METHOD AND APPARATUS FOR DEPLOYING AND RETRIEVING OBJECTS IN A CAVITY
20170319322 · 2017-11-09
Inventors
- Mitchell Eggers (Pearland, TX, US)
- Jeremy Durack (Pearland, TX, US)
- Joseph Steele (Pearland, TX, US)
- Michael Hogan (Pearland, TX, US)
- Raymond Kirk (Pearland, TX, US)
- David Franklin (Pearland, TX, US)
Cpc classification
A61F2002/9505
HUMAN NECESSITIES
A61F2/95
HUMAN NECESSITIES
International classification
Abstract
The present invention relates generally to a method and apparatus for deploying and/or retrieving an object (e.g., a vena cava filter) in a cavity (e.g., a vena cava) using a system configured to: (i) maintain grip of the unsheathed object in the cavity until deliberately released, (ii) prevent premature release of the object in the cavity, and/or (iii) facilitate retrieval by first everting said object, then withdrawing the object through a guiding catheter (e.g., retrieval via eversion).
Claims
1. A system configured to deliver an object to, and retrieve the object from, a location in a cavity, the system comprising: a guiding catheter configured to provide a conduit to and from the location for the object; object deployment components configured to facilitate deployment of the object through the guiding catheter at the location in the cavity; and a retention mechanism configured to secure the object while the object is in the cavity, the retention mechanism comprising: (i) an outer tube with distal fingers that protrude distally through an opening in an end of the object; and (ii) an inner rod or inner tube within the outer tube that prevents the distal fingers on the outer tube from collapsing; wherein, responsive to the inner rod or inner tube being withdrawn proximally with respect to the outer tube, the distal fingers of the outer tube collapse to facilitate withdrawal of the distal fingers through the opening in the end of the object, and withdrawal of the inner rod or inner tube and the outer tube from the object, thereby releasing the object at the location within the cavity.
2. The system of claim 1, wherein the object deployment components comprise a balloon configured to expand the object at the location.
3. The system of claim 2, further comprising an interlock mechanism configured to prevent release of the object at the location in the cavity before a target position of the object in the cavity is achieved.
4. The system of claim 3, wherein actuation of the interlock mechanism enables the release of the object by the retention mechanism, thereby facilitating deployment of the object at the location in the cavity.
5. The system of claim 3, wherein the interlock mechanism is configured to prevent premature release of the object before the object is balloon expanded to a predetermined pressure.
6. The system of claim 3, wherein the interlock mechanism comprises: (i) a piston in a cylinder that is advanced through the cylinder by balloon pressure; and (ii) a spring loaded trigger operatively coupled to the piston configured to move responsive to movement by the piston to disengage a release switch to facilitate release of the object at the location in the cavity.
7. The system of claim 6, wherein the interlock mechanism further comprises an orifice configured to conduct the balloon pressure to the cylinder, the orifice having a diameter that is smaller than a diameter of the cylinder.
8. The system of claim 7, wherein the spring loaded trigger includes a body, a foot portion, and a leg portion extending between the body and the foot portion; the foot portion operatively coupled to the piston, the foot portion supported by a ledge and configured to be pushed off the ledge by the piston and cause the spring loaded trigger to disengage the release switch.
9. The system of claim 1, wherein, prior to release of the object at the location in the cavity the retention mechanism enables a user to pull proximally on the end of the object causing the object to evert, and with continued pulling advance the object into the guiding catheter for removal from the cavity.
10. The system of claim 1, wherein the cavity is the vena cava and the object is a vena cava filter.
11. A system configured to retrieve an object from a location in a cavity, the system comprising: a guiding catheter configured to provide a conduit to and from the location for the object; and an extraction device catheter comprising grasping and extraction components for grasping and extracting the object, the extraction device catheter configured such that the grasping and extraction components are located at a distal end of the extraction device catheter and actuator controls for the grasping and extraction components are located at a proximal end of the extraction device catheter.
12. The system of claim 11, wherein the extraction device catheter is configured such that the actuator controls comprise a sliding handle and thumb grip located at the proximal end of the extraction device catheter configured to be compressed relative to each other to cause the grasping and extraction components to grasp the object and extend relative to each other to cause the grasping and extraction components to release the object.
13. The system of claim 12, wherein the extraction device catheter is advanced through the guiding catheter to the location of the object and the grasping and extraction components grasp and secure the object responsive to the sliding handle and thumb grip being compressed relative to each other, which enables a user to pull proximally on an end of the object causing the object to evert, and with continued pulling advance the object into the guiding catheter for removal from the cavity.
