MXPA97003075A - Fixed release device - Google Patents

Abstract

A fixator releasing device is disclosed that includes an inner tube that a distant portion that holds the fixator in the release device, at least part of the inner tube is formed of a spiral wound wire, a movable outer tube is used to restrain the fixator in a radically contracted state in the distal portion of the inner tube, a substantially straight elongated wire is configured within the spirally wound wire and joined in the distal portion and in the proximal portion of the wound wire, the outer tube may have at least one lateral door adjacent to the distal portion in communication with the annular space between the outer tube and the inner tube allowing the radiopaque fluid to be injected through the annular space and out of the side door in the vicinity of the fixed

Description

FI3AD0R RELEASE DEVICE ñNTECEI) ENTFR w | fl INVENTION In recent years, fasteners have been developed for use in different body lumens to maintain the invention patent of said lumens. Applications for fixatives include bile ducts, the esophagus, respiratory tracts, and various blood vessels. To release a fixative at a treatment site within the body, the fixative must be radially expandable from a small diameter configuration for transport to a treatment site. Ur > once it is in the treatment site, the fixator should be radially expandable to obtain a larger diameter configuration for coupling the walls that define the lumen of the body to be treated. The radially self-expanding fasteners, as described in the Patents of E.U.A. Nos. 4,655,771 and 5,061,275 are generally preferred because of their self-expanding characteristics. A device does not need to radially expand these fasteners once the fixative is in the treatment site. Instead, the fixator can be released to the treatment site in a reduced diameter configuration and then the fixator can self-expand radially in engagement with the wall defining the lumen of the body to be treated.

The delivery devices known in the art generally have a movable external tubular member that restrains the fixator in a contracted state in an internal catheter. The external tubular member is removed from. contact with the fixator to allow the fixator to self-expand radially to unfold in a lumen of the body. When the fixative is to be released to a distant body site, such as the bile duct or a blood vessel, the fixator release device will preferably give the physician the ability to visualize the place of the fixative under a fluoroscope. A desirable feature of a fixator device is the ability to inject a radiopaque or contrast medium through the device and illuminate the treatment area. With this ability the doctor can ensure that the fixative is deployed at the treatment site. The currently available fixer release devices are deficient in this regard, as they do not have the ability to allow radiopaque or contrast fluid to be injected directly into the area where visualization is most important to the physician. Another desirable feature for a fixator release device is the ability to "recapture" a partially deployed fixator. This feature would allow the physician to replace a fixator after partial unfolding if the location in the partial display is not correct.

The fixator release device must also be flexible and longitudinally rigid. Flexibility is desirable for the fixator release device to navigate the sometimes difficult path used to obtain the treatment site. This is especially true where the treatment site is a blood vessel, such as the renal, carotid or coronary arteries. The longitudinal stiffness is preferred to provide "pushing capacity". This "push capacity" ensures that the physician will be able to push the fixator release device through the anatomy to the appropriate treatment site. Therefore, it would be desirable to provide a fixator release device that allows the physician the ability to observe the fixative during unfolding under a fluoroscope. It would be desirable to provide a fixator release device that has the ability to "recapture" a partially deployed fixator. In addition, it would be desirable to provide a fixator release device that is flexible. It would still be more desirable to provide a fixator release device that is longitudinally rigid.

BRIEF DESCRIPTION OF THE INVENTION These and other objects are achieved by means of the fixator release device of the present invention. The fixator release device includes an elongated inner tube that may or may not include a central lumen to accommodate a guidewire. At least a portion of the inner tube is formed from a serpentine wire. The proximal portion of the inner tube may be formed of a hard, preferably metallic, tube. The distal portion of the inner tube may be coated with a suitable polymer, if desired. A flexible external hose can surround the inner tube to limit the fixative in a radically contracted state in the inner tube. When it is desired to deploy the fixative at a treatment site, the external hose is moved proximally with respect to the inner tube to unclog the fixator and allow the fixator to self-expand radially in engagement with the vessel wall. One or more side doors can be formed in the flexible outer hose near its distant end. This allows the radiopaque fluid to be injected through the annular space between the flexible outer hose and the inner tube and exit the side doors adjacent to the fixator during unfolding. As a result, the clinician has the opportunity to observe the fixator during unfolding and ensure that the fixator is properly placed. A small recapturing cuff can be located in the inner tube in the area that holds the fixative.

