Patent Application
20250032237
The present invention relates generally to implantable devices for the treatment of incontinence and more particularly for at least partially absorbable slings for the treatment of urinary incontinence.
Incontinence, including urinary incontinence, impacts the quality of life of people of all ages. It is common and well known that people with incontinence suffer from a loss of self-esteem, societal embarrassment, a self-imposed reduction in social and sensual activities. As a result, sufferers tend to isolate themselves, which leads to anxiety, depression, and an overall decrease in their mental health.
Incontinence is the loss of control of urine (urinary incontinence) or feces (fecal incontinence). The loss of control can be due to a number of factors, including injury, advanced age, and other illnesses impacting bone and muscle structure and integrity. While originally considered a condition associated with advanced age, the medical community now understands that individuals of all ages can suffer from incontinence. In fact, it is very common for new mothers to, at least temporarily, suffer from incontinence after the birth of their child. This is due to the stresses and strains placed on the pelvic floor structure (e.g., muscles, ligaments, and bones), the urinary system, and the gastric system while giving birth.
The urinary system consists of the kidneys, ureters, bladder, bladder outlet, and urethra. The bladder, a hollow and muscular organ, is a temporary reservoir receiving urine produced by the kidneys. The bladder temporarily stores the urine at a low pressure, which is prevented from leaving the bladder by resistance from a competent bladder outlet (i.e., the bladder neck, urethra, and muscular sphincter). During voiding, the bladder contracts sufficiently to expel the urine, while at the same time the bladder outlet relaxes and opens to prevent obstruction of the expelled urine.
The bladder and bladder outlet are supported in the pelvis by various ligaments, musculature, and fascial attachments. The urethra is connected to the bladder neck that is composed of smooth muscles forming an internal sphincter. The urethra carries the urine away from the bladder neck to the urethral opening. In the male, the urethra extends from the bladder neck to the tip of the penis—composed of the bladder neck, prostate, external sphincter, and distal urethra. In the female, the bladder neck, sphincter, and distal urethra terminate in the introitus.
While there are several causes of incontinence, mentioned above, it generally occurs due to one or more of the following conditions: 1) when the bladder is overactive and contracts without control and the sphincter muscle is unable to prevent the urine being expelled or leaked out; 2) an increase in abdominal pressure (e.g., by way of a sneeze or cough) and the sphincter is again unable to prevent the urine being expelled or leaked out; or 3) injury to the pelvic structure (e.g., a torn muscle or ligament) that results in movement of the bladder, bladder neck, or urethra from their proper anatomical location, resulting in the sphincter being unable to close properly, resulting in leaking urine. It is not uncommon for an individual suffering from incontinence to have one or more of the aforementioned conditions. This can occur alone or in combination. The etiology for an overactive bladder (urge incontinence”) may be neurological or idiopathic. The etiology of underactive outlet (“stress incontinence”) may be due to a loss of the supporting structures or intrinsic urethral dysfunction.
Incontinence is broken into five (5) types: stress incontinence, urge incontinence, mixed incontinence, overflow incontinence and functional incontinence:
Stress Urinary Incontinence (“SUI”) is an involuntary loss of urine occurring when there is a sudden increase in intra-abdominal pressure. This can occur as a result of coughing, sneezing, lifting, straining, exercise and, in severe cases, even simply changing body position.
Urge Incontinence occurs as a sudden and immediate need to urinate, resulting in a loss of bladder control prior to reaching the toilet. Urge incontinence is a result of an involuntary bladder contraction, which create the urge to urinate.
Mixed Incontinence, the most common form of urinary incontinence, is a combination of the symptoms for both stress and urge incontinence.
Overflow Incontinence consists of a constant dripping or leakage of urine out of the urethra. This occurs as a result of an overfilled bladder.
Functional Incontinence results when a person has difficulty toileting from one place to another. It is generally caused by factors outside the lower urinary tract, such as deficits in physical function and/or cognitive function.
