Contraceptive system

ES 2 219 787 T3

DESCRIPTION

Contraceptive system.

Field of the invention

The present invention relates to the field of sterilization and contraceptive devices and, more particularly, to reversible contraceptive devices.

Background of the invention

Conventional contraceptive strategies generally fall into three categories: physical barriers, medications, and surgery. While each of them has certain advantages, they also have several disadvantages. Barriers such as condoms and diaphragms are subject to failure due to breakage or displacement. Drug strategies such as the pill and Norplant, which rely on artificial control of hormone levels, suffer from known and unknown side effects from long-term use. Finally, surgical procedures, such as tubal ligation and vasectomy, simultaneously involve the costs and risks of surgery, and are often not reversible. Therefore, there remains a need for an effective and safe contraceptive method, particularly a non-surgical method that is reversible.

Description of the invention

The present invention relates to a contraceptive device as defined in the claims. More specifically, the present invention is directed to a sterilization or contraceptive system that obstructs a reproductive region or lumen by preventing passage of reproductive cells through the region or lumen. The invention includes a dilatable obstruction element within the body lumen from a first configuration suitable for introduction into the body lumen to a second, larger configuration that facilitates the holding of the dilated obstruction element in at least one section of a wall that defines the reproductive body lumen. The invention also includes means for facilitating attachment of the dilated obstruction element to the wall of the body lumen and means for contracting the dilated obstruction element and the section of wall attached to the obstruction element to obstruct the reproductive body lumen sufficiently to prevent infection. passage of reproductive cells.

A current preferred embodiment of the invention comprises a reversible contraceptive system that can be used to also obstruct the fallopian tubes of a female patient, the vas deferens of a male patient, or other reproductive region. A key feature of the contraceptive system consists of an obstruction element that is first attached to the wall defining the reproductive region in a dilated situation and then compressed into cross-sectional dimensions that cause compression of the attached section. from the wall and thus blocks the vessel corridor to prevent the passage of reproductive cells. The obstruction element can be reopened by any number of appropriate means. For example, by compressing the obstruction element around an obturator or mandrel that can be left in place to effectively block the corridor until the patient wishes to reverse the procedure. The obturator can be removed by suitable means such as a conventional laparoscopic or other instruments to reopen the corridor. In addition, a dilatation balloon catheter can be used to dilate the opening after the obturator is removed. Other ways to reopen the reproductive lumen include leaving the proximal portion of the obstruction element open when the element is compressed, so that an inflatable element such as a balloon can be inserted and dilated over a catheter. Through a series of step-by-step expansions and advances, the entire corridor can be reopened.

Preferably, the obstruction element comprises a tubular element made from a shape memory alloy material and has a primary configuration having relatively small transverse dimensions that facilitate insertion of the element into the desired body lumen. Once in place, the obstruction element is then dilated to a second configuration with transverse dimensions that are approximately or slightly larger than the body lumen, so that the obstruction element can be attached to the wall defining the lumen. bodily. With the opening, the lattice-like framework of the obstruction element was dilated within the body lumen, endothelialization through the open structure fixes the obstruction element to the wall defining the body lumen. By heating the obstruction element formed from the shape memory alloy material to a temperature at or above the transition temperature of the shape memory material, it is transformed into an original compressed or closed configuration causing the attached wall to close the obstruction element permanently so that the corridor is obstructed. The obstruction element can be delivered to a desired area within the body lumen by appropriate means, such as a conventional balloon catheter similar to those used to deliver coils, aortic grafts, and various types of prostheses.

In a current preferred embodiment, the obstruction element has a lattice or open frame, so that endothelial tissue grows through the openings of the lattice frame in order to interlock the obstruction element and the wall. of the body lumen. The surface of the obstruction element can be treated to promote endothelialization.

Once the obstruction element is implanted into the body lumen and has been sufficiently endothelialized to fix it to the body wall (which may take a week or more), it can be activated by warning the obstruction element at a temperature of or above of the transition temperature of the shape memory material to return to its original compressed form. Since endothelialization has fixed the obstruction element to the wall of the body lumen, contraction of the obstruction element in its original compressed form causes the wall defining the body lumen to compress along with the obstruction element, blocking effectively the broker.

Alternatively, a seal may be located within the obstruction element prior to heat activation, so that the obstruction element compresses over the seal to block the lumen.

ES 2 219 787 T3

The obstruction element can be mounted outside of a balloon of a dilatation balloon catheter in the first configuration with small cross-sectional dimensions, and can then be inserted and positioned within the reproductive lumen region to close. The balloon is inflated to dilate the obstruction element, preferably with the outer diameter slightly larger than the inner dimensions of the reproductive lumen to which it is attached. The plugging element will remain in the open configuration until heated to a temperature at or above its martensite to austenite transition temperature which returns it to its compressed condition. If the obstruction element is compressed around an obturator, the obturator can be removed to reopen the corridor when the patient wishes to be fertile again.

