JP4440916B2 - Slidable tube filter - Google Patents

Description

  The present invention provides a medical device that can be used for minimally invasive medical procedures, for example, by placing it in a blood vessel via a catheter. Although a variety of such medical devices can be made with the present invention, the present invention is particularly useful as a filter for use in blood vessels or other pathways in a patient's body.

  In various medical procedures, or when dealing with certain situations, a filter may be placed in a path or tube in the patient's body. For example, a rotating bar is used to remove atheroma from a lumen in a patient's blood vessel. These rotating bars can effectively remove atheroma, but the removed object simply floats downstream through the blood vessel with the blood flow. A filter may be used to capture such removed objects before it moves too far downstream and becomes blocked in blood flow in narrower vessels.

  In order to capture particulate matter released or produced in such procedures, some investigators have proposed various traps or filters. However, most of such filters have generally not proven to be exceptionally effective in practical use. These filters tend to be cumbersome to use and, if not properly seated in the blood vessel, can move to a more distal position where they are more harmful than effective, which can cause problems with accurate placement. there were. In addition, these filters can generally only capture relatively large thrombi and have not been effective in removing smaller thrombotic particles from the bloodstream.

  The problems with most temporary filters that are used only during a particular procedure and are intended to be subsequently withdrawn with the captured thrombus are further explained. Even though the trap can effectively capture the removed object, it is relatively difficult to retract the trap into a catheter that is moved without easily releasing the captured thrombus into the bloodstream or It has proven to be complex and has spoiled the purpose of the temporary filter tool. For this reason, most atherectomy devices and the like tend to suck out the patient's blood during the procedure to remove the removed objects that are entrained in the bloodstream.

  One promising filter structure that overcomes many of these difficulties is shown in WO 96/01591 (International Application No. PCT / US95 / 08613), the teachings of which are incorporated herein by reference. included. In general, this reference teaches a trap that can be used to filter particles from blood or other fluids flowing through bodily tracts. In one illustrated embodiment, the trap has a basket 270 that can be placed and retracted through a catheter or the like and is particularly suitable for use in minimally invasive procedures such as angioplasty and atherectomy procedures. It shall be This trap optimally resting on the mandrel 260 further facilitates its use as the most common angioplasty balloon, and an ather removal device is used in connection with such a mandrel. While this trap is highly useful and shows great promise in many common procedures, it may improve ease of placement and / or withdrawal.

  There are also some medical instruments that are permanently placed in the patient's tract, but it can be cumbersome to properly position these devices at the desired treatment location using minimally invasive techniques. For example, an occlusive device may be used to occlude arterial blood vessels or diaphragm defects. Some of these occlusion devices expand radially to an expanded profile and substantially fill the lumen of the blood vessel or extend beyond the margin on one side of the diaphragm defect. That said, when these occlusion devices are placed through the delivery catheter, the friction between the occlusion device and the catheter wall makes it difficult to place the devices in precisely selected locations. These problems are exacerbated when moving long catheters through more tortuous paths.

  The present invention provides a medical device that can be easily placed and retracted during a minimally invasive medical procedure. In one preferred embodiment, the medical device can take the form of a filter that can be used in any path of a patient, whether placed in a blood vessel, urinary tract, or other type of path.

  One embodiment of the present invention provides a retractable medical device having a mandrel and an actuating member in a preferred shape to achieve a particular purpose. The mandrel has a distal end portion and a stopper spaced from the distal end portion toward the proximal end. The proximal portion of the mandrel extends in the proximal direction from the stopper, and the distal portion of the mandrel extends in the distal direction from the stopper. The actuating member has a radially expandable body having a proximal slider and a distal slider. The proximal end side slider is slidably supported on the proximal end portion of the mandrel, and the distal end side slider is slidably supported on the distal end portion of the mandrel. The proximal and distal sliders are slidable along the mandrel independently of each other, so the distance between the proximal slider and the distal slider changes to allow different outer shapes of the actuating member. To do.

  Another embodiment of the medical device of the present invention includes a mandrel and a suitably shaped actuating member. Similar to the previous embodiment, the mandrel has a distal end and a stopper that is spaced proximally from the distal end. The proximal end portion of the mandrel extends toward the proximal end from the stopper, and the distal end portion of the mandrel extends from the stopper toward the distal end portion. The actuating member of this embodiment has a radially expandable outer shape and a radially expandable body adapted to flexibly adopt the radially expanded outer shape when there is no opposing biasing force. . The radially expandable body is attached to the mandrel by a proximal slider and a distal slider. The proximal slider is supported so that it can slide near the proximal end of the mandrel, and the distal slider is supported so that it can slide on the distal end of the mandrel. The proximal and distal sliders are slidable along the mandrel independently of each other, so the distance between the proximal slider and the distal slider changes to allow different outer shapes of the actuating member. To do.

  In a particular application of the invention, it has a mandrel substantially similar to that described above and also has an actuating member. The actuating member of this embodiment is formed of a preferred outer shape that is radially expanded and a flexible tubular knitted ribbon that assumes a radially contracted shape when extended axially. The proximal and distal sliders are attached to a tubular ribbon having a ribbon length extending therebetween. The proximal end slider is slidably supported at the proximal end of the mandrel, and the distal end slider is slidably supported at the distal end of the mandrel. The proximal and distal sliders can slide on the mandrel independently of each other.

