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:
HEMOSTASIS DEVICE
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 invention relates to the field of medical devices. More specifically, the present invention pertains to a hemostasis device.
BACKGROUND OF INVENTION
[002] Postpartum hemorrhage (PPH) is a significant medical condition, defined by excessive blood loss following childbirth, which can lead to life-threatening complications for the mother. The primary cause of PPH is uterine atony, a condition in which the uterus fails to contract adequately after delivery, resulting in substantial blood loss. This life-threatening condition occurs in approximately 10% of deliveries and remains one of the leading causes of maternal mortality worldwide.
[003] Historically, maternal hemorrhage has been a major challenge in obstetric care. In developing countries, such as India, obstetrical hemorrhage accounts for approximately 20% of maternal deaths, making it one of the primary contributors to maternal mortality. On a global scale, PPH is recognized as the leading cause of maternal death.
[004] Over the years, various devices have been developed to manage PPH. Among these, balloon catheters have been widely adopted as a standard tool to control blood loss by applying pressure on uterus walls. These balloon catheters are designed to manage postpartum hemorrhage, particularly in cases where uterine atony is the underlying cause. The process involves inserting the balloon catheter into the uterus, inflating the balloon, and applying pressure to the uterine walls, stimulating contractions to minimize bleeding and enhance uterine stability.
[005] Despite their widespread use, balloon catheters face several critical limitations that hinder their efficacy and safety, particularly in emergency scenarios where time is of the essence. The insertion and placement of balloon catheters are often challenging and require significant skill to achieve precise positioning. Proper placement at the site of bleeding, typically the placental site, is essential for effective pressure. Incorrect placement of the balloon can result in inadequate control of hemorrhage.
[006] In addition to placement challenges, the insertion process itself poses risks. Navigating the balloon catheter through the cervix, especially when the cervix is dilated, can complicate the procedure and increase the likelihood of uterine or cervical injury. In emergencies, the need for rapid and efficient insertion further exacerbates these difficulties. Improper handling or repeated attempts to reposition the device may introduce infection risks and delay treatment, worsening the patient’s condition. Moreover, healthcare providers who lack extensive experience in postpartum hemorrhage management may find the use of balloon catheters intimidating and challenging, leading to suboptimal outcomes.
[007] Balloon catheters have significant limitations in obstetric care, particularly in cases requiring minimally invasive uterine compression to prevent excessive bleeding. Their effectiveness is further restricted in post-cesarean care, where weaker uterine contractions may reduce their efficacy.
[008] Thus, there arises a need for a hemostasis device that overcomes the problems associated with conventional hemostasis devices.
SUMMARY OF INVENTION
[009] The present invention relates to a hemostasis device for preventing hemorrhage in a cavity of a patient’s body. The device includes a catheter, an inflating element, and a guiding element. The catheter includes a shaft having a first lumen, and a second lumen configured to provide a passage for an inflation fluid. The inflating element is mounted on the shaft towards a distal end of the shaft. The inflating element includes a cavity fluidically coupled to the second lumen of the shaft. The inflating element is configurable between an inflated state and a deflated state. The guiding element is coupled to the catheter. The guiding element includes a stem disposed within the first lumen of the shaft. The stem includes a tapered portion provided at a distal end of the stem and configured to engage with the first lumen of the shaft. A diameter of the tapered portion decreases from a maximum diameter to a minimum diameter. The minimum diameter of the tapered portion is less than the diameter of the first lumen of the shaft and the maximum diameter of the tapered portion is greater than the diameter of the first lumen of the shaft. The stem further includes a body portion extending from the tapered portion to a proximal end of the stem. A diameter of the body portion is less than the minimum diameter of the tapered portion.
[0010] The foregoing features and other features as well as the advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
BRIEF DESCRIPTION OF DRAWINGS
[0011] 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 instrumentalities disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[0012] Fig. 1A depicts a perspective view of a hemostasis device 10, in accordance with an embodiment of the present disclosure.
[0013] Fig. 1B depicts an exploded view of the hemostasis device 10, in accordance with an embodiment of the present disclosure.
[0014] Fig. 2A depicts a perspective view of a catheter 100, in accordance with an embodiment of the present disclosure.
[0015] Fig. 2B depicts a longitudinal cross-sectional view of the catheter 100, in accordance with an embodiment of the present disclosure.
[0016] Fig. 2C depicts a transversal cross-sectional view of the catheter 100, in accordance with an embodiment of the present disclosure.
[0017] Fig. 3 depicts a perspective view of the catheter 100 without an inflating element 120, in accordance with an embodiment of the present disclosure.
[0018] Fig. 4 depicts a perspective view of a guiding element 200, in accordance with an embodiment of the present disclosure.
[0019] Fig. 5 depicts a perspective view of a stem 210 of the guiding element 200, in accordance with an embodiment of the present disclosure.
[0020] Fig. 5A depicts a detailed view of a plurality of ribs 212 of the stem 210, in accordance with an embodiment of the present disclosure.
[0021] Fig. 6A depicts a perspective view of a collar 220 of the guiding element 200, in accordance with an embodiment of the present disclosure.