This recapturing sleeve may have a soft durometer and a plurality of grooves formed therein. This combination of characteristics creates high friction and mechanical interference between the recapture sleeve and the fixer to hold the fixator in the inner tube as the outer tube moves proximally and distantly over most of the length of the fixator. This provides the release device with the "recapturability" feature. In summary, the present invention relates to a device for releasing a radially self-expanding fixer to a remote treatment site in a body passageway, having an elongated inner tube with a distal portion and a proximal portion made of a wire wound in spiral; an outer tube movably around at least part of the inner tube; and a substantially straight elongated wire configured in or out of the spiral wound wire and attached to the spiral wound wire in the distal portion and in the proximal portion of the spiral wound wire. The device may be laterally flexible but in essence it is longitudinally rigid. The straight wire may have a generally circular cross section with a diameter of about 0.127 mm to about 0.254 rom, and the straight wire may have a generally rectangular cross section and sides of about 0.051 mm to about 0.305 mm. The spiral wound wire can have a generally rectangular cross section and sides of about 0.051 m to about 0.406 m. The spiral wound wire can have a generally circular cross section with a diameter of about 0.102 mm to about 0.51 m. The straight wire and / or the spiral wound wire can be made of a material such as stainless steel, a superelastic alloy such as ninitol, nickel and its alloys, or titanium and its alloys. The present invention also relates to a device for releasing a radially self-expanding fixator to a remote treatment site in a passage of the body, having: an elongated inner tube with a distal portion and a proximal portion made of a wire wound in spiral; an outer tube having a distal portion and a proximal portion movably around at least the distal portion of the inner tube wherein the outer tube has at least one side door located in the distal portion of the outer tube; and a substantially elongate straight wire configured in or out of the spiral wound wire and attached to the spiral wound wire at the distal portion and the proximal portion of the spirally wound wire. The present invention also relates to a device for releasing a radially self-expanding fastener to a remote treatment location in a passageway of the body, having an elongated inner tube with a distal portion and a proximal portion made of a spiral wound wire; an outer tube movably around at least part of the inner tube; a substantially straight elongated wire configured in or out of the spiral wound wire and attached to the spiral wound wire in the distal portion and in the proximal portion of the spiral wound wire; and a recapturing sleeve coaxially located along the distal portion and the elongated inner tube. The recapturing sleeve may be made of a tube that has a smooth hardness and may have a plurality of grooves formed therein. The elongated inner tube may be at least partially coated by means of a lubricious material inside, outside, or both internally and externally. The present invention also relates to a method for deploying a radially self-expanding fixator at a remote treatment site in a body passageway, including the steps of inserting a delivery device having an elongate inner tube having a distal portion and a proximal portion made of a coiled wire, an outer tube having a distal portion and a proximal portion movably around at least part of the inner tube wherein the outer tube has at least one side door located in the distal portion of the outer tube, and a substantially straight elongated wire configured in or out of the spirally wound wire and attached to the spiral wound wire at the distal portion and the proximal portion of spiral wound wire; partially unfold the fixator by moving the. external tube in a proximal direction; and injecting radiopaque fluid through an annular space between the inner tube and the outer tube so that the radiopaque fluid flows through at least one side door in the area where the fixator must be deployed.

BRIEF DESCRIPTION OF THE DRAWINGS The above objects and other objects and advantages of this invention will be apparent upon consideration of the following detailed description, taken in conjunction with the accompanying drawings, wherein the reference signals refer to similar parts thereof. The following detailed description and drawings are provided to illustrate, and not limit, the present invention. Figure 1 is a side view, partly in section of a first embodiment of the present invention; Figure 2 is an elongated side view of the distal portion of a second embodiment of the present invention; Figure 3 is a perspective vieta of a recapturing sleeve of the present invention; Figure 4 is a side view of an inner tube of the present invention; Figure 5 is a view taken on line 5-5 of Figure 4; and Figures 6 to 8 are side views of a distal portion of a fastener release device of the present invention of a radially self-expandable fastener in several stages of a fastener deployment operation.