  Yet another embodiment of the present invention provides a filtration device that can be temporarily placed in a flow path of a patient's body. This device has a distal end portion and an enlarged diameter stopper that is held near the proximal end from the distal end portion. The filter is made of a flexible tubular knitted ribbon and has a proximal slider and a distal slider. The proximal-side slider is slidably supported along a mandrel closer to the proximal end from the stopper, and the distal-side slider is supported along a mandrel between the stopper and the distal end of the mandrel. The filter has a wilting profile where the sliders are separated from each other by a first distance along the mandrel and the filter has a first diameter. The filter also has an expanded profile with each slider separated by a second short distance along the mandrel and the filter having a second diameter. The first diameter of the filter is smaller than the second diameter.

  The present invention also contemplates a method of using a medical device in a conduit. The medical device desirably includes a mandrel having a distal end portion and a stopper spaced from the distal end portion toward the proximal end. It also has an actuating member, which is formed from a flexible tubular braided ribbon and has proximal and distal sliders that slide along a mandrel closer to the proximal end than the stopper The tip slider is supported along a mandrel between the stopper and the tip of the mandrel. The tip of the mandrel is inserted into the lumen of the tube. The actuating member is pushed toward the treatment position along the lumen in the distal direction by urging the mandrel toward the distal side so that the stopper engages with the distal side slider and applies a distal side biasing force thereto. . This tip side biasing force acts against the restoring force of the actuating member to extend the actuating member in the axial direction, and reduces friction between the actuating member and the tube wall.

  1 and 2 are schematic views of one medical device according to the present invention. The medical device has a filtration device 10 that can be placed in a passage in a patient's body. As mentioned above, the filter can be used in any passage in the patient's body, including blood vessels, urinary tracts or bile ducts and airways. The filtration device 10 is intended to be placed in a patient's vessel in a minimally invasive procedure, such as introducing a filtration device into a blood vessel via an introducer catheter (not shown in FIGS. 1 and 2). It is optimal to be configured.

  The filtration device 10 of the present invention generally has a mandrel 20 and a filter 50. Conceptually, the mandrel 20 can be thought of as having the primary function of positioning and controlling the placement of the filter 50, while the filter can be thought of as the primary therapeutic or actuating member of the device 10.

  The mandrel 20 must be properly flexible so that the device can be placed in a curved body passage without kinking or otherwise obstructing proper placement of the filter 50. In most situations, the mandrel 20 is composed of an elongated metal wire, although the mandrel can be formed from any material having any size suitable for the role in which the filtration device 10 is used. In a particularly preferred embodiment, the mandrel 20 is formed from nitilol, which is a substantially stoichiometric alloy of nickel and titanium with excellent “superelastic” properties. The use of nitilol for medical guidewires and associated devices is known in the art and need not be discussed in detail here. If it is desired to do so, the leading edge of the mandrel may have a flexible wire 22 that extends through its entirety and is spirally wound. The use of such helical coils to increase tip flexibility is well known in guide wire technology.

  The mandrel 20 has a diameter expansion stopper 40 attached thereto. The stopper 40 is spaced from the distal end portion 25 of the mandrel 20 toward the proximal end side. The stopper 40 is desirably spaced from the proximal end of the helical coil 22 of the mandrel toward the proximal end. In this way, the tip-side slider 60 of the filter 50 can move relatively freely along the length of the mandrel away from the stopper without any trouble.

  The stopper 40 can be formed from any desired material and can be attached to the mandrel 20 in any desired manner. That said, when a stopper is used to bias the filter 50 within the lumen of the tube in which the device 10 is to be placed, the stopper should be attached to the mandrel relatively firmly. By way of example, the stopper 40 may comprise a standard radiopaque identification band that is securely crimped to the mandrel 20 and / or attached to the mandrel using an adhesive or solder. The exact length and shape of the stopper 40 is not important. The drawing depicts the stopper 40 as a relatively short cylinder mounted around the outer periphery of the mandrel. However, the stopper 40 can take a more spherical shape and can theoretically even be formed integrally with the mandrel.

  The stopper 40 effectively divides the mandrel into a distal end portion and a proximal end portion. The tip portion 30 of the mandrel can be considered as a portion extending from the stopper 40 toward the tip 25 of the mandrel closer to the tip portion. Similarly, the base end portion 35 of the mandrel 20 can be considered to consist of a portion extending from the stopper 40 toward the base end of the mandrel closer to the base end.

  The filter 50 shown in FIGS. 1 to 5 has an elongated, generally tubular body portion 52 that extends from the distal end side slider 60 to the proximal end side slider 65 to the proximal end side slider 65. The filter body 52 can be formed from any material that is available and suitable for use. In many applications, such as, for example, the filtration of blood within a patient's vasculature, the filter body 52 generally comprises a knitted tubular knit of a predetermined length. The use of Nichiol tubular braided ribbons to make medical devices is described in some detail in WO 96/01591, the teachings of which are incorporated above by reference. In simple terms, however, this method involves a set of wires wrapped around a mandrel around one mandrel and the other set spiraled around in another direction. A knitted tubular ribbon consisting of two sets of Nichiol wires wrapped in a spiral can be used. This knitted ribbon is then placed in contact with the forming surface of the forming element which defines the shape of the desired actuating member. By heat treating the knitted fabric in contact with the forming surface of the forming element, an actuating member having substantially any desired shape can be generated.

  The body 52 of the filter 50 is desirably made from a suitably flexible, flexible material. In particular, the filter 52 desirably has a radially inflated outer shape that attempts to be resiliently resilient without an opposing biasing force, such as the shape shown in FIGS. A fuselage 52 formed from a Nichiol tubular ribbon that is thermoformed into the desired shape is well suited for this purpose.

