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:
CONTROLLED RECEPTACLE DELIVERY SYSTEM
2. APPLICANT:
Meril Corporation (I) Private Limited, an Indian company of the address Survey No. 135/139, Muktanand Marg, Bilakhia House, Pardi, Vapi, Valsad-396191 Gujarat, India.

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

 
FIELD OF INVENTION
[001] The present disclosure relates to an instrument. More particularly, the present disclosure relates to a retrieval instrument used in a surgery.
BACKGROUND OF INVENTION
[002] Laparoscopy is a surgical approach which is minimally invasive for diagnosis and treatment of the organs preferably, in the abdomen and pelvis. The approach may require a small incision in the target area to host an imaging instrument and/or a specialized surgical instrument. The imaging instrument such as a laparoscope or a camera provides internal diagnostic information and assists the expert during the surgical procedure. A surgical instrument is inserted into the target area for incision and removal of the affected tissue/organ. The tissue/organ removed during a laparoscopic surgery, may include a gall bladder, appendix, ovaries or fallopian tubes, uterus, hernias, part of the intestine, spleen, cysts or tumors, etc.
[003] One of the specialized surgical instruments used in a laparoscopic surgery for removal of the affected tissue, is a retrieval pouch system. The specialized retrieval pouch system assists in removal of a severed tissue/organ by providing a safe passage, reducing damage to nearby tissues.
[004] A retrieval pouch system includes a pouch which may be expanded or released to capture the severed tissue/organ. The pouch is released once the pouch is in proximity to the severed tissue/organ inside the body. Conventional retrieval pouch systems face issues like improper expansion of the pouch during release of the pouch to capture the severed tissue/organ, damaging the pouch itself. Other major issue faced by the retrieval pouch systems is the uncalibrated deployment of the pouch. The uncalibrated deployment of the system causes inconsistent deployment of the pouch which may lead to various complications such as hernia, infections, improper removal, surgical errors, etc. These complications can further lead to additional medical interventions, increased healthcare costs, and emotional distress for patients, further underscoring the need for more effective solutions.
[005] Therefore, there arises a need for a pouch retrieval system which can overcome the problems associated with the conventional instruments.
SUMMARY OF THE INVENTION
[006] 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.
[007] The present disclosure relates to a medical instrument. The instrument is inserted inside the body via an incision. In an embodiment, the instrument includes a conduit having a pathway, and an inner rod. The inner rod is configured to reside inside the pathway, and defines at least two tracks. Each track includes an upper set of teeth and a lower set of teeth placed axially adjacent to the upper set of teeth. The instrument further includes at least two clamps operationally engaged with respective track of the inner rod, an actuator operationally actuates the at least two clamps, and a medical accessory coupled to a distal end of the inner rod, the medical accessory resides inside the pathway in an undeployed state of the medical accessory. The clamps operationally engage with at least one of the upper set of teeth or the lower set of teeth to allow the movement of the medical accessory in a predefined direction, in a controlled manner.
[008]
BRIEF DESCRIPTION OF THE DRAWINGS
[009] The summary above and the detailed description of descriptive embodiments, is better understood when read in conjunction with the apportioned drawings. For illustration of 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.
[0010] Fig. 1a depicts an isometric view of a medical instrument 100 in an undeployed state, according to an embodiment of the present disclosure.
[0011] Fig. 1b depicts an isometric view of the medical instrument 100 in a deployed state, according to an embodiment of the present disclosure.
[0012] Fig. 2 depicts an exploded view of the medical instrument 100, according to an embodiment of the present disclosure.
[0013] Fig. 3. depicts an isometric view of a conduit 110, according to an embodiment of the present disclosure.
[0014] Figs. 4a-4d depict perspective views of an inner rod 130, according to an embodiment of the present disclosure.
[0015] Fig. 5 depicts a clamp 154, according to an embodiment of the present disclosure.
[0016] Fig. 6 depicts a lever 150, according to an embodiment of the present disclosure.
[0017] Fig. 6a depicts a first member 150a of the lever 150, according to an embodiment of the present disclosure.
[0018] Fig. 6b depicts a second member 150b of the lever 150, according to an embodiment of the present disclosure.
[0019] Fig. 6c depicts the coupling between the clamp 154 and the second member 150b, according to an embodiment of the present disclosure.
[0020] Fig. 7a depicts an exploded view of the actuator 170, according to an embodiment of the present disclosure.
[0021] Fig. 7b depicts the actuator 170 mounted on the inner rod 130, according to an embodiment of the present disclosure.
[0022] Figs. 8a-8b depict a handle 190, according to an embodiment of the present disclosure.
[0023] Fig. 9a depicts the frame 210 coupled to the inner rod 130, according to an embodiment of the present disclosure.
[0024] Fig. 9b depicts the frame 210 with the receptacle 200 coupled to the inner rod 130, according to an embodiment of the present disclosure.
[0025] Fig. 9c depicts the receptacle 200, according to an embodiment of the present disclosure.
[0026] Fig. 9d depicts a frame 210 of the receptacle 200, according to an embodiment of the present disclosure.
[0027] Fig. 10 depicts a flowchart of an exemplary method 1000 of operating the medical instrument 100, according to an embodiment of the present disclosure.
[0028] Figs. 11 depicts a perspective view of the medical instrument 100 during a resection procedure, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE DRAWINGS
[0029] Prior to describing the disclosure 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.
[0030] 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.