DETAILED DESCRIPTION OF THE INVENTION The following detailed description of the delivery device 20 is based on its use with a self-expanding fixator 10 as described in US Pat. Nos. 4,655,771 and 5,061,275. Said fixer 10 has an interlaced wire mesh structure. However, it should be understood that the delivery device 20 could be used with other radially self-expanding fixators. The fixator 10 is placed in a fixator releasing device 20 in a contracted radial state for delivery to a treatment site in a blood vessel. The fastener 10 is carried by the distal portion of the release device 20. The proximal portion of the release device 20 generally remains outside the body for manipulation by the operator. The delivery device 20 comprises an elongated inner tube 30, preferably having an axially extending lumen 35 therethrough. The tube Inner 30 has a distal portion 32 that is formed from a serpentine wire. This wire forming the distal portion 32 can be wound onto a mandrel with a suitable external diameter such that the resulting streamers are closely spaced similarly to a solid spring. The wire forming the distal portion 32 may have a round or rectangular cross section. A rectangular cross section is preferred due to many reasons. This presents a smoother inner surface to the lumen 35 so that a guidewire can be easily slid through it., if desired. It also minimizes the thickness of the wall of the inner tube 30. The dimensions of the wire can be chosen to maximize the strength and flexibility of the remote portion 32, while minimizing its size. A wire having dimensions of 0.102 mm by 0.305 mm is preferred, although other dimensions may be used depending on the particular application. For example, the spiral wound wire can have a generally rectangular cross section with dimensions of about 0.051 mm to about 0.406 mm. This wire can be formed of any suitable material such as stainless steel, a superelastic alloy such as nitinol, nickel and its alloys or titanium and its alloys. Preferably, stainless steel is used. The spirally wound wire will usually be tightly wound, and in some cases the tangled streamers will be firmly supported one on the other. In some cases, the rolled wire will be wound so that the spaces exist between some or all of the streamers. A straight wire 34 extends through the lumen 35 over a length of the distal portion 32 and is attached thereto at each end. In other embodiments, the straight wire 34 will be configured outside the inner tube 30. In some cases, more than one wire 34 will preferably be configured inside and / or outside the spiral wound wire. The wire 34 prevents the inner tube 30 from unraveling within the body as a spring, and allows the wound wire to remain essentially longitudinally rigid. The wire 34 can be attached to the inner tube 30 by any normal means such as arc welding, welding, brazing or using adhesives. However, laser welding is preferred. It can be attached to one or more points at each end. It will generally be attached at or near the ends of the wound wire, but the joint can alternatively be made away from the ends of the wound wire. Preferably, the wire 34 has a circular cross section with a diameter of 0.165 mm. Generally, diameters of around 0.127 mm to 0.254 mm are adequate. Smaller diameters will generally minimize attachment with a guidewire that can pass through lumen 35. Other dimensions may be used depending on the particular application. The wire 34 may also have a rectangular cross section, and may have sides of about 0.051 m to about 0.305 mm. A suitable polymer such as polyurethane, FEP, PTFE or silicone can be used to coat the outer diameter of the distal portion 32. Said coating can increase the structural strength and can also limit the wire 34 when configured outside the inner tube 30. The cladding the lubricity of the distal portion 32 can also be increased. However, it has been found that an uncoated remote portion 32 is generally sufficiently lubricious and that there is minimal interference with the outer tube 50. The elongated inner tube of the present invention will typically be from about 50 to about 250 crn, depending on the particular indication. The portion made of the spiral wound wire can be the total length of the inner tube or less than the total length. In the case of renal indications, for example, the proximal portion of more than 18-38 cm of inner tube may comprise a tube of rigid material, and the remainder may comprise a spiral wound wire. In some cases, the spiral wound wire will extend into the nearest section of the elongated inner tube and will be configured within a tube of rigid material in the proximal portion. One or more normal radiopaque markers, 36, 37 can be placed on the remote portion 32 so that they are located on one side or on either side of the fixer 10 when it is placed in the remote portion 32.

