CN118139601A

CN118139601A - Prosthetic implant with a housing provided with a flexible needle stop patch made of two or more layers of textile material

Info

Publication number: CN118139601A
Application number: CN202280070196.4A
Authority: CN
Inventors: M·霍夫曼
Original assignee: Mentor Worldwide LLC
Current assignee: Mentor Worldwide LLC
Priority date: 2021-08-19
Filing date: 2022-07-25
Publication date: 2024-06-04

Abstract

A prosthetic implant such as a tissue expander includes a silicone housing having a front wall and a rear wall, and a needle stop patch secured to an inner surface of the rear wall of the silicone housing. The needle stop patch has two or more layers of fabric material stacked on top of each other. The fabric material is flexible and includes woven threads or fibers. The bonding material bonds the two or more layers of the fabric material stacked on top of each other. The outer edges of the respective layers are thinned to minimize the stair-step effect between adjacent ones of the layers. A self-sealing membrane covers the front wall of the silicone housing. The denier level of the fabric layer increases between the top and bottom layers to gradually increase the resistance of the needle to passing through the needle stop patch.

Description

Prosthetic implant with a housing provided with a flexible needle stop patch made of two or more layers of textile material

Cross Reference to Related Applications

This patent application claims the benefit of U.S. provisional application serial No. 63/234,848, filed on 8/19 2022, the disclosure of which is incorporated herein by reference.

Background

Technical Field

The present application relates generally to implantable prosthetic implants such as breast implants and tissue dilators, and more particularly to needle stops and needle shields incorporated into the housing of a tissue dilator.

Description of the Related Art

Tissue expanders are devices that are implanted under the skin or muscle and then gradually inflated with a fluid to stretch the overlying tissue. Tissue expanders are commonly used to form a pouch for receiving a permanent prosthesis or to create increased skin surface area in the event of new skin intended to be used for implantation or reconstruction.

Tissue expanders are typically formed from silicone polymer shells. After implantation, a fluid (such as saline) is periodically injected into the tissue expander to expand it over time. In injection, the surrounding skin is allowed to stretch and grow to create an increased skin surface and an increased tissue pocket for receiving the permanent implant.

The tissue dilator may be provided with an injection port (e.g., a port comprising a septum) that may be pierced with a hypodermic needle to introduce fluid into the dilator. However, it may be difficult to accurately locate the injection port through the stacked tissue. If the injection port is missed and the needle pierces the housing of the tissue dilator, the dilator may leak. In most cases, this requires removal and replacement of the dilator. This problem may be addressed by providing an injection port remote from the tissue dilator but in fluid communication with the dilator. Such a system is described in U.S. patent number 4,190,040.

Other solutions include eliminating the need for an injection site altogether by forming a dilator with a self-sealing housing that can be pierced at any point with a hypodermic needle for the purpose of adding fluid to the housing. For example, U.S. patent No. 5,066,303 discloses a tissue expander formed using a self-sealing housing material that is reported to be safely penetrable at any location.

U.S. patent No. 6,743,254 to Guest et al, assigned to man-tuo corporation (Mentor Corporation), the disclosure of which is incorporated herein by reference, teaches a tissue dilator that includes a self-sealing region around an injection port. The self-sealing region reduces the risk of leakage in the dilator when a hypodermic needle used to fill the dilator misses the injection port, thereby reducing the frequency of the need to remove the dilator due to leakage caused by accidental puncturing.

The tissue expander may incorporate flexible needle stops that enable the tissue expander to be folded for insertion into a patient. For example, U.S. patent number 4,908,029 to Bark et al discloses a flexible needle stop that includes a normally deployed impermeable needle barrier formed of a flexible, foldable material. The flexible, foldable material may be a single ply of material, a web of material, and/or one or more layers of squamous elements arranged side by side. The squamous member is physically non-connective and has a size that allows the needle stop to flex. The flexible needle stop may include a beaded periphery that provides the needle stop with elastic memory and helps to restore the needle stop member to its normal deployed state after removal of the folding constraint. The needle stop may be freely disposed within, attached to an inner surface of, or incorporated into a housing wall of the tissue expander.

U.S. patent application publication 2016/0074152 to Chitre et al discloses a method of manufacturing a needle shield suitable for implantation into an inflatable prosthesis of a mammal. The method comprises the following steps: providing a first layer of puncture resistant member, such as an elongate strip; providing a second layer of puncture resistant member such that the second layer of member overlies and is offset from the first layer of member; and molding or otherwise applying a flexible material to the first layer member and the second layer panel to form a device that can be used as a needle guard for an inflatable prosthesis. The step of applying or molding includes attaching the member to the flexible material (e.g., encapsulating the member within the flexible material).

The materials are typically evaluated to determine their suitability for use in manufacturing needle stoppers. Fig. 1 and 2 illustrate a prior art system 50 configured for testing materials used to fabricate a needle stop of a prosthetic device. The system 50 tests the material to ensure that the needle used to fill the prosthetic implant will fail (e.g., by bending) before the material used to stop the needle fails. Test system 50 includes an Instron machine 52 that holds a needle 54. The Intron machine 52 moves the needle 54 up and down along the vertical axis A ₁ so that the sharp needle tip at the lower end of the needle engages the material being evaluated.

