1. Field of the Invention
The present invention relates to medical procedures and devices. More particularly, the invention relates to a device and method for advancing a stent through a constricted lumen, such as a coronary artery, in a patient.
2. Description of the Related Art
Percutaneous transluminal coronary angioplasty, also referred to as PTCA, is a well-known, non-surgical treatment used for opening blocked arteries. This procedure is sometimes referred to as balloon angioplasty or balloon dilation. Angioplasty is typically performed in a cardiac catheterization lab, or “cath lab,” by a cardiologist and cardiology team. The procedure widens, or “dilates,” blocked arteries, and can help prevent the complications of atherosclerosis.
During angioplasty, a small needle is used to first puncture the femoral artery at the level of the patient's hip. Less commonly, access may be acquired using an artery in the arm or wrist area. The punctured artery is used as the point of entry to advance the equipment used to open blockages inside a coronary artery. To aid in maintaining access through the femoral artery, an introducer sheath is placed in the femoral artery. The introducer sheath is typically a short, tubular device that extends into and out of the epidermal puncture by several inches.
Next, a guidewire is inserted through the introducer sheath. The guidewire defines a thin, elongated wire. The guidewire includes a soft, flexible tip for navigating through vessels without insulting the inner vessel wall. The distal end of the guidewire is manipulated through the arterial system to reach the ascending of the aorta.
A guide catheter is next inserted into the sheath. The guide catheter defines an elongate tube radially dimensioned to be inserted from the femoral artery into the coronary artery. The guide catheter is run over the guidewire through the sheath. The guide catheter is further passed through the femoral artery until it reaches into the aorta. The distal end of the guide catheter rests at or near the opening of the artery under treatment.
A balloon catheter is next advanced over the guidewire and through the sheath. The balloon catheter is further advanced through the guide catheter and then beyond its distal end. The balloon catheter is still further advanced over the guidewire and placed adjacent a targeted area of treatment within the coronary artery. Once positioned, the balloon catheter is fully inflated at least once, and often several times, in order to expand the balloon against the inner wall of the vessel. Expansion of the balloon causes the arterial wall to stretch, and also flattens the deposits along the wall that are causing the blockage.
More recently, an additional procedure has been developed for use in clearing arterial blockages. This procedure involves the placement of a permanent stent along the balloon. The stent defines a small, expandable tubular device that is run into the artery around the balloon. When the balloon is inflated, the balloon radially expands the stent into frictional engagement with the surrounding inner wall of the vessel. The stent props open a clogged artery to enable fuller blood flow. The stent may also include medicaments for treatment of the vessel wall to decrease the chance of reblockage and development of scar tissue. When the balloon is contracted for removal from the artery, the stent is released from the balloon and remains in place within the coronary artery. The stent provides a more permanent way to clear arterial blockages.
It has been observed that in some patients it is difficult to advance the stent much beyond the distal end of the guide catheter. In this respect, coronary arteries sometimes develop calcium or other deposits of various thicknesses along a vessel wall. While a small buildup may not call for placement of an expensive stent, such a buildup may nevertheless impede the advancement of the stent to the point of more desired treatment. Alternatively, the tortuous geometry of a coronary artery may create a restriction in the advancement of the stent.
Therefore, a need exists for a procedure for advancing the stent through the partially constricted artery. A need also exists for a medical device that facilitates the advancement of the stent through a constricted lumen in a coronary artery, or through a previously placed coronary stent.
A method for advancing a stent through a constricted lumen of a patient is first provided. In one aspect, the method includes the step of running an access tube into the patient lumen. The access tube defines a tubular body having a distal end and a proximal end. A slip wire is connected to the access tube. The method further includes the steps of further advancing the access tube into a constricted portion of the lumen, running a stent into the lumen, advancing the stent into the proximal end of the access tube, and still further advancing the stent through the access tube, thereby providing passage of the stent through the constricted portion of the lumen.
In one embodiment, the method also comprises the steps of inserting a distal end of a coronary guidewire into the coronary artery of the patient; manipulating the guidewire so that the distal end of the guidewire is delivered beyond the targeted treatment area within the artery; and, advancing a distal end of a tubular guide catheter over the guidewire to a selected point within the patient lumen but short of the distal end of the guidewire. In this embodiment, the step of running an access tube into the patient lumen comprises placing the access tube over the guidewire and urging the slip wire through the tubular catheter, into the coronary artery, and into the constricted portion of the artery where difficulty in passing a stent was encountered.