[0022] Fig. 6B depicts a cross-sectional view of the collar 220 of the guiding element 200, in accordance with an embodiment of the present disclosure.
[0023] Fig. 7 depicts a perspective view of a handle 250 of the guiding element 200, in accordance with an embodiment of the present disclosure.
[0024] Fig. 8 depicts a longitudinal cross-sectional view of the hemostasis device 10, in accordance with an embodiment of the present disclosure.
[0025] Fig. 9 illustrates a flowchart representing a method 900 for preventing blood flow from a target site using the hemostasis device 10, in accordance with an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[0026] 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.
[0027] 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.
[0028] 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.
[0029] 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.
[0030] The present disclosure relates to a hemostasis device (or device) for preventing hemorrhage (PPH) in a cavity of a patient’s body. The device includes a catheter having a plurality of lumens and an inflating element positioned at a distal end of the catheter. The inflating element is fluidically coupled with at least one of the lumens. The inflating element is configurable to be in an inflated state or a deflated state. The plurality of lumens facilitates fluid inflow and outflow when required. The inflated state of the balloon applies pressure to the walls (e.g., a blood vessel, an organ, a tissue, uterus walls) to control hemorrhage from a cavity of the patient.
[0031] Additionally, the device includes a guiding element that is coupled to the catheter through an interlocking mechanism provided at the distal end of the catheter. The guiding element, which may include a stylet, a trocar, or any other semi-rigid or rigid structures, facilitates precise insertion of the catheter. The guiding element ensures precise navigation of the catheter to a target site inside the patient’s body. During the insertion process, the guiding element provides control, allowing healthcare professionals to accurately guide the catheter to the target site (e.g., through the cervix and into the uterus). The guiding element facilitates precise placement of the inflating element within the target site, for example, around the placental area. The precise placement of an inflating element allows the inflating element to directly address the target site, effectively managing postpartum hemorrhage (PPH). Additionally, the guiding element has a blunt tip, minimizing the risk of injury during insertion, which in turn lowers the risk of infection and enhances patient comfort. Once the inflating element is placed correctly, the guiding element can be removed without disrupting the catheter’s placement, thereby minimizing complications and allowing for faster and more efficient completion of the procedure.
[0032] Further, the device allows for a non-invasive procedure to manage the PPH, reducing the need for surgical interventions such as hysterectomy. The device offers a safer alternative to more invasive procedures, preserving the uterus and improving patient recovery. Furthermore, the device is configured for use in post-cesarean delivery care and emergency obstetric care, ensuring applicability in a wide range of clinical scenarios. The device adaptability allows healthcare providers to efficiently manage postpartum hemorrhage (PPH) in both planned and urgent situations, minimizing complications.
[0033] Referring now to figures, Figs. 1A depicts a perspective view and 1B depicts an exploded view of a hemostasis device 10, in accordance with an embodiment of the present disclosure. The hemostasis device 10 (interchangeably referred to as device 10 hereafter) is configured to prevent hemorrhage in a cavity of a patient’s body, for example, postpartum hemorrhage in a patient’s uterus. The device 10 has a proximal end 10a and a distal end 10b. The device 10 includes a catheter 100 and a guiding element 200. The catheter 100 is adapted to accommodate the guiding element 200. The guide element 200 helps in guiding the catheter 100 to a target site of the patient body. The guiding element 200 allows healthcare professionals to control the insertion of the catheter 100 with precision and ease.
[0034] Figs. 2A depicts a perspective view, Fig. 2B depicts a longitudinal cross-sectional view, and Fig. 2C depicts a transversal cross-sectional view of the catheter 100, in accordance with an embodiment of the present disclosure. The catheter 100 has a proximal end 100a and a distal end 100b. The catheter 100 includes a shaft 110, an inflating element 120, and a hub 130. The inflating element 120 is provided towards the distal end 100b of the catheter 100 and the hub 130 is provided at the proximal end 100a of the catheter 100. In an embodiment, the shaft 110, the inflating element 120, and the hub 130 are integrally coupled with each other.
[0035] In an embodiment, the shaft 110 has a tubular structure and a flexible, elongated body. The shaft 110 has a proximal end 110a and a distal end 110b (as depicted in Fig. 3), defining a length therebetween. The proximal end 110a of shaft 110 is coupled to the hub 130. The distal end 110b of the shaft 110 is provided with an inlet port 113 configured to receive a body fluid, such as blood, from the target site. The configuration of the inlet port 113 can be designed to optimize fluid entry based on the specific requirements of the procedure. In an embodiment, the inlet port 113 may include two openings (not shown) provided diametrically opposite to each other at the distal end 110b of the shaft 110. The dimension of the shaft 110 may be chosen based on the procedural requirements. In an embodiment, the shaft 110 has an outer and inner diameter. The outer diameter of the shaft 110 may range from 7.5 mm to 8.5 mm. In an embodiment, the outer diameter of the shaft 110 is 8 mm. The inner diameter of the shaft 110 may range from 5.5 mm to 6.5 mm. In an embodiment, the inner diameter of the shaft 110 is 6 mm. In an embodiment, the shaft 110 may be made of a biocompatible material, such as, without limitation, medical-grade polyurethane, etc. In an embodiment, the shaft 110 is made of medical-grade silicone, which is flexible and durable, ensuring patient safety during use. The shaft 110 may be manufactured using an injection molding or extrusion process.
