Various aspects of the present disclosure relate generally to medical devices and related methods. More specifically, the present disclosure relates to medical devices for delivering an elongate device.
Medical devices, such as lasers, needles, infusion tubes, sensors, and the like may include an elongate body, and may be arranged for delivery through a working channel of an insertion device (e.g., a ureteroscope, a hysteroscope, a bronchoscope, a cystoscope, and similar devices). The elongate body of such medical devices may be selectively extended and retracted relative to the working channel of the insertion device to deploy or retract the elongate body to perform one or more therapies, treatments, or diagnostic evaluations on a subject. For example, the medical device may include a laser having an elongate body arranged for delivery through a working channel of a ureteroscope. Such elongated medical devices often must be threaded through a seal or valve in order to prevent irrigation or fluid backflow through the port or channel through which the elongated device accesses the insertion device. However, using a seal or valve can be time-consuming because the elongated device must be “inched” through the valve or seal in small increments as the elongated device lacks sufficient stiffness to allow a long pushing of the device through the valve or seal, without the device kinking or being damaged. As such, medical professionals must spend time tediously threading small portions of the elongated device through the seal or valve and into the insertion device. Moreover, if one forgoes using a seal or valve to expedite the insertion of the elongated device into the insertion device, there is the danger of an inadvertent escape of pressurized body fluids or of foreign contaminants entering the patient. Finally, if one uses a thicker covering around the elongated medical device to introduce the elongated medical device into the valve and into the insertion device, such an inducer remains on the elongated device, which makes manipulating the elongated device during the procedure more difficult. These efforts also increase the cost, complexity, and/or risks of the medical procedure involving an insertion device.
The devices and methods of the current disclosure may rectify some of the deficiencies described above or address other aspects of the prior art.
Examples of the present disclosure relate to, among other things, medical retrieval devices. Each of the aspects disclosed herein may include one or more of the features described in connection with any of the other disclosed aspects.
One aspect of this disclosure is an introducer sheath. The introducer sheath may comprise: a distal and a proximal end; a lumen extending from the distal end to the proximal end; a tab formed at the distal end and extending distal to the lumen; and a frangible portion extending between the distal end and the proximal end.
According to this aspect, the lumen may extend to a proximal end face of the proximal end. The frangible portion may include a slit, a perforation, a reduced thickness, or a gap in the introducer sheath. The frangible portion may also extend in a straight line between the distal end and the proximal end. Furthermore, the frangible portion may be located circumferentially opposite the tab. The introducer sheath may include at least one opening. One of the at least one openings may be in the proximal end. The frangible portion may extend through the at least one opening that is in the proximal end. The frangible portion may extend to a proximal end face of the proximal end. The tab may be an integral portion of the introducer sheath. The tab may also be formed of a separate member from a body of the introducer sheath. A valve may be coupled to the proximal end of the introducer sheath. The valve coupled to the proximal end may at least partially overlap an opening in the proximal end. The opening in the proximal end may be located circumferentially opposite the tab. The introducer sheath may have a length between 70 cm and 80 cm.
Another aspect is a method of introducing a medical device into an insertion device by using an insertion sheath, the medical device including an elongate body and the insertion sheath surrounding a portion of the elongate body, the method comprising: introducing a distal end of the elongate body into a port of the insertion device; pulling a distally extending tab of the introducer sheath to urge the elongate body further into the insertion device; and incrementally separating the introducer sheath from the elongate body during the pulling of the distally extending tab.
According to this aspect, pulling the distally extending tab of the introducer sheath may include causing the introducer sheath to fully separate from the elongate body. The method may further comprise threading, capping, or otherwise attaching a seal or valve to the insertion device after the introducer sheath has been fully separated.
Another aspect is a medical device system. The medical device system may comprise a medical device including an elongate body; an introducer sheath having a distal end and a proximal end, a lumen extending from the distal end to the proximal end, a tab formed at the distal end and extending distal to the lumen, and a frangible portion extending between the distal end and the proximal end, wherein the introducer sheath surrounds the medical device and is coupled to the medical device such that movement of the introducer sheath moves the medical device.
According to this aspect, the medical device system's introducer sheath may include at least one opening, and the frangible portion may pass through and extend beyond the at least one opening toward both the distal end and proximal end. The medical device system may also include a seal or valve positioned around both the introducer sheath and the medical device. The seal or valve may be positioned around at least one opening in the introducer sheath.
Both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the features, as claimed. As used herein, the terms “comprises,” “comprising,” or other variations thereof, are intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements, but may include other elements not expressly listed or inherent to such a process, method, article, or apparatus. Additionally, the term “exemplary” is used herein in the sense of “example,” rather than “ideal.”
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary features of the present disclosure and together with the description, serve to explain the principles of the disclosure.
Examples of the present disclosure relate to medical device introducer sheaths for introduction of an elongate body of the medical device into a seal, valve, scope, or port of an insertion device. The introducer sheath may be used to assist in delivery of the elongate body into any appropriate insertion device.