The test system 50 includes a fixture plate 56 that holds a material 58 being evaluated. According to standard ASTM 1441-03, needle 54 must fail material 58 before the material fails. A 21 gauge needle having a length of 1.5 inches was used during testing according to ASTM 1441-03 standard. Instron machine 52 applies a downward force on needle 54 against material 58 and the 21 gauge needle breaks at about 6.5 lbs/ft. Thus, in order for material 58 to meet ASTM 1441-03 and be suitable for use as an effective needle stop barrier, material 58 must avoid penetration of the needle with forces greater than 6.5 lbs/ft. If the needle 54 penetrates the material 58 before the needle fails (e.g., bends), the material 58 does not meet the ASTM 1441-03 standard and cannot be used to make an effective needle guard.

Referring to fig. 3, when a particular material (e.g., sheet metal) is used to fabricate the needle stop, the sharp needle tip 60 of the needle 54 (fig. 2) may be damaged. In fig. 3, sharp needle tip 60 is damaged and bent into a fishhook configuration. In addition, the side surfaces within the tapered region 62 of the needle 54 are also damaged.

In a prosthetic implant having a self-sealing housing, a needle is passed through the housing and advanced into the lumen of the housing to fill the prosthetic implant with a filling material (e.g., gel; saline solution). If the prosthetic implant has a conventional needle guard, the sharp point of the needle may be damaged (e.g., bent into a fishhook shape) if it is pressed against the needle guard. When the damaged needle is later withdrawn from the housing (e.g., after the housing is filled), the damaged tip of the needle may tear or puncture the housing, which may result in catastrophic damage to the housing (including a housing intended to self-seal after needle withdrawal).

Referring to fig. 4, when the damaged needle 54 shown in fig. 3 is withdrawn from the housing 64 of the prosthetic device, the fishhook tip 60 may form a tear 66 or hole in the housing 64. The tear 66 created by the fishhook tip 60 of the broken needle 54 will allow the filler material 68 filling the interior of the housing 64 to flow out of the tear 66. Thus, catastrophic damage to the housing 64 of the prosthetic device may result when the damaged needle is withdrawn from the housing after filling the housing with gel or saline solution.

In view of the above-described deficiencies in the prior art, it would be desirable to provide a prosthetic implant having a needle stop that resists forces greater than 6.5 pounds (in the case of a21 gauge needle) while minimizing needle tip damage that could lead to failure of the housing of the implant.

Disclosure of Invention

Conventional breast tissue dilators typically incorporate an integrated injection port. While the injection port provides an important function, namely the ability to inflate and deflate the tissue dilator via percutaneous penetration with a needle, it also increases the volume of the tissue dilator, resulting in reduced flexibility and potentially increased discomfort and palpability to the patient when the dilator is folded and inserted into the breast pocket.

In one embodiment, a needle stop patch configuration is disclosed that minimizes needle tip damage that may lead to tearing and damage to the housing, nor is it generally avoidable for self-sealing housing constructions. The prior art includes a number of disclosures of self-sealing elastomeric housing films that address self-sealing when penetrated by a normal needle, but do not contemplate withdrawal of a potentially damaged needle tip. The needle stop patches disclosed herein improve upon the prior art by reducing the likelihood of needle deformation that may lead to tearing and leakage of the housing.

In one embodiment, the needle stop patch provides an impenetrable rear backing that provides a number of improvements over the prior art.

First, the needle stop patches disclosed herein cannot be pierced by needles below a specified gauge (i.e., the needle must fail without penetrating the needle stop patch).

In one embodiment, the needle stop patch is flexible (i.e., low bending stiffness) so that it can be easily folded and inserted into the breast pocket.

In one embodiment, the needle stop patch has a sufficient thickness and is in open communication with the interior lumen of the housing such that when the needle is pressed against the needle stop patch, the needle aperture is not blocked and the dilator can be inflated even if the dilator is in an initially contracted/empty state.

In one embodiment, the needle stop patch is configured such that it prevents penetration of the needle while minimizing damage to the needle tip. In conventional dilator injection ports, the tip of the needle may be damaged into a "fishhook" shape when the needle is pressed against the port stop. This is typically alleviated by using a more flexible polymer damping layer on the stopper, but tip damage is still possible given the rigid nature of the stopper. The needle stop patches disclosed herein are made of multiple layers of fabric material. One or more of the layers may comprise an elastomeric sheet. The layers of fabric material create a large friction on the needle so that the penetration force is widely distributed over the needle rather than concentrated at the tip.

As used herein, the term textile material refers to a flexible material made by creating an interlocking network of threads that are created by spinning raw fibers from natural or synthetic sources into twisted long threads. The fabric may be formed by braiding, knitting, crocheting, knotting, tatting, felting, bonding or braiding the threads together.