  In the filtering device 10 shown in FIGS. 1 to 5, the body portion 52 of the filter 50 has a substantially tubular shape having a tapered proximal end portion and a distal end portion. The outer diameter of the generally tubular central portion of the torso 52 is substantially within the lumen of the blood vessel to ensure that any emboli that may have been entrained in the patient's bloodstream are effectively captured. Should be dimensioned to meet the requirements. As will be described in more detail below, alternative shapes for the filter body 152 are depicted in FIGS. 7 and 8 and medical devices intended to achieve different medical purposes are shown in FIGS. 11 and 13. Has been. Various other filter shapes, as well as other types of medical device shapes, will be readily apparent to those skilled in the art in light of the present teachings.

  The filter 50 is attached to the mandrel 20 or the mandrel 20 by a proximal-side slider 65 attached to the body 52 adjacent to the proximal end and a distal-side slider 60 attached adjacent to the distal end of the body 52. Is carried by. The distal-side slider 60 freely slides along at least the proximal end portion of the mandrel distal end portion 30, while the proximal-side slider 65 moves along at least the distal end portion of the mandrel proximal end portion 35. Should slide freely. For reasons explained in more detail below in connection with FIGS. 3-5, the mandrel stopper 40 effectively defines the limits of the travel range of these sliders 60,65.

  Each slider 60, 65 should slide along a respective length of the mandrel, but the slider can take any desired shape. In the illustrated embodiment, each slider has a relatively thin ring carried around the mandrel. In any desired manner, such as brazing or sedgeing the body knitted fabric between the two layers of the ring, or soldering, welding or otherwise attaching the knitted fabric to the ring, A thin ring can be attached to the body 52. One suitable tip slider structure is shown in more detail in FIG. The proximal slider can have substantially the same shape, but is not shown here for simplicity purposes only.

  In the embodiment shown in FIG. 6, the tip side slider 60 has a relatively rigid annular ring 61 having an inner member 61a and an outer member 61b. One or both members of the ring 61 are preferably formed from a radiopaque material so that the surgeon can better see the position of the slider 60 during the procedure. The inner member 61a of the ring is received inside the outer member 61b and defines an annular space therebetween. The inner diameter of the inner member is larger than the outer diameter of the mandrel 20 to facilitate the sliding of the ring 61 relative thereto. Movement of the slider 60 relative to the mandrel is further facilitated by coating one or both of the inner surface of the inner member 61a and the outer surface of the mandrel 20 with an anti-friction coating such as polytetrafluoroethylene or a lubricious hydrophilic coating. Can be done.

  The knitted end of the body 52 is received in an annular space between the inner member 61a and the outer member 61b of the ring. The knitted fabric is secured in this space by suitable means such as, for example, by suitable solder or adhesive, or by brazing the knitted fabric between the inner and outer members. FIG. 6 shows two approaches using a knitted fabric gripped between two members of the ring 61 and held by a weld or adhesive joint 62 at the tip of the ring.

  3 to 5 schematically show the filtration device 10 of FIGS. 1 and 2 in partial cross-sectional views. In particular, the filter 50 is shown in cross-section, while the mandrel 20 and its components are shown in side view. This is intended to better illustrate the interaction between the mandrel stopper 40 and the sliders 60, 62 of the filter 50.

  In FIG. 3, the filter 50 is shown with a radially expanded profile, which has a tendency to take when there is no biasing force to counter. The mandrel stopper 40 is located in the body portion 52 of the filter, and no biasing force is applied to either of the sliders 60 and 65.

  In this outer shape, the mandrel 20 can move proximally and distally with respect to the filter 50 without substantially affecting the shape and position of the filter. The limits of this range of mandrel free movement with respect to the filter are generally defined by the relationship between the stopper 40 and the sliders 60,65. In particular, the mandrel has a front end position at which the stopper 40 contacts the front end slider 60 but does not apply any force thereto, and a base end position at which the stopper 40 contacts the base end slider 65 but does not apply any significant force thereto. Can move. This allows the filter 50 (or any other actuating member carried on the mandrel) to be positioned fairly accurately within the patient's tract and retains its position even if the guidewire is moved slightly during use. To do. This can be advantageous in situations where other devices are exchanged over the guide wire (eg, in an angioplasty and athenome removal procedures).

  As described above, the inner diameter of the substantially annular ring that defines the sliders 60 and 65 is preferably larger than the outer diameter of the mandrel. However, the inner diameter of these sliders must be smaller than the outer diameter of the stopper 40. In this way, the stopper functions to limit the movement of the slider. As a result, the stopper 40 functions as an effective restriction with respect to the movement of the distal end side slider 60 toward the proximal end and the movement of the proximal end side slider 65 toward the distal end. Apart from this relationship with respect to the slider 40 and the fact that both sliders are indirectly connected to each other by the filter body 52, the proximal and distal sliders are essentially independent of each other on the mandrel. Can slide along.

  The advantages of this arrangement are depicted in FIGS. In FIG. 4, the mandrel 20 is pushed to the tip side (to the left side as indicated by the arrow in this figure), and is pushed toward the tip with respect to the tip side slider 60. This exerts a tip side biasing force on the tip of the body portion 52 of the filter. Theoretically, if the filter is used in a friction-free environment, the filter will move with the mandrel without any discernible change in the shape of the fuselage 52. However, this is not the case for many medical uses. Instead, there is generally some force that completely restrains the free movement of the filter within the passage of the patient's body. As shown schematically in FIG. 3, the filter body 52 flexibly expands and physically contacts the inner surface of the tube V. This contact with the inner wall of the tube tends to hold the filter 50 in place as the mandrel stopper moves between the two sliders 60, 65 toward the proximal end and toward the distal end. When the mandrel is urged toward the distal end and a distal force is applied to the distal slider 60 (shown in FIG. 4), this force tends to extend the body portion 52 in the axial direction.