At its distal end, an inner tube 30 is provided with a tip 31, through which the lumen 35 continues. The tip 31 is preferably capped to facilitate insertion of the delivery device 20 through a narrow opening in a blood vessel. body. It is usually smooth and without sharp edges. The tip 31 is generally flexible so that it can be easily tracked on a guidewire. Preferably, a UV curable adhesive is used to attach the tip 31 to the wound wire forming the distal portion 32. In addition, the tip 31 may be printed on the plasma to provide a clean surface for better adhesion between the serpentine wire and the tip 31. The proximal portion 33 of the inner tube 30 may be formed from a tube of rigid material, such as stainless steel, mixed body, polymer, or some other suitably rigid material. The proximal portion 33, when formed of a rigid material, provides * more "pushability" to the release device 20 and also provides a "work surface" for the unfolding mechanism of the release device 20. Preferably, the adhesive such a cyanoacrylate is used to join the distal end of the proximal portion 36 to the proximal end of the distal portion 32. Preferably, a short, low durometer re-capture sleeve 40 is coaxially located near the distal portion 32. The length of the recapturing cuff 40 should be sufficient to hold the fixer 10 in place. It has been found that the recapturing sleeve 40 is preferably 2 to 3 mm in length. In general, the lengths of 1 rn to the length of the fixer constricted in the release device are adequate. The recapturing sleeve 40 is preferably formed of silicone or other polymer tube material such as polyurethane with a Shore hardness between about 30A and 90A. A low durometer co or such for the recapturing sleeve 40 creates a greater frictional force with the fastener 10 that exists between the outer tube 50 and the fastener 10. The recapturing sleeve 40 is preferably formed with a plurality of grooves formed therein. same. These grooves result in a mechanical interference fit between the fastener 10, and the recapture sleeve 40 is preferably formed with a plurality of grooves formed therein. These grooves result in a mechanical interference fit between the fastener 10 and the recapture sleeve 40 to help hold the fastener 10 in the inner tube 30. In this way, when the fastener 10 has been partially deployed by the proximal movement of the fastener 10. outer tube 50 and it is desired to recapture the fixer 10 to reposition the fixer 10 in the lumen of the body, the outer tube 50 can be moved away from the fixer 10 to reconstruct the fixer 10 in the inner tube 30 without the fixator 10 move axially on the inner tube 30 with the outer tube 50. The exact location of the recapturing sleeve 40 on the inner tube 30 depends on the maximum desired amount at which the fixer 10 can be deployed with the recapturability still possible. Preferably, the recapturing sleeve 40 should be located on the fourth closest to the length of the fixer 10 when it is construed in the inner tube 30, such as about 3-10 mm away from the maximum marker band 36. The outer tube 50 it surrounds the inner tube 30 coaxially. Preferably, the outer tube 50 is formed of any suitable polymer such as polyurethane, polyamide block amide nylon or some other polyamide. The outer tube 50 may be coated on the inside and / or on the outside with a lubricious coating, such as silicone, to facilitate movement in the vessel and during deployment or during the recapturing of the fixer 10. The proximal end of the inner tube 50 is connected to a valve body 60 having a side door 61. This arrangement allows outer tube 50 to be moved from fixer 10 by moving valve body 60 in the proximal direction. The side door 61 allows a fluid such as radiopaque fluid to be injected between the outer tube 50 and the inner tube 30. The valve body 60 preferably extends over the proximal portion 33 of the inner tube 30. This allows the valve body 60 slide easily over the inner tube 30 and secure the inner tube 30 by means of a compression joint and threaded screw knob. The outer tube 50 may include at least one and preferably two side doors 54 located along its distal portion. Additional side doors 54 can also be used. The side doors 54 allow the radiopaque fluid that is injected through the annular space between the outer tube 50 and the inner tube 30 to exit the release device 20 in the region where the fixer 10 is deployed. The side doors 54 are preferably located circumferentially close to the outer tube 50 so that each one is disengaged from the other by 180 °. The use of multiple doors 54 allows the flow of radiopaque fluid from the delivery device 20, even if a door is blocked. The side doors 54 must have a diameter large enough to allow enough radiopaque fluid to flow therefrom