Description:FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(Section 10 and Rule 13)

1. TITLE OF THE INVENTION: TISSUE TREATMENT SYSTEM

2. APPLICANT:
Meril Life Sciences Pvt. Ltd., an Indian company of the address Survey No. 135/139 Bilakhia House, Muktanand Marg, Chala, Vapi- 396191, Gujarat, India

The following specification particularly describes the invention and the manner in which it is to be performed:

FIELD OF INVENTION
[1] The present invention relates to a medical device. More specifically, the present invention relates to medical device for tissue treatment.
BACKGROUND OF INVENTION
[2] The second biggest cause of death in the world is cancer. For instance, there are more than 2.3 million cases of breast cancer that occur every year, making it the most common cancer among the adults.
[3] Ablation therapy is the most common course of treatment for cancers. In simple language, ablation corresponds to the removal or destruction of cancerous tissue. The ablation of cancerous tissue may be performed by various procedures such as via explorative surgery, hormonal regulation, prescription drugs, radiation exposure (for e.g., radiofrequency), heat exposure, etc.
[4] Most preferred form of ablation therapy is via radiofrequency because radiofrequency can be easily delivered to the cancerous tissue (or surgical site) via percutaneous procedures. In radiofrequency form of ablation therapy, multiple needle-like electrodes (or tines) are passed through the skin into the cancerous tissue. Thereafter, the electrodes are stimulated to emit radiation in order to ablate the cancerous tissue. For ablation therapy, it is imperative to remove tissue fluids (for e.g., blood, pus, air, etc.) from the surgical site before applying radiofrequency. Conventionally, tissue fluid is drawn out from the surgical site by using a vacuum aspirator or the like.
[5] However, conventional method to remove tissue fluid suffers from a number of drawbacks that may render the surgical site unfit for ablation or cause potential health hazards for the patient. For example, more often than not, the tissue fluid drawn from the surgical site has a turbulent and/or inconsistent flow. Said turbulent flow requires more energy to draw the fluid out from the surgical site thereby generating undesirable heat at the surgical site. Further, there is always a risk of back flow of the tissue fluid once the vacuum source is removed and/or during the ablation procedure (via the electrodes).
[6] Hence, there is a need for a system that overcomes the drawbacks of the conventional systems.
SUMMARY OF INVENTION
[7] Particular embodiments of the present disclosure are described herein below with reference to the accompanying drawings, however, it is to be understood that the disclosed embodiments are mere examples of the disclosure, which may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.
[8] The present invention relates to an adapter including a handle, a cannula, at least one baffle, and at least one valve. The cannula is partially disposed within the handle and extends from a first end to a second end defining a lumen. The second end of the cannula is configured to puncture and penetrate a surgical site. The baffle is disposed within the handle and extends from a first first-flow end to a second flow-end defining a lumen. The second-flow end of the baffle is coupled to the first end of the cannula. A plurality of plates helically extends along an axis of the lumen within a baffle body between the first-flow end and the second-flow end. The valve is disposed within the handle. The valve includes at least a first port and a second port. The first port is coupled to the first-flow end of the baffle. The second port is coupled to at least one of a vacuum generation source or a saline injector. The lumen of the cannula, the lumen of the baffle, the first port and the second port of the valve define a fluid pathway configured to at least facilitate aspiration of tissue fluid from the surgical site when the second port is coupled to the vacuum generation source, or facilitate flow of saline to the surgical site when the second port is coupled to the saline injector.
BRIEF DESCRIPTION OF ACCOMPANYING DRAWINGS
[9] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentality disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[10] Fig. 1 depicts an adapter 100 in accordance with an embodiment of the present invention.
[11] Fig. 1a depicts a partial cross-section of a baffle 105 of the adapter 100 in accordance with an embodiment of the present invention.
[12] Fig. 2 depicts a stylet 200 along with the adapter 100 in accordance with an embodiment of the present invention.
[13] Fig. 3 depicts an ablation electrode 300 along with the adapter 100 in accordance with an embodiment of the present invention.
[14] Fig. 3a depicts the ablation electrode 300 with tines 309 in an expanded state in accordance with an embodiment of the present invention.
[15] Fig. 4 depicts a method to prepare and ablate a tumor in accordance with an embodiment of the present invention.
[16] DETAILED DESCRIPTION OF THE DRAWINGS
[17] Prior to describing the invention in detail, definitions of certain words or phrases used throughout this patent document will be defined: the terms "include" and "comprise", as well as derivatives thereof, mean inclusion without limitation; the term "or" is inclusive, meaning and/or; the phrases "coupled with" and "associated therewith", as well as derivatives thereof, may mean to include, be included within, interconnect with, contain, be contained within, connect to or with, couple to or with, be communicable with, cooperate with, interleave, juxtapose, be proximate to, be bound to or with, have a property of, or the like. Definitions of certain words and phrases are provided throughout this patent document, and those of ordinary skill in the art will understand that such definitions apply in many, if not most, instances to prior as well as future uses of such defined words and phrases.
