WO2018006015A1

WO2018006015A1 - Catheter and related devices

Info

Publication number: WO2018006015A1
Application number: PCT/US2017/040370
Authority: WO
Inventors: Luca Pesce; Alfonso USSIA
Original assignee: Luca Pesce; Ussia Alfonso
Priority date: 2016-07-01
Filing date: 2017-06-30
Publication date: 2018-01-04

Abstract

The medical apparatus can include a catheter (170) or catheter-deployed devices. The catheter can include an articulation catheter or a passive catheter. The catheter can include a proximal end region (170x) and a distal end region (170y) opposite to the proximal end region. The catheter can include a handle (100) coupled to the proximal end region of the catheter and configured to deflect the distal end region of the catheter in multiple planes. One or more back modules (200) can be coupled to the handle distally from the catheter. Each of the back modules can be configured to deliver a medical device via the catheter. Thus, the catheter can be steered in multiple directions with improved accuracy and flexibility. Multiple medical devices can be delivered into a body via the catheter.

Description

CATHETER AND RELATED DEVICES

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to United States provisional patent application, Serial No. 62/357,762, filed on July 1, 2016. Priority to the provisional patent application is expressly claimed, and the disclosure of the provisional application is hereby incorporated herein by reference in their entireties and for all purposes.

FIELD

[0002] The disclosed embodiments relate to medical apparatuses and more particularly, but not exclusively, to intravascular catheters, catheter handles, and catheter-deployed devices.

BACKGROUND

[0003] Existing catheters have limited flexibility. Directions of catheter deflection are difficult to control and accuracy of such control is highly dependent on operator skills. Further, many medical procedures require multiple devices being delivered into a body. It is difficult to deliver multiple devices into the body in a coordinated manner. Such procedures are often associated with great complexity and safety risk.

[0004] In view of the foregoing, there is a need for medical apparatuses that overcome the disadvantages of currently-available apparatuses.

SUMMARY

[0005] The present disclosure relates to a medical apparatus and methods for making and using the same.

[0006] In accordance with a first aspect disclosed herein, there is set forth a medical apparatus, including:

[0007] a catheter including a proximal end region and a distal end region opposite to the proximal end region; and [0008] a handle coupled to the proximal end region of the catheter and configured to deflect the distal end region of the catheter in multiple planes.

[0009] In some embodiments of the disclosed apparatus, the apparatus further includes one or more back modules coupled to the handle opposite the catheter.

[0010] In some embodiments of the disclosed apparatus, each of the one or more back modules is configured to translocate a device to the catheter via the handle.

[0011] In some embodiments of the disclosed apparatus, each of the one or more back modules is configured to deliver a device to the catheter via the handle.

[0012] In some embodiments of the disclosed apparatus, the handle includes:

[0013] a central core; and

[0014] one or more translocation apparatuses distributed circumferentially about the central core and configured to deflect the distal end region of the catheter in the multiple planes.

[0015] In some embodiments of the disclosed apparatus, a selected translocation apparatus of the one or more translocation apparatuses includes an adapter slidably attached to the central core.

[0016] In some embodiments of the disclosed apparatus, the selected translocation apparatus includes a wire including a proximal end region connecting to the adapter and a distal end region connecting to the distal end region of the catheter.

[0017] In some embodiments of the disclosed apparatus, the apparatus further includes a balloon externally mounted on a selected region of the catheter.

[0018] In some embodiments of the disclosed apparatus, the catheter defines one or more inflation conduits in fluid communication with the balloon.

[0019] In some embodiments of the disclosed apparatus, the handle includes an inflation port in fluid communication with the one or more inflation conduits. [0020] In some embodiments of the disclosed apparatus, the balloon is configured to stabilize the distal end region of the catheter in a blood vessel upon inflation.

[0021] In some embodiments of the disclosed apparatus, the balloon is configured dilate a vessel or an orifice.

[0022] In some embodiments of the disclosed apparatus, the catheter includes one or more articulation links at the distal end region of the catheter.

[0023] In some embodiments of the disclosed apparatus, the catheter defines a catheter lumen for accommodating a mandrel with a selected stiffness, a selected shape, or a combination thereof.

[0024] In some embodiments of the disclosed apparatus, the catheter defines:

[0025] a first catheter lumen terminating at a first location of the distal end region of the catheter; and

[0026] a second catheter lumen terminating at a second location of the distal end region of the catheter that is different from the first location.

[0027] In accordance with another aspect disclosed herein, there is set forth a medical apparatus, comprising:

[0028] a catheter including a proximal end region and a distal end region opposite to the proximal end region;

[0029] a handle coupled to the proximal end region of the catheter; and

[0030] one or more back modules coupled to the handle distally from the catheter.

[0031] In some embodiments of the disclosed apparatus, the one or more back modules are interconnected in series.

[0032] In some embodiments of the disclosed apparatus, the one or more back modules are each configured to translocate at least one device to the catheter via the handle. [0033] In some embodiments of the disclosed apparatus, a selected back module of the one or more back modules defines one or more module lumens.

[0034] In some embodiments of the disclosed apparatus, the selected back module includes a latch configured to translocate relative to the handle to move a device through a selected module lumen of the one or more module lumens.

[0035] In accordance with another aspect disclosed herein, there is set forth an apparatus for retrieving and/or repositioning an implantable device, comprising:

[0036] a catheter including a proximal end region and a distal end region opposite to the proximal end region;

[0037] a handle coupled to the proximal end region of the catheter; and

[0038] a back module coupled to the handle distally from the catheter and configured for:

[0039] deploying an expandable and retrievable cone into a selected position in a body via the catheter; and

[0040] deploying a snare via the catheter to retrieve the implantable device into the expandable cone.

