L-PRF MESH REPAIR FOR INGUINAL HERNIA

Abstract

A platelet-rich fibrin (PRF) three-dimensional, adhesive, biocompatible and biodegradable scaffold and/or membrane is obtained by collecting a blood sample, followed by centrifugation of the blood sample to obtain a platelet-rich fibrin clot and an exudate followed by compressing platelet-rich fibrin clot to extract the exudate until the final product being a platelet-rich fibrin three-dimensional, adhesive, biocompatible and biodegradable scaffold is obtained. A hyper-acute serum is obtained by collecting a blood sample, followed by centrifugation of said blood sample to obtain a platelet-rich fibrin clot and an exudate followed by compressing platelet-rich fibrin clot to obtain the membrane and extract the exudate being the final product hyper-acute serum. A process for the preparation of a platelet-rich fibrin three-dimensional, adhesive, biocompatible and biodegradable scaffold and/or membrane and a hyper-acute serum is also provided. A method for the treatment of inguinal hernia in a patient in need thereof is also provided.

Claims

1. A platelet-rich fibrin (PRF) three-dimensional, adhesive, biocompatible and biodegradable scaffold and/or membrane obtained by collecting a blood sample, followed by centrifugation of said blood sample to obtain a platelet-rich fibrin clot and an exudate followed by compressing platelet-rich fibrin clot to extract the exudate until the final product, being a platelet-rich fibrin three-dimensional, adhesive, biocompatible and biodegradable scaffold, is obtained.

2. A hyper-acute serum obtained by collecting a blood sample, followed by centrifugation of said blood sample to obtain a platelet-rich fibrin (PRF) clot and an exudate followed by compressing platelet-rich fibrin clot to obtain a membrane and extract the exudate, being the final product hyper-acute serum.

3. A process for the preparation of a platelet-rich fibrin (PRF) three-dimensional, adhesive, biocompatible and biodegradable scaffold and/or membrane and a hyper-acute serum comprising the following steps: a) collecting blood samples, followed by centrifugation to obtain a platelet-rich fibrin clot and an exudate; and b) compressing the platelet-rich fibrin clot as obtained in step a) to extract the exudate to obtain the final products being the hyper-acute serum and a platelet-rich fibrin (PRF) three-dimensional, adhesive, biocompatible and biodegradable scaffold and/or membrane.

4. A method for the treatment of inguinal hernia in a patient in need thereof comprising the step of: a) performing a transverse incision on the inguinal region; b) positioning a self-retaining retractor with smooth non-traumatic branches into a surgical access created by the incision; c) preparing with minimal manipulation of the inguinal sac from the spermatic cord and to make a space where a mesh will be located, minimizing detachment of tissues and respecting any nerves that cross the area, while checking hemostasis step by step; d) isolating and examining contents of the inguinal sac of step c); e) repositioning the inguinal sac into the patient's abdomen and the internal inguinal ring refashioned using stitches wherein in case of direct hernia the trasversalis fascia is approximated with the same suture material; f) customizing a mesh to the patient's inguinal region, wherein the mesh is a soft, light, macroporous, monofilament, polypropylene mesh BARD, configured to the shape and size of the inguinal canal and fixed in place with a 2 cm overlap of the mesh above the tubercle; g) fixing the mesh by using a platelet-rich fibrin three-dimensional, adhesive, biocompatible and biodegradable scaffold and/or membrane and a hyper-acute serum to fix the mesh and secure a tension-free technique prepared by collecting the patient's blood in glass-coated plastic tubes and immediately centrifuging to obtain three distinct layers in the centrifugation tube: red blood corpuscles RBCs at a bottom of the tube, platelet-poor plasma PPP on the top of the tube, and the PRF clot in the middle of the tube, removing the PRF clot was from the tube with surgical tweezers; squeezing out serum from the PRF clot to generates PRF membranes and the hyper-acute serum, PRF clots used to fix the mesh; h) applying both components, membranes and hyper-acute serum on a posterior fascia (trasversalis) and the mesh attached over them; i) using two single stitches to adjust the mesh: one in the tubercle area avoiding the periosteum and another one to close the mesh tails; j) suturing the anterior fascia below the spermatic cord using stitches to press the mesh between the anterior and the trasversalis fascia; and k) fat suturing and skin intradermic suture.