[0036] The shaft 110 includes a plurality of lumens (as depicted in Fig. 2B and 2C) that partially extend along a length of the shaft 110. In an embodiment, the plurality of lumens includes a first lumen 112a, and a second lumen 112b. The first lumen 112a is concentrically disposed within the second lumen 112b as depicted in Fig. 2C. The plurality of lumens may be integrated within the shaft 110. The plurality of lumens may be made up of a biocompatible material, such as, without limitation, medical-grade silicone, nylon, polyamide, polyurethane, etc. In an embodiment, the plurality of lumens is made of a medical-grade silicone, which is flexible and durable, ensuring safety during use. In an embodiment, the first lumen 112a is configured to receive the guiding element 200. The diameter of the first lumen 112a may be equal to the inner diameter of the shaft 110. The second lumen 112b is configured to provide a passage for an inflation fluid.
[0037] The shaft 110 includes at least one slit 117 (shown in Fig. 3) provided on an outer surface of the shaft 110 in section of the shaft 110 disposed within the inflating element 120. The slit 117 is fluidically coupled to the second lumen 112b of the shaft 110 and configured to provide passage for the inflation fluid to enter into the inflating element 120. In an embodiment, the shaft 110 may include a plurality of slits (not shown).
[0038] The shaft 110 has a distal tip 136 at the distal end 110b. The distal tip 136 is configured to be atraumatic and smooth, minimizing irritation or damage to surrounding tissues during insertion and navigation within the body. In an embodiment, the distal tip 136 has a semi-circular shape, though it may have any other shape, for example, conical, or frustum. The distal tip 136 may be polished to facilitate easy advancement through anatomical structures while ensuring patient comfort and reducing the risk of trauma. In an embodiment, the distal tip 136 has a closed configuration. The closed configuration of the distal tip 136 prevents direct exposure of the lumens of the catheter 100, helping to maintain sterility.
[0039] The inflating element 120 is mounted on the shaft 110 towards the distal end 110b of the shaft 110. The inflating element 120 is configurable to be in an inflated state or a deflated state. In the inflated state, the inflating element 120 may have a cylindrical shape. The inflating element 120 is coupled to the shaft 110 towards the distal end 110b of the shaft 110. The inflating element 120 has a proximal end 120a and a distal end 120b (as depicted in Fig. 2B) defining a length. The proximal end 120a and distal end 120b of the inflating element 120 are coupled to the shaft 110 using a technique, such as, without limitation, bonded, welding, etc. In an example implementation, the proximal end 120a and the distal end 120b of the inflating element 120 are welded to the shaft 110. The inflating element 120 includes a cavity 125 fluidically coupled to the second lumen 112b of the shaft 110. The length of the inflating element 120 may be chosen based on the application of the device and the patient’s anatomy. The length of the inflating element 120 in the inflated state may range from 70 mm to 115 mm. In an embodiment, the length of the inflating element 120 in the inflated state is 105 mm.
[0040] The inflating element 120 may be made of a biocompatible material such as, without limitation, medical-grade silicone, nylon, polyamide, polyurethane, etc. In an embodiment, the inflating element 120 is made of medical-grade silicone, which is flexible and durable, ensuring patient safety during use in a post-partum heomostasis procedure. The inflating element 120 may be manufactured separately using a molding process, followed by a curing process to harden and set the material. After curing, the inflating element 120 is coupled to (e.g., welded to) the shaft 110. In an embodiment, the inflating element 120, in the inflated state, has an outer diameter that may range from 25 mm to 95 mm. In an exemplary embodiment, the outer diameter of the inflating element 120 in the inflated state is 90 mm. The inflation fluid may be a gaseous inflation medium, such as air, O2, N2, Ar2, CO2, etc., or a liquid inflation medium, such as sterile water, a glycerin solution, etc. In an embodiment, the inflation fluid is saline water.
[0041] In an embodiment, the inflating element 120 has a wall 121 that extends from the proximal end 120a to the distal end 120b of the inflating element 120. The wall 121 is coupled to, e.g., welded to, the shaft 110. The wall 121 of the inflating element 120 and the outer surface of the section of the shaft 110 disposed within the inflating element 120 form the cavity 125 therebetween. The cavity 125 is configured to receive the inflation fluid. In an embodiment, the inflating element 120 is configured to be in the inflated state in response to the injection of the inflation fluid into the cavity 125 of the inflating element 120. The inflating element 120 is configured to be in the deflated state in response to the discharge of the inflation fluid from the cavity 125 of the inflating element 120.
[0042] The hub 130 is coupled to the proximal end 110a of the shaft 110. The hub 130 is configured to allow the healthcare professional to hold and operate the device 10. The hub 130 includes a first port 132 and a second port 133. The first port 132 is configured to allow the guiding element 200 to be inserted into the first lumen 112a of the shaft 110. The second port 133 is fluidically coupled to the second lumen 112b of the shaft 110 and an inflating device (e. g. syringe, pump, etc.), allowing controlled flow of the inflation fluid within the cavity 125 of the inflating element 120 via the second lumen 112b of the shaft 110. The hub 130 includes an annular projection 134 provided within the first port 132 of the hub 130. The annular projection 134 is configured to couple the hub 130 with the guiding element 200.