to "light up" the area to be treated. It has been found that a diameter of about 0.254 to 0.635 mm, and preferably about 0.381 m is suitable where the delivery device 20 is used to deploy a fixative in the renal artery of a human being. As a result, the physician using the releasing device 20 to deploy the fixator 10 can visualize the fixator 10 under a fluoroscope during the unfolding procedure of the fixator, since the radiopaque fluid will "illuminate" the vessel where the fixator must deploy. In this way, the physician can ensure that the fixator 10 is properly located at the treatment site before completing the unfolding of the fixer 10. The location of the side doors 54 will preferably be close to the distal end of the outer tube 50. Without the doors sideways 54, the radiopaque fluid would generally exit the outer tube 50 at its distal end and flow past the unfolding area of the fastener, due to the flow of fluid from the body passing the release device 20. Having side doors 54 near the distal end of the external tube 50, the radiopaque fluid can flow out of the release device 20 in the exact unfolding area of the fixator. A suitable location for the side doors 54 is approximately 4-10 mm proximal to the distal end of the outer tube 50, and preferably approximately 7 near the distal end of the outer tube 50. The side doors 54 should not interfere with the distal ends and of the fixer 10 during unfolding or recapturing. When the fastener 10 is formed of an interlaced wire structure, the ends of the fastener 10 contain a plurality of exposed wire ends. If the side doors 54 cross over each end of the remote end of the fixer 10, it is possible that one of the exposed wires would mate with one of the side doors 54 and prevent unfolding or recapturing. In this manner, the side doors 54 should be located in the outer tube 50 so that the side doors 54 are close to the distal end of the fastener 10 when the fastener 10 is construed in the inner tube 30 by the outer tube 50 and distant from the proximal end of the fixer 10 when partially deployed in the inner tube 30 by the outer tube 50. To release the fixer 10 to a treatment location in a body vessel, the fixer 10 is placed in a radially compressed state in a coaxial relationship on the remote portion 33. The fixer 10 is construed in the inner tube 30 by the outer tube 50. It is important that the fixator .1.0 is not very tightly limited in the inner tube 30. The outer tube 50 must apply sufficient force to the fixator. 10 to keep the fixer 10 in place. The outer tube 50 can be removed from the relationship surrounding the fastener 10 by pulling the valve body 60 and the outer tube 50 in a proximal direction. Along with the movement of the outer tube 50 in the proximal direction, the distal end of the fixer 10 will be exposed in a radial direction for engagement against the wall of the body vessel. At this point, the radiopaque fluid can be injected into the annular space between the outer tube 50 and the inner tube 30 so that it comes out through the side doors 54. This allows the physician to see the location of the fixator 10 under a fluoroscope. If the clinician observes that the fixator 10 is properly positioned, the outer tube 50 can be moved closer together to further deploy the fixer 10 until the fixer 10 is fully deployed. On the other hand, if the fixer 10 is improperly located, the outer tube 50 can be moved Distantly and / or the inner tube 30 can be moved proximally to recapture the fastener 10 back to the inner tube 30 and under the outer tube 50 for movement to the proper location. A safety stop can be placed on the proximal portion 33 of the proximal inner tube 30 of the valve body 60. The safety stop is comprised of a tubular locking member that prevents movement of the valve body 60 in the proximal direction when the Safety stop is secured in place. In this way, the safety stop can be located so as to prevent the valve body 60 from moving very closely to prevent complete unfolding of the fastener 10. In this way, the operator of the release device 20 must verify the location of the fixer 10 before full unfolding. Another feature of the invention is the use of printed markings in the proximal portion 33. These markings are located so as to give the operator of the release device 20 an indication of the amount to which the fixer 10 has been deployed when the body of valve 60 reaches the markings. In this way, it is observed that a fixator release device is provided to give the physician the opportunity to see the location of the fixator during the unfolding procedure, which allows for the "recapturing" of the fixator and to be flexible and longitudinally rigid. The modalities described are presented for purposes of illustration and not limitation.

