This invention relates to surgical instruments, and more particularly to endovascular snaring instruments.
A clot in a patient's blood vessel poses grave risks for those portions of a patient's anatomy that are downstream from the clot. Because a clot can inhibit blood flow, cells that rely for their nourishment on blood passing through the obstructed vessel can die. If those cells are particularly essential to life, such as cells associated with the brain or the heart, the patient can also die.
When a blood clot is small relative to the blood vessel, or where the clot is obstructing a relatively minor blood vessel, the patient is generally in no immediate danger. Nevertheless, there does exist the more insidious danger of the blood clot becoming detached and coming to rest again in another blood vessel in which its obstructive effect is less benign. Additionally, there exists the danger that small blood clots migrating through the circulatory system will coalesce with a stationary clot and thereby cause it to enlarge by accretion. When this occurs, a clot of negligible size can grow into a significant obstruction. This growth can occur rapidly because as the clot grows, it introduces more turbulence into the blood flow. This turbulence tends to break up thrombocytes as they pass through the turbulent zone, thereby causing additional clotting.
Conventional methods of removing a blood clot rely on the introduction of medicaments, such as enzymes, that dissolve blood clots. Because the enzymes, such as streptokinase, are introduced into the bloodstream, their effects are systemic rather than local. In addition, the process of dissolving a clot is a time-consuming one during which the patient continues to be in some danger.
Mechanical methods of removing a blood clot have been generally unsuccessful because of the fragility of the clot. When disturbed by a conventional mechanical device, a clot can easily fragment into smaller clots, each of which then begins migrating through the blood stream before settling at an unpredictable location.
The invention is based on the recognition that the effective capture area of a snare can be increased by incorporating certain structures on that portion of the snare that is intended to ensnare an object.
In one aspect, the invention features a snare including a support defining an axis, a capture-area enhancer coupled to a flexible section on the support; a core-wire extending along the axis and anchored to the flexible section, and an actuator engaged to a proximal end of the core-wire. The core-wire has a first state, in which it defines a first path and a second state, in which it defines a second path. The actuator selectively causes the core-wire to transition between the first state and the second state.
In some embodiments, the first state of the core-wire is a relaxed state and the second state of the core-wire is a tensioned state.
Embodiments also include those in which the capture-area enhancer includes a plurality of threads attached to the flexible section, those in which the capture-area enhancer includes a sock, for example a nitinol mesh sock or a polymer sock, that covers the flexible section, those in which the capture-area enhancer includes a suture wound on the flexible section, those in which the capture-area enhancer includes a spiny coating on the flexible section, and those in which the capture-area enhancer includes a hydrogel coating on the flexible section.
Additional embodiments include those having a drug-releasing polymer coating on the flexible section.
Yet other embodiments include those having an additional core-wire extending along the axis and anchored to the flexible section and an additional actuator engaged to a proximal end of the additional core-wire. The additional core-wire has a first state, in which it defines an additional first path, and a second state, in which it defines an additional second path. The additional actuator selectively causes the additional core-wire to transition from the first state to the second state.
Other embodiments include a power source in electrical communication with the core wire. The power source provides current to heat the core wire, thereby causing the core wire to transition between the first and second state.
In another aspect, the invention features a snare including a support defining an axis, and a capture area enhancer coupled to a flexible distal section of the support. The flexible distal section has an uncompressed state and a compressed state, and defines a first path relative to the axis when in the compressed state. The snare also includes a core-wire extending along the axis and anchored to the flexible distal section. The core-wire has a relaxed state and a tensioned state, and defines a second path relative to the axis when in the relaxed state. The snare also includes an actuator engaged to a proximal end of the core-wire for selectively applying a tensile force thereto. The tensile force causes the core-wire to transition from its relaxed state, in which the flexible distal section is in its uncompressed state, to its tensioned state, in which the flexible distal section is in its compressed state.
Embodiments of the invention include those in which the capture-area enhancer includes a plurality of threads attached to the distal section, those in which the capture-area enhancer includes a sock covering the distal section, those in which the capture-area enhancer includes a hydrogel coating on the distal section, those in which the capture-area enhancer includes a suture wound on the distal section, and those in which the capture-area enhancer includes a spiny coating on the distal section.
In yet another aspect, the invention features a surgical snare for ensnaring an object in a patient. The snare includes a flexible section that selectively switches between an insertion shape and an ensnaring shape; and a capture-area enhancer configured to deploy when the flexible section assumes the ensnaring shape.
