A sub-endometrial needle for administrating a platelet-rich plasma / stem cell solution

Abstract

The present invention is related to medical surgical equipment More preferably, the present invention provides a sub-endometrial needle (100) adapted to receive a removable syringe with stem cell / platelet-rich plasma solution and for administering the said stem cell / platelet-rich plasma solution into the sub- endometrial lining comprising of long needle shaft (101), a needle distal end (102) comprising a bevel (104) and marking (105), a needle proximal end (103) comprising a hub (106), characterized in that the hub is consisting of stop cock valve (108) with flow control knob (109) and syringe interacting part (107) adapted for securing the syringe inside the said needle hub.

Description

[0001] TITLE OF THE INVENTION

[0002] A SUB-ENDOMETRIAL NEEDLE FOR ADMINISTRATING A PLATELET¬

[0003] RICH PLASMA / STEM CELL SOLUTION

[0004] FIELD OF INVENTION

[0005] The present invention is related to medical surgical equipment. More preferably, the present invention provides a modified hysteroscopic injector devised for injection of Platelet-rich plasma or stem cells sterile solution in sub endometrial zone for treatment of thin endometrium. Therefore, the present invention provides a novel sub-endometrial needle for administrating a platelet-rich plasma / stem cell solution.

[0006] BACKGROUD AND PRIOR ART OF THE INVENTION

[0007] In recent years, there has been a notable surge in the demand for in vitro fertilization (IVF) treatment all over the world. One significant reason for the rise in IVF demand is the growing recognition of infertility as a concern affecting both males and females. Couples have come to understand the importance of determining the underlying cause of infertility and seeking appropriate treatment.

[0008] Many women undertaking IVF treatment undergo the transfer of multiple good quality embryos and never have a successful pregnancy, suggesting a major impediment to implantation. Where, the women embryos fail to successfully implant, rather than being incapable of producing embryos, which of course implies an underlying implantation deficit such as thin endometrium.

[0009] A thin endometrium can significantly impact fertility because the endometrial lining plays a critical role in implantation and sustaining early pregnancy. The endometrium provides a nurturing environment for the embryo to implant and develop. A thin endometrium may lack sufficient blood supply and nutrients, reducing the chances of successful implantation. The ideal thickness of the endometrial lining during the implantation window (usually around the time of ovulation) is typically between 7-14 mm. A good adequately thick linings within this range are associated with higher implantation and pregnancy rates.

[0010] The impact of thin endometrium on IVF includes reduced implantation rates. A thin endometrium may not provide a conducive environment for the embryo to implant and therefore increase risk of miscarriage. If implantation occurs, a thin endometrium may not support the pregnancy, leading to early pregnancy loss.

[0011] Therefore, in IVF or IUI cycles, thin endometrium is associated with reduced success rates, even when high-quality embryos are transferred.

[0012] • Causes for thin endometrium:

[0013] 1. Hormonal Imbalances: Low estrogenic levels, as oestrogen is crucial for endometrial growth.

[0014] 2. Uterine Scarring (Asherman’s Syndrome): Scar tissue from previous surgeries, infections, or trauma can lead to a thinner lining.

[0015] 3. Chronic Endometritis: Long-term inflammation of the uterine lining due to various infections.

[0016] 4. Certain Medications: Prolonged use of clomiphene citrate (Clomid) or other fertility drugs may thin the endometrial lining.

[0017] 5. Reduced Blood Flow: Poor uterine blood flow can result in inadequate endometrial development.

[0018] Platelet-Rich Plasma (PRP) has emerged as a viable treatment technique in reproductive medicine, substantially improving endometrial receptivity by increasing the health of endometrium lining.

[0019] So, above thin endometrium fertility issue can be solved by Platelet-Rich Plasma (PRP) therapy or Stem cell therapy. As Platelets contain growth factors and cytokines that are vital for tissue repair and regeneration. Its key components are various growth factors Such as platelet-derived growth factor (PDGF), transforming growth factor-beta (TGF-P), and vascular endothelial growth factor (VEGF) and cytokines: Help modulate inflammation and promote tissue healing. PRP is a simple and minimally invasive procedure. In this therapy, a small amount of blood is taken from the patient’s body, usually from the arm, and then centrifugation of that blood is done. This helps to separate the platelets from the other components of the blood. After this, the concentrated platelet-rich plasma is then injected into a particular area under ultrasound guidance such as in the uterus.

