1. Field of the Invention
The present invention relates generally to devices for cutting a material or substance. More specifically, devices for efficient severing or cutting of a material or substance such as soft tissue suitable for use in open surgical and/or minimally invasive procedures are disclosed.
2. Description of Related Art
Standard methods of severing of tissue may include using a scalpel, scissors, and radio frequency energy. Minimally invasive procedures in soft tissue such as the breast, however, are difficult to perform using standard scissors and scalpel. Furthermore, in a closed environment, radio frequency current dissipates into the surrounding tissue causing a decreased ability to achieve a current at the cutting electrode of sufficient high density to initiate a cut. To overcome this problem, high power settings are often required to initiate the cut which often is painful and increases thermal damage to the tissue whether using a standard or a custom electrosurgical generator.
Another problem associated with severing tissue is the control of bleeding. Radio frequency energy controls bleeding by coagulating small blood vessels. Another method of controlling bleeding is through the use of heat. For example, the Shaw Hemostatic Scalpel uses direct heat. However, while the bleeding is generally controlled, the cutting of tissue is often slower than with radio frequency energy and the knife edge readily dulls. The Harmonic Scalpel (Ethicon Endosurgery) uses ultrasonic energy generally at 50 kHz to heat the tissue so as to coagulate severed blood vessels but cuts slower than a standard electrosurgical electrode and is costly as a custom ultrasonic generator is required.
A further disadvantage of using radio frequency energy is the generation of smoke. The smoke is malodorous and can contain airborne viral particles that may be infectious. Furthermore, during laparoscopic procedures, the smoke generated within the abdominal cavity often obscures visualization of the procedure. When the smoke becomes too dense, the procedure is delayed until the smoke is released through one of the trocar ports and after enough carbon dioxide gas has reinsufflated the abdominal cavity. This unnecessarily prolongs the operative time.
Accordingly, there is a need for efficient severing or cutting of tissue preferably with the ability to control bleeding from small severed blood vessels that can be used during a minimally invasive procedure and/or during an open surgical procedure.
Devices for efficient severing or cutting of a material or substance such as soft tissue suitable for use in open surgical and/or minimally invasive procedures are disclosed. It should be appreciated that the present invention can be implemented in numerous ways, including as a process, an apparatus, a system, a device, and a method. Several inventive embodiments of the present invention are described below.
A cutting assembly generally includes a first and a second cutting blade each having an inner surface, an outer surface opposite the inner surface, one or more cutting edges, and a set of cutting teeth disposed along at least a portion of the cutting edge, the cutting assembly being configured with the first inner surface opposing the second inner surface so that the first set of cutting teeth is aligned with and configured to cooperate with the second set of cutting teeth. The cutting blades are preferably serrated with multiple teeth on one or more edges.
A tissue cutting device generally includes a probe defining a probe axis, the cutting assembly configured to be in a storage configuration or a cutting configuration, and a cutting apparatus coupled to the cutting assembly to rotate and/or oscillate at least one of the cutting blades relative to the other when the cutting assembly is in the cutting configuration. The cutting apparatus may rotate/oscillate the first cutting blade while maintaining the second cutting blade stationary relative to the probe or may rotate/oscillate the first cutting blade and the second cutting blade in opposing directions. When the teeth of the first oscillating/rotating cutting blade approximates opposing teeth of the second cutting blade, material or tissue caught between the opposing teeth of the blades is sheared. The multiple teeth along both cutting blades define a multiple scissor array that severs or shears material or tissue along a length of the advancing cutting assembly. Where the cutting apparatus oscillates at least one of the cutting blades, the oscillation has a peak to peak distance of at least a distance between two adjacent cutting teeth on the first and/or second set of cutting teeth. The cutting teeth may include edge serrations. The cutting blades may provide cooperating blade alignment elements so as to align the first and second cutting blades relative to each other.
The cutting assembly may be at least partially retracted within the probe in the storage configuration and at least partially return to the cutting configuration when extended through a distal end of the probe. The probe may include a cover slidable between a proximal position in which the cutting assembly is at least partially in the cutting configuration and a distal position in which the cover at least partially houses the cutting assembly in the storage configuration. The probe may define one or more openings along a length in a distal region thereof from which the cutting assembly extends from the storage configuration to the cutting configuration in a direction generally orthogonal to a probe axis.
In one embodiment, the first and second cutting blades are generally circle arcs in shape and at least one of the first and second cutting blades is configured to pivot relative to the other about a cutting assembly pivot. In another embodiment, the first and second cutting blades form embedded cylinders such that the cutting assembly defines a cutting direction generally in alignment with the probe axis. In yet another embodiment, multiple cutting assemblies each defining a cutting axis generally orthogonal to the probe axis are coupled to each other circumferentially via a loop cable, the cutting assemblies and the loop cable being configured to be rotatable about the probe axis.
