Floppy Distal End Section with Stiff Solid Shaft
20220193379 · 2022-06-23
Inventors
Cpc classification
A61M2025/09175
HUMAN NECESSITIES
A61M2025/09075
HUMAN NECESSITIES
International classification
Abstract
A section is disclosed for use with a portion assembly. The section can include a solid core section with a distal section having a first diameter, and a proximal section having a second diameter, wherein the second diameter can be greater than the first diameter. The section can include a coil wound around the distal section of the solid core section. The proximal section can have a flexural stiffness that is less than a flexural stiffness of the distal section. A length of the distal section of the section may be shorter than the length of the portion. A length of the proximal section of the section may be longer than the length of the portion.
Claims
1. A section, comprising: a solid core section including a proximal section and a distal section; and a coil wound around the distal section of the solid core section, wherein the proximal section has a flexural stiffness that is less than a flexural stiffness of the distal section.
2. The section of claim 1, wherein a diameter of the proximal portion of the solid core section is greater than a diameter of the distal portion of the solid core section.
3. The section of claim 1, wherein the distal section is configured for insertion into a patient vasculature.
4. The section of claim 1, wherein the distal section is configured to guide a portion along the patient vasculature.
5. The section of claim 1, wherein the proximal section is configured to be inserted through a portion, and wherein the proximal section provides a column strength to the portion.
6. The section of claim 1, wherein the section is configured so that, during insertion, the proximal section provides a column strength to a proximal portion of the portion while the distal section simultaneously provides guidance to a distal portion of the portion along the patient vasculature.
7. The section of claim 1, wherein the flexural stiffness of the proximal section is configured to enable manual displacement of the proximal section into the portion without kinking or breaking.
8. The section of claim 1, wherein the proximal portion of the solid core section defines an outer diameter of a portion of the section.
9. The section of claim 1, wherein the proximal section is longer than the distal section.
10. The section of claim 1, further comprising an atraumatic distal tip.
11. A portion assembly comprising: a portion; and a section disposed at least partially through a lumen of the portion, the section including a solid core section and comprising: a distal section having a first diameter, and a proximal section having a second diameter, wherein the second diameter is greater than the first diameter.
12. The portion assembly of claim 11, wherein a length of the distal section of the section is shorter than the length of the portion.
13. The portion assembly of claim 11, wherein a length of the proximal section of the section is longer than the length of the portion.
14. The portion assembly of claim 11, wherein a distal end of the section is disposed within the lumen.
15. The portion assembly of claim 11, wherein, during use, the distal section of the section extends distally beyond the distal end of the portion, and wherein the proximal section of the section is disposed through the lumen.
16. The portion assembly of claim 11, further comprising: an introducer portion disposed through the lumen, the introducer portion including an introducer portion lumen; and an introducer needle disposed at least partially through the introducer portion lumen.
17. The portion assembly of claim 16, wherein the introducer needle is disposed only through a distal portion of the introducer portion lumen, and wherein the section is disposed through a proximal portion of the introducer portion lumen.
18. A method of using a section comprising the steps of: obtaining a section including a solid core section and comprising: a distal section having a first diameter, and a proximal section having a second diameter, wherein the second diameter is greater than the first diameter; obtaining a portion; threading the section through the lumen and into a vasculature of a patient, wherein the portion is external to the patient; positioning the section within a lumen of the portion so that the proximal section is disposed within the lumen, wherein a distal end of a proximal section is positioned adjacent a distal tip of the portion; inserting the distal tip of the portion together with the distal end of the proximal section of the section through a vascular puncture site; and advancing the portion through the vasculature along the section.
19. The method of claim 18, wherein the advancing step comprises adjusting the position of the section within the lumen so that the distal end of the proximal section is positioned adjacent the vascular puncture site.
20. The method of claim 18, wherein the advancing step further comprises: displacing the portion together with the section distally into the vasculature a first distance; and retracting proximally the section through the lumen the first distance so that the distal end of the proximal section is repositioned adjacent the vasculature puncture site.
21. The method of claim 20, wherein the advancing step further comprises repeating the displacing and retracting steps.
22. The method of claim 18, wherein the inserting step comprises applying a distally-directed compression force to the portion and the section while simultaneously grasping the portion at a proximal end and grasping the proximal portion of the section.
23. The method of claim 18, wherein the portion comprises an introducer needle disposed with the lumen of the portion,
24. The method of claim 18, wherein the method of claim 18 further comprises removing the introducer needle from the lumen prior to the threading step.
Description
DRAWINGS
[0018]
[0019]
[0020]
[0021]
[0022]
[0023]
[0024]
[0025]
DETAILED DESCRIPTION
[0026] Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.
