Medical Procedure Protection Systems

Abstract

A device for use during a medical procedure on or near the penis includes a body having an opening of a minimum size that allows an infant's penis to protrude through the opening during use during the medical procedure, wherein the device is placed over a patient's penis with the penis protruding through the opening and the body is adjacent to the patient's skin during the procedure to provide protection during the medical procedure.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 441,604, entitled "CIRCUMCISION PROTECTION SYSTEM," filed January 2, 2023, which is incorporated herein by reference in its entirety. [Background technology]

[0002] Medical procedures for the penis include penile enlargement, circumcision (circumcision), penile implants, straightening a curved penis (phalloplasty), correction of penile fractures, vasectomy, vas recanalization, prostate biopsy, UroLift (transurethral prostate lift), transurethral needle ablation, prostate procedures such as transurethral resection of the prostate (TURP) and transurethral incision of the prostate (TUIP), central venous catheterization, and orchidopexy.

[0003] Newborn male circumcision is common, at least in the U.S. The risk of these medical procedures, particularly circumcision, is unintentional injury to the patient, such as nicking or severing the femoral artery.

[0004] Therefore, there is a need for devices and methods for protecting patients during medical procedures on or near the penis. Documents of interest are Chinese Utility Model No. 202682170, Chinese Utility Model No. 21096269 (CN21096269), U.S. Patent No. 6,580,011, and U.S. Patent Application Publication No. 2012 / 0220912. Summary of the Invention

[0005] The present invention is a system for protecting a patient during a medical procedure, such as circumcision, which includes a device and a method for using the device.

[0006] The protective device comprises a body (preferably mesh) having an outer periphery and a circular or oval opening extending therethrough, the opening having a rim. The opening is sized to fit comfortably over the penis and preferably has a diameter of about 1 to about 1.5 inches. The outer periphery has a diameter of about 6 to about 10 inches. Preferably, the mesh is made of wire having a diameter of about 0.5 to about 1.5 millimeters. The wires of the mesh are sufficiently dense that even a scalpel pressed with a force of 20 Newtons cannot penetrate the mesh. Typically, the mesh is flexible enough to bend twice over.

[0007] Preferably, both the opening and the periphery are circular.

[0008] Preferably, the edges of the opening and periphery are sufficiently smooth so as not to injure or irritate the patient during circumcision, although in the case of rough edges, a covering can be placed on the periphery of the body, the edge of the opening, or both.

[0009] In the method according to the invention, the following steps can be carried out:

[0010] (a) Select a device that has a body with an opening therethrough, the opening being located at or near the center of the body.

[0011] (b) Place the selected device over the patient's penis with the penis protruding through the opening and the mesh adjacent to the patient's skin.

[0012] (c) after step (b), circumcising the protruding penis;

[0013] Stated differently, the device is useful during medical procedures near or involving the penis and comprises a flexible body having an outer periphery and an opening therethrough, the opening having a diameter of about 0.2 to about 1.5 inches. The outer periphery of the body has a diameter of at least about 6 inches. The body has sufficient strength to prevent a #10 scalpel from penetrating the body when pressed with a force of 10 Newtons, preferably 20 Newtons, and more preferably 15 Newtons. Because needles may be used in medical procedures, preferably the body has sufficient strength to prevent a 28-gauge needle from penetrating the body when pressed with a force of 10 Newtons, more preferably a 28-gauge needle from penetrating the body when pressed with a force of 20 Newtons, and most preferably a 28-gauge needle from penetrating the body when pressed with a force of 15 Newtons. While it is desirable for the body to be strong enough to prevent penetration by both a scalpel and a needle, it is sufficient for the body to resist such forces from either the scalpel or the needle. The size of the opening will vary depending on the particular application. Generally, the opening is large enough to allow an infant's penis having a circumference of 0.5 inches to protrude through the opening. The opening is usually located in the center or approximately the center of the body. Preferably, the body is a mesh. The mesh can have holes measuring from about 0.02 mm to about 0.2 mm, preferably up to about 0.16 mm. The mesh can be formed of wire having a diameter of from about 0.02 mm to about 0.15 mm, preferably up to about 0.12 mm. The mesh can be made of stainless steel having square holes with sides of about 0.14 mm, a wire diameter of about 0.112 mm, 100 per inch, about 30% open area between the wires, and a weight of about 0.6 kg per square meter.

