The present disclosure relates generally to a delivery system for detachable treatment devices, and more particularly to a delivery sheath including a narrowed diameter region of an attachment zone sized to restrict distal movement of an overlap of a deployment wire and an enlarged outer diameter region of a treatment device.
Medical treatment devices, such as, for example, embolization coils, microcoils, and plugs, are used to restrict or block blood flow to arterio-venous malformations and other vascular lesions. For example, these treatment devices may be delivered into an aneurysm of a patient to prevent blood from entering the aneurysm. Embolization is typically a non-surgical, minimally invasive procedure that involves pushing or injecting the treatment devices, or, alternatively, detaching the treatment devices at the treatment site. Both delivery methods offer benefits and suffer drawbacks, particularly depending on the specifics of the procedure being performed.
According to one example, U.S. Pat. No. 8,333,796 to Tompkins et al. discloses embolic coil implant systems and methods for mechanically retaining and releasing coils. According to one embodiment, an urging means and aperture are disposed within a sidewall of an implant tool. A filament is disposed within a lumen of the implant tool and pushes a portion of a coil into the aperture, against the urging means, to releasably retain a proximal portion of the coil. When the filament is withdrawn, the urging means presses the retained portion of the coil away from the aperture and into the lumen of the implant tool. The proximal portion of the coil is then released through a distal opening of the implant tool. Although the embolic coil deployment system of the Tompkins et al. reference may be suitable for some applications, there is a continuing need for improved deployment systems, including those that offer control, reliability, simplicity, and the ability to navigate tortuous anatomy.
The present disclosure is directed toward one or more of the problems or issues set forth above.
In one aspect, a detachable treatment device delivery system includes a delivery sheath defining a lumen extending from a proximal opening to a distal opening. A treatment device has a proximal attachment segment, which includes an enlarged outer diameter region, configured for receipt within the delivery sheath. The detachable treatment device delivery system also includes a deployment wire configured for receipt within the delivery sheath. A delivery configuration is defined by an overlap of a distal segment of the deployment wire and the enlarged outer diameter region of the treatment device within an attachment zone defined by the delivery sheath. The deployment wire and the treatment device have a combined outer diameter at the overlap, and, in the delivery configuration, the overlap is proximally spaced from a narrowed diameter region of the attachment zone. A diameter of the narrowed diameter region is less than the combined outer diameter. In a deployed configuration, the deployment wire is proximally spaced from the attachment zone, and the proximal attachment segment is distally spaced from the attachment zone and the distal opening. A diameter of the enlarged outer diameter region is less than the diameter of the narrowed diameter region.
In another aspect, a method of deploying a treatment device using a detachable treatment device delivery system is provided. The detachable treatment device delivery system includes a delivery sheath defining a lumen extending from a proximal opening to a distal opening, and a deployment wire. The treatment device includes a proximal attachment segment having an enlarged outer diameter region. The method includes creating an overlap of a distal segment of the deployment wire with the enlarged outer diameter region of the treatment device within an attachment zone defined by the delivery sheath. The deployment wire and the treatment device have a combined outer diameter at the overlap. Distal movement of the treatment device is restricted using a narrowed diameter region of the attachment zone. The overlap is proximally spaced from the narrowed diameter region and a diameter of the narrowed diameter region is less than the combined outer diameter. The method also includes proximally retracting the deployment wire within the delivery sheath such that the deployment wire is proximally spaced from the attachment zone, and releasing the treatment device from the delivery sheath through the distal opening responsive to the proximally retracting step such that the proximal attachment segment of the treatment device is distally spaced from the attachment zone and the distal opening. A diameter of the enlarged outer diameter region is less than the diameter of the narrowed diameter region.
Referring to
The detachable treatment device delivery system 10 includes a delivery sheath 12 having an elongate tubular body 14 defining a lumen 16 extending from a proximal opening 18 to a distal opening 20. In the present disclosure, “proximal” will be used to refer to the end of a component or feature that is closest to a clinician, while “distal” is used to refer to a component or feature that is farthest away from the clinician. Such meanings are consistent with conventional use of the terms and, as such, should be understood by those skilled in the art.
The elongate tubular body 14 may be made from any common medical tube material, such as, for example, polytetrafluoroethylene (PTFE), high density polyethylene (HDPE), nylon, polyetheretherketone (PEEK), or any vinyl, plastic, rubber, silicone, or metal and may exhibit both stiffness, or firmness, and flexibility. Materials as well as dimensions may vary depending on the particular application. However, it may be desirable to dimension the delivery sheath 12 for receipt within a particular catheter or microcatheter. For example, the delivery sheath 12 may have an outer diameter, according to all potential configurations, that is less than 0.035 inch, or other selected catheter inner diameter. A length of the delivery sheath 12 may be between about 50 centimeters to about 225 centimeters, which may correspond to a delivery catheter with which the detachable treatment device delivery system 10 is to be used.
A treatment device 22, which may, for example, be an embolization coil 24, has a proximal attachment segment 26 configured and sized for receipt within the delivery sheath 12. According to a delivery configuration, as shown in
Although treatment device 22 is exemplified as an embolization coil, it should be appreciated that various other treatment devices, including plugs, may be used with the detachable treatment device delivery system 10 instead of the embolization coil 24. To accommodate use with the detachable treatment device delivery system 10, the treatment device 22 preferably includes the proximal attachment segment 26, which is configured for receipt within the delivery sheath 12. In particular, the proximal attachment segment 26 should be sized and shaped for receipt within the delivery sheath 12 and configured for detachable retention within the delivery sheath 12 as described herein. The proximal attachment segment 26 may be integral with the distal end 28, or the proximal attachment segment 26 and the distal end 28 may be separate components that are attached together using known attachment means.