[0031] 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.
[0032] 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.
[0033] A medical accessory is a device or component designed to perform a specific function in a medical procedure. The accessory may include, such as, without limitation, a tissue collector, blades, forceps, graspers, or other functional components designed to assist in medical interventions.
[0034] The present disclosure relates to a medical instrument. Whie the present disclosure relates to a medical instrument for deploying an accessory used in tissue collection, it is not limited to this application. The disclosed medical instrument may also be adapted for deploying other medical accessories, including but not limited to, blades, forceps, graspers, etc., and the same are within the scope of the present disclosure.
[0035] In an embodiment, the medical instrument is an assembly of components including, without limitation, one or more guided tracks, an inner rod, a clamp, an actuator, etc. The inner rod features the one or more guided tracks with each track including plural sets of teeth. The plural sets of teeth include an upper set of teeth and a lower set of teeth. The plural sets of teeth are provided on a partial portion of the inner rod. The plural sets of teeth help in controlled linear movement of the medical accessory both in proximal and distal directions.
[0036] The clamps engage with the lower set of teeth and the upper set of teeth to allow controlled and restricted movement of the inner rod in one of the proximal or distal direction. The clamps engage with one set of teeth at a time allowing the movement of the inner rod in only one direction. This engagement of the clamps with the upper set of teeth or the lower set of teeth, prevents accidental movement of the inner rod say, retraction/movement until desired.
[0037] The clamps are kept under tension by the actuator ensuring that the inner rod is securely locked in place once the medical accessory is deployed. In other words, the actuator locks the movement of the inner rod in one direction either proximal or distal. The actuator is configured to change the direction of motion of the inner rod. The actuator includes an actuation mechanism which switches the engagement of the clamp from the upper set of teeth to the lower set of teeth or as required. This in turn allows the inner rod to move in a different direction then the previous one.
[0038] The actuator enables controlled and restricted movement of the inner rod, ensuring that the medical accessory is deployed and retracted with high precision. Premature deployment is eliminated due to the engagement of the upper set of teeth and the lower set of teeth with the clamp. Further, to deploy or retract the medical accessory, a certain amount of force is required to be exerted for proximal or distal movement of the inner rod which ensures regulated and restricted movement of the inner rod in the proximal or distal direction. This allows for fine adjustments to the deployment of the medical accessory, giving the operator the ability to deploy the medical accessory in a gradual and controlled manner while handling delicate tissue with ease.
[0039] By preventing trauma to internal organs, reducing pressure on the abdominal wall, and ensuring proper pouch placement, the medical instrument significantly lowers the risk of complications such as organ damage, hernia formation, and infection. In addition, the medical instrument eliminates the need for additional instruments (e.g., forceps or graspers) to manually adjust or open the medical accessory, streamlining the procedure and reducing overall surgery time.
[0040] The medical instrument with a medical accessory for collecting a severed specimen such as a tissue or an organ, during the surgery. The instrument here is explained by taking an example of a laparoscopic medical procedure, however the instrument can be used in other application areas such as but not limited to open surgeries [open cholecystectomy (gallbladder removal), open appendectomy, open colorectal surgery], gynecologic surgeries [hysterectomy (Open or Vaginal), myomectomy (Open)], thoracic surgery [e.g., lobectomy], urologic surgeries [open nephrectomy (kidney removal), open prostatectomy].
[0041] Now referring to the figures, Figs. 1a and 1b depict isometric views while Fig. 2 depicts an exploded view of a medical instrument 100 (hereinafter, instrument 100). The instrument 100 is meant for deploying a medical accessory at a target site, for example, a receptacle 200 for retrieving a severed tissue or organ from a target site during a surgical procedure. The instrument 100 has a proximal end 100a and a distal end 100b. In an embodiment, the instrument 100 includes a conduit 110, an inner rod 130, a lever 150, an actuator 170, and a handle 190. In the depicted embodiment, the medical accessory is a receptacle 200. The instrument 100 is configured to deploy the receptable 200 from an undeployed state to a deployed state to secure a severed specimen (such as, a cut tissue or organ) during the medical procedure.
[0042] Fig. 1a depicts the instrument 100 in an undeployed state. In the undeployed state, the receptacle 200 is concealed inside the instrument 100. In an embodiment, the instrument 100, in the undeployed state, is placed in the required environment for specimen collection. Once placed at the target site, the instrument is deployed from the undeployed state wherein the receptacle 200 is released from the instrument 100 as depicted in Fig. 1b. In the deployed state, the receptacle 200 attains a pre-defined shape and is configured to collect or receive the severed specimen.
[0043] Fig. 3 depicts the conduit 110 of the instrument 100, according to an embodiment of the present disclosure. The conduit 110 has an elongated, tubular structure. The conduit 110 has a proximal end 110a and a distal end 110b. The conduit 110 is hollow from inside, thus defining at least one a lumen/pathway 113 extending through an entire length of the conduit 110. The lumen 113 is configured to facilitate passage for movement of at least one component of the instrument 100 such as the inner rod 130. The conduit 110 may include a uniform or tapered pathway 113. In an embodiment, the conduit 110 has a smooth outer surface to ensure minimal trauma to the body lumen in which the instrument 100 is to be inserted. The conduit 110 is located distally from a medical practitioner using the instrument 100.
