None.
This disclosure relates to endoscopy and devices for navigating gastrointestinal structures within a human body.
A guidewire is a device used to navigate through gastrointestinal structures (e.g., bile and/or pancreatic ducts, esophagus strictures, etc.) to reach a target site within the body. In many instances the guidewire must navigate a narrow and/or tortuous path in the gastrointestinal system (e.g., the pancreatobiliary system). The tortuous path may require the guidewire to bend, twist, turn, or otherwise be positioned to follow one or more branches of ducts to be located deep into the gastrointestinal system (e.g., the biliary or pancreatic systems). Upon achieving deep cannulation of the bile/pancreatic duct, the guidewire acts as a guide that another device (e.g., a catheter) can follow to perform the required diagnostic procedure (e.g., biopsy) and/or the treatment (e.g., stenting) steps in the procedure. Without a guidewire, pancreatobiliary endoscopy is not possible.
Guidewires are typically characterized by their pushability, steerability, torque and opacity. Pushability is the amount of force needed to advance the wire. Steerability is the ability and responsiveness of the wire tip to navigate gastrointestinal structures. Torque is the response of the wire to turning by the operator when navigating gastrointestinal structures. Its opacity is its level of visibility under fluoroscopic imaging.
In one embodiment, a wire includes an outer surface that defines a diameter. A winding extends around the wire and defines an undulating surface that extends along a length of the wire. A peak of the undulating surface is defined by the winding and a valley of the undulating surface is defined by the outer surface of the wire.
In another embodiment, a guidewire includes a wire with an outer surface that defines a diameter and a recess extending into and helically around the wire. A winding is configured to fit within the recess and extend helically around the wire.
In yet another embodiment, a method of producing a guidewire includes coupling a first end of a winding to a wire, wrapping the winding around the wire, and coupling a second end of the winding to the wire.
The disclosure is best understood from the following detailed description when read in conjunction with the accompanying drawings. It is emphasized that, according to common practice, the various features of the drawings are not to-scale. On the contrary, the dimensions of the various features are arbitrarily expanded or reduced for clarity.
Disclosed herein are devices and methods for navigating a tortuous path through gastrointestinal structures of a patient to reach a target site. The devices and methods, more specifically, include a guidewire wrapped with a winding. The winding extends around a circumference of the guidewire and extends along a length of the guidewire. The winding creates an undulating surface that provides a tactile sensation for a user (e.g., clinician, operator, etc.) that is directing the guidewire. The tactile sensation is created by friction between the fingers of the user and the guidewire and allow for complex manipulations of the guidewire as it is directed through the tortuous path.
The proximal wire 114 is shown to include a winding 116. The winding 116 is coupled with the proximal wire 114 and extends radially from the proximal wire 114 such that the winding 116 extends radially beyond an outer surface of the proximal wire 114. As shown, the winding 116 extends around the proximal wire 114 in a helical manner. In some embodiments, the winding 116 covers the entire length of the proximal wire 114. The winding 116 can also cover a portion of the proximal wire 114 and leave a remaining portion of the proximal wire 114 uncovered (e.g., without the winding 116 extending radially therefrom). Arranged as described, the winding 116 defines an undulating surface 118 along at least a portion of the length of the proximal wire 114, where peaks 120 of the undulating surface 118 are defined by the winding 116 and valleys 122 of the undulating surface 118 are defined by the outer surface of the proximal wire 114. The peaks 120 and valleys 122 create corrugations (e.g., ribs) that provide a larger surface area for a user to grip than a guidewire with no winding. The larger surface area provides for more contact between the fingers of the user and the guidewire 100 than a guidewire with no windings, thereby causing more friction between the fingers of the user and the guidewire 100 than a guidewire with no windings. Accordingly, the user has more control with the guidewire 100 than if a guidewire with no winding were used. For example, the user can exert less force on the guidewire 100 when manipulating the guidewire 100 (e.g., pushing, turning, bending, twisting, knuckling, etc.) to reach the target site than if a guidewire with no winding were used. The winding 116 will be further described with reference to
As shown, the winding 116 is coupled to the second wire 222 such that a bottom surface of the winding 116 is recessed radially relative to an outer surface of the first wire 220 and the remainder wire 224. The top surface of the winding 116 extends radially from the outer surface of the first wire 220 such that the top surface of the winding 116 extends radially beyond the outer surface of the first wire 220 and the remainder wire 224. Accordingly, even though the winding 116 is partially recessed, the winding 116 still creates the undulating surface 118 as described with reference to
In some embodiments, an outer diameter of the second wire 222 is the same as that of the first wire 220 and the remainder wire 224 such that the first wire 220, the second wire 222, and the remainder wire 224 are a single wire with no transitions (e.g., no transition wire 226 and no transition wire 228). In such embodiments, the winding 116 still creates the undulating surface 118.