There have been a number of treatment options available for patients suffering from urinary incontinence. The options include both external and internal treatments. External treatments consist generally of biofeedback, electrical stimulation, or Kegel exercises (repeated contraction of the pelvic floor muscles). Internal treatments consist of injectable materials (to bulk up injured or failing tissue), prosthetic vaginal-insertable devices (e.g., pessaries that hold closed or pinch the urethra), and surgery. While external treatments are generally considered a first line treatment, many patients need surgery to correct their incontinence. The most common operations for a male patient with stress incontinence are an artificial urinary sphincter or a male sling. The most prominent surgical procedure for the treatment of underactive outlet in women is a sling procedure.
Female sling procedures consist of placing a surgical device (“sling”) proximate to the urethra, bladder neck, or mid-urethra in order to stabilize or support the bladder neck, urethra, or a combination of the two. Over the years there have been several different sling procedures and slings developed. The sling procedures and slings have varied in surgical approach and variations in the design of the slings. Slings have also been made of various artificial and autologous materials and various anchoring mechanisms used to anchor the sling to the patients' abdominal muscles, ligaments, or bone.
Although serious complications associated with slings and sling surgical procedures are infrequent, they do occur. Complications have included urethral obstruction, development of a different type of incontinence, urinary retention, surgical site infection, and damage to surrounding tissue by erosion into the urinary tract or other pelvic organs. While many of these complications have been attributed to the sling procedures for the treatment of pelvic prolapse, there is still a need for a new surgical procedure to treat urinary incontinence that reduces or eliminates many of these complications.
In addition to intraoperative surgical complications during implantation, complications associated with sling procedures may be related to the anchoring points or the material utilized during the sling manufacturing process. Permanent materials have been associated with infection, pain, and difficulty with attempts to remove or modify the results.
There have been attempts at developing hybrid slings consisting of slings having one or more non-absorbable portions and one or more absorbable portions. The absorbable portion of the hybrid slings were absorbed over time. The intent of these hybrid slings was to have an absorbable portion of the sling support the urethra or bladder neck, and the non-absorbable portion of the sling act as an anchor. These early hybrid slings were an attempt to eliminate erosion beneath the urethra. Unfortunately, these slings either absorbed too quickly, causing a reoccurrence of incontinence or problems with the permanent portions of the implants.
For these reasons, there is an established need to obtain a minimally invasive yet highly effective absorbable sling and sling system that can be implanted with minimal morbidity resulting from the method of implantation or the material that is utilized.
While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular example embodiments described. On the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.
The drawing figures are not necessarily to scale.
The following description is meant to be illustrative only and not limiting. Other embodiments of this invention will be apparent to those of ordinary skill in the art in view of this description.
The present invention is directed to various embodiments of slings suitable for and methods of implanting the slings in the treatment of female and male incontinence, including but not limited to stress urinary incontinence (“SUI”) diagnosed with urethral hypermobility or intrinsic sphincter deficiency. Although the invention, as disclosed herein generally refers to SUI, treatment of other urological disorders such as urge incontinence, mixed incontinence, overflow incontinence, functional incontinence, and other non-urological disorders, such as fecal incontinence and hernia repair, are also included within the scope of the present invention. It is contemplated that the present invention may also be utilized in conjunction with other procedures and instruments, such as, but not limited to, procedures for addressing cystocele prolapse, vaginal prolapse and anatomic hypermobility.
The various sling embodiments of the present invention may be surgically implanted by various surgical techniques and methods, including but not limited to a transvaginal approach, a transabdominal approach, and a laparoscopic approach. Additionally, the various sling embodiments may be implanted via a number of surgical approaches, including but not limited to transobturator, suprapubic, pre-pubic, or transperineal paths.
Referring to
As particularly illustrated in the example embodiment of
As illustrated in
The sleeve member 30 is designed to be easily removed or separated from sling assembly 20 after implantation. The sleeve member 30 may include one or more slits, perforations, or openings 31 to permit sleeve member 30 to separate into one or more portions that can each be removed from the surgical site. The opening(s) 31 may extend perpendicular or parallel to a long axis of sleeve member 31. The junctures 12a and 12b can be cut or severed with a scalpel or scissors to aid in separating support member 22 and sleeve member 30.