The cutting assembly may be configured as at least a partial loop attached to a loop holder defining a loop holder axis generally orthogonal to the probe axis, the loop generally returning to the cutting configuration from the storage configuration. The loop holder is configured to rotate the loop cutting assembly about the loop holder axis when the cutting assembly is in the cutting configuration so as to adjust a loop angle defined between the probe axis and the cutting assembly.
At least one of the cutting blades may be operatively coupled to an energy source selected from radio frequency, laser and ultrasonic energy, heat, cold, and air or liquid pressure. At least one of the cutting blades may be at least partially insulated.
A coagulator may be incorporated into the cutting assembly. For example, the coagulator may be disposed on the first and/or second outer surfaces of the cutting blades. The coagulator can be coupled to an energy source such as a radio frequency energy, laser, cold, ultrasonic heating, and/or electrical resistive heating source. The coagulator may be an inductive coil configured around at least a portion of at least one of the first and second cutting blades. An energy source may be coupled to the coagulator to deliver an electrical current through the inductive coil to cause at least part of the cutting assembly surrounded by the inductive coil to increase in temperature through inductive heating. A temperature sensor may also be incorporated into the cutting assembly to provide a feedback mechanism for controlling a temperature of at least one of the cutting blades and the coagulator. A tissue collector may be incorporated into at least one of the cutting assembly and the probe.
A method for cutting tissue generally includes positioning a distal region of a probe of a tissue cutting device adjacent to a region of tissue to be severed, the probe defining a probe axis, returning a cutting assembly to a cutting configuration from a storage configuration, moving at least one of a first cutting blade and a second cutting blade of the cutting assembly relative to the other, the moving being at least one of rotating and oscillating, the first cutting blade having a first inner surface, a first outer surface opposite the first inner surface, a first cutting edge, and a first set of cutting teeth disposed along at least a portion of the first cutting edge, the second cutting blade having a second inner surface, a second outer surface opposite the second inner surface, a second cutting edge, and a second set of cutting teeth disposed along at least a portion of the second cutting edge, the first inner surface being configured opposing the second inner surface so that the first set of cutting teeth is aligned with and configured to cooperate with the second set of cutting teeth, and one of advancing and retracting the tissue cutting device during the moving of at least one of the cutting blades such that the cutting assembly severs the tissue.
These and other features and advantages of the present invention will be presented in more detail in the following detailed description and the accompanying figures which illustrate by way of example principles of the invention.
The present invention will be readily understood by the following detailed description in conjunction with the accompanying drawings, wherein like reference numerals designate like structural elements.
Devices for efficient severing or cutting of a material or substance such as soft tissue suitable for use in open surgical and/or minimally invasive procedures are disclosed. The following description is presented to enable any person skilled in the art to make and use the invention. Descriptions of specific embodiments and applications are provided only as examples and various modifications will be readily apparent to those skilled in the art. The general principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the invention. Thus, the present invention is to be accorded the widest scope encompassing numerous alternatives, modifications and equivalents consistent with the principles and features disclosed herein. For purpose of clarity, details relating to technical material that is known in the technical fields related to the invention have not been described in detail so as not to unnecessarily obscure the present invention.
Exemplary embodiments of a cutting assembly 600 are illustrated in
An exemplary embodiment of the cutting blade 100 is illustrated in
A convergence of tooth edges 127, 128, 129 defines a tooth peak 124 which is shown configured as a tip. The relation of bevel surface 127f to the inner surface 114 defines a bevel angle α1 and the relation of bevel surface 128f to the inner surface 114 defines a bevel angle α2 as shown in
The valley 140 defines a valley edge 148 and a valley height 146. The valley edge 148 defines a valley angle δ. The valley angle δ is preferably 45° to increase the sharpness of the valley edge 148. The valley edge 148 can be linear, curved, faceted, serrated and/or regular or irregular. The valley edge 148 defines a valley edge length 142. The valley edge length 142 can range from 0 to almost the cutting blade length 104. The valley edge lengths 142 along the cutting blade 100 can be symmetric or asymmetric. A width of the tooth 120 at the valley edge 148 defines a tooth base width 134.
Tooth edges 127, 128 in relation to adjacent valley edges 148 define tooth edge angles γ1 and γ2. In the embodiment illustrated in
In curved tooth edges 127, 128 as shown in
The cutting blade 100 may be formed from a metal, a metal alloy, glass, mineral, ceramic, plastic and/or a polymer. The cutting blade 100 may be rigid or flexible. A flexible cutting blade 100 is preferably configured from a material having sufficient elastic properties to prevent a significant permanent deformity when external stresses are placed on the flexible cutting blade 100 when the external stresses do not exceed the strain limits of the material of the flexible cutting blade 100. Furthermore, the material of the cutting blade 100 preferably has sufficient strength to prevent deformation of the cutting blade 100 during the cutting procedure. The cutting blade 100 is configured using techniques and methods well known to those skilled in the art and may include machining, lasering, stamping, and/or chemical etching. In a further embodiment, the cutting blade 100 may include multiple materials. The multiple materials can be configured as one or more layers, segments and/or portions that are continuous or discontinuous and symmetric or asymmetric. The multiple material provide properties such as electrical insulation, heat insulation, varying conductivity (for example, heat or electricity), increased hardness, lubricity, and/or sensors (for example, temperature). Materials configured as surface coatings on the cutting blade 100 may include polymers, plastics, ceramics, diamond-like carbon, diamond and/or diamond-like noncomposite coatings (metal-doped and nonmetal-doped). One or more liquid materials may also be incorporated into the cutting assembly 600 to facilitate, for example, lubricity or heat insulation. Such materials include, for example, silicone and perfluorinated fluids.