Reference will now be made in detail to examples of the present disclosure described above and illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.
The terms “proximal” and “distal” are used herein to refer to the relative positions of the components of an exemplary medical device or insertion device. When used herein, “proximal” refers to a position relatively closer to an operator using the medical device or insertion device or closer to the exterior of the body or patient. In contrast, “distal” refers to a position relatively further away from the operator using the medical device or insertion device, or closer to the interior of the body or patient.
Medical device 10 will be described as a retrieval basket device; however, it is understood that medical device 10 may be any type of medical device used in conjunction with insertion device 102 to deliver medical therapy to a target site inside a patient. For example, the medical device may alternatively be a laser fiber, an irrigation and/or aspiration tube, a snare, forceps, and/or a needle.
As shown in
As shown in
Introducer sheath 20 may include a frangible portion 24 along the length of the introducer sheath 20, extending between the distal end 23 and the proximal end face of the proximal end 21. Frangible portion 24 may be formed by cutting a slit along the length of the introducer sheath 20. Frangible portion 24 may also be formed by a perforation or reduced thickness portion of the introducer sheath 20, or by a longitudinally extending gap or discontinuity in the introducer sheath 20. Frangible portion 24 may be formed from the first opening 26 at the distal end 23 to the proximal end face of proximal end 21, and frangible portion 24 may run in a straight line from the first opening 26 at the distal end 23 to the proximal end face of proximal end 21. Frangible portion 24 may be the same length as the introducer sheath 20, or a shorter length. Frangible portion 24 may be located circumferentially opposite tab 22 and aligned with a longitudinal axis of second opening 28 so that the frangible portion 24 ends at a distal end of second opening 28 and starts again at a proximal end of second opening 28. It is understood, however, that frangible portion 24 may be located at any circumferential position along introducer sheath 20.
Introducer sheath 20 may be circular (
Introducer sheath 20 may be formed by a tubular extrusion. Introducer sheath 20 may also be formed by sizing a tubular extrusion to the outer diameter of elongate body 14. Frangible portion 24 may then be formed in the introducer sheath 20. For example, frangible portion 24 may be formed by cutting a slit with a scalpel inserted into the outer diameter of introducer sheath 20. The introducer sheath 20 may be dragged against the scalpel lengthwise to form frangible portion 24. Alternatively, frangible portion 24 may be formed by cutting a slit in introducer sheath 20 while introducer sheath 20 is being formed or extruded. Moreover, frangible portion 24 may be formed as the gap in a C-shaped tubular extrusion forming introducer sheath 20. Such a C-shaped introducer sheath 20 may be reheated to form a circular cross-sectional shape, where the edges of the C-shaped configuration overlap. A C-shaped introducer sheath may also be formed by heating a flat strip of material through a smaller die to create a C-shaped configuration or a circular cross-sectional shape, where the edges of the C-shaped configuration overlap.
Introducer sheath 20 may be formed of elastomeric. Introducer sheath 20 may also be formed of silicone, thermoplastic elastomer, ethylene-propylene, fluorocarbon, or other similar materials.
The introducer sheath 20 may be matched to a specific elongate body 14 of a specific medical device 10 such that the introducer sheath's inner diameter and length correspond to the specific elongate body 14 and specific medical device 10. In another example, the introducer sheath 20 may have an inner diameter slightly smaller than the outer diameter of the elongate body 14 of the medical device 10 such that, when coupled, the introducer sheath 20 snugly encircles the elongate body 14. In a further example, the introducer sheath 20 may have an inner diameter equal to or slightly larger than the outer diameter of the elongate body 14 of the medical device 10 such that, when coupled, the introducer sheath 20 is free to slide along the elongate body 14 when the introducer sheath 20 and the elongate body 14 are in a straight condition, but are friction coupled when either the introducer sheath 20 or elongate body 14, or both elements, are curved, bent, or otherwise not straight.
The introducer sheath 20 and elongate body 14 may form alternative or additional frictional engagements, couplings, or associations. For example, as shown in
Next,
It should be noted that the relationship of the length of the elongate body 14 and introducer sheath 20 determines the position of the distal end 36 of the elongate body 14, and thus the retrieval basket 16, relative to the distal end 106 of the insertion device 102 after completing the introduction via introducer sheath 20. Different types of scopes vary in working length from approximately 70 cm to approximately 220 cm. In some examples, the introducer sheath 20 has a length such that, when the proximal end 21 of introducer sheath 20 is located adjacent port 104, the distal end 36 of the elongate body 14 and the retrieval basket 16 are positioned flush with the distal end 106, just proximal to the distal end 106, or just distal to the distal end 106 (
Another aspect of the present disclosure is described with reference to
To insert the fragile or sensitive components of the elongate body 14, including the retrieval basket 16 through the normally closed seal or valve 40, the introducer sheath 70 surrounds the elongate body 14, including the distal end 36 which is not shown in
After the distal end 36 of elongate body 14 has been positioned past the normally closed seal or valve 40, the tapered tip 75 of the introducer sheath 70 may be retracted proximally to close the normally closed seal or valve 40 around the elongate body 14. The user may elect to leave the introducer sheath 70 on the elongate body 14 proximal to the normally closed seal or valve 40, allowing the user to prop open the normally closed seal or valve 40 again with tapered tip 75 to adjust the position of the normally closed seal or valve 40 relative to elongate body 14. The user may also elect to remove the introducer sheath 70 by pulling the tab 72 in a direction E away from the elongate body 14, such that the frangible portion 74 splits and separates the introducer sheath 70 from the elongate body 14. Removing the introducer sheath 70 from the elongate body 14 may allow for a longer working length of the elongate body 14 and avoid interference or obstruction from the introducer sheath 70 during manipulation of the elongate body 14 during the medical procedure. Valve 30 may also then be threaded, capped, or otherwise attached to normally closed seal or valve 40.