14. The system of claim 13, wherein the grasping and extraction components comprise jaws configured to close around the end of the object responsive to the sliding handle and thumb grip being compressed relative to each other.
15. The system of claim 11, wherein the cavity is the vena cava and the object is a vena cava filter.
16. A method for delivering an object to, and retrieving the object from, a location in a cavity with a delivery system, the system comprising a guiding catheter, object deployment components, and a retention mechanism, the method comprising: forming, with the guiding catheter, a conduit to and from the location for the object; facilitating, with the object deployment components, deployment of the object through the guiding catheter at the location in the cavity; and securing, with the retention mechanism, the object while the object is in the cavity, the retention mechanism comprising: (i) an outer tube with distal fingers that protrude distally through an opening in an end of the object; and (ii) an inner rod or inner tube within the outer tube that prevents the distal fingers on the outer tube from collapsing, wherein, responsive to the inner rod or inner tube being withdrawn proximally with respect to the outer tube, the distal fingers of the outer tube collapse to facilitate withdrawal of the distal fingers through the opening in the end of the object, and withdrawal of the inner rod or inner tube and the outer tube from the object, thereby releasing the object at the location within the cavity.
17. The method of claim 16, wherein the object deployment components comprise a balloon configured to expand the object at the location, and the method further comprises deploying the object with the balloon.
18. The method of claim 16, wherein the system further comprises an interlock mechanism, and the method further comprises preventing, with the interlock mechanism, release of the object at the location in the cavity before a target position of the object in the cavity is achieved.
19. The method of claim 18, wherein the method further comprises receiving, with the interlock mechanism, actuation to enable the release of the object by the retention mechanism, thereby facilitating deployment of the object at the location in the cavity.
20. The method of claim 18, further comprising preventing, with the interlock mechanism, premature release of the object before the object is balloon expanded to a predetermined pressure.
21. The method of claim 18, wherein the interlock mechanism comprises: (i) a piston in a cylinder that is advanced through the cylinder by balloon pressure; and (ii) a spring loaded trigger operatively coupled to the piston configured to move responsive to movement by the piston to disengage a release switch to facilitate release of the object at the location in the cavity.
22. The method of claim 21, further comprising conducting, with an orifice, the balloon pressure to the cylinder, the orifice having a diameter that is smaller than a diameter of the cylinder.
23. The method of claim 22, wherein the spring loaded trigger includes a body, a foot portion, and a leg portion extending between the body and the foot portion; the foot portion operatively coupled to the piston, the foot portion supported by a ledge and configured to be pushed off the ledge by the piston and cause the spring loaded trigger to disengage the release switch.
24. The method of claim 16, further comprising, prior to release of the object at the location in the cavity before the target position of the object in the cavity is achieved, enabling a user to pull proximally on the end of the object causing the object to evert, and with continued pulling advance the object into the guiding catheter for removal from the cavity.
25. The method of claim 16, wherein the cavity is a vena cava, wherein the object is a vena cava filter.
26. A method for retrieving an object from a location in a cavity with a retrieval system, the system comprising a guiding catheter and an extraction device catheter, the method comprising: grasping, with the extraction device catheter, the object at the location in the cavity, the extraction device catheter configured such that grasping and extraction components are located at a distal end of the extraction device catheter and actuator controls for the grasping and extraction components are located at a proximal end of the extraction device catheter; and enabling with the extraction device catheter, a user to pull proximally on an end of the object causing the object to evert, and with continued pulling advance the object into the guiding catheter for removal from the cavity.
27. The method of claim 26, wherein the extraction device catheter is configured such that the actuator controls comprise a sliding handle and thumb grip located at the proximal end of the extraction device catheter, and wherein the method further comprises compressing the sliding handle and thumb grip relative to each other to cause the grasping and extraction components to grasp the object and extending the sliding handle and thumb grip relative to each other to cause the grasping and extraction components to release the object.
28. The method of claim 27, wherein the grasping and extraction components comprise jaws configured to close around the end of the object responsive to the sliding handle and thumb grip being compressed relative to each other.
29. The method of claim 26, wherein the cavity is a vena cava, wherein the object is a vena cava filter.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION OF THE INVENTION
[0035] Embodiments of the present invention will now be described in detail with reference to the drawings, which are provided as illustrative examples so as to enable those skilled in the art to practice the invention. Notably, the figures and example below are not meant to limit the scope of the present invention to a single embodiment, but other embodiments are possible by way of interchange of some or all of the described or illustrated elements. Wherever convenient, the same reference numbers will be used throughout the drawings to refer to same or like parts. Where certain elements of these embodiments can be partially or fully implemented using known components, only those portions of such known components that are necessary for an understanding of the present invention will be described, and detailed descriptions of other portions of such known components will be omitted so as not to obscure the invention. In the present specification, an embodiment showing a singular component should not be considered limiting. Rather, the invention is intended to encompass other embodiments including a plurality of the same component, and vice-versa, unless explicitly stated otherwise herein. Moreover, applicants do not intend for any term in the specification or claims to be ascribed an uncommon or special meaning unless explicitly set forth as such. Further, the present invention encompasses present and future known equivalents to the components referred to herein by way of illustration. The terms “proximal” and “distal” are used with reference to the operator of the extraction device. In particular the distal end will be nearest to the object of extraction, while the proximal end will be nearest to the operator.