Claims (15)

NQVEPflD PE Lfl INVENTION CLAIMS

1. - A device (20) for releasing a radially self-expanding fixer (10) to a remote treatment location in a passageway of the body comprising: an elongated inner tube (30) comprising a spiral wound wire having a distal portion (32) and a proximal portion (33); an outer tube (50) movably around at least a part of the inner tube (30); and a spirally wound straight wire (34) attached to the coiled wire in the distant portion (32) and in the proximal portion (33) thereof.

2. The device (20) according to claim 1, further characterized in that the spirally wound straight wire (34) is formed within the spiral wound wire and the device (20) is laterally flexible but substantially longitudinally rigid.

3. The device (20) according to claim 1, further characterized by the straight wire (34) has a generally circular cross section with a diameter of about 0.127 mm to about 0.254 mm. /

4. The device (20) according to claim 1, further characterized by the straight wire (34) has a generally rectangular cross section and 0 7 It has sides of around 0.051 nm to about 0.305 nm.

5. The device (20) according to claim 1, further characterized in that the spiral wound wire has a generally rectangular cross section and has sides of about 0.051 nm to about 0.406 rn.

6. The device (20) according to claim 1, further characterized in that the spiral wound wire has a generally circular cross section with a diameter of about 0.102 mm to about 0.51 mm.

7. The device (20) according to claim 1, further characterized in that the straight wire (34) and / or the spiral wound wire is formed of a material selected from the group consisting of stainless steel, a superelastic alloy such as nitinol, nickel and its alloys and titanium and its alloys.

8. A device (20) for releasing a radially self-expanding fixator (10) to a remote treatment location in a body passageway comprising: an elongated inner tube (30) having a distal portion and a proximal portion comprising a spiral wound wire having a distal portion and a proximal portion; an outer tube (50) having a distal portion and a proximal portion movably around at least the distal portion of the inner tube wherein the outer tube (50) has at least one side door (54) located in the distal portion of the outer tube (50); and a substantially straight elongate wire (34) attached to the spiral wound wire in the distal portion and the proximal portion thereof.

9. The device (20) according to claim 8, further characterized in that the substantially straight elongated wire (34) is formed within the spiral wound wire and the device (20) is laterally flexible but essentially laterally rigid.

10. A device (20) for releasing a radially self-expanding fixer (10) to a remote treatment location in a body passageway, comprising: an elongated inner tube (30) comprising a spiral wound wire having a distant portion and a proximal portion; an outer tube (50) movably around at least part of the inner tube (30); a substantially straight elongated wire (34) attached to the spiral wound wire in the distal portion and in the proximal portion thereof; and a recapturing sleeve (40) located coaxially on the distal portion (32) of the elongated inner tube (30).

11. The die (20) according to claim 10, further characterized in that the recapturing sleeve (40) is formed of a tube having a smooth durometer and having a plurality of grooves formed therein.

12. - The device (20) according to claim 10, further characterized in that the elongated inner tube (30) has an interior and an exterior and the internal tube (30) is at least partially covered by a lubricious material in the interior, on the outside, or both inside and outside.

13. The device (20) according to claim 10, further characterized in that the substantially straight elongate wire (34) is formed within the spiral wound wire and the device (20) is laterally flexible but substantially longitudinally rigid.

14. A method for deploying a radially self-expanding fixer (10) in a remote place of treatment in a passageway of the body, comprising; inserting a releasing device (20) having an elongated inner tube (30) comprising a spiral wound wire having a distal portion and a proximal portion, an outer tube (50) having a distal portion and a movable proximal portion around at least part of the inner tube (30) wherein the outer tube (50) has at least one side door (54) located in the distal portion of the outer tube (50), and a substantially straight elongated wire (34) ) joined to the spiral wound wire at the distal portion and the proximal portion of the spiral wound wire; partially unfolding the fixator (10) by moving the outer tube (50) in a proximal direction; and injecting the radiopaque fluid through an annular space between the inner tube (30) and the outer tube (50) so that the radiopaque fluid flows through at least one side door (54) in the area where the fixator ( 10) must be displayed.

15. The method according to claim 14, further characterized in that the substantially straight elongated wire (34) is formed within the spiral wound wire and the device (20) is laterally flexible but substantially longitudinally rigid.