Materials and methods for securing bodily implants

In one embodiment, a medical device includes a resorbable material that is configured to be disposed within the body of the patient proximate a bodily implant. The resorbable material is configured to frictionally retain the implant in place within the body of the patient for at least a period of time. In one embodiment, a kit includes an implant and a resorbable material. The implant is configured to be disposed within a body of a patient. The resorbable material is configured to be disposed within the body of the patient proximate the implant to frictionally retain the implant in place within the body of the patient for a period of time. The resorbable material is configured to be resorbed by the body after the period of time.

TECHNICAL FIELD

This disclosure relates generally to medical devices and more particularly to implants configured to provide support within a body of a patient and materials and methods for securing such implants within the body of the patient.

BACKGROUND

A variety of medical procedures are performed to treat various female pelvic dysfunctions, including procedures to treat urinary incontinence, and correcting various prolapse conditions such as uterine prolapse, cystoceles, rectoceles, and vaginal vault prolapse.

Women often experience vaginal prolapses due to age or other factors. For example, women may experience a cystocele, a rectocele and/or a hysterocele. A cystocele occurs when the bladder bulges into the vagina, and a rectocele occurs when the rectum bulges into the vagina. A hysterocele occurs when the uterus descends into the vagina. An enterocele (small bowel prolapse) can also occur, when the small bowel pushes through the upper wall of the vagina.

Treatments of such dysfunctions have included suturing procedures or the use of implants for support or suspension. A hysterocele is often treated with a hysterectomy followed by a vaginal vault suspension. Various devices and procedures are used to deliver and secure pelvic implants within a variety of different anatomical structures within a pelvic region. Implants can be delivered to a pelvic region through one or more vaginal incisions, and/or through exterior incisions in the patient.

Existing implants differ in many ways including size, shape, material, number and location of straps, and in the method in which they are delivered and placed within a pelvic region. Additionally, depending on the particular condition to be treated and the implant used, pelvic floor repair can require various fixation locations within a pelvic region. For example, an implant can be secured using a number of fixation points.

In some implants, sutures may be used to bridge, anchor and suspend the implants in place within the body of the patient. In other implants, the implants include arm members or anchors that extend to and couple to bodily tissue to suspend or retain the implant in place within the body of the patient. As tissue in-growth occurs on the implants, however, the sutures, arms, or other anchoring members may no longer be necessary to retain the implant in place within the body of the patient. The tissue in-growth may support the implant within the body such that the sutures, arm members, and other anchor members are pulled from their anchor locations. This pulling within the body of the patient may be painful and/or harmful to the body of the patient.

Accordingly, it is desirable to provide an implant that does not include specific fixation points within the body of the patient. Additionally, it is desirable to provide an implant and a securement mechanism that allows the implant to be secured within the body of the patient for a period of time (for example, while the tissue in-growth is occurring).

SUMMARY

In one embodiment, a medical device includes a resorbable material that is configured to be disposed within the body of the patient proximate a bodily implant. The resorbable material is configured to frictionally retain the implant in place within the body of the patient for at least a period of time. In one embodiment, a kit includes an implant and a resorbable material. The implant is configured to be disposed within a body of a patient. The resorbable material is configured to be disposed within the body of the patient proximate the implant to frictionally retain the implant in place within the body of the patient for a period of time. The resorbable material is configured to be resorbed by the body after the period of time.

DETAILED DESCRIPTION

The devices and methods described herein are generally directed to bodily implants. For example, in some embodiments the implants are configured to be placed in the pelvic region of the patient. For example, the implant may be a posterior support implant, an anterior support implant, a total pelvic floor repair implant, an incontinence sling implant. An implant can be placed into the pelvic space of a male or female patient.

An implant according to an embodiment of the invention can be implanted, for example, through a vaginal incision, in a retro-pubic direction (behind the pubic bone), or in a pre-pubic direction (in front of the pubic bone). In other embodiments, an implant can be placed in the direction of other anatomical structures as desired. A procedure to deploy a pelvic implant can include vaginal incisions, such as an anterior vaginal incision and/or a posterior vaginal incision.

FIG. 1is a schematic illustration of a medical device100according to an embodiment of the invention. The medical device100includes an implant110and a material150.

In some embodiments, the implant110is configured to be placed and secured within a body of a patient. The implant110is configured to provide support to a portion of the body. For example, in some embodiments, the implant110may be placed and secured proximate the bladder of the patient to provide support to the bladder of the patient. In other embodiments, the implant110is configured to be placed and secured proximate the uterus of the patient to provide support to the uterus of the patient. In further embodiments, the implant110is configured to be placed and secured at other locations within the body of the patient.