In one embodiment, the self-sealing housing membrane self-seals when pierced with a needle below a specified gauge size. In one embodiment, a self-sealing tissue expander is disclosed that eliminates the need for ports by incorporating a self-sealing housing.

In one embodiment, a prosthetic implant (such as a tissue expander) preferably includes a silicone housing having a front wall and a rear wall, and a needle stop patch secured to an inner surface of the rear wall of the silicone housing.

In one embodiment, the needle stop patch may include two or more layers of fabric material (e.g., 4-10 layers) that are stacked on top of each other to form a multi-layer structure.

In one embodiment, a bonding material is used to bond together two or more layers of fabric material stacked on top of each other.

In one embodiment, the fabric material may comprise natural or synthetic threads or fibers that are woven together to form a layer of the needle stop patch.

In one embodiment, a bonding material (e.g., a curable silicone material) is preferably passed through two or more layers of fabric material to bond the layers together.

In one embodiment, each of the two or more layers has an outer edge defining an outer perimeter. In one embodiment, only the outer perimeter of two or more layers are bonded together.

In one embodiment, the layers have different dimensions. In one embodiment, the outer perimeter of the top layer of the two or more layers defines a first area and the outer perimeter of the bottom layer of the two or more layers defines a second area that is greater than the first area of the top layer.

In one embodiment, the outer perimeter of the middle layer of two or more layers between the top layer and the bottom layer defines a middle area that is greater than the first area of the top layer and less than the second area of the bottom layer.

In one embodiment, the respective outer edges of two or more layers are thinned to minimize the stair-step effect between adjacent ones of the two or more layers.

In one embodiment, the adhesive material may secure the needle stop patch to the back wall of the silicone housing.

In one embodiment, each of the two or more layers of fabric material has a circular or oval shape.

In one embodiment, the bonding material has a loop shape that matches the circular or oval shape of each of the two or more layers of fabric material.

In one embodiment, at least one of the two or more layers of fabric material is laminated in an elastomeric sheet.

In one embodiment, the front wall of the silicone housing may comprise a self-sealing membrane.

In one embodiment, the self-sealing film may comprise a three-layer construction including a middle layer of elastomeric material having a first major surface and a second major surface, a first outer layer of elastomeric material overlying the first major surface of the middle layer, and a second outer layer of elastomeric material overlying the second major surface of the middle layer, whereby the elastomeric material of the middle layer retains the elastomeric materials of the first and second outer layers in a contracted configuration.

In one embodiment, each of the two or more layers of fabric material has a top surface, a bottom surface, and a plurality of apertures extending from the top surface to the bottom surface.

In one embodiment, the needle may be used to fill the silicone housing with a fluid (e.g., gel; saline solution). In one embodiment, the needle has a cross-sectional area, and the total combined area of the plurality of apertures of each layer is preferably greater than the cross-sectional area of the needle.

In one embodiment, the denier of the two or more layers of the needle stop patch increases gradually from the top layer to the bottom layer of the patch to provide the needle stop patch with a level of resistance that increases gradually from the top layer to the bottom layer.

In one embodiment, the top layer of the two or more layers of fabric material has a first denier and the bottom layer of the two or more layers of fabric material has a second denier greater than the first denier of the top layer.

In one embodiment, a prosthetic implant preferably includes a silicone housing having an anterior wall and a posterior wall, and a needle stop patch secured to an inner surface of the posterior wall of the silicone housing.

In one embodiment, the needle stop patch preferably comprises multiple layers of fabric material stacked on top of each other, and an adhesive material for connecting the multiple layers of fabric material stacked on top of each other together.

In one embodiment, the self-sealing membrane may be integrated into the front wall of the silicone housing.

In one embodiment, the self-sealing film desirably includes a middle layer of elastomeric material having a first major surface and a second major surface, a first outer layer of elastomeric material overlying the first major surface of the middle layer, and a second outer layer of elastomeric material overlying the second major surface of the middle layer, whereby the elastomeric material of the middle layer maintains the elastomeric materials of the first and second outer layers in a contracted condition.

In one embodiment, the outer surface of the elastomeric material of the first outer layer is secured to the inner surface of the front wall of the silicone shell.

In one embodiment, the top layer in the multilayer has an outer edge defining a first area and the bottom layer in the multilayer has an outer edge defining a second area that is greater than the first area of the top layer.

In one embodiment, the intermediate layer of the multilayer located between the top layer and the bottom layer preferably has an outer edge defining an intermediate area that is greater than the first area of the top layer and less than the second area of the bottom layer.

In one embodiment, the respective outer edges of each of the multiple layers are desirably thinned to minimize the stair-step effect between adjacent ones of the multiple layers.

In one embodiment, each layer of the multi-layer textile material has a top surface, a bottom surface, and a plurality of apertures extending from the top surface to the bottom surface.

In one embodiment, the needle may be used to fill the silicone housing with a fluid. In one embodiment, the needle has a cross-sectional area, and the total combined area of the plurality of apertures of each layer is preferably greater than the cross-sectional area of the needle.