[0044] The conduit 110 is coupled to the lever 150 at the proximal end 110a of the conduit 110. The conduit 110 may be fixedly coupled to the lever 150 using a coupling technique such as, but not limited to, bonding, slot fit, snap fit, press fit, etc. In an embodiment, the conduit 110 is coupled to the lever 150 via a slot fit coupling mechanism. In an embodiment, the conduit 110 includes a slot 111 towards the proximal end 110a of the conduit 110. The slot 111 is configured to receive at least a component of the lever 150 for coupling (explained in detail below).
[0045] The conduit 110 may be made from a material, such as, but not limited to, polycarbonate (PC), polyvinyl chloride (PVC), acrylonitrile butadiene styrene (ABS) etc. In an embodiment, the conduit 110 is made from polycarbonate (PC). The conduit 110 may have a length, an outer diameter and an inner diameter. The length of the conduit 110 may vary depending upon the location of target site. The outer diameter of the conduit 110 depends upon size of a trocar (an instrument used to create pathway for the conduit 110 to reach the target site in such surgeries). The inner diameter of the conduit 110 depends upon an outer diameter of the inner rod 130. The outer diameter of the conduit 110 ranges from 10 mm to 12 mm and the length of the conduit 110 ranges from 200 mm to 350 mm. In an exemplary implementation, the outer diameter and the length of the conduit 110 are 10 mm and 300 mm, respectively. The inner diameter of the conduit 110 may be chosen to be greater than an outer diameter of the inner rod 130.
[0046] Now referring to Fig. 4a, which depicts the inner rod 130. The inner rod 130 is configured to slidably reside inside the pathway 113 of the conduit 110. The inner rod 130 has a proximal end 130a and a distal end 130b. The inner rod 130 may be made from a material, such as, but not limited to polycarbonate (PC), acrylonitrile butadiene styrene (ABS) etc. In an embodiment, the inner rod 130 is made from polycarbonate (PC). In an embodiment, the inner rod 130 is cylindrical. It is to be noted that the inner rod 130 may have any other shape, such as, without limitation, cube, cuboidal, polygonal prism, etc. The shape of the inner rod 130 generally corresponds to the shape of the conduit 110 and selected accordingly.
[0047] The inner rod 130 may feature a solid interior with no lumen. Alternately, the inner rod 130 may feature a hollow interior defining at least one lumen. In an embodiment, the inner rod 130 has a solid interior. The inner rod 130 includes a first slot 131 and a second slot 132 towards the proximal end 130a. The first slot 131 is configured to couple the inner rod 130 to the handle 190 using a coupling technique, such as, but not limited to, slot-fit, snap-fit, press-fit, clearance fit, taper-fit, etc. In an embodiment, the proximal end 130a of the inner rod 130 is slot fitted to the handle 190 via the first slot 131. The second slot 132 is configured to receive a surface of the lever 150. In an embodiment, the inner rod 130 includes a stopper 133. The stopper 133 is configured to restrict the proximal and/or distal movement of the inner rod 130 inside the conduit 110. A surface of the lever 150 engages with the surface of the stopper 133. The stopper 133 is configured to restrict movement of the conduit 110 towards the distal end 110b. When the stopper 133 engages with the lever 150, the stopper 133 acts as an indicator to the operator that the medical accessory (e.g., receptacle 200) is deployed from the conduit 110. Together, the second slot 132 and the stopper 133 are configured to restrict the motion of the lever 150 beyond the stopper 133 and prevent its slippage.
[0048] Moving on, the inner rod 130 defines at least two tracks. Specifically, at least one side of the inner rod 130 includes at least one track 138 extending across at least a portion of the length of the inner rod 130. In an embodiment, at least two tracks (138a, 138b) are provided, each diametrically opposite to the other, on the inner rod 130. Each track 138 defines a smooth surface for attaching at least two sets of a plurality of teeth. In other embodiments, the number and placement of the tracks 138 may vary basis factors such as diameter and length of the inner rod 130 and the conduit 110.
[0049] The track 138 may include a uniform, flared or tapered profile. The track 138 may be etched, or engraved on the surface of the inner rod 130 or, the track 138 may be a standalone structure coupled to the inner rod 130 using any suitable technique.
[0050] The two sets of the plurality of teeth include an upper set of teeth 135 and a lower set of teeth 136 (Figs. 4b and 4c). In an embodiment, the upper set of teeth 135 are coupled to the respective track 138 (i.e. 138a or 138b) using a coupling mechanism such as, but not limited to bonding, soldering, clamping, heat sealing, etc. In an embodiment, the upper set of teeth 135 are bonded to the respective track 138. In alternate embodiments, the upper set of teeth 135 are carved on the surface of the inner rod 130 directly using any technique such as, but not limited to, machining, engraving, etching, etc.
[0051] The upper set of teeth 135 and the lower set of teeth 136 are one of bonded or machined till a predefined length to at least one surface of the inner rod 130. The upper set of teeth 135 extend up to at least a portion of the length and the width of the track 138 (i.e. 138a or 138b) of the inner rod 130. For example, width is determined based on an inner diameter of the conduit while the length is defined based on the length at which the receptable 200 is to be deployed. For example, the upper set of teeth 135 extend up to 50-60% of the length of the track 138 (i.e. 138a or 138b) of the inner rod 130. In an embodiment, the length of the upper set of teeth is 145 mm and width is 8 mm. The upper set of teeth 135 control the proximal and/or distal movement of the inner rod 130 in at least one pre-direction. In an embodiment, the upper set of teeth 135 control the distal movement of the inner rod 130 i.e. towards the distal end 100b of the instrument 100. In other words, the upper set of teeth 135 is configured to control a distal motion of the medical accessory (which has been explained later).