[0043] The hub 130 may be made of a material such as, without limitation, polypropylene, polycarbonate, polyethylene terephthalate (PET), high-density polyethylene (HDPE), low-density polyethylene (LDPE), etc. In an embodiment, the hub 130 is made of medical-grade silicone. The hub 130 is coupled to the shaft 110 through a suitable coupling technique, such as adhesive bonding, RF welding, UV bonding, etc. In an example implementation, a distal end of the hub 130 is coupled to the proximal end 110a of the shaft 110 using adhesive bonding. In another example implementation, the hub 130, the shaft 110, and the inflating element 120 may be formed as a single, integrated element.
[0044] Fig. 4 depicts a perspective view of the guiding element 200, in accordance with an embodiment of the present disclosure. The guiding element 200 is coupled to the catheter 100. The guiding element 200 serves as a stabilizing and directional tool, enabling the catheter 100 to navigate efficiently and accurately to the target site, such as a uterus or any other organ, thereby minimizing potential complications and improving procedural outcomes. The guiding element 200 has a proximal end 200a and a distal end 200b. The guiding element 200 includes a stem 210, a collar 220, and a handle 250. The stem 210 is disposed at the distal end 200b, and the handle 250 is disposed at the proximal end 200a of the guiding element 200. The stem 210 is coupled to the handle 250 via the collar 220.
[0045] Fig. 5 depicts a perspective view of the stem 210, in accordance with an embodiment of the present disclosure. The stem 210 has a proximal end 210a and a distal end 210b, defining a length therebetween. The stem 210 has an elongated, flexible, and sturdy structure, providing the necessary support to guide the catheter 100 to the target site. The stem 210 may have a solid or hollow core. The stem 210 may be made of steel, nickel alloy, titanium, nitinol, etc. In an embodiment, the stem 210 is made of stainless steel. In an embodiment, the stem 210 may be plated with chromium, which allows the stem 210 to be both flexible and rigid, providing the necessary support for guiding the catheter 100 into the target site. The stem 210 has a tubular structure and includes a lumen 211 extending from the proximal end 210a to the distal end 210b of the stem 210 and configured to provide a passage to a body fluid. The stem 210 may be manufactured using a cold rolling and machining, or grinding process. The stem 210 has a blunt tip 213 at the distal end 210b. The blunt tip 213 has a smooth surface that prevents unintended perforation of the first lumen 112a of the catheter 100, ensuring safe navigation through the device 10. Additionally, the blunt tip 213 enhances overall safety by reducing the likelihood of trauma or injury to both the catheter 100 and the surrounding uterine tissue, making the insertion process more controlled and atraumatic.
[0046] The stem 210 is disposed within the first lumen 112a of the shaft 110. In an embodiment, the stem 210 includes a tapered portion 214 provided at the distal end 210b of the stem 210 and configured to engage with the first lumen 112a. The stem 210 includes a body portion 216 extending from the tapered portion 214 to the proximal end 210a of the stem 210. The body portion 216 has a uniform diameter. The tapered portion 214 has a diameter that gradually decreases from a maximum diameter to a minimum diameter. In an embodiment, the tapered portion 214 has the maximum diameter at a proximal end of the tapered portion 214 and the minimum diameter at a distal end of the tapered portion 214, such that the diameter of the tapered portion 214 increases from the distal end to the proximal end of the tapered portion 214. This facilitates easier insertion of the stem 210 into the shaft 110. It is possible, though, that the maximum and the minimum diameter are provided at the distal and proximal end, respectively, of the tapered portion 214. The minimum diameter of the tapered portion 214 is greater than the diameter of the body portion 216, i.e., the diameter of the body portion 216 is smaller than the minimum diameter of the tapered portion 214, such that there is clearance between an inner surface of the first lumen 112a and an outer surface of the body portion 216. The tapered portion 214 is coupled to the shaft 110 towards a distal end 110b of the shaft 110 via an interference fit. In an embodiment, the minimum and maximum diameters of the tapered portion 214 are designed such that the minimum diameter of the tapered portion 214 is less than the diameter of the first lumen 112a and the maximum diameter of the tapered portion 214 is greater than the diameter of the first lumen 112a. Thus, a ratio of the minimum diameter of the tapered portion 214 and the diameter of the first lumen 112a (hereinafter, a first predefined ratio) has a value less than one. Similarly, a ratio of the maximum diameter of the tapered portion 214 and the diameter of the first lumen 112a (hereinafter, a second predefined ratio) has a value greater than one. Consequently, when the tapered portion 214 is coupled to the first lumen 112a, there is a positive interference between the tapered portion 214 and the first lumen 112a through such dimensional alignment. The positive interference coupling secures the stem 210 within the first lumen 112a of the catheter 100. This secure connection stabilizes the stem 210, ensuring a firm and reliable coupling between the guiding element 200 and the catheter 100, preventing disengagement therebetween throughout the procedure. In an embodiment, the distal end of the tapered portion 214 is disposed between the distal end 110b of the shaft 110 and the distal end 120b of the inflating element 120. In an embodiment, the proximal end of the tapered portion 214 is disposed at the proximal end 120a of the inflating element 120. The first predefined ratio may range between 0.98 and 0.9983. In an exemplary embodiment, the first predefined ratio is 0.9917. The second predefined ratio may range between 1.008 and 1.025. In an exemplary embodiment, the second predefined ratio is 1.017. In an example implementation, the diameter of the first lumen 112a is 6 mm, the minimum diameter of the tapered portion 214 is 5.95 mm and the maximum diameter of the tapered portion 214 is 6.1 mm. The length of the tapered portion 214 may range from 70 mm and 80 mm. In an exemplary embodiment, the length of the tapered portion 214 is 75 mm.