[0014] In a typical medical procedure on a patient, the following steps are performed:

[0015] A. Select a device with a flexible body having an opening that is large enough to allow an infant's penis, having a circumference of 0.5 inches, to protrude through the opening.

[0016] B. Place the selected device over the patient's penis, with the penis protruding through the opening and the body adjacent to the patient's skin.

[0017] C. After step B, a medical procedure such as circumcision is performed. [Brief explanation of the drawings]

[0018] These and other features, aspects, and advantages of the present invention will be better understood with reference to the following drawings.

[0019] [Figure 1] FIG. 1 is a plan view of an apparatus according to the invention. [Figure 2] FIG. 2 is a plan view of a device according to the present invention including a covering that covers the outer edge of the mesh and the edge of the penile opening. [Figure 3] FIG. 3 is a schematic diagram illustrating the use of the device according to the invention. DETAILED DESCRIPTION OF THE INVENTION

[0020] 1, a device 10 useful during circumcision includes a body 12, also referred to as a substrate. The body 12 has a periphery 14 and an opening 16 extending therethrough. Preferably, the opening is centrally located. Thus, the device is donut-shaped.

[0021] The outer periphery has a diameter of at least about 6 inches, and typically has a diameter of about 6 to about 10 inches to provide adequate coverage in the methods described below. The opening 16 can be centrally located, but can also be off-center, such as near the center.

[0022] Although perimeter 14 is shown as being circular in FIG. 1, the device is useful with perimeters of any shape, such as rectangular, polygonal, oval, and triangular.

[0023] The opening 16 is sized to accommodate the baby's penis protruding therethrough. The circumference of an infant's penis is typically 0.5 inches. The preferred diameter of the opening is about 1 to about 1.5 inches.

[0024] The opening 16 is preferably circular, but may be other shapes, such as oval or triangular. When the opening 16 is not circular, references to the "diameter" refer to the shortest distance across the opening. Thus, if the opening is oval in shape, the term "diameter" refers to the smaller diameter of the oval. In other words, in all versions, the opening 16 must be large enough so that the infant's penis can extend therethrough without difficulty.

[0025] Body 12 is formed from a material that is flexible, non-irritating to the patient's body, sufficiently resistant to penetration such that a scalpel or needle pressed with a force of 10 Newtons, preferably 20 Newtons, and more preferably 50 Newtons cannot penetrate the body, and that can be sterilized, such as by autoclaving. In other words, the body is designed to resist penetration by needles, scissors, and scalpels when a medical professional uses a reasonable amount of force during the procedure (typically at least 20 Newtons, and usually 50 Newtons) to prevent accidental slippage of a blade, needle, or scissors during the circumcision procedure. Thus, the body will not be penetrated by forces of less than 10 Newtons, preferably less than 20 Newtons, and more preferably less than 50 Newtons. Of course, the body can also be designed to resist penetration by forces greater than 50 Newtons. To determine whether a material is suitable for testing with a scalpel, it can be determined by using a scalpel commonly used by surgeons, i.e., a No. 10 scalpel in accordance with ASTM F1790 / F1790M-15 in effect as of the filing date of this application. To determine whether a material is suitable for needles commonly used by surgeons, it can be determined by using a 28-gauge needle in accordance with ASTM F2878-19 in effect as of the filing date of this application. Therefore, the above forces are measured using these ASTM tests with a number 10 scalpel and a 28 gauge needle. Preferably, materials will meet these tests for both needles and scalpels, although in some cases, depending on the medical procedure, the material may only need to meet the tests for either the needle or scalpel.

[0026] Preferably, the material is a mesh, more particularly a stainless steel mesh such as that available under the brand name Labalpha, specifically stainless steel 304, smooth finish, 100 mesh, approximately 0.14 millimeter holes, and approximately 0.11 millimeter wire diameter, which withstood penetration with a force of over 130 Newtons.

[0027] Other suitable materials include plastics such as plastic polymers including polycarbonate, polypropylene, polyethylene, polyvinyl chloride, acrylonitrile butadiene styrene, polystyrene, polyethylene terephthalate glycol, and polymethyl methacrylate. Preferably, the materials used are medical grade.