[0052] The lower set of teeth 136 is provided axially adjacent to the upper set of teeth 135 on the respective tracks 138 (138a or 138b) of the inner rod 130. In an embodiment, the lower set of teeth 136 are coupled to the respective tracks 138 using a coupling mechanism such as, but not limited to bonding, soldering, clamping, heat sealing, etc. In an embodiment, the lower set of teeth 136 are bonded to the track 138. In an alternate embodiment, the lower set of teeth 136 are carved or machined on the surface of the respective track 138 adjacent to the upper set of teeth 135 by using any technique such as, but not limited to, milling, etching, engraving etc.
[0053] The lower set of teeth 136 extend up to at least a portion of the length and the width of the track 138 of the inner rod 130. For example, width is determined based on an inner diameter of the conduit while the length is defined based on the length at which the receptable 200 is to be deployed. For example, the lower set of teeth 136 extend up to 50-60% of the length of the track 138 of the inner rod 130. In an embodiment, the length of the upper set of teeth is 145 mm and width is 8 mm. The lower set of teeth 136 control the proximal and/or distal movement of the inner rod 130 in at least one pre-defined direction opposite to that controlled by the upper set of teeth 135. In an embodiment, the lower set of teeth 136 controls the proximal movement of the inner rod 130 i.e. towards the proximal side 100a of the instrument 100. In other words, the lower set of teeth 136 is configure to control a proximal motion of the medical accessory (explained later).
[0054] In an embodiment, both the tracks 138a and 138b include the upper set of teeth 135 and the lower set of teeth 136.
[0055] In an embodiment, the upper set of teeth 135 and the lower set of teeth 136 are aligned in parallel to and on the respective tracks 138 of the inner rod 130. Alternately, the upper set of teeth 135 and lower set of teeth 136 are placed at an angle with respect to the axis of the inner rod and along the respective tracks 138. The lower set of teeth 136 and the upper set of teeth 135 may include a uniform, flared or tapered profile. In an embodiment, the profile of the lower set of teeth 136 and the upper set of teeth 135 corresponds to the profile of the respective planar surface on which the lower set of teeth 136 and the upper set of teeth 135 are placed or carved.
[0056] Each tooth of the upper set of teeth 135 includes an angled profile inclined at an angle ranging from 15 to 30 degrees. In an embodiment, the upper set of teeth 135 has an incline of 25 degrees. Each tooth of the lower set of teeth 136 includes an angled profile inclined at an angle ranging from 15 to 30 degrees. In an embodiment, the lower set of teeth 136 has an incline of 25 degrees. The upper set of teeth 135 and the lower set of teeth 136 may be inclined in the same direction or in a opposite direction. In an embodiment, an inclination of the upper set of teeth 135 is in a direction opposite to a direction of an inclination of the lower set of teeth 136. In an exemplary embodiment, the upper set of teeth 135 are inclined in the distal direction. And, the lower set of teeth 136 are inclined in the proximal direction.
[0057] During operations, the inclined upper set of teeth 135 and the lower set of teeth 136 provide a smoother engagement and a controlled steady proximal and/or distal motion to the inner rod 130 inside the conduit 110 both in the proximal or distal direction. For example, the upper set of teeth 135 provides smooth engagement surface for movement of the inner rod 130 in the distal direction. Similarly, the lower set of teeth 136 provides smooth engagement surface for movement of the inner rod 130 in the proximal direction.
[0058] The medical accessory is coupled to the distal end 130b of the inner rod 130. In an embodiment, the distal portion of the inner rod 130 beyond the tracks, is solid. The distal end 130b includes at one first groove 137 (shown in Fig. 4d). In an embodiment, the inner rod 130 includes two first grooves 137. The first grooves 137 are configured to couple a medical accessory to the inner rod 130. The first groove 137 extends across at least a portion of the longitudinal length of the distal portion of the inner rod 130. In an embodiment, the first groove 137 extends along the entire longitudinal length of the distal portion of the inner rod 130. In an embodiment, the first groove 137 defines a rectangular slit. In an embodiment, the two first grooves 137 are parallel to each other. Alternatively, the first grooves 137 may be provided at predefined angles from each other in the inner rod 130.
[0059] In an embodiment, the medical instrument 100 includes at least two clamps 154. One clamp 154 of the at least two clamps 154 is illustrated IN Fig. 5. The clamp 154 is configured to control the movement of the inner rod 130 in one of a proximal or distal direction. In an embodiment, two clamps 154 are provided. Each clamp 154 includes a body 155 and two free ends. One of the free ends is configured as a notch 156 while the other free end is configured as a hook 157.
[0060] The clamp 154 is positioned such that the notch 156 of the clamp 154 operationally engages with at least a portion of the inner rod 130 to restrict linear movement of the inner rod 130 and the medical accessory. In an embodiment, the notch 156 operationally engages with respective track of the inner rod (130). For example, , the notch 156 operationally engages with at least one of the upper set of teeth 135 or the lower set of teeth 136 provided on at least one track of the inner rod 130. For instance, the engagement between the notch 156 of the clamp 154 and the upper set of teeth 135 of the inner rod 130 allows the inner rod 130 to move in the distal direction or towards the distal end 100b of the instrument 100 and prevents the inner rod 130 to move in the proximal direction. Similarly, the engagement between the notch 156 and the lower set of teeth 136 allows the inner rod 130 to move in a proximal direction or towards the proximal end 100a of the instrument 100 and prevents the inner rod 130 from moving in the distal direction. Thus, the operational engagement between the notch 156 of the clamp 154 and the inner rod 130 allows movement of the inner rod 130 in only one direction for example proximal or distal at a time. The said arrangement prohibits any unwanted movement of the inner rod 130 such as, in an opposite direction.