[18] Reference throughout this specification to “one embodiment,” “an embodiment,” or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in one embodiment,” “in an embodiment,” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment, but mean “one or more but not all embodiments” unless expressly specified otherwise. The terms “including,” “comprising,” “having,” and variations thereof mean “including but not limited to” unless expressly specified otherwise. An enumerated listing of items does not imply that any or all of the items are mutually exclusive and/or mutually inclusive, unless expressly specified otherwise. The terms “a,” “an,” and “the” also refer to “one or more” unless expressly specified otherwise.
[19] Although the operations of exemplary embodiments of the disclosed method may be described in a particular, sequential order for convenient presentation, it should be understood that the disclosed embodiments can encompass an order of operations other than the particular, sequential order disclosed. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Further, descriptions and disclosures provided in association with one particular embodiment are not limited to that embodiment, and may be applied to any embodiment disclosed herein. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed system, method, and apparatus can be used in combination with other systems, methods, and apparatuses.
[20] Furthermore, the described features, advantages, and characteristics of the embodiments may be combined in any suitable manner. One skilled in the relevant art will recognize that the embodiments may be practiced without one or more of the specific features or advantages of a particular embodiment. In other instances, additional features and advantages may be recognized in certain embodiments that may not be present in all embodiments. These features and advantages of the embodiments will become more fully apparent from the following description and apportioned claims, or may be learned by the practice of embodiments as set forth hereinafter.
[21] The present invention discloses a tissue treatment system (or system). The system is used to drain and ablate cancerous tissue in vivo. For example, the system may be used on cancerous tissue present inside breast, liver, lungs, etc.
[22] The system of the present invention minimizes blood loss during the procedure (compared to incision procedures). The system includes an adapter, a stylet and an ablation electrode. The stylet and the ablation electrode are selectively coupled to the adapter. The stylet helps to make room for the ablation electrode at the surgical site. The ablation electrode helps to ablate the cancerous tissue at the surgical site.
[23] The adapter along with the stylet is used to drain the surgical site of any tissue fluid before the cancerous tissue is ablated. The adapter is provided with a baffle including a plurality of plates having a pitch that is half of a diameter of the plates. The baffle of the adapter helps to maintain a laminar flow of the tissue fluids (drained from the surgical site) thereby avoiding inconsistent flow, turbulence, irregular fluctuation, etc. in the fluid flow even when the system of the present invention is used in a vertical or inclined orientation (with respect to the gravity plane).
[24] Now referring to the figures, Fig. 1 depicts an exemplary adapter 100 of the system. The adapter 100 provides access to a surgical site 1. In an exemplary embodiment, the surgical site 1 corresponds to a cancerous tissue 1a disposed under the dermal tissue 1b. The adapter 100 is toggled between at least a first configuration and a second configuration. The adapter 100, in its first configuration, is used with a stylet 200 (as shown in Fig. 2). The adapter 100, in its second configuration, is used with an ablation electrode 300 (as shown in Figs. 3 and 3a).
[25] The adapter 100 includes a plurality of components operationally coupled to each other. In an exemplary embodiment, as shown in Fig. 1, the adapter 100 includes a handle 101, a cannula 103, at least one baffle 105, and at least one valve 107. The cannula 103, the baffle 105 and the valve 107 is fluidically coupled to each other. In an exemplary embodiment, as shown in Fig. 1, the baffle 105 couples the cannula 103 to the valve 107.
[26] The handle 101 acts as a backbone of the adapter 100. The handle 101 is made of a material including but not limited to Polycarbonate, Acrylonitrile Butadiene Styrene (ABS), Polyurethane, Silicones, HDPE (High Density Polyethylene), LDPE (Low Density Polyethylene), Polyesters, etc. In an exemplary embodiment, the handle 101 is made of Acrylonitrile Butadiene Styrene (ABS). In an alternate embodiment, the handle 101 is made of Polycarbonate. The handle 101 has a proximal end 101a and a distal end 101b. The handle 101 has a length ranging from 100 mm to 200 mm. The handle 101 has a diameter ranging from 20 mm to 50 mm. In an exemplary embodiment, the length and diameter of the handle 101 is 150 mm and 30 mm respectively.