The implant110may be of any shape and size. In some embodiments, the implant110is shaped to be inserted into a body of a patient and provide support for a portion of the body of the patient. For example, in some embodiments, the implant110is square. In other embodiments, the implant110is rectangular. In yet further embodiments, the implant110is round or oval.

In some embodiments, the implant110includes a top edge112, a bottom edge114, a first side edge116, and a second side edge118. The implant110also includes an upper surface122and a lower surface (not illustrated) opposite the upper surface122.

The implant110may be formed of any biocompatible material or materials. In some embodiments, the implant110is formed of a mesh material. For example, the implant110may be formed of Advantage® mesh or the Polyform™ synthetic mesh, both as sold by Boston Scientific Corporation. In some embodiments, in the implant110may be formed of a polymer material. In some embodiments, the implant110is made of polypropylene. In some embodiments, the mesh material of the implant110allows for and/or promotes tissue in-growth to secure the implant110to the bodily tissue of the patient.

In some embodiments, the implant110is formed of a natural or non-synthetic material. For example, in some embodiments, the implant110is formed from bovine Xenform® as sold by Boston Scientific Corporation or cadaveric tissue Repliform® (human dermic) as sold by Boston Scientific Corporation.

In some embodiments, the implant110is formed of a multiple materials. For example, in some embodiments, a first portion of the implant110is formed of a synthetic material and a second portion of the implant110is formed of a natural material.

The material150is configured to be disposed within the body of the patient and help retain the implant110in place within the body of the patient.

In some embodiments, the material150is configured to retain the implant110in place within the body of the patient until the implant110is supported or retained in place by the body itself. For example, in some embodiments, the material150is configured to retain the implant in place within the body of the patient until the implant110undergoes tissue ingrowth (or tissue ingrowth occurs on the implant110).

In some embodiments, the material150is biocompatible and biodegradable. For example, in some embodiments, the material150is a resorbable material and is configured to be resorbed or otherwise broken down and absorbed by the body of the patient. Accordingly, the material150can be placed within the body of the patient proximate the implant110to retain the implant110in place within the body of the patient for a period of time (for example, until the material is resorbed). For example, in some embodiments, the material150is configured to retain the implant110in place within the body of the patient until scarring, scar material, or tissue ingrowth occurs on the implant110to retain the implant110in place within the body of the patient. Once the scarring, scar material, or tissue ingrowth occurs on the implant110, the implant110may be sufficiently retained within the body of the patient and the material150is resorbed by the body of the patient.

For example, in some embodiments, the material150is configured to retain the implant110in place within the body of the patient for a few days. Specifically, in some embodiments, the material150is configured to retain the implant110within the body of the patient for a period of 3 to 7 days. After the period of time, the scarring or tissue ingrowth on the implant110will help retain the implant110in place and positioned within the body of the patient.

In some embodiments, the material150is a foam material. For example, in some embodiments, the foam material is configured to be placed within the body of the patient in a first, compressed state and is configured to expand to a second state once the foam material is placed within the body of the patient. In other words, the volume of the foam material increases when the foam material is placed within the body of the patient. For example, in some embodiments, the foam material may be stored or retained outside of the body of the patient under a pressure (for example, in a pressurized container) to keep the foam material in its first, compressed state. Once the foam material is disposed within the body of the patient, the removal of the pressure (or the lower pressure of the body against the foam material) allows the foam material to expand to its second state or configuration.

In some embodiments, the material150helps to eliminate open areas in the body of the patient proximate the implant110. In such embodiments, the material150, for example, may help prevent blood or fluid accumulation proximate the implant110. In some such embodiments, the material150may help prevent mesh erosion.

The material150may be any biocompatible material configured to help retain the implant in place within the body of the patient for a period of time. For example, in some embodiments, the material150includes alginate, collagen, poly(lactic-co-glycolic acid) (PLGA), or another polysaccharide. In other embodiments, the material150includes another type of biodegradable or resorbable material. In some embodiments, the material150is bioabsorbable.

In some embodiments, the material150includes an additive that provides a benefit or supplement to the body of the patient. For example, in some embodiments, the material150includes alginate and an additive. In some embodiments, the material150includes collagen, PLGA, or another polysaccharide and an additive. In some embodiments, the material includes more than one additive.