[0061] Further, optionally, the engagement between the clamp 154 and the inner rod 130 generates haptic feedback. That is, the engagement of the notch 156 and one of the upper set of teeth 135 or the lower set of teeth 136 enables movement of the inner rod 130 in a proximal or distal direction (depending upon which set of teeth are engaged with the notch 156 of the clamp 154). In response to the engagement between the notch 156 and one of the upper set of teeth 135 or lower set of teeth 136, a tactile sensation (e.g., vibrational sensation) is generated allowing the user to perceive the movement and engagement of the clamp 154 and inner rod 130. The haptic feedback provides continuous physical confirmation to the user regarding the progression or regression of the inner rod 130 inside the conduit 110.
[0062] It is to be noted that the clamp 154 may be mounted on a movable component. An exemplary movable component is a lever 150 as described below, along with its coupling with the clamp 154. Other possible embodiments can include the placement of the clamp 154 inside the conduit 110. The conduit 110 can include possible modifications and arrangements inside the passage provided by the pathway 113. The possible modification and arrangement the conduit 110 includes can host the clamp 154 and an actuation mechanism to actuate the direction of the inner rod 130 inside the conduit 110.
[0063] Fig. 6 depicts a lever 150. The lever 150 is provided towards the proximal end 100a of the instrument 100. The lever 150 may be made from any suitable material, such as, but not limited to polycarbonate (PC), acrylonitrile butadiene styrene (ABS) etc. In an embodiment, the lever 150 is made from polycarbonate (PC). The lever 150 may have a profile such as, but not limited to curved, elongated, etc. The lever 150 provides a comfortable grip to the operator to comfortably hold the instrument 100 during procedure.
[0064] The lever 150 includes a first member 150a and a second member 150b as depicted in Figs. 6a and 6b respectively. The first member 150a and the second member 150b may be coupled using any coupling method such as, but not limited to, snap-fit, press-fit, male-female locking etc. In an embodiment, the first member 150a and the second member 150b of the lever 150 are coupled using a male female locking mechanism.
[0065] The lever 150 is ergonomically designed for a comfortable grip to hold the instrument 100. It should be understood that a person skilled in the art will appreciate that numerous variations to the shape of the lever 150 can be made while practicing the inventive features of the present disclosure and the same are within the scope of the present disclosure.
[0066] In an embodiment, the lever 150 includes a channel 151 defining a passage across the width of the lever 150. In an embodiment, the inner rod 130 extends through the channel 151. The channel 151 is dimensionally carved such that it facilitates proximal and/or distal movement of the inner rod 130. The channel 151 is also configured to receive at least a portion of the proximal end 110a of the conduit 110.
[0067] In an embodiment, the lever 150 includes a projection 152 is provided towards a distal end. The projection 152 is placed across the width of the channel 151. The projection 152 is configured to seat within the slot 111 of the conduit 110 for slot fitting the lever 150 with the conduit 110.
[0068] Further, the first member 150a of the lever 150 includes an opening 153. The opening 153 is configured to receive at least a component of the actuator 170. The lever 150 and the actuator 170 may be coupled using any coupling technique such as, but not limited to, snap-fit, press-fit, friction-fit, etc. In an embodiment, the lever 150 and the actuator 170 are coupled using press-fit.
[0069] The clamp 154 may be removably coupled to the lever 150 using a suitable coupling technique, such as, but not limited to, snap-fit, press-fit, slot-fit, etc. In an embodiment, the clamp 154 is coupled to the lever 150 using a press-fit coupling mechanism. In an embodiment, the second member 150b of the lever 150 includes two slots 151a provided proximally to the projection 152. The slots 151a are provided opposite to each other at an edge of the channel 151. Each slot 151a is configured to receive a clamp 154. Specifically, the hook 157 of each clamp 154 is removably coupled to the lever 150. In an embodiment, each slot 151a is configured to receive the hook 157 of the respective clamp 154, as shown in Fig. 6c. The clamps 154 are positioned such that the notch 156 of the clamp 154 are disposed in the channel 151. As explained earlier, the notch 156 of the clamp 154 is configured to operationally engage with a respective portion of the inner rod 130 passing through the channel 151. The engagement between each slot 151a and a corresponding clamp 154 prevents slippage of the clamp 154 during the movement of the inner rod 130 within the conduit 110.
[0070] As depicted in Fig. 7a, the actuator 170 includes a triggering mechanism. In an embodiment, the actuator 170 includes a housing 171, a cover 173, a pusher 175 and an engager 177. The actuator 170 is configured to trigger controlled movement of the inner rod 130 in either the proximal direction or distal direction of the instrument 100. The housing 171 is inserted in the opening 153 of the lever 150 via a slot-fit mechanism.
