MXPA99001501A - Wire device with express end - Google Patents

Abstract

An apparatus and method is described by which a distal end portion of a wire can be deposited at selected sites in body conduits. The apparatus includes an elongated wire having a distal end section for separation and delivery in an objective location, the wire also having a discontinuity located towards the rear of the distal end section for breaking when vibrational energy is applied to the wire. Also, a source of vibrational energy that connects to the proximal end of the wire for the selective application of vibrational energy in the wire is included to travel to the discontinuity and cause the separation of the end section. The discontinuities can take the form of cuts formed in the wire, sections of reduced diameter in the wire, adhesive, welded couplings between the wire and the distal end section, or the transition of the wire into a large mass placed in the extreme section dist

Description

WIRE DEVICE WITH REMOVABLE EXTREME BACKGROUND OF THE INVENTION The present invention relates to a method and apparatus for stringing wires into body cavities and separating end sections of the wire using vibration energy, for example, in the form of elastic waves. Various methods have been developed to occlude and / or stabilize and seal the vasculature of bodily ducts, tissue defects and aneurysms with the use of endovascular catheters including injectable particles, injectable adhesive and releasable coils, and other devices. The use of the detachable coils seems to be gaining wider acceptance for aneurysm therapy, perhaps due to the ease and precision of the controlX of placement and arrangement of the coil at the desired occlusion site. A method for placing and separating the coils at an occlusion site includes the formation of the coil at the distal end of a wire, and then stringing the coil and wire through the catheter until "the coil is placed at the site of the coil. occlusion. An electric current is then applied to the proximal end of the wire and conducted through the wire to the point of origin or junction of the spiral where the spiral is caused, for example, by electrolysis, to separate from the wire. See U.S. Patent Nos. 5,569,245, 5,624,449, 5,122,136, 5,540,680, and 5,354,295. Among the problems associated with the electrically detachable spiral method is the time needed to effect the separation (which changes with the increasing number of devices placed), the unreliability of "that the spiral will separate, the discomfort with the use of a grounding needle (insertable in the patient's muscle) necessary for the proper functioning of the device, the production of particulates from the separation site (electrolysis) and the inability to select the size of the spiral in vivo.

SUMMARY OF THE INVENTION An object of the invention is to provide an apparatus and method for selecly separating an end section of a wire in a body conduit by non-electrical means. It is also an object of the invention to provide this apparatus and method in which the end section of the wire can be easily and reliably separated, regardless of the number of devices placed in. Another objec of the invention is to provide this apparatus and method in which Yet another object of the invention is to provide this apparatus and method, in accordance with one aspect thereof, in which multiple sections of the end segment of the wire can each be selecly separated at different times. of the invention is to provide this apparatus and method in which little preparation of the wire and the end section is required to allow the subsequent use and separation of the end segment It is also an object of the invention to provide this apparatus and method having different types of extreme lightweight sections, the above objecs and other objecs of the invention are made in a specific illustra embodiment of a wire apparatus with the detachable distal end including an elongated wire (solid or hollow) having a distal end section, and a discontinuity located towards the rear of the distal end section to break when vibration energy is applied to it, and a vibrational energy generator to apply the vibrational energy in the wire that travels to the discontinuity and causes the separation of the distal end section. During use, the wire must be threaded or threaded through a vasculature or body duct at a target location, and then vibrational energy will be applied to the wire to make the distal end section separate at the target location to, for example, occlude the conduit. According to one aspect of the invention, the discontinuity could include a cut in the wire, a hole, a section of reduced diameter, a sudden increase in mass, an adhesive, or a joint welded by point to be attached to the section distal end of the wire, or a thermal section, or chemically treated. According to another aspect of the invention, the distal end section could include a plurality of discontinuities, each adapted to be broken at a different vibrational level or frequency, to separate this portion of the distal end section that is distal to the discontinuity that goes to break. According to yet another aspect of the invention, the vibrational energy generator constitutes an ultrasound generator.