In one embodiment, the denier of each layer of the needle stop patch increases gradually from the top layer to the bottom layer to gradually increase the level of resistance within the needle stop patch.

In one embodiment, the top layer of the multi-layer fabric material has a first denier and the bottom layer of the multi-layer fabric material has a second denier greater than the first denier of the top layer.

In one embodiment, a method of manufacturing a multilayer needle stop patch for a silicone housing preferably comprises: obtaining a first layer of fabric material, the first layer having an outer edge defining a first area of the first layer; and centering a second layer of fabric material on the first layer, the second layer having an outer edge defining a second area of the second layer, the second area being smaller than the first area of the first layer.

In one embodiment, the method preferably comprises: the third layer of fabric material is centered on the second layer, the third layer having an outer edge defining a third area of the third layer, the third area being smaller than the second area of the second layer.

In one embodiment, the method preferably comprises: centering a fourth layer of fabric material on the third layer, the fourth layer having an outer edge defining a fourth area of the fourth layer, the fourth area being smaller than the third area of the third layer.

In one embodiment, the method includes bonding respective outer edges of the first, second, third, and fourth layers together to form a multi-layer stack.

In one embodiment, the respective outer edges of each layer are thinned to reduce the stair-step effect between the first, second, third and fourth layers.

In one embodiment, the method comprises: a silicone housing having a front wall and a back wall is provided and a first layer of a multi-layer needle stop patch is secured to an inner surface of the back wall of the silicone housing.

In one embodiment, each layer may include a plurality of holes extending from its top surface to its bottom surface.

In one embodiment, the first layer of the fabric material has a first denier, the second layer of the fabric material has a second denier less than the first denier, the third layer of the fabric material has a third denier less than the second denier, and the fourth layer of the fabric material has a fourth denier less than the third denier.

In one embodiment, at least one of the layers of fabric material is laminated in an elastomeric sheet.

These and other preferred embodiments of the present patent application will be described in more detail herein.

Drawings

FIG. 1 is a schematic diagram of a prior art system for testing a needle stop.

Fig. 2 is a perspective view of a prior art system for testing a needle stop.

Fig. 3 is a perspective view of a prior art needle that is damaged and has a curved needle tip.

Fig. 4 is a perspective view of a prior art prosthetic implant having a hole in the outer shell and a filler material leaking through the hole.

Fig. 5 is a cross-sectional view of a prosthetic implant having a self-sealing housing and a needle stop patch covering a back wall of the self-sealing housing according to one embodiment of the present patent application.

Fig. 6 is a schematic cross-sectional view of a self-sealing housing of the prosthetic implant shown in fig. 5 according to one embodiment of the present patent application.

Fig. 7 is a schematic cross-sectional view of the needle stop patch shown in fig. 5 according to one embodiment of the present patent application.

Fig. 8 is a cross-sectional view of a needle stop patch covering a back wall of a housing of a prosthetic implant according to one embodiment of the present patent application.

Fig. 9A illustrates a first stage of a method of manufacturing a needle stop patch according to one embodiment of the application.

Fig. 9B illustrates a second stage of a method of manufacturing a needle stop patch according to one embodiment of the present application.

Fig. 9C illustrates a third stage of a method of manufacturing a needle stop patch according to one embodiment of the present application.

Fig. 9D illustrates a fourth stage of a method of manufacturing a needle stop patch according to one embodiment of the present application.

Fig. 10A is a top view of the assembly shown in fig. 9A.

Fig. 10B is a top view of the assembly shown in fig. 9B.

Fig. 10C is a top view of the assembly shown in fig. 9C.

Fig. 10D is a top view of the assembly shown in fig. 9A.

Fig. 11 shows a top view of a first fabric layer of a needle stop patch and a cross-sectional view of a needle according to one embodiment of the present application.

Fig. 12 shows a top view of the first fabric layer and the second fabric layer of fig. 11 assembled with the first fabric layer to make a needle stop patch according to one embodiment of the present application.

Fig. 13 is a cross-sectional view of the first and second fabric layers of fig. 12 after the second fabric layer has been assembled on the first fabric layer.

Fig. 14 is a cross-sectional view of a needle stop patch of a housing of a prosthetic implant according to one embodiment of the present patent application.

Fig. 15 is a graph of the force required to penetrate needle stop patches made of different materials and having different layers to show the penetration resistance of different needle stop patches.

Fig. 16 illustrates a prior art method of testing the stiffness of a fabric material to determine its suitability for use in a needle stop patch according to one embodiment of the present patent application.

Fig. 17 is a graph showing the flexibility of a needle stop patch having different designs and how the flexibility varies in response to the number of layers of fabric added to the needle stop patch according to one embodiment of the present patent application.