  A flexible tubular knitted ribbon tends to take a radially contracted shape when extending in the axial direction. (Some of this characteristic and its influence are described in the above-mentioned International Publication No. WO96 / 01591. As a result, the mandrel 20 is urged in the distal direction to push the distal slider 60 in the distal direction. Otherwise, this tip force acts against the recovery force of the flexible ribbon that urges the ribbon into an expanded shape (FIG. 3). The torso 52 tends to extend in the axial direction and to a radially contracted shape, which in turn reduces the force with which the torso engages the wall of the vessel V and the filter 50 and tube Therefore, urging the mandrel in the distal direction to move the filter 50 toward the distal end will simultaneously reduce the friction between the filter and the tube wall, and move the filter to the tube. Into the lumen of This makes it easier to push the filter in the distal direction, allowing the mandrel to become smaller, allowing the outer diameter of the shrunken device to be smaller and placed in a smaller tube. In addition, reducing the friction between the filter and the vessel wall limits the damage to the vessel wall to the intima and allows the filter to be placed and moved with minimal trauma. Make it possible.

  FIG. 5 is similar to FIG. 4 but shows the situation that occurs when the mandrel is retracted proximally. In this figure, the stopper 40 of the mandrel is in contact with the proximal end side slider 65 of the filter 50 and exerts a biasing force closer to the proximal end. As described above with reference to FIG. 4, this proximal biasing force acts against the restoring force of the body portion 52, and the body portion extends in the axial direction and contracts in the radial direction. This further causes the device to be pulled proximally along the lumen of the tube for repositioning to a proximal position or withdrawal from the patient's body at the end of the procedure.

  As can be seen by comparing FIG. 3 with FIGS. 4 and 5, the proximal slider 65 and the distal slider 60 are mainly limited by the indirect connection to each other via the filter body 52. Can move relatively independently of each other. For example, when the mandrel 20 is pushed toward the distal end side slider 60 (FIG. 4) in the distal direction, the proximal end side slider slides toward the proximal end side along the proximal end portion 35 of the mandrel. Similarly, when the mandrel is pulled out to the base end side and the base end side slider 65 is urged to the base end side, the tip end side slider freely moves along the tip end portion 30 of the mandrel to the tip end side. Ideally, there should be a sufficient distance between the distal shoulder of the stopper 40 and the proximal end of the helical coil 22 at the distal end of the mandrel.

  Another notable point of the device highlighted in FIGS. 3-5 is that the spacing of the sliders 60, 65 changes in response to a mandrel acting on one of the sliders. First, referring to FIG. 3, the body 52 is engaged with the wall of the tube, and the proximal slider and the distal slider are separated from each other by a first distance. However, when the mandrel stopper 40 biases one of the sliders, the body 52 tends to extend in the axial direction and the distance between the two sliders increases.

  It will be understood that the shape change between the radially expanded shape shown in FIG. 3 and the radially contracted shape of FIGS. 4 and 5 is exaggerated to emphasize this change. Should. For example, in FIGS. 4 and 5, the filter body 52 is shown as being completely spaced from the tube wall. However, in most medical situations, the body of the filter still tries to at least lightly touch the vascular intima of the tube, and the change in shape of the body is probably not dramatic.

  FIGS. 9 and 10 schematically illustrate some of the advantages of the present invention when using a catheter to place and remove a device in a body path. FIG. 9 schematically illustrates the device of FIGS. 1-5 being positioned through the catheter C. FIG. In particular, the entire length of the mandrel 20 and the entire filter 50 are accommodated in the lumen of the catheter C. The mandrel 20 is urged in the distal direction and comes out of the distal end of the catheter C. The stopper 40 applies a distal end biasing force to the distal end side slider 60 within a relatively narrow range of the catheter C. The body portion 52 of the filter 50 applies an outward force to the inner surface of the catheter C, and increases the friction between the filter and the catheter C. The tip side biasing force of the stopper 40 acting on the slider 60 tends to extend the body 52 of the filter in the axial direction and shrink in the radial direction, thereby reducing the friction between the filter and the catheter C. This considerably facilitates the placement of the instrument through the catheter C. FIG. 10 schematically shows the removal of the device of FIGS. 1-5 and 9 already placed in the patient's tube. In particular, the filter 50 is drawn into the lumen of the catheter C proximally. This is started by positioning the distal end of the catheter C proximally from the proximal slider 65 and then moving the catheter C relative to the stopper 40. This can be done by urging the catheter C to the distal side or pulling the mandrel 20 to the proximal side while the operator sees the fit at that time.

  The catheter C frictionally engages the filter body 52 and attempts to compress it radially. As a result, the slider 65 comes into contact with the stopper 40. Further movement of the catheter C with respect to the mandrel biases many portions of the length of the torso 52 into the lumen of the catheter C. At the same time, the distal slider 60 slides toward the distal end along the distal portion 30 of the mandrel and attempts to extend the body 52 in the axial direction in response to radial compression caused by the catheter C.