5. The platelet-rich fibrin (PRF) three-dimensional, adhesive, biocompatible and biodegradable scaffold and/or membrane according to claim 1 obtained by collecting blood samples, followed by centrifugation, wherein the blood sample is 9 ml of fresh blood centrifuged at 2700 rpm for 12 minutes or 10 ml of fresh blood centrifuged at 1500 rpm for 14 minutes.

6. The hyper-acute serum according to claim 2 obtained by collecting blood samples, followed by centrifugation, wherein the blood sample is 9 ml of fresh blood centrifuged at 2700 rpm for 12 minutes or 10 ml of fresh blood centrifuged at 1500 rpm for 14 minutes.

7. The process for the production of a platelet-rich fibrin (PRF) three-dimensional, adhesive, biocompatible and biodegradable scaffold and/or membrane and a hyper-acute serum according to claim 3, wherein the blood sample is 9 ml of fresh blood which is immediately centrifuged at 2700 rpm for 12 minutes or the blood sample is 10 ml of fresh blood immediately centrifuged at 1500 rpm for 14 minutes.

8. The method for the treatment of inguinal hernia according to claim 4, wherein the method is carried out using transabdominal preperitoneal patch plasty (TAPP) laparoscopy, or totally extraperitoneal (TEP) laparoscopy.

9. The method for the treatment of Inguinal Hernia according to claim 4 wherein in step h), three (3) to five (5) L-PRF clots used to fix the mesh.

10. The method for the treatment of inguinal hernia according to claim 4 wherein stitches are polyglactin (vicryl) 2-0 or polyglycolic acid-Vicryl.

11. The method for the treatment of inguinal hernia according to claim 4, wherein the method is carried out under local or general anesthesia.

12. The method for the treatment of inguinal hernia according to claim 4, wherein the transverse incision on the inguinal region is 5-6 cm in length.

13. The method for the treatment of inguinal hernia according to claim 4, wherein the stiches used are polyglactin (vicryl) 2-0 or polyglycolic acid-Vicryl.

14. The method for the treatment of inguinal hernia according to claim 4, wherein the platelet-rich fibrin (PRF) three-dimensional, adhesive, biocompatible and biodegradable scaffold and/or membrane and a hyper-acute serum to fix the mesh and secure a tension-free technique is prepared by collecting 9 ml fresh patient's blood and immediately centrifuging at 2700 rpm for 12 minutes.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0085] The following detailed description of the preferred embodiment of the present invention will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there are shown in the drawings embodiments which are presently preferred. It is understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown. In the drawings:

[0086] FIG. 1 is a depiction of a patient's blood in a glass-coated plastic tube immediately centrifuging to obtain three distinct layers in the centrifugation tube;

[0087] FIG. 2 is shows a PRF clot being removed from a centrifuge tube;

[0088] FIG. 3 shows a PRF and hyper-acute serum positioned onto the transversalis fascia;

[0089] FIG. 4 shows a PRF being placed in position; and

[0090] FIG. 5 shows PRF applied to the posterior wall of the inguinal canal.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0091] Certain terminology is used in the following description for convenience only and is not limiting. The words “right,” “left,” “top,” and “bottom” designate directions in the drawings to which reference is made. The words “a” and “one,” as used in the claims and in the corresponding portions of the specification, are defined as including one or more of the referenced items unless specifically stated otherwise. This terminology includes the words above specifically mentioned, derivatives thereof, and words of similar import. The phrase “at least one” followed by a list of two or more items, such as “A, B, or C,” means any individual one of A, B or C as well as any combination thereof.

[0092] Within the meaning of the present invention PRF is an autologous biomaterial that is made of a strong fibrin matrix which variably contains a high concentration of vital and non-vital: platelets, leucocytes and circulating MSCs; variable pool of cytokines an elevated concentration of long releasing growth factors (GFs). These include platelet-derived growth factor (PDGF A-B), vascular endothelial growth factor (VEGF), transforming growth factor (TGF β-1,2), insulin-like growth factor (IGF-I), epidermal growth factor (EGF); connective tissue growth factor (CTGF); bone morphogenetic protein 2 (BMP-2), an elevated concentration of fibrin, fibronectin, vitronectin, and thrombospondin, a variable pool of heat shock proteins HSPs. [Dhurat R, Sukesh M S. Principles and Methods of Preparation of Platelet-Rich Plasma: A Review and Author's Perspective. J Cutan Aesthet Surg. 2014 October-December; 7(4): 189-197].