[27] Additionally or optionally, the handle 101 is provided with one or more wings 101c. In an exemplary embodiment, as shown in Fig. 1, the handle 101 includes two wings 101c. The wings 101c are ergonomically designed to enable a user to operate the adapter 100. The wings 101c are removably coupled to the handle 101. Alternatively, the wings 101c form an integral structure with the handle 101.
[28] The handle 101 of the adapter 100 houses the plurality of components of the adapter 100 either completely or partially. For example, the cannula 103 of the adapter 100 is at least partially disposed within the handle 101. In an exemplary embodiment, as shown in Fig. 1, the cannula 103 extends away from the baffle 105 and through the distal end 101b of the handle 101. The cannula 103 has a pre-defined shape including but not limited to cylindrical, triangular, rectangular, hexagonal, etc. In an exemplary embodiment, as shown in Fig. 1, the cannula 103 is a hollow cylinder defining a lumen 103a. The cannula 103 is made of material including but not limited to Medical Grade Stainless steel, Platinum, Gold, Silver, etc. In an exemplary embodiment, the cannula 103 is made of Stainless Steel 316L.
[29] The cannula 103 extends between a first end 103b and a second end 103c. The first end 103b of the cannula 103 is coupled to the baffle 105 (described below). The second end 103c of the cannula 103 is a free end and is configured to puncture and penetrate the surgical site 1 (for example, at least one of the cancerous tissue 1a or the dermal tissue 1b). In an exemplary embodiment, as shown in Fig. 1, second end 103c of the cannula 103 is beveled to facilitate easy puncture of the tissues.
[30] Additionally or optionally, the surgical site 1 is imaged by medical imaging tools to locate the cancerous tissue 1a under the dermal tissue 1b before puncturing the surgical site 1 using the second end 103c of the cannula 103.
[31] The cannula 103 has a length ranging from 50 mm to 200 mm. The cannula 103 has a diameter ranging from 1 mm to 10 mm. In an exemplary embodiment, the length and diameter of the cannula 103 is 150 mm and 4 mm respectively.
[32] During the ablation procedure, the cannula 103 is visible under various imaging techniques including but not limited to computerized tomography (CT) scan, magnetic resonance imaging (MRI) scan, X-ray, ultrasound, etc.
[33] The baffle 105 is disposed within the handle 101. The baffle 105 extends between a first-flow end 105a and a second-flow end 105b. The first-flow end 105a of the baffle 105 is coupled to the valve 107 (described below). The second-flow end 105b of the baffle 105 is coupled to the first end 103b of the cannula 103. The cannula 103 is removably coupled to the baffle 105. Alternatively, the baffle 105 and the cannula 103 form an integral structure. In an exemplary embodiment, as shown in Fig. 1, the first end 103b of the cannula 103 is screwed within the second-flow end 105b of the baffle 105.
[34] A baffle body 105d of the baffle 105 has a pre-defined shape including but not limited to cylindrical, triangular, rectangular, pentagonal, hexagonal, etc. The baffle body 105d of the baffle 105 is made of a material including but not limited to Polycarbonate, Acrylonitrile Butadiene Styrene (ABS), Polyurethane, Silicones, High Density Polyethylene (HDPE), Low Density Polyethylene (LDPE), Polyesters, etc. In an exemplary embodiment, as shown in Fig. 1, the baffle body 105d of the baffle 105 is cylindrically shaped and is made of Acrylonitrile Butadiene Styrene (ABS). In an alternate embodiment, the baffle body 105d is made of polycarbonate. The baffle body 105d has a length ranging from 10 mm to 100 mm. The baffle body 105d has a diameter ranging from 10 mm to 50 mm. In an exemplary embodiment, the length and diameter of the baffle body 105d is 30 mm and 20 mm respectively.
[35] The baffle 105 includes a plurality of plates 105c housed within the baffle body 105d. The plates 105c of the baffle 105 are made of a pre-defined material including but not limited to Polycarbonate, Acrylonitrile Butadiene Styrene (ABS), Polyurethane, Silicones, High Density Polyethylene (HDPE), Low Density Polyethylene (LDPE), Polyesters etc. In an exemplary embodiment, the plates 105c are made of Acrylonitrile Butadiene Styrene (ABS). In an alternate embodiment, the plates 105c are made of polycarbonate. The plates 105c of the baffle 105 have a pre-defined shape including but not limited to circular, semi-circular, quadrilateral, spiral, helical, etc. The plates 105c are disposed inside the baffle body 105d either discretely or as an integral structure. The plates 105c at least partially extend helically between the first-flow end 105a and the second-flow end 105b of the baffle 105. In an exemplary embodiment, as shown in Fig 1, the plates 105c forms an integral structure in a helix configuration. The baffle 105 helps to maintain a laminar flow of the tissue fluids thereby avoiding inconsistent flow, turbulence, irregular fluctuation, etc. in the fluid flow.