  These two-leaf drawings highlight some of the advantages of embodiments of the present invention. In particular, the filter body 52 extends in the axial direction and contracts in the radial direction in response to movement of the mandrel 20 with respect to the catheter C. When placing the instrument (FIG. 9), the stopper 40 urges the distal slider 60 toward the distal end and effectively pushes the filter 50 along the catheter C toward the distal end. Stopper 40 is shown as pushing proximal slider 65 proximally when the instrument is removed (for repositioning or removal from the patient's body). Again, this biasing force tends to extend the filter body 52 in the axial direction and shrink it radially. This axial extension and radial reduction of the body 52 in FIGS. 9 and 10 reduces friction with the lumen. Furthermore, the reduction in diameter during withdrawal back into catheter C (FIG. 10) makes it easier for the filter to deflate into the lumen of catheter C and makes it easier to introduce the filter into the catheter. This same capability can also be used to advantage when initially placing the filter as described below.

  As mentioned above, FIGS. 7 and 8 illustrate alternative embodiments of the present invention. There are many similarities between the instrument shown in FIGS. 1-6 and the instrument illustrated in FIGS. For ease of explanation, the members of FIGS. 7 and 8 that perform functions similar to those of FIGS. 1-6 are given the same reference numerals, but with the addition of 100. Accordingly, FIGS. 1-6 refer to a filtration device 10 having a mandrel 20, and FIGS. 7 and 8 show a filtration device 100 having a mandrel 120.

  The main difference between the filter 150 of FIGS. 7 and 8 and the filter 50 of FIGS. 1 to 6 is the shape of the filter when it is completely expanded in the radial direction. The filter 50 has a generally tubular body portion that is spaced apart and has tapered ends. In contrast, the filter 150 of FIGS. 7 and 8 has a generally umbrella-shaped body portion 152 that is received inside the tip of the knitted fabric with the base end of the knitted fabric that defines the body portion reversed. is doing. As a result, in the fully-arranged filter 150 shown in FIG. 7, the distal-side slider 160 and the proximal-side slider 165 are more prone to each other than the spacers 60 and 65 of the fully-arranged filter 50 shown in FIGS. Located close together.

  FIG. 8 illustrates the filter 150 in the axially expanded and radially contracted state caused by pulling the mandrel 120 toward the proximal end. When the mandrel 120 is withdrawn proximally within the patient's tube, the stopper 140 contacts the proximal slider 165 and biases it proximally. In the embodiment of FIGS. 1-5, 9, and 10, this attempts to extend the body 52 of the filter 50 in the axial direction without substantially changing the shape of the filter. The filter 150 of FIGS. 7 and 8 is more complex in a fully positioned and expanded state (shown in FIG. 7). Rather than simply extending the shape shown in FIG. 7 in the axial direction and contracting in the radial direction, the proximal end of the knitted fabric received inside the distal end of the knitted fabric tends to turn over. The tip of the knitting (i.e., the outer portion of the knitting shown in FIG. 7) tries to stay in place with frictional engagement with the tube wall during this procedure. As a result, the shape of the inner surface of the umbrella tries to change first without causing a significant change in the outer shape.

  As the mandrel is continuously pulled out and the proximal slider 165 and distal slider 160 move further apart, the body 152 will try to assume a shape that looks more like the shape of the filter 50 of the previous embodiment. When the base end side slider 165 is continuously urged to the base end side, the base end side slider 165 tries to further extend the body part until it reaches a shape as schematically shown in FIG. This facilitates the withdrawal of the trap, but care should be taken that any particular material held inside the umbrella-shaped torso 152 is not thrown into the patient's bloodstream and adversely affected. . This can be done, for example, by breaking up the captured thrombus using a thrombolytic agent, or by sucking particulate matter through the catheter before withdrawing the mandrel 120 proximally.

  In a particularly useful process for withdrawing the deployed filter 150 from within the patient's bloodstream, the tip of the catheter (not shown in FIGS. 7 and 8) is positioned within the body 152 of the umbrella filter. Until then, the catheter C is biased distally along the proximal end 135 of the mandrel. If necessary, any particulate matter inside is aspirated out of the patient's body via catheter C. Thereafter, the mandrel is pulled out to the proximal end side, and the proximal slider 165 is pulled into the catheter C. As described above in connection with FIG. 10, this helps the filter body 152 to retract into the lumen of the catheter C. If it is desired to do so, the catheter C can be held in the same position while the remainder of the filter 150 is pulled inside. Alternatively, the catheter C and mandrel can be pulled together a short distance together so that the distal end of the catheter C is slightly proximal than the proximal end of the placement filter shown in FIG. Is located. This makes it easier for the body 152 to be retracted into the catheter C. Once at least a majority of the filter 150 is received within the lumen of the catheter C, the catheter, filter and mandrel 120 can be removed as a unit from the patient's body.

  FIG. 11 shows a medical device similar to the embodiment shown in FIGS. 1-5, 9 and 10. However, the shape of the body portion 52 ′ of the plug 50 ′ is significantly different from the shape of the body portion 52 of the filter 50 described above. While most of the length of the filter 50 is not constrained, it attempts to have a constant diameter, but the body 52 'of the plug 50' has a more complex shape. Although this device can also be used to filter fluid flowing through a tube, its construction is particularly adapted to temporarily or permanently occluding the tube.