Referring again to
To maintain the cutting blades 100, 100a in close apposition, one or more blade aligners 117 may be provided, preferably on bases 130, 130a. The blade aligners 117 may define slots 118 and slot fasteners 119. The slot fasteners 119 pass through at least adjacent slots 118 of the cutting blades 100, 100a. The slots 118 allow at least one of the cutting blades 100, 100a to oscillate relative to the other while the slot fasteners 119 keep the cutting blades 100, 100a in close approximation. Another embodiment of a blade aligner 117 includes grooves (not shown) on the bases 130, 130a of the cutting blades 100, 100a that interconnect with each other. Various other suitable mechanisms for keeping the cutting blades 100, 100a in close approximation may be alternatively or additionally utilized.
In further exemplary embodiment as illustrated in
In an alternative embodiment (not shown), cutting blade 100 and cutting blade 100a oscillate in opposing directions. Cutting blades 100, 100a oscillating in opposing directions reduces movement of the material being cut by preventing the material from moving in a single direction at a given moment in time. In another alternative embodiment (not shown), the cutting assembly 600 may include one or more cutting blades that rotate. A nonrotating cutting blade or a secondary cutting blade rotating in an opposing direction facilitates fixation of the material being cut by preventing the material from moving in the direction of the primary rotating cutting blade.
In a further embodiment, the cutting assembly has three or more cutting blades. For example, a central cutting blade may oscillate while two outer cutting blades do not oscillate. Alternatively, the central cutting blade does not oscillate while the two outer cutting blades oscillate, preferably in opposing directions. Various other suitable combinations of cutting blade configuration, cutting assembly configuration, oscillation and/or rotation may be employed.
In a further exemplary embodiment as shown in
In an alternative as shown in
Various exemplary embodiments of a tissue cutting device 800 including the cutting assembly 600, a probe 820 and a handle 840 are illustrated in
When one or more external energy sources are used, one or more energy couplers 846 extend from the handle 840 to the one or more external energy sources. For example, when radio frequency energy is incorporated, an external electrosurgical generator is operatively coupled to the tissue cutting device 800 using the energy coupler 846. When incorporating radio frequency energy, the tissue cutting device 800 may be a monopolar or a bipolar system.
The cutting assembly 600 is preferably housed in a sheath or probe cover 830 and/or the probe 820 when not oscillating or cutting. The cutting assembly 600 is exposed by advancing through a distal end 823 of the probe 820 and/or by retracting the probe cover 830 prior to, simultaneously with, or during activation of the oscillation. A cutting assembly advancer 844 is located on the handle 840 when the cutting assembly 600 is housed in the probe 820. Control of retraction of the probe cover 830 or advancement of the cutting assembly 600 through the distal end 823 and oscillation of the cutting assembly 600 may be separate or combined. In one alternative, a safety mechanism operatively couples retraction of the probe cover 830 with activation of oscillation. Activation of a safety controller (not shown) located on the handle 840, retracts the probe cover 830 and activates the oscillation. When the safety controller is deactivated, the oscillation stops and the probe cover 830 advances over the cutting assembly 600. The safety controller may be in any suitable configuration and may include, for example, one or more buttons, triggers, levers, knobs, and/or pedals.
Various additional components may be incorporated in the tissue cutting device 800. For example, a tissue collector (such as a tissue collector 890 shown in
In
In the exemplary embodiment illustrated in
In a further exemplary embodiment illustrated in
In the exemplary embodiments illustrated in
In
In a further exemplary embodiment as shown in
While the exemplary embodiments of the present invention are described and illustrated herein, it will be appreciated that they are merely illustrative and that modifications can be made to these embodiments without departing from the spirit and scope of the invention. Thus, the scope of the invention is intended to be defined only in terms of the following claims as may be amended, with each claim being expressly incorporated into this Description of Specific Embodiments as an embodiment of the invention.
This application is related to co-pending U.S. patent application Ser. No. 10/______ (Attorney Docket No. MNOAP008), entitled “Tissue Cutting Devices and Methods” and filed on Mar. 31, 2004, the entirety of which is incorporated by reference herein.