US20040153008A1 - Probe anchor - Google Patents

Abstract

A probe anchor that attaches a probe to a tissue adjacent a birth canal, comprising: (a) a soft tissue anchor including a release mechanism; (b) a cable sufficiently pliable that it will not harm a fetus during passage through the birth canal coupled at one end thereof to said release mechanism; and (c) a control coupled to an opposite end of said cable and operative to remotely release said release mechanism using said cable without requiring manual stabilization directly to said anchor.

Description

RELATED APPLICATIONS
• This application claims the benefit under 119(e) of the following US provisional applications: serial No. 60/295,569 filed 5 Jun. 2001, serial No. 60/295,573, filed 5 Jun. 2001, serial No. 60/309,783, filed 6 Aug. 2001 and serial No. 60/338,671, filed Dec. 11, 2001. This application is also related to a PCT application filed on even date with this application by applicant in the Israel receiving office and having[0001]attorney docket 330/02764, the disclosure of all of these applications is incorporated herein by reference.
FIELD OF THE INVENTION
• The present invention relates to anchoring a probe to biological tissue.[0002]
BACKGROUND OF THE INVENTION
• Measuring cervical dilation and/or the descent of the fetus in the birth canal, is considered an essential element for properly following the progress of the birth process. When birth canal measurements are made manually, a professional attendant makes, on the average, 10 examinations of the birth canal causing the mother discomfort and/or embarrassment. Additionally, such manual exams are subjective, possibly providing inaccurate information, introducing infection into the birth canal and/or missing key events in between examinations.[0003]
• Securing a sterile probe to the tissue adjacent the birth canal, meaning the tissue lining the birth canal, the tissue of the cervix and/or the fetus, for the purpose of monitoring the mother and/or fetus during the birth process, presents difficulties in attaching a probe anchor to the wet, moving tissue adjacent the birth canal. Additionally or alternatively, the probe anchor is routinely subject to strong, sustained movement during birth contractures, jarring during fetal presentation and can be entirely displaced due to birth canal tissue distortion and/or the baby's movement through the birth canal.[0004]
• A prior art measurement system, for example, uses V calipers with a strain gauge between its arms that spans the cervix and substantially blocks other monitoring and/or treatment services. Another prior art measurement system, for example, uses a multi-switch membrane that is inserted between the fetus and uterine wall. The placement of this membrane is technically difficult, creates obstruction of the birth area and is uncomfortable for the mother.[0005]
• Probe anchors that are implanted in the tissue of the birth canal, for example clamps and/or sutures, may cause discomfort as the tissue of the cervix and/or birth canal expands during the birth process and squeezes and/or strains against the probe anchor. In addition, an implanted probe may cause harm to the fetus, for example if it protrudes significantly into the path of the fetal descent through the birth canal, or if it includes a sharp spike that can otherwise interact with the fetus or other birth canal adjacent tissue. Following the birth process, the implanted probe may be difficult to remove from the birth canal and/or cause harm to the mother. One possible cause for difficulty is that the birth canal tissues following birth are typically thinned, stressed and/or dilated.[0006]
• Eibling in U.S. Pat. No. 5,284,141, Kemper et al. in U.S. Pat. No. 5,438,996, Bullard et al. in U.S. Pat. No. 5,851,188, Pettit et al. in U.S. Pat. No. 5,671,736, Sinanan et al. in U.S. Pat. No. 6,173,715 B1 and Urion et al. in U.S. Pat. No. 5,680,859, demonstrate a monitor probe with a barb that enters the skin through a single point to attach monitor wires to biological tissue that is easily dislodged from the tissue.[0007]
• Levinson et al. in U.S. Pat. No. 5,727,547, demonstrate a fetal oximeter sensor that is secured in place using suture, possibly posing difficulties during installation.[0008]
• Sliwa et al. in U.S. Pat. No. 6,039,701 and WO 98/09565, Zartman in U.S. Pat. No. 4,677,967, Meathrel et al. in U.S. Pat. No. 5,833,622 and Jerath in U.S. Pat. No. 5,222,485, define monitor probes that block a large area of the birth canal, possibly requiring removal to allow presentation of the fetus during the birth process.[0009]
• Sherman et al. in U.S. Pat. No. 5,713,371 demonstrate a long spring-loaded jaw incorporating an ultrasound transmitter that attaches to tissue that may obstruct the birth canal.[0010]
• Anderson et al. in U.S. Pat. No. 5,645,062, Ritson et al. in U.S. Pat. No. 5,851,179, Munro et al. in WO 00/46319 and Remon et al. in WO 00/47644, present probes with adhesive material that do not readily remove from the biological tissue following use.[0011]
• Grafton et al. in U.S. Pat. No. 5,964,783 demonstrate a biodegradable attachment for attaching material to bone that is unsuitable for use in soft tissue probe attachment.[0012]
SUMMARY OF THE INVENTION
• An aspect of some embodiments of the present invention relates to providing a probe anchor for use during the birth process that readily attaches to and/or removes from tissue of the birth canal by operation of a control extension whose operation is effected external and/or internal to the birth canal. Operation of the control remote from the anchor allows the operator's hands to easily attach and/or remove the probe anchor in the wet, moving tissue associated with the birth process.[0013]
• In an exemplary embodiment, a probe extension aids in the remote insertion and/or the removal of an anchor from an anchor area. For example, the extension is attached to the anchor mechanism of the probe and manipulation of the extension causes deployment and/or retraction of an anchor mechanism of the probe. Additionally or alternatively, the extension is a tubular structure whose rotation, for example, causes deployment and/or retraction of an anchor mechanism of the probe.[0014]