  A method of making and using a vaso-occlusive device having a shape similar to that of the body portion 52 'of FIG. 11 is disclosed in International Publication No. WO 96/01591, the teachings of which are incorporated above. That being said, in short, the body 52 'has a pair of enlarged diameter portions separated by a central portion having a reduced diameter. If desired to do so, the surface of the device is coated with a thrombus or nylon fiber or the like that can be attached to the body 52 '. Conversely, if plug 50 'or filter 50 is to be used only for the purpose of filtering the fluid flowing therethrough and it is preferred that all blood passing through the actuating member does not clot there. The body part can also be coated with an antithrombogenic agent.

  One of the difficulties encountered when using the vaso-occlusive device disclosed in WO 96/01591 is the friction between the body of the vaso-occlusive device and the catheter through which it is placed. The stopper 40 for biasing the distal slider 60 in FIG. 11 tends to extend the body portion 52 ′ of the plug 50 ′ in the axial direction and contract in the radial direction when it is urged along the catheter C. . This reduces friction between the plug 50 'and the catheter C and makes it much easier to place the instrument at the desired treatment location. This structure also facilitates repositioning of the plug 50 'if the initial placement is not precisely located at the desired location. In particular, the withdrawal of the mandrel 20 to the proximal side causes a proximal biasing force to act on the proximal slider 65 and facilitates the retrieval of the instrument into the placement catheter, many of which are related to FIG. As described above. When the plug is fully retracted into the catheter, the catheter can be repositioned and the plug can be repositioned out of the catheter again at the new location.

  The plug 50 ′ of FIG. 11 can be used as a temporary closure device, but can be removed at the end of the procedure or course of treatment. Nevertheless, under other circumstances, it may be preferable to more permanently occlude the flow path in which the plug 50 'is disposed. Although the stopper 40 in contact with the sliders 60, 65 facilitates placement and repositioning, attachment of the stopper 40 to the mandrel 20 will effectively prevent removal of the mandrel from the plug.

  The mandrel 20 can be partially or fully withdrawn from the plug in a variety of different ways. For example, the base end portion 35 of the mandrel can be detachably attached to the stopper 40 by, for example, screw joining. However, if the tip 30 is not locked to some extent against rotation (for example, by spline coupling between the tip 30 and the tip-side slider 60), it will be difficult to separate these components from each other.

  FIG. 12 depicts a preferred embodiment of a stopper 40 ′ that can be used to remove the mandrel 20 leaving the filter 50 or plug 50 ′ in place within the patient's body. In the above embodiment, both the stopper 40 and the proximal slider 65 are essentially annular in shape, and the stopper has a relatively constant outer diameter that is larger than the slider's relatively constant inner diameter. As a result, the stopper 40 cannot be easily pulled out from the inside of the enclosure of the body portion 52 of the filter 50.

  However, the stopper 40 ′ of FIG. 12 can be removed from the interior of the filter 50, plug 50 ′, or other device having a suitably employed proximal slider. The stopper 40 ′ has an external screw 42 ′ extending outwardly from the stopper body 44 ′. The proximal slider (not shown in this figure) has an internal thread surface dimensioned to engage the external thread 42 'of the stopper 40'. Apart from a spiral slot or keyway shaped to receive the stopper screw 42 ', the inner diameter of the proximal slider is slightly larger than the outer diameter of the stopper body 44' but has a screw 42 '. It is smaller than the maximum diameter of the stopper. In normal operation, this ensures that the stopper 40 'abuts the proximal slider so that the instrument functions as described above.

  Nevertheless, if the operator decides to leave the filter 50 or plug 50 'in place, the mandrel is pulled by pulling the mandrel proximally until the stopper 40 is lightly touching the proximal slider. It can be removed from the filter or plug. When the mandrel is rotated about its axis, the screw 42 'moves along the slot in the proximal slider. In this manner, the stopper can be removed through the proximal slider and the mandrel can be completely removed from the patient's body, leaving the medical device in place within the blood vessel.

  The present invention also contemplates a method of using a medical device in a patient's body pathway. For convenience, the following description refers to FIGS. 1-5 and the reference numerals used therein. However, the present invention can be used in any of a wide variety having various actuating members (including the plug 50 'and the drain catheter 250 shown in other figures), and in the filtration device 10 having the filter 50 as its actuating member. It should be understood that it need not be limited.

  By this method, the medical device is introduced into a tube in the patient's body. In the medical device 10 shown in FIGS. 1-5, this would include inserting the tip 25 of the mandrel 20 into the lumen of the patient's tube V. This is more commonly done directly or by using an introducer sheath. Such introducer sheaths are commonly used to introduce medical devices for minimally invasive procedures. Once the mandrel is introduced into the tube, the mandrel can be biased distally to introduce the actuating member, ie, the filter 50 of FIGS. 1-5, and into the tube. 1 to 5, the action and introduction of the stopper 40 on the tip side slider 60 in order to urge the mandrel in the tip direction and to shrink the filter body portion 50 into a radially contracted shape. This is easily achieved by making both contact with the sheath. The same tendency of the filter body 52 extending axially and radially contracting as described above in connection with FIG. 4 is the same as the friction between the filter body 52 and the inner surface of the introducer sheath as the filter travels therethrough. Is also reduced.

  The filter 50 is urged in the distal direction along the lumen of the tube V to a predetermined treatment position. For example, the treatment location is simply a convenient location within the patient's tract located on the distal side of the occlusion that is processed using an angioplasty balloon or an athenectomy tool. As described above, the filter 50 can advance along the tube by urging the mandrel in the distal direction so that the stopper 40 engages with the distal side slider 60. This causes a tip-direction biasing force to act on the tip-side slider, which acts against the restoring force of the body portion 52 of the filter. As a result, the body portion 52 tends to extend in the axial direction and take a shape contracted in the radial direction. This reduces the friction between the filter 50 and the tube wall and facilitates travel along it.