[0027] Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.
[0028] With respect to “proximal,” a “proximal portion” or a “proximal-end portion” of, for example, a portion disclosed herein includes a portion of the portion intended to be near a clinician when the portion is used on a patient. Likewise, a “proximal length” of, for example, the portion includes a length of the portion intended to be near the clinician when the portion is used on the patient. A “proximal end” of, for example, the portion includes an end of the portion intended to be near the clinician when the portion is used on the patient. The proximal portion, the proximal-end portion, or the proximal length of the portion can include the proximal end of the portion; however, the proximal portion, the proximal-end portion, or the proximal length of the portion need not include the proximal end of the portion. That is, unless context suggests otherwise, the proximal portion, the proximal-end portion, or the proximal length of the portion is not a terminal portion or terminal length of the portion.
[0029] With respect to “distal,” a “distal portion” or a “distal-end portion” of, for example, a portion disclosed herein includes a portion of the portion intended to be near or in a patient when the portion is used on the patient. Likewise, a “distal length” of, for example, the portion includes a length of the portion intended to be near or in the patient when the portion is used on the patient. A “distal end” of, for example, the portion includes an end of the portion intended to be near or in the patient when the portion is used on the patient. The distal portion, the distal-end portion, or the distal length of the portion can include the distal end of the portion; however, the distal portion, the distal-end portion, or the distal length of the portion need not include the distal end of the portion. That is, unless context suggests otherwise, the distal portion, the distal-end portion, or the distal length of the portion is not a terminal portion or terminal length of the portion.
[0030] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.
[0031] As set forth above, there is a need to provide column strength to a proximal portion of the portion for advancement of the portion through the puncture sites and a simultaneous need to provide guidance of a distal portion of the portion along the vascular path. Disclosed herein are sections, portion assemblies, and methods that address the foregoing.
[0032]
[0033] The distal section 110 may be configured to be disposed within a vasculature of a patient. In some embodiments, the distal section 101 may comprise a flexibility that is consistent with medical sections configured to traverse a vasculature. As such, the distal section 110 may comprise a flexibility sufficient to traverse a vasculature without causing injury to the vascular wall. In other words, the distal section 110 may flex during insertion to conform with the vasculature structure without plastic deformation, kinking, and/or breaking. The distal section 110 may also comprise sufficient stiffness to facilitate insertion via a distally applied compression force without buckling within the vasculature. In some embodiments, the distal section 110 may include a length sufficient to extend from the vasculature insertion site to a desired location within the vasculature such as the lower ⅓ of the superior vena cava (“SVC”) of the heart, for example. As such, placement of intravascular devices may include use of the section 100 as an intravascular section. The distal section 110 may comprise a round cross section having a diameter 111 consistent with insertion through the portion and the vasculature.
[0034] In some embodiments, the distal section 110 may comprise a preformed shape 112 to aid insertion through the vasculature such as an atraumatic tip. In some embodiments, the preformed shape 112 may aid in preventing injury or damage to the soft tissues of the vasculature during advancement and/or retraction of the section 100. In some embodiments, the preformed shape 112 includes a curved portion adjacent the distal tip 101. The curved portion may be configured so that a distal extension of a longitudinal axis of the section intersects the section. Such an embodiment may cause a curved portion of the section to contact the vascular wall and thereby inhibit direct contact of the distal tip 101 with the vascular wall. The distal section 110 includes a length 123.
[0035] The proximal section 120 may be configured to be manually inserted into a lumen of a portion. The proximal section 120 may be configured for manual handling by a clinician and may comprise a flexural stiffness that facilitates manual displacement of the proximal section 120 distally into the portion without plastic deformation, kinking, and/or breaking. The stiffness of the proximal section 120 may enhance a stiffness of the portion, i.e., provide a column strength to the portion to aid insertion of the portion into the patient. The proximal section 120 may comprise a diameter 124 consistent with disposition of the proximal section 120 within the portion. In some embodiments, the diameter 124 may be the same, larger, or smaller than a diameter 114 of the distal section 110. In some embodiments, the proximal section 120 may be configured to be at least partially disposed within the vasculature of a patient. In some embodiments, a length 125 of the proximal section 120 may be longer than the length 123 of the distal section 110.
[0036] In some embodiments, the proximal section 120 may include indicia 128. The indicia 110 may be indicative of a distance to a distal end 126 of the proximal section 120. In some instances, the distal end of the portion may not be visible to a clinician, such as an instance where the distal end is disposed within the patient. A location of indicia 128 with respect to a proximal end of the portion may indicate a position of the distal end 126 of the proximal section 120 with respect to the distal end of the portion. The indicia 110 may also be indicative of a distance to the distal end 101 of the section 100. In some instances, a clinician may observe the indicia 128 to assess the position of the distal end 101 along the vasculature of the patient.
