Implant Delivery System

Abstract

An implant delivery system having an implant-pusher junction that has improved flexibility due to a shortened heater and tapered marker band. The heater capsule includes a coil having a complex shape made possible through additive manufacturing. The complex shape generates increased heat over a shorter length when compared to traditional linear coils. The marker band includes a tapered end that allows the implant to pivot relative to the pusher.

Claims

1. An implant delivery system comprising: a pusher; a heater capsule at a distal end of the pusher and including: an outer capsule; a heater element defining a plurality of planes, each plane including an inner ring and an outer ring, wherein one of said inner ring and said outer ring of each plane is connected to an inner ring or an outer ring, respectively, of an adjacent plane, said heater element further having an electrical connection to said outer capsule; a first lead wire connected to said heater element; a second lead wire connected to said outer capsule.

2. The implant delivery system of claim 1 wherein said first lead wire comprises a positive lead wire.

3. The implant delivery system of claim 1 further comprising at least one insulative layer disposed between two of said planes.

4. The implant delivery system of claim 1 wherein said heater element defines an internal passage.

5. The implant delivery system of claim 4 wherein said internal passage is sized to receive a tether.

6. The implant delivery system of claim 1 wherein said outer capsule includes tabs used for electrically attaching said second lead wire to said outer capsule.

7. The implant delivery system of claim 1 wherein said heater element includes tabs used for electrically attaching said first lead wire to said heater element.

8. The implant delivery system of claim 1 further comprising a stretch-resistant wire extending through said pusher to said outer capsule.

9. The implant delivery system of claim 8 wherein said outer capsule includes tabs used for attaching said stretch-resistant wire to said outer capsule.

10. A flexible junction between a pusher and an implantable coil comprising: a delivery pusher having a heater capsule at least partially contained within a distal end thereof and including: an outer capsule; a heater element contained within said outer capsule having a C-shape and defining a plurality of planes, each plane including an inner ring and an outer ring, wherein one of said inner ring and said outer ring of each plane is connected to an inner ring or an outer ring, respectively, of an adjacent plane, said heater element further having an electrical connection to said outer capsule; an implantable coil having a marker band at a proximal end thereof, said marker band including a proximally tapered end configured to pivot within a distal structure of said pusher.

11. The flexible junction of claim 10 wherein said heater element is connectable to a first lead wire.

12. The flexible junction of claim 10 wherein said outer capsule is connectable to a second lead wire.

13. The flexible junction of claim 10 further comprising at least one insulative layer disposed between two of said planes.

14. The flexible junction of claim 10 wherein said heater element defines an internal passage.

15. The flexible junction of claim 14 wherein said internal passage is sized to receive a tether.

16. The implant delivery system of claim 10 further comprising a stretch-resistant wire extending through said delivery pusher to said outer capsule.

17. The implant delivery system of claim 16 wherein said outer capsule includes tabs used for attaching said stretch-resistant wire to said outer capsule.

18. A marker for an implant comprising: a distal portion; a proximal portion attached to the distal portion, said proximal portion tapering proximally such that when at least partially inserted into a junction of a pusher, said taper allows said marker to pivot relative to said pusher.

19. The marker of claim 18 wherein said distal portion has a diameter smaller than a diameter of said proximal portion.

20. The marker of claim 18 wherein said distal portion is sized to fit within an implantable coil.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] These and other aspects, features and advantages of which embodiments of the invention are capable of will be apparent and elucidated from the following description of embodiments of the present invention, reference being made to the accompanying drawings, in which:

[0015] FIG. 1 is a perspective view of an embodiment of a heater element of the invention;

[0016] FIG. 2 is a perspective view of an embodiment of a heater capsule of the invention;

[0017] FIG. 3 is a transparent perspective view of an embodiment of a heater capsule of the invention;

[0018] FIG. 4 is a transparent plan view of an embodiment of a pusher of the invention;

[0019] FIG. 5 is a plan view of an embodiment of a marker band of the invention inserted into a proximal end of an implantable coil;

[0020] FIG. 6 is a transparent elevation of an embodiment of a marker band of the invention inserted into a proximal end of an implantable coil; and,

[0021] FIG. 7 is a plan view of an embodiment of a marker band of the invention connected to a pusher.