[0047] Additionally, the stem 210 includes a plurality of ribs 212 provided on an outer surface of the body portion 216 of the stem 210 (as depicted in fig, 5A). The ribs 212 may extend radially outward. In an embodiment, the height of the ribs 212 may be designed such that a top surface of the ribs 212 contacts an inner surface of the first lumen 112a. The ribs 212 enhance the rigidity, stability, and overall integrity of the stem 210. The ribs 212 prevent deformation, maintain the shape of the stem 210 under various loading conditions, and improve the overall durability and reliability of the stem 210 during insertion and removal from the catheter 100. The ribs 212 offer structural reinforcement and distribute forces exerted on the stem 210, thereby reducing the risk of collapse or failure during use. The plurality of ribs 212 also facilitates easier insertion and removal of the guiding element 200 from and into the catheter 100.
[0048] The ribs 212 may be designed in a variety of ways according to the requirements. For example, the length of the ribs 212 may be uniform or vary to achieve different levels of rigidity and flexibility. The ribs 212 may be made of the same material as the stem 210 or of different materials to achieve specific functional benefits. In an embodiment, the ribs 212 are made of stainless steel. In an embodiment, the ribs 212 may be plated with chromium to prevent bending and collapsing of the stem 210 during insertion and removal from the catheter 100. Other suitable materials for the ribs 212 include steel, nickel alloy, titanium, nitinol, etc. allowing for variations in strength, flexibility, and corrosion resistance. The selection of materials and structural configurations of the ribs 212 is done based on ensuring that the stem 210 maintains its integrity under a wide range of operational conditions, enhancing overall performance and reliability. The ribs 212 may have pre-defined shapes including, rectangle, curved, circular, etc. In an exemplary embodiment, the ribs 212 is rectangular.
[0049] The ribs 212 may be provide at least partially along the length of the body portion 216. The number of ribs 212 may be selected based on structural requirements. The ribs 212 may be arranged in a predefined pattern to ensure sufficient reinforcement at a predefined position. The position of ribs 212 may be uniform or non-uniform, depending on structural and functional needs. The predefined pattern may include a longitudinal pattern, a helical pattern, a circumferential pattern, a grid, or combinations thereof.
[0050] In an embodiment, the plurality of ribs 212 includes two or more sets of ribs (A) arranged longitudinally and spaced apart from each other along a length of the body portion 216 of the stem 210. Each set of ribs (A) (as shown in Fig. 5) includes two or more ribs provided circumferentially on the outer surface of the body portion 216 of the stem 210 as shown in Fig. 5A. The longitudinal pattern of the ribs 212 provide axial reinforcement which prevents bending of the stem 210. The longitudinal ribs are particularly beneficial in applications requiring controlled flexibility while ensuring sufficient structural support.
[0051] In another embodiment, the helical pattern involves arranging the ribs 212 in a spiral formation along the body portion 216 of the stem 210. The helical pattern configuration enhances torsional resistance and improves flexibility while maintaining structural integrity. The ribs 212 arranged in a helical pattern can effectively distribute stress along the length of the stem 210, reducing localized pressure points and enhancing overall durability.
[0052] In another embodiment, the circumferential pattern includes the ribs 212 arranged in rings around the body portion 216. This pattern enhances radial strength and resistance to deformation, making it particularly suitable for applications requiring uniform reinforcement across the outer surface. The ribs 212 arranged in a circumferential pattern can maintain the shape of the stem 210 under varying pressure conditions.
[0053] In another embodiment, the grid pattern includes the ribs 212 arranged in an intersecting manner, combining longitudinal and circumferential reinforcement elements. This configuration provides multidirectional strength, enhancing the structural integrity of the stem 210 under complex loading conditions. The ribs 212 arranged in a grid pattern which is ideal for applications demanding high rigidity and stability. In some embodiment, a combination of these patterns may be used to achieve specific structural and functional benefits by integrating multiple reinforcement strategies.
