MEDICAL DEVICES WITH REINFORCED WIRES
20210128885 · 2021-05-06
Inventors
Cpc classification
A61M2025/0059
HUMAN NECESSITIES
A61M2025/09133
HUMAN NECESSITIES
International classification
Abstract
A medical device includes: a wire having a proximal end, a distal end, and a body extending between the proximal end and the distal end; and a coil disposed around a segment of the wire, wherein the coil comprises a proximal coil end, a distal coil end, and a coil body extending between the proximal coil end and the distal coil end; wherein the coil body comprises loops made from an elongated member having a cross-section, wherein the cross-section of the elongated member comprises a first side facing the wire, and a second side being opposite the first side and facing away from the wire; and wherein the second side of the cross-section of the elongated member has a higher curvature than the first side of the cross-section of the elongated member.
Claims
1. A medical device, comprising: a wire having a proximal end, a distal end, and a body extending between the proximal end and the distal end; and a coil disposed around a segment of the wire, wherein the coil comprises a proximal coil end, a distal coil end, and a coil body extending between the proximal coil end and the distal coil end, wherein the coil body comprises loops made from an elongated member having a cross-section, wherein the cross-section of the elongated member comprises a first side facing the wire, and a second side being opposite the first side and facing away from the wire, and wherein the second side of the cross-section of the elongated member has a higher curvature than the first side of the cross-section of the elongated member.
2. The medical device of claim 1, wherein at least a part of the first side comprises a rectilinear profile.
3. The medical device of claim 1, wherein at least a part of the second side comprises a curvilinear profile.
4. The medical device of claim 1, wherein the first side has a width, and the cross-section of the elongated member has a height that is perpendicular to the width, and wherein the width is at greater than the height.
5. The medical device of claim 4, wherein the width is at least two times the height.
6. The medical device of claim 4, wherein the height is a dimension of a lateral side of the cross-section, the lateral side having a rectilinear profile and is configured to abut against one of the loops of the coil.
7. The medical device of claim 1, wherein the cross-section of the elongated member comprises a D-shape cross-section.
8. The medical device of claim 1, wherein the coil body is configured to form a smooth profile along a length of the wire as the wire undergoes bending so that no part of the coil body forms any sharp bend, and/or wherein adjacent ones of the loops of the coil are configured to stay aligned as the wire with the coil undergoes bending.
9. The medical device of claim 1, wherein the distal coil end of the coil is proximal to the distal end of the wire.
10. The medical device of claim 1, wherein the wire with the coil forms a guidewire.
11. The medical device of claim 1, wherein the wire with the coil forms a pushwire configured to push an object.
12. A medical device comprising: a wire having a proximal end, a distal end, and a body extending between the proximal end and the distal end; and a coil disposed around a segment of the wire, wherein the coil comprises a proximal coil end, a distal coil end, and a coil body extending between the proximal coil end and the distal coil end, wherein the coil body is configured to form a smooth profile along a length of the wire as the wire undergoes bending so that no part of the coil body forms any sharp bend, and/or wherein adjacent ones of the loops of the coil are configured to stay aligned as the wire with the coil undergoes bending.
13. The medical device of claim 12, wherein the coil body comprises loops made from an elongated member having a cross-section comprising a first side facing the wire and a second side being opposite the first side and facing away from the wire, and wherein the second side of the cross-section of the elongated member has a higher curvature than the first side of the cross-section of the elongated member.
14. The medical device of claim 13, wherein at least a part of the first side comprises a rectilinear profile.
15. The medical device of claim 13, wherein at least a part of the second side comprises a curvilinear profile.
16. The medical device of claim 13, wherein the first side has a width, and the cross-section of the elongated member has a height that is perpendicular to the width, and wherein the width is at least two times the height.
17. The medical device of claim 16, wherein the height is a dimension of a lateral side of the cross-section, the lateral side having a rectilinear profile and is configured to abut against one of the loops of the coil.
18. The medical device of claim 13, wherein the cross-section of the elongated member comprises a D-shape cross-section.
19. The medical device of claim 12, wherein the wire with the coil forms a pushwire configured to push an object, and wherein the object comprises a stent or an embolic coil.