[0093] For PRF production, blood samples are collected from the patient in sterile plastic-coated tubes to be immediately treated in a centrifuge, are known various protocols to centrifuge blood and thereby produce different kinds of PRF with different properties.

[0094] After centrifugation, through the activation of autologous thrombin, a fibrin clot is created. As depicted in FIG. 1, three distinct layers can be seen in the tube 10 as red blood corpuscles RBCs 40 at the bottom of the tube, platelet-poor plasma PPP 20 on the top of the tube, and the PRF clot 30 in the middle of the tube.

[0095] The PRF clot 30 can be removed from the tube 10 with surgical tweezers 50 (FIG. 2). The clot 30 by itself contains a great amount of exudate, which is rich in growth factors, and this exudate can be pressed out by gentle compression of the clot in order to obtain PRF membranes.

[0096] Serum squeezed out from the PRF clot, called hyper-acute serum, has a greater cell proliferative effect on different connective cell lineages such as bone marrow mesenchymal stem cells (MSCs), osteoblasts, chondroblasts and fibroblast cells [Simon M, Major B, Vácz G, Kuten O, Hornyák I, Hinsenkamp A et al. The Effects of Hyperacute Serum on the Elements of the Human Subchondral Bone Marrow Niche. Stem Cells Int. 2018; 2018:4854619].

[0097] PRF does not require any biochemical additives like anticoagulants or bovine thrombin for fibrin polymerization to be made

[0098] PRF can be produced using different amount of blood generally 8-12 ml per vials (red coated tube) and can be produced in multiple vials up to the maximum amount that can be allocated in the centrifuge.

[0099] Therefore, other PRFs produced with different amounts of blood, centrifuge speed and time and, with the characteristics reported above and below should be considered suitable for the claimed invention.

[0100] A PRF (platelet-rich fibrin) three-dimensional, adhesive, biocompatible and biodegradable scaffold and/or membrane is obtained by collecting a blood sample, followed by centrifugation of said blood sample to obtain a platelet-rich fibrin clot 30 and an exudate followed by compressing platelet-rich fibrin clot to extract the exudate until the final product being a platelet-rich fibrin three-dimensional, adhesive, biocompatible and biodegradable scaffold is obtained.

[0101] A hyper-acute serum is obtained by collecting a blood sample, followed by centrifugation of said blood sample to obtain a platelet-rich fibrin clot and an exudate followed by compressing platelet-rich fibrin clot to obtain the membrane and extract the exudate being the final product hyper-acute serum.

[0102] A process for the preparation of a Platelet-rich fibrin three-dimensional, adhesive, biocompatible and biodegradable scaffold and/or membrane and a hyper-acute serum includes the following steps:

a) collecting blood samples, followed by centrifugation to obtain a platelet-rich fibrin clot and an exudate;
b) gently compressing the platelet-rich fibrin clot as obtained in step a) to extract the exudate to obtain the final products being the hyper-acute serum and a platelet-rich fibrin (PRF) three-dimensional, adhesive, biocompatible and biodegradable scaffold and/or membrane.

[0103] A method for the treatment of inguinal hernia in a patient in need thereof includes the steps of:

a) performing a small transverse incision on the inguinal region;
b) positioning a self-retaining retractor 60 with smooth non-traumatic branches;
c) sharply cutting tissues avoiding any stretching or shredding during the dissection;
d) preparation with minimal manipulation of the sac from the cord and to make the space where the mesh will be located, minimizing the detachment of tissues and respecting the nerves that cross the area, while hemostasis checked step by step;
e) isolation and examination of the content of the sac of step d);
f) repositioning of the sac into the abdomen and the internal inguinal ring refashioned using stitches wherein in case of direct hernia the trasversalis fascia is approximated with the same suture material;
g) customization of a mesh to the patient's inguinal region, wherein the mesh is a soft, light, macropores, monofilament, polypropylene mesh BARD, designed according to the shape and size of the inguinal canal and fixed in place with a 2 cm overlap of the mesh above the tubercle;
h) mesh fixation by using a platelet-rich fibrin three-dimensional, adhesive, biocompatible and biodegradable scaffold and/or membrane and a hyper-acute serum to fix the mesh and secure a tension-free technique prepared by collecting patient's blood in glass-coated plastic tubes and immediately centrifuging to obtain three distinct layers in the centrifugation tube: red blood corpuscles RBCs at the bottom of the tube, platelet-poor plasma PPP on the top of the tube, and the PRF clot in the middle of the tube, removing the PRF clot was from the tube with surgical tweezers; squeezing out serum from the PRF clot to generates PRF membranes and the hyper-acute serum, PRF clots used to fix the mesh;
i) application of both components membranes and hyper-acute serum on the posterior fascia (trasversalis) and the mesh attached over them (FIG. 3);
j) using two single stitches to adjust the mesh: one in the tubercle area avoiding the periosteum and another one to close the mesh tails;
k) suturing the anterior fascia below the spermatic cord using stitches to press the mesh between the anterior and the trasversalis fascia; and
l) fat suturing and skin intradermic suture.

