Balloon occlusion device having a proximal valve
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.
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 INVENTIONThe 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 INVENTIONIn 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 INVENTIONIn 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 DRAWINGSThe 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:
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 to
If desired, at least one radiopaque marker 108 may be disposed at the distal end portion of the elongated body 105 proximate the balloon 120. Preferably, at least one radiopaque marker 108 is disposed within the distal end of the cavity defined by the balloon, and if desired, at least one proximal radiopaque marker 106 is disposed within the proximal end of the cavity defined by the balloon. The medical device 100 also may include a flexible tip 160. The flexible tip 160 may extend from the distal end portion 102 of the medical device 100.
In accordance with the present invention, the medical device 100 includes at its proximal end portion 104 a valve body 150, wherein the valve body 150 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. The medical device 100 will be described in greater detail below.
The elongated body 105 of the medical device 100 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 the elongated body 105 of the medical device 100 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 the elongated body 105 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. The elongated body 105 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, the elongated body 105 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.
The elongated body 105 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.
The elongated body 105 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 the medical device 100 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 to
As shown in
In accordance with another embodiment of the invention, referring now to
As previously noted, an inflatable balloon is provided at the distal end portion of the medical device of the present invention. The balloon 120 may be constructed of any suitable, flexible bio-compatible materials depending upon the intended function of the medical device 100. The balloon may be inelastic, if desired, although generally elastic materials are preferred. Examples of materials of which the balloon 120 may be formed are urethane, polyvinyl chloride, silicone or other similar materials which have good elastomeric properties. Preferably the balloon 120 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 to
Alternatively, the balloon 120 may be disposed asymmetrically upon only a portion of the outer wall circumference if desired. Furthermore, if desired, the proximal end of the balloon 120 may be disposed about the extreme distal end of the elongated body 105 as shown in
As shown in
As embodied in
The balloon 120 may be integrally formed onto the elongated body 105 adjacent to the distal end portion 102 of the elongated body 105 through dip forming, spray forming, extrusion, heat forming, or similar manufacturing processes. Preferably the balloon 120 is formed independent of the elongated body 105 by employing one of or a plurality of the processes above and then fixedly attached to the elongated body 105. Prior to affixing the balloon 120 to the elongated body 105, any coating applied to the elongated body 105 in the area where the balloon 120 is to be affixed is first removed if necessary. The balloon 120 is then positioned adjacent the distal end portion 102 such that the proximal end 124 and the distal end 122 of the balloon 120 extend beyond the apertures 107 formed in the elongated body 105. The balloon 120 may be fixedly attached to the elongated body with a bio-compatible adhesive such as Loctite® 4014. Heat shrink tubing 125 may be disposed about the proximal end 124 and the distal end 122 of the balloon to further affix the balloon 121 to the elongated body 105.
As shown in
A bio-compatible adhesive 112 may be applied to the edges of the heat shrink tubing 125 as shown in
It shall be understood that the balloon 120 may be disposed about the elongated body 105 at any distance along the distal end portion 102 of the elongated body 105, so long as the balloon is sealingly disposed in fluid communication with the lumen 101 of the elongated body 105.
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 the elongated body 105. 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 the elongated body 105, 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 to
The cavity 156 of the valve body 150 may further include a pliable coating to aid in the sealing of the valve body to the elongated body 105. The coating may be silicone, urethane, TFE. In a preferred embodiment the pliable coating is a parylene coating. The valve body 150 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 closed proximal end portion 154, such as a plug 158 disposed within the lumen 151 of the valve body 150. The plug 158 may be formed of the materials listed above. In a preferred embodiment the plug 158 may be formed of solder, wherein a solder, such as that described above may be utilized to form the plug 158.
Referring now to
In accordance with the present invention, referring now to
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 the proximal end 154 of the tube is sealed with a plug 158. The plug 158 may be constructed of a bio-compatible material such as titanium, Nitinol, stainless steel, nylon, delrin, and other similar materials. In a preferred embodiment the plug 158 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.
