The present invention relates generally to medical devices and methods. More particularly, the present invention relates to surgical tool tip holders for use in laparoscopic and endoscopic procedures where a single tool shaft can be used with multiple interchangeable surgical tool tips.
Laparoscope, endoscopic and other minimally invasive surgical procedures have been widely adopted and have replaced many open surgical procedures. Laparoscopic procedures are performed within body cavities, such as the abdomen or thorax, and rely on introducing a shaft of a surgical tool through tissue via a small incision, trocar or other entry site which provide access into the cavity. In laparoscopic procedures, the shaft manipulates a tool or end effector to perform a surgical protocol while viewing the surgical field within the cavity using a laparoscopic camera. One drawback in performing laparoscopic and other minimally invasive procedures is the need to frequently exchange tools through a limited number of access points.
It has been proposed to increase the efficiency of laparoscopic and other minimally invasive procedures by introducing a plurality of surgical tool tips into the surgical field, such as an insufflated abdomen or a thorax, and subsequently exchanging tools on a single or limited number of tool shafts, thus avoiding the need to remove and exchange complete tools through the access points. Such surgical tools exchange systems and procedures are described, for example, in commonly owned U.S. Patent Publication Nos. 2013/0150871 and 2015/0216515, the full disclosures of which are incorporated herein by reference.
U.S. Patent Publication No. 2015/0216515 describes the use of a tool tip holder, referred to as a cassette, for introducing, holding and facilitating the exchange of multiple tools in an insufflated abdomen, thorax or other surgical field. The tool cassette includes up to five articulated segments, most or all of which carry deployable tool tip holders and one of which may be an external attachment segment. The tool cassettes are introduced through an incision or port in a straightened configuration, curved for stabilization, and either placed on a tissue surface or pulled against an upper wall of the thorax using a manipulator attached to the external attachment segment.
While functional and of significant benefit in performing laparoscopic and other minimally invasive procedures, the designs disclosed in U.S. Patent Publication Nos. 2013/0150871 and 2015/0216515, are first generation designs, and it would be advantageous to provide additional and alternative designs having improved ease-of use, design simplicity, reliability, compactness, and the like. At least some of these objectives will be met by the inventions described and claimed hereinafter.
U.S. Patent Publications 2013/0150871 and 2015/0216515 have been described above. See also U.S. Pat. Nos. 5,925,002; 6,309,397; 8,747,394; 8,858,538; 7,492,116; as well as U.S. Publication Nos. 2003/0114731; 2005/0043718; U.S. 2005/0165449; U.S. 2005/0209607; U.S. 2006/0020287; U.S. 2006/0041273; U.S. 2007/0198000; U.S. 2008/0021274; U.S. 2008/0108871; U.S. 2008/0147096; US. 2008/0167672; U.S. 2008/0275480; U.S. 2009/0005638; U.S. 2009/0005635; U.S. 2009/0182193; U.S. 2010/0016855; U.S. 2010/0057078; U.S. 2010/0188493; U.S. 2011/0087267; U.S. 2012/0083826; U.S. 2012/01322450; U.S. 2013/0066304; and U.S. 2013/0211196.
In a first aspect, the present invention provides a tool tip holder or cassette comprising a deployment mechanism and a plurality of tool carriers. The tool carriers are coupled to the deployment mechanism, and each tool carrier has a tool access end and a base end. The deployment mechanism is adapted to selectively reconfigure the plurality of tool carriers from a linear or otherwise straightened arrangement useful for introduction to and removal of the tip holder from the surgical filed into a parallel cluster useful for accessing tool tips in each tool carrier.
By “parallel cluster,” it is meant that longitudinal axes of the plurality of tool carriers are held in a parallel arrangement, typically in a symmetric pattern about a center axis. Usually, but not necessarily, the tool carriers have access ends and base ends which are aligned in planes perpendicular to the center axis so that the parallel clusters have a generally cylindrical arrangement with the tool access ends present in a circular periphery at one end of the cylinder and the base ends present in a circular periphery at the other end of the cylinder. While the cross-sectional peripheries will usually be circular, in other instances they could be ellipsoidal, polygonal, and the like.