[0054] Fig. 6A depicts a perspective view, and Fig. 6B depicts cross-sectional views of the collar 220, in accordance with an embodiment of the present disclosure. The collar 220 is coupled to the stem 210 and the handle 250. The collar 220 is disposed within the hub 130. The collar 220 has a cylindrical structure. The collar 220 has a proximal end 220a and a distal end 220b. The collar 220 is disposed in the hub 130 and is coupled to the hub 130. The collar 220 includes an annular groove 232 provided circumferentially on an outer surface of the collar 220. The annular projection 134 is configured to mate with the annular groove 232 of the collar 220, thereby coupling the collar 220 with the hub 130. The collar 220 includes a first hole 224, a second hole 228, and a third hole 230. The first hole 224 is provided at the distal end 220b of the collar 220, and the second hole 228 is provided at the proximal end 220a of the collar 220. The first hole 224 extends longitudinally towards the proximal end 220a of the collar 220 for a partial length of the collar 220. The second hole 228 extends longitudinally towards the distal end 220b of the collar 220 for a partial length of the collar 220. The first hole 224 and the second hole 228 are spaced apart from each other by a predefined distance. The third hole 230 is disposed between the second hole 228 and the first hole 224, connecting them with each other.
[0055] The stem 210 is fixedly coupled with the collar 220. The first hole 224 of the collar 220 is configured to receive the proximal end 210a of the stem 210. The diameter of the first hole 224 corresponds to the diameter of the proximal end 210a of the stem 210. The first hole 224 may be threaded, partially threaded, or smooth. In an embodiment, the first hole 224 has a smooth surface and is coupled with the proximal end 210a of the stem 210 using an adhesive bonding technique such as Loctite® adhesive to ensure a bond between the collar 220 and the proximal end 210a of the stem 210. Following the application of the adhesive, it may undergo UV curing to complete the bonding process. This method firmly attaches the stem 210 to the collar 220, providing rigidity and stability to the guiding element 200.
[0056] The second hole 228 is used to couple the handle 250 with the collar 220. The second hole 228 may be threaded, partially threaded, or smooth. In an embodiment, the second hole 228 is provided with internal threads 233.
[0057] The third hole 230 is configured to provide a passage for the body fluid. The third hole 230 and the lumen 211 of the stem 210 are axially aligned to facilitate the flow of the body fluid such as blood from the cavity inside the patient’s body to the hub 130.
[0058] The dimension of the collar 220 may be chosen based on the dimension of the hub 130. The length of the collar 220 may range from 22.5 mm to 23.5 mm. In an embodiment, the length of the collar 220 is 23 mm. The outer diameter of the collar 220 may range from 8.7 mm to 9.3 mm. In an exemplary embodiment, the length of the collar 220 is 9 mm. The collar 220 may be made of a biocompatible material such as polypropylene, polycarbonate, polyethylene terephthalate (PET), high-density polyethylene (HDPE), low-density polyethylene (LDPE), or the like, or combinations thereof. In an embodiment, the collar 220 is made of medical-grade polypropylene (PP) and low-density polyethylene (LDPE), offering strength and durability. The collar 220 may be manufactured using a molding process.
[0059] Fig. 7 depicts a perspective view of the handle 250, in accordance with an embodiment of the present disclosure. The handle 250 is removably coupled to the collar 220 using the second hole 228. The handle 250 includes a coupling shaft 252 and a disc 254. The coupling shaft 252 extends longitudinally from the disc 254. In an embodiment, the diameter of the disc 254 is larger than the diameter of the coupling shaft 252, forming a T-shaped configuration. The handle 250 may be made of a material such as polypropylene, polycarbonate, polyethylene terephthalate (PET), high-density polyethylene (HDPE), low-density polyethylene (LDPE), or the like, or combinations thereof. In an embodiment, the handle 250 is made of medical-grade polypropylene (PP) and low-density polyethylene (LDPE), both of which offer superior strength and durability. The handle 250 may be manufactured using an injection molding process.
[0060] In an embodiment, the coupling shaft 252 is configured to reside within and is coupled to the second hole 228 of the collar 220. In an embodiment, the coupling shaft 252 may be cylindrical with a uniform diameter. The diameter of the coupling shaft 252 corresponds to the diameter of the second hole 228 of the collar 220. In an embodiment, the outer surface of the coupling shaft 252 may be smooth, semi-threaded, or fully threaded. In an embodiment, the coupling shaft 252 includes threads 252a provided on the outer surface of the coupling shaft 252. The threads 252a of the coupling shaft 252 are configured to mate with the internal threads 233 of the second hole 228 of the collar 220.
[0061] In an embodiment, the disc 254 is coupled to the coupling shaft 252. The disc 254 is configured to rotate, enabling the handle 250 to couple and decouple with the collar 220. Rotating the disc 254 in one direction locks the handle 250 to the collar 220, while rotating the disc 254 in the opposite direction releases the coupling of the handle 250 with the collar 220. The handle 250 is disengaged from the collar 220 when fluid extraction is required, allowing the suction device to operate efficiently without obstruction. The disc 254 may have a predefined shape, such as a square, a triangle, a rectangle, a polygon, etc. In an embodiment, the disc 254 is triangle-shaped with rounded corners and arched sides providing a more ergonomic grip to the user. The exterior surface of the disc 254 is smooth and continuous, minimizing the risk of discomfort, irritation, or slippage during use. The integration of these features results in a robust, functional, and user-friendly handle 250 that enhances the overall performance of the device 10.