20. A medical device, comprising: a wire having a proximal end, a distal end, and a body extending between the proximal end and the distal end; and a coil disposed around a segment of the wire, wherein the coil comprises a proximal coil end, a distal coil end, and a coil body extending between the proximal coil end and the distal coil end, wherein the coil body comprises loops made from an elongated member having a cross-section comprising a first side facing the wire and a second side being opposite the first side and facing away from the wire, wherein the first side has a width, and the cross-section of the elongated member has a height that is perpendicular to the width, and wherein the width is at least two times the height, and wherein the height is a dimension of a lateral side of the cross-section, the lateral side having a rectilinear profile and is configured to abut against one of the loops of the coil.
Description
BRIEF DESCRIPTION OF THE FIGURES
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DETAILED DESCRIPTION
[0047] Various embodiments are described hereinafter with reference to the figures. The figures are not necessarily drawn to scale, and elements of similar structures or functions are represented by like reference numerals throughout the figures. It should also be understood that the figures are only intended to facilitate the description of the embodiments, and are not intended as an exhaustive description of the claimed inventions, or as a limitation on the scope thereof, which is defined only by the appended claims and their equivalents.
[0048] In addition, the respective illustrated embodiments need not have all of the depicted features. Also, an aspect or an advantage described in conjunction with a particular embodiment is not necessarily limited to that embodiment and can be practiced in any other embodiments even if not so illustrated, or if not so explicitly described.
[0049] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.
[0050] All numeric values are herein assumed to be modified by the term “about,” whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the terms “about” may include numbers that are rounded to the nearest significant figure.
[0051] The recitation of numerical ranges by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).
[0052] As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
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[0054] Referring to
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[0057] As shown in
[0058] Thus, as shown above, despite the intended configuration shown in
[0059] In other embodiments, the coil 200 may be formed with an elongated member having a rectangular cross-section.
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[0061] As shown in the above examples, wire 100 with coil 200 having circular cross section, rectangular cross section, square cross section, or other cross sections with right angles at the outside of the coil 200, may behave in a manner that is different from an intended design, and/or may break during use. As a result, the wire 100 may fail to have sufficient column strength support or kink resistance necessary to deliver, for example, a low-profile implant. It would be desirable to provide guidewires and/or delivery wires with reinforcement coil that facilitates advancement through tortuous vasculature, while avoiding or minimizing breaking, abrasion, or other failure of the delivery system.
[0062]
[0063] As shown in
[0064] In the illustrated embodiments, an entirety of the first side 510 comprises a rectilinear profile. In other embodiments, one or more parts of the first side 510 may have a curvilinear profile. For example, in other embodiments, opposite ends of the first side 510 may form a smooth curvilinear transition with respective lateral sides 520 of the cross-section 550. In addition, as shown in
[0065] Also, in the illustrated embodiments, at least a part of the second side 540 of the cross-section 550 comprises a curvilinear profile. In other embodiments, one or more parts of the second side 540 may have a rectilinear profile. In further embodiments, the second side 540 may have other profiles as long as an end of the second side 540 together with the adjacent lateral side 520 of the cross section 550 forms an angle that is not a 90° angle (e.g., any angle that is larger than 90°), or forms a smooth or curvilinear transition.
[0066] In the illustrated embodiments, the coil body 506 is configured to form a smooth profile along a length of the wire 100 as the wire 100 undergoes bending so that no part of the coil body forms any sharp bend (e.g., kink, plastic deformation, etc.). Alternatively or additionally, adjacent ones of the loops 530 of the coil 500 may be configured to stay aligned as the wire 100 with the coil 500 undergoes bending.
[0067] In some embodiments, the medical device 450 may further include a delivery catheter configured to house the wire 100 with the coil 500.
[0068] In the illustrated embodiments, the distal coil end 504 of the coil 500 is proximal to the distal end 454 of the wire 100. In other embodiments, the distal end 504 of the coil 500 may be distal to the distal end 454 of the wire 100.