  Once the filter reaches the desired treatment position, the axial force on the mandrel can be easily released. This causes the body 52 to expand in the radial direction and cause the two sliders 60, 65 to draw together along the mandrel and contract in the axial direction. If it is determined that the filter is not accurately positioned at the desired treatment position, push the mandrel distally or pull it proximally, and again the filter will naturally expand radially and When the stopper of the mandrel acts on the slider, it can be easily repositioned by contracting in the axial direction by itself. When it is time to remove the filter 50 from the patient's tube, or when it is time to move it proximally to a new treatment position, the operator simply retracts the instrument radially by pulling the mandrel proximally. This facilitates the movement of the tip in the tube as shown in FIG.

  Under some circumstances, it may be desirable to limit trauma to the vessel intima that may otherwise occur when the filter 50 is pulled along the vessel to the desired treatment location. This is accomplished by using the catheter to position the instrument adjacent to the desired treatment location and / or remove the instrument from the tube after it has been placed.

  According to one such method, the catheter is positioned adjacent to the treatment location within the patient's body. This can be done in any desired manner. For example, the mandrel 20 and the catheter can be advanced simultaneously through the patient's tube. However, in a particularly preferred embodiment, the catheter is positioned at the desired treatment location before the mandrel 20 is inserted into the catheter. This allows the operator to guide the catheter to the location without obstruction by the mandrel, or if the desired treatment location is in a narrower or tortuous vessel and the guidewire can later be removed Follow the wire to advance the catheter.

  If the catheter tip is positioned adjacent to the treatment location, the mandrel tip 25 can be inserted into the proximal end of the catheter (not shown) outside the patient's body. Once the distal slider 60 of the filter 50 enters the proximal end of the catheter, the catheter frictionally engages the filter body 52. When the mandrel is further urged toward the distal end, the stopper 40 causes the distal end side bias force to act on the distal end side slider 60. Similar to the procedure shown in FIG. 10, this distal biasing force tends to cause the body 52 to extend axially and contract radially, and further facilitates entry of the body into the lumen of the catheter. To.

  Once filter 50 is received within the catheter, it can continue to be biased along the entire length of the catheter. As described above with reference to FIG. 9, urging the stopper 40 in the distal direction with respect to the distal side slider 60 extends the body portion in the axial direction and contracts in the radial direction so that the forward movement is performed. To reduce friction between the body and the catheter. If the catheter tip is positioned just proximal to the desired treatment location, the mandrel can be biased distally until the instrument exits the catheter tip. Preferably, the torso has a tendency to expand in the radial direction by itself until it reaches a radially expanded shape that engages the tube wall (B in FIG. 9). Instead, the catheter tip may be located closer to the tip than the desired treatment location. Under such circumstances, advancement of the mandrel is stopped when the operator measures that the filter is in the desired treatment position by means of the radiopaque sliders 60,65. The catheter can then be withdrawn while holding the mandrel 20 in place. When the distal end of the catheter is pulled out from the body portion 52 of the instrument to the proximal end side, the catheter stays substantially in the same position due to contact with the stopper 40 and tends to expand in the radial direction together with the distal end side slider 60.

  Under many circumstances, it may be desirable to place the filter 50 in a temporary manner so that it can be easily removed as described below. Nevertheless, under other circumstances, it may be desirable to leave the instrument in place in the patient's body for an extended period of time or even permanently. This is the most likely scenario for a plug 50 'placed in a patient's vascular system, for example, as a tube closure device.

  The mandrel is preferably removed from the patient's body, either partially or as a whole. By constructing a connection that allows selective disconnection between one length of the mandrel and the other length, the filter 50 and most of the distal portion are brought into the patient's body while removing most of the proximal end. Most of the lengths of these lengths can be removed from each other. These length portions can be joined in any manner known by the art, such as by screw engagement means or by soldering which can be melted or softened by application of electrical resistance heating of the mandrels. .

  More preferably, however, the entire mandrel 20 is removed from the patient's body. This can be done by pulling out the stopper 40 through the proximal slider 65 of the filter. One suitable stopper 40 'is shown in FIG. This stopper 40 'used in connection with a specially adopted proximal slider (not shown but described above) is used to remove the stopper through the proximal slider for removal of the mandrel. be able to. As previously described, this is accomplished by bringing the stopper 40 'into contact with the proximal slider and then rotating the mandrel 20 about its axis. This allows a screw 42 'extending radially outward from the stopper body 44' to pass along the mating slot in the proximal slider. After the mandrel is fully rotated and the stopper is fully withdrawn through the proximal slider, through the center of the filter body 52 and completely withdrawing the distal end 30 of the mandrel proximally from the patient's body The mandrel can be easily removed from the body.

  If the instrument should not remain permanently in its original position, the filter 50 can be removed from the body by drawing it into the lumen of the catheter C. This can be done to remove the filter 50 from the patient's body at the end of the procedure, or simply to reposition the filter to a new position. As described in more detail above with respect to FIG. 10, the mandrel 20 can be based by advancing the catheter past the filter 50 in the distal direction while holding the mandrel stationary or by holding the catheter in a fixed position. The filter 50 can be pulled into the lumen of the catheter C by pulling it out to the end. In any case, when the stopper 40 is urged to the proximal end side with respect to the proximal end slider 65, the body portion 52 tends to extend in the axial direction and contract in the radial direction, and the body portion 52 into the lumen of the catheter. Facilitates entry and reduces friction between the catheter and the portion of the body 52 already received therein. Once filter 50 is received within the catheter, the catheter is held in place and mandrel 20 and filter 50 are completely removed from the catheter. Alternatively, the catheter, mandrel and filter 50 can all be removed from the patient's body as a whole at the same time.