[0037] The proximal section 120 may comprise a distal transition portion 122. The distal transition portion 122 may define a smooth transition of physical properties between the distal section 110 and the proximal section 120. The distal transition portion 122 may comprise a taper to transition the diameter 114 of the distal section 110 to the diameter 124 of the proximal section 120. The distal transition portion 122 may also be constructed to transition the flexibility of the distal section 110 to the stiffness of the proximal section 120. In some embodiments, the distal transition portion 126 may define a strain relief.
[0038]
[0039] The section 130 may include a section transition portion 133. The section transition portion 133 may include a taper between the thin diameter 134 and the thick diameter 135. The section transition portion 133 may inhibit plastic deformation, kinking, and/or breaking of the section 130 at the interface between the thin diameter 134 and the thick diameter 135. The section transition portion 133 may define a strain relief of the section 130. The distal section portion 131 may be wound with a coil 140. A diameter of the coil 140 may define the diameter 114 of the distal section 110, and the thick diameter 135 of the section 130 may define the diameter 124 of the proximal section 120. In some embodiments, the thick diameter 135 of the section 130 may define the stiffness of the proximal section 130.
[0040] The section may include alternative structures of the section 100. For example, the section 130 may comprise a constant diameter, such as the diameter 134, along the length of the section 100. The proximal portion 132 of the section may be include a cannula disposed around and attached to the section 130 to define the diameter 124 of the proximal section 120 and to add stiffness to the section 130. Other alternative structures, as may be contemplated by one of ordinary skill, are also considered part of this disclosure.
[0041]
[0042] The introducer 206 includes an introducer portion 232 and an introducer needle 226. The introducer portion 232 includes an introducer-portion tube 234, an introducer-portion hub 236 about a proximal-end portion of the portion tube 234, and a distal tip 238 at a distal end of the introducer-portion tube 234. The introducer 206 is coupled to the portion 202, such that the introducer-portion tube 234 is disposed within the primary lumen 208. When coupled together, the introducer-portion tube 234 extends 1) distally beyond the distal tip 230 of the portion and 2) proximally beyond a proximal end of the primary leg 228.
[0043] In some embodiments, the portion 202 includes a side aperture 204 extending through a wall of the soft portion tube 220 into the primary lumen 208 and further through a wall of the introducer-portion tube 234 into a single lumen of the introducer portion 232. The introducer needle 226 is disposed through the side aperture 104 and into the single lumen of the introducer portion 232 such that a beveled tip 246 of the introducer needle 126 extends past the distal tip 238 of the introducer portion 232 for establishing a percutaneous puncture. In some embodiments, the side aperture 204 may be omitted and the introducer needle 226 may be inserted into the introducer portion 232 via the introducer-portion hub 236.
[0044] In some embodiments, the portion assembly 100 may further include an access section 248 that may be disposed in a needle lumen of the introducer needle 126 such that a distal end of the access section 248 is proximal the beveled tip 246 of the introducer needle 226. This allows for immediate advancement of the distal end of the access section 248 beyond the beveled tip 246 of introducer needle 226 and into the vasculature upon establishing access thereto. In other embodiments, the access section 248 may be omitted.
[0045] As stated above, the portion assembly 200 includes the section 100 in accordance with some embodiments. In the illustrated embodiment, the section 100 may be disposed in the single lumen of the introducer portion 232 such the distal end 101 of the section 100 is proximal of the side aperture 204 but distal of the portion hub 222, which allows for immediate advancement of the distal end 101 of the section 100 into the vasculature upon removing the introducer needle 226 from the lumen of the introducer portion 232. In some embodiments, the proximal section 120 of the section 100 may be disposed proximal of the introducer-portion hub 236. In some embodiments, a portion of the distal section 110 of the section 100 may also be disposed proximal of the introducer-portion hub 236. In other embodiments, a portion of the proximal section 120 may disposed within the single lumen of the introducer portion 232. In some embodiments, the section 100 may not be inserted into the single lumen of the introducer portion 232 when the portion assembly 200 is in the ready-to-deploy state.
[0046] In some embodiments, the length 125 of proximal section 120 may be sufficiently long to extend from a proximal end of the portion to a distal end of the portion. In some embodiments, the length 125 may be sufficiently long so that, when the distal end 126 of the proximal section 120 is disposed adjacent the distal end of the portion, a portion of the proximal section 120 extends proximally away from the proximal end of the portion. The extending portion of the proximal section 120 may be sufficiently long such that the clinician may grasp and manipulate the proximal section 120.