[0071] The housing 171 is configured to receive the cover 173 and the pusher 175. A base of the housing 171 includes one or more holes 171a to receive the pusher 175. The pusher 175 includes one or more legs 175a. In an embodiment, the pusher 175 includes two legs 175a. The two legs are provided diametrically opposite to each other, thereby defining two slots 175b therebetween. The one or more legs 175a of the pusher 175 are seated within a respective hole of the one or more holes 171a provided in the housing 171. The pusher 175 is movable in an axial direction with respect to the housing 171. In response to the pusher 175 being pushed downwards, the one or more legs 175a of the pusher 175 move axially within the one or more holes 171a of the housing 171. The cover 173 is configured to encompass the pusher 175.
[0072] In an embodiment, the engager 177 is operationally coupled to the pusher 175. In response to the pusher 175 being pushed axially downwards, the one or more legs 175a of the pusher 175 push the engager 177 axially downwards.
[0073] The engager 177 includes at least one prong 179. In an embodiment, the engager 177 includes two prongs 179. Each of the prongs 179 is configured to engage with at least a component of each of the clamp 154. In an embodiment, the prong 179 are configured to engage with the body 155 of the clamp 154 upon activation of the actuator 170, as depicted in Fig. 7b. The actuator 170 operationally actuates the at least two clamps 154.
[0074] In an embodiment, when the stopper 133 engages with the lever 150, at least a portion of the clamp 154 is not engaged to either the upper set of teeth 135 or the lower set of teeth 136 as depicted in Fig. 7b. In other words, the lever 150 is in the proximal end 130a of the inner rod 130, the notch 156 of the respective clamps 154 are disposed in the second slot 132 of the inner rod 130. At this stage, the clamp 154 contacts the smooth surface of the track 138 and the actuator 170 is activated.
[0075] In an embodiment, the engager 177 is pressed downwards, thereby activating the actuator 170. In response to the activation of the actuator 170, the prongs 179 engage with and push the body 155 of the clamp 154 downwards. During the downward movement of the body 155, the notch 156 follows the direction of movement of the body 155 of the clamp 154. In other words, in response to the engagement between prongs 179 with the notch 156 of the clamps 154, the engagement of the clamps 154 from the upper set of teeth 135 to the lower set of teeth 136 is switched. The downward movement of the notch 156 actuated by the actuator 170, allows the clamp 154 to disengage with the upper set of teeth 135 and engage with the lower set of teeth 136. The notch 156 transitions from the upper set of teeth 135 to the lower set of teeth 136 of the inner rod 130 allowing the inner rod 130 to move in a proximal direction of the instrument 100. Other embodiments of the actuation can include a different orientation and mechanism of the actuator 170. The actuator 170 serves the purpose of setting a direction of the movement of the inner rod 130 inside the conduit 110, any possible alteration and modification can be done to achieve this actuation phenomenon.
[0076] Now moving to Figs. 8a-8b, the handle 190 is positioned towards the proximal end 100a of the instrument 100, specifically coupled to the proximal end 130a of the inner rod 130. The handle 190 is configured to provide a comfortable grip to operator to exert a force onto the inner rod 130 during the operations. For example, the handle 190 includes a cavity 197 that enables an operator to hold the handle 190 comfortably and exert a force in a linear direction towards the distal end 100b or the proximal end 100a of the instrument 100, such as a pull force or a push force. In response to the handle 190 being pushed in the distal direction, the inner rod 130 is configured to move towards the distal end 100b or the proximal end 100a of the instrument 100 inside the conduit 110.
[0077] The handle 190 may be made from any suitable biocompatible material such as, but not limited to, polycarbonate (PC), acrylonitrile butadiene styrene (ABS) etc. In an embodiment, the handle 190 is made of Polycarbonate. The handle 190 can have any shape such as, but not limited to, cylindrical, spherical, cuboidal, polyhedral, shoe shape or foot shape etc. In an embodiment, the handle 190 assumes a shape of shoe or a foot.
[0078] The handle 190 includes a first segment and a second segment as depicted in Figs. 8a and 8b respectively. The first segment and the second segment are coupled using a coupling technique such as, but not limited to, slot fit, press fit, male-female coupling etc. In an embodiment, the first segment and the second segment of the handle 190 are coupled using a male female coupling mechanism. The first segment and the second segment include one or more protrusions and sockets facilitating the coupling of the first segment and the second segment.
[0079] Further, the first segment and the second segment of the handle 190 define an orifice 195 towards a distal side of the handle 190. The orifice 195 is configured to receive at least a portion of the distal end 130b of the inner rod 130. The orifice 195 defines a second groove 199 extending across the surface of the orifice 195. The second groove 199 is configured to receive the first slot 131 of the inner rod 130, coupling the rod 130 and the handle 190 via slot fit.
[0080] Though the present disclosure describes an embodiment in which the handle is moved to operate the instrument. However, it should be appreciated that a slight modification may be made in the instrument for moving the lever to operate the instrument and the same is within the scope of the present disclosure.
[0081] The instrument 100 described above is used in conjunction with a medical accessory to perform a required operation. For example, the instrument may include a collapsible receptacle 200 that can be released or collapsed as needed to collect a specimen from a target site. Alternately, the instrument may include a blade, a pair of forceps, which can be exposed or covered by the conduit 110 as needed to cut a specimen at a target site. Similarly, other accessories that can be used along with the teachings of the instrument 100 are within the scope of the present disclosure.
