BRIEF DESCRIPTION OF THE DRAWINGS
In describing the preferred embodiments of the present invention, reference will be made to the accompanying drawings, wherein:
FIG. 1 is an enlarged partially sectioned view of an occlusion device deployment system in accordance with a preferred embodiment of the present invention;
FIG. 2 is an enlarged partially sectioned view of the occlusion device deployment system shown in FIG. 1, during release of the occlusion device;
FIG. 3 is a perspective view of one embodiment of a coupling element in accordance with the present invention, shown prior to deformation of the interference element;
FIG. 4 is a perspective view of the coupling element of FIG. 3, shown after the interference element has been deformed;
FIG. 5 is a cross-sectional view of the coupling element shown in FIG. 3, taken along lines 5-5;
FIG. 6 is a cross-sectional view of the coupling element shown in FIG. 4, taken along lines 6-6;
FIG. 7 is an enlarged partially sectioned view of one embodiment of an occlusion device deployment system in combination with another embodiment of the occlusion device;
FIG. 8 is an enlarged partially sectioned view of the occlusion device deployment system shown in FIG. 7, during release of the occlusion device;
FIG. 9 is a cross-sectional view of another embodiment the coupling element in accordance with the present invention, shown after the coupling element has been deformed; and
FIG. 10 is a cross-sectional view of the coupling element of FIG. 9 shown connected to a headpiece having a tubular configuration.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Therefore, specific details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention in virtually any appropriate manner.
FIGS. 1 and 2 generally illustrate a preferred embodiment of the hydraulic occlusion device deployment system and occlusion device of the present invention. The deployment system, generally designated at 10, includes an elongated deployment catheter 12 that can be inserted and advanced through a guide catheter (not shown) to guide an occlusion device 11 to a preselected site within the vascular 14 of a patient in a manner generally known in the art.
The illustrated deployment catheter 12 is comprised of a series of ribbon coils 16 enclosed within a polymer sheath 18. It will be understood that the deployment catheter can be any type of deployment catheter suitable for deployment of occlusion devices The deployment catheter 12 includes a proximal end portion (not shown) and a distal end portion 20. A lumen 22 extends along the deployment catheter 12 from the proximal end portion to the distal end portion 20.
A hydraulic source (not shown) is operatively connected to the proximal end portion of the deployment catheter 12 to inject fluid into the deployment catheter lumen 22 and to increase fluid pressure within said lumen. The hydraulic source can be similar to the hydraulic syringe system disclosed in U.S. Pat. No. 6,544,225 to Lulo, et al., assigned to the same assignee of the present application and incorporated herein by reference. The hydraulic source could also be any other suitable hydraulic source known in the art. Typical hydraulic fluid is saline solution or other material suitable for internal medical use.
A coupling sleeve 24 is located at the distal end portion 20 of the deployment catheter 12. The coupling sleeve 24 has a tubular configuration that includes a lumen 26 (shown in FIG. 2) which communicates with lumen 22. The coupling sleeve 24 is preferably made of a rigid or semi-rigid material so that the configuration of the coupling sleeve does not substantially change, i.e., expand, upon an increase in fluid pressure within the lumen 26. Preferably, the coupling sleeve is comprised of a metal hypotube. Alternatively, the coupling sleeve 24 can be comprised of any other rigid or semi-rigid material that does not change configuration in response to fluid pressure within a catheter, such as a high Durometer polymer.
The coupling sleeve 24 has an indented proximal end portion 28 that is sized to fit into the lumen 22 at the distal end portion 20 of deployment catheter 12. The coupling sleeve 24 and the deployment catheter 12 are preferably separate components that are secured together by, for example, adhesive or solder. It is also contemplated that the coupling sleeve 24 and the deployment catheter 12 could be a unitary structure form by, for example, extrusion or molding.
The occlusion device 11 includes an embolic element 30 and a headpiece 32 which are illustrated as separate components that are secured together by adhesive or solder; however, it will be understood that the embolic element 30 and the headpiece 32 can be of a unitary structure which forms the occlusion device.