The linear or straightened arrangement of the tool carriers has a low profile which is particularly suited for minimally invasive introduction of the tool tip holder assembly through an access port into an abdominal or thoracic surgical field. The tool tip holder can be reconfigured into the parallel cluster arrangement after introduction to the surgical field, and the parallel cluster arrangement is particularly suited for removal and return of individual surgical tool tips from and to individual tool carriers of the tool tip holder while present in the surgical field. The deployment mechanism will typically allow the tool tip holder assembly to be reconfigured remotely by the surgeon using a manipulator, an inflator, or other tool introduced concurrently with or after the tool tip holder has been placed, as will be described in greater detail below.
The tool tip holder of the present invention will typically further comprise one or more surgical working tips removably placed in at least some of the plurality of tool carriers. The surgical tool tips will usually be placed into the tool carriers prior to introduction of the tool tip holder into the patient, but in some instances, it may be possible to introduce and/or exchange surgical tool tips after the procedure has commenced. The individual tool carriers will usually comprise tubular bodies, such cylindrical bodies, but will often have flat surfaces or facets to facilitate forming the parallel clusters, as described in more detail below.
In a preferred aspect, the tool tip holders or cassettes of the present invention may further comprise a hub segment configured to occupy a center region of the parallel cluster when the tool carriers are unconstrained, i.e., free to self-assemble or be assembled into the parallel cluster as described in more detail below. The hub is typically further configured to removably attach to a manipulator. The manipulator may be pre-attached to the hub of the tool tip holder or may be introduced separately into the surgical field before or after the tool tip holder has been introduced but prior to the reconfiguration of the initial linear arrangement tool carriers into the desired parallel cluster.
In some examples, the tool carriers and the hub may each comprise one or more magnetic elements, where the magnetic elements on the hub are configured to attract the magnetic elements on the tool carriers to hold or stabilize the tool carriers in their parallel cluster configuration while allowing limited displacement to facilitate removal and return of tool tips from the tool carriers.
In other examples, one or more of the tool carriers may comprise a mechanical latch mechanism, such as a hook, lock-and-key arrangement, snap, or the like, configured to selectively engage the hub to maintain all the tool carriers in the cluster formation while allowing limited displacement of one or more tool carriers (typically a pair of tool carriers joined at the top by a spring or other coupling element) to facilitate removal and return of tool tips from the tool carriers. In preferred instances, both magnetic elements and a latch mechanism will be used, where the magnets provide an initial alignment, and the latch stabilizes the cluster configuration as the tool carriers are displaced and surgical tools removed and returned to individual carrier.
In some examples, individual tool carriers or groups of tools carriers may be configured to be displaced away from the hub to facilitate access to a tool carried by the tool carrier. For example, the individual tool carriers or groups of tools carriers may be configured to be displaced away from the hub by engagement with a pusher, such as a wire, ribbon, or other elongate, typically flexible element that can be advanced over or through the shaft.
In some examples, the tool tip cassette may further comprise a tether attached to the hub and configured to temporarily support the parallel cluster of tool carriers prior to capture by a tool tip cassette deployment and support tool.
In some instances, the deployment and support tool may comprise a reciprocatable tip. The reciprocatable tip will typically be configured to pierce tissue when distally advanced. In other instances, the reciprocatable tip may be conjured to lock, unlock, manipulate, and otherwise interact with the tool tip holder as described in detail herein below. For example, the reciprocatable tip may be configured to engage and release the tool tip cassette when said cassette in its parallel cluster arrangement.
In many instances, the hub comprises flat faces or facets disposed axially about its periphery, with each flat face being configured to engage a first flat surface on one of the tool carriers. For example, the plurality of tool carriers may comprise any one of (1) three tool carriers with axial facets having a 120° spacing, (2) four tool carriers with axial facets having a 90° spacing, (3) five tool carriers with axial facets having a 72° spacing, (4) six tool carriers with axial facets having a 60° spacing, (5) seven tool carriers with axial facts having a 51.4° spacing, and (6) eight tool carriers with spring axial facets having a 45° spacing. Often, each tool carrier will comprise two additional flat surfaces arranged symmetrically on each side of first flat surface and configured to nest with adjacent tool carriers when the tool carriers are in the parallel cluster formation.