[0082] The medical accessory is coupled to the distal end 130b of the inner rod 130. The medical accessory resides inside the pathway 113 of the conduit 110 towards the distal end 110b. The clamps 154 operationally engage with at least one of the upper set of teeth 135 or the lower set of teeth 136 to allow the movement of the medical accessory in a predefined direction, in a controlled manner.
[0083] As an exemplary depiction, a receptacle 200 to hold and contain a specimen (for example, a severed tissue, a severed organ etc.) during a procedure is depicted in Figs. 9a-9d. The receptacle 200 is attached to the distal end 110b of the instrument 100 as depicted in Fig. 9a. At least a portion of the receptacle 200 is configured to collapse and expand as needed, to secure the specimen. In the undeployed state, at least a portion of the receptacle 200 resides inside the pathway 113 of the conduit 110 towards its distal end 110b. The receptacle 200 resides in a folded or rolled state inside the conduit 110. During deployment, the receptacle 200 is pushed out from the distal end 110b of the conduit 110 by the distal movement of the inner rod 130 inside the conduit 110.
[0084] In an exemplary embodiment, as depicted in Figs. 9b-9c, the receptacle 200 includes a basket 230 with a frame 210. The receptacle 200 has a proximal end 200a and a distal end 200b. The frame 210 may be a unitary structure or a modular structure. In an embodiment, the frame 210 is a modular structure defining a first prong 211 and a second prong 212 (Fig. 9d). The frame 210 can be fixedly coupled to the basket 230 using a coupling technique, such as, but not limited to, groove type, slot type, male-female type etc. The frame 210 is coupled to the basket 230 defining a closed space to receive a specimen. The frame 210 is coupled to the distal end 130b of the inner rod 130. In an embodiment, the first prong 211 and the second prong 212 of the frame 210 towards the proximal end 200a of the receptacle 200, are inserted in the first grooves 137 towards the distal end 130b of the inner rod 130.
[0085] The frame 210 is responsible to provide structural integrity to the receptacle 200. At least a portion of the frame 210 resides inside the lumen 113 of the conduit 110. The frame 210 is configured to move proximal side and distal side inside the conduit 110 when pushed or pulled by the inner rod 130. The frame 210 has reconfigurable shape. In other words, the frame 210 may be reconfigure its shape from a collapsed state to an expanded state. In an undeployed state, the frame 210 is disposed within the pathways 113 of the conduit 110. During the distal movement, the frame 210 is released from the conduit 110 and attains an expanded state due to the material from which the frame 210 is made. In the expanded state, the frame 210 defines an opening 250. In an embodiment, in the expanded state, the opening 250 defined by the first prong 211 and the second prong 212 of the frame 210 is of a curvilinear shape. During the proximal movement, at least a portion of the frame 210 is retrieved back inside the conduit 110. The proximal motion of the frame 210 results in sealing of the opening 250. In the deployed state, the frame 210 is moved distally and defines an opening 250 to receive a specimen.
[0086] The frame 210 may be made from a biocompatible shape memory material. In an embodiment the frame 210 is made from Stainless steel (S.S). The shape memory material allows the frame 210 to acquire a shape such as, but not limited to, curvilinear, square, rectangle, circular, etc. The shape memory material is configured to retain an original shape once the acting stress is removed, here the shape memory material of the frame 210 acquires the pre-determined curvilinear shape once pushed outside of the passage 113 of the conduit 110. In an embodiment, the basket 230 and the frame 210 are coupled using a coupling technique, such as, but not limited to, bonding, groove type, slot type, male-female type, etc.
[0087] In an embodiment, the basket 230 and the frame 210 are coupled by groove type coupling. The coupling of the frame 210 and the basket 230 defines a close space or a receptacle with an opening configured to hold a removed or severed specimen or tissue during the procedure. The basket 230 may be made from any suitable material, such as, but not limited to, thermoplastic polyurethane (TPU), polyurethane (PU) etc. In an embodiment, the basket 230 is made from thermoplastic polyurethane (TPU). The thermoplastic polyurethane (TPU) material increases the strength by up to 20% -30 % then Polyurethane material thus making it resistant to wear and tear during the operation.
[0088] Now, the working of the instrument 100 is explained in conjunction with a flowchart 1000 provided in Fig. 10 and corresponding illustrations as in Fig. 11.
[0089] Fig. 10 illustrates a flowchart of a method 1000 of the working of the instrument 100. During a procedure, for example, a laparoscopy procedure, the instrument 100 is configured to remove and collect a surgically operated tissue or organ from inside a target area of a human body such as the abdomen.
[0090] At step 1001, the operator holds the instrument 100 via the lever 150 and inserts the conduit 110 inside the target area of the body through a small incision made by trocar via the distal end 100b of the instrument 100. The procedure is performed under an image guidance system which assists the operator to determine an optimal length for the conduit 110 to be inserted.
[0091] At step 1002, the operator holds the handle 190 via the ergonomic grip provided by the cavity 197 and pushes the handle 190 towards the distal end 100b of the instrument 100. As result, the inner rod 130 is moved in the distal direction and the receptacle 200 coupled to the distal end 130b the inner rod 130 is partially exposed. That is, the receptacle 200 is partially uncovered from the conduit 110 (see Fig. 11). In this state, the actuator 170 remains idle and the notches of the clamps 154 are engaged to the upper set of teeth 135 of the inner rod 130. The operator continues to push the handle 190 until the stopper 133 comes in contact with the channel 151 of the lever 150 and prohibits any further movement. Now, the receptacle 200 is fully exposed from the conduit 110. The frame 210 attains the expanded state causing the basket 230 to attain the open configuration. The open configuration is meant to collect a severed tissue or organ (T) removed during the procedure by the operator.