[0041] In some embodiments of the disclosed apparatus, the cone is collapsable.

[0042] In accordance with another aspect disclosed herein, there is set forth an apparatus for ablation, comprising:

[0043] a catheter including a proximal end region and a distal end region opposite to the proximal end region;

[0044] a handle coupled to the proximal end region of the catheter; and

[0045] a back module coupled to the handle distally from the catheter and configured for:

[0046] operating, via the catheter, an ablation guide for circumnavigating a vessel to guide an ablation catheter to perform an ablation procedure. BRIEF DESCRIPTION OF DRAWINGS

[0047] Fig. 1A is a perspective view of one embodiment of a handle.

[0048] Fig. IB is a perspective view of one embodiment of a handle 100 without housing 102.

[0049] Fig. 1C is a perspective view of one embodiment of a handle 100 without housing 102 and housing cap 103.

[0050] Fig. ID is a perspective view of a combined device composed of a handle 100, a catheter 170 and a back module 200.

[0051]Fig. 2A is a perspective view of one embodiment of thumbwheel 120 and adapter 130 in an unmated conformation.

[0052] Fig. 2B is a cut-away perspective view of one embodiment of thumbwheel 120 and adapter 130 in a mated conformation.

[0053] Fig. 2C is a perspective view of one embodiment of the central core 150 and associated handle elements.

[0054] Fig. 2D is a cut-away view of one embodiment of a handle 100.

[0055] Fig. 3 A is a cut-away view of one embodiment of a handle 100.

[0056] Fig. 3B is a cut-away view of one embodiment of a handle 100.

[0057] Figs. 4A-4D are perspective views of various catheters shafts 170.

[0058] Fig. 5 A is a perspective view of the distal end region of a catheter when balloon 190b is deflated.

[0059] Fig. 5B is a perspective view of the distal end region of a catheter when balloon 190b is inflated.

[0060] Fig. 5C is a perspective view of the distal end regions of a catheter inserted when balloon 190 is inflated. [0061] Fig. 6A is a perspective view of catheter 170 inserted within the heart anatomy with balloon 190b deflated.

[0062] Fig. 6B is a perspective view of catheter 170 inserted within the heart anatomy with balloon 190b inflated and secured against a vessel wall.

[0063] Fig. 6C is a perspective view of catheter 170 inserted within the heart anatomy with balloon 190b inflated and catheter tip 170b oriented towards the atria septal wall.

[0064] Figs. 7A-7E are perspective views of various articulation joints 175 described herein.

[0065] Fig 7F is a perspective view of a 4-backbones articulation joint 175 in a multiplane deflected configuration.

[0066] Figs. 8A-8B are perspective views of a 4-backbone articulation joint 175 described herein in various deflected configurations.

[0067] Figs. 9A-9B are perspective exploded views of the distal end regions of various catheter embodiments described herein.

[0068] Figs. 9C-9D are perspective views of the distal end regions of various catheter embodiments described herein.

[0069] Fig. 1 OA is a perspective view of the distal end region of an embodiment of the catheter with balloon 190 inflated and articulating tip deflected.

[0070] Figs. 10B- IOC are perspective views of the distal end regions of various catheter embodiments described herein with balloons 190b inflated and articulating tip deflected.

[0071]Fig. 11 A is a perspective view of the distal end region of one embodiment of a handle 100.

[0072] Fig. 1 IB is a cross-sectional perspective view of the distal end region of one embodiment of a handle 100. [0073] Fig. 11C is a cross-sectional perspective view of one embodiment of a multi-lumen catheter.

[0074]Fig. 12 is an exploded view of one embodiment of back module 200.

[0075] Fig. 13 A is a perspective view of one embodiment of a handle 100 and back module 200 combination unmated.

[0076] Fig. 13B is a perspective view of one embodiment of a handle 100 and back module 200 combination mated.

[0077]Fig. 14A is a perspective view of one embodiment of a handle 100 and dual back module 200 combination unmated.

[0078] Fig. 14B is a perspective view of one embodiment of a handle 100 and dual back module 200 combination mated.

[0079] Fig. 15A is a cross-sectional view of one embodiment of a mated handle 100 and a back module 200.

[0080] Fig. 15B is a cross-sectional view of one embodiment of a mated handle 100 and two back modules 200.

[0081] Fig. 16A is a perspective view of one embodiment of back module 200 without back handle 210 and back cap 240.

[0082] Fig. 16B is a cross-sectional view of one embodiment of a mated handle 100 and back module 200 along the midsection plane of the back module 200.

[0083] Fig. 16C is a perspective view of one embodiment of back module 200 without back cap 240.

[0084] Fig. 16D is a cross-sectional view of one embodiment of a mated handle 100 and back module 200 along the midsection planes of a lock screw 221b. [0085] Fig. 16E is a cross-sectional view of one embodiment of a mated handle 100 and back module 200 along the midsection planes of latch 230.

[0086]Fig. 16F is a perspective view of the distal end region of catheter 170 with snare 300 inserted within.

[0087] Fig. 17A is a cross-sectional view of one embodiment of a mated handle 100 and two back modules 200 along the midsection plane of latches 230.