Detailed Description

Referring to fig. 5, in one embodiment, a prosthetic implant 100 (e.g., a tissue expander) preferably includes a housing 102 (e.g., a silicone housing) having an inner lumen 104 that can be filled with a fluid such as saline to expand the size of the housing. In one embodiment, the housing 102 may be made from a self-sealing film, such as that disclosed in commonly assigned U.S. provisional application No. 63/157,285 filed on day 3 and 5 of 2021, the disclosure of which is incorporated herein by reference. In one embodiment, the housing 102 preferably has a rear wall 105 covered by a needle stop patch 106 comprising one or more layers of fabric material, also referred to herein as a fabric layer.

Referring to fig. 6, in one embodiment, a self-sealing housing film 102 (fig. 5), such as the self-sealing film disclosed in commonly assigned U.S. provisional application No. 63/157,285 filed on 3-month-5-2021, the disclosure of which is incorporated herein by reference, may have three layers, including a silicone elastomer of the middle layer 108 and a silicone elastomer of the first and second outer layers 110A, 110B that are held in shrinkage by the middle layer 108.

Referring to fig. 7, in one embodiment, the needle stop patch 106 (fig. 5) preferably comprises one or more layers of fabric material. In one embodiment, the needle stop patch 106 preferably comprises one or more layers of fabric material that are joined together to form the needle stop patch. In one embodiment, needle stop patch 106 preferably includes a first fabric layer 112 that includes interwoven threads 114A-114C. The first fabric layer 112 may be laminated or embedded in the polymeric material of the first layer 115.

In one embodiment, the needle stop patch 106 desirably includes a second fabric layer 116 that includes a plurality of interwoven threads 118A-118C that are free to move relative to one another.

In one embodiment, the needle stop patch 106 preferably includes a third fabric layer 120 having a plurality of interwoven threads 122A-122C that are free to move relative to one another.

In one embodiment, the needle stop patch 106 preferably includes a fourth fabric layer 124 having a plurality of interwoven threads 126A-126C that are free to move relative to one another.

In one embodiment, the second fabric layer 116, the third fabric layer 120, and the fourth fabric layer 124 are not laminated and/or embedded within the polymer layer.

In one embodiment, the needle stop patch 106 preferably includes a fifth fabric layer 128 having a plurality of interwoven threads 130A-130D which are laminated and/or embedded within a layer of polymeric material 132.

In one embodiment, the needle stop patch 106 is preferably positioned on the posterior wall of the housing of the prosthetic implant. In one embodiment, the bottom surface 134 of the fifth layer 128 of the needle stop patch 106 is preferably secured to the inner surface of the posterior wall of the housing of the prosthetic implant.

Referring to fig. 5 and 7, in one embodiment, a needle 135 having a tapered distal end 136 provided with a sharp needle tip 138 may be inserted through the housing 102 of the prosthetic implant 100 to fill the implant housing. If sharp needle tip 138 is advanced too far toward rear wall 105 of housing 102, sharp needle tip 138 may contact needle stop patch 106.

Referring to fig. 7, in one embodiment, the multi-fabric layer construction of the needle stop patch 106 preferably engages the tapered distal end 136 of the needle 135 to exert a frictional force on the sides of the needle as it is advanced in the direction DIR 1. The plurality of fabric layers 112, 116, 120, 124, and 128 preferably have a particular denier and thread weave or geometry that "grips" the tapered distal end 136 and the needle tip 138 so that forces are not excessively concentrated on the needle tip. In one embodiment, each individual fabric layer 112, 116, 120, 124, and 128 of the needle stop patch 106 is not itself impermeable, however, the cumulative effect of the multiple fabric layer construction desirably provides sufficient resistance to the needle from passing completely through the needle stop patch 106 and/or piercing the bottom surface 134 of the fifth fabric layer 128 of the needle stop patch 106.

As used herein, denier is the unit of linear mass density based on the length and weight of a thread or fiber. A single strand is considered to be 1 denier, or more specifically, about 1 gram of 9,000 meter long strands. The higher the denier, the larger the diameter of the thread or fiber for a given material. Or for a given diameter, the higher the denier, the greater the density of the thread or fiber.

In one embodiment, the denier of the five layers 112, 116, 120, 124, and 128 may be increased between the first layer 112 and the fifth layer 128 to gradually increase the level of resistance of the needle passing through the needle stop patch 106.

Referring to fig. 8, in one embodiment, the needle stop patch 206 preferably includes a plurality of fabric layers 212, 216, 220, and 224. In one embodiment, fabric layers 212, 216, 220, and 224 have respective peripheral edges defining different outer diameters. In one embodiment, the peripheral edges of the fabric layers are thinned or tapered relative to each other to reduce the stair-step effect and promote a progressive stiffness gradient between the respective fabric layers 212, 216, 220, and 224. In one embodiment, the first fabric layer 212 has an outer diameter OD ₁ that is greater than an outer diameter OD ₂ of the second fabric layer 216. In turn, the second fabric layer 216 has a second outer diameter OD ₂ that is greater than the third outer diameter OD ₃ of the third fabric layer 220. In turn, the third fabric layer 220 has a third outer diameter OD ₃ that is greater than the fourth outer diameter OD ₄ of the fourth fabric layer 224.