[0047]
[0048]
[0049] Referring specifically to
[0050]
[0051]
[0052] In some embodiments, the process of inserting the portion 202 as illustrated in
Methods
[0053] Any methods disclosed herein include one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified. Moreover, sub-routines or only a portion of a method described herein may be a separate method within the scope of this disclosure. Stated otherwise, some methods may include only a portion of the steps described in a more detailed method.
[0054] Methods of using the section 100 may include the following steps or processes. A method may include a step of inserting the section 100 into the lumen 208 of a portion 202 before the portion 202 is inserted into the patient. In some embodiments, the distal end 101 of the section 100 is disposed within the lumen 208. The section may enter the lumen 208 at a proximal end of the lumen 208. In some embodiments, a distal portion of the distal section 110 of the section 100 may be disposed within the lumen 208 while a proximal portion of the distal section 110 is disposed outside the lumen 208. In other embodiments, the entire distal section 110 may be disposed within the lumen 208. In some embodiments, a distal portion of the proximal section 120 may be disposed within the lumen. In some embodiments, the section 100 into the lumen 208 of a portion 202 after the portion 202 is at least partially inserted into the patient
[0055] In some embodiments, the portion may include an introducer portion 232, including an introducer-portion lumen, disposed within the lumen 208. In such embodiments, the inserting step may include inserting the section 100 into the introducer-portion lumen. In such embodiments, the distal end 101 of the section 100 is disposed within the introducer-portion lumen. The section may enter the introducer-portion lumen at a proximal end of the introducer-portion lumen. In some embodiments, a distal portion of the distal section 110 of the section 100 may be disposed within the introducer-portion lumen while a proximal portion of the distal section 110 is disposed outside the introducer-portion lumen. In other embodiments, the entire distal section 110 may be disposed within the introducer-portion lumen. In some embodiments, a distal portion of the proximal section 120 may be disposed within the introducer-portion lumen.
[0056] A method may further include a step of inserting the introducing section 248 into the introducer-portion lumen. The introducing section 248 may be inserted through a side aperture 204 entering into the introducer-portion lumen. The introducing section 248 may be further inserted distally through the introducer-portion lumen and positioned so that a distal end of the introducing section 248 is positioned within the introducer-portion lumen between the side aperture 204 and the distal tip 238 of the introducer portion 232.
[0057] A method may further include a step of establishing a needle tract from an area of skin 300 to the blood vessel 310 of the patient with the beveled tip 246 of the introducer needle 226. In some embodiments, the method may include advancing the introducer needle 226 through the side aperture 204. As set forth above with respect to the ready-to-deploy state of the portion assembly 200 illustrated in
[0058] A method may further include a step of advancing the access section 248 through the introducer needle 226 and into the blood vessel 310 of the patient.
[0059] A method may further include a step of advancing the distal-end portion of the introducer portion 232 into the blood vessel 310 over the access section 248.
[0060] A method may further include a step of withdrawing the introducer needle 226 from both the blood vessel 310 and the portion assembly 200 leaving the access section 248 and the introducer portion 232 inserted within the blood vessel 310.
[0061] A method may further include a step of advancing the section 100 through the introducer portion 232 and into the blood vessel 310. In some embodiments, the step of advancing the section 100 may include first withdrawing the introducer needle 226 from both the blood vessel 310, the lumen 208 and the introducer portion 232.
[0062] A method may further include a step of advancing the section 100 through the introducer portion 232 such that the stiff proximal section 120 of the section 100 is disposed within the portion 202 thereby adding stiffness to the portion 202.
[0063] A method may further include a step of positioning the section 100 within the portion 202 such that a distal end 126 of the proximal section 120 of the section 100 is disposed adjacent the distal tip 230 of the portion 202.
[0064] A method may further include a step of positioning the section 100 within the portion 202 such that a distal end 126 of the stiff proximal section 120 of the section 100 is disposed adjacent the blood vessel puncture site 312.
[0065] A method may further include a step of advancing both the introducer portion 232 and the portion 202 farther into the blood-vessel 310 a first distance while simultaneously grasping the proximal section 120 of the section 100 and the portion 202.
[0066] A method may further include a step of proximally retracting the section 100 the first distance within the portion 202 such that the distal end 126 of the proximal section 120 of the section 100 is repositioned adjacent the blood vessel puncture site 312.
[0067] A method may further include a step of advancing the portion 202 through the vasculature along the section 100.
[0068] A method may further include a step of removing the section 100 from the portion 202.
[0069] A method may further include a step of removing the introducing portion 232 from the portion 202.
[0070] While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and/or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and/or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.