[0020] Similarly, the Stem cell therapy is a form of regenerative medicine that uses stem cells or their derivatives to promote the repair, regeneration, or replacement of damaged tissues and organs. Stem cells have the unique ability to develop into various specialized cell types, making them valuable in treating a wide range of diseases and injuries. Stem cells are undifferentiated cells capable of self-renewal (They can divide and replicate for long periods) and differentiation (They can develop into specific cell types, such as muscle, nerve, or blood cells.)

[0021] Therefore, the Platelet-rich plasma (PRP) or Stem cell that can help improve endometrial thickness and receptivity, and can be used to treat thin endometrium, wherein PRP solution / Stem cell sterile solution is injected into the sub-endometrial zone.

[0022] Sub-endometrial PRP or stem cell injection is relatively new technique of regenerative medicine used for treatment of thin endometrium. Currently no specific injection needle is available or not yet designed especially for this purpose. The needles which are commonly used world wide are ovum pick up needles with or without temporary modifications such as attaching flexible tubing.

[0023] Some practitioners also uses commonly used hysteroscopic needles such as wing needle (to inject local anaesthetic agent in the endometrium), Lina operascope needle for cystoscopic injections in urinary bladder wall or angiography microcatheters. The main problem associated with commonly used hysteroscopic needles are mixing of Stem cell or PRP solution with distension medium used (Media used to distend the uterine cavity) and thereby dilution of Stem cell or PRP solution and hence affecting the required concentration to be injected into a sub-endometrium lining. Therefore, there is need of appropriate injection system / injector for injecting a highly purified and sterile solution of stem cell / PRP into the sub-endometrium without any dilution with distension medium.

[0024] Hence, the ideal hysteroscopic needle for sub-endometrial stem cell / PRP injection should have following features: i. Thin diameter, so as to go through working channel of operative hysteroscope ii. Long length iii. Fine and flexible to allow precise injection under direct vision of the uterine cavity and sub-endometrial zone. iv. The Stem cell or PRP solution should not get mixed with the distension medium used therein v. Distension medium under high pressure should not enter in the injector needle causing backflow of the high-pressure fluid in the syringe attached.

[0025] Therefore, it would further be advantageous to provide such injection system with less complex structure, low cost as minimum joints and easy handling for effective injection of Stem cell / PRP solution. This would enable medical practitioner to safely inject pure and adequate quantity of PRP / stem cell solution into depth of endometrial lining typically between 7-14 mm. That will increase the higher implantation and pregnancy rates. SUMMARY OF THE INVENTION:

[0026] The present invention provides a novel sub-endometrial needle (100) adapted to receive a removable syringe with stem cell / platelet-rich plasma solution and for administering the said stem cell / platelet-rich plasma solution into the sub- endometrial lining comprising of:

[0027] -a long needle shaft (101),

[0028] -aneedle distal end (102) comprising a bevel (104) and marking (105), more specifically marking / grooves (105) selected between 8 to 15 and at a distance of 1 mm each.,

[0029] - a needle proximal end (103) comprising a hub (106), characterized in that the hub is consisting of stop cock valve (108) with flow control knob (109) and syringe interacting part (107) adapted for securing the syringe inside the said needle hub.

[0030] The non-limiting example type of bevel (104) is selected from Quincke bevel (30- 45° tip angle) regular bevel (12-15°) and short bevel (18-20° tip angle).

[0031] The non-limiting examples of material of construction of needle (100) selected from stainless steel or niobium and alloy thereof. Therefore, the present invention needle is sterile and can be use multiple time. Thus saves cost of treatment.

[0032] DESCRIPTION OF DRAWINGS:

[0033] For a more description of the invention the complete specification is accompanying with figures and in which:

[0034] Figure No. 1 - Illustrate the perspective view of sub-endometrium injector (100) as per present invention. Figure No. 2 - Illustrate the front view of tip of sub-endometrium injector (100) as per present invention.

[0035] Figure No. 3 - Illustrate the front view of tip of sub-endometrium injector (100) as per present invention.

[0036] Figure No. 4- Illustrate the front view of hub of view of sub-endometrium injector (100) as per present invention.

[0037] BRIEF DESCRIPTION OF THE INVENTION

[0038] In any embodiment described herein, the open-ended terms "comprising," "comprises,” and the like (which are synonymous with "including," "having” and "characterized by") may be replaced by the respective partially closed phrases "consisting essentially of," consists essentially of," and the like or the respective closed phrases "consisting of," "consists of, the like.