As illustrated in
The composition and configuration of support member or sling 22 imparts it with the ability to strategically support desired tissues and organs, and selectively accelerating tissue ingrowth, while also possibly reducing complications. In one example embodiment, as illustrated in
As particularly illustrated in
As also depicted in
In one example embodiment of the present invention, support member or sling 22 includes one or more accelerated ingrowth zones 24c that are configured to have an increased or accelerated tissue ingrowth compared to the anchor zones 24a and the support zone 24b. The accelerated ingrowth zones 24c are generally positioned between the anchor zones 24a and support zone 24b. In this manner, accelerated ingrowth zones 24c quickly form tissue-sling connectors or connections that provide early anchoring for support zone 24b, while support member or sling 22 is forming the tissue bridge. As a result, early urinary incontinence control is achieved. Eventually, all or a portion of support member 22 is absorbed leaving the tissue bridge to support the urethra or bladder neck. Absorption of all or most of the support member or sling 22 greatly reduces previous complications.
The present invention also includes a modified implant 10 that can be used when needed, including but not limited to when there is extensive pelvic floor damage or injury. In these cases, the support member or sling 22 is configured to only be partially absorbed by the patient's body. What remains after absorption is a hybrid sling-tissue bridge comprising a tissue bridge portion that extends the full or partial length of support member or sling 22 and a reinforcing sling portion 22a. As illustrated in
The tissue-sling connectors or connections created by the accelerated ingrowth zones 24c can become part of the tissue bridge or the hybrid support-tissue bridge. The tissue-sling connectors or connections, comprising dense areas of tissue ingrowth that will continue to provide additional anchoring and support to the support zone 24b of the tissue bridge even after the absorption process is complete.
The support member or sling 22 of the present invention have a number of configurations. For instance, as illustrated in
In another example embodiment of the invention, as illustrated in
In one embodiment, the support member or sling 22 is made of a porous material that is, as mentioned above, ideally completely or partially absorbable by a patient's body. The porous material comprises one or more woven or inter-linked filaments or fibers that form multiple fiber junctions throughout the porous material. The fiber junctions may be formed via weaving, bonding, ultrasonic welding, or other junction forming techniques, including combinations thereof. The porous material includes a plurality of pores formed during the manufacturing process that permit tissue in-growth and fixation with the porous material. The porous material may comprise a woven monofilament, knitted with a warp tricot.
In another example embodiment of the present invention, as illustrated in
As mentioned above, the weaving and stitch pattern/count of the various layers of the implant may be varied to provide support members or sling 22 of varying properties and characteristics. The length and thickness of the support members or sling 22 can be generally uniform or vary along the length and width of the support member or sling 22. In one example embodiment, the anchor zones 24a, support zone 24b, and accelerated ingrowth zones 24c have a height of approximately 1 cm. The length of the support member or sling 22 may be approximately 30 cm and the length of the accelerated ingrowth zones 24c may be approximately 3.0 cm. The length and height of the support member or sling 22 and its parts may vary depending upon the type of procedure being performed and the needs of the patient. For instance, the support member or sling 22 may be less than 30 cm in length for a “min-sling” procedure. Additionally, the support member or sling 22 may be slightly longer or shorter than 30 cm for a retropubic or obturator surgical approach. Further, a larger patient may need a generally larger sling 22 while a smaller patient may require a smaller sling 22.
The thickness and density of fibers or filaments forming any part of the implant 10 may be the same or vary along their length and width. For example, the anchor zones 24a and support zone 24b can consists of thicker fibers with denser patterns to allow for a slower degradation time of the implant 10 at the anchoring sites, which results in a longer mechanical support and longer time to form the tissue bridge via gradual load transfer from implant 10 to the newly formed tissue bridge. Additionally, or alternatively, fibers or filaments of accelerated ingrowth zones 24c can be thinner, and a less dense pattern to achieve faster degradation and to trigger fibroblasts and the tissue regeneration process.
In another example embodiment, the anchor zones 24a, support zone 24b, and accelerated ingrowth zones 24c comprise materials and/or combinations of materials and agents that are configured to elicit different tissue responses and then be absorbed by a patient's body. The materials or agents (and/or combinations of agents and materials) comprise pharmacologic, biologic, and cellular therapies designed to target specific steps or subsets involved in deposition of collagen and tissue in-growth. Modification of the segment to promote collagen deposition and tissue ingrowth.