A method for advancing a stent through a constricted artery of a human patient is also provided. The method includes the steps of inserting a guide catheter into the femoral artery of the patient; inserting the distal end of a coronary guidewire into the guide catheter; manipulating the guidewire through the guide catheter and into a coronary artery so that the distal end of the guidewire is positioned along and beyond a targeted treatment area within a coronary artery; inserting an access tube onto the guidewire, the access tube defining a tubular body having a distal end and a proximal end, with a slip wire connected to the access tube; urging the slip wire into the guide catheter so as to advance the distal end of the access tube over the guidewire and towards the distal end of the catheter; further advancing the access tube into a constricted portion of the coronary artery beyond the distal end of the catheter; placing an intravascular balloon and stent into the artery; advancing the stent through the catheter over the coronary guidewire; further advancing the stent into the proximal end of the access tube; and, still further advancing the stent through the access tube. In this way, passage of the stent through the constricted portion of the coronary artery is provided.
In one embodiment, the method further includes the steps of still further advancing the stent through the access tube; and then disposing the stent at a determined point of treatment within the coronary artery. The method may also include the steps of removing the guidewire from the femoral artery, actuating the stent so as to implant the stent at the determined point of treatment, and removing the slip wire and connected access tube from the coronary artery and the femoral artery.
Preferably, the access tube comprises an elongated tubular wall having a slit running substantially along a length of the access tube. The wall defines a bore within the access tube. The wall is fabricated from a hydrophilic material such as Nitinol™ material or the like. The access tube receives the guidewire and the stent through the bore.
In another embodiment, a method for inflating a stent in a coronary artery of a human patient is provided. The method comprises the steps of running an access tube into the coronary artery, locating the access tube along a point of treatment within the coronary artery, running the stent into the access tube to the point of treatment, withdrawing the access tube so as to expose the stent to the surrounding coronary artery, and inflating the stent so as to permanently dilate the coronary artery at the point of treatment.
A medical device for advancing a stent through a constricted lumen of a patient is also provided. In one embodiment, the device includes a slip wire having a proximal end and a distal end; and a tubular body near the distal end of the slip wire, the tubular body having a proximal opening, a distal opening, and a tubular wall defined therebetween. The wall is fabricated from a deformable and hydrophilic material. Preferably, the wall comprises a slit running substantially along its length.
So that the manner in which the above recited features of the present invention can be better understood, certain drawings are appended hereto. It is to be noted, however, that the appended drawings illustrate only selected embodiments of the inventions and are therefore not to be considered limiting of scope, for the inventions may admit to other equally effective embodiments and applications.
Definitions
As used herein, the term “patient” refers to any mammal in need of medical treatment.
The term “lumen” refers to any opening in a patient including, for example, a human artery.
The term “access artery” may be any artery used by a medical service provider such as a cardiologist or cardiology team to obtain access to an area of occlusion within a patient's arterial system. This may be, for example, an artery in the patient's arm or wrist. It may also be, for example, an artery near the patient's groin, such as the femoral artery.
The terms “constricted lumen” or “constricted portion of a lumen” mean any restriction to the passage of a stent. Non-limiting examples include buildup of material along an arterial wall, a tortuous bend in an artery (or other lumen) or a previously-placed stent.
Description of Specific Embodiments
The medical device 10 includes an access tube 12 and a slip wire 14. The slip wire 14 defines a long, slender, solid member used for feeding the access tube 12 into the patient's artery 30. The slip wire 14 may be fabricated from any material that is of sufficient stiffness to allow the medical service provider to apply compression to the wire 14 in order to urge the devise 10 into the patient and through a lumen. Such materials may be, for example, a metallic material such as an alloy, or a composite material such as a polycarbonate. The slip wire 14 should also be flexible enough to allow the wire 14 to negotiate turns such as may be encountered within the patient's arterial system.