In some embodiments, the cover 330 covers the tip tubing 328 after the tip tubing 328 is assembled to the tip wire 110. The cover 330 can also be coupled with the tip tubing 328 after the tip tubing 328 is assembled to the tip wire 110 (e.g., with adhesive, etc.).
As shown, the outer surface of first wire 220 extends radially beyond the outer surface of the second wire 222 by a height of H2. Each of the first coil 116a and the second coil 116b extends beyond the outer surface of second wire 222 by a height of H1, where H1 is equal to the cross-sectional diameter of the winding 116. In some embodiments, H1 is at least 0.01 mm. In some embodiments, H1 is at least 0.05 mm, or at least 0.07 mm, or at least 0.10 mm. Accordingly, in some embodiments the winding 116 extends radially beyond the outer surface of the first wire 220 by a height of H1-H2. As described above, in some implementations the outer diameters of the first wire 220, the second wire 222, and the remainder wire 224 are the same (e.g., the first wire 220, the second wire 222, and the remainder wire 224 may be a unitary component). In such implementations, H2 is equal to zero and the winding 116 extends radially beyond the outer surfaces of the first wire 220, the second wire 222, and the remainder wire 224 by a height of H1.
In addition, a distance between the first coil 116a and the second coil 116b is defined as D1. D1 is arranged such that a finger of the user contacts at least the first coil 116a and the second coil 116b when manipulating the guidewire 100. For example, there is a maximum threshold distance over which a finger of a user can fit between the first coil 116a and the second coil 116b such that the user perceives the guidewire 100 as having no undulating surface 118. Accordingly, D1 is at most equal to the maximum threshold distance. In some embodiments, the maximum threshold distance is twenty mm. The maximum threshold distance can also be, for example, fifteen mm, ten mm, five mm, four mm, etc. Furthermore, D1 is arranged such that the user can distinguish between the first coil 116a and the second coil 116b when manipulating the guidewire 100. For example, as D1 becomes smaller there is a minimum threshold distance under which the user cannot determine that there are multiple surfaces (e.g., the user perceives the guidewire as having no undulating surface 118). Accordingly, D1 is at least equal to the minimum threshold distance. In some embodiments, the minimum threshold distance is 0.5 mm. The minimum threshold distance can also be, for example, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, or 1.0 mm.
As shown, the first coil 116a and the second coil 116b of the winding 116 have a circular cross-section. In some embodiments, the winding 116 can have different cross-sectional shapes. For example, the winding 116 can have a cross-sectional shape including an ellipse, a square, a pentagon, a hexagon, an octagon, or any other geometric shape that would provide the functionality described herein.
As described with reference
The proximal wire 644 defines the recess 646 that extends into and helically around the proximal wire 644. The recess 646 is configured to receive a winding 750. The winding 750 is similar to the winding 116 such that the description of the winding 116 pertains to the winding 750.
Each of the first coil 750a and the second coil 750b extends beyond the outer surface of proximal wire 644 by a height of H4. In some embodiments, H4 is at least 0.01 mm. In some embodiments, H4 is greater than zero and less than the diameter of the winding 750. In addition, a distance between the first coil 750a and the second coil 750b is defined as D3. D3 is arranged such that a finger of the user contacts at least the first coil 750a and the second coil 750b when manipulating the guidewire 638. For example, there is a maximum threshold distance over which a finger of a user can fit between the first coil 750a and the second coil 750b such that the user perceives the guidewire 638 as having no undulating surface. Accordingly, D3 is at most equal to the maximum threshold distance. In some embodiments, the maximum threshold distance is twenty mm. The maximum threshold distance can also be, for example, fifteen mm, ten mm, five mm, four mm, etc. Furthermore, D3 is arranged such that the user can distinguish between the first coil 750a and the second coil 750b when manipulating the guidewire 638. For example, as D3 becomes smaller there is a minimum threshold distance under which the user cannot determine that there are multiple surfaces (e.g., the user perceives the guidewire as having no undulating surface). Accordingly, D3 is at least equal to the minimum threshold distance. In some embodiments, the minimum threshold distance is 0.5 mm. The minimum threshold distance can also be, for example, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, or 1.0 mm.
