Patent Application
20070066985
The present invention relates generally to medical devices and related methods. More specifically, particular embodiments of the invention relate to tissue acquisition devices (e.g., biopsy forceps) having a separate hemostasis capability for use in, for example, acquiring tissue samples from a body.
Biopsy forceps are widely used to obtain tissue samples. A biopsy forceps generally includes a distal cutting member configured to sever tissue samples and a tissue receptacle for holding one or more of the severed tissue samples. Severing tissue from a tissue site causes that tissue site to bleed. To stop or minimize the bleeding during the procedure, “hot” biopsy forceps may be used to direct cauterizing electric current or thermal energy to the tissue site through the distal cutting member to cauterize the bleeding tissue site. Such “hot” biopsy forceps, however, may damage the tissue samples collected in the biopsy forceps, such that a proper diagnosis of the tissue samples may be difficult.
Thus, there is a need for biopsy forceps having a separate hemostasis capability, which does not damage the tissue sample without compromising the tissue acquisition and/or hemostasis capabilities.
Therefore, various exemplary embodiments of the invention may provide biopsy forceps having a separate hemostatic device integrated with the biopsy forceps, which may effectively stop the bleeding at the tissue site without damaging the tissue samples obtained by the biopsy forceps.
To attain the advantages and in accordance with the purpose of the invention, as embodied and broadly described herein, one aspect of the invention may provide a medical device comprising an elongated tubular member having a proximal end and a distal end, a tissue cutting member proximate the distal end of the tubular member, and a hemostatic member proximate the distal end of the tubular member and adjacent the tissue cutting member. In some exemplary aspects, at least one of the tissue cutting member and the hemostatic member may be fixedly connected to the tubular member.
According to another exemplary aspect of the invention, a method of performing a medical procedure may be provided. The method may comprise inserting a medical device into a patient's body, where the medical device may comprise an elongated tubular member having a proximal end and a distal end, a tissue cutting member proximate the distal end of the tubular member, and a hemostatic member proximate the distal end of the tubular member and adjacent the tissue cutting member. At least one of the tissue cutting member and the hemostatic member may be fixedly connected to the tubular member. The method may also include positioning the distal end of the tubular member near a target site, severing tissue from the target site with the tissue cutting member, and stopping bleeding at the target site with the hemostatic member. In an aspect, the method may further comprise removing the medical device out of the patient's body. In another aspect, stopping bleeding may comprise moving the hemostatic member axially relative to the tissue cutting member.
According to another aspect, both of the tissue cutting member and the hemostatic member may be fixedly connected to the tubular member. In various other aspects, one of the tissue cutting member and the hemostatic member may be fixedly connected to the tubular member, and the other of the tissue cutting member and the hemostatic member may be movably arranged within the tubular member. In one aspect, the tubular member may define a lumen extending between the proximal end and the distal end, and the lumen may be configured to accommodate the other of the tissue cutting member and the hemostatic member.
In some aspects of the invention, the tissue cutting member may comprise a tissue acquisition device. The tissue acquisition device may comprise a biopsy forceps. Alternatively or additionally, the tissue cutting member may comprise at least one of a snare, scissors, pincer, needle, knife, needleknife, and basket.
In another aspect, the hemostatic member may comprise one of a laser fiber probe, a heater probe, an injection needle configured to inject a therapeutic agent, an electrocautery device, a clip applicator, a ligation device configured to apply a band or loop, and a gas-induced plasma probe.
According to one aspect of the invention, the elongated member may be sufficiently flexible to traverse tortuous anatomy of a patient.
Additional objects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The objects and advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate an exemplary embodiment of the invention and together with the description, serve to explain the principles of the invention. In the drawings:
Reference will now be made in detail to the exemplary embodiments consistent with the present invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.
As shown in
As best shown in
The hemostatic device 20 may comprise a laser fiber configured to direct a localized laser energy onto the bleeding tissue site, so as to coagulate the bleeding tissue. Alternatively or additionally, the hemostatic device 20 may comprise an applicator, an injection needle, or a spray nozzle configured to apply a therapeutic agent, such as, for example, hemostatic agent, sclerosing agent, and/or coagulating agent, to the surface of the bleeding tissue site. For example, in some exemplary embodiments, epinephrine, ethanol, and hypertonic saline may be used for non-variceal bleeding, and sodium tetradecyl sulfate, sodium morrhuate, ethanolamine oleate, polidocanol, and ethanol may be used for variceal bleeding. Any other known therapeutic agent may be used alternatively or additionally.
The hemostatic device 20 may be axially extendable and/or radially rotatable to facilitate accurate positioning of the device 20 with respect to the tissue to be treated.
Depending on the type of the hemostatic device 20, the jaw assembly 10 may be suitably insulated from the hemostatic device 20 to prevent or minimize the damage to the severed tissue contained in the biopsy forceps.
The tubular body 5 may be sufficiently flexible to traverse through a tortuous body lumen, yet sufficiently stiff to resist compressive force applied thereto during normal operation. The tubular body 5 may or may not be hollow. For example, the tubular body 5 may define at least one lumen 4, 6 along its longitudinal axis to accommodate the jaw assembly 10 and/or the hemostatic device 20, as shown in
In some other exemplary embodiments, at least one of the jaw assembly 10 and the hemostatic device 20 may be fixedly connected to the tubular body 5. For example, the jaw assembly 10 may be fixedly connected to the tubular body 5, for example by a pivot pin 15 as shown in
According to another exemplary embodiment, both the jaw assembly 10 and the hemostatic device 20 may be fixedly connected to the tubular body 5. For example, the jaw assembly 10 and the hemostatic device 20 may be integrally formed with the tubular body 5. When the jaw assembly 10 and the hemostatic device 20 are integrally formed, the tubular body 5 may still define one or more lumens or passageways therein.
When the jaw assembly 10 or the hemostatic device 20 is fixedly connected to the tubular body 5, the jaw assembly 10 or the hemostatic device 20 may be configured to extend radially and/or axially, at least to a certain extent, to facilitate positioning relative to the tissue site. This may permit accurate positioning of the jaw assembly 10 and/or the hemostatic device 20 with respect to the target tissue.
According to some aspects of the invention, the medical device 1 may employ various different types of a hemostatic device. For example, the device 1 may include a clip applicator 120 configured to deploy one or more detachable clips (e.g., hemoclips), as shown in
In another exemplary embodiment, the device 1 may include a loop applicator 220. As shown in
According to still another exemplary embodiment of the invention, the device 1 may include a band applicator 320. As shown in
Other various types of a hemostatic device may be used alternatively or additionally. For example, in some exemplary embodiments, the hemostatic device 20 may include an electrocautery device configured to allow cauterizing electric current (e.g., bipolar or monopolar current) to flow to the bleeding tissue site to stop the bleeding. In still another exemplary embodiment, the hemostatic device 20 may comprise a gas-induced plasma coagulation device (e.g., argon plasma coagulation device) configured to direct heat energy generated by ionizing the gas onto the bleeding tissue site to coagulate the bleeding tissue. Any other hemostasis device known in the art may also be used additionally or alternatively.
The operation of the medical device 1, according to an exemplary embodiment of the invention, will be described in detail with reference to
As shown in
Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.