The present invention provides effective sterilization or contraception for both men and women and importantly is easily reversed. Furthermore, the implantation and activation of the obstruction element in addition to the subsequent restoration of the container obviously requires user-friendly minimally invasive devices such as catheters, guidewires, guide catheters, and the like. These and other advantages of the invention will become more apparent from the detailed description of the invention when taken in conjunction with the accompanying exemplary drawings.

Brief description of the drawings

Figure 1 shows a catheter with an obstruction element having the characteristics of the invention mounted on an expandable element on a distal section of the catheter.

Figures 2 and 3 show an embodiment of the obstruction element in the closed or expanded and contracted configuration respectively.

Figures 4 and 5 show another embodiment of the obstruction element in the closed and expanded configuration respectively.

Figures 6 and 7 show another embodiment of an obstruction element in the closed and expanded configuration respectively.

Figure 8 depicts the obstruction element on a delivery catheter as shown in Figure 1 within a lumen or reproductive region.

Figure 9 illustrates the dilation of the obstruction element within the lumen or reproductive region.

Figure 10 shows the female reproductive anatomy and shows the obstruction element located inside the fallopian tubes of a female patient.

Figure 11 shows the reproductive anatomy of man and represents an obstruction element inside a vas deferens of a male patient.

Figure 12 shows the obstruction element fixed to the wall of the reproductive region by endothelial tissue.

Figure 13 is a cross-sectional view of the endothelialized obstruction element as shown in Figure 12 taken along lines 13-13.

Figure 14 shows the obstruction element in a compressed state after being activated by a heated serum.

Figure 15 is a cross-sectional view of the compressed obstruction member as shown in Figure 14 taken along lines 15-15.

Figure 16 is similar to Figure 14 and shows the element compressed around a removable elongated plug or mandrel.

Figure 17 shows the obstruction element being activated distal to the proximal end in order to keep the proximal end partially open to facilitate reopening of the corridor.

Detailed description of the invention

Figure 1 shows a catheter 10 useful in the practice of the invention, comprising an elongated shaft 12 having an inflation lumen 14 that is in fluid communication with inflatable member 16 mounted on a distal section of the catheter shaft and adapter. 18. The obstruction element 20, a self-supporting metal element of shape memory material, carefully shapes the diameter of the deflatable inflatable element 16 to facilitate insertion into the desired body lumen. The obstruction element 20 is formed to have an original compressed configuration with relatively small cross-sectional dimensions. The obstruction member 20 can be deformed to facilitate mounting on the inflatable member 16 and expanded by the inflatable member into an open expanded configuration within the body lumen. After heating to a transition temperature it will return to the original setting. In this embodiment, the obstruction element 20 has an opening, the lattice-like structure facilitating endothelialization that fixes the obstruction element to the wall defining the body lumen. Preferably, the obstruction element is provided equal to or slightly larger than the dimensions of the body lumen on the inside. For placement within the fallopian tubes of a female patient, the dilated transverse dimensions should be about 0.1 mm to 5 mm.

The obstruction element may have an appropriate number of configurations as shown schematically in Figures 2-7. Figure 2 illustrates the obstruction element 22 in an open configuration and Figure 3 its configuration with relatively small dimensions for introduction and advancement into the patient's body lumen. The obstruction element 22 can be constructed with a length of shape memory hypodermic tube. The grooves 24 cut into the wall of the tube allow the obstruction element to expand into an open configuration as shown in Figure 2. Similarly, in Figures 4 and 5, the obstruction element 26 consists of a coil 28 of a memory cable or strip. Figures 6 and 7 show the obstruction element 30, comprising a braided cable tube or shape memory strip 32. Finally, in Figures 1 and 8, the obstruction element 20 comprises a number of closed sinusoidal rings of shape memory wire or strip and is mounted on an inflatable element 16 of the catheter 10.

Inflation of inflatable member 16 expands obstruction member 20 in a reproductive region 38 to an opening, a diameter configuration

ES 2 219 787 T3 relatively large as shown in the figure

9.

In each of these embodiments, the stopper member shape memory material should have a transition temperature sufficiently above the normal range of human body temperature to avoid accidental activation that could prematurely compress the stopper member. On the other hand, the transition temperature should be high enough so that the thermal activation of the obstruction element does not cause undesirable thermal damage to the surrounding tissue. The shape memory material is preferably a shape memory nickel-titanium alloy such as NITINOL and preferably has a transition temperature of between 43 ° C to about 70 ° C.

In each of the embodiments described above, certain conventional refinements may be employed. For example, the shell surface of the obstruction element can be designed to facilitate endothelial growth. Such modifications generally comprise providing the obstruction member with a lattice or open frame to promote endothelial growth within as well as around the member to secure the security device to the wall of the body lumen. Suitable surface techniques include EDM machinery, laser drilling, photo-etching, synthesized coating process, and the like. Additionally, increasing the surface area of ​​the obstruction element can also provide greater adhesion in the endothelial tissue. Suitable surface treatments include plasma etching, shot blasting, machinery, and other treatments to harden the surface. In other embodiments, the shape memory material can be covered or seeded to promote endothelialization. For example, the obstruction device can be covered with a polymer that has a drug, enzyme, or protein impregnated inside it to induce or promote the growth of endothelial tissue. In another refinement, the obstruction element may be laminated or otherwise incorporate copper to produce an inflammatory response in the tissue of the wall that defines the body lumen, further contributing to the obstruction of the lumen. Other inflammatory materials may also be appropriate. For example, the clogging element can be radioactive, emitting alpha, beta, or gamma particles.

