires that thevalve body550 be rotationally translated first and then axially translated in order to open the seal between the valve body and the elongated body. This greatly reduces or eliminates the possibility of thevalve body550 from being accidentally opened.
• Referring now toFIGS. 25-27 there is shown another alternative embodiment in accordance with the medical device of the present invention. Referring now toFIG. 25 there is shown a partial cross-sectional side view of an alternative embodiment of theproximal end portion904 of anelongated body905, wherein theproximal end portion904 further includes apin990 disposed axially through the walls andlumen901 of theproximal end portion904. Better understanding of the location of thepin990 may be understood with reference to the cross-sectional top view ofFIG. 26 illustrating thepin990 being disposed through theproximal end portion904 of theelongated body905 perpendicular to the top view. Referring now toFIG. 27, there is shown a corresponding embodiment of avalve body950, wherein thevalve body950 includes atrack930. The track provides a guide for positioning thevalve body950 when thegroove930 engages thepin990. Astep917 forms a tapered portion on the proximal end of thevalve body950, wherein then thevalve body990 is inserted within thelumen901 of theelongated body905 the tapered portion engages the inner diameter of the proximal end portion of the elongated body therefore forming a fluid tight seal. In order to effectuate a seal between the tapered portion of thevalve body950 and thelumen901 of theproximal end portion904 of theelongated body905 involves two movements, one axial movement and a second rotational force. The second rotational force requires that a deliberate action on the part of an operator to disengage the seal once the seal has been formed. The second action of the rotational force also makes it more difficult for the operator to inadvertently open the port by merely pulling axially on thevalve body950. Alternatively, thepin990 can extend beyond the outer surface of the elongated body, and the valve body can be configured to be disposed about the outside of the proximal end portion of the elongated body with the groove being formed on an inside surface of the valve body.
• Thetrack930 may be formed within the outer surface of thevalve body950 utilizing any of the processes as described above.
• Referring now toFIGS. 28-32, there is shown an additional alternative embodiment in accordance with the present invention. Referring toFIG. 28 there is shown partial cross-sectional top view of amedical device800, wherein themedical device800 includes anelongated body805 having a distal portion (not shown) and aproximal end portion804, wherein theproximal end portion804 includes at least one groove formed therein as shown inFIG. 30. Themedical device800 further includes anopening815 disposed adjacent to theproximal end portion804 of theelongated body805. As shown inFIG. 29, theopening815 may be formed as a skive. Although theopening815 is shown to be embodied as a skive this should not be considered limiting in any manner, it is contemplated that any of the openings described herein may be utilized in addition to or as an alternative to the skive. Theskive815 may be formed utilizing any of the methods described above.
• Referring now toFIG. 31 there is shown avalve body850, wherein the valve body includes aproximal end portion854 and adistal end portion852 and atapered portion817 disposed therebetween.
• As shown inFIGS. 28 and 32, thevalve body850 is disposed proximally within thelumen801 of themedical device800 when in the opened position, To close the medical device, thevalve body850 is advanced distally within thelumen801 of theelongated body805 until the taperedsection817 passes the distal portion of theopening815 and engages the inner surface of the proximal end portion of the elongated member. If desired, a groove and protrusion configuration also can be provided. In this manner, thevalve body850 is then rotated to lock thevalve body850 into place. Therefore, as described above with regard toFIGS. 25-27 the valve body cannot be inadvertently removed from theinner lumen801 of theelongated body805 without first applying a rotational force to thevalve body850.
• The alternative embodiments of themedical device900 and800 illustrated inFIGS. 25-32 may be constructed according to the aspects and methods described above wherein the same materials may also be utilized. In addition, thevalve bodies950 and850 may further include a coating such as that described above with regard toFIGS. 9 and 10 and thevalve body150 disclosed therein to effectuate a better seal upon themedical device900 and800.
• Thegroove830 formed within theproximal end portion804 of theelongated body805 may be formed utilizing any of the methods described above with reference to themedical device100. Preferably thegroove830 is formed within the side wall of the elongated body through a crimping or dimpling process.