The parts of the absorbable implant 10 may comprise any absorbable material. For example, naturally absorbable materials such as catgut, collagen serosa or sheep submucosa can be used. Synthetic absorbable materials such as polybutylene succinate (“PBS”), polyglycolide (“PGA”), polylactide (“PLA”), copolymers of polyglycolide and polylactide, lactomer, poly-p-dioxanone (“PDS”), PDS and Irgacare, poly-4-hydroxybutyrate (“P4HB”), and the like can also be used. The list of materials should be considered exhaustive and other materials are within the spirit and scope of the present invention.
The accelerated ingrowth zones 24c can comprise either a tissue ingrowth accelerant material or an additive tissue ingrowth accelerant. As an additive, the tissue ingrowth accelerant may be combined with the absorbable material of the accelerated ingrowth zones 24c by coating, seeding, adhering, binding, weaving, spinning, printing and the like. Any tissue ingrowth accelerating material may be used. For example, collagen material may be interwoven with the any parts of implant 10. In another example embodiment, a collagen material may be seeded in at least the accelerated ingrowth zones 24c. The collagen material may be collected from the pelvic tissue of a cadaver and combined with the accelerated ingrowth zones 24c.
Hyaluronic acid (“HA”) growth factors such as but not limited to, fibroblast growth factor (“FBG”), RGD cytokines (IL 1-beta, IL-6), tumor necrosis factor (“TNF”), platelet derived growth factor (“PDGF”), vascular endothelial growth factor (“VEGF”), and transforming growth factor (“TGF”), corticosteroids, hormones can be added to accelerated ingrowth zones 24c to facilitate fibroblasts, improve collagen formation by the fibroblasts, attenuate the inflammatory response, to avoid scar and fibrotic tissue formation.
In one example embodiment, cadaver collagen is collected, processed into a filament, and then interwoven into portions of support member or sling 22. Example weaving patterns, as discussed above, are illustrated in
In another example embodiment, as mentioned above, hyaluronic acid (“HA”) can be used as an agent to accelerate the tissue ingrowth in the accelerated ingrowth zones 24c. The accelerated ingrowth zones 24c can be soaked in HA prior to implantation. Alternatively, HA can be incorporated into slow-release seeds that are then combined with the accelerated ingrowth zones 24c. The coating of the seeds is configured to release the HA over a particular period of time. While HA has been described as the tissue ingrowth accelerant agent, other materials may also be employed.
In another example embodiment, the tissue ingrowth accelerant agent is incorporated into the material of the accelerated ingrowth zones 24c during the manufacturing process. In this embodiment, as the material of the accelerated ingrowth zones 24c is absorbed it releases the tissue ingrowth accelerant agent, which in turn causes an acceleration of tissue ingrowth. This delayed release of the ingrowth accelerant agent can be accomplished by coating the sling material with a slow decaying material that upon decaying releases the ingrowth accelerant agent into the surrounding tissue, thereby increasing tissue ingrowth.
The support member or sling 22 of the present invention, can have any number of accelerated ingrowth zones 24c. As illustrated in
Accelerated tissue ingrowth zones 24c can include fast degrading fibers or filaments that can be formed by changing the fiber size, weaving pattern, surface modifications via physical or chemical processes resulting surface cracks on the fibers, and/or via functionalization through coating, binding or incorporation of the molecules such as (included but not limited to) collagen, HA, dextran, cytokines (IL-6, IL1-β), RGD, growth factors (FGF, NGF, TNF, PDGF, VEGF etc.) an/or incorporation of other faster degrading material/polymer.
As illustrated in
The dilators 52a and 52 each have a shape and configuration to dilate or open a delivery path for ease of implanting the support member or sling 22. Additionally, as illustrated in
Each of the opposed dilators 52a and 52b have a second end 56 configured to mate with a distal end 66 of a delivery needle 60 (see
The delivery needle 60 can also be inserted into first end 54 of the dilators 52a and 52b to be able to drive dilators 52a and 52 into position. This configuration may be used for instance, during a transvaginal procedure where the dilators 52a and 52b are inserted via a vaginal incision.