The slip wire 14 has a proximal end 18 and a distal end 19. In the perspective view of
The access tube 12 of the medical device 10 comprises a tubular body 22 disposed near the distal end 19 of the slip wire 14. The access tube 12 has a proximal end 21 and a distal end 26. It is preferred that the proximal end 21 of the tube 12 be flanged outwardly, while the distal end 26 of the tube 12 be flanged inwardly. The proximal 21 end and the distal end 26 are open, and the access tube 12 defines an elongated bore 15 (as best illustrated in
The access tube 12 is fabricated from a flexible material. Preferably, the access tube 12 is also fabricated from a water absorbent or hydrophilic material. In this way, as the tube 12 contacts blood or other fluids within an artery 30, the tube 12 acquires a slippery property. An example of a suitable material is Nitinol™ material.
The access tube 12 is configured to collapse when encountering a reduced inner diameter portion of a lumen. In the arrangement of
It is noted here that the slip wire 14 preferably runs the length of the access tube 12 and extends beyond the access tube 12. This imbues a sufficient stiffness to the access tube 12 to allow it to withstand compressive forces exerted along the tube 12 as the medical service provider, e.g., a cardiologist, pushes the medical device 10 into the patient's body.
It is also noted that the distal end 19 of the slip wire 14 may include a softer, more compliant portion than the remainder of the slip wire 14. The distal end 19 may also include a curved tip (not shown). Such features allow the medical device 10 to be urged through an arterial system without unduly insulting or injuring the inner walls of the vessel 30.
The access tube 12 also preferably includes opposing radiopaque markers 18. One marker 18 is positioned near the proximal end 21 of the tube 12, while the other marker 18 is positioned near the distal end 26 of the tube 12. The markers 18 may be attached to the wall of the access tube 12. However, it is preferred that the markers 18 be incorporated into the slip wire 14. The radiopaque markers 18 are used by the cardiologist or other medical service provider to confirm the position of the access tube 12 within the patient.
A portion of a guide catheter 24 is seen in
In
Certain components are also shown residing within the access tube 12. First, a guidewire 20 has been previously placed in the patient's artery 30. The guidewire 20 can be seen in
The slip wire 14 of the medical device 10 is also shown in
The cross-sectional view of
During balloon angioplasty, a stent is advanced into the patient's arterial system, and into a coronary artery proximate the patient's heart.
In the view of
In order to employ the device 10, the cardiology team will remove the stent 40 from the patient's body.
Upon removal of the stent 40, the cardiologist will direct that the medical device 10 be inserted into the patient lumen 30. The device 10 will then be advanced through the guide catheter 24 within the artery 30 (step shown in
As noted, the access tube 12 is fabricated from a hydrophilic material which has a lubricative quality as it moves through vessels. These features permit the access tube to move through the constriction 34. The compliant nature of the wall that forms the access tube 12 can be seen. In this respect, the profile of the access tube 12 at least partially conforms to the inner diameter of the surrounding artery 32. Further, the slit 16 permits the radius of the access tube 12 to more readily comply with the partial occlusion 34 presented in the artery 32. In this respect, the body or wall of the access tube 12 is able to radially constrict.
The length of the access tube 12 may vary. In one arrangement, the length is short enough to traverse an anticipated section of coronary blockage. In another arrangement, the length is long enough so that the proximal end 21 of the access tube 12 remains within the guide catheter 24 while the distal end 26 extends beyond an anticipated section of coronary blockage.
It is to be noted that other variations of the use of the access tube 12 exist. For instance, the access tube 12 may be advanced within the artery bore 35 to the point of partial blockage 34 before the stent 40 is ever inserted into the patient. If it is anticipated that a second point of partial blockage will be encountered, then the stent 40 may be retained within the bore 15 of the access tube 12 and the access tube 12 then advanced along with the stent 40 therein. Once this second portion is navigated, the stent 40 may be urged beyond the access tube 12 and to the desired point of treatment. The medical device 10 may then be withdrawn from the patient. The medical device 10 may be removed before or after expansion of the stent 40.
Alternatively, the medical device 10 may be advanced within the patient's arterial system to the point of desired treatment ahead of a stent 40. Once the access tube 12 is positioned across the substantially blocked artery, the cardiologist will push the stent 40 into the access tube 12. When the stent 40 is at the point of desired treatment and ready for inflation, the access tube 12 is pulled back to expose the stent 40. In this way, the stent 40 is able to be placed within an area of treatment without injuring the surrounding artery wall. The medical device 10 is removed before expansion of the stent 40.
It is also noted that in
While this disclosure is written in the context of advancing a stent through a human patient's coronary artery, it is understood that the device and procedures have equal utility in navigating through narrow and constricted lumen of any biological type and in any mammal.