[0088] Fig. 17B is a cross-sectional view of one embodiment of a mated handle 100 and two back modules 200 along the midsection planes of lock screws 221a,c.

[0089] Fig. 17C is a cross-sectional view of one embodiment of a mated handle 100 and two back modules 200 along the midsection planes of lock screws 221b,d.

[0090] Figs. 18A-18B are perspective views of embodiments of distal catheter ends.

[0091] Fig. 19 is a perspective view of one embodiment of a deployed snare 410 and cone 420.

[0092] Figs. 20A-20D illustrate various uses of a catheter.

[0093] Fig. 21 is an exploded view of one embodiment of a universal clamp system 600.

[0094] Figs. 22A-22B illustrate embodiments of assembled universal clamp systems 600.

[0095] Figs. 22C-22E illustrate the use of some embodiments of universal clamp systems 600.

DETAILED DESCRIPTION

[0096] The present disclosure relates to intravascular catheters that have an articulating distal end that enables the operator to direct more easily the catheter through the subject's vascular system. The disclosure also provides devices that may be deployed from or used in association with an intravascular catheter.

[0097] "Proximal" is a relative term that refers to the direction or side towards the operator or the outside of the body. For example, an operator withdrawing a catheter from a patient is translating the catheter in the proximal direction. [0098] "Distal" is a relative term that refers to the direction or side away from the operator. For example, an operator inserting a catheter into a patient is translating the catheter in a distal direction.

[0099] The disclosure provides an articulation catheter and associated devices, methods for use, and methods for manufacture. Articulation catheters generally refer to intravascular catheters in which the distal end region may be deflected in at least one direction by the operator (e.g., surgeon or physician). Deflection of the distal catheter end allows the operator to more accurately "steer" the catheter within the subject's vascular system, thereby increasing the speed and accuracy with which the operator can position the distal catheter end at the target site.

Articulation catheters are distinct from passive or flexible catheters which are not under the directional control of the operator. These catheters change direction and/or conform to the vasculature under the force/pressure of the distal end region encountering the blood vessel wall and passively deflecting toward the vessel lumen.

[00100] Fig. 1A shows an exemplary embodiment of a catheter handle (or handle) 100 and associated structures that allow the operator to articulate the catheter's distal end region with high precision and control. A catheter (or catheter shaft) 170 can include a proximal end region 170x and a distal end region 170y (shown in Figs. 5A-5C) opposite to the proximal end region 170x. The catheter handle 100 and associated structures can enable an operator to articulate the distal end region 170y of the catheter 170 with high precision and control. The catheter handle 100 is shown as being coupled to the proximal end region 170x of the catheter 170 and configured to deflect the distal end region 170y of the catheter 170 two-dimensionally and/or three- dimensionally. In other words, the catheter handle 100 can deflect the distal end region 170y of the catheter 170 in a multi-dimensional manner such as in a two-dimensional manner and/or in a three-dimensional manner. Stated somewhat differently, the catheter handle 100 can enable the distal end region 170y to deflect in multiple planes. For example, the catheter handle 100 can enable the distal end region 170y to deflect in multiple planes simultaneously. Additionally and/or alternatively, the catheter handle 100 can enable the distal end region 170y to deflect in one selected plane at one time, and in a different selected plane at another time. For example, the distal end region 170y can deflect in a first plane at a first time and in a second plane at a second time, the first and second planes being different.

[0100] Fig. 1C illustrates the internal components of one embodiment of a handle 100. As is described in more detail below, the handle 100 can have one or more (e.g., one, two, three, four, or more) threaded rods 110 on which are individually mounted a thumbwheel 120 that may be translocated along the rod 110 in the proximal/distal direction by the operator. Adapters 130 are connected to thumbwheels 120 and therefore are simultaneously translocated along rods 110. The movement of adapters 130 along rods 110 tensions wires 140 (shown in Fig. 2D) that deflect the distal catheter tip. The lumen of catheter 170 may be accessed in a standard manner through access port 160, optionally mounted on the proximal face of the handle 100 (shown in Fig. 3 A). Optionally, adapters 130 are further guided by channels 151 in central core 150. Optionally, the handle 100 can have one or more (e.g., two) balloon inflation ports 101. Fig. 1A illustrates the handle 100 contained in housing 102 sealed on the proximal face by proximal end cap 103. Housing 102 has apertures 104 aligned with thumbwheels 120 such that the operator can access thumbwheels 120. Apertures 104 extend in the longitudinal direction of housing 102 and may have a length that is the substantially majority of rods 110. The features and specific embodiments of the handle 100 and the associated articulation catheter tip, methods for use, and methods for manufacture are now described in more detail.

[0101] Handle Mechanism

[0102]Fig. 2A is a perspective view of one embodiment of thumbwheel 120 and adapter 130 in which the two components are not mated. Fig. 2B is a cross-sectional view of thumbwheel 120 and adapter 130 in a mated configuration. Thumbwheel 120 is characterized by one or more gripping surfaces or features such as grooves and a channel 121 through which rod 110 passes. Channel 121 may be threaded to mate with threads on rod 110 in order to facilitate translocation in a proximal/distal direction upon actuation of the thumbwheel 120. As illustrated in Fig. IB, thumbwheel 120 is designed to protrude, at least in part, through apertures 104 in the housing 102 in order to be accessible by the operator. For embodiments in which thumbwheel 120 and adapter 130 are provided as separate elements, thumbwheel 120 further comprises mating member 122 which is one member of a mating pair. Fig. 2A and 2B illustrate mating member 122 as the female or receptacle for a male mating member 132. Although these figures illustrate the mating pair members in a hook-and-groove or snap-and-channel configuration, any suitable mating pairs may be used provided that the mating pair allows for the free rotation of thumbwheel 120 without causing rotation of adapter 130.