Turning to
The delivery needle(s) 60 include a handle 62 that is either fixed to or detachable from the delivery needle 60. The handle 62 can be molded and may include indicia thereon that is configured to aid in identifying the particular side of implantation.
Utilizing delivery tools 60, a surgeon can surgically place implant 10 into a therapeutically effective position relative to a physiological environment intended to be supported (e.g., urethra or bladder neck). As illustrated in
In one aspect of the present invention, support member or sling 22 may include a tension adjustment or control member 70 woven through it for transferring sling adjustment forces from one portion of support member or sling 22 to other portions of support member or sling 22, such as ends 14a and 14b. The tension adjustment member 70 affords effective repositioning of support member or sling 22 while avoiding undesirable permanent deformation of support member or sling 22. The tension adjustment member 70 may be manufactured from a permanent or absorbable material similar to support member or sling 22.
The tension adjustment member 70 is preferably threaded or woven along the length of support member or sling 22. The tension adjustment member 70 can be connected at one or more points along its length. For example, the tension adjustment member 70 may be affixed at junctures formed during the weaving process to distribute the anchoring points and spread the tension along its length.
Turning to the illustration of
As particularly illustrated in
As illustrated in
In yet another example embodiment of the present invention, as illustrated in
As discussed above, accelerated ingrowth zones 24c can also be formed in support member or sling 22 by simply changing one or more of the knitting parameters, densities, or the porous structure of support member or sling 22. For instance, as illustrated in
As illustrated in
The support member 22 can be constructed by combining electrospun and non-spun fabrics, fibers, or filaments. The number of layers can vary and any number is within the spirit and scope of the invention, but surgeons may find a two or three layered support member 22 sufficient. In another example embodiment, support member 22 can be made from one or more fibers having a co-polymer spun in or on the fibers. As with other embodiments described herein, support member can be made or constructed of fibers having different resorbable degradation profiles knitted together, different surface modifications, or different coatings. While the configuration of implants 10 have been described as having different fibers with different properties, it is also within the sprit and scope of the invention that different fibers may also contain some of the same properties.
As discussed above, the Z-configuration of support member or sling 22 allows accelerated ingrowth zones 24c to be positioned next to, proximate to, or overlap with at least a portion of an adjacent accelerated ingrowth zones 24c. In this configuration there is a localized increase in tissue ingrowth in accelerated ingrowth zones 24c. This can be particularly helpful with a patient that has thin pelvic tissue, which has been known to be difficult to treat with slings. Not only does this configuration accelerate tissue ingrowth it also can increase the size of the accelerated ingrowth zone 24c, which can aid in increasing thicker/stronger tissue to support the implant 10, and tissue or organ, during absorption and then support the tissue bridge that will then individually, or in conjunction with one or more reinforcement members, support the tissue or organ.
As also discussed above, accelerated ingrowth zones 24c in these configurations may have the same or different knit pattern as support member or sling 22. In another embodiment, the fibers or filaments making up the zones, 24a and 24b, and particularly 24c, may be treated with post-knit modifications to accelerate tissue ingrowth, degradation, or both. These post knit modifications can be achieved chemically, physically, or mechanically to obtain surface alterations. One such alteration is illustrated in
Accelerated ingrowth in accelerated ingrowth zones 24c can also be accomplished by functionalization through coating, binding or incorporation of molecules including, but not limited to, collagen, hyaluronic acid (“HA”), dextran, cytokines (IL-6, IL1-β), RGD, growth factors (e.g., FGF, NGF, TNF, PDGF, VEGF etc.). Accelerated ingrowth can also be accomplished by incorporating faster degrading material or polymers including but not limited to polylactic acid (“PLA”), polyvinyl alcohol (“PVA”), Poly lactic co glycolic acid (“PLGL”).