In one embodiment, four fabric layers 212, 216, 220, and 224 are joined together. In one embodiment, the four fabric layers 212, 216, 220, and 224 are connected together at their respective peripheral edges via an adhesive material 240 that extends through the different fabric layers. In one embodiment, the adhesive material 240 may have an annular shape extending adjacent to the outer perimeter of the needle stop patch 206. In one embodiment, the central regions of fabric layers 212, 216, 220, and 224 are not joined together, which preferably increases the flexibility of needle stop patch 206 and minimizes the stiffness of the needle stop patch.

In one embodiment, the needle stop patch 206 may be secured to a wall of the housing of the prosthetic implant. In one embodiment, the needle stop patch 206 may be secured to an inner surface of the rear wall 205 of the housing 202. In one embodiment, the bottom surface 225 of the fourth fabric layer 224 is secured to the inner surface of the rear wall 215 of the housing 202. In one embodiment, an adhesive material 240 may be used to secure the needle stop patch 206 to the housing wall.

Referring to fig. 9A and 10A, in one embodiment, the first layer 212 of the needle stop patch 206 preferably has a top surface and a bottom surface 225. A first ring 240A of adhesive material may be assembled with the first fabric layer 212. The first ring 240A of adhesive material may be centered on the first fabric layer 212.

Referring to fig. 9B and 10B, in one embodiment, the second fabric layer 216 is positioned over a first loop 240A of bonding material that extends between a bottom surface of the second fabric layer 216 and a top surface of the first fabric layer 212. The second fabric layer 216 may be centered over the first fabric layer 212. The area of the first fabric layer 212 is preferably greater than the area of the second fabric layer 216.

Referring to fig. 9B and 10B, in one embodiment, a second ring 240B of adhesive material may be positioned over the top surface of the second fabric layer 216.

Referring to fig. 9C and 10C, in one embodiment, the third layer of fabric material 220 may be positioned over a second ring 240B of adhesive material that extends between a bottom surface of the third layer of fabric 220 and a top surface of the second layer of fabric 216. The third fabric layer 220 may be centered over the second fabric layer 216. The area of the second fabric layer 216 is preferably greater than the area of the third fabric layer 220.

Referring to fig. 9C and 10C, in one embodiment, a third ring 240C of adhesive material is positioned on the top surface of the third fabric layer 220.

Referring to fig. 9D and 10D, in one embodiment, the fourth fabric layer 224 is positioned over a third loop 240C of bonding material that extends between the bottom surface of the fourth fabric layer 224 and the top surface of the third fabric layer 220. The fourth fabric layer 224 may be centered over the third fabric layer 220. The area of the third fabric layer 220 is preferably greater than the area of the fourth fabric layer 224.

In one embodiment, the loops 240A, 240B, and 240C of adhesive material preferably have the same respective outer diameters and are preferably aligned with each other to connect the four fabric layers 212, 216, 220, and 224 of the needle stop patch 206.

In one embodiment, the respective outer peripheral edges of the four fabric layers may be compressed such that the bonding material within the loops of bonding material 240A, 240B, 240C flows through the weave of the respective fabric layers to bond the fabric layers adjacent to their outer peripheral edges together. As described above, in one embodiment, only the outer peripheral edges of the four fabric layers 212, 216, 220, and 224 are bonded together via the rings 240A-240C of bonding material to enhance flexibility and/or reduce the overall stiffness of the needle stop patch 206. The flexibility of the needle stop patch 206 preferably enables the patch and the housing containing the patch to fold during insertion into a patient.

Referring to fig. 11, in one embodiment, the needle stop patch 306 preferably includes a fabric layer 312 having a plurality of spaced apart apertures 350A-350I extending therethrough. In one embodiment, the holes 350A-350I preferably enable fluid to communicate with the inner lumen of the housing when the filling needle bottoms out on the needle stop patch 306, even in cases where the fabric layer may block the holes.

In one embodiment, each aperture 350A-350I of the fabric layer 312 desirably has an inner diameter ID ₁ of about 0.1mm to 3 mm. In one embodiment, the sum of the areas of the apertures 350A-350I is preferably greater than the outer diameter OD ₅ of the fill needle 336, which may engage the fabric layer 312 to prevent any obstruction and/or accumulation of fluid within the needle stop patch 306. Needle stop patch 306 is designed such that the sum of the areas of apertures 350A-350I formed in fabric layer 312 is greater than outer diameter OD ₅ of needle 336, preferably avoiding accumulation of fluid within one or more fabric layers, which prevents localized fluid accumulation within the needle stop patch. In one embodiment, the pores between the fibers are naturally formed as part of a weave, non-weave, knit, and other pattern, generally acting as fluid channels. In one embodiment, the holes through the fabric are further created via an additional cutting or punching process.