DETAILED DESCRIPTION OF THE INVENTION

[0022] Specific embodiments of the invention will now be described with reference to the accompanying drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. The terminology used in the detailed description of the embodiments illustrated in the accompanying drawings is not intended to be limiting of the invention. In the drawings, like numbers refer to like elements.

[0023] FIG. 1 shows an embodiment of a heater element 10 in accordance with the present invention. The heater element is a complex shape formed through an additive manufacturing process such as 3D printing.

[0024] This heater element embodiment 10 is of a unitary construction and includes a complex, double element. The double element is a continuous length of material that begins at a distal tab 12 and extends in a first plane 14A around an outer ring 16A of the C-shape, or incomplete circle shape, and then turns inwardly to form an inner ring 18A of the C-shape, in the same first plane 14A. The inner ring extends back to the other end of the C, adjacent the tab 12, at which point the element plane connects to an adjacent, second plane 14B and forms another C-shaped layer, beginning this time with the inner ring 18B and ending with an outer ring 16B. This pattern is repeated until a number of planes (six planes 14A-F are shown in the example of FIG. 1) are formed sufficient to generate enough heat to break a tether that extends through the heater and is used to connect the implant to the pusher. This repeating pattern with inner and outer rings effectively doubles the amount of element length for a given length of the heater 10. As such, the heating element 10 of the present invention can generate as much heat as a conventional heating element having twice the longitudinal length.

[0025] Through additive manufacturing, alternative complex element shapes could be developed that would not be possible with more conventional manufacturing methods. One skilled in the art will realize the present invention should not be construed to be limited to the C-shaped embodiment of FIG. 1. This is just an example of a double-layer, nested element design that generates significant heat over a short longitudinal length. Other examples may include, but are not limited to, planar wave designs, vertical wave designs, triple-nested designs, angled planes, etc.

[0026] According to one embodiment, the heater element 10 defines an internal passage 20. The internal passage 20 may be sized to solely contain a tether connecting the implant to the pusher 60. According to another embodiment, the internal passage 20 may be large enough to contain the tether and other components, such as a support mandrel or electrical wires.

[0027] A proximal end 22 of the heater element 10 includes a passage 24 defined between tabs 26. The passage 24 is sized to receive a lead wire 68 (FIG. 4). In the example provided, the lead wire 68 is a positive lead wire. The tabs 26 are for use in joining methods such as laser welding, soldering, or the like. In one non-limiting example, the passage 24 between the tabs 26 is sized such that the terminal lead wire 68 has a friction fit between the tabs 26. Thus, the tabs 26 may hold the terminal lead wire 68 in place during a laser welding operation or other joining method. Alternatively, the tabs may be spaced apart wider than the lead wire to allow ease of insertion.

[0028] FIGS. 2 and 3 show an embodiment of a heater element 10 as part of a heater capsule 30 of the invention. The heater capsule 30 may be used with a pusher 60 (FIG. 4) usable to deliver an embolic coil to a treatment site, such as an aneurysm. The heater capsule 30 generally includes an outer capsule 32 at least partially surrounding an inner heater element 10. The outer capsule 32 functions to protect the inner heater element 10 and is configured to mate with the distal end 62 of the pusher 60, as shown in FIG. 4. Once installed in the pusher, the heater capsule can be used to release an implant from a pusher, as shown FIG. 20 of U.S. Pat. No. 9,867,622 to Bowman.

[0029] In the embodiment of FIG. 2, the outer capsule 32 includes a body 34 and a cap 36. The body 34 has openings 38 and 40 at a proximal end 42 of the body 34, opposite the cap 36, which is at a distal end 44 of the body 34. The openings 38 and 40 are sized to receive wires, such as terminal leads, and include protruding tabs 46 and 48 for use in joining the leads to the tabs through the use of methods such as laser welding, soldering, or the like.

[0030] In one embodiment, opening 38 is used to receive a negative terminal lead wire 66 (FIG. 4) used in completing a circuit that provides power to the heater capsule 30. Thus, the outer capsule 32 is constructed of an electrically conductive material such as copper, silver, steel, brass, gold, and alloys thereof, just to name some non-limiting examples. Non-metallic electrically conductive materials may also be used. The opening 38 is defined by the gap between the tabs 46 and is sized to receive the terminal lead wire 66. In one example, the gap between the tabs 46 is sized such that the terminal lead wire 66 has a friction fit between the tabs 46. Thus, the tabs 46 may hold the terminal lead wire 66 in place during the laser welding operation or other joining method.