As illustrated in
In another example embodiment, as illustrated in
Anchoring zones 24a can also comprise exclusively or partially of slow degrading fibers or filaments formed by changing the size of fiber or filaments 35, their weaving pattern and/or incorporating other slow degrading material or polymers such as but not limited to thermoplastic polyurethane (“TPU”). A combination of faster and slower degradable polymers can also be used to optimize the local host response to implant 10. A combination of different knit patterns, to influence the tissue response to implant 10.
Referring to
As illustrated in
Turning to
This configuration also includes at least one biofunctional or bioactive member 80 comprising one or more interconnected filaments 33/35 that can be woven into a mesh strip or a mesh sheath 82 having opposed open ends 84a and 84b. The biofunctional bioactive member 80 or sheath 82 is positionable or connected to at least a portion of support member 22 and when combined define at least one repositionable bioactive zone 86 on support member 22.
The biofunctional or bioactive sheath 82 is configured to pass support member 22 through its open ends 84a and 84b. In this manner, a surgeon is able to move or slide biofunctional or bioactive sheath 82 along a length of support member 22. Additionally, a surgeon is able to cut or divide biofunctional or bioactive sheath 82 to create or form multiple smaller biofunctional or bioactive sheaths 82 to allow for the creation of a number of bioactive zones 86 along the length of support member 22.
There are a number of different biofunctional or bioactive member(s) 80, with each having or causing a different bioactivity within the patient or within a particular location within a patient. For instance, one biofunctional bioactive member 80 is constructed or configured to control a rate tissue ingrowth. The biofunctional or bioactive member 80 can be combined or coated with at least one tissue growth accelerant, such as hyaluronic acid, collagen, growth factors, or hormones that are disposed on at least a portion of the biofunctional or bioactive member 80. A biofunctional or bioactive member 80 can also be combined or coated with any known material capable of decreasing a rate of tissue ingrowth.
Another biofunctional or bioactive member 80 has a bioactivity configured to control an increase or a decrease in degradation of the fibers or filaments 33/35 of the biofunctional or bioactive member 80, or support member 22. By increasing or decreasing a rate of degradation of the fibers or filaments 33/35, a surgeon can control how long the implant 10, or portions thereof, is in a particular location. As mentioned above, this is important for patients with complex tissue conditions or disorders. For instance, a patient that has given birth in their lifetime, but also suffers from a disease like rheumatoid arthritis, may have thin pelvic tissue in one location and tears in another location. In this case, a surgeon can configure implant 10 to address the locations of each particular condition of the pelvic tissue.
The implantable article kit may also include one or more sleeves 30 that can at least temporarily enclose support member 22 and biofunctional or bioactive member(s) 80. Once in an operating theater, a surgeon can remove the biofunctional or bioactive member(s) 80 from sleeve 30 and prepare it for combining with support member 22. Once they are combined, a surgeon may insert the combined implant 10 back into one of the sleeves 30 for use during implantation. The sleeve 30 can then be removed once support member 22 is implanted.
For implants 10 having a Z-configuration, positioning biofunctional or bioactive member(s) 80 with the overlapping areas creates overlapping bioactive zones that are configured to increase or control a rate of a bioactivity. This configuration also permits a surgeon to have different bioactive properties within a single overlapping bioactive zone. For instance, a surgeon can construct implant 10 to have accelerated tissue ingrowth and delayed fiber or filament 33/35 degradation to permit the quickest tissue ingrowth while delaying implant 10 degradation to provide the maximum time for formation of the tissue bridge.
The biofunctional or bioactive member(s) 80 are configured to exhibit a number of bioactive conditions including, but not limited to, accelerated tissue ingrowth, accelerated fiber degradation, reduced fiber degradation, rate of an eluding material or compound, such as an antibiotic or antimicrobial. Other bioactive conditions are also within the spirit and scope of the present invention.
In another example embodiment, biofunctional or bioactive member(s) 80 can also be configured to contain or release a scar reducing agent while biofunctional or bioactive member 80, or support member 22, degrades. This property or characteristic may be particularly helpful for a patient that has had previous surgeries and has a lot of pelvic scar tissue. This implant 10 configuration allow the patient to temporarily treat their incontinence with the support member 22, while it degrades, and while the biofunctional or bioactive member 80 eludes the scar-reducing chemical or agent to reduce the amount of scar tissue. Later, a surgeon can perform another procedure with a different implant 10 configuration to strategically place a tissue bridge that will provide natural long-lasting support of the tissue or organ.