Other features and advantages of the invention will be apparent from the following detailed description, and from the claims. The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.
Surgical instruments described herein use an inhomogeneous core-wire that, when subjected to a pulling force, stretches by different amounts at different locations. At least one portion of the wire has a relaxed state in which it takes the shape of a coil and a tensioned state in which it becomes straight. This portion of the wire is attached to and controls the shape of a flexible portion of the instrument. The tension on the core-wire is controlled by a surgeon selectively pulling and releasing the wire.
Referring to
The cannula 12 in the illustrated embodiment is tubular. However, this is not a requirement. The function of the cannula 12 is to support the flexible section 18 when the surgeon applies a force sufficient to toggle the flexible section 18 into its extended state. The cannula 12 can be a metal, such as nitinol, stainless steels, or MP35N®. The cannula 12 can also be made from a polymer, constructed from polyimide, any of the various nylons and polytetrafluoroethylenes such as those sold under the trade name TEFLON®; or it can be a composite tube made from any number of polymers. In addition, the cannula 12 can encapsulate a metallic spring, braid, or similar structure. In some embodiments, the cannula 12 is integral with the flexible section 18.
In the particular embodiment shown by
To enable a surgeon to track the position of the instrument 10 within the body, the flexible section 18 can be made of a radio-opaque material such as Pt, W, Ir, Tn, Au, Ag, or an alloy thereof. Alternatively, the flexible section 18 can be made of coilable polymer, stainless steel, MP35N®, or similar a substance, in which case the flexible section 18 is coated with a radio-opaque coating. The flexible section 18 may be a close wound coil, with or without preload, or it may be an open wound coil. The flexible section 18 can also include baffles, bellows, or any such flexible and compressible member.
A cut-away view of the surgical instrument 10 shown in
The core-wire 26 is preferably made of a shaped-memory and super-elastic alloy. Such a metal has the property that when deformed and heated past a critical temperature, it “remembers” its deformed shape. When cooled and subjected to further deformation, such a wire springs back to this remembered shape. A suitable super-elastic metal from which the core-wire can be manufactured is a nickel-titanium alloy sold under the trade name nitinol. In the case of nickel-titanium alloy, the critical temperature is in the neighborhood of 700 degrees Fahrenheit. However, other materials can be used, each with a different critical temperature.
Because the core-wire 26 is anchored to both the end-cap 20 of the flexible section 18 and to the actuator 24, and because the flexible section 18 is flexible, the core-wire 26 and the flexible section 18 follow the same path relative to the axis. When the core-wire 26 is in its coiled state, as shown in
As shown in
For a given tensile force, the extent to which a material is stretched depends on its cross-sectional area. This phenomenon is familiar to anyone who has pulled on a piece of taffy and observed that the thin section is far easier to stretch than the thick section. The extent to which the material is stretched is referred to as “strain.” The cause of strain is “stress,” a quantity which, like pressure, is a force per unit area. Stress can be thought of as pressure acting in the opposite direction. Whereas an applied pressure tends to compress a material, an applied stress tends to stretch a material.
For many materials, no significant strain occurs until a threshold of tensile force is reached. Once that threshold is reached, the material responds readily to additional force. This threshold at which a material begins to respond to an applied tensile force is referred to as the “yield force” of the material.
As noted above, the core-wire 26 transitions from a coiled state to an extended state because the distal section 38 of the core-wire 26 and the proximal section 36 of the core-wire 26 have different yield forces. This difference in yield forces can be achieved by having a core-wire 26 in which the distal section 38 has a smaller cross-sectional area than the proximal section 36. A differential yield force in the core-wire 26 can also be achieved by having the distal and proximal sections 38, 36 of the core-wire 26 be made of different materials. In such an embodiment, the proximal section 36 would be made of a first material that experiences a negligible amount of strain for a given applied stress. The distal section 38 could then be made of a super-elastic material that stretches readily in response to the same applied stress. The proximal and distal sections 36, 38 of the core-wire 26 could then have the same cross-sectional area but would nevertheless experience different strains when a tensile force is applied to the core-wire 26.