[0069] In some embodiments, the wire 100 with the coil 500 forms a guidewire. In other embodiments, the wire 100 with the coil 500 forms a pushwire configured to push an object, which may be any implant, such as a stent or an embolic coil.
[0070] As shown in
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[0075] As shown in
[0076] In one or more embodiments described herein, the coil 500 may be configured to provide structural support for the wire 100 so that the wire 100 with the coil 500 (forming the medical device 450) has a desirable flexibility, a desirable kink-resistance, a desirable pushability, a desirable torqueability, or any combination of the foregoing. In some embodiments, a desirable flexibility and kink-resistance are considered to be achieved by the medical device 450 (e.g., a guidewire, a pushwire, a delivery wire, etc.) if the wire 100 and the coil 500 do not break, do not have any plastic deformation and kink, and/or do not form “serrated” sharp edges after having been delivered through a vasculature. In addition, in some embodiments, a desired torqueability is considered to be achieved by the medical device 450 if a twisting or torqueing motion applied at a proximal end about a longitudinal axis of the medical device 450 to turn the proximal end of the medical device 450 by an angle P will result in a turning of the distal end of the medical device 450 by an angle D that is at least 80% of P, or more preferably at least 90% of P, or even more preferably at least 95% of P (e.g., 100% of P, which means that the distal end of the medical device 450 has 1:1 response with respect to a torque applied at the proximal end of the medical device 450). Also, in some embodiments, a desired pushability may be achieved if the medical device 450 does not kink or buckle while being advanced inside a vessel or inside a catheter.
[0077] In addition, in one or more embodiments described herein, the wire 100 may be 50 to 300 cm in length, and together with the coil 500 may be 0.002 to 0.1 cm in diameter, depending upon the application. In other embodiments, the wire 100 may be shorter than 50 cm or longer than 300 cm in length. Also, in other embodiments, the wire 100 with the coil 500 may have a cross-sectional dimension that is larger than 0.1 cm, or less than 0.002 cm.
[0078] Also, in one or more embodiments described herein, the coil 500 may be made from any materials. By means of non-limiting examples, the coil may be made from stainless steel, alloys (e.g., Nitinol®, stainless steel, etc.), biocompatible metal, polymeric material(s) such as polyethylene, or any combinations thereof. In some embodiments, the coil 500 may be disposed around a portion of the wire 100. In other embodiments, the coil 500 may be disposed around the entire length of the wire 100. The pitch of the coil 500 may be varied along the length of the wire 100 to vary the stiffness of the wire 100. Also, in some embodiments, the medical device 450 may include multiple coils 500 disposed around the wire 100.
[0079] In one or more embodiments, the wire 100 and/or the coil 500 may include markings for purpose of imaging (e.g., markers composed of radio-opaque material(s)). In some embodiments, the wire 100 and/or the coil 500 may be made of radio-opaque material(s). In other embodiments, a radiopaque marker may be disposed on a distal portion of the coil 500. An epoxy bond may be used to attach the marker to the wire 100. The marker may be in a form of a band, but in other embodiments, the marker may have other shapes.
[0080] Also, in some embodiments, the coil 500 may be tightly wound around the wire 100. In other embodiments, the coil 500 may be loosely wound around the wire 100. In one or more embodiments, the coil 500 may have a tight pitch so that adjacent 530 loops of the coil 500 abut each other. In other embodiments, adjacent loops 530 of the coil 500 may be spaced away from each other.
[0081] The following items are exemplary features of embodiments described herein. Each item may be an embodiment itself or may be a part of an embodiment. One or more items described below may be combined with other item(s) in an embodiment.
[0082] Item 1: A medical device includes: a wire having a proximal end, a distal end, and a body extending between the proximal end and the distal end; and a coil disposed around a segment of the wire, wherein the coil comprises a proximal coil end, a distal coil end, and a coil body extending between the proximal coil end and the distal coil end; wherein the coil body comprises loops made from an elongated member having a cross-section, wherein the cross-section of the elongated member comprises a first side facing the wire, and a second side being opposite the first side and facing away from the wire; and wherein the second side of the cross-section of the elongated member has a higher curvature than the first side of the cross-section of the elongated member.