[0103] Adapter 130 has a generally annular structure and provides a connection between thumbwheel 120 and wire 140. The annular void 131 may or may not be threaded to engage threads on rod 110 and is aligned with channel 121 to for a contiguous channel through which rod 110 passes when fully assembled. One face of the adapter further comprises mating member 132 adapted to engage mating member 122 on thumbwheel 120 to form a unitary structure. Adapter 130 also has tab 133 adapted to engage channel 151 on central core 150.

[0104] Adapter 130 further comprises an attachment point for wire 140 which extends in the distal direction. In one embodiment, illustrated in Figs. 2B, 2C, and 2D, the proximal end of wire 140 is anchored within housing 134 within tab 133. In one configuration, the proximal end of wire 140 is attached to spring 135 contained within housing 134. In another configuration, spring is attached directly to the central core 150 and therefore cannot be translocated in the proximal/distal direction.

[0105] Fig. 2D is a cross-sectional illustration of the assembled internal components of the handle 100. As illustrated, thumbwheel 120 is mated with adapter 130 to form a continuous channel through which rod 110 is disposed. Threads on rod 110 are engaged with threads within channel 121 of thumbwheel 120. Tab 133 of adapter 130 is engaged with channel 151 of central core 150. Spring 135 is contained within housing 134 for tab 130 and serves as a proximal anchor point for wire 140. Tab 133 is slidably engaged with channel 151 on the outer surface of central core 150. In addition to one or more channels 151 , the central core 150 is characterized by at least one central lumen 152 which is contiguous with the catheter lumen 171. Wires 140 extend in the distal direction from adapter 130 and enter the central core 150 through apertures 153 and extend to the articulation tip of the catheter 170.

[0106] Fig. 3 A is a plan view of the handle 100 further illustrating proximal cap 103 which is engaged with housing 102 to be held in place. Proximal cap 103 further comprises an access port 160 that is generally centrally-disposed and in communication with the central core lumen 152 and, ultimately, the catheter lumen 171. Deployable devices and/or fluids may be introduced into the subject through access port 160. Proximal cap 103 also has one or more mating members onto which may be reversibly attached a back-end module as described in more detail below.

[0107] In use, a thumbwheel 120 is translocated in the proximal direction to tension wire 140, thereby causing the distal catheter tip to deflect in the direction of that thumbwheel 120. Optionally two thumbwheels 120 can be translocated equal distances to generate tension in 2 wires 140 and induce the distal tip to deflect in the direction and/or a plane between the thumbwheels 120. Optionally, two or more thumbwheels 120 can be translocated unequal distances to generate uneven tension in 2 or more wires 140 and induce the distal tip to deflect along a three-dimensional curvature as shown in Fig. 7F. For example, translocating one thumbwheel 120 by a first distance can tension a corresponding wire 140 and induces the distal tip to deflect in one plane. Translocating another thumbwheel 120 by a second distance, unequal to the first distance, can tension the wire 140 and deflects the distal tip out of the plane. Optionally, one or more thumbwheels 120 controlling the opposing wires may be translocated in the distal direction to loosen the opposing wires 140, thereby allowing catheter tip deflection without placing an undue strain on those opposing wires 140. Springs 135 also protect against wire 140 breakage or undesired slack by allowing the opposing wires 140 to lengthen when the distal catheter tip is defected in the opposite direction.

[0108] Although the foregoing embodiments have described rod 110 and thumbwheel 120 as being structurally and functionally mated via interlocking threads, it is understood that any suitable mating system may be used provided that the mating members may be reversibly interlocked such that the thumbwheel 120 or equivalent structure may be easily and reversibly translocated in the proximal/distal direction and temporarily locked into place. For example, other mating systems include a tab-and-notch (e.g., ratchetting teeth) or a tab-and-detent system.

[0109] In some embodiments, the handle 100 may have one two, three, four, or more translocation apparatuses (i.e., combination of threaded rod 110, thumbwheel 120, adapter 130, and wire 140) alone or in combination with one, two, three, four, or more fixed wires 140 (i.e., in which wires 140 are attached directly or via spring 135 to the central core 150). The selection of the number and orientation of translocation apparatuses and/or fixed wires will vary based on the desired articulation properties of the distal catheter end. For example, in one embodiment, the handle 100 has three translocation apparatuses disposed at about 120° about the circumference of the handle 100. This configuration allows the operator to easily deflect the distal catheter end in any directions along the three thumbwheels (i.e., along three planes of deflection radially spaced at 120° angles), or using simultaneously two radially adjacent thumbwheels 120, in any directions between the thumbwheels 120, for total six possible deflection planes spaced radially at 60° angles. In another embodiment, the handle 100 has four translocation apparatuses disposed at about 90° about the circumference of the handle 100. This configuration also allows the operator to easily deflect the distal catheter end along four planes of deflection radially spaced at 90°, or using simultaneously two radially adjacent thumbwheels 120, in any directions between the thumbwheels 120, for total eight possible deflection planes spaced radially at 45° angles. Other combinations of translocation apparatuses and fixed wires are possible and useful based on the desired deflection/articulation properties of the distal catheter tip.