The deployment mechanism may have any one of the variety of structures. For example, a self-assembling deployment mechanism may comprise spring elements which link the tool access ends and the base ends of adjacent tool carriers, wherein the spring elements on adjacent tool carriers are typically circumferentially offset so that the spring elements cause the tool carriers to fold into the parallel cluster when unconstrained. In preferred instances, the springs members may comprise two legs having a U-shape when unconstrained, wherein a first leg is attached to a base end or a tool access end of one tool carrier and a second leg is attached to a base end or a tool access end of an adjacent tool carrier.
A hub used in combination with the spring elements is typically be attached to the base end of a first tool carrier by a U-shaped spring configured so that the plurality of tool carriers fold into the parallel cluster about a periphery of the hub when released from constraint.
Such self-assembling tool tip holders will typically require some structure, functionality, or other means configured apply a radial constraint to maintain the tool carriers in a generally straightened or otherwise elongated configuration for delivery to the patient, typically comprising a straight over tube having a passage for receiving, straightening, and delivering the plurality of tool carriers to a surgical site. While the use of a straight over tube is generally preferred, in some instance the over tube could have a small curvature or other nonlinearity so long as a deviation would not interfere with introduction and/or removal of the tool tip holder in its elongated configuration.
In other instances, the deployment mechanism may comprise an inflatable structure, where the plurality of tool carriers can be straightened or axially elongated, i.e., aligned generally axially, when the inflatable structure is deflated for delivery and removal of the tool tip holders. The inflatable structure will have a geometry selected and configured to arrange into a parallel cluster when the inflatable structure is inflated at a deployment site in the patient.
In specific instances, the inflatable structure may comprise a ring or disc. For example, the inflatable structure may comprise an open ring, often with a C-shape, with spokes or fingers projecting radially inwardly, wherein the tool tip holders are attached to radially inward ends of the spokes or fingers.
In a still further aspect, the present invention provides a tool tip delivery system including any of the tool tip holders described previously together with a support/release tool. The support/release tool comprises a shaft having a proximal end, a distal end, and a handle at the proximal end of the shaft. The distal end of the shaft is configured to detachably engage the tool tip holder, typically a manipulator segment that is attached to the hub.
In some instances, the support/release tool and the manipulator segment are configured to selectively align and misalign magnets in the hub with magnets in the tool carriers of the tool tip holder to form and release the parallel cluster arrangement. For example, the magnets within the hub may be mounted to axially translate, and the support/release tool and/or manipulator segment may comprise a pusher or puller to move the hub magnets in and out of alignment with the tool carrier magnets. In a specific example, the manipulator segment comprises a puller cable, and the hub magnet is spring-mounted so that puller cable can apply tension to align the hub and tool tip holder magnets while the cassette manipulator remains attached to the hub. The support/release tool includes an actuator, such as a translatable rod, which engages the manipulator segment and allows a user to shift the magnets alignment as desired.
In specific examples, the manipulator segment and hub may be connected via a universal joint, where the universal joint is typically located at the distal end of the manipulator segment and the proximal end of the hub.
In some instances, the tool tip cassette delivery system of the present invention may further comprise a first interlock configured to prevent disengagement of the surgical tool tip from the shaft when the tip is removed from the tool carrier.
In some instances, the tool tip cassette delivery system of the present invention may further comprise a second interlock configured to prevent loss of the surgical tool tip from the tool carrier when the tool tip is not engaged with the tool driver.
In yet another aspect, the present invention provides a method for delivering surgical tools to a surgical working space. The method may comprise providing a tool tip cassette including a plurality of tool carriers joined end-to-end. A tool tip cassette is percutaneously introduced to the surgical working site while the plurality of tool carriers is in a linearized arrangement. The plurality of tool carriers is reconfigured from the linearized arrangement into a parallel cluster while in the surgical working space, allowing surgical tools to be retrieved from and returned to individual tool carriers while the plurality of tool carriers remains in the parallel cluster arrangement in the surgical working space.