The embolic element 30 is preferably an embolic coil which can be of the type that takes a substantially linear configuration for being advanced through the guide catheter and a randomly oriented relaxed condition after it has exited from the guide catheter. Alternatively, the embolic element 30 may be any other type of embolic element which may take on various forms and configurations, such as hydrogels, foams, bioactive coils, braids, cables and hybrid devices.
The occlusion device headpiece 32 has a distal end portion 34 and an indented proximal end portion 36. The distal end portion 34 is connected to the embolic element 30, and the proximal end portion 36 is sized to fit within the lumen 26 of the coupling sleeve 24.
A coupling element 38 is located at the proximal end portion 36 of the headpiece 32. In the illustrated embodiment, referring to FIGS. 5 and 6, the coupling element 38 is generally cylindrical and includes a proximal wall 40 and a circumferential sidewall 42 defining a cavity 44 within the coupling element. An opening 46 is located at the distal end 48 of the coupling element 38. The coupling element 38 is attached to the headpiece 32 by placing the coupling element over the indented proximal end portion 36 of the headpiece so that the proximal end portion 36 of the headpiece enters the opening 46 and is located within the cavity 44 of the coupling element, as shown in FIGS. 1 and 2. The coupling element 38 and the headpiece 32 are then secured together, for example, by adhesives or solder. The proximal end portion 36 of the headpiece 32 is indented so that the circumferential sidewall 42 of the coupling element 38 can fit between the headpiece 32 and the coupling sleeve 24. When desired, the size of the indent of the proximal end portion 36 of the headpiece 32 is substantially equal to the thickness of the circumferential sidewall 42 so that the outer surface of the circumferential wall and outer surface of the headpiece generally align.
Referring to FIGS. 3, 4, 5 and 6, the proximal wall 40 of the coupling element 38 includes a deformable interference element 50. Illustratively, the deformable interference element 50 is comprised of a radially flared proximal tip 52 of the coupling element. The deformable interference element 50 includes an initial configuration, as illustrated in FIGS. 3 and 5, and a slightly deformed or folded configuration, as illustrated in FIGS. 4 and 6. Preferably, the interference element 50 is made from a deformable material that will deform when a hydraulic pressure between about 100 psi and about 1000 psi, typically between about 200 psi and about 900 psi, is applied to the interference element. Such materials include flexible metals, metal alloys, such as Nitinol, and deformable polymers
Referring to FIGS. 3 and 5, in the initial configuration, the flared proximal tip 52 is flared radially and the outer surface 54 of the proximal wall 40 is flat. When the headpiece 32 is placed within the coupling sleeve 24 prior to deployment, the radial flared proximal tip 52 engages an interference surface located on the deployment catheter. In the illustrated embodiment, the radial flared proximal tip 52 has a larger diameter then a lip 56 located at the proximal end of the coupling sleeve 24, and the radial flared proximal tip 52 engages with the lip 56 to provide a high strength attachment between the headpiece 32 and the coupling sleeve 24, as illustrated and FIG. 1.
Referring to FIG. 2, when fluid 58 enters the lumen 22 and hydraulic pressure is applied to the coupling element 38, the interference element 50 transitions into a deformed configuration. In the deformed configuration, the flared proximal tip 52 is slighted folded or deformed inwardly In the illustrated embodiments, the surface 54 of the proximal wall 40 of the coupling element 38 is thereby curved in a concaved dish-like shape, as illustrated in FIGS. 2, 4 and 6. The deformed configuration allows the flared proximal tip 52 of the coupling member 38 to be advanced distally past the lip 56 of the coupling sleeve 24, and the headpiece 32 is pushed out to the lumen 26 of coupling sleeve 24 under the force of the hydraulic pressure.
In use, with the flared proximal tip 52 of the coupling member 38 in the initial configuration and engaging lip 56 of the coupling sleeve 24, the headpiece 32 of the occlusion device 11 is disposed within the lumen 26 of the coupling sleeve 24 to securely attach the occlusion device 11 to the deployment catheter 12, as illustrate in FIG. 1.
A guide catheter can be inserted into the vasculature system of a patient, and the distal end portion of the guide catheter can be positioned at a preselected location within a blood vessel, typically in conjunction with other devices and professional procedures as generally known in the art. The deployment catheter 12 having an occlusion device 11 is inserted into a proximal end portion of the guide catheter, and the deployment catheter 12 is advanced through the guide catheter until the occlusion device 11 reaches the distal end portion of the guide catheter.