BRIEF DESCRIPTION OF THE DRAWINGS The foregoing and other objects, features and advantages of the invention will be more apparent from a consideration of the following detailed description which is presented together with the accompanying drawings, in which: Figure 1 shows a side view , fragmented, in section, showing a wire made according to the principles of the present invention, placed in a catheter in a blood vessel, which the proximal end of X wire is coupled to an ultrasound generator and the distal end of the wire is form in a tangled mass placed in an aneurysm; Figures 2-6 show side views, fragmented of different embodiments to provide the discontinuities to allow separation of the spiral end sections of the placed wires, all in accordance with the principles of the present invention; Figure 7 is a fragmentary, side view of the spiral end sections having a plurality of discontinuities for separation of the tuned resonator, in accordance with the principles of the present invention; Figures 8 and 9 show side, fragmented views of the patterns of guidewire / catheter combinations where the friction between the guidewire and the catheter is minimized; Figure 10 is a graphical view of a wire illustrating the nodal points that respond to the different vibrational frequencies for the separation of the end sections.

DETAILED DESCRIPTION Reference will now be made to the drawings in which "the various elements of the present invention will be given numerical designations and with which the invention will be described to enable one skilled in the art to make and use the invention. Figure 1 shows a side view, in section of a blood vessel 4 in which an aneurysm 8 is shown formed on one side of the vessel A fragmented view of a catheter 12 is shown threaded in vessel 4, with a terminal end 12a positioned adjacent the aneurysm 8. Threaded through X catheter 12 is a wire 16 ("wire" can also "identify any long, solid or hollow prismatic element), which extends completely through catheter 12 and out from the terminal end 12a in the aneurysm 8 (or the inlet thereof) to substantially fill the aneurysm with a rolled end section 16a (the end section 16a can be entangled (formed in different specific shapes, etc., as well as rolled) of the wire 16. What will be known as a discontinuity 20 is formed between the end section 16a of the wire and the rest of the wire 16. The discontinuity 20 can take different forms and structures, but all are designed to break, separate or fractionate when vibrational energy is applied to the wire 16. The source of vibrational energy in the embodiment of Figure 1 is an ultrasound generator 24, but could be something as simple as a striker, mallet, hammer, etc., to strike the wire 16 to cause a vibration or mechanical energy to propagate to the discontinuity 20. In use, the catheter 20 is threaded through a vasculature or body duct to a site in that the end section 16a of the wire is to be placed, such as the aneurysm 8 in Figure 1. The purpose of this placement, "for example, is to provide an occlusion in the conduit to prevent the coagulation of blood from flowing, or, as in the scheme of Figure 1, to scar the aneurysm 8 to thereby fill the aneurysm with scar tissue to prevent swelling of the aneurysm, etc. . The end section 16a is shown to be coiled or entangled, but when it is screwed through the catheter 12, it would be reinforced, but then when the terminal end 12a of the catheter is pushed, the end section would again take on the normally coiled or matted condition., as shown (also favored by the heating of the body). That the end section 16a has been guided to the desired target site, the ultrasound generator 24 would be connected at the proximal end of the wire 16 and an ultrasound signal would be applied thereto. The frequency and amplitude of the signal (observed in a spectrum analyzer 28) would be selected to produce high voltage at discontinuity 20, fatiguing the wire so that it breaks, separates or otherwise breaks up in the discontinuity , leaving the end section 16a in the aneurysm 8. The separation is carried out quickly, reliably and without pain for the individual. Figure 2 shows a fragmented side view of a cut of a wire 30 made, for example, of stainless steel, connected to a tubular end section 30 made, for example, of a nickel titanium or platinum alloy. The terminal end of the wire 30 is of decreasing section, as shown and inserted into a hole 34a in the proximal end of the end section 34, there secured by an adhesive, solder 35. A spiral 36 made, for example, of Stainless steel is welded, or otherwise attached to the terminal end of the wire 30 to favor the bond between the wire and the end section 34. The end section 34 includes a plurality of cuts 37 made to extend generally in the transverse direction in the end section and in accordance with the shape of the end section in a coiled or entangled configuration, and to allow more exposure of the surface area of the end section to the blood to induce coagulation. See co-pending US Patent Application No. 08 / 568,493, filed December 7, 1995, "for a further description of the use of the cuts in the wire to allow for flexibility and form control, while maintaining the dynamic twisting moment Two or more cuts 38 (rotated 90 ° with respect to one another) are shown positioned toward the rear from the plurality of cuts 37 by a distance greater than the distance between cuts 37, and are provided for serving as the discontinuity to break (fatigue) when a vibrational signal is applied