Referring to fig. 12, in one embodiment, the needle stop patch 306 preferably includes a first fabric layer 312 having apertures 350A-350I and a second fabric layer 316 that may be attached to the first fabric layer 312 using methods similar to those shown and described above in fig. 9A-9D and 10A-10D. In one embodiment, second fabric layer 316 preferably includes apertures 352A-352I extending therethrough. The apertures 352A-352I of the second fabric layer 312 are preferably offset from the apertures 350A-350I of the first fabric layer 316 such that when the first and second fabric layers 312, 316 are assembled to one another, the apertures in the respective layers are not aligned with one another.

Fig. 13 shows the first fabric layer 312 and the second fabric layer 316 assembled to each other. In one embodiment, the apertures 350A, 350C of the first fabric layer 312 are not aligned with the apertures 352A, 352C on the second fabric layer 316. In fig. 13, only the central regions of the first and second fabric layers 312 and 316 are shown, and thus the outer circumferences of the first and second fabric layers are not shown. In fig. 13, all holes shown in the first and second layers in fig. 12 are not shown in fig. 13. Fig. 13 provides only one example of how the apertures and corresponding layers 312, 316 may be misaligned with one another.

Referring to fig. 14, in one embodiment, the needle stop patch 406 preferably has multiple layers of fabric, whereby the fabric denier/weave and polymer material stiffness of each layer may be gradually increased to provide a progressive stop effect on the needle tip passing through the needle stop patch 406. In one embodiment, the top layer 324 has a lower hardness than the first middle layer 320. In turn, the first intermediate layer 320 has a lower hardness than the second intermediate layer 316. In turn, the second middle layer 316 has a lower hardness than the bottom layer 312. Thus, for each successive layer from top layer 424 to bottom layer 412, the stiffness of the respective layers 324, 320, 316, and 312 gradually increases to provide a progressive stop effect on the needle tip engaging and/or passing through needle stop patch 406 in the DIR2 indication direction.

In one embodiment, the respective layers 424, 420, 416, and 412 preferably have different outer diameters, such that the final assembly has a skived edge designed to reduce any stair-step effect, thereby facilitating a progressive stiffness gradient.

In one embodiment, a bonding material 440 may be used to bond the layers 424, 420, 416, and 412 together. In one embodiment, the bonding material 440 preferably bonds only the outer periphery of the respective layers to enhance flexibility and reduce the overall stiffness of the needle stop patch 406.

In one embodiment, the addition of an additional layer of fabric to the needle stop patch may increase the needle penetration resistance provided by the needle stop patch. For example, a needle stop patch having five fabric layers may provide greater penetration resistance than a needle stop patch having four fabric layers.

Fig. 15 is a graph showing the increased penetration resistance when an additional layer of fabric is added to the needle stop patch. The graph plots how the penetration resistance is increased by adding an additional layer to the needle stop patch.

In one embodiment, it may be desirable to maximize the flexibility of the needle stop patch by increasing the flexibility of the fabric layer used to make the needle stop patch. Referring to fig. 16, in one embodiment, a prior art test system 550 may be used to evaluate the stiffness and/or flexibility of the fabric layer. In one embodiment, the test system 550 preferably includes a horizontally extending surface 552 adapted to support the fixed end of the fabric layer 512. The fabric layer 512 desirably includes a hanging end 515 that is unsupported by the support surface 552 such that the hanging end 515 is free to flex downward into an unsupported open space. In one embodiment, the fixed end of the fabric layer 512 has a length of about 0.25 inches and the hanging end 515 of the fabric layer 512 has a hanging length of about 2.75 inches. In one embodiment, the width of the fabric layer 512 may be about two (2) inches.

In one embodiment, it is desirable to increase the penetration resistance of the needle stop patch without significant loss of flexibility of the needle stop patch. Fig. 17 is a graph showing that different materials may be selected to maximize penetration resistance while not providing significant loss of flexibility. In fig. 17, a needle stop patch comprising a fabric layer made of 0.015 inch polyester is significantly more flexible than a needle stop patch comprising a fabric layer made of 0.027 inch polyester.

While the foregoing is directed to embodiments of the present invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof, and the scope thereof is determined by the claims that follow. For example, the present invention contemplates that any features shown in any of the embodiments described herein or incorporated by reference herein may be combined with any features shown in any of the other embodiments described herein or incorporated by reference herein and still fall within the scope of the present invention.

Claims

1. A prosthetic implant, the prosthetic implant comprising:

A silicone housing having a front wall and a rear wall;

a needle stop patch secured to an inner surface of the rear wall of the silicone housing;

the needle stop patch comprises two or more layers of fabric material stacked on top of each other;

and a bonding material for bonding the two or more layers of the fabric material stacked on each other.

2. The prosthetic implant of claim 1, wherein the fabric material comprises braided wires or fibers.

3. The prosthetic implant of claim 1, wherein the bonding material passes through the two or more layers of the fabric material.

4. The prosthetic implant of claim 3, wherein each of the two or more layers has an outer edge defining an outer periphery.

5. The prosthetic implant of claim 4, wherein only the outer perimeter of each of the two or more layers is bonded together.