Once the occlusion device 11 reaches the distal end portion of the guide catheter, the occlusion device 11 may be moved out of the distal end portion of the guide catheter by moving the guide catheter in a retrograde manner, by advancing the deployment catheter 12, or by a combination of moving the guide catheter in a retrograde manner and advancing the deployment catheter.
The occlusion device 11 can include at least one radiopaque marker, preferably located in the headpiece 32, so that the position of the occlusion device 11 can be monitored by fluoroscopy. After the occlusion device 11 has exited the guide catheter, if it is determined that the occlusion device is in the wrong position and/or a different occlusion device is required, the deployment catheter 12 can be retracted to move the occlusion device back into the guide catheter. Once in the guide catheter, the occlusion device 11 can be repositioned or completely removed from the patient.
After it has been determined that the occlusion device 11 is at the desired location within the patient, the hydraulic source is activated to inject fluid 58 into the lumen 22 of the deployment catheter 12 and to increase the fluid pressure within the lumen 22. The increased fluid pressure is applied to the coupling element 38 which causes the interference element 50 to deform, e.g., the flared proximal tip 52 slightly folds or deforms inward, as illustrated in FIG. 2. With the interference element 50 deformed, hydraulic pressure advances the interference element 50 past the lip 56 of the coupling sleeve 24, and the headpiece 32 is pushed out of the coupling sleeve 24, thereby deploying the occlusion device.
FIGS. 7 and 8 illustrate the deployment system 10 that is illustrated in combination with an alternative embodiment of the occlusion device, generally designated as 11a.
In the alternative embodiment of the occlusion device 11a, the proximal end portion 36a of the headpiece 32a of the occlusion device at least partially defines a relief area 37a (FIG. 7) that allows the proximal wall 40a of the coupling element 38a to deform, typically be flexing or bending, which aids in the deformation of the interference element 50a (FIGS. 8 and 9). For example, to release the occlusion device 11a from the delivery catheter 12, wall 40a bends in an arcuate manner so that proximal end surface 54a has a concave-like shape which draws the flared tip 52a of the interference element 50a radially inward so that the interference element disengages lip 56.
The relief area 37a is a space that accommodates the deformation of coupling element 38a by receiving a portion of the coupling element. Preferably, the relief area 37a can be at least partially defined by the proximal end portion 36a of the headpiece 32a. In the embodiment illustrated in FIGS. 7 and 8, the relief area 37a is defined by a concave proximal end surface 41a. The relief area 37a defined by the concave surface receives a portion of wall 40a allowing the wall to bend, thereby deforming the flared tip 52a by drawing the flared tip radially inward.
As illustrated in FIG. 10, in an alternative embodiment, the headpiece could have a proximal end portion 36b that is open ended, such as being of a tubular shape. With this approach, the opening in the lumen 43b of the tubular proximal end portion 36b of the headpiece defines a relief area 37b.
The operation of the deployment system of FIGS. 7 and 8 is similar to the operation of the deployment system illustrated in FIGS. 1 and 2. The deployment catheter 12 is manipulated to guide and position the occlusion device 11a at a desired delivery site within the body. Once the occlusion device 11a is at the desire location, the hydraulic source is activated to increase the fluid pressure within lumen 22. The increased fluid pressure acts upon wall 40a of coupling element 38a causing wall 40a to bend (FIGS. 8 and 9). When wall 40a bends, a portion of the wall moves into and occupies the relief space 37a, and the flared proximal tip 52a of interference element 50a is drawn radially inward, thereby disengaging the flared tip 52a from lip 56. With the flared tip 52a drawn radially inward, hydraulic pressure advances the interference element 50a past lip 56 of the coupling sleeve 24, and the headpiece is pushed out of the coupling sleeve to deploy the occlusion device 11a.
It will be understood that the embodiments of the present invention which have been described are illustrative of some of the applications of the principles of the present invention. Numerous modifications may be made by those skilled in the art without departing from the true spirit and scope of the invention, including those combinations of features that are individually disclosed or claimed herein.
Patent Application
20070288050