to the wire 30. The cuts 30, of course, could be formed at the same time that the other cuts 37 are formed but, for example, could be deeper (cut) thinner) wider or adjacent to a mass 39 placed in the end section 34, or a combination, to separate or break when the vibrational signal is applied to the wire 30. Figure 3 shows a fragmented, lateral view of a cut of another embodiment of a wire with discontinuity according to the present invention. In this, a wire 40 made, for example, of stainless steel, fits into the recess 44a of an end section 44 made, for example, of nickel-titanium alloy wire 40 would be kept in the recess by a adhesive, such as epoxy or cyanoacrylate A plurality of cuts 48 are made in the end section 44 to wind and shape the end section as desired for final placement in a target site in a body duct. 49 is also formed in the wire 40 to provide the desired discontinuity A coiled dough 47 could also be added around the wire 40 to further exaggerate the discontinuity The cut 49 could advantageously be about% of the distance through the wire 40 in the cross direction that serves to break or separate when an ultrasonic signal is applied to the wire Figure 4a shows another modality of a discontinuity between a wire 50 and an end section 54, again includes the cuts 58. The end end of the wire 50 is joined by a section of adhesive 59 at the proximal end of the end section 54. The adhesive 59 is selected to be somewhat brittle, for example, sodium silicate, so that, when an ultrasound signal is applied to the wire 50, the adhesive 59 will fracture to allow the end section 54 to be separated from the wire 50. Otherwise, the section 59 of the wire 50 can be a heat-treated section (including H + embrittlement) to make the brittle wire at this location, or a chemically treated section, eg, etched, to make the wire weaker at the location. Figure 4B shows the discontinuity formed as a gap 51, while Figure 4C shows the discontinuity as a spot weld 53 joining the wire 55 side by side to an end section 56. A coiled dough 57 provides additional discontinuity. The spot welding process heats the wire 55 making it more susceptible to fatigue and breakage. In fact, warming can only be used to create a "discontinuity". Figure 5 shows a discontinuity similar to that of Figure 3, except that the discontinuity does not comprise a cut in the wire 60 or the end section 64. In contrast, the discontinuity is formed in the connection or connection between the wire 60 and the end section 64 wherein the wire is inserted into the recess 64a of the end section and held in place by a blood soluble adhesive 68, such as sodium silicate. When the end section 64 is guided through the blood vessel by the aXambre 60 (i.e., through a catheter inserted into a blood vessel), the blood is introduced into the hollow 64a of the end section 64, together with the blood makes contact with the adhesive 68 at the proximal end of the end section, operates to dissolve the adhesive and allows separation of the end section of the wire. The application of a vibrational signal, such as an ultrasound signal, on the wire 60 accelerates the dissolution and final separation of the end section 64 of the wire 60 to allow placement of the end section at the target site. In fact, it is possible to use two mechanisms to test the separation - providing greater security, guaranteeing separation. The embodiment of Figure 6 includes a wire 70 at the distal end of which a heavy mass of material 74 is placed, preferably wound around the distal end. For example, the mass 74 may include platinum coils. The sudden transition of the wire 70 to the heavy mass 74 provides a discontinuity at the location 78 just behind the mass, so that when the vibrational energy of a certain frequency and amplitude is applied to the wire, the wire breaks at the discontinuity or Stress point 78, releasing mass, 74 at a target site in a body canal. The 70"wire could also be made of platinum, stainless steel or nickel-titanium alloy Figure 7 shows a form of a separable wire 80 having a plurality of longitudinally spaced cuts 84 in sections 86 and 88, which act as separate discontinuities The discontinuities 84 of the section 86 are formed or "tuned" to a predetermined depth, width and / or spacing to break in response to the amplitudes of frequencies different from the vibration energy than the discontinuities of the section 88. this way, the user can selectively apply the vibration energy in the wire 80 to cause a selected section of the discontinuities 84 to break.This breaking can be carried out in a suspensive manner to deposit the wire lengths in different locations in a conduit body to deposit all lengths (to serve as emboli) in one place The "tuning" of the discontinuities 84 is a function of the characteristics of the cuts, but also the lengths of the segment between the discontinuities. This synchronization can be used to "deposit" large numbers of particles as for AVM therapy. The cuts 84 create springs to isolate uncut sections, intermediates of wire 80 that have a mass. When a wave of vibrational energy at the resonant frequency of the spring / mass system is applied on the wire 80, the wire is excited longitudinally and the sections of mass between the cuts vibrate longitudinally at a high amplitude which fatigue the spring elements (location of the cuts) causing them to break. The wire 80 can advantageously be made of stainless steel or nickel titanium alloy. Figures 8 and 9 show fragmentary, cross-sectional side views of a