[0110] Catheter Design

[0111] Fig. 4A-4D illustrates various catheter designs that may be used in accordance with the principles of this disclosure. In some embodiments, wires 140 pass through conduits from the proximal attachment point in the handle 100 to the distal catheter tip. The advantage of providing dedicated conduits for the wires 140 is that the wires 140 will not interfere with any instruments or devices that may be deployed though the central catheter lumen(s) and also eliminates the possibility that those catheter-deployed devices and instruments will damage wires 140. Fig. 4A illustrates a catheter 170 having single centrally-disposed lumen 171, a plurality of conduits 172a- 172d through which the wires 140 pass, and a plurality of balloon inflation conduits 173a, 173b which are in fluid communication with inflation ports 101 (shown in Fig. 3B). The conduits 172 are approximately 90° to each other, thereby allowing the operator to translocate four wires 140 connected to the distal catheter tip. Fig. 4B illustrates another embodiment of a single-lumen catheter having three wire conduits 172a-172c and a plurality of balloon inflation conduits 173a, 173b. In this embodiment, the three conduits 172 are approximately 120° to each other, thereby allowing the operator to translocate three wires 140 connected to the distal catheter 170. Fig. 4C illustrates a catheter having two centrally-disposed lumens 171a-171b of approximately equal size, four conduits 172a-172d, and two inflation conduits 173 a- 173b. Double-lumen catheters are particularly useful for simultaneously deploying two devices, operating two instruments, or combinations thereof. Fig. 4D illustrates another embodiment of a double-lumen catheter in which the centrally-disposed lumens 171a, 171b have an unequal size. This type of catheter is particularly useful in combination with preformed rigid wires, described in more detail below, in which the smaller lumen 171a acts as a conduit for the rigid wire and the larger lumen 171b is used to deploy the catheter-delivered device or instrument. In any of the foregoing examples, it is understood that the inflation conduits 173 need not be disposed at 180° to each other. Additionally and/or alternatively, the catheter 170 can define a single inflation conduit 173 or a plurality of uniform and/or different inflation conduits 173. Any suitable orientation or number of conduits may be used.

[0112] Optionally, as illustrated in Fig. 5 A, the catheter may further comprise an externally- mounted balloon 190 in fluid communication with the inflation port 101 via the inflation conduits 173. The balloon 190 can include a proficient balloon, a non-proficient resilient balloon, a non- resilient balloon, a generic balloon, an ad-hoc designed balloon, or a combination thereof. Fig. 5 A shows the balloon 190 as including a proficient balloon 190b. The balloon 190b is composed of 2, 3 or more inflatable beams radially aligned symmetrically or asymmetrically which allow blood profusion between the balloon and catheter 170 also when inflated and in contact with the wall of a blood vessel. Fig. 5 A illustrates the balloon 190b in the deflated conformation and Fig. 5B illustrates the balloon 190b in the inflated conformation. Fig. 5C shows the balloon 190 as including a non-proficient generic balloon 190a. In some embodiments, the balloon is inflated with a radio-opaque substance to enable the operator to visualize the positioning of the balloon 190, catheter 170, and surrounding tissues. In some embodiments, the balloon 190 is used to dilate a vessel or an orifice (i.e. to perform a septostomy), or to deploy a device such as a stent. In other embodiments, the balloon is used to be inflated against tissue wall of a vessel in order to stabilize the distal end region of the catheter 170 during positioning within the cardiovascular anatomy and thus enhancing the orientation accuracy of the catheter tip when maneuvering the articulation link 175. In other embodiments, the balloon comprises radio-opaque markers. Figs. 6A-C show a sequence of intra-cardiac procedural steps as example of a possible clinical application of catheter 170. Fig. 6A shows the catheter 170 tracked in the heart's left atrium through the inferior vena cava. Fig. 6B shows catheter 170 in the left atrium after balloon 190b has been inflated against the vessel walls. Fig. 6C shows catheter 170 with tip 170b tracked within the right atrium after being oriented and advanced across the septal tissue wall between the left and right atria. A similar sequence can be applicable to any intra-cardiac procedural steps requiring precise orientation of the catheter distal tip, such as ablation, patent foramen ovale (PFO) closures, and/or the like.

[0113] The catheter 170 can be generally cylindrical and substantially solid. However, in order to allow for articulation, the distal end region of the catheter further comprises one, two, three, four, or more articulation links 175. Articulation links 175 are flexible stent-like structures integrated within the catheter 170 body. Articulation links 175 generally are formed from sinusoidal struts according to known methods including, for example, laser etching or cutting. Articulation links 175 may be cut into a unitary catheter body 175 or may be provided as separate elements that are assembled with other catheter body pieces. Figs. 7A-7B illustrate a 3-backbone articulation link allowing deflection of the catheter tip 170b along 6 planes spaced radially at angles of 60°. The generally sinusoidal struts are aligned out-of-phase (i.e., peaks align with valleys on adjacent strut). Fig. 7C-7D illustrate a 2-backbone articulation link 175 allowing deflection of the catheter tip 170b along 2 planes spaced radially 90° apart. The generally sinusoidal struts are aligned in-phase (i.e., peaks align with peaks on adjacent struts). Fig. 7E illustrate a 4-backbone articulation link allowing deflection of the catheter tip along 8 planes spaced radially at angles of 45° as shown in Figs. 8A and 8B or in multiplane shapes as shown in Fig. 7F. The generally sinusoidal struts are aligned out-of-phase (i.e., peaks align with valleys on adjacent strut). The artisan understands that any strut pattern known in the art may be used to create an articulation link having the desired properties (e.g., stiffness) and directionality. In some embodiments, the articulation link is covered by a flexible mesh or other material to facilitate smooth passage through the blood vessels without impeding the flexible quality of the articulation link. In some embodiments, the catheter 170 comprises one or more (e.g., one, two, three, four, or more) active articulation links 175 in which wires 140 are attached to the distal end region of the articulation links 175 or a point more distal (e.g., nose cone of the distal catheter end) in order to facilitate articulation/bending by the operator via the translocation apparatus(es) in the handle 100. Optionally, the catheter 170 also comprises one or more (e.g., one, two, three, four, or more) passive articulation links 175. Passive articulation links 175 are constructed according to the same principles and designs as the active articulation links 175 except that there are no wires 140 connected to those links 175. Passive articulation links 175 may conform to the contours of the blood vessel through which the catheter passes but without active manipulation by the operator.