• Themedical device100 descried and illustrated herein may be utilized in vascular interventional procedures such as angioplasty or stenting. In such procedures, an access site to the patient's vasculature is formed, typically within the patient's femoral artery. The patient is systematically heparinized during the procedure. Via the femoral artery approach, a long 9-French access sheath is inserted through the common femoral artery and is advanced into a desired position. Once access has been established, themedical device100 is inserted into the patient's vasculature.
• Through the use of fluoroscopy and the soft steerableflexible tip160 of themedical device100, themedical device100 is placed adjacent a site in which a medical procedure is to be performed. Placement of themedical device100 can be confirmed by fluoroscopy confirmation of the plurality ofmarker bands108/106 disposed upon thedistal end portion102 of themedical device100. Theballoon120 may then be inflated by opening thevalve body150, wherein inflation fluid may be introduced through theopenings113 in the proximal end portion of themedical device100, such as described by Teitelbaum, U.S. Pat. No. 5,807,330. After theballoon120 is inflated to a sufficient diameter, thevalve body150 may be moved into a closed position thereby forming a fluid tight seal. Theballoon120 remains inflated, while the source of inflation fluid may then be removed from theproximal end portion104 of themedical device100. An example of a device which may be utilized to introduce inflation fluid is a Tuohy-Borst device, wherein the Tuohy-Borst device may be removed from themedical device100 as desired. Alternatively, a removable inflator box may be provided, which is capable of creating a sealed chamber about the proximal end portion of the elongated member, and allowing selective movement of the valve body between the open and closed positions as known in the art. Examples of inflation fluid which may be utilized are saline or carbon dioxide, preferably contrast fluid is utilized as the inflation fluid thereby enabling visualization of theballoon120 under fluoroscopy.
• At this point a balloon angioplasty catheter may be inserted over themedical device100, wherein theballoon120 acts to anchor themedical device100 within the patient's vasculature as well as to occlude the vessel. If desired, themedical device100 may be utilized to pre-dilate the stenosis within the vessel is the appropriate balloon construction is provided. Alternatively, an angioplasty balloon catheter, and/or a stent delivery device and/or other known interventional devices may be advanced over themedical device100 to the site to perform a desired procedure as is known in the art. Debris thus created by the interventional device during an interventional procedure can be removed through an aspiration catheter which may be advanced over themedical device100 as described below.
• Following the interventional procedure, the interventional device is removed from themedical device100 and an aspiration catheter may be advanced over themedical device100 to a position near the site. Vigorous flushing of the site may be performed by injecting a large volume of saline into the site. Alternatively or additionally, debris may be removed distal the lesion through a lumen of an aspiration catheter by selectively positioning the aspiration catheter within the site.
• After debris has been removed from the site and the aspiration catheter is removed from themedical device100, thevalve body150 is moved from a closed position to an open position wherein the inflation fluid may be removed, thereby deflating theballoon120 of themedical device100. At this time themedical device100 may be withdrawn from the patient's vasculature. Alternatively, themedical device100 may remain as positioned, wherein additional interventional procedures may be performed at the site, wherein the site may be aspirated as described following any interventional procedure. Themedical device100 may remain as positioned as long as there is a need to perform additional interventional procedures.
• Although the present invention has been described in considerable detail with reference to certain preferred embodiments, it is contemplated that one skilled in the art may make modifications to the device herein without departing from the scope of the invention. Therefore, the scope of the amended claims should not be considered limited to the embodiments described herein.

Claims (2)

1. A medical device for vessel occlusion, the medical device comprising:

an elongated body having a distal end portion, a proximal end portion, and a lumen disposed therethrough;

an balloon disposed at the distal end portion of the elongated body, the balloon in fluid communication with the lumen;

an opening defined at the proximal end portion of the elongated body, the opening being in fluid communication with the balloon via the lumen; and

a valve body moveably disposed at the porixmal end portion of the elongated body, the valve body movable between a closed position and an open position, the valve body configured to engage a surface of the elongated body, distal to the opening, to seal the opening when the valve body is in the closed position.

2-20. (canceled)

Images