Vascular dilator systems, kits, and methods

Abstract

Vascular dilator systems, kits, and methods allowing for sheathless introduction of a treatment device into a body vessel or body cavity are disclosed. A vascular dilator system can include a dilator assembly, including a tubular shaft and a deformable member, and optionally, the treatment device. The deformable member can include a non-biodegradable material and can have a diameter at a proximal end portion that is greater than a diameter at a distal end portion. The distal end portion of the deformable member can be coupled to an outer surface of the tubular shaft, at or near a shaft distal end portion. The proximal end portion of the deformable member can include a diameter configured to receive or stretch around a distal end portion of the treatment device. In use, the deformable member can provide a tapered bridge between the outer surface of the tubular shaft and an outer surface of the treatment device.

What is claimed is: 
     
         1 . A system comprising:
 a dilator assembly including a tubular shaft and a deformable member,   the tubular shaft having an outer surface increasing in diameter between a shaft distal end portion and a shaft proximal end portion, and   the deformable member, including a non-biodegradable material, having an inner surface diameter at a deformable member proximal end portion, as positioned during advancement within a body vessel or body cavity, which is greater than an inner surface diameter at a deformable member distal end portion, as positioned during advancement within the body vessel or body cavity, the deformable member distal end portion coupled to the outer surface of the tubular shaft at or near the shaft distal end portion.   
     
     
         2 . The system of  claim 1 , further comprising a treatment device extending a length less than a length of the tubular shaft, from a device proximal end portion to a device distal end portion, and having a lumen diameter greater than a largest diameter of the outer surface of the tubular shaft. 
     
     
         3 . The system of  claim 2 , wherein the lumen diameter is sufficiently sized such that the tubular shaft and the deformable member can be removed through the treatment device lumen, when the proximal end portion of the deformable member is folded back around the shaft distal end portion. 
     
     
         4 . The system of  claim 2 , wherein the device distal end portion is configured to be received over the tubular shaft, at the shaft proximal end portion, and advanced to a location adjacent the deformable member proximal end portion. 
     
     
         5 . The system of  claim 4 , wherein the inner surface diameter at the deformable member proximal end portion, as positioned during advancement within the body vessel or body cavity, is configured to receive and surround an outer surface of the treatment device at the device distal end portion. 
     
     
         6 . The system of  claim 5 , wherein the inner surface diameter at the deformable member proximal end portion, as positioned during advancement within the body vessel or body cavity, is greater than an outer surface diameter of the treatment device at the device distal end portion. 
     
     
         7 . The system of  claim 5 , wherein the deformable member proximal end portion, as positioned during advancement within the body vessel or body cavity, is configured to stretch around the outer surface of the treatment device at the device distal end portion. 
     
     
         8 . The system of  claim 2 , wherein the shaft proximal end portion includes a first locking mechanism portion and the device proximal end portion includes a second locking mechanism portion, the second locking mechanism portion configured to engage with the first locking mechanism portion. 
     
     
         9 . The system of  claim 1 , wherein the dilator assembly further includes a marker element detectable by imaging or electronic means. 
     
     
         10 . The system of  claim 1 , wherein one or both of:
 the tubular shaft includes a polyether ether ketone (PEEK) material, or   the deformable member includes an elastic material and a hydrophilic coating.   
     
     
         11 . A system comprising:
 a dilator assembly including a tubular shaft, extending from a shaft proximal end portion to a shaft distal end portion, and a deformable member,   the deformable member having an inner surface increasing in diameter between a deformable member distal end, as positioned during advancement within a body vessel or body cavity, and a deformable member proximal end, as positioned during advancement within a body vessel or body cavity, the deformable member distal end coupled to an outer surface of the tubular shaft at or near the shaft distal end portion; and   a treatment device extending a length less than a length of the tubular shaft, from a device proximal end to a device distal end, and having a lumen diameter sized such that the tubular shaft and the deformable member can be removed, from the device proximal end, through the treatment device lumen when the proximal end portion of the deformable member is folded back around the shaft distal end portion.