Cancer spreading or metastasis is a severe condition that a surgeon would strive to control in order to save patients' lives. The cancer cells often travel through vascular or lymphatic systems to remote sites, which can induce secondary tumors. Excision of lymphatic tissue is an important component of many surgical operations. Termed “lymph node dissection”, this procedure provides prognostic value for patients and in some cases may prevent subsequent cancer metastasis. The conventional lymph node dissection involves surgical removal of lymphatic nodes and vessels near the primary tumors and in the regional lymphatic tissue that provides lymphatic drainage for the primary tumor.
The human body transports fluids and cells in the lymphatic and vascular systems to maintain normal and healthy functions. Cancer cells can infiltrate the lymphatic system and spread from an original tumor to a remote site. Once disseminated, eradication of cancer is usually not possible. Although chemotherapy may help slow the growth of cancer in metastatic disease, relapse and progression is common and death is inevitable in most solid tumors. In many solid tumors, the tumor is removed along with the surrounding lymphatic channels. This is done to determine if the cancer has penetrated the lymphatic system and in some cases it can eradicate the cancer within the lymphatic system. Termed lymph node dissection, these procedures are performed for many types of cancer including breast, prostate, stomach, uterine, cervical, urinary bladder, testicular, and others.
The commonly used technique for removing the lymphatic tissue is time consuming It requires intricate cutting and cauterizing using various surgical tools to grasp, resect, or collect the tissue. The tissue must be precisely cut to avoid damage to the surrounding arteries, veins, and nerve bundles. During the procedures the patient is anesthetized for prolonged period of times, which may put the patient at a higher risk for the adverse events and complications. Thus, there is an important need for more efficient techniques and devices for removing tissues, such as lymphatic tissue.
Exemplary embodiments of the present disclosure include a tissue removal device comprising: an elongated housing comprising a proximal end and a distal end; an electric motor; a fixed cauterizing element proximal to the distal end of the housing; and a rotating cauterizing element proximal to the distal end of the housing, where the electric motor is coupled to the rotating cauterizing element. In specific embodiments, the elongated housing may be generally cylindrical or close to cylindrical, and in certain embodiments the electric motor may be coupled to the rotating cauterizing element via a drive extension within the elongated housing.
Particular embodiments may comprise a drive member coupled to the electric motor and the drive extension. In certain embodiments, the fixed cauterizing element may comprise a fixed cutting element that is electrically conductive; the rotating cauterizing element may comprise a rotating cutting element that is electrically conductive; and the fixed cutting element may be in contact with the rotating cutting element. In specific embodiments, the tissue removal device may be configured so that an electric power source can be electrically coupled to the fixed cauterizing element. In particular embodiments, the fixed cutting element can be electrically coupled to the electric power source via a wire extending along a primary length of the elongated housing.
In certain embodiments, the tissue removal device may be configured so that radio frequency electric power is provided to the fixed cutting element. Particular embodiments may comprise a first control switch configured to supply electrical power to the fixed cutting element at a first power level sufficient to cauterize tissue. Specific embodiments can further comprise a second control switch configured to supply electrical power to the fixed cutting element at a second power level sufficient to coagulate blood vessels. In certain embodiments the wire may be located in a channel in the elongated housing.
In particular embodiments, the rotating cauterizing element may comprise a rotating cutting element holder that is not electrically conductive and the fixed cauterizing element may comprise a fixed cutting element holder that is not electrically conductive. In specific embodiments, the fixed cutting element may extend to an outer circumference of the fixed cutting element holder.
In certain embodiments, the elongated housing may comprise an opening at the distal end and the rotating cauterizing element may be configured to rotate from a first position to a second position, where the first position does not cover the opening at the distal end and where the second position covers the opening at the distal end. Particular embodiments may also comprise a vacuum source configured to create a vacuum within the housing.
Specific embodiments may include a method of removing tissue, where the method comprises: placing a tissue removal device proximal to a section of tissue; inserting the section of tissue into the distal end of the elongated housing; and moving the rotating cauterizing element from a first position to a second position to remove the section of tissue from a target site. In particular embodiments, the tissue removal device may comprise: an elongated housing comprising a proximal end and a distal end; an electric motor; a fixed cauterizing element proximal to the distal end of the housing; and a rotating cauterizing element proximal to the distal end of the housing, wherein the electric motor is coupled to the rotating cauterizing element.
Certain embodiments may also comprise supplying electric power to the fixed cauterizing element. Specific embodiments may also comprise transmitting electric power from the fixed cauterizing element to the rotating cauterizing element. In certain embodiments, the electric power may be sufficient to cauterize tissue at the target site. In particular embodiments, the electric power may be sufficient to coagulate blood vessels at the target site. In specific embodiments, inserting the section of tissue into the distal end of the elongated housing comprises applying a vacuum device to the housing to draw the section of tissue into the housing. In particular embodiments, the tissue may comprise lymphatic tissue. In certain embodiments, the tissue may comprise fat tissue.