The valve body 150 defines a cavity 151 therein to receive the outer diameter of the elongated body 105. 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, the elongated body 105 of the medical device may include a reduced cross-sectional dimension at the proximal end portion 104 to enhance sealing properties and to create a low profile valve configuration, as shown in
If desired, the proximal end portion 104 of the elongated body 105 may have a closed or blind end, such as by providing a plug 103 disposed to seal the lumen 101 as shown in
Referring now to
Another alternative embodiment in accordance with the present invention is illustrated in
Referring now to FIGS. 7, 13-14, 18, and 19 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, and 19, the reduced diameter area may include a plurality of steps, wherein the first step 117 transitions the outer diameter of the elongated body 105 to a first reduced diameter section 115 as described above. A second step 118 may be disposed proximal to the first step 117, wherein the second step 118 provides a transition between the first reduced diameter portion 115 and a second reduced diameter portion 116.
The second step 118 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 in
Referring now to
In accordance with the present invention an opening is provided at the proximal end portion 104 of the elongated body 105, the opening being in fluid communication with the balloon 120 via the lumen 101 of the elongated body 105, 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 one opening 113 disposed through the wall of the elongated body 105 at the proximal end portion 104 thereof. Preferably, and when the proximal end portion 104 is provided with an area of reduced cross-section, the opening is located within the reduced diameter area 115 of the proximal end portion 104 of the elongated body 105.
In accordance with the present invention, the opening 113 may be formed in a variety of manners, some of which are illustrated in
Referring now to
Referring now to
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 to
Referring now to
Referring now to
The track 930 may be formed within the outer surface of the valve body 950 utilizing any of the processes as described above.
Referring now to
Referring now to
As shown in
The alternative embodiments of the medical device 900 and 800 illustrated in
The groove 830 formed within the proximal end portion 804 of the elongated body 805 may be formed utilizing any of the methods described above with reference to the medical device 100. Preferably the groove 830 is formed within the side wall of the elongated body through a crimping or dimpling process.
The medical device 100 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, the medical device 100 is inserted into the patient's vasculature.
Through the use of fluoroscopy and the soft steerable flexible tip 160 of the medical device 100, the medical device 100 is placed adjacent a site in which a medical procedure is to be performed. Placement of the medical device 100 can be confirmed by fluoroscopy confirmation of the plurality of marker bands 108/106 disposed upon the distal end portion 102 of the medical device 100. The balloon 120 may then be inflated by opening the valve body 150, wherein inflation fluid may be introduced through the openings 113 in the proximal end portion of the medical device 100, such as described by Teitelbaum, U.S. Pat. No. 5,807,330. After the balloon 120 is inflated to a sufficient diameter, the valve body 150 may be moved into a closed position thereby forming a fluid tight seal. The balloon 120 remains inflated, while the source of inflation fluid may then be removed from the proximal end portion 104 of the medical device 100. 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 the medical device 100 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 the balloon 120 under fluoroscopy.
At this point a balloon angioplasty catheter may be inserted over the medical device 100, wherein the balloon 120 acts to anchor the medical device 100 within the patient's vasculature as well as to occlude the vessel. If desired, the medical device 100 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 the medical device 100 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 the medical device 100 as described below.
Following the interventional procedure, the interventional device is removed from the medical device 100 and an aspiration catheter may be advanced over the medical device 100 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 the medical device 100, the valve body 150 is moved from a closed position to an open position wherein the inflation fluid may be removed, thereby deflating the balloon 120 of the medical device 100. At this time the medical device 100 may be withdrawn from the patient's vasculature. Alternatively, the medical device 100 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. The medical device 100 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
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)
Type: Application
Filed: Jul 26, 2005
Publication Date: Nov 24, 2005
Inventors: Lynn Crawford (Irvine, CA), Albert Burdulis (San Francisco, CA), Tim Reynolds (Sunnyvale, CA), Dan Shumer (San Jose, CA), Daryl Edmiston (West Jordan, UT), Steve Johnson (West Jordan, UT), Karri Schlegel (Salt Lake City, UT)
Application Number: 11/189,536