When a surgeon applies a proximally directed tensile force along the core-wire 26, that force causes a stress at each point on the core-wire 26. Because the distal section 38 of the core-wire 26 has a smaller cross-section than the proximal section 36 of the core-wire 26, the stress experienced by those points in the distal section 38 is greater than that experienced by those points in the proximal section 36. Since strain depends on stress, the distal section 38 of the core-wire 26 undergoes more strain than the proximal section 36 of the core-wire 26, and thus becomes significantly longer. This causes the distal section 38 of the core-wire 26 to extend. In this extended state, the core-wire 26 no longer constrains the flexible section 18 to follow a coiled path. The flexible section 18 is thus free to revert to its equilibrium compressed state in which it extends along the axis, as shown in
When the surgeon removes the proximally-directed longitudinal force, hereafter referred to as the “tensile force,” on the core-wire 26, the distal section 38 of the core-wire 26 reverts to its relaxed state in which it defines a coiled path. Because the core-wire 26 is anchored to the flexible section 18, it constrains the flexible section 18 to follow the coiled path, as shown in
The actuator 24 can be a handle with a trigger 27 as shown in
In those embodiments in which the core wire 26 is a wire made of a single material, the diameter of the wire varies along its length. The ratio of the cross-sectional areas of the proximal and distal sections 36, 38 of the core-wire 26 will depend on the material properties of the core-wire 26. The ratio is selected such that a suitable differential strain can be achieved with only a modest exertion of force. The diameters of the two sections of the core-wire 26 are such that the applied tensile force will be insufficient for the core-wire 26 to lose the memory of its remembered shape. In general, this means that the tensile force must be such that the distal section 38 is elongated by less than 8% of its relaxed length, and preferably within 2% to 7% of its relaxed length.
There exist a variety of methods for manufacturing a core-wire 26 having two or more sections that differ in their yield forces. In one method, a continuous wire made of a shaped-memory metal is ground to a smaller diameter to form the distal section 38. The distal section 38 is then heat-set to the desired shape. To achieve actuation of the core-wire 26, there must be a sufficient difference in the yield force of the proximal section 36 and the yield force of the distal section 38. This is achieved by ensuring that the ratio of the diameter of the proximal section 36 to that of the distal section 38 is about 1.35 or greater. For a core-wire 26 having a non-circular cross-section, this is achieved by ensuring that the ratio of the cross-sectional area of the proximal section 36 to that of the distal section 38 is about 1.8 or greater.
The actual transition from one state to another can be viewed as a wave traveling along the core-wire 26. The direction in which this wave travels can be controlled by controlling the taper of the transition between the proximal section 36 and the distal section 38. In the case of a taper as shown in
A surgical instrument 10 as described above is also described in U.S. Pat. Nos. 6,500,185 and 6,652,536, the contents of which are herein incorporated by reference.
Various modifications to the surgical instrument 10 include the following:
In one variation, the flexible section 18 is used to deliver medication. This can be achieved by coating the flexible section 18 with a polymer and incorporating a drug into that polymer. Suitable drugs that may be embedded in a polymer include heparin, nitrous oxide, thrombolytic medications, and anti-platelet medications, Plavix Aspirin tissue plasmagen activator (“TPA”) Urokinase Retavase Reopro, Integrilin, and Angiomax.
A variety of polymers can be used as a coating. Exemplary polymers include hydrophilic polymers, such as polyvinyl alcohol, polyacrylic acid, polyacrylic acid amide polyethylene oxide, polyethylene glycol, copolymers of polyethylene oxide (“PEO”) and polypropylene oxide (“PPO”) with urethane, such as those sold under the trade name TECOGEL or TECOPHILIC by Thermedics Detection Inc. of 207 Lowell Street, Wilmington, Mass., and HYDROMED® copolymeric urethanes sold by Carbomedics of 1300 East Anderson Lane, Austin, Tex., that swell when in contact with bodily fluids, including blood, and release drug by a dissolution of the drug into the blood. Other substances suitable for use as a coating include hydrogels such as alginates, collagen, gelatin, albumin or dextran derivatives.
Also suitable for use as a coating are hydrophobic polymers. These hydrophobic polymers release lipophilic drugs by dissolution into lipids or other drug dissolving components. Exemplary polymers include polybutylacrylate copolymers, polystyrene isobutylene copolymers, poly styrene isobutylene styrene copolymers and styrene butadiene copolymers.
2. Snare with Capture-Area Enhancement
The flexible section 18 can also be modified by the addition of a capture-area enhancer to provide greater surface area, or capture area, for capture of blood clots or other objects. Such capture-area enhancers are configured to deploy when the flexible section 18 assumes its ensnaring shape.