For example, in some embodiments, the material150includes additives to facilitate the placement of a large volume of additives into the body of the patient. For example, in some embodiments, the material150includes an additive such as an antibiotic. For example in some embodiments, the material150includes minocycline, tetracycline, or rifampicin. In other embodiments, the material150includes an additive such as an anti-inflammatory, such as, but not limited to, ketorolac or naproxen.

In some embodiments, the material150includes a trophic factor, such as tropic factors to recruit cells to produce ligamentous tissue or to stimulate cells to regulate collagen deposition. For example, in some embodiments, the trophic factors include members of the Transforming Growth Factor beta family (TGFb), the Fibroblast Growth Factor family (FGF) and the Bone Morphogenic Protein family (BMP).

In some embodiments, the material150includes an active pharmaceutical ingredient. In some embodiments, the material150includes stem cells. In other embodiments, the material150includes a material or substance that is configured to promote tissue ingrowth on the implant110.

In some embodiments, the additives may also be grafted or otherwise disposed on the implant110, for example, in areas where additional collagen production is desired.

In some embodiments, the material150is configured such that the material150may provide a support or scaffold to the body of the patient. In some such embodiments, tissue, such as prolapsed tissue, may be secured to the material either by sutures, adhesives, or by tissue in-growth.

In use the implant110may be inserted into a body of a patient. For example, in some embodiments, the implant110is inserted into a body of a patient through a vaginal incision such as an anterior or posterior vaginal incision. In other embodiments, the implant110is placed or disposed within the body of the patient through a different bodily incision or opening.

In some embodiments, the implant110is positioned within the body of the patient such that the implant110may provide support to a portion of the body of the patient. For example, in some embodiments, the implant110is placed proximate a bladder, a bladder neck, or a urethera of a patient and is configured to provide support to such portion of the body of the patient. In other embodiments, the implant110is placed or positioned proximate another portion or organ of the body of the patient and is configured to provide support to such bodily portion.

The material150may then be inserted or disposed within the body of the patient. In some embodiments, the material150is inserted into the body of the patient through the same bodily incision or opening that the implant110was inserted into the body through. In other embodiments, the material150is inserted into the body of the patient through a bodily incision or opening different than the incision or opening that was used to insert the implant110into the body of the patient. In some embodiments, the material150is inserted into the body of the patient using an insertion tool, such as a syringe. In other embodiments, the material may be inserted into the body of the patient using another insertion tool.

In some embodiments, the material150is inserted into the body proximate the implant110. For example, in some embodiments, the material150is configured to contact the implant110(such as the upper surface122and/or the lower surface of the implant110). In some embodiments, the material150is configured to be disposed within the body of the patient such that it extends from one end portion of the implant110to another end portion of the implant110. In some embodiment, the material150is configured to be disposed within the body of the patient such that it substantially surrounds the implant110. In other words, in some embodiments, the material is configured to be disposed within the body of the patient such that it extends along both the upper surface122and the lower surface of the implant110from one end portion of the implant110to the opposite end portion of the implant110.

In some embodiments, the material is configured to mechanically support the implant110within the body of the patient. For example, in some embodiments, the material150is configured to be disposed within the body of the patient proximate the implant110and is configured to apply a pressure or a force against the implant110to frictionally couple the implant within the body of the patient. For example, in some embodiments, the material150is configured to apply a pressure or a force against the implant110to pressure or force the implant110against bodily tissue to frictionally couple the implant110to the bodily tissue (or to the material150itself).

In some embodiments, the material150may be disposed within the body of the patient in empty space of the body proximate the implant110. Empty space is the space within the body of the patient that is not occupied by bodily organs, bones, or other portions of the body of the patient. Accordingly, the material150may be placed within the empty space of the body of the patient proximate the implant110to help prevent the implant110from moving within the empty space of the patient. In some embodiments, the material150is inserted into the patient until the material entirely fills the empty space of the patient proximate the implant110. In other embodiments, the material150is configured to fill about 50% of the empty space of the patient proximate the implant110. In other embodiments, the material150is configured to fill more than 50% of the empty space proximate the implant110. In yet further embodiments, the material150is configured to fill less than 50% of the empty space proximate the implant110.

In some embodiments, the medical device100is used in conjunction with a pessary. The pessary may be inserted into the vagina or rectum of the patient to help retain the implant in place within the body of the patient. For example, in some embodiments, the implant110is inserted into a pelvic region of the patient and a pessary is placed within the vagina of the patient after the implant has been inserted and positioned within the body. The pessary may be configured to retain the vagina in an expanded position or configuration and apply a force against the implant110to maintain the position of the implant within the body of the patient.