6. The prosthetic implant of claim 4, wherein the outer perimeter of a top layer of the two or more layers defines a first area and the outer perimeter of a bottom layer of the two or more layers defines a second area that is greater than the first area of the top layer, and wherein the outer perimeter of an intermediate layer of the two or more layers between the top layer and the bottom layer defines an intermediate area that is greater than the first area and less than the second area.

7. The prosthetic implant of claim 6, wherein the respective outer edges of the two or more layers are skived to minimize a stair step effect between adjacent ones of the two or more layers.

8. The prosthetic implant of claim 1, wherein the adhesive material secures the needle stop patch to the rear wall of the silicone housing.

9. The prosthetic implant of claim 1, wherein each of the two or more layers of the fabric material has a circular or oval shape.

10. The prosthetic implant of claim 9, wherein the bonding material has an annular shape that matches the circular or oval shape of each of the two or more layers of the fabric material.

11. The prosthetic implant of claim 1, wherein each of the two or more layers of the fabric material is laminated in an elastomeric sheet to form two or more elastomeric layers.

12. The prosthetic implant of claim 1, wherein the anterior wall of the silicone shell comprises a self-sealing membrane, wherein the self-sealing membrane has a three-layer construction comprising:

A middle layer of elastomeric material having a first major surface and a second major surface;

A first outer layer of elastomeric material overlying the first major surface of the middle layer;

A second outer layer of elastomeric material overlying the second major surface of the middle layer, wherein the elastomeric material of the middle layer retains the elastomeric materials of the first and second outer layers in a contracted state.

13. The prosthetic implant of claim 1, wherein each of the two or more layers of the fabric material has a top surface, a bottom surface, and a plurality of holes extending from the top surface to the bottom surface, the prosthetic implant further comprising a needle for filling the silicone shell with a fluid, the needle having a cross-sectional area, wherein a total combined area of the plurality of holes of each of the layers is greater than the cross-sectional area of the needle.

14. The prosthetic implant of claim 1, wherein the denier of the two or more layers increases gradually from a top layer to a bottom layer of the needle stop patch to provide the needle stop patch with a level of resistance that increases gradually from the top layer to the bottom layer.

15. A prosthetic implant, the prosthetic implant comprising:

A silicone housing having a front wall and a rear wall;

The needle stop patch comprises a plurality of layers of fabric material stacked on top of each other;

and an adhesive material for connecting the plurality of layers of the fabric material stacked on each other.

16. The prosthetic implant of claim 15, further comprising a self-sealing membrane integrated into the anterior wall of the silicone shell.

17. The prosthetic implant of claim 16, wherein the self-sealing membrane comprises:

A second outer layer of elastomeric material overlying the second major surface of the middle layer, wherein the elastomeric material of the middle layer retains the elastomeric materials of the first and second outer layers in a contracted state, and wherein an outer surface of the elastomeric material of the first outer layer is secured to an inner surface of the front wall of the silicone housing.

18. The prosthetic implant of claim 15, wherein the plurality of layers of the fabric material stacked on top of one another comprises:

A top layer having an outer edge defining a first area;

A bottom layer having an outer edge defining a second area, the second area being greater than the first area of the top layer; and

An intermediate layer disposed between the top layer and the bottom layer, the intermediate layer having an outer edge defining an intermediate area that is greater than the first area of the top layer and less than the second area of the bottom layer.

19. The prosthetic implant of claim 18, wherein the respective outer edge of each of the multiple layers is skived to minimize a stair step effect between adjacent ones of the multiple layers.

20. The prosthetic implant of claim 15, wherein each of the layers of the fabric material has a top surface, a bottom surface, and a plurality of holes extending from the top surface to the bottom surface, the prosthetic implant further comprising a needle for filling the silicone shell with a fluid, the needle having a cross-sectional area, wherein a total combined area of the plurality of holes of each of the layers is greater than the cross-sectional area of the needle.

21. The prosthetic implant of claim 18, wherein the denier of each of the layers increases gradually from the top layer to the bottom layer to gradually increase the level of resistance within the needle stop patch.

22. A method of manufacturing a multilayer needle stop patch for a silicone housing, the method comprising:

obtaining a first layer of fabric material, wherein the first layer has an outer edge defining a first area of the first layer;

Centering a second layer of fabric material on the first layer, wherein the second layer is centered on the first layer and has an outer edge defining a second area of the second layer, the second area being smaller than the first area of the first layer;

centering a third layer of fabric material on the second layer, wherein the third layer is centered on the second layer and has an outer edge defining a third area of the third layer, the third area being smaller than the second area of the second layer;

centering a fourth layer of fabric material on the third layer, wherein the fourth layer is centered on the third layer and has an outer edge defining a fourth area of the fourth layer, the fourth area being less than the third area of the third layer;

bonding the respective outer edges of the first, second, third and fourth layers together.

23. The method of claim 22, wherein the respective outer edges of the layers are thinned to reduce a stair step effect between the first, second, third, and fourth layers.

24. The method of claim 22, the method further comprising:

Providing a silicone housing having a front wall and a rear wall;

The first layer of the multi-layer needle guard is secured to an inner surface of the back wall of the silicone housing.