[0104] The centrifugation of blood sample is performed at any appropriate and/or effective and/or suitable combination of time and speed to obtain the final products, i.e. a platelet-rich fibrin three-dimensional, adhesive, biocompatible and biodegradable scaffold and/or a hyper-acute serum. An example of an appropriate combination is centrifugation at 2700 rpm for 12 minutes.

[0105] In an embodiment the platelet-rich fibrin (PRF) three-dimensional, adhesive, biocompatible and biodegradable scaffold and/or membrane is obtained by collecting blood samples, followed by centrifugation, wherein the blood sample is 9 ml of fresh blood centrifuged at 2700 rpm for 12 minutes or 10 ml of fresh blood centrifuged at 1500 rpm for 14 minutes. Preferably the hyper-acute serum is obtained by collecting blood samples, followed by centrifugation, wherein the blood sample is 9 ml of fresh blood centrifuged at 2700 rpm for 12 minutes or 10 ml of fresh blood centrifuged at 1500 rpm for 14 minutes.

[0106] In an embodiment the process for the production of a platelet-rich fibrin (PRF) three-dimensional, adhesive, biocompatible and biodegradable scaffold and/or membrane and a hyper-acute serum comprises the following steps:

a) collecting blood samples, followed by centrifugation, preferably the blood sample is 9 ml of fresh blood which is immediately centrifuged at 2700 rpm for 12 minutes or the blood sample is 10 ml of fresh blood immediately centrifuged at 1500 rpm for 14 minutes; and
b) gently compressing the platelet-rich fibrin (PRF) clot as obtained in step a) to extract the exudate to obtain the final product being the hyper-acute serum to obtain a Platelet-rich fibrin (PRF) three-dimensional, adhesive, biocompatible and biodegradable scaffold and/or membrane and a hyper-acute serum as final products.

[0107] The surgical method includes any variation such as laparoscopy, including TAAP and TEP, and different types of suture material.

[0108] Preferably in step h), 3 to 5 L-PRF clots are used to fix the mesh.

[0109] Stitches can be polyglactin (vicryl) 2-0 or polyglycolic acid-Vicryl.

[0110] The open mesh repair procedure can be delivered under local or general anesthesia.

[0111] Preferably the platelet-rich fibrin (PRF) is L-PRF.

[0112] In an embodiment the treatment of an inguinal hernia comprises the steps of:

a) performing a small transverse incision of 5-6 cm on the inguinal region;
b) positioning a self-retaining retractor with smooth non-traumatic branches;
c) sharply cutting tissues avoiding any stretching or shredding during the dissection;
d) preparation with minimal manipulation of the inguinal sac from the cord and to make the space where the mesh will be located, minimizing the detachment of tissues and respecting the nerves that cross the area, while hemostasis checked step by step;
e) isolation and examination of the content of the sac of step d);
f) repositioning of the inguinal sac into the abdomen and the internal inguinal ring refashioned using polyglactin (vicryl) 2-0 or polyglycolic acid-Vicryl) stitches wherein in case of direct hernia the trasversalis fascia is approximated with the same suture material;
g) customization of a mesh to the patient's inguinal region, wherein the mesh is a soft, light, macroporous, monofilament, polypropylene mesh BARD, designed according to the shape and size of the inguinal canal and fixed in place with a 2 cm overlap of the mesh above the tubercle;
h) mesh fixation by using a Platelet-rich fibrin (PRF) three-dimensional, adhesive, biocompatible and biodegradable scaffold and/or membrane and a hyper-acute serum to fix the mesh and secure a tension-free technique prepared by collecting 9 ml fresh patient's blood in glass-coated plastic tubes and immediately centrifuging at 2700 rpm for 12 minutes to obtain three distinct layers in the centrifugation tube: red blood corpuscles RBCs at the bottom of the tube, platelet-poor plasma PPP on the top of the tube, and the PRF clot in the middle of the tube, removing the L-PRF clot was from the tube with surgical tweezers; squeezing out serum from the PRF clot to generates PRF membranes and the hyper-acute serum, at least 3 L-PRF clots used to fix the mesh;
i) application of both components membranes and hyper-acute serum on the posterior fascia (trasversalis) and the mesh attached over them;
j) using two single stitches in Vicryl 2-0 or polyglycolic acid-Vicryl to adjust the mesh: one in the tubercle area avoiding the periosteum and another one to close the mesh tails;
k) suturing the Anterior fascia below the spermatic cord using Vicryl 2-0 or polyglycolic acid-Vicryl stitches to press the mesh between the anterior and the trasversalis fascia; and
l) fat suturing with Vicryl 2-0 or polyglycolic acid-Vicryl and skin intradermic suture with Monocryl 3-0.