guidewire construction type for transmitting vibrational energy along a wire surrounded by a catheter or sleeve. Referring to Figure 8, a wire 90 positioned within a catheter or sleeve 94 is shown but held without touching the sleeve by supports, eg, in the form of spheres, longitudinally and uniformly spaced along the length of the wire and the sleeve. The supports 98 are placed at nodal velocity points [sic] of the vibrational energy waves which are transmitted along the wire / sleeve combination to make the separation of the end section (not shown). The nodal points of speed, of course, are locations in a mechanical wave where there is little or no movement or velocity of the structure 'carrier of the wave, while the intermediate locations between supports 98 are called antinodes where there is maximum movement of the carrier structure of the wave. By providing the brackets 98, the wire and sleeve are kept separate so as to avoid friction between the two as the wave of vibrational energy travels through the wire / sleeve combination. In this way, little energy is lost along the length of the wire and the sleeve and thus the separation of the extreme section would take less time. Figure 9 is a side view, of a fragmented section of a wire 100 about which a sleeve 104 is placed and between which a hydrophilic coating or lubricant 108 is placed to allow the wire and sleeve to move relative to each other. the other without significant friction and in this way without loss of Xa vibrational energy. Figure 10 shows a graphical representation of a wire 110"having discontinuities 114, 118, and 122 spaced longitudinally along the wire. Graphically superimposed on the wire 110 are three vibrational energy waves 114a, 118a and 122a. To cause the wire 110 to separate into one of the selected discontinuities, a wave of vibrational energy is applied to the wire so that the nodal point of the wave falls into the desired discontinuity. A wave of vibrational energy causes mechanical resonance in the longitudinal direction where the nodal points fall at locations that separate each half wavelength. As mentioned briefly at the beginning, at the nodal points along the wire, the speed or movement of the wire is minimal, but the effort is maximum and so, by applying a wave of vibrational energy, such as wave 114a in the wire 110, since a nodal point of the wave 114a is in the discontinuity 114, the wire would be separated in this location where the greatest effort is occurring and the wire is weaker. In the same way, if it is desired that the separation occur at discontinuity 118, then the wave of vibrational energy 118a would be applied on the wire, and so on. In the manner described, suitable mechanical energy waves can be applied to the wires to cause separation at the selected discontinuities along the wire. The different modalities described above can be used to occlude blood flows, to create scar tissue in aneurysms, in a known way, but the modalities can also be used to separate any type of device with extreme section., such as a tubal block, in a body duct, for example, a fallopian tube, to block the passage of the ovules, to separate the elements that contain drugs for delivery in a target site, and so on. That is, the modalities are not limited only to use in vasculature ducts. It would be desirable to know immediately when the end section of a wire has been separated from the wire so that the wire can be removed from the body conduit. For each of the above-described embodiments "including a laying wire portion and an end section for final separation at a target site, the wire combinations and end sections all have natural or resonant frequencies. In this way, when vibrational energy is applied to a wire, such as in the wire 16 of Figure 1, the resonant frequency of the combination of the wire 16 and the end section 16a will have a certain resonant frequency that can be detected by methods of conventional spectrum analysis. This resonant frequency is shown in the spectrum analyzer 28 but as soon as the end section 16a of the wire is separated from the wire, the resonant frequency of the wire portion is different and will, of course, be displayed in the analyzer 28. In this way, a simple observation of the resonant frequency display in the analyzer 28 will provide a user with instant information of when the end section or spiral has been separated. Instead of the spectrum analyzer 28, a microcontroller may be provided to monitor the resonant frequencies and signal a change in frequency by illuminating a focus or sounding an alarm. In the manner described, a method and apparatus has been described by which an end section of a wire can be easily, reliably and rapidly separated from the wire supply portion, generally without pain for the individual. be in the form of a spiral, mass or other device and can be placed in vasculature ducts or other bodily conduits.The vibrational energy is used to break the discontinuities by separating the supply portion of the wire from the end section and in this way no Electric current of any kind is necessary, making the procedure much safer for the individual It should be understood that the arrangements described above are only illustrative of the application of the principles of the present invention Numerous modifications and alternative arrangements can be devised by the skilled in the art without departing from the spirit and scope of the present invention, and the appended claims are proposed to cover these modifications and arrangements.