[0114] Figs. 9 A and 9B provide an exploded view of a catheter 170 having a modular construction of various elements described herein. Specifically, the embodiment illustrated in Fig. 9A comprises a proximal catheter segment 170a that is attached at its distal end region to the handle 100 (shown in Fig. 1 A), a balloon segment 190a, a first articulation link 175a, a second articulation link 175b, and/or a distal catheter tip 170b. The embodiment illustrated in Fig. 9B comprises a proximal catheter segment 170a that is attached at its distal end region to the handle 100 (shown in Fig. 1 A), a balloon segment 190a, an articulation link 175c, and/or a distal catheter tip 170b. Figs. 9C and 9D each illustrate an assembled catheter 170. Fig. 10A illustrates a catheter 170 comprising a balloon 190a (inflated) and two active articulation links 175a,b in a deflected or articulated conformation in which each articulation link 175 is under independent control of the operator. Figs. 10B and IOC each illustrate an assembled catheter 170 comprising a balloon 190b (inflated) and one 4-backbones active articulation link 175c in different deflected or articulated conformation.

[0115] Shafts/Mandrels

[0116] In some embodiments, the handle 100 further comprises a mandrel insertion port 161 and the handle is supplied with a mandrel or wire shaft 162 of variable stiffness. The mandrel insertion port 161 may be provided in any convenient location on the handle 100 or catheter 170. In one embodiment illustrated in Fig. 11 A, the mandrel insertion port 161 is located near the distal end region of the housing 102, shown here as having a frustroconical shape. As illustrated in Fig. 1 IB, the mandrel insertion port 161 is in communication with the catheter lumen 171. The mandrel or wire shaft 162 may be inserted into the catheter 170 through the insertion port 161 and provide a desired stiffness and/or shape to the catheter 170. In one embodiment illustrated in Fig. 11C, insertion port 161 is in communication with one lumen 171a of a multi-lumenal catheter 170. Optionally, the lumen 171a dedicated to housing the mandrel or wire shaft 162 has a smaller diameter than the main lumen 171b.

[0117] Back Module

[0118] One or more back modules 200 may be used to deliver and control cardiovascular devices (e.g., ablation catheters, bioptomes, guidewires, etc.) and other catheter-delivered devices and tools (e.g., snares and trans-septal puncture needles) through the articulation catheter system described above. Fig. 12 is an exploded view of a back module 200 to further illustrate components of the back module 200. The back module 200 consists of a back handle 210, a back core 220 comprising lock screws 221, a latch 230, and/or a back cap 240. The distal face of the back handle contains a mating pair member 211 that is complementary and capable of reversibly securely mating the back module 200 with the proximal face of the handle 100 through the mating pair members on the proximal face of the housing 102. The latch 230 reversibly engages with the back handle 210. In some embodiments, the reversible engagement is a ratchet (tooth-and-groove) system that may be easily translocated in the distal direction in an intermittent locking fashion, and translocated in the proximal direction by releasing a locking mechanism that otherwise prevents proximal movement. Back core 220 is attached to the latch 230. As shown in Figs. 16A- 16D, the delivered device, for example, a guide wire 105 or other surgical and cardiovascular devices compatible with the size of catheter lumen 171 (shown in Fig. 2D), such as snares, ablation catheters, bioptomes, stents delivery systems etc., can pass through one of the two lumens 212a,b of the back module 200 (shown in Fig. 12), and can be locked in place within a back core 220 using the corresponding lock screws 221a,b, respectively. The device then may be advanced and/or withdrawn through the catheter by translocating the latch 230 in the longitudinal (proximal and/or distal) direction. Back cap 240 also contains one member of a reversible mating pair in order to facilitate the attachment of a second back module 200. Figs. 13 A and 13B illustrate the process of mating a first back module 200 with the handle 100 in which the device (e.g., a guidewire 105) is disposed through the lumen of the back module 200. Fig. 15A is a cross- sectional view of one back module 200 mated to the handle 100 to further illustrate the principles and construction of these modular devices.