[0039] Similarly, the open-ended terms "injector," "needle,” "device,” "system,” "apparatus,” and the like may be replaced by the respective partially closed phrases.

[0040] The present invention is related to injection system for administrating a plateletrich plasma / stem cell solution into the sub-endometrium zone, which is the junction between the endometrium and myometrium. The endometrium is the tissue that lines the uterus, or womb, and plays a key role in human reproduction. The normal endometrial thickness for pregnancy is between 8-15 millimeters. This thickness is ideal for creating a healthy environment for the embryo to attach and grow. Thin endometrium refers to endometrium lining less than 7 mm.

[0041] But as discussed in the background of the invention, the thin endometrium becomes a very important factor in conceiving. One of the methods for treatment of thin endometrium lining involves sub-endometrial platelet-rich plasma (PRP) therapy, which is a minimally invasive procedure that involves injecting PRP into the sub- endometrial layer of the uterus to improve endometrial thickness and vascularity. This can help with embryo implantation and clinical pregnancy rates, especially for women with thin endometrium.

[0042] The invention addresses the limitation of existing used oval pickup needle by providing a clear and reliable indication of proper location of injection. This newly developed PRP injection system promotes targeted delivery of PRP solution / Stem cell solution and reduces the risk of dilution with distension medium.

[0043] The said objective of present invention is achieved by incorporating the two features into the injector device, firstly a modified needle’s tip and secondly a modified needle hub.

[0044] Referring to Figure no. 1, the present invention provides sub-endometrial stem cell or platelet-rich plasma (PRP) solution injector (100) comprising of needle shaft (101), needle tip (102) and needle adapter (103). Wherein Luer lock syringe can be easily attached to the hub end of said needle (100) to inject the PRP solution / Stem cell solution into the pelvic cavity of women.

[0045] According to important embodiment of the present invention and referring to Figure no. 2, 3 and 4, the present invention provides sub-endometrial stem cell or plateletrich plasma (PRP) solution injector (100) comprising of bevel (104) and marking (105) at the distal end of injector and needle hub (106), valve (108) having plug to open and close the valve (109) and syringe inlet (107) having internal threading at the proximal end.

[0046] According to one of the embodiment of the present invention, the sub-endometrium needle is modified at the tip (102) orthe working end ofthe injector. Typically, this is designed to be a sharp, sloping edge tip (bevel). Non limiting example of bevel includes short bevel (30-45° tip angle) and long bevel (12-15°). This tip pierces the endometrium to deliver PRP solution / stem cell solution in a sub-endometrial region. Preferably, as per invention features, this tip has markings (105) on it at a distance of 1 mm each and preferably such 10 marking or more than that, so that a medical practitioner knows how much deep the needle is going inside the endometrium and so that the PRP solution / stem cell solution can be precisely delivered at desired depth (i.e. not too much deep in myometrium nor too much superficial inside the endometrium itself.)

[0047] According to one more embodiment of the present invention, the needle is modified at the hub (106) and said modification of the sub-endometrium Injector is designed for attachment of a syringe filled with Stem cell / PRP solution. Here a Luer lock syringe can be easily attached by twisting movement of the syringe. The luer lock syringe if fitted, provide leak-free connections between sub-endometrium Injector and syringe filled with stem cell or PRP solution. It also maintains a continuous lumen for fluid flow.

[0048] Further, the modified hub (106) is provided with a stop cock valve (108) to prevent back flow of the distension medium in to the injector and attached syringe. Stopcocks serves to regulate, interrupt or completely stop the flow of stem cell or PRP solution and high-pressure distension medium. When the knob of the stop cock valve is in direction of the injector, the lumen remains open and the solution can be injected by pushing piston of the syringe. Once the desired amount of solution is injected the operator can turn the knob at 90 degrees so as to close the valve. Once the knob is turned 90 degrees to the long end of the injector the injector gets closed and the solution can not be pushed in by any force on piston of the syringe.