[0062] An exemplary method of assembling the device 10 is explained below. In an embodiment, the stem 210 and the collar 220 may be pre-assembled, and the inflating element 120 and the catheter 100 may also be pre-assembled (as depicted in cross-sectional view of the Fig. 8). The distal end 210b of the stem 210 is inserted into the catheter 100 from the proximal end 100a of the catheter 100 through the first port 132 of the hub 130. The insertion continues until the distal end 210b of the stem 210 is positioned between the distal end 110b of the shaft 110 and the distal end 120b of the inflating element 120, and the annular groove 232 of the collar 220 engages with the annular projection 134 of the hub 130 of the catheter 100. As a result, the guiding element 200 is securely coupled to the catheter 100. In an embodiment, the proximal end of the tapered portion 214 is at the proximal end 120a of the inflating element 120. As a result, the tapered portion 214 of the stem 210 engages with the first lumen 112a of the catheter 100, forming an interlocking between them as explained earlier. The threads 252a of the handle 250 are then engaged with the internal threads 233 of the collar 220, thereby forming the guiding element 200.
[0063] An exemplary working of the device 10 is explained below. The catheter 100 is navigated to a desired location such that the inflating element 120 is at a target site such as a uterus or any other organ. The guiding element 200 helps in maintaining the stiffness in the shaft 110, facilitating easy insertion and navigation. The inflation fluid is delivered into the cavity 125 of the inflating element 120 via the second port 133 of the hub 130. As the inflation fluid fills the cavity 125, the inflation fluid exerts pressure on the inner surface of the wall 121 of the inflating element 120, causing the wall 121 to expand uniformly. The expansion of the wall 121 applies direct and even pressure against the walls of the target site, such as the uterine wall, compressing the blood vessels in the area. The compression restricts blood flow and facilitates clot formation, effectively controlling bleeding. The controlled delivery of the inflation fluid ensures consistent expansion of the inflating element 120, providing reliable and targeted pressure without compromising the surrounding tissues of the target site. As the applied pressure stabilizes the target site and clot formation is reinforced, hemostasis is achieved.
[0064] In addition, according to an embodiment, to maintain a clean and stable environment at the target site, excess body fluid, such as blood, is removed. This may be achieved by disengaging the handle 250 from the collar 220, allowing the body fluid to naturally drain through the first port 132 of the hub 130. The gravitational force directs the fluid through the inlet port 113, the lumen 211, and the third hole 230, ensuring a clear field and preventing fluid accumulation at the target site.
[0065] In an embodiment, the excess body fluid may be removed by disengaging the handle 250 from the collar 220 and coupling a suction apparatus with the first port 132 of the hub 130. The suction apparatus is configured to generate suction force that channels the body fluid through the inlet port 113, the lumen 211, and the third hole 230, ensuring a clear field and preventing fluid accumulation at the target site.
[0066] Once hemostasis is achieved and bleeding is effectively controlled, the inflation fluid within the cavity 125 of the inflating element 120 is withdrawn through the second port 133 via the second lumen 112b. As the inflation fluid is removed, the wall 121 of the inflating element 120 gradually deflates, reducing pressure on the target site while maintaining clot stability. The controlled deflation ensures minimal disturbance to the surrounding tissues and prevents rebleeding. Upon confirming the stability of the target site and the absence of active bleeding, the guiding element 200 and the catheter 100 are gently removed with precision to avoid trauma to the treated area, ensuring patient comfort and promoting optimal recovery.
[0067] Fig. 9 illustrates a flowchart of a method 900 for preventing blood flow from a target site using the hemostasis device 10, in accordance with an embodiment of the present disclosure. The insertion of the device 10 may be performed under fluoroscopic guidance or any other guiding technique. At step 901, the device 10 is inserted into a patient’s body through an appropriate access point. In an exemplary embodiment, to control post-partum haemorrhage (PPH), the device 10 may be inserted through cervix or an abdominal cavity created through a surgical incision. The insertion of the device 10 is carefully performed to ensure minimal discomfort and accurate placement, with real-time imaging or navigation assistance used to guide the device 10 to the target site.
[0068] At step 903, the device 10 is navigated to a target site within the pelvic or abdominal cavity. In an example embodiment, the device 10 is navigated to a site of placenta previa. The positioning of the device 10 is adjusted as needed to ensure that the inflating element 120, when inflated, is in optimal contact with the uterine walls.
[0069] At step 905, once the device 10 is properly positioned at the target site, the inflating element 120 is inflated to apply controlled pressure on the surrounding tissue, such as the uterine wall, to achieve hemostasis, effectively preventing or minimizing bleeding by compressing the blood vessels in the affected target site as explained earlier.
[0070] At step 907, once hemostasis is confirmed, excess body fluids are optionally removed from the target site as described earlier.
[0071] At step 909, after ensuring that bleeding is controlled and the target site remains stable, the inflating element 120 is deflated by gradually withdrawing the inflation fluid from the inflating element 120. The controlled deflation of the inflating element 120 minimizes tissue disturbance and prevents rebleeding.
[0072] At step 911, the device 10 is withdrawn from the patient’s body, completing the procedure.