[0028] A suitable mesh is made from stainless steel 316, has square holes 0.14 mm on a side, has a wire diameter of 0.112 mm, is circular and approximately 9 inches in diameter, with a circular opening in the center approximately 1.5 inches in diameter. It has 100 meshes per inch, i.e., 100 vertical and 100 horizontal wires per square inch, an open area (between the wires) of approximately 30%, and weighs approximately 63 kg per square meter. It is available from TSWN (Taiwan Special Wire Mesh Co., Ltd.) in Taiwan, part number 316 100x0.11x10".

[0029] Referring to Figure 2, an alternative version of device 20 according to the present invention is shown. The device of Figure 2 is an improvement over device 10 of Figure 1. The version of Figure 2 is adapted for situations where the outer edge 14 of the body of Figure 1 is not sufficiently smooth to avoid injury or irritation to the patient during circumcision. Therefore, outer edge 14 of the body can be provided with a covering 22. Similarly, a covering 24 can be placed on edge 26 of the central opening.

[0030] The dimensions given for the diameter of the opening 16 are based on the inclusive dimensions of the sheath, which is indicated in Figure 2 by the double arrow 28. Similarly, the diameter of the device, which is about 6 to about 10 inches, includes the sheath 22.

[0031] Either or both of the coatings 22 or 24 can be used. The coatings 22 and 24 are preferably formed from a durable material such as medical grade silicone, polyethylene, polyvinyl chloride, polypropylene, or Kevlar. The coatings can be formed as separate pieces that are attached to the body, such as by epoxy adhesive or crimping. Alternatively, the coatings can be applied as a coating, such as a spray-on coating that cures in place.

[0032] Referring to Figure 3, a circumcision is performed normally, but with the use of a safety device 10. As shown diagrammatically in Figure 3, an infant 32 is placed on its back, and a sterile drape 34 is placed over the infant, covering the abdominal area, including the femoral artery. The device 10 is placed on the drape adjacent to the infant's skin, with the infant's penis 36 protruding through the opening 16. Typically, the device is placed against the sterile drape. A conventional circumcision is then performed on the protruding penis. Circumcisions are typically performed with a clamp placed on the penis. Commonly used clamps include a Gomco clamp, a Plastibel device, and a Morgen clamp. The clamp or ring is placed on the penis, and a medical professional trims away excess foreskin.

[0033] The device and method are particularly useful for infants, but may be used in men of any age, and may also have applications in women, such as for central venous catheter placement.

Claims

1. 1. An apparatus for use during tallying, comprising: a flexible mesh having a perimeter and circular or oval openings therethrough; The opening is located at or near the center, the opening has a diameter of about 1 inch to about 1.5 inches; the perimeter of the mesh has a diameter of about 6 inches to about 10 inches; The device wherein the mesh is made of wires that are sufficiently dense so that a scalpel pressed with a force of 20 Newtons cannot penetrate the mesh.

2. 1. An apparatus for use during tallying, comprising: a flexible stainless steel mesh having a periphery and a central circular opening therethrough; the opening has a diameter of about 1 to about 1.5 inches; the perimeter of the mesh has a diameter of about 6 to about 10 inches; the mesh is made of wires having a diameter of about 0.5 to about 1.5 mm; A device wherein the wires are spaced closely enough that a scalpel pressed with a force of 20 Newtons cannot penetrate the mesh, and the mesh is flexible enough to bend twice over.

3. 10. The device of claim 1, wherein the edges of the opening and the periphery are sufficiently smooth to avoid injury or irritation to a patient during tallying.

4. The device of claim 1 , further comprising a coating on the outer periphery.

5. the opening has an edge; The device of claim 4 , further comprising a coating on the edge of the opening.

6. the opening has an edge; The device of claim 1 , comprising a coating on the edge of the opening.

7. the opening is circular; The device of claim 1 , wherein the periphery is circular.

8. 1. A method for performing a circumcision on a patient, comprising: a) selecting a device comprising a flexible mesh having an opening therethrough, said opening being located at or near the center of said mesh; b) placing the selected device over the patient's penis with the penis protruding through the opening and the mesh adjacent the patient's skin; c) circumcising the protruding penis after step (b).