[0031] Opening 40 may be used to attach a stretch-resistant wire 64 (FIG. 2) that extends proximally through the pusher 60. The stretch resistant wire 64 may prevent a coil 61 of the pusher 60 from unduly stretching during movement within a patient. In one example, this stretch-resistant wire 64 is a stainless steel wire which can be welded to the tabs 48 using laser-welding. The stretch resistant wire 64 may also be a polymer tether. The opening 40 is defined by a gap between the tabs 48 and is sized to receive the stretch-resistant wire 64. In one example, the gap between the tabs 48 is sized such that the stretch-resistant wire 64 has a friction fit between the tabs 48 such that the tabs 48 may hold the stretch-resistant wire 64 in place during the laser welding operation or other joining method. Alternatively, the tabs may be spaced apart wider than the lead wire to allow ease of insertion.

[0032] The cap 36 of the capsule 32 defines a lumen 50, through which a tether is routed for connecting the implant to the pusher 60. The lumen 50 may have a diameter that matches or approximates the diameter of the internal passage 20 of the heater element 10. The tether passes through the heater 10 and is severed, melted or broken by the heater 10 when the heater 10 is activated in order to release the implant. The cap has a diameter that is greater than the capsule body 34 such that an overhang 52 is created. The overhang 52 acts as a stop against the pusher 60 when the capsule 32 is inserted into the distal end 62 of the pusher coil 61. A protrusion 54 extends proximally from the proximal side of the cap 36 and acts against a distal terminus 62 of the pusher coil 61.

[0033] In the example of FIGS. 1-4, the circuit providing power to the heater element 10 begins at a power source in the handle (not shown) at a proximal end of the pusher 60. The positive lead wire 68 extends through the pusher 60 and is electrically connected to the tabs 26 of the heater 10. The current flows through the inner and outer elements 18 and 16, respectively of the various planes 14F-A and up to the distal tab 12, which is electrically connected to the outer capsule 32 of the heater capsule 30. The current then flows through the outer capsule 32 to the tabs 46 and back through the negative lead wire 66 back to the power source. The current could also flow in the reverse direction, as one skilled in the art will understand.

[0034] FIG. 3 shows a transparent view of an assembled heater capsule 30. Included in this view are insulative layers 58, which ensure that the current flowing through the heater does not short to the outer capsule 32 prematurely before reaching the distal tab 12. One advantage of the 3d printing techniques used in making the heater is that the insulative layers 58 can be formed concurrently with the heater elements. The insulative layers 58 may be formed of an insulative material such as such as polyimide, parylene, and ceramic, just to name a few non-limiting examples.

[0035] Many delivery pushers used to deliver an embolic coil utilize a marker band just proximal of the embolic coil. The embodiments of FIGS. 5-7 utilize a marker band 80 that includes a proximal portion 82 that is shaped to allow more implant flexibility especially once the implant is outside of the delivery catheter. A distal portion 84 of the marker is smaller and sits within the implant while the proximal portion 82 of the marker is enlarged and has a tapered shape. The distal portion 84 of the marker supports the implant 86 while the implant 86 is connected to the delivery pusher, while the angled marker still allows a bit of freedom of movement as the implant is pushed out from the delivery catheter, thereby reducing the friction and kick associated with overly stiff implants during delivery. FIG. 6 is transparent to better show this distal portion 84 within the implant 86. The distal portion 84 may be welded in place.

[0036] The example of FIGS. 5-7 is a straight taper, but other embodiments would also accomplish the pivot result. For example, the proximal portion 82 could be rounded, chamfered, beveled, just to name a few non-limiting examples.

[0037] FIG. 7 demonstrates how the tapered portion 82 interfaces with the cap 36 of the outer capsule 32 of the heater capsule 30. The proximal portion 82 is tapered to nest within a distal structure at the distal end of the pusher 60. Because the tapered portion 82 has a tapered diameter that is smaller than the diameter of the distal end of the pusher, the marker 80 is allowed to pivot within the distal end of the pusher, much like a ball and socket joint. This allows a greater degree of freedom when pushing the implant coil into the aneurysm.

[0038] Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.