[0113] In an embodiment a small (5-6 cm) transverse incision on the inguinal region reduces skin tension following the natural Langer's lines; they are linear clefts in the skin that indicate the direction and orientation of the underlying collagen fibers. A small incision provides a proper exposition of the inguinal region. Retractors need to be moved gently; they should have smooth and not dentate edges.

[0114] Minimal manipulation is suggested to avoid any stretching and shredding of tissue. Tissue needs to be sharply cut following a constant dissection line, recognizing any different tissue layers to perform those minimal dissections necessary for completing the operation. Hemostasis needs to be checked step by step.

[0115] After the inguinal sac has been isolated and its contents examined, it will be repositioned into the abdomen and the internal inguinal ring refashioned using polyglactin (vicryl) 2-0 stitches. In the case of direct hernia, the trasversalis fascia needs to be approximated with the same suture material.

[0116] In preparing a suitable space to position the mesh, it is important to minimize the detachment of tissues and in particular to respect as much as possible the nerves that cross the area. The choice of an appropriate size, soft, light, macroporous, monofilament, polypropylene mesh is fundamental, as is the fixation method.

[0117] L-PRF clot with both components membrane and hyper-acute serum was used to fixing the mesh and secure a real tension-free technique.

[0118] Only two single stitches have been applied to the mesh: one in the tubercle area and another one to close the mesh tails. Vicryl 2-0 absorbable is always used to reduce risks of chronic nerve entrapment syndrome.

[0119] The anterior fascia is sutured below the spermatic cord using vicryl 2-0 stitches, to reduce the empty space and press the mesh between the trasversalis (posterior) and anterior fascia, ensuring that the spermatic cord is not on the way.

[0120] The fascia, sutured with absorbable (vicryl 2-0) stitches, places and compresses the mesh in the right space reducing the postoperative collection, indeed facilitating the integration process.

[0121] These basic principles reduce edema, collection and postoperative acute inflammation. These are the main factors that hinder the integration process and trigger postoperative pain.

[0122] In particular, PRF combines the benefits of fibrin glue sealant with the ability to streamline the integration of the mesh by optimizing connective tissue regeneration. Moreover, PRF regenerative capacities substantially prevent chronic fibrotic inflammation, mesh retraction, hard and painful scars and chronic nerve entrapment syndrome.

[0123] L-PRF shows some additional and essential clinical improvements: satisfactory fixation of the mesh; superior hemostasis; less local inflammation; avoidance of nerve entrapment; streamlining the mesh integration process and tissue regeneration.

[0124] The L-PRF is an autologous platelet-rich fibrin centrifuge product. The centrifuge characteristics and centrifugation protocols impact significantly on the characteristics of PRF.

[0125] The centrifugation protocol we have been using enables the production of L-PRF with good glue and scaffolding performance and also with tissue regeneration properties.

[0126] The surgical method, also named PRF-open mesh repair, is a tension-free technique that follows sound regenerative surgery principles.

[0127] The surgical technique, material choice, biological method of fixation and the regenerative properties of PRF, all described above, minimize wound site inflammation and assist correct integration of the mesh.

[0128] Postoperative advantages: less pain and shorter time of recovery are clear short-term benefits. Mid-long term benefits: lower incidence of chronic pain due to a correct process of wound healing and minimizing the risk of nerve entrapment.