[0036] As used herein, the singular form of “a”, “an”, and “the” include plural references unless the context clearly dictates otherwise. As used herein, the statement that two or more parts or components are “coupled” shall mean that the parts are joined or operate together either directly or indirectly, i.e., through one or more intermediate parts or components, so long as a link occurs. As used herein, “directly coupled” means that two elements are directly in contact with each other. As used herein, “fixedly coupled” or “fixed” means that two components are coupled so as to move as one while maintaining a constant orientation relative to each other.
[0037] As used herein, the word “unitary” means a component is created as a single piece or unit. That is, a component that includes pieces that are created separately and then coupled together as a unit is not a “unitary” component or body. As employed herein, the statement that two or more parts or components “engage” one another shall mean that the parts exert a force against one another either directly or through one or more intermediate parts or components. As employed herein, the term “number” shall mean one or an integer greater than one (i.e., a plurality).
[0038] Directional phrases used herein, such as, for example and without limitation, top, bottom, left, right, upper, lower, front, back, and derivatives thereof, relate to the orientation of the elements shown in the drawings and are not limiting upon the claims unless expressly recited therein.
[0039] The present invention relates generally to a method and apparatus for deploying and retrieving an object (e.g., a vena cava filter) in a cavity using a catheter configured to: (i) maintain grip of the unsheathed object in the cavity until deliberately released, (ii) prevent, using an interlock, premature release of the object in the cavity, and/or (iii) facilitate retrieval by first everting said object, then withdrawing the object through a guiding catheter (e.g., retrieval via eversion).
[0040] Although the present invention can be used to deploy and retrieve a plethora of implantable medical devices in a cavity, deployment and retrieval of a flexible IVC filter intended to prevent pulmonary embolism (PE) is shown and described herein as one example embodiment to illustrate details of the present method and apparatus. The flexibility of such an IVC filter often requires ballooning during deployment, which poses both new challenges and opportunities for their accompanying delivery systems. For example, the increased flexibility of absorbable IVC filters enables retrieval via the eversion method described herein (e.g., in the event that the filter must be retrieved before resorption). Consequently there is a current demand for the novel delivery system described herein that can both accommodate and exploit the unique features of a flexible IVC filter and/or other filters.
[0041] First, the retrieval via eversion method and apparatus will be described using miniaturized grasping forceps to extract a flexible IVC filter subsequent to deployment. Following such description, the delivery system method and apparatus allowing both deployment and retrieval of a flexible IVC filter will be described in detail with the featured interlock mechanism to prevent premature filter release. It should be noted, that even though these descriptions are treated somewhat separately, both of these descriptions refer to the components and operation of present system 100.
[0042] Referring to
[0043]
[0044] Following secure grasping of the IVC filter 4 tip 6, the extraction device catheter 2 is gently pulled proximally towards the operator (e.g., toward end 54) causing the IVC filter 4 to evert 60 as shown in
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[0049] Filter deployment with the delivery system 100 includes pulling (e.g., by an operator) the barrel slide 103 proximally 204, which effectively pulls the outer catheter 102 and introducer 200 proximally 204 to unsheathe the filter 101 as shown in
[0050] Filter deployment with the delivery system 100 includes “ballooning” the compressed flexible IVC filter 101 (e.g., expanding the diameter of the IVC filter 101 compressed over the balloon to fit snug against the IVC wall) as shown in
[0051] As shown in the magnified view in
[0052] An interlock mechanism 300 within the handle 104 (
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[0054] In some embodiments, the spring loaded trigger 182 includes a body 361, a foot portion 363, a leg portion 365 extending between the body 361 and the foot portion 363, and/or other components. In some embodiments, body 361 includes a sleeve, groove, and/or other components 367 configured to receive an end of the pin 180. The foot portion 363 is operatively coupled to the piston 184 via translator 183. The foot portion 363 is supported by the ledge 312 and configured to be pushed off the ledge 312 by the piston 184 (via translator 183) and cause the spring loaded trigger 182 to disengage the release switch 106 (e.g., when body 361, leg portion 365, and foot portion 363 fall 310 (and/or are pushed by spring 181). In some embodiments, the ledge 312 is formed by a portion of cylinder 308. In some embodiments ledge 312 is formed by a portion of cylinder 308 that is opposite orifice 185 (described below). In some embodiments, leg portion 365 extends from body 361 toward ledge 312 such that foot portion 363 rests on ledge 312 as shown and described.