In some embodiments, the pessary may be used after the implant110and material150have been placed within the body of the patient. In other embodiments, the pessary is used and placed within the body of the patient after only the implant110has been placed within the body of the patient.

FIGS. 2A-2Dare top views of various implants according to embodiments of the invention. As illustrated inFIG. 2A, the implant210may have a generally square shape. As illustrated inFIG. 2B, the implant310may have a generally circular or oval shape. As illustrated inFIG. 2C, the implant410may have a generally rectangular shape. As illustrated inFIG. 2D, the implant510may have an irregular shape.

In some embodiments, the material may be inserted into a body of a patient using an insertion tool. For example, a syringe may be used to insert the material150into the body of the patient.

FIG. 3is a perspective view of an insertion tool680containing a material650. The insertion tool includes a reservoir684and a needle portion686. The insertion tool680may be used to insert, advance, or otherwise dispose the material650into the body of the patient. For example, in some embodiments, the insertion tool650may be used to insert the material650into the body of a patient through a vaginal incision. In other embodiments, the insertion tool680may be used to insert the material into the body of the patient through another incision or opening of the body.

In the illustrated embodiment, the insertion tool680includes a plunger or actuator682that may be advanced or activated to eject the material650from the reservoir684of the insertion tool680, through the needle portion686of the insertion tool680, and into the body of the patient. For example, in the illustrated embodiment, the plunger or actuator682may be advanced in the direction of arrow A to eject the material650from the insertion tool680.

In some embodiments, the insertion tool680is configured to retain the material650in a compressed state or configuration. For example, in some embodiments, the insertion tool680is configured to apply or retain a pressure on the material650to retain the material650in a compressed state or configuration. For example, in some embodiments, the reservoir684is configured to apply pressure to the material650to retain the material650in its compressed state or configuration.

FIG. 4is a schematic illustration of a medial device700disposed within a body of a patient. In the illustrated embodiment, the implant710is disposed between a bladder B and a vagina V of the patient. The implant710is configured and positioned to provide support to the bladder B of the patient. The material750is disposed within the anterior compartment AC (such as the empty space of the anterior compartment AC). In some embodiments, the material750is disposed within the body of the patient such that the material750surrounds the implant710. The material750is configured to retain the implant710in place and positioned within the body of the patient until scarring or tissue ingrowth occurs on the implant710. For example, in some embodiments, once the scarring or tissue ingrowth occurs the material750is resorbed by the body of the patient and the implant710remains in place within the body of the patient (as illustrated inFIG. 5).

FIG. 6is a flow chart that illustrates a method800for placing a medical device within a body of a patient. In one embodiment, the method800includes creating a bodily incision or opening (810). In some embodiments, the creating a bodily incision or opening (810) includes creating a vaginal incision. For example, in some embodiments, an anterior vaginal incision is created. In other embodiments, a posterior vaginal incision is created.

In some embodiments, the method includes inserting an implant through the bodily incision (820). For example, in some embodiments, the implant is inserted into the body of the patient through an anterior vaginal incision. In other embodiments, the implant is inserted through a posterior vaginal incision. In yet a further embodiment, the implant is inserted through a different bodily incision.

In some embodiments, the implant is inserted into the body of the patient such that the implant is positioned to provide support to a portion of the body of the patient. For example, in some embodiments, the implant is positioned within the body such that the implant is configured to provide support to a bladder, a bladder neck, or a urethra of the patient. In other embodiments, the implant is positioned within the body such that the implant is configured to provide support to a uterus, rectum or other portion of the body of the patient in the pelvic region of the patient. In yet a further embodiment, the implant is positioned within the body such that the implant is configured to provide support to another portion or organ of the body of the patient.

In some embodiments, the method includes disposing a material into the body of the patient proximate the implant to frictionally couple the implant in place within the body of the patient (830). In some embodiments, the material is disposed within the body of the patient such that the implant is frictionally coupled implant in place within the body of the patient for a period of time. For example, in some embodiments, the material is configured to be resorbed by the body of the patient and is disposed within the body such that the implant is coupled in place within the body of the patient for 3 to 7 days. In other embodiments, the material is configured to be disposed within the body of the patient such that the implant is coupled in place for a period of time longer than 7 days. In some embodiments, the material is configured to remain within the body to retain the implant in place within the body of the patient for a time sufficient for scarring or ingrowth to occur on the implant.