[36] Fig. 1a depicts a partial view of the plates 105c. The plates 105c have a diameter ‘d’ ranging from 5 mm to 30 mm. The plates 105c have a pitch ‘p’ ranging from 2.5 mm to 15 mm (based on their diameter ‘d’ of the plates 105c). In an exemplary embodiment, the pitch ‘p’ of the plates 105c is half of the diameter ‘d’ of the plates 105c. In an exemplary embodiment, the diameter ‘d’ and the pitch ‘p’ of the plates 105c is 20mm and 10mm respectively. The said relation between the diameter ‘d’ and pitch ‘p’ of the plates 105c maintains the laminar flow of tissue fluid even when the system of the present invention is used in a vertical or inclined orientation (with respect to the gravity plane).
[37] The plates 105c (and the baffle 105) define a lumen 105c1 passing through a center of the plates 105c. The lumen 105c1 has a diameter ‘l’ ranging from 1 mm to 15 mm. In an exemplary embodiment, the diameter ‘l’ of the lumen 105c1 is 4mm. The lumen 105c1 couples the first-flow end 105a to the second-flow end 105b. The plates 105c define an axis ‘x-x’ passing axially through a center of the lumen 105c1 of the plates 105c. In an exemplary embodiment, as shown in Fig. 1a, the plates 105c are helically arranged along the axis ‘x-x’. In an exemplary embodiment, an initial radius of the helix of the plates (105c) is constant throughout the axis (‘x-x’) of the lumen (105c1), thus aiding in laminar flow of tissue fluids.
[38] Further, as shown in Fig. 1a, the plates 105c defines two angles with respect to the axis ‘x-x’. First, the plates 105c define a first angle ‘?1’ between a tangent ‘t’ of the plate 105c and the axis ‘x-x’. Second, the plates 105c defines a second angle ‘?2’ between the tangent ‘t’ of the plate 105c and an imaginary line ‘i’ that is perpendicular to the axis ‘x-x’. The sum of the first angle ‘?1’ and the second angle ‘?2’ amounts to 90°.
[39] The first angle ?1 includes a pre-determined relation between the pitch ‘p’ of the plates 105c and the diameter ‘l’ of the lumen 105c1. In an exemplary embodiment, pitch ‘p’ times tangent of first angle ?1 equals to the circumference of the lumen 105c1. The said relation between the first angle ?1 and the pitch ‘p’ of the plates 105c helps the baffle 105 to ensure laminar flow of the tissue fluid, thereby preserving energy of the system and maintaining integrity of the surgical site 1.
[40] The valve 107 is disposed within the handle 101. The valve 107 includes at least two ports. In an exemplary embodiment, as shown in Fig. 1, the valve 107 includes a first port 107a, a second port 107b and a third port 107c. The first port 107a of the valve 107 is fluidically coupled to the first-flow end 105a of the baffle 105. In an exemplary embodiment, the first port 107a of the valve 107 is coupled to the first-flow end 105a of the baffle 105 via adhesive bonding. Other functionally equivalent means to couple the valve 107 to the baffle 105 is within the scope of the teachings of the present invention.
[41] The second port 107b of the valve 107 is coupled to an external device (not shown). The external device includes without limitation a vacuum generation source, a saline injector, etc. as required.
[42] The third port 107c of the valve 107 is configured to receive one of the stylet 200 or the ablation electrode 300 depending upon user requirements. In an exemplary embodiment, as shown in Fig. 2, the second port 107b of the valve 107 is coupled to the vacuum generation source when the stylet 200 is inserted within the adapter 100 via the third port 107c of the valve 107 (described below). In another exemplary embodiment, as shown in Fig. 3, the second port 107b of the valve 107 is coupled to the saline injector when the ablation electrode 300 is inserted within the adapter 100 via the third port 107c of the valve 107.
[43] Additionally or optionally, the valve 107 is coupled to a rubber bush (not shown) for preventing fluid flow/leak through the third port 107c of the adapter 100 when the stylet 200 or the ablation electrode 300 is inserted within the adapter 100. In an exemplary embodiment, the rubber bush is fixedly disposed within the third port 107c of the valve 107. In an alternate embodiment, the rubber bush is removably disposed within the third port 107c of the valve 107. The rubber bush has a self-sealing property which helps the rubber bush to seal the third port 107c when the stylet 200 or the ablation electrode 300 is withdrawn from the adapter 100.