  While the preferred embodiment of the present invention has been described, it should be understood that various changes, applications and modifications can be made without departing from the spirit of the invention and the scope of the appended claims.

1 is a schematic perspective view of one medical device according to the present invention in a deployed state. FIG. FIG. 2 is a schematic side view of the medical device of FIG. 1 in a deployed state. FIG. 3 is a schematic side view of the medical device of FIGS. 1 and 2 in partial section. FIG. 3 is a schematic side view of the medical device of FIGS. 1 and 2, which is a partial cross-section but has a partially deflated outer shape by pushing the mandrel toward the tip. FIG. 3 is a schematic side view of the medical device of FIGS. 1 and 2, which is a partial cross-section, but has a contoured shape in which the mandrel is drawn toward the proximal end and is partially deflated. FIG. 3 is a schematic cutaway view in partial cross-section of the medical device of FIGS. 1 and 2 illustrating the relationship between a mandrel, a stopper, and a distal slider. FIG. 6 is a schematic side view of an alternative medical device of the present invention in a deployed state. FIG. 8 is a schematic side view of the medical device of FIG. 7 in partial cross-section but with a partially deflated outer shape generated by drawing the mandrel proximally within the tube. FIG. 2 is a schematic side view of the medical device of FIG. 1 in a partially sectioned but partially contoured shape generated by biasing the mandrel toward the distal end within the catheter. FIG. 2 is a schematic side view of the medical device of FIG. 1 in a partial cross-section, but showing the manner in which the medical device is withdrawn using a retrieval catheter. FIG. 6 is a schematic side view of a partial cross-section of a medical device according to another embodiment of the present invention in a deployed state. FIG. 6 is a schematic side view of a stopper of the present invention used to facilitate withdrawal of a mandrel for permanent placement of a medical device.

Claims (16)

A guide wire having a distal end portion and a stopper spaced from the distal end portion to the proximal end side, wherein a proximal end portion of the guide wire extends from the stopper to the proximal end side, and the guide wire A guide wire extending from the stopper toward the tip side, and a guide wire,
An actuating member having a radially inflatable body having a base end slider and a tip end slider, the base end slider being slidably carried along a portion near the base end of the guide wire The distal end side slider is slidably supported along the distal end portion of the guide wire so that the distance between the proximal end side slider and the distal end side slider changes to make the outer shape of the operating member different. The proximal end slider and the distal end slider are slidable along the guide wire independently of each other, and the inflatable body portion includes a distal end portion connected to the distal end slider, and the base A retractable medical device comprising the actuating member comprising an elastic metal having a proximal end connected to an end slider.   The actuating member has an inflatable profile and is capable of contracting to pass through a lumen, and the actuating member elastically returns to the inflated profile when there is no bias. Medical device as described in.   The medical device according to claim 1, wherein the body portion of the actuating member has a radially contracted outer shape when a distance between the proximal end slider and the distal end slider increases.   In use, the stopper abuts against the proximal slider and exerts a proximal biasing force on the slider, and the proximal biasing force acts against a restoring force of the body portion. The medical device according to claim 3, wherein the body portion is configured to extend in the axial direction and contract in the radial direction.   In use, the stopper abuts against the tip side slider and acts on the tip side biasing force against the tip side slider, and the tip side biasing force acts against the restoring force of the body part to cause the body part to move. The medical device according to claim 3, wherein the medical device is configured to extend in an axial direction and contract in a radial direction.   The medical instrument according to claim 1, further comprising a control sheath, wherein the base end side slider and the distal end side slider are separated from each other, and the body portion can be contracted in the sheath.   The wall of the control sheath is configured to exert a biasing force against the restoring force in the radial direction of the body portion, and the distance between the proximal slider and the distal slider is maintained by the biasing force. The medical device according to claim 6.   The medical device of claim 1, wherein the actuating member has a preferred radially expanded profile and is formed from an elastic tubular knitted ribbon that has a radially contracted profile when stretched axially.   The medical device according to claim 8, wherein the stopper has an outer diameter larger than an inner diameter of either the proximal end slider or the distal end slider.   The medical device according to claim 8, wherein the stopper is dimensioned so as to bias the distal-side slider when the guide wire is biased in the distal direction.   The medical device according to claim 1, wherein the operating member includes a filter.   The medical device according to claim 1, wherein the operating member includes a closing member.   The stopper has an outer surface having a radially extending threaded portion, and the proximal slider has a slot configured to receive the radially extending threaded portion on the stopper. The medical device of claim 1 having an inner surface.   The proximal slider includes a proximal annular ring that forms an opening having an inner diameter, and the distal slider includes a distal annular ring that forms an opening having an inner diameter, The medical instrument according to claim 1, wherein the inner diameter of the opening of the annular ring and the inner diameter of the opening of the distal annular ring are substantially equal.   The proximal end portion of the guide wire has a proximal end diameter, the distal end portion of the guide wire has a distal end diameter, and the proximal end diameter and the distal end diameter are substantially equal. Medical instruments.   The medical device of claim 11, wherein the filter comprises a metal.

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