[0119] In another embodiment, two catheter devices tracked within catheter 170 can be inserted in lumens 212a,b of back module 200, and secured to latch 230 using lock screws 221a,b. Activating both lock screws 221,a,b allows combined translations of the devices using a single latch 230, while locking only one or the other lock screws 221a,b allows independent translation of the devices tracked in the correspondent lumen 212a or 212b. In another application of this embodiment, lock screws 221a.b of back module 200 can be used to secure to latch 230 the two proximal ends of wire 304 (shown in Fig. 16F), forming snare device 303 (shown in Fig. 16F). Latch 230 then can be translated to advance or retrieve the looped wire 304 within catheter tip 170b. This locking configuration is particularly useful to minimize the risk of potential intracardiac procedural complications due to snares entangled within the cardiovascular anatomy or prosthesis. In those clinical scenarios, the operator can remove the entangled looped wire while catheter 170 is inserted within the vascular anatomy, by releasing lock screws 221a,b, pulling one of the wire proximal ends 304a or 304b and fully externalizing the wire 304 from the catheter 170 and back module 200,

[0120] Figs. 14A and 14B illustrate the process of mating a second back module 200b to a combined device consisting of a first back module 200 and a handle 100. Fig. 15B is a cross- sectional view of two back modules 200 mated to the handle 100 to further illustrate the principles and construction of these modular devices. Figs. 17A-17C illustrate cross-sectional views of the latches 230a,b and lock screws 221a,b,c,d of back modules 200a and 200b operating two catheter devices. As illustrated in Fig. 17A, the four lock screws 221a,b,c,d are loosened in order to allow the devices (e.g. guide wires 105a, 105b) to pass through lumens 212a,b of the back modules 200a and 200b. Lock screw 221a of back module 200a can be activated to lock one catheter device to latch 230a. The opposite lock screw 221b of back module 200b can be used to lock the second catheter device to latch 230b. This configuration allows independent translation of each device using latches 230a and 230b. Independent translation of each device tracked within catheter 170 can be achieved securing the catheters to latches 230a,b with any opposite combinations of lock screws (i.e. 221a/221d, or 221b/221c), while activating both lock screws 221a,b or 221c,d of the same back module, can allow combined translation of both devices simultaneously using a single latch 230.

[0121] In some embodiments, lumen 152 of the central core 150 of the handle 100, may be bifurcated to segregate two devices into a dual-lumen catheter. This is particularly useful for embodiments in which two back modules are used and each of the devices is independently operated by a dedicated back module.

[0122] Accessory Devices

[0123] In some embodiments, a multi-lumen catheter (e.g., having two, three, four, or more lumens within which devices can be inserted) may be configured such that one or more of the catheter lumens terminate at a location other than the distal end region of the catheter. For example, Fig. 18A illustrates a dual-lumen catheter 300 in which a first lumen 301 terminates at the distal end region of the catheter and the second lumen 302 terminates at a point proximal to the distal end region. Fig. 18B illustrates two devices, snares 303a,b in this case, deployed from each of the catheter lumens. The two devices may be independently operated using dedicated back modules 200.

[0124] Fig. 19 illustrates a combination device 400 having a snare 410 and an expandable cone 420. This device 400 can be used to perform cardiovascular procedures to retrieve or reposition implantable devices such as stent 430, clips, and to solve secondary complications in interventional cardiology procedures in the heart. In operation, the cone 420 is deployed from the catheter. Next, the snare 410 is deployed to retrieve the implantable device 430 which is then withdrawn into the body of cone 420. In one embodiment, the device 430 is retrieved within the catheter, followed by retrieval of cone 420, and then the catheter, including the device 430, is removed from the body. In other embodiments, device 430 may be too large or not appropriately constructed to allow full retrieval within the catheter lumen. In this case, the device 430 and catheter may be withdrawn from the body, wherein cone 420 protects the inner vessel wall from damage as the device 430 is withdrawn. In another embodiment, the device 430 is not fully withdrawn from the body but instead is repositioned within the body, released from snare 410, and snare 410 and cone 420 are withdrawn from the body. Device 430 may be fully or partially withdrawn into the catheter during repositioning. Alternatively, device 430 is captured by snare 410 and moved within the body without being withdrawn into the catheter, wherein cone 420 provides protection to the body surfaces (e.g., inner wall of the blood vessel).

[0125] Fig. 20A-20D illustrates an ablation guide 500 and its method of use. The proficient ablation guide may be used in the treatment of atrial fibrillation. The ablation guide 500 is a self- expanding form having a guide body 505, preferably circular or ovoid, supported by a plurality of struts 510 that attach the guide body 505 to the push rod (not shown) delivered through catheter 170. In use, the ablation guide 500 is deployed from the catheter using a back module 200 until it contacts the inner surface of the atrial wall. The guide 500 is extended from the catheter and expanded until it circumnavigates a vessel and/or the lumenal opening of the pulmonary vein. Placement of the guide 500 may be visualized by standard techniques such as fluoroscopy. Once positioned, the optional balloon 190 may be inflated to stabilize and anchor the catheter and the guide 500. The ablation catheter 515 is then deployed from the catheter and the ablation procedure is performed with reduced risk of misguiding the ablation catheter tip (i.e. ablating an unnecessary location) and reduced need for additional dye injections required for visualization during the procedure. Optionally, a second back module 200 can be connected to the first back module 200 prior to insertion of the ablation catheter to allow translocating during the procedure the ablation catheter using latch 230 rather than manually by the operator. The various devices are then withdrawn into the catheter and removed from the body. In another embodiment, guide 500 is deployed within the pulmonary veins to visualize and distinguish those vessels from the atrium without requiring additional dye injections. The ablation catheter tip is then advanced and protruded between the cone struts and used to ablate the area surrounding the pulmonary vein entrance (visualized by the cone deployed within it). This method reduces the risk of burning the tissue within the pulmonary veins which is a significant risk and complication in ablation procedures.