[44] The adapter 100 defines a fluid pathway from the second end 103c of the cannula 103 to the second port 107b and/or the third port 107c of the valve 107. For example, as shown in Fig. 1, the fluid pathway originates from the second end 103c of the cannula 103, passes through the lumen 103a of the cannula 103, passes through the lumen 105c1 of the baffle 105 via the first-flow and second-flow ends 105a, 105b, enters the valve 107 via the first port 107a and ends at the second and/or third port 107b, 107c.
[45] Fig. 2 depicts the adapter 100 (as shown in Fig. 1) operationally coupled with the stylet 200. The stylet 200 has a proximal end 200a and a distal end 200b. The stylet 200 includes without limitation a stem 201 and a handle 203. The handle 203 of the stylet 200 is disposed at the proximal end 200a. The handle 203 is used to interact with the stylet 200. The handle 203 is made of a material including but not limited to Polyvinyl chloride (PVC), ABS (Acrylonitrile Butadiene Styrene), Bakelite, High Density Polyethylene (HDPE) etc. In an exemplary embodiment, the handle 203 is made of Acrylonitrile Butadiene Styrene (ABS).
[46] The stem 201 of the stylet 200 extends away from the handle 203 and towards the distal end 200b of the stylet 200. The stem 201 is removably coupled to the handle 203. Alternatively, the stem 201 and the handle 203 forms an integral structure. The stem 201 is made of a material including but not limited to stainless steel, Nitinol, Gold, Platinum, Silver, etc. In an exemplary embodiment, the stem 201 of the stylet 200 is made of stainless steel. The stem 201 has a length ranging from 100 mm to 300 mm. In an exemplary embodiment, the length of the stem 201 is 255 mm. In an exemplary embodiment, the stem 201 has a needle-like shape. The stem 201 is used to puncture the cancerous tissue 1a and/or the dermal tissue 1b.
[47] In the first configuration of the adapter 100, as shown in Fig. 2, the stem 201 of the stylet 200 is inserted within the third port 107c of the valve 107 such that the distal end 200b of the stylet 200 exits the second end 103c of the cannula 103. The stem 201 of the stylet 200 passes across the fluid pathway of the adapter 100. Further, the vacuum generator source is coupled to the second port 107b of the valve 107.
[48] In the first configuration of the adapter 100, the adapter 100 along with the stylet 200 is used to first puncture the dermal tissue 1b and the cancerous tissue 1a. Thereafter, the vacuum source generator is turned on to aspirate (or drain) the surgical site 1 of any tissue fluids. As shown in Fig. 2, depicted via consecutive arrows, the tissue fluid is evacuated through the fluid pathway of the adapter 100 and towards the second port 107b of the valve 107. The stylet 200 further helps to make room for the ablation electrode 300 at the surgical site 1 (as shown in Figs. 3 and 3a).
[49] Alternatively, the adapter 100 alone (without the stylet 200) is used to puncture the dermal tissue 1b and the cancerous tissue 1a.
[50] Figs. 3 and 3a depicts the adapter 100 (as shown in Fig. 1) operationally coupled with the ablation electrode 300. The ablation electrode 300 has a proximal end 300a and a distal end 300b. The ablation electrode 300 includes a plurality of components including but not limited to a handle 301, a switch 303, a tube 305, an electrode 307 and a plurality of tines 309.
[51] The handle 301 of the ablation electrode 300 is disposed at the proximal end 300a. The handle 301 is used to interact with the ablation electrode 300. The handle 301 is made of a material including but not limited to Polyvinyl Chloride (PVC), Acrylonitrile Butadiene Styrene (ABS), Bakelite, High Density Polyethylene (HDPE), etc. In an exemplary embodiment, the handle 301 is made of Acrylonitrile Butadiene Styrene (ABS). In an alternate embodiment, the handle 301 is made of polycarbonate.
[52] The handle 301 is provided with a slot 301a. The slot 301a is configured to at least partially receive the switch 303. In an exemplary embodiment, the switch 303 is configured to slide within the slot 301a of the handle 301. The switch 303 is made of a material including but not limited to Acrylonitrile Butadiene Styrene (ABS), etc. The switch 303 is partially disposed inside the handle 301 and partially outside the handle 301 to enable the user to actuate the tube 305 from outside the handle 301 (described below).
[53] The handle 301 is provided with a lumen 301b. The lumen 301b is configured to partially receive the tube 305 and the electrode 307. The lumen 301b of the handle 301 extends from a first end 301c to a second end 301d of the handle 301.
[54] In an exemplary embodiment, as shown in Fig. 3a, the tube 305 extends from the switch 303 towards and out of the second end 301d of the handle 301. The tube 305 is coupled to the switch 303 such that the tube 305 mimics the axial motion of the switch 303 in the slot 301a of the handle 301. The switch 303 along with the tube 305 helps to control a degree of expansion of the tines 309 (described below).