In some embodiments, the material is inserted or disposed within the body of the patient through a bodily incision or opening. In some embodiments, the material is inserted or disposed within the body of the patient through the same incision that is used to insert the implant within the body of the patient. In other embodiments, the material is inserted into the body of the patient through an incision or opening that is different than the incision or opening that is used to insert the implant into the body of the patient.

In some embodiments, the material is inserted or disposed within the body of the patient using an insertion tool. For example, in some embodiments, a syringe is used to insert or dispose the material into the body of the patient.

In some embodiments, the material is disposed within the body of the patient such that the material is configured to force the implant against bodily tissue surrounding the implant to frictionally couple the implant in place within the body of the patient. In some embodiments, the material is disposed within the body of the patient such that the implant is compressed or forced against bodily tissue to frictionally couple the implant within the body of the patient. In some embodiments, the material is disposed within the body of the patient such that the material substantially surrounds the implant to frictionally retain the implant within the body of the patient. For example, in such embodiments, a portion of the material is disposed between implant and the bodily tissue and the implant is compressed or forced against the material (and the bodily tissue) to frictionally couple the implant within the body of the patient (for example, to the bodily tissue).

In some embodiments, only a portion of the implant is forced or frictionally coupled within the body of the patient. For example, in some embodiments, only an end portion of the implant is contacted by the material and forced against bodily tissue to couple the implant within the body of the patient. In other embodiments, the entire implant is frictionally coupled or forced against bodily tissue to couple the implant in place within the body of the patient.

In some embodiments, the material is disposed within the body of the implant in a compressed, first state or configuration. The material is allowed to expand to a second state or configuration once it is within the body of the patient. For example, in some embodiments, the material is a foam material that is configured to expand once it is placed within the body of the patient.

In some embodiments, the material is disposed within an empty space of the body of the patient. For example, in some embodiments, the material is disposed within a space of the body of the patient that is generally empty (i.e., does not include other organs or bone structure of the patient). In some embodiments the material is disposed within the body of the patient such that about half or more than half of the empty space proximate the implant is filled with the material.

In some embodiments, a medical device includes a resorbable material configured to be disposed within the body of the patient proximate a bodily implant. The resorbable material is configured to frictionally retain the implant in place within the body of the patient for at least a period of time.

In some embodiments, the resorbable material includes at least one of a group consisting of an antibiotic, stem cells, and a trophic factor. In some embodiments, the resorbable material is a foam material. In some embodiments, the resorbable material is a foam material and is configured to be inserted into the body of the patient in a first state and is configured to expand to a second state while disposed within the body of the patient. In some embodiments, the resorbable material is configured to be disposed in an empty space of the body of the patient proximate the implant and apply a force against the implant to frictionally couple the implant to bodily tissue for the period of time.

In some embodiments, a kit includes an implant and a resorbable material. The implant is configured to be disposed within a body of a patient. The resorbable material is configured to be disposed within the body of the patient proximate the implant to frictionally retain the implant in place within the body of the patient for a period of time. The resorbable material is configured to be resorbed by the body after the period of time.

In some embodiments, the resorbable material includes at least one of the group consisting of an antibiotic, stem cells, and a trophic factor. In some embodiments, the resorbable material is a foam material. In some embodiments, the resorbable material is a foam material and is configured to be inserted into the body of the patient in a first state and is configured to expand to a second state while disposed within the body of the patient. In some embodiments, the resorbable material is configured to be disposed in an empty space of the body of the patient proximate the implant and apply a force against the implant to frictionally couple to bodily tissue for the period of time.

In some embodiments, the implant is formed of a mesh material. In some embodiments, the implant is configured to receive tissue growth thereon. In some embodiments, the implant is configured to receive tissue growth thereon to help retain the implant in place within the body of the patient at a time after the period of time.

In some embodiments, a method of placing an implant within a body of a patient includes (1) inserting the implant into the body of the patient, and (2) disposing a material into the body of the patient proximate the implant to frictionally couple the implant in place within the body of the patient for at least a period of time.

In some embodiments, the disposing a material includes disposing the material within the body of the patient such that implant is forced against bodily tissue surrounding the implant. In some embodiments, the disposing a material includes disposing the material within empty space of the body proximate the implant.

In some embodiments, the method includes creating a vaginal incision and the inserting the implant includes inserting the implant through the vaginal incision.

In some embodiments, the method includes creating a vaginal incision and the inserting the implant includes inserting the implant through the vaginal incision such that that the implant is positioned to provide support to a portion of the body of the patient.

In some embodiments, the disposing includes disposing a resorbable material into the body of the patient. In some embodiments, the inserting includes inserting an implant that is configured to receive tissue ingrowth thereon.