[0049] The present invention also provides the method of use of a sub-endometrial needle / inj ection device for administrating a platelet-rich plasma / stem cell solution. In process of hysteroscopy process the medical practitioner use distension medium of normal saline at the pressure of around 100-120 mm of Hg. Typically, hysteroscopy is done to see interior of the uterus. While doing hysteroscopy for thin endometrium, practitioner inject the stem cell solution or PRP solution in all four walls of the uterus and fundus of the uterus. It takes certain time to decide and project exact point of injection and during that phase sub-endometrium injector is in operative cannel of the hysteroscope. The distension medium going in the cavity finds path of the least resistance to come back which is operative cannel and the sub-endometrium injector. If the stock cock (108) is not provided to the injector the fluid at the pressure of 110-120 mm of Hg with easily enters in the injector and as it is under pressure it with come inside the attached syringe and fdl attached syringe and dilute the stem cell or PRP solution. The stock cock overcomes this problem by simply turning the knob 90 degrees to the long axis it closes the lumen and fluid cannot enter in the injector. While injector is in the operative channel of the hysteroscope or in the distended cavity of the uterus the stop cock has to be in closed position. Once the uterine wall is pierced at the desired site and up to desired depth the stop cock has to opened and the solution is to be injected. Once desired amount of the solution is injected the stop cock has to turned off by turning knob by 90 degrees. The operator / surgeon should wait for 1 minute at this point so that during that period the stem cell or sub-endometrium solution will get absorbed in the sub endometrial zone. After one minute surgeon withdraws the injector and locate next point of injection. When the next point of injection is pierced the stock cock has to be opened to push the solution and closed after desired amount of solution is injected.

[0050] One more advantage of present invention is the reusability, as the entire needle (100) is made up of medical grade metal and hence can be sterilize after every use. As currently available needle for said procedure is single use ovum pick up needles which has connecting plastic hub and plastic tubing. So this type of needle are used and through. The cost of such ovum pick up needles are very high and each patient needs to bear this cost at every treatment stage.

[0051] Therefore, the inventors of the present invention, developed a multiuse subendometrium needle (100) and hence the invention provides an economic benefits the patients.

[0052] The present invention also provides a protective sheath to safe guard the long and delicate bevel of said needle (100). Wherein, the hallow tube can be securely placed above the shaft of said needle. This is called outer sheath and it is provided to cover the injector in storage phase. It can be threaded on the injector, and the threads for the same are provided at the hub of the injector. The present invention is further described with the help of the following nonlimiting examples, which are given by way of illustration.

[0053] Example 1: Typical dimensions of the sub-endometrium injector:

[0054] 1. Bevel of the injector: 10mm

[0055] 2. Shaft of the injector: 440mm

[0056] 3. Hub of the needle 20 mm

[0057] 4. Overall length of the injector 470mm

[0058] 5. Lenth of the protective sheath: 410 mm

[0059] 6. Diameter of the injector: a. 4Fr = 1.33 mm b. 5Fr = 1.66 mm

[0060] MATERIAL USED:

[0061] Medical grade stainless steel is used for production of this injector which can withstand high temperature and pressure for sufficient duration which makes the sub-endometrium injector fully autoclavable and reusable.

[0062] Advantages of present invention:

[0063] As present invention have provided the multiple use sub-endometrium needle for easy and accurately injecting the sterile stem cell solution or PRP solution into the endometrium tissue at specific location i.e. at the depth of endometrial lining typically between 7-14 mm.

[0064] Because, the invention needle (100) provides an marking at the tip that enable medical practitioner to identify the depth of injection tip and also needle provided with stock cock at the proximal end that avoids back entering distal fluid inside the attached syringe and ultimately avoids contamination / mixing of dilute the stem cell or PRP solution, which was ready for injection.

Claims

CLAIMSWe claim;1. A sub-endometrial needle ( 100) adapted to receive a removable syringe with stem cell / platelet-rich plasma solution and for administering the said stem cell / platelet-rich plasma solution into the sub-endometrial lining comprising of:-a long needle shaft (101),-a needle distal end (102) comprising a bevel (104) and marking (105),- a needle proximal end (103) comprising a hub (106), characterized in that the hub is consisting of stop cock valve (108) with flow control knob (109) and syringe interacting part (107) adapted for securing the syringe inside the said needle hub.

2. The sub-endometrial needle (100) as claimed in claim 1, wherein bevel (104) is selected from Quincke bevel having 30-45° tip angle.

3. The sub-endometrial needle ( 100) as claimed in claim 1 , wherein number of marking (105) is selected between 8 to 15 and at a distance of 1 mm each.

4. The sub-endometrial needle (100) as claimed in claim 1, wherein stop cock valve (108) selected from one way.

5. The sub-endometrial needle (100) as claimed in claim 1, wherein the material of construction of needle (100) selected from stainless steel.

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