[55] The tube 305 is made of a material including but not limited to medical grade Stainless Steel, Nitinol, Platinum, Gold, Silver, etc. In an exemplary embodiment, the tube 305 is made of Stainless Steel. The tube 305 has a length ranging from 100 mm to 300 mm. The tube 305 has a diameter ranging from 0.5 mm to 10 mm. In an exemplary embodiment, the length and diameter of the tube 305 is 250mm and 4mm respectively.
[56] In an exemplary embodiment, the electrode 307 extends across the lumen 301b of the handle 301. The electrode 307 is at least partially disposed within the tube 305 such that the tube 305 is configured to slide over the electrode 307. The electrode 307 is made of a material including but not limited to shape memory nitinol, etc. In an exemplary embodiment, the electrode 307 is made of nitinol. The electrode 307 helps to connect a radio wave and/or a microwave generator to the tines 309.
[57] The tines 309 are disposed at the distal end 300b of the ablation electrode 300. The tines 309 have an expanded state (as shown in Fig. 3a) and a collapsed state (not shown). In the collapsed state, the tines 309 are disposed within tube 305. The switch 303 is actuated to slide the tube 305 over the electrode 307 thereby releasing the tines 309 from within the tube 305. The tines 309 are configured to self-expand once the tines 309 are at least partially released from within the tube 305.
[58] The tines 309 have a length ranging from 1 mm to 70 mm. In an exemplary embodiment, the length of the tines 309 is 30 mm. The degree of expansion of the tines 309 depends upon a length of the tines 309 that is released from the within the tube 305.
[59] In the expanded state, the tines 309 make a pre-defined pattern. In an exemplary embodiment, as shown in Fig. 3a, the tines 309 make an umbrella-like pattern.
[60] The tines 309 are made of a self-expandable material including but not limited to shape memory nitinol, etc. The tines 309 emits radio waves and/or microwaves to ablate the cancerous tissue 1a. The radio waves have a frequency ranging from 350 kHz to 500 kHz. The microwaves have a frequency ranging from 900 MHz to 2500 MHz.
[61] Additionally or optionally, at least one sensor (not shown) is provided at the distal end 300b of the ablation electrode 300. In an exemplary embodiment, a thermocouple sensor is provided at the distal end 300b of the ablation electrode 300. The sensor pierces the cancerous tissue 1a. The sensor helps the user to monitor the temperature of the surgical site 1 thereby enabling the user to accordingly control the intensity of radio waves and/or microwaves emitted to ablate the cancerous tissue 1a.
[62] In the second configuration of the adapter 100, as shown in Fig. 3, the tube 305 of the ablation electrode 300 is inserted within the third port 107c of the valve 107 such that the distal end 300b of the ablation electrode 300 exits the second end 103c of the cannula 103. The tube 305 of the ablation electrode 300 passes across the fluid pathway of the adapter 100. Further, the saline injector is coupled to the second port 107b of the valve 107 and the radio wave/microwave generator is coupled to the electrode 307.
[63] In the second configuration of the adapter 100, the tines 309 of the ablation electrode 300 are released from the tube 305 (by retracting the tube 305 using the switch 303) to ablate the cancerous tissue 1a. The saline injector is coupled to the second port 107b of the valve 107. The saline injector pumps saline (or other solution) to the surgical site 1 via the fluid pathway of the adapter 100. The saline maintains moisture percentage, conductivity and cooling at the surgical site 1 during ablation of the cancerous tissue 1a. Further, the baffle 105 of the adapter 100 ensures laminar flow of the saline towards the surgical site 1.
[64] In the first configuration of the adapter 100, the second port 107b of the valve 107 is configured to evacuate tissue fluid from the surgical site 1. And, in the second configuration of the adapter 100, the second port 107b of the valve 107 is configured to supply saline to the surgical site 1. Thus, the adapter 100 of the present invention is self-sufficient in evacuating tissue fluid as well as supplying saline without requiring additional devices/probes.
[65] Fig. 4 depicts an exemplary method 400 to prepare and ablate a tumor using the system of the present invention. Additionally or optionally, the surgical site 1 is imaged by medical imaging tools to locate the cancerous tissue 1a under the dermal tissue 1b before commencing the method 400.
[66] The method 400 commences at step 401, by advancing the adapter 100 (without the stylet 200 and the ablation electrode 300) towards the surgical site 1 thereby puncturing the dermal tissue 1b and the cancerous tissue 1a using the cannula 103 of the adapter 100.
[67] At step 403, the stylet 200 is inserted within the adapter 100 to obtain the first configuration of the adapter 100. The stylet 200 pierces the cancerous tissue 1a at the surgical site 1 to make room for the ablation electrode 300.