9. 1. A device for use during circumcision, comprising: a body having an outer periphery and a circular or elliptical opening therethrough; The opening is located at a central or off-central position of the body; the opening has a diameter of about 1 to about 1.5 inches; the outer periphery of the body has a diameter of about 6 to about 10 inches; The device wherein the body is formed of a flexible material and has sufficient resistance to penetration such that a scalpel pressed with a force of 20 Newtons cannot penetrate the body.

10. 1. A device for use during a medical procedure involving the penis, comprising: a flexible body having a periphery and an opening therethrough; the opening has a diameter of about 0.2 to about 1.5 inches; the outer periphery of the body has a diameter of at least about 6 inches; The device, wherein the body has sufficient strength such that a number 10 scalpel pressed with a force of 10 Newtons cannot penetrate the body.

11. 1. A device for use during a medical procedure on or near the penis, comprising: a flexible body having a periphery and an opening therethrough; the opening has a diameter of about 0.2 to about 1.5 inches; the outer periphery of the body has a diameter of at least about 6 inches; The device, wherein the body has sufficient strength such that a 28 gauge needle pressed with a force of 10 Newtons cannot penetrate the body.

12. 11. The device of claim 10, wherein a No. 10 scalpel pressed with a force of 20 Newtons cannot penetrate the body.

13. 13. The device of claim 12, wherein a number 10 scalpel pressed with a force of 50 Newtons cannot penetrate the body.

14. 11. The device of claim 10, wherein the body is strong enough that a 28 gauge needle pressed with a force of 10 Newtons cannot penetrate the body.

15. 15. The device of claim 14, wherein the body is strong enough that a 28 gauge needle pressed with a force of 20 Newtons cannot penetrate the body.

16. 16. The device of claim 15, wherein the body is strong enough that a 28 gauge needle pressed with a force of 50 Newtons cannot penetrate the body.

17. 1. A method for performing a medical procedure on a patient, comprising: a) selecting a device having a flexible body with an opening therethrough, said opening being the smallest size that will allow an infant's penis having a circumference of 0.5 inches to protrude therethrough; b) placing the selected device over the patient's penis with the penis protruding through the opening and the body adjacent to the patient's skin; c) performing a medical procedure after step (b).

18. The method of claim 17 , wherein the body is a mesh.

19. 18. The method of claim 17, wherein the medical procedure is circumcision.

20. 1. A device for use during a medical procedure on or near the penis, comprising: a body having an opening therethrough; the opening is large enough to allow an infant's penis having a circumference of 0.5 inches to protrude therethrough; The device, wherein the body has sufficient strength such that a number 10 scalpel pressed with a force of 10 Newtons cannot penetrate the body.

21. 1. A device for use during a medical procedure on or near the penis, comprising: a body having an opening therethrough; the opening is large enough to allow an infant's penis having a circumference of 0.5 inches to protrude therethrough; The device, wherein the body has sufficient strength such that a 28 gauge tool pressed with a force of 10 Newtons cannot penetrate the body.

22. 22. The device of claim 20 or 21, wherein the opening is located at or near the center of the body.

23. 22. The device of claim 20 or 21, wherein the body has a diameter of at least 6 inches.

24. 22. The device of claim 20 or 21, wherein the body is a mesh.

25. 25. The device of claim 24, wherein the mesh has holes with a size of about 0.02 mm to about 20 mm.

26. 26. The device of claim 25, wherein the mesh has holes with a size of about 0.02 mm to about 0.16 mm.

27. 25. The device of claim 24, wherein the mesh is formed from wires having a diameter of about 0.02 mm to about 0.15 mm.

28. 28. The device of claim 27, wherein the mesh is formed of wires having a diameter of about 0.02 mm to about 0.12 mm.

29. 25. The apparatus of claim 24, wherein the mesh is made of stainless steel having square holes with sides of approximately 0.14 mm, a wire diameter of 0.112 mm, 100 meshes per inch, an open area between wires of approximately 30%, and a weight of approximately 0.6 kg per square meter.

30. 1. A device suitable for use during a medical procedure on or near the penis, comprising: a flexible mesh having a perimeter and circular or oval openings therethrough; the opening is centrally or off-centered in the body; the mesh is made of wire having a diameter of about 0.02 mm to about 0.15 mm; The mesh has holes with a size of about 0.02 mm to about 20 mm.

Images