[0126] In one embodiment of the ablation procedure, a modular device having the handle 100 and mated back module 200 is provided. The catheter is inserted into the subject and advanced to the right atrium. The operator manipulates the articulation catheter according to the procedures described herein. Upon reaching the right atrium with the distal end region of catheter 170, a puncture needle is inserted through insertion port 260 in back module 200, lumen 152 of central core 150, and catheter lumen 171 until it reaches the distal end region of catheter 170. The push rod of the puncture needle is then locked in place by lock 240 and/or lock screws 221. The puncture needle is then advanced using latch 230 of back handle 210 or manually until the puncture needle penetrates the intra-atrial septum. The puncture needle is then withdrawn from the body through the insertion port 260. The distal end region of catheter shaft 170 is advanced into the left atrium through the puncture in the intra-atrial septum. Ablation guide 500 in inserted into the body through insertion port 260. The pulmonary vein is visualized and contacted by the ablation guide 500. The ablation procedure proceeds as described above with the ablation catheter being inserted either through the first back module 200 through which the ablation guide 500 was inserted, or through a second back module 200 that is attached to the proximal face of back cap 250 of the first back module 200 either before or during the surgical procedure.

[0127] Fig. 21 illustrates an exploded view of a universal clamp system 600 that may be used to lock a guidewire or push rod to a sheath or catheter to prevent the accidental loss or movement of that wire/rod. The clamp system 600 consists of two individual claims 610a,b, each having a female side 611 and a male side 612, and a spring 613 disposed therebetween. A spacer rod 620 connects the two individual clamps and is removable from at least one clamp which is also slidably engaged with rod 620. Optionally, rod 620 is held in place at the removable end by screw 630. Figs. 22A-22E illustrate various uses and configurations of the claim system 600.

[0128] It will be appreciated by persons having ordinary skill in the art that many variations, additions, modifications, and other applications may be made to what has been particularly shown and described herein by way of embodiments, without departing from the spirit or scope of the disclosure. Therefore, it is intended that scope of the disclosure, as defined by the claims below, includes all foreseeable variations, additions, modifications or applications.

Claims

CLAIMS What is claimed is:

1. A medical apparatus, comprising:

a catheter including a proximal end region and a distal end region opposite to the proximal end region; and

a handle coupled to the proximal end region of the catheter and configured to deflect the distal end region of the catheter in multiple planes.

2. The apparatus of claim 1, further comprising one or more back modules coupled to said handle opposite said catheter.

3. The apparatus of claim 2, wherein each of said one or more back modules is configured to translocate a device to said catheter via said handle.

4. The apparatus of any one of claims 1-3, wherein said handle includes:

a central core; and

one or more translocation apparatuses distributed circumferentially about the central core and configured to deflect the distal end region of said catheter in the multiple planes.

5. The apparatus of claim 4, wherein a selected translocation apparatus of the one or more translocation apparatuses includes an adapter slidably attached to the central core.

6. The apparatus of claim 5, wherein the selected translocation apparatus includes a wire including a proximal end region connecting to the adapter and a distal end region connecting to the distal end region of said catheter.

7. The apparatus of any one of claims 1-6, further comprising a balloon externally mounted on a selected region of said catheter.

8. The apparatus of claim 7, wherein said catheter defines one or more inflation conduits in fluid communication with the balloon.

9. The apparatus of claim 8, wherein said handle includes an inflation port in fluid communication with the one or more inflation conduits.

10. The apparatus of any one of claims 7-9, wherein the balloon is configured to stabilize the distal end region of said catheter in a blood vessel upon inflation.

11. The apparatus of any one of claims 7-10, wherein the balloon is configured dilate a vessel or an orifice.

12. The apparatus of any one of claims 1-11, wherein said catheter includes one or more articulation links at the distal end region of said catheter.

13. The apparatus of any one of claims 1-12, wherein said catheter defines a catheter lumen for accommodating a mandrel with a selected stiffness, a selected shape, or a combination thereof.

14. The apparatus of any one of claims 1-13, wherein said catheter defines:

a first catheter lumen terminating at a first location of the distal end region of said catheter; and

a second catheter lumen terminating at a second location of the distal end region of said catheter that is different from the first location.

15. A medical apparatus, comprising:

a catheter including a proximal end region and a distal end region opposite to the proximal end region;

a handle coupled to the proximal end region of the catheter; and

one or more back modules coupled to said handle distally from said catheter.

16. The apparatus of claim 15, wherein said one or more back modules are interconnected in series.

17. The apparatus of claim 15 or claim 16, wherein the one or more back modules are each configured to translocate at least one device to said catheter via said handle.

18. The apparatus of claim 17, wherein a selected back module of said one or more back modules defines one or more module lumens.

19. The apparatus of claim 18, wherein the selected back module includes a latch configured to translocate relative to said handle to move a device through a selected module lumen of the one or more module lumens.

20. An apparatus for retrieving and/or repositioning an implantable device, comprising:

a handle coupled to the proximal end region of the catheter; and

a back module coupled to said handle distally from said catheter and configured for: deploying an expandable and retrievable cone into a selected position in a body via said catheter; and deploying a snare via said catheter to retrieve the implantable device into the expandable cone.

21. An apparatus for ablation, comprising: a catheter including a proximal end region and a distal end region opposite to the proximal end region; a handle coupled to the proximal end region of the catheter; and a back module coupled to said handle distally from said catheter and configured for operating, via said catheter, an ablation guide for circumnavigating a vessel to guide an ablation catheter to perform an ablation procedure.