[68] At step 405, the vacuum generation source is coupled to the valve 107 of the adapter 100 and turned on to aspirate the tissue fluid from the surgical site 1. In an exemplary embodiment, the tissue fluid evacuates the surgical site 1 by following a laminar flow through the fluid pathway of the adapter 100. The plurality of plates 105c inside the baffle body 105d of the adapter 100 ensures the laminar flow of the tissue fluid and prevents any back flow. Further, the pitch ‘p’ of the plates 105c is half of the diameter ‘d’ of the plates 105c which ensures the laminar flow of the tissue fluid even when the system of the present invention is used in a vertical or inclined orientation (with respect to the gravity plane).
[69] At step 407, the vacuum generation source is turned off and the stylet 200 is withdrawn from the adapter 100 thereby leaving the adapter 100 at the surgical site 1. In an exemplary embodiment, the baffle 105 prevents any back flow of fluids to the surgical site 1 through the adapter 100 once the vacuum generation source is turned off. In yet another exemplary embodiment, the rubber bush disposed at the third port 107c of the valve 107 prevents any fluid leak out of the adapter 100 when the stylet 200 is withdrawn from the adapter 100.
[70] At step 409, the ablation electrode 300 is inserted within the adapter 100 thereby obtaining the second configuration of the adapter 100.
[71] At step 411, the switch 303 of the ablation electrode 300 is axially retracted in the slot 301a of the handle 301 to release the tines 309 from within the tube 305.
[72] In an exemplary embodiment, only a pre-determined length of the tines 309 is released from the tube 305 depending on a diameter (or size) of the cancerous tissue 1a. The pre-determined length of the tines 309 released from the tube 305 is controlled by an amount of sliding motion of the switch 303 within the slot 301a of the handle 301.
[73] At step 413, the saline injector is coupled to the valve 107 of the adapter 100 and turned on to provide a steady flow of saline at the surgical site 1, as required. The saline maintains moisture percentage, conductivity and cooling at the surgical site 1 during ablation of the cancerous tissue 1a. Further, the plates 105c inside the baffle body 105d of the adapter 100 ensure laminar flow of the saline towards the surgical site 1. The adapter 100 of the present invention is self-sufficient in evacuating tissue fluid as well as supplying saline without requiring additional devices/probes.
[74] At step 415, the radio wave and/or microwave generator coupled to the electrode 307 of the ablation electrode 300 is turned on to ablate the cancerous tissue 1a. The radio waves have a frequency ranging from 350 kHz to 500 kHz. The microwaves have a frequency ranging from 900 MHz to 2500 MHz.
[75] During ablation, the intensity of the radio waves and the microwaves are controlled with respect to the temperature of the surgical site 1 as reported by the sensor provided at the distal end 300b of the ablation electrode 300.
[76] At step 417, the ablation electrode 300 along with the adapter 100 is withdrawn from the surgical site 1.
[77] The present invention will now be explained via the following examples.
[78] Example 1 (Prior art): An incision was made at a surgical site to ablate cancerous tissue. The tissue fluid was aspirated out by applying a vacuum source at the surgical site. The vacuum source led to turbulent and inconsistent flow of the tissue fluid causing the temperature of the surgical site to rise. Further, upon removal of the vacuum source, some of the tissue fluid flowed back to the surgical site. The rise in temperature of the surgical site along with presence of residual tissue fluid at the surgical site made the surgical site unfit for ablation using the ablation electrode. The procedure was terminated prematurely without ablating the cancerous tissue.
[79] Example 2 (Present invention): The adapter 100 (without the stylet 200 or the ablation electrode 300) was advanced towards the surgical site 1 thereby puncturing the dermal tissue 1b and the cancerous tissue 1a. The stylet 200 was inserted within the adapter 100 to further pierce the cancerous tissue 1a, thereby making room for the ablation electrode 300. The vacuum generation source was coupled to the valve 107 of the adapter 100 and was turned on to aspirate the tissue fluid from the surgical site 1. The baffle 105 of the adapter 100 ensured laminar flow of the tissue fluid (even when the adapter 100 was inclined and oriented vertically with respect to the gravity plane) and prevented any back flow. The baffle 105 further prevented back flow of the tissue fluid to the surgical site 1 while the vacuum generation source was disengaged from the adapter 100. The stylet 200 was withdrawn from the adapter 100 thereby leaving the adapter 100 at the surgical site 1.