[0092] At step 1003, the operator gathers or collects the severed tissue or organ inside the receptacle 200 in the open configuration as depicted in Fig. 11.
[0093] At step 1004, after collection of the severed tissue, the operator presses the actuator 170, consequently pressing the body 155 and the notch 156 of the clamp 154 downwards. The clamp 154 is disengaged from the upper set of teeth 135 and engages with the lower set of teeth 136 of the inner rod 130. This allows the inner rod 130 to move towards the proximal end 100a of the instrument 100. The operator thereafter, exerts a force to pull the handle 190 towards the proximal end 100a of the instrument 100, consequently moving the inner rod 130 inside the conduit 110. Due to the movement of the rod 130 towards the proximal end 100a, the frame 210 re-enters the pathway 113 of the conduit 110. The re-entry of the frame 210 forces the receptacle 200 to contract again. In the contracted state, the open edges of the frame 210 are sealed and the basket 230 collapses. This sealing secures the collected tissue inside the basket 230.
[0094] At step 1005, after securing the removed tissue, the operator removes the conduit 110 and the basket 230 of the instrument 100 from the body.
[0095] The controlled proximal and/or distal movement mechanism discussed above depicts one possible embodiment. In other embodiments, several other possible modifications can be done to the conduit 110, and the inner rod 130 for controlled proximal and/or distal movement of the inner rod. In one such possible modification, the lumen 113 of the conduit 110 may include a guided rail structure for the inner rod to move controllably. In other embodiments, the lumen may include a plurality of upper set of teeth and the lower set of teeth and the inner rod may include a clamp like structure. The clamp like structure of the inner rod can be designed such that the clamp is operationally engaged to the teeth inside the lumen of the conduit to move controllably.
[0096] 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. A medical instrument (100) comprising:
a. a conduit (110) having a pathway (113);
b. an inner rod (130) configured to reside inside the pathway (113), the inner rod (130) defining at least two tracks (138a, 138b), each track including;
i. an upper set of teeth (135) and
ii. a lower set of teeth (136) placed axially adjacent to the upper set of teeth (135);
c. at least two clamps (154) operationally engaged with respective track of the inner rod (130);
d. an actuator (170) operationally actuates the at least two clamps (154); and
e. a medical accessory coupled to a distal end (130b) of the inner rod (130), the medical accessory resides inside the pathway (113) in an undeployed state of the medical accessory;
wherein the clamps (154) operationally engage with at least one of the upper set of teeth (135) or the lower set of teeth (136) to allow the movement of the medical accessory in a predefined direction, in a controlled manner.
2. The medical instrument (100) as claimed in claim 1, wherein:
a. the upper set of teeth (135) is configured to control a distal motion of the medical accessory; and
b. the lower set of teeth (136) is configured to control a proximal motion of the medical accessory.
3. The medical instrument (100) as claimed in claim 1, wherein tooth of the upper set of teeth (135) and the lower set of teeth (136) have a respective angled profile ranging between 15 degrees to 30 degrees.
4. The medical instrument (100) as claimed in claim 1, wherein an inclination of the upper set of teeth (135) is in a direction opposite to a direction of an inclination of the lower set of teeth (136).
5. The medical instrument (100) as claimed in claim 1, wherein the medical instrument (100) includes a handle (190) provided at the proximal end (130a) of the inner rod (130) to operate the inner rod (130).
6. The medical instrument (100) as claimed in claim 1, wherein the medical accessory includes at least one of a receptacle (200), a blade, and a pair of forceps.
7. The medical instrument (100) as claimed in claim 6, wherein the receptacle (200) comprises:
a. a frame (210) having a reconfigurable shape coupled to the distal end (130b) of the inner rod (130); and
b. a basket (230) coupled to the frame (210) defining a closed space to receive a specimen;
wherein in a deployed state, the frame (210) is moved distally and defines an opening (250) to receive a specimen.
8. The medical instrument as claimed in claim 1, wherein each clamp of the at least two clamps (154) include:
a. a body (155);
b. a notch (156) at one end of the body (155), the notch (156) being operationally engaged with one of the upper set of teeth (135) or the lower set of teeth (136) of the inner rod (130) to restrict linear movement of the inner rod (130) and the medical accessory; and
c. a hook (157) at other end of the body (155) removably coupled to the lever (150).
9. The medical instrument (100) as claimed in claim 1, wherein the actuator (170) includes an engager (177) having at least one prong (179) operationally engaged with the clamps (154), wherein, in response to the engagement between the at least prong (179) with a notch (156) of the clamp (154), the engagement of the clamp (154) from the upper set of teeth (135) to the lower set of teeth (136) is switched.
10. The medical instrument (100) as claimed in claim 1, wherein a distal end (130b) of the inner rod (130) includes at least one first groove (137) configured to couple the medical accessory with the inner rod (130).
11. The medical instrument (100) as claimed in claim 1, wherein the inner rod (130) includes a stopper (133) to indicate deployment of the medical accessory.
12. The medical instrument (100) as claimed in claim 1, wherein the upper set of teeth (135) and the lower set of teeth (136) are one of bonded or machined till a predefined length to at least one surface of the inner rod (130).