[0129] Clinical Results

[0130] 5 male patients were treated with the PRF-open mesh repair technique. Patients' average age was 52; 4 patients affected by single primary inguinal hernia and 1 had a bilateral one. 3 direct and 3 indirect inguinal hernias were intraoperatively detected. 3 patients were ASA II, 1 ASA I and 1 ASA III.

[0131] Four patients had general anesthesia and one had local. A small (5-6 cm) transverse incision in the inguinal region was performed. A self-retaining retractor with smooth non-traumatic branches positioned. Tissues were sharply cut avoiding any stretching or shredding during the dissection. Minimal manipulation used to prepare the sac from the cord and to make the space where the mesh will be located. It is important to minimize the detachment of tissues and in particular to respect as much as possible the nerves that cross the area. hemostasis checked step by step.

[0132] After the inguinal sac was isolated and content examined, it was repositioned into the abdomen and the internal inguinal ring refashioned using polyglactin (vicryl) 2-0 stitches. In case of direct hernia, the trasversalis fascia was approximated with the same suture material.

[0133] The mesh was then customized to be suitable for the patient's inguinal region. We choose a soft, light, macroporous, monofilament, polypropylene mesh BARD.

[0134] The mesh was designed according to the shape and size of the inguinal canal and fixed in place with a 2 cm overlap of the mesh above the tubercle.

[0135] Mesh fixation. We used L-PRF clot (Leukocyte-Platelet Rich Fibrin) with both components: membrane and hyper-acute serum to fix the mesh and secure a tension-free technique.

[0136] The L-PRF clot was prepared with an IntraSpin centrifuge using 9 ml fresh patient's blood in glass-coated plastic tubes and immediately centrifuged at 2700 rpm for 12 minutes.

[0137] After centrifugation, three distinct layers were in the tube: red blood corpuscles RBCs at the bottom of the tube, platelet-poor plasma PPP on the top of the tube, and the PRF clot in the middle of the tube.

[0138] The L-PRF clot was removed from the tube with surgical tweezers. Serum squeezed out from the PRF clot generates PRF membranes and the hyper-acute serum. We have used 3-5 L-PRF clots to fix the mesh. Both components membranes and hyper-acute serum were applied on the posterior fascia (trasversalis) and the mesh attached over them.

[0139] Only two single stitches in Vicryl 2-0 used to adjust the mesh: one in the tubercle area avoiding the periosteum and another one to close the mesh tails.

[0140] Anterior fascia closure. Fascia sutured below the spermatic cord using Vicryl 2-0 stitches to press the mesh between the anterior and the trasversalis fascia.

[0141] Fat sutured with Vicryl 2-0 and skin intradermic suture with monocryl 3-0.

[0142] Buvicaine 20 ml 0.5% as local anesthetic infiltration at the end of the procedure.

TABLE-US-00001 TABLE 1 Has been reported the intensity of pain (VAS) at 3 hours, 24 hours, 48 hours, 7 days, 15 days, 1 month, 3 months and 6 months after the operation 3 h 24 h 48 h 7 days 15 days 1 months 3 months 6 months Right 1 2 1 0 0 0 0 0 Hernia Left 1 6 5 4 4 2 0 0 Hernia Post-operative VAS score reported during follow up for the Right (PRF-opens mesh repair) and the Left inguinal hernia (Lichtenstein technique).

[0143] Oral paracetamol was prescribed after discharge 1 gr TDS per 5 days. Postoperative pain was measured with VAS (Visual Analog Scale) by direct interview or by a phone call at 3 hours, 24 hours, 48 hours, 7 days, 15 days, 1 month, 3 months and 6 months after the operation.

[0144] Clinical checks were set at 1 month and 6 months. Chronic groin pain was diagnosed whether still present at the 6th-month follow-up. Data were anonymized and stored and elaborated in an electronic database. As highlighted in Table 1 above, post-operative pain in the PRF-open mesh repair was not reported at 7 days whereas in the Lichtenstein technique, post-operative pain was reported up to one month.

[0145] The references cited throughout this application are incorporated for all purposes apparent herein and in the references themselves as if each reference was fully set forth. For the sake of presentation, specific ones of these references are cited at particular locations herein. A citation of a reference at a particular location indicates a manner(s) in which the teachings of the reference are incorporated. However, a citation of a reference at a particular location does not limit the manner in which all of the teachings of the cited reference are incorporated for all purposes.

[0146] It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but is intended to cover all modifications which are within the spirit and scope of the invention as defined by the appended claims; the above description; and/or shown in the attached drawings.