[80] Thereafter, the ablation electrode 300 was inserted within the adapter 100. The switch 303 of the ablation electrode 300 was axially retracted in the slot 301a of the handle 301 to release the tines 309 from within the tube 305. The saline injector was coupled to the adapter 100 and turned on to provide a steady flow of saline at the surgical site 1. The radio wave generator coupled to the electrode 307 of the ablation electrode 300 was turned on to ablate the cancerous tissue 1a. The ablation electrode 300 along with the adapter 100 was withdrawn from the surgical site 1.
[81] During the entire procedure, very minimal amount of blood was lost thus preventing unwarranted trauma to the patient. Further, the temperature of the surgical site 1 was carefully monitored during the procedure thus protecting the healthy surrounding tissues.
[82] Further, the physician easily carried out the entire procedure using the same adapter 100 for aspirating tissue fluid from the surgical site 1 as well as delivering saline at the surgical site 1.
[83] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. , Claims:WE CLAIM
1. An adapter (100) comprising:
a handle (101);
a cannula (103) partially disposed within the handle (101) and extending from a first end (103b) to a second end (103c) defining a lumen (103a), wherein the second end (103c) of the cannula (103) is configured to puncture and penetrate a surgical site (1);
at least one baffle (105) disposed within the handle (101) and extending from a first first-flow end (105a) to a second flow-end (105b) defining a lumen (105c1), the second-flow end (105b) of the baffle (105) is coupled to the first end (103b) of the cannula (103), wherein a plurality of plates (105c) helically extends along an axis (x-x) of the lumen (105c1) within a baffle body (105d) between the first-flow end (105a) and the second-flow end (105b);
at least one valve (107) disposed within the handle (101), including at least a first port (107a) and a second port (107b), the first port (107a) coupled to the first-flow end (105a) of the baffle (105), the second port (107b) being coupled to at least one of a vacuum generation source or a saline injector;
wherein, the lumen (103a) of the cannula (103), the lumen (105c1) of the baffle (105), the first port (107a) and the second port (107b) of the valve (107) define a fluid pathway configured to at least:
facilitate aspiration of tissue fluid from the surgical site (1) when the second port (107b) is coupled to the vacuum generation source, or
facilitate flow of saline to the surgical site (1) when the second port (107b) is coupled to the saline injector.
2. The adapter (100) as claimed in claim 1, wherein a pitch ‘p’ of the plates (105c) is half of a diameter ‘d’ of the plates (105c).
3. The adapter (100) as claimed in claim 2, wherein the diameter ‘d’ of the plates (105c) ranges from 5 mm to 30 mm.
4. The adapter (100) as claimed in claim 2, wherein the pitch ‘p’ of the plates (105c) ranges from 2.5 mm to 15 mm.
5. The adapter (100) as claimed in claim 1, wherein a diameter ‘l’ of the lumen (105c1) of the baffle (105) ranges from 1 mm to 15 mm.
6. The adapter (100) as claimed in claim 1, wherein the valve (107) includes a third port (107c) configured to receive at least one of a stylet (200) or an ablation electrode (300).
7. The adapter (100) as claimed in claim 6, wherein the stylet (200) includes:
a proximal end (200a) and a distal end (200b);
a handle (203) disposed at the proximal end (200a); and
a stem (201) extending away from the handle (203) towards the distal end (200b).
8. The adapter (100) as claimed in claim 6, wherein the ablation electrode (300) includes:
a proximal end (300a) and a distal end (300b);
a handle (301) disposed at the proximal end (300a), including a slot (301a) and a lumen (301b), the slot (301a) is configured to at least partially receive a switch (303) configured to slide within the slot (301a);
a tube (305) at least partially disposed within the lumen (301b) of the handle (301), coupled to the switch (303);
an electrode (307) extending across the lumen (301b) of the handle (301) and at least partially disposed within the tube (305); and
a plurality of tines (309) disposed at the distal end (300b), coupled to the electrode (307);
wherein, the switch (303) is configured to slide the tube (305) to release the plurality of tines (309) from within the tube (305).
9. The adapter (100) as claimed in claim 8, wherein the tines (309) are configured to self-expand once the tines (309) are at least partially released from within the tube (305).
10. The adapter (100) as claimed in claim 8, wherein the tines (309) emit radio waves having frequency ranging from 350 kHz to 500 kHz.
11. The adapter (100) as claimed in claim 8, wherein the tines (309) emit microwaves having frequency ranging from 900 MHz to 2500 MHz.
12. The adapter (100) as claimed in claim 8, wherein at least one thermocouple sensor is provided at the distal end (300b) of the ablation electrode (300).
13. The adapter (100) as claimed in claim 1, wherein a third port (107c) the valve (107) is coupled to a rubber bush.
14. The adapter (100) as claimed in claim 1, wherein an initial radius of the helix of the plates (105c) is constant throughout the axis (x-x) of the lumen (105c1).