Alternatively, the tapered tip 75 may be inserted into the normally closed seal or valve 40, and the distal end 36 of elongate body 14 together with the surrounding introducer sheath 70 may pass in direction D through the normally closed seal or valve 40, allowing for the introducer sheath 70 to shield the fragile or sensitive components in the elongate body 14.
Once the distal end 36 of elongate body 14 has been positioned distally to the normally closed seal or valve 40, the introducer sheath 70 and the tapered tip 75 may be retracted proximally such that the elongate body 14 emerges from the opening in tapered tip 75 and such that normally closed seal or valve 40 closes around the elongate body 14. The user may elect to leave the introducer sheath 70 on the elongate body 14 proximal to the normally closed seal or valve 40, allowing the user to prop open the normally closed seal or valve 40 again with tapered tip 75 and introducer sheath 70 to adjust the position of the normally closed seal or valve 40 relative to elongate body 14. The user may also elect to remove the introducer sheath 70 by pulling the tab 72 in a direction E away from the elongate body 14, such that the frangible portion 74 splits and separates the introducer sheath 70 from the elongate body 14, which may allow for a longer working length of the elongate body 14 and avoid interference or obstruction from the introducer sheath 70 during manipulation of the elongate body 14 during the medical procedure. Valve 30 may also then be threaded, capped, or otherwise attached to normally closed seal or valve 40. In this example where introducer sheath 70 passes through normally closed seal or valve 40 together with elongate body 14, introducer sheath 70 may be longer than the 1 cm to 10 cm length previously discussed with respect to this aspect of the disclosure.
Another aspect of the present disclosure is described with reference to
Here,
To insert the fragile or sensitive components of the elongate body 14 through the normally closed seal or valve 50 in direction F, the introducer sheath 90 surrounds the elongate body 14, including the distal end 36 which is not shown in
Alternatively, once the tapered tip 95 has been inserted to prop open the normally closed seal or valve 50, both the introducer sheath 90 and the elongate body 14 may be inserted in direction F through the normally closed seal or valve 50 with the introducer sheath 90 protecting the fragile or sensitive components of the elongate body 14 and the retrieval basket 16. After the distal end 36 of the elongate body 14 has been selectively positioned past the normally closed seal or valve 50, that is, when the normally closed seal or valve 50 is selectively positioned along the elongate body 14, the user may retract the introducer sheath 90 and its tapered tip 95 to close the normally closed seal or valve 50 and may elect to leave the introducer sheath on the elongate body 14 on the proximal side of the normally closed seal or valve 50, allowing the user to prop open the normally closed seal or valve 50 again with tapered tip 95 and introducer sheath 90 to adjust the position of the normally closed seal or valve 50 relative to elongate body 14.
The user may also elect to remove the introducer sheath 90 after the distal end 36 of the elongate body 14 has been selectively positioned past the normally closed seal or valve 50 by pulling the introducer sheath 90 distally fully past the normally closed seal or valve 50 in direction F such that the normally closed seal or valve 50 closes around the elongate body 14. Then, the user may continue to slide the introducer sheath 90 in direction F off the distal end 36 of the elongate body 14, removing the introducer sheath 90. As a result, the normally closed seal or valve 50 may be positioned more quickly on the elongate body 14 at the desired position, as shown in
While principles of the present disclosure are described herein with reference to illustrative examples for particular applications, it should be understood that the disclosure is not limited thereto. Those having ordinary skill in the art and access to the teachings provided herein will recognize additional modifications, applications, embodiments, and substitution of equivalents all fall within the scope of the features described herein. Accordingly, the claimed features are not to be considered as limited by the foregoing description.
This application claims the benefit of priority to U.S. Provisional Application No. 62/373,630, filed Aug. 11, 2016, which is incorporated by reference herein in its entirety.
Number | Date | Country | |
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62373630 | Aug 2016 | US |
Number | Date | Country | |
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Parent | 18050075 | Oct 2022 | US |
Child | 18514304 | US | |
Parent | 15673111 | Aug 2017 | US |
Child | 18050075 | US |