Embodiments of the invention are directed to devices and methods that improve the surgical efficiency and shorten the operation time for tissue removal. To serve this purpose, a tissue removal device is designed using both mechanical dissection and suction to grasp, resect and collect all or part of a target tissue. In exemplary embodiments, heating elements can be included for tissue removal and/or cauterization to stop bleeding, as explained in further detail below. The device described herein can be used in a wide range of tissue removal surgeries including both open and laparoscopic surgery. Also, the device is capable of removing other kinds of tissues such as fat and skin tissues, in addition to lymphatic tissues. Use of the device described herein renders the tissue removal methods significantly faster than the conventional methods of surgery. The device is configured for use in both open and laproscopic surgery, and the shortened surgery times will subsequently reduce the time for patients under anesthesia and make it possible for the surgeon to work with ease and efficiency using minimally invasive techniques.
In the following, the term “coupled” is defined as connected, although not necessarily directly, and not necessarily mechanically.
In certain aspects, the surgery is carried out in the affected tissues in which contact between the other body parts and the target need to be minimized The current device is designed in a way to minimize bleeding and inadvertent damage with adjacent viable tissue.
Certain embodiments are directed to a device for resecting a target tissue comprising: (a) a mechanical cutting head having an exterior face and an interior face, (i) the cutting head comprising at least two fixed blades, the fixed blades forming flow channels in the cutting head; and (ii) one or more movable blades positioned interior to the fixed blades of the cutting head; and (b) a mounting head coupled to and fluidically connected to the cutting head, the mounting head being configured to provide a suction force to draw the target tissue inside the cutting head where the target tissue is cut by the moveable blades and fixed blades during use.
The device can further comprising heating elements positioned on or in the fixed blades. In certain aspects, the heating elements are capable of cauterizing tissue.
In certain aspects, the cutting head is 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 mm to 8, 9, 10, 11, 12, 13, 14, or 15 mm, including all values and ranges there between, in diameter or at its maximum width. In a further aspect, the cutting head can be 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 cm to 8, 9, 10, 11, 12, 13, 14, or 15 cm, including all values and ranges there between, in diameter or at its maximum width. In a particular aspect, the cutting head is 3 mm to 10 mm in diameter or at its maximum width. In certain aspects, the cutting head is 10 mm in diameter or at its maximum width.
In certain aspects, the device comprises 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more fixed blades. In a further aspect, the device comprises 4 fixed blades. In a further aspect, the device has at least the same number of moveable as it does fixed blades. In a further aspect, the device has 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or more moveable blades. In certain aspects, the device has at least 4 moveable blades.
In certain aspects, the fixed blades have an angle of between 55 and 60 degrees relative to the long axis of the device. In a further aspect, the fixed blades have an angle of between 57 and 58 degrees relative to the long axis of the device. In still a further aspect, the fixed blades have an angle of about 57.5 or 57.47 degrees relative to the long axis of the device.
Certain embodiments are directed to an apparatus for resecting a target tissue comprising a device of claim 1 operatively coupled to a vacuum source and a collection container.
Further embodiments are directed to a fixed blade assembly having an optimized flow velocity through the assembly comprising four or more fixed blades having an angle of 55 to 60 degrees relative to the short axis of the assembly. In certain aspects, the blade angle is between 57 and 58 degrees relative to the short axis of the assembly. In further aspects, the blade angle is or is about 57.47 degrees relative to the short axis of the assembly. In still a further aspect, the assembly has 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more fixed blades. In certain aspects, the assembly has a maximum width of 3, 4, 5, 6, 7, 8, 9, or 10 mm. In a further aspect, the assembly has a maximum width of 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 cm
Certain embodiments are directed to methods of resecting a target tissue comprising inserting a device as described herein in to a patient in need of target tissue removal and contacting the target tissue with the device, wherein the target tissue is grasped by the device, drawn inside the device, cut from the patient, and collected. In certain aspects, the target tissue is lymphatic, fat, or skin tissue. In certain aspects, the device is inserted by open or laparoscopic surgery.
Other embodiments of the invention are discussed throughout this application. Any embodiment discussed with respect to one aspect of the invention applies to other aspects of the invention as well and vice versa. Each embodiment described herein is understood to be embodiments of the invention that are applicable to all aspects of the invention
The use of the word “a” or “an” when used in conjunction with the term “comprising” in the claims and/or the specification may mean “one,” but it is also consistent with the meaning of “one or more” or “at least one.” The term “about” means, in general, the stated value plus or minus 5%. The use of the term “or” in the claims is used to mean “and/or” unless explicitly indicated to refer to alternatives only or the alternative are mutually exclusive, although the disclosure supports a definition that refers to only alternatives and “and/or.”
The terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as “has” and “having”), “include” (and any form of include, such as “includes” and “including”) and “contain” (and any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, a method or device that “comprises,” “has,” “includes” or “contains” one or more steps or elements, possesses those one or more steps or elements, but is not limited to possessing only those one or more elements. Likewise, a step of a method or an element of a device that “comprises,” “has,” “includes” or “contains” one or more features, possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed.
Other objects, features and advantages of the present invention will become apparent from the following detailed description. It should be understood, however, that the detailed description and the specific examples, while indicating specific embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will be apparent to those skilled in the art from this detailed description.
The following drawings form part of the present specification and are included to further demonstrate certain aspects of the present disclosure. The invention may be better understood by reference to one of these drawings in combination with the detailed description of specific embodiments presented herein.
Referring initially to
As will be explained in further detail below, housing 210 is generally cylindrical in shape and further comprises an inlet 216 near distal end 214. Housing 210 also comprises an outlet 213 located near proximal end 212. Inlet 216 can allow air and the tissue to be removed to enter housing 210, while outlet 213 can allow air and the tissue that has been removed from a target site to exit housing 210.
Referring now to
Referring specifically now to
Referring back now to
As shown in
In certain embodiments, tissue removal device 200 can be configured to provide radio frequency electric power to the fixed cutting element 241. In the embodiment shown, tissue removal device 200 can comprise a first control switch 251 configured to supply electrical power to the fixed cutting element 241 at a first power level sufficient to cauterize lymphatic tissue. Tissue removal device 200 can further comprise a second control switch 252 configured to supply electrical power to fixed cutting element 241 at a second power level sufficient to coagulate blood vessels. As previously mentioned fixed cutting element 241 and rotating cutting element 247 are in contact with each other and are electrically conductive. Accordingly, the electrical power supplied to fixed cutting element 241 is also conducted to rotating cutting element 247. This configuration allows both fixed cutting element 241 and rotating cutting element 247 to cauterize tissue and/or coagulate blood vessels.
In the embodiment shown, a third control switch 253 can be used to control the level of vacuum applied to compartment 219 in housing 210. It is understood that the location and configuration of control switches 251, 252 and 253 are shown for example only, and that other exemplary embodiments may comprise a different location and configuration. For example, in certain embodiments, tissue removal device 200 may comprise an ergonomic handle that incorporates the control switches.
The exemplary embodiment shown and described in
Referring now to
When suction is applied the fluid source is turned off and the stop valve at the fluid adapter is kept close. As a result, suction force is generated at the distal tip of the device that functions to draw tissue through the flow channels and inside the device. The shape of the fixed blades is optimized for maximizing the flow velocity near the distal tip of the device (
In certain aspects the device can be operated in cleaning mode. The cleaning mode can be used with the device inside or outside the body of a patient. The cleaning mode is initiated if any scrap accumulates and jams the passage through the moving blades. In certain aspects a flow regulating valve and/or stop valve can be opened for cleaning purposes allowing a fluid to flow. The fluid is then sucked in to the head mount. In certain aspects the cleaning fluid (e.g., air) can be pumped in using a pressure source (e.g., air blower). The fluid can dislodge or move any accumulated tissue scraps from the moving blades and make the device re-usable. In certain aspects the device is used in a continuous mode where a number of target tissue sites can be removed without removing and re-inserting the device. In certain aspects the cleaning fluid can also offer lubrication. In certain aspects, the cleaning fluid can also be used as a diluting agent.
All of the apparatus, systems and/or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the devices, systems and methods of this invention have been described in terms of particular embodiments, it will be apparent to those of skill in the art that variations may be applied to the devices, systems and/or methods in the steps or in the sequence of steps of the method described herein without departing from the concept, spirit and scope of the invention. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope and concept of the invention as defined by the appended claims.
The contents of the following references are incorporated by reference herein:
This application claims priority to U.S. Provisional Patent Application Ser. No. 61/624,223 filed Apr. 13, 2012, the entire contents of which are incorporated herein by reference.
This invention was made with government support under 5K25CA116291 awarded by the National Institutes of Health and HRD#0932339 awarded by National Science Foundation. The government has certain rights in the invention.
Filing Document | Filing Date | Country | Kind |
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PCT/US13/36467 | 4/12/2013 | WO | 00 |
Number | Date | Country | |
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61624223 | Apr 2012 | US |