[0083] Item 2: At least a part of the first side comprises a rectilinear profile.
[0084] Item 3: At least a part of the second side comprises a curvilinear profile.
[0085] Item 4: The first side has a width, and the cross-section of the elongated member has a height that is perpendicular to the width, and wherein the width is at least two times the height.
[0086] Item 5: The height is a dimension of a lateral side of the cross-section, the lateral side having a rectilinear profile and is configured to abut against one of the loops of the coil.
[0087] Item 6: The cross-section of the elongated member comprises a D-shape cross-section.
[0088] Item 7: The coil body is configured to form a smooth profile along a length of the wire as the wire undergoes bending so that no part of the coil body forms any sharp bend, and/or adjacent ones of the loops of the coil are configured to stay aligned as the wire with the coil undergoes bending.
[0089] Item 8: The distal coil end of the coil is proximal to the distal end of the wire.
[0090] Item 9: The wire with the coil forms a guidewire.
[0091] Item 10: The wire with the coil forms a pushwire configured to push an object.
[0092] Item 11: The object comprises a stent or an embolic coil.
[0093] Item 12: A medical device includes: a wire having a proximal end, a distal end, and a body extending between the proximal end and the distal end; and a coil disposed around a segment of the wire, wherein the coil comprises a proximal coil end, a distal coil end, and a coil body extending between the proximal coil end and the distal coil end; wherein the coil body is configured to form a smooth profile along a length of the wire as the wire undergoes bending so that no part of the coil body forms any sharp bend, and/or wherein adjacent ones of the loops of the coil are configured to stay aligned as the wire with the coil undergoes bending.
[0094] Item 13: The coil body comprises loops made from an elongated member having a cross-section, wherein the cross-section of the elongated member comprises a first side facing the wire, and a second side being opposite the first side and facing away from the wire; and wherein the second side of the cross-section of the elongated member has a higher curvature than the first side of the cross-section of the elongated member.
[0095] Item 14: At least a part of the first side comprises a rectilinear profile.
[0096] Item 15: At least a part of the second side comprises a curvilinear profile.
[0097] Item 16: The first side has a width, and the cross-section of the elongated member has a height that is perpendicular to the width, and wherein the width is at least two times the height.
[0098] Item 17: The height is a dimension of a lateral side of the cross-section, the lateral side having a rectilinear profile and is configured to abut against one of the loops of the coil.
[0099] Item 18: The cross-section of the elongated member comprises a D-shape cross-section.
[0100] Item 19: The wire with the coil forms a pushwire configured to push an object, and wherein the object comprises a stent or an embolic coil.
[0101] Item 20: A medical device includes: a wire having a proximal end, a distal end, and a body extending between the proximal end and the distal end; and a coil disposed around a segment of the wire, wherein the coil comprises a proximal coil end, a distal coil end, and a coil body extending between the proximal coil end and the distal coil end; wherein the coil body comprises loops made from an elongated member having a cross-section, wherein the cross-section of the elongated member comprises a first side facing the wire, and a second side being opposite the first side and facing away from the wire; wherein the first side has a width, and the cross-section of the elongated member has a height that is perpendicular to the width, and wherein the width is at least two times the height; and wherein the height is a dimension of a lateral side of the cross-section, the lateral side having a rectilinear profile and is configured to abut against one of the loops of the coil.
[0102] Although particular embodiments have been shown and described herein, it will be understood by those skilled in the art that they are not intended to limit the disclosed inventions, and it will be obvious to those skilled in the art that various changes, permutations, and modifications may be made (e.g., the dimensions of various parts, combinations of parts) without departing from the scope of the disclosed inventions, which is to be defined only by the following claims and their equivalents. The specification and drawings are, accordingly, to be regarded in an illustrative rather than restrictive sense. The various embodiments shown and described herein are intended to cover alternatives, modifications, and equivalents of the disclosed inventions, which may be included within the scope of the appended claims.