As shown, the first coil 750a and the second coil 750b of the winding 750 have a circular cross-section. In some embodiments, the winding 750 can have different cross-sectional shapes. For example, the winding 750 can have a cross-sectional shape including an ellipse, a square, a pentagon, a hexagon, an octagon, or any other geometric shape that would provide the functionality described above.
Furthermore, the recess 646 is shown as having a rectangular cross-section. In some embodiments, the recess 646 can have different cross-sectional shapes. For example, the recess 646 can have a cross-sectional shape including an ellipse, a square, a pentagon, a hexagon, an octagon, or any other geometric shape.
As shown, the cross-sectional shapes of the winding 750 and the recess 646 are different. In some embodiments, the cross-sectional shapes of the winding 750 and the recess 646 are the same. For example, the cross-sectional shape of the winding 750 can be a square, and the cross-sectional shape of the recess 646 can be a square.
At operation 972, the guidewire is prepared to receive a winding. For example, and with reference to
At operation 974, the winding start is coupled to the guidewire. For example, the winding 116 and the winding 750 each include a distal end (e.g., the winding start) that is coupled to the second wire 222 and the proximal wire 644, respectively. Coupling can be achieved via mechanical processes such as welding, soldering, brazing, etc. Coupling can also be achieved via chemical processes like adhesive bonding.
At operation 976, the winding is wrapped around the guidewire. For example, the winding 116 is wrapped around the second wire 222 so as to maintain D1 above the minimum threshold distance and below the maximum threshold distance. In some embodiments, the winding 116 is coupled to the second wire 222 at various positions along the length of the second wire 222 such that D1 remains substantially the same (e.g., within ten percent) along the length of the second wire 222. As another example, the winding 750 is wrapped around the proximal wire 644 such that the winding 750 remains within the recess 646. Accordingly, it may not be necessary to couple the winding 750 to the proximal wire 644 at various locations along the length of the proximal wire 644 as the recess 646 defines the spacing D3 between coils of the winding 750.
At operation 978, the winding end is coupled to the guidewire. For example, the winding 116 and the winding 750 each include a proximal end (e.g., the winding end) that is coupled to the second wire 222 and the proximal wire 644, respectively. Coupling can be achieved via mechanical processes such as welding, soldering, brazing, etc. Coupling can also be achieved via chemical processes like adhesive bonding. In some instances, the winding end is coupled to the guidewire at the proximal end of the guidewire such that the proximal end of the guidewire is covered by the winding. In some embodiments, the winding end is coupled to the guidewire such that a remainder of the guidewire is not covered by the winding.
At operation 980, the guidewire is wrapped. As described above, the guidewire (e.g., the guidewire 100 or the guidewire 638) is covered to protect the components of the guidewire. For example, the guidewire may be inserted through a piece of shrink tubing, and the shrink tubing may be heated up such that the shrink tubing shrinks around the guidewire, thereby maintaining the position of the winding 116 and the winding 750 on the second wire 222 and the proximal wire 644, respectively.
At operation 982, the guidewire is coated. In some instance, a lubricious coating is applied to the guidewire to facilitate insertion into and navigation through tortuous gastrointestinal structures. In some embodiments, the coating is applied just to the tip of the guidewire (e.g., the tip wire 110 and the tip wire 640). The coating may also be applied to the entire guidewire or a portion thereof.
While the disclosure has been described in connection with certain embodiments, it is to be understood that the disclosure is not to be limited to the disclosed embodiments but, on the contrary, is intended to cover various modifications and equivalent arrangements included within the scope of the appended claims, which scope is to be accorded the broadest interpretation so as to encompass all such modifications and equivalent structures as is permitted under the law.