Claims (50)

1. A wire apparatus with the detachable distal end, which consists of: an elongated wire, which includes a distal end section for placement and separation in a target body location, the wire includes a discontinuity located toward the back of the distal end section to break when vibrational energy is applied thereto, and the means to selectively apply vibrational energy in the wire to traverse it to the discontinuity and make the separation of the distal end section.

2. The apparatus, as mentioned in claim 1, wherein the discontinuity comprises a cut in the wire.

3. The apparatus, as mentioned in claim 1, wherein the discontinuity comprises a reduced diameter section.

4. The apparatus, as mentioned in claim 1, wherein the discontinuity consists of a thermo-treated section to weaken the wire.

The apparatus, as mentioned in claim 1, wherein the discontinuity comprises a chemically treated section or embrittled H + to weaken the wire.

6. The apparatus, as mentioned in claim 5, wherein the section is chemically etched.

The apparatus, as mentioned in claim 1, wherein the discontinuity consists of a hole extending through the wire.

8. The apparatus, as mentioned in claim 1, wherein the discontinuity consists of an abrupt mass of material in or on the wire.

9. The apparatus, as mentioned in the claim I, wherein the wire includes a first section extending from the proximal end to a terminal end, and wherein the distal end section is coupled to the terminal end, this coupling forming the discontinuity.

10. The apparatus, as mentioned in claim 9, further includes an adhesive junction of the distal end section with the terminal end of the first section.

11. The apparatus, as recited in claim 10, wherein the adhesive is soluble in blood.

12. The apparatus, as mentioned in the claim II, wherein the adhesive comprises a sugar-based adhesive.

The apparatus, as mentioned in claim 10, wherein the adhesive forms a brittle joint.

14. The apparatus, as mentioned in claim 13, wherein the adhesive comprises water-soluble vitreous adhesive.

15. The apparatus, as recited in claim 9, further includes welding the distal end section at the terminal end of the first section.

16. The apparatus, as mentioned in claim 9, further includes a welded joint joining the distal end section with the terminal end of the first section.

The apparatus, as recited in claim 1, wherein the wire includes a first section extending from the proximal end to a terminal end, wherein the distal end section engages the terminal end, and wherein the The distal end section includes a plurality of generally transverse cuts longitudinally spaced along the distal end section to control the lateral flexibility of the distal end section, with at least one of the cuts being closer to the coupling between the first section and the section. distal end than the other cuts and being a predetermined distance apart from the other cuts, forming at least one cut the discontinuity.

18. The apparatus, as mentioned in claim 17, wherein the at least one cut is deeper than the other cuts.

19. The apparatus, as mentioned in claim 17, wherein the at least one cut is wider than the other cuts.

The apparatus, as mentioned in claim 17, wherein the first section is constructed of stainless steel, and wherein the distal end section is constructed of nickel-titanium alloy.

21. The apparatus, as mentioned in claim 17, wherein the at least one cut is coxta to a depth to facilitate the breaking of the distal end section at the location of at least one cut when vibrational energy is applied thereto.

22. The apparatus, as mentioned in claim 1, wherein the wire, except for the distal end section, is formed of stainless steel, and wherein the distal end section is formed of nickel-titanium alloy.

23. The apparatus, as recited in claim 1, wherein the means for applying the vibrational energy comprises an ultrasonic generator engageable with the distal end of the wire.

The apparatus, as mentioned in claim 1, wherein the means for applying the vibrational energy comprises the means by which the proximal end of the wire can be mechanically tapped.

25. The apparatus, as mentioned in claim 1, wherein the wire is a solid wire.

26. The apparatus, as mentioned in claim 1, wherein the wire is a tubular wire.

27. The apparatus for vascular occlusion comprising: a wire for screwing into a vasculature conduit for an occlusion site, a distal end coupled to the wire and adapted for separation when mechanical energy is applied to the proximal end of the wire; and a mechanical power generator may be attached at the proximal end of the wire to selectively apply mechanical energy thereto, to cause separation of the distal end for disposition at the occlusion site.