According to the exemplary embodiment, the proximal attachment segment 26 includes an enlarged outer diameter region 30. For reasons that will become more apparent below, the enlarged outer diameter region 30 is enlarged relative to a distal portion 32 of the proximal attachment segment 26. That is, the enlarged outer diameter region 30 has a larger diameter and/or area than the distal portion 32 of the proximal attachment segment 26 that is received through the distal opening 20 of the delivery sheath 12 in the delivery configuration. The proximal attachment segment 26 may be made from similar materials as the distal end 28 of the treatment device 22 or may be made from different materials than the distal end 28.
The detachable treatment device delivery system 10 also includes a deployment wire 34 configured for receipt within the delivery sheath 12. The deployment wire 34 may have an elongate body 36 made from any of a variety of medical grade materials, including those identified with respect to the delivery sheath 12. As shown in the delivery configuration of
The delivery configuration of
The narrowed diameter region 50 may coincide with the distal opening 20 of the delivery sheath 12 and, as shown in
According to some embodiments, a compressive band 56 may be positioned over the delivery sheath 12 at the attachment zone Z and/or the narrowed diameter region 50. The compressive band 56 may assist in maintaining the diameter d1 of the narrowed diameter region 50 and/or, according to some embodiments, may define all or a portion of the narrowed diameter region 50. The compressive band 56 may be, or may include, a radiopaque marker 58 to facilitate fluoroscopic visualization of the attachment zone Z and/or the narrowed diameter region 50. Additional or alternative radiopaque markings may be provided on components of the detachable treatment device delivery system 10, including radiopaque markings on portions of the deployment wire 34 and/or treatment device 22.
The handle 42 may be manipulated to move the detachable treatment device delivery system 10 from the delivery configuration of
As stated above, one or more portions of the proximal attachment segment 26, which includes the enlarged outer diameter region 30, may be urged against a preformed coiled shape in a delivery configuration. Alternatively, portions of the proximal attachment segment 26 may have a preformed straightened shape that remains straightened after the treatment device 22 has been deployed. According to the deployed configuration, one or both of the distal end 28 and the proximal attachment segment 26 may conform to a preformed coiled shape, as is known to those skilled in the art.
According to an alternative embodiment, as shown in
According to an alternative embodiment, as shown in
Turning now to
Referring generally to
Those skilled in the art should appreciate that the detachable treatment device delivery system 10 may be provided in the preloaded state described above and may also include a delivery cannula for maintaining a straightened configuration of the distal end 28 of the treatment device 22 during delivery. The delivery cannula may be configured to retract during advancement of the detachable treatment device delivery system 10 through a delivery catheter, which may be a microcatheter. The delivery catheter, according to one example, may then maintain a straightened configuration of the distal end 28 of the treatment device 22 as the detachable treatment device delivery system 10 is advanced, in the delivery configuration, to a treatment site within a patient, such as, for example, a vascular structure.
When the detachable treatment device delivery system 10 is properly positioned, the handle 42 may be manipulated to proximally retract the deployment wire 34 within the delivery sheath 12 such that the deployment wire 34 is proximally spaced from the attachment zone Z. As such, the deployment wire 34 no longer blocks or restricts passage of the enlarged outer diameter region 30 distally through the distal opening 20. The treatment device 22 may be then be completely released from the delivery sheath 12 through the distal opening 20 in response to the retraction of the deployment wire 34 such that the proximal attachment segment 26, including the enlarged outer diameter region 30, of the treatment device 22 is distally spaced from the attachment zone Z and the distal opening 20.
The distal segment 48 of the deployment wire 34, the proximal attachment segment 26 of the treatment device 22, including the enlarged outer diameter region 30, and the narrowed diameter region 50 are sized and configured to provide the releasable engagement of the treatment device 22 with the delivery sheath 12 that is described herein. In particular, when the enlarged outer diameter region 30 and the deployment wire 34 are overlapped, the enlarged outer diameter region 30 is prevented from advancing proximally through the narrowed diameter region 50. According to some embodiments, the combined outer diameter d4 at the overlap 46 may substantially match a diameter defined by the inner wall 52 at a position proximal to the narrowed diameter region 50. For example, it may be desirable for the wall 52 to frictionally engage the overlap 46 and reduce movement of the deployment wire 34 and the treatment device 22 in the delivery configuration. Alternatively, or additionally, it may be desirable to include additional features that restrict longitudinal movement of the deployment wire 34 and the treatment device 22 during delivery.
The detachable treatment device delivery system 10 provides a low profile means for reliably and precisely detaching a treatment device 22 at a treatment site. For example, the delivery sheath 12 may have a continuous, low profile outer diameter that may effectively advance through a relatively small catheter, such as a microcatheter. The detachable treatment device delivery system 10 may be relatively flexible to navigate tortuous anatomy, while reliably maintaining the releasable attachment of the treatment device 22 during the navigation. Control of the treatment device 22 remains after the detachable treatment device delivery system 10 is proximally advanced relative to the delivery catheter and until the deployment wire 34 is retracted to release the treatment device 22.
It should be understood that the above description is intended for illustrative purposes only, and is not intended to limit the scope of the present disclosure in any way. Thus, those skilled in the art will appreciate that other aspects of the disclosure can be obtained from a study of the drawings, the disclosure and the appended claims.
Number | Date | Country | |
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61868624 | Aug 2013 | US |