Examples of capture-area enhancers include threads 40, as shown in
Other examples include a spiny coating 44, such as that shown in
Other modifications include the placement of a sock 48 over the flexible section 18. Exemplary socks 48 include those made of nitinol mesh, as shown in
Capture-area enhancers such as those described above, spread the force exerted by a snared object on the flexible section 18 over a greater surface area. This reduces the likelihood that the snared object will disintegrate into smaller objects that elude the snare. Additionally, the capture-area enhancers shown herein effectively fill in gaps between adjacent turns of the flexible section 18, thereby increasing the likelihood that stray fragments that might otherwise escape through those gaps will ultimately be captured.
3. Snare with Multiple Core-Wires
In another embodiment, shown in
The configuration shown in
The four different paths shown in
In some embodiments, the core wires 50, 52 have different lengths. For example,
Multiple core wire embodiments, are useful for creating a grasping mechanism, such as a claw or an articulating member, that can assume several distinct shapes. Such embodiments provide increasingly prehensile snares.
FIG 10A shows the shape assumed by the flexible section 18 when both the first and second core-wires 50, 52 are relaxed.
4. Snare with Loosely-Wound Distal Section
In some snares, the flexible section 18 tends to resist the core-wire 26 as the core-wire 26 transitions into its relaxed state. This difficulty arises when the flexible section is a close wound coil as shown in
To avoid this difficulty, certain embodiments of the snare feature a flexible section 18, as shown in
5. Guide Catheter with Expandable Distal Segment
To deliver a snare to a site at which a clot is located, one typically introduces the snare through a guide catheter. Typically, the guide catheter is barely wide enough to accommodate the snare with its flexible section 18 in the low-profile tensioned state.
Once the snare captures a clot, it is in its relaxed high-profile state. With this being the case, the flexible section 18 is too big to be retracted into the guide catheter. As a result, the guide catheter and the snare are removed with the flexible section 18 of the snare, and its captured clot, still hanging outside the catheter. During this removal procedure, there exists a risk that portions of the clot may break off and cause difficulties elsewhere in the patient.
A guide catheter with an expandable distal segment circumvents this difficulty. One example of such a catheter, or other tubular member, as shown in
The nitinol coil 60 is connected to an electrical power source 63, such as a battery, that provides current for heating the coil 60. When the coil 60 is heated past its Aƒ temperature, it transitions into a super-elastic state. As the coil 60 is heated past its transition temperature, it assumes a new shape, show in
The elastomer 61 may be a drug eluting polymer with a time releasing capability for releasing any combination of the drugs described above.
6. Snare with Variable Strength Distal Segment
Another difficulty associated with withdrawal of an ensnared clot is that the core-wire 26 in its relaxed state has a tendency to stretch when subjected to relatively small forces. As a result, in the course of withdrawing the ensnared clot, it is possible for the snare to deform when it encounters an obstacle. This may result in loosening the grip that the snare has on the clot, which in turn may cause portions of the clot to escape.
To avoid this difficulty, it is desirable to maintain the snare in its relaxed state, but to strengthen the material so that it does not readily deform when in its relaxed state. In the snares shown in
To use the snare, one turns the current off and ensnares the clot. Then, with the clot safely ensnared, one allows the current to flow, thereby heating the distal section 38 of the core-wire 26 past its Aƒ temperature and causing the distal tip to stiffen. The snare, with the ensnared clot, is then withdrawn.
A suitable snare device has a nitinol corewire 26 with an Aƒ near 40-41 degrees C and a cross-sectional area that is smaller at the distal region than at the proximal region.
During insertion and delivery, the tip is made straight. In this configuration, it is desirable for the distal section to have low stiffness so as to be atraumatic.
A core-wire 26 can be made to have this property by reducing the product of the core-wire cross-sectional area and the tensile loading plateau. However, doing so compromises the snare's ability to grab and retrieve.
To negate this compromise, heat may be applied to the distal, coiled segment of the nitinol core-wire 26, resulting in a coiled core-wire 26.
One way to heat the core-wire 26 is to provide a switch 68 to connect a battery 62 between the support member, e.g. the flexible section 18, and the core-wire 26, as shown in
Another way to heat the core-wire 26 is to use the patient as part of the circuit, as shown in
This application claims priority under 35 U.S.C. § 119 to U.S. Provisional Patent Application Ser. No. 60/648,891, filed Feb. 1, 2005, the entire contents of which are hereby incorporated by reference.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/US06/03661 | 2/1/2006 | WO | 00 | 3/26/2008 |
Number | Date | Country | |
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60648891 | Feb 2005 | US |