In some instances, the methods may further comprise reconfiguring the plurality of tool carriers from the parallel cluster arrangement to the linearized arrangement while in the surgical working space. The tool tip cassette may be percutaneously removed from the surgical working site while the plurality of tool carriers is in the linearized arrangement.
In some instances, reconfiguring the plurality of tool carriers from the linearized arrangement into the parallel cluster may comprise releasing the tool tip cassette from constraint.
In some instances, reconfiguring the plurality of tool carriers from the linearized arrangement into the parallel cluster may comprise applying a force to the tool tip cassette to affect the reconfiguration.
In some instances, the methods may further comprise capturing the tool tip cassette with a tool tip cassette deployment and support tool after the plurality of tool carriers have assumed the parallel cluster configuration.
Typically, the tool tip cassette deployment and support tool are percutaneously introduced through a percutaneous passage separate from that used to introduce the tool tip cassette.
In some instances, the methods may further comprise manipulating a surgical tool driver to engage and remove a surgical tool from an individual tool carrier after the plurality of tool carriers have assumed the parallel cluster configuration.
Typically, the surgical tool driver is percutaneously introduced through a percutaneous passage separate from that used to introduce the tool tip cassette and/or the tool tip cassette deployment and support tool.
As shown in
The hub 14 is typically connected to a manipulator segment 16 which is configured to detachably engage a support/release tool 30, as shown in
The hub 14 typically has a tubular body 34 with a periphery comprising flat faces or “facets” 36 which engage individual tool carrier 12 as they are brought into alignment with the hub. The hub 14 also carries a magnetic shuttle 38 which is secured on a distal side to a spring 40 which in turn is fixed to a closed distal end of the tubular body 34, allowing the shuttle to translate within the hub interior under biasing from the spring. As will be described in more detail below, the magnetic shuttle 38 carries individual magnets 44 (
A rod 43 in the support/release tool 30 couples to a cable 42 in the manipulator segment 16 when the tool 30 is attached to the manipulator segment through the open end 24, as shown in
The tool carrier array 10 is shown in a straightened or elongated configuration suitable for delivery to a patient in
Referring now to
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While the inflatable supports 72 in
As seen in
Usually, the hub 90 will have to be disengaged from the tool array 70 before the array can be removed from the patient. To facilitate such disengagement, a plurality of pins 100 may be located near the bottom of hub 90, as seen in
As shown in
As described with reference to previous embodiments, the tool carriers of the present invention may be magnetically coupled to the hub after cluster formation. The tool tip cassette 240 now being described includes a mechanical latch 250, typically formed as a hook, to connect a free distal tool carrier 242′ of the cluster to the hub 244 (i.e., the tool carrier in the linked chain furthest from the hub 244). As shown in
The surgical tool driver 300 is illustrated
As shown in
In the tool actuation mode, a piercing tip 334 may be distantly advanced and rotated, as shown in
The ratchet 318 and ratchet selector 320 are engaged and momentarily disengaged as shown in
As shown in
While the previous embodiments of both the tool tip cassette deployment and support tool 200 and the surgical tool driver 300 employ split nose cones to allow advancement of tissue-piercing tip, in other embodiments (not illustrated) an auger tip having a retractable sharp could be used without a splittable nose cone or other protector. Such auger tips could provide easier tissue penetration for percutaneous access (drilling vs piercing/stretching) and potentially allow more robust connection to the tools and cassette.
While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.
This application is a continuation of International Application No. PCT/US2023/060250, filed Jan. 6, 2023, which claims the benefit of U.S. Provisional No. 63/298,157, filed Jan. 10, 2022, the entire content of which is incorporated herein by reference. All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.
Number | Date | Country | |
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63298157 | Jan 2022 | US |
Number | Date | Country | |
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Parent | PCT/US2023/060250 | Jan 2023 | WO |
Child | 18767774 | US |