Any constructs of implant 10 discussed herein may be developed using electro spun technology having two, three, or more layers. They may also comprise one or more layers combining spun- and non-spun fiber constructs. Additionally, any of the disclosed implant 10 constructs may be spun fibers or filaments 33 and 35 combined with molecules 37 described above including, but not limited to, collagen, HA, dextran, cytokines (IL-6, IL1-β), RGD, growth factors (FGF, NGF, TNF, PDGF, VEGF etc.).
Similarly, any implant 10 constructs may have surface modification or alterations (e.g., cracks 31 or pores 31a) on a portion of or on the entire support member or sling 22. The fibers 33 and 35 of implants 10 and its support member or sling 10 may be treated with any process that alters or increases its surface to be more or less hydrophilic for fibroblasts. One example process includes plasma treatment. Any process may be employed that will affect tissue ingrowth, cell adherence and may modify immunologic response as well. These other processes include coatings of antimicrobial peptides, antibiotics, or drug eluting materials, and the like. As discussed above, any surface of constructs or implants 10 can also be altered by using one or more chemical groups that allow biofunctionalization to be obtained (e.g., COOH groups) for covalent binding of molecules via EDC-NHS chemistry or similar chemistry, or any other surface modification resulting in more hydrophilic surfaces.
The term “sling” is used generally to include a wide variety of shapes and sizes, materials, and treatments. While support member or sling 22 is preferably rectangular for treating SUI in females, other shapes are also contemplated. Depending on the treatment addressed (e.g., to provide hammock support for the bladder or bladder neck, or to address a rectocele, enterocele or prolapse), support member or sling 22 may be any of a wide variety of shapes. As an example, support member or sling 22 may be of the general shape of the slings described and shown in Moir et al., The Gauze-Hammock Operation, Journal of Obstetrics and Gynaecology of the British Commonwealth, Volume 75, No. 1, Pps. 1-9 (1968). Any shape of support member or sling 22 capable of providing a hammock support for an anatomical structure such as the urethra, bladder or the juncture between the bladder and bladder neck may be used.
The term “pore,” “crack,” or “channel” is not intended to be limiting, the pores or channels may comprise polygonal shaped holes with diagonals of 0.132 inches and 0.076 inches or variations thereof. The quantity and type of fiber junctions, fiber weave, pattern, and material type influence various support member or sling 22 properties or characteristics. In one example embodiment, a non-mesh support member or sling 22 configuration is also included within the scope of the invention. The support member or sling 22 monofilaments may be knitted with a warp tricot (as described above). The stitch count may be 27.5 courses/inch (+ or −2 courses) and 13 wales/inch (+ or −2 wales) or any variations thereof.
In another example embodiment, other substances may be included with support member or sling 22. These substances include, without limitation, drugs, hormones, antibiotics, antimicrobial substances, dyes, silicone elastomers, polyurethanes, radiopaque filaments or substances, anti-bacterial substances, chemicals, or agents, including any combinations thereof. The substances may be used to enhance treatment effects, reduce potential sling or implant 10 rejection by the body, enhance visualization, indicate proper sling 22 orientation, resist infection or other effects.
While the invention has been described in connection with what is presently considered to be the most practical and preferred embodiments, it will be apparent to those of ordinary skill in the art that the invention is not to be limited to the disclosed embodiments. It will be readily apparent to those of ordinary skill in the art that many modifications and equivalent arrangements can be made thereof without departing from the spirit and scope of the present disclosure, such scope to be accorded the broadest interpretation of the appended claims so as to encompass all equivalent structures and products. Moreover, features or aspects of various example embodiments may be mixed and matched (even if such combination is not explicitly described herein) without departing from the scope of the invention.
The present application claims the benefit of U.S. Provisional Patent Application No. 63/286,057, filed Dec. 5, 2021, which is incorporated herein in its entirety by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2022/051868 | 12/5/2022 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63286057 | Dec 2021 | US |