[0055] Orifice 185 is configured to facilitate avoidance of erroneous triggering of the interlock mechanism 300 in the event the operator pushes the syringe plunger 122 (
[0056] In some embodiments, orifice 185 and cylinder 308 are oriented along a first axis 378 of handle 104 such that length 374 and length 376 extend along axis 378. In some embodiments, spring loaded trigger 182, spring 181, and pin 180 occupy a second cylinder 390 that is oriented along a second axis 392 of handle 104. In some embodiments, second axis 392 and first axis 378 are substantially perpendicular to each other. In some embodiments, spring loaded trigger 182 falls 310 (and/or is pushed by spring 181) in cylinder 390 responsive to foot portion 314 of trigger 182 sliding off of ledge 312 when pushed by the translator 183 and the piston 184.
[0057] Delivery system 100 (
[0058] A series of magnified figures (
[0059] In some embodiments, e.g., when it is desired to retrieve the IVC filter immediately following insertion in the IVC due to malposition, inappropriate sizing, and/or for other reasons, it is possible to use the retention mechanism represented, for example, by the retention fingers 151 of the retention tube 150 together with the lock rod 155 in the lock position (e.g.,
[0060] It should be noted that the shapes (e.g., cylindrical, etc.) and dimensions described herein are not intended to be limiting. The components of the present system may have any shape and/or size that allows them to function as described herein.
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[0062] At an operation 402, a conduit is formed to and from the location for the object in the body cavity. In some embodiments, operation 402 is performed by a guiding catheter similar to and/or the same as guiding catheter 1 (shown in
[0063] At an operation 404, deployment of the object is facilitated. In some embodiments, deployment is facilitated with object deployment components. In some embodiments, the object deployment components comprise a balloon configured to expand the object at the location, a pressure gage, fluid, a plunger, and/or other components. In some embodiments, operation 404 is performed by object deployment components the same as or similar to delivery system 100, dilator 299, guide wire 201, handle 104, balloon 130, pressure gage 120, syringe 121 filled with diluted contrast solution, plunger 122 (shown in
[0064] At an operation 406, release of the object at the location before a target position is achieved is prevented. In some embodiments, operation 406 is performed by an interlock mechanism similar to and/or the same as interlock mechanism 300 (shown in
[0065] At an operation 408, the object is secured while the object is in the cavity. In some embodiments, operation 408 is caused by a retention mechanism similar to and/or the same as the retention mechanism formed by retention tube 150 and retention fingers 151 (shown in
[0066] At an operation 410, the object is grasped and extracted from the location in the cavity. In some embodiments, operation 410 occurs after the object has been deployed at the location in the body. In some embodiments, operation 410 is caused by a grasping and extraction device similar to and/or the same as extraction device catheter 2, extraction device 53, and/or a sliding handle 20 and thumb grip 21 (shown in
[0067] In some embodiments (e.g., before the object is fully deployed at the location in the cavity), operation 410 is caused by retaining grip of the device using a combination of retention tube 150 with retention fingers 151 and an inner lock tube 155, such grip being strong enough to facilitate retrieval via eversion as described previously.
[0068] In some embodiments, the grasping and extraction components comprise jaws configured to close around the (e.g., distal) end of a vena cava filter responsive to the sliding handle and thumb grip being compressed relative to each other. In some embodiments, the object is a vena cava filter, and operation 410 includes advancing the extraction device catheter through the guiding catheter to the location of the object and grasping and securing the object responsive to the sliding handle and thumb grip being compressed relative to each other; and enabling a user to pull proximally on the end of the vena cava filter causing the vena cava filter to evert, and with continued pulling advance the vena cava filter into the guiding catheter for removal from the cavity.
[0069] In the claims, any reference signs placed between parentheses shall not be construed as limiting the claim. The word “comprising” or “including” does not exclude the presence of elements or steps other than those listed in a claim. In a device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The word “a” or “an” preceding an element does not exclude the presence of a plurality of such elements. In any device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The mere fact that certain elements are recited in mutually different dependent claims does not indicate that these elements cannot be used in combination.
[0070] Although the description provided above provides detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments, it is to be understood that such detail is solely for that purpose and that the disclosure is not limited to the expressly disclosed embodiments, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.