28. The apparatus, as mentioned in the claim 27, further comprises the discontinuity means located at or near the coupling of the distal end of the wire, which, when mechanical energy is applied thereto, is broken.

29. The apparatus, as mentioned in claim 28, wherein the discontinuity means is located in the wire.

30. The apparatus, as mentioned in the claim 28, wherein the discontinuity means is located at the distal end.

31. The apparatus, as mentioned in claim 8, wherein the discontinuity means comprises a generally transverse cut.

32. The apparatus, as recited in claim 228, wherein the discontinuity means comprises a fragile adhesive bond coupling the distal end with the wire.

33. The apparatus, as mentioned in claim 28, wherein the one wherein the discontinuity means comprises a blood-soluble adhesive bond coupling the distal end with the wire.

34. The apparatus, as recited in claim 28, wherein the discontinuity means comprises a solder joint coupling the distal end with the wire.

35. The apparatus, as mentioned in claim 28, wherein the discontinuity means comprises a welded joint coupling the distal end with the wire.

36. The apparatus, as mentioned in claim 28, wherein the discontinuity means comprises a section of reduced diameter of the wire.

37. The apparatus, as mentioned in claim 28, wherein the discontinuity means comprises a weakened, heat-treated section of the wire.

38. The apparatus, as recited in claim 28, wherein the discontinuity means comprises a chemically etched section of the wire.

39. The apparatus, as mentioned in claim 28, wherein the discontinuity means comprises a mass attached to the wire.

40. The apparatus, as recited in claim 28, wherein the distal end is composed of a material formed to be wound when it is free, and is selected from the group consisting of nickel-titanium alloy and platinum.

41. The apparatus, as mentioned in claim 28, wherein the mechanical energy generator comprises an ultrasound generator, wherein the wire and the distal end, when coupled, exhibit a first resonant frequency when ultrasonic energy is applied. At the same time, and a second resonant frequency when the distal end is separated, the apparatus further includes the means which can be attached to the proximal end of the wire to detect and display the resonant energy exhibited by the wire.

42. The apparatus, as mentioned in claim 27, wherein the distal end comprises a mass sufficiently greater than the mass of the wire, so that the mass of the distal end is separated from the wire when mechanical energy is applied at the proximal end of the wire.

43. The apparatus, as mentioned in claim 42, wherein the mass at the distal end is composed of platinum.

44. The apparatus for selectively occluding the body cavities comprises: a wire for screwing into a body cavity, the wire including a distal end section having a plurality of spaced apart discontinuities to define segments between these, each discontinuity adapted to separate when a selected vibrational energy frequency is applied to it, and the means to apply selected vibrational energy frequencies at a proximal end of the wire to cause at least some of the discontinuities to be separated and thus Separate the segment or segments located distally from the separated discontinuities.

45. The apparatus, as recited in claim 44, wherein each discontinuity is adapted to break in response to a different energy frequency.

46. The apparatus, as mentioned in claim 44, wherein the means for applying the vibrational energy frequency comprises an ultrasound generator.

47. The apparatus, as recited in claim 44, wherein the means for applying the vibrational energy frequency is adapted to apply the vibrational energy frequencies in the wire, such that one or more selected discontinuities are broken.

48. A method of positioning an occlusive implement at a target location in a vasculature conduit comprises: (a) winding an elongate wire in the vasculature conduit such that a distal end, which forms an occlusive element, is placed in the target location, the distal end of the wire being detachable when ultrasound energy is applied to the wire, (b) applying an ultrasound signal on the wire to make the distal end thereof separate at the target location, and (c) Separate the wire from the vasculature conduit, leaving the distal end at the target location.

49. A method for separating the terminal end of a wire at a target vasculature site "comprising the steps of: (a) guiding the terminal end of the wire towards the target site, and (b) applying an ultrasound signal to the target site. wire to make the terminal end thereof separate at the target site.

50. The method, as recited in claim 49, wherein step (b) comprises applying the ultrasound signal in a discontinuity formed in the wire in a position proximal to the terminal end.