The practice of the invention comprises the following general steps. An obstruction element 20 having a relatively small transverse dimension is mounted on the exterior of balloon 16 of catheter 10 as shown in Figure 1. Catheter 10 is advanced under endoscopic or fluoroscopic visualization until obstruction element 20 is positioned. inside one of the fallopian tubes 34 of a female patient, as shown in Figure 10. Inflation fluid is introduced through adapter 18 which inflates inflatable element 16. As shown in Figures 9-10, inflation of inflatable element 16 expands obstruction element 20 into an open configuration and depositing it in the lumen. 38. Catheter 10 is removed, leaving dilated obstruction member 20 implanted in body lumen 38 as shown in FIG. 12. Another expandable element is delivered to the other fallopian tube of the patient and dilated within the same manner. Alternatively, the obstruction element may be positioned in a positional dilatation within the vas deferens 36 of a male patient, as shown in FIG. 11, to provide the male contraceptive using the same procedures.

After a period of a week or more, the endothelial cells lining the lumen will proliferate, growing around the open framework of the obstruction element 20 as shown in Figures 12 and 13, thereby fixing the wall that defines the lumen. body 38 to the dilated obstruction member 20. The dilated obstruction member 20 is then sufficiently endothelialized within the reproductive region 38 of the patient, activated by heat to return to its original compressed configuration. The obstruction element can be activated by various means, including heated fluid, RF energy, laser energy, or other appropriate energy sources. A suitable activation system is shown in Figure 14 where the distal end of catheter 40 is positioned adjacent to obstruction element 20, serum somewhat above the transition temperature is introduced to wash obstruction element 20, raising its temperature at the transition point or higher, causing the obstruction element 20 to compress into its closed, reduced diameter configuration. The layer of endothelial tissue that forms within the lattice-like structure of the obstruction element helps to block and close the lumen in a way that prevents the passage of reproductive cells, ova, or sperm.

In figure 16 an alternative embodiment of the invention is shown where a shutter 42 is positioned within the obstruction element 20 in the dilated situation, so that upon activation the obstruction element 20 compresses on the obturator 42, blocking the lumen 38. Preferably, the plug is made of an inert material, such as a fluoropolymer, eg, PTFE. Other suitable materials include high density polyethylene and silicone. A number of modifications to the plug may also be appropriate. For example, the obturator can be used as a drug delivery device, similar to the NorplantTM device. The obturator can also be used to elicit an inflammatory response as described above to increase lumen obstruction. In such embodiments, the plug 42 preferably has an outer diameter of from about 0.25mm to 4mm. The plug 42 may also have holes, grooves that are deep or help to preserve at least part of the natural lining of the reproductive region.

The obstruction of the lumen can be reversed simply by removing the obturator 42. If a corridor larger than the corridor left by the withdrawn obturator 42 is desired, a balloon catheter can be inserted into the body lumen until the balloon is released. into the lumen by removing the obturator and then inflating the balloon over the catheter to dilate the obstruction element 20, deforming it into an open configuration. It may be desired that, when the dilated obstruction element is activated to confi4

ES 2 219 787 T3 compressed guration to leave the proximal end of the obstruction element somewhat open or in a dilated condition to facilitate introduction of the dilatation balloon over a catheter to facilitate opening of the body lumen. As shown in Figure 15, the catheter 40 used to activate the obstruction element can be positioned within the proximal end of the obstruction element, such that the proximal end is unable to fully return to its closed configuration. The reproductive region can subsequently be closed and contraception would again be desired by heating the obstruction element 20 in a manner that activates the transformation to the compressed configuration.

In embodiments of the invention employing plug 40, various other strategies are suitable for reversing the obstruction. For example, obturator 40 can be simply removed, restoring lumen 38 to open. Alternatively, plug 40 may be hollow with a removable core (not shown). This core can be formed from a softer material, such as silicone, or it can be threaded, in order to facilitate its removal. Similarly, the plug can be threaded onto itself such that removal would involve a twisting motion, minimizing the force on the tissue in which the obstruction element is located.

In other embodiments, mechanical, adhesive, or other means may be employed to secure the dilated obstruction member 20 to the wall of the vessel that defines the reproductive corridor 38. For example, the means for attaching a coil or prosthetic device to an arterial or aortic wall described in US patents US 4,140,126; US 4,562,596; US 4,577,631; US 4,787,899; US 5,104,399; US 5,167,614; US 5,275,622; US 5,456,713; and US 5,489,295 can be used in the present invention to interlock the wall defining the reproductive region and the expandable element.

Various modifications and improvements can be made to the present invention. For example, an expandable mechanical element such as described in US Patent No. 4,585,000 can be used to expand the expandable element within the reproductive region to engage the wall.