[0073] The device of the present disclosure offers significant advantages in controlling postpartum haemorrhage (PPH). Accurate placement of the inflating element at the target site is ensured, optimizing effectiveness. The device enables a minimally invasive procedure, reducing the need for surgical interventions such as hysterectomy, which promotes faster recovery. The rigidity of the guiding element provides stability during insertion, preventing catheter displacement and offering enhanced control over the procedure. Further, the guiding element prevents the misplacement of the inflating element, enhancing the accuracy and efficacy of the procedure. The blunt tip of the stem minimizes the risk of accidental punctures, ensuring a safe and secure insertion. Additionally, the device streamlines the insertion process, reducing procedure time—a critical factor in emergencies. Once the inflating element is properly positioned, the guiding element can be easily removed without disruption. Ultimately, the device contributes to safer, more efficient management of PPH, offering a vital alternative to more invasive methods. Furthermore, the device is reusable, making the device cost-effective and sustainable.
[0074] 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 hemostasis device (10) for preventing hemorrhage in a cavity of a patient’s body, the device (10) comprising:
a. a catheter (100) comprising a shaft (110) having:
i. a first lumen (112a); and
ii. a second lumen (112b) configured to provide a passage for an inflation fluid;
b. an inflating element (120) mounted on the shaft (110) towards a distal end (110b) of the shaft (110), the inflating element (120) comprising a cavity (125) fluidically coupled to the second lumen (112b) of the shaft (110), the inflating element (120) is configurable between an inflated state and a deflated state; and
c. a guiding element (200) coupled to the catheter (100), the guiding element (200) comprising a stem (210) disposed within the first lumen (112a) of the shaft (110), the stem (210) comprising:
i. a tapered portion (214) provided at a distal end (210b) of the stem (210) and configured to engage with the first lumen (112a) of the shaft (110), wherein a diameter of the tapered portion (214) decreases from a maximum diameter to a minimum diameter, wherein the minimum diameter of the tapered portion (214) is less than the diameter of the first lumen (112a) of the shaft (110) and the maximum diameter of the tapered portion (214) is greater than the diameter of the first lumen (112a) of the shaft (110); and
ii. a body portion (216) extending from the tapered portion (214) to a proximal end (210a) of the stem (210), wherein a diameter of the body portion (216) is less than the minimum diameter of the tapered portion (214).
2. The hemostasis device (10) as claimed in claim 1, wherein the catheter (100) comprises a hub (130) coupled to a proximal end (110a) of the shaft (110), wherein the guiding element (200) comprises:
a. a collar (220) coupled to the stem (210) and the hub (130), the collar (220) comprising:
i. a first hole (224) provided at a distal end (220b) of the collar (220) and configured to receive the proximal end (210a) of the stem (210); and
ii. a second hole (228) provided at a proximal end (220a) of the collar (220); and
b. a handle (250) removably coupled to the collar (220), the handle (250) comprising:
i. a coupling shaft (252) disposed within and coupled to the second hole (228) of the collar (220); and
ii. a disc (254) coupled to the coupling shaft (252).
3. The hemostasis device (10) as claimed in claim 2, wherein the collar (220) comprises an annular groove (232) configured to engage with an annular projection (134) provided in the hub (130).
4. The hemostasis device (10) as claimed in claim 2, wherein the coupling shaft (252) comprises threads (252a) on an outer surface, and the second hole (228) of the collar (220) comprises internal threads (233) configured to engage with the threads (252a) of the coupling shaft (252).
5. The hemostasis device (10) as claimed in claim 2, wherein the collar (220) comprises a third hole (230) provided between the first hole (224) and the second hole (228) of the collar (220) and configured to provide a passage for a body fluid.
6. The hemostasis device (10) as claimed in claim 1, wherein the shaft (110) comprises an inlet port (113) at the distal end (110b) of the shaft (110), the inlet port (113) is configured to receive a body fluid.
7. The hemostasis device (10) as claimed in claim 1, wherein the stem (210) comprises a lumen (211) is configured to provide a passage for a body fluid.
8. The hemostasis device (10) as claimed in claim 1, wherein the distal end (210b) of the stem (210) comprises a blunt tip (213).
9. The hemostasis device (10) as claimed in claim 1, wherein the stem (210) comprises a plurality of ribs (212) provided on an outer surface of a body portion (216) of the stem (210), the plurality of ribs (212) is arranged in a predefined pattern.
10. The hemostasis device (10) as claimed in claim 9, wherein the predefined pattern comprises a helical pattern, a circumferential pattern, a longitudinal pattern, a grid, or combinations thereof.
11. The hemostasis device (10) as claimed in claim 9, wherein the plurality of ribs (212) comprises two or more sets of ribs (A) arranged longitudinally and spaced apart from each other along a length of the body portion (216) of the stem (210), wherein each set of ribs (A) comprises two or more ribs (212) provided circumferentially.
12. The hemostasis device (10) as claimed in claim 1, wherein the tapered portion (214) of the stem (210) has the maximum diameter at a proximal end of the tapered portion (214) and the minimum diameter at a distal end of the tapered portion (214).
13. The hemostasis device (10) as claimed in claim 1, wherein the shaft (110) comprises at least one slit (117) provided on an outer surface of a section of the shaft (110) residing within the inflating element (120), the slit (117) is fluidically coupled to the second lumen (112b) of the shaft (110) and is configured to provide passage for the inflation fluid to enter the cavity (125).