• In an exemplary embodiment, a probe anchored in tissue adjacent the birth canal has one or more wires that connect said probe to a monitor and provide information on the birth process. In an exemplary embodiment, the probe, wires and/or their attachments provide information on fetal position and/or EKG information and can be placed in position with either left or right hand by a single operator, for example an obstetrician, without assistance from additional personnel. In an exemplary embodiment, the probe, wires and/or their connections are color coded, for example, for proper positional placement. In an exemplary embodiment, the probe, wires and/or their connections are sufficiently pliant, for example, that they do not present a risk to the mother and/or fetus before, during and/or after the birth process. In an exemplary embodiment, the probe, wires and/or their connections do not prevent the mother from moving in association with the birth process, for example, leaning on the bed and/or walking. Additionally or alternatively, they do not obstruct the birth canal and/or manual examination of the birth canal, during the birth process.[0015]
• In an exemplary embodiment, the wires are formed into an antenna that sends, for example radiofrequency signals, to a signal receptor connected to a monitor display. In an exemplary embodiment, passage of the fetus through the birth canal is unhindered by the antenna.[0016]
• An aspect of some embodiments of the present invention relates to providing a probe anchor mechanism that secures a probe to and/or through one or more points in a tissue of the mother and/or the fetus during the birth process. In an exemplary embodiment, the anchor and/or its mechanism are operable in a sterile environment and/or are disposable following use. In an exemplary embodiment, the attachment is provided by a curved wire that extends from the probe through the tissue so the tissue is secured along a cord of the wire's curvature. As the cervical tissue expands and/or moves during labor, the tissue pierced by, and thus fastened with the curved wire, moves to a longer cord length position on the curved wire. The greater cord length allows expansion of the fastened tissue without increasing force on the tissue, affording greater comfort to the subject than, for example, a rigid clamping fastener. A rigid clamp, for example a rigid caliper operated by a screw mechanism that fixes the caliper jaw in place, does not expand as the amount of tissue between the jaws increases, resulting in pinching of the expanding tissue, reduction of blood supply within the fastened tissue and possible harm due to apoxia and/or local trauma as the tissue chaffs between the fixed clamp jaws.[0017]
• In an exemplary embodiment, the probe anchor has two or more legs with sharp ends facing each other that secure in an anchor area and/or compress the tissue of the anchor area in between the sharp ends. Optionally, the two sharp ends are flexibly attached to the probe to allow for cervical tissue movement and/or expansion during the birth process. In an exemplary embodiment, a probe anchor comprises an expandable anchor that secures to a tissue by expanding within the tissue, for example a tissue adjacent the birth canal and/or other tissue areas in the body.[0018]
• An aspect of some embodiments of the present invention relates to providing a probe anchor that secures in and/or against a tissue of the birth canal and/or another body tissue whose anchor mechanism, for example a curved wire or two or more legs with sharp ends, is tensioned towards the open position. In an exemplary embodiment, the curved wire and/or legs with sharp ends are pressed against a tension force, caused for example by a spring mechanism, to anchor in the tissue. Optionally, a pin or other restraining element is provided to prevent the anchor from opening.[0019]
• In an exemplary embodiment of the invention, this type of normally open anchor (and other embodiments described below) may be used to provide an anchor in which the implantation technique is decoupled from the removal technique. This decoupling may be exhibited, for example, by using a different method to attach and to detach the anchor. Alternatively or additionally, the decoupling is exhibited by the force required to open the device not be complementary to the force exerted by the device when it closes. This contrasts, for example, with normally closed anchors which are implanted by releasing the anchor to a closed position but require considerable force to be brought back to an open position. Other methods of providing this potential advantage are, for example, an anchor which is inserted easily and (possibly) after a while, deforms or otherwise changes so that it is also relatively easy to remove. In some embodiments of the invention described below, the easy removal is timed and/or designed to allow the anchor to stay attached during the monitoring of part or all of a birth process.[0020]
• In an exemplary embodiment, a probe anchor readily removes from attachment to the birth canal and/or fetus at any stage of the birth process only by action of an operator and without intrusion of the operator's hands in the birth canal. Optionally, the anchor mechanism is maintained in the closed position with a retainer mechanism. Disengaging the retainer mechanism, for example following labor, allows the anchor mechanism to open so the probe is readily removed from the tissue. The open anchor mechanism adds a safety feature in that the retracted sharp end will not damage tissue during attachment and/or removal from the birth canal.[0021]
• In an exemplary embodiment, when the anchor is implanted it is tensioned towards a closed position. Once deployed, it changes to a normally open position, for example at once, after a time period and/or due to the application of a causative effect, such as force or heat.[0022]
• In an exemplary embodiment, a control which allows the anchor to open and/or close is located distant from the anchor area so that removal of the probe is optionally affected without necessitating placing the operator's hands in the cervix.[0023]
• An aspect of some embodiments of the present invention relates to providing a probe with an anchor attachment for attachment to a body tissue, for example, the birth canal, heart and/or intestines, whose configuration and/or surface geometry on removal is altered in respect to its configuration and/or surface geometry during placement in the birth canal. For example a curved wire and/or two or more legs with sharp ends and/or an expandable anchor deforms and/or weakens over a period of time, for example due to a chemical reaction and/or interaction with the surrounding tissue.[0024]
• In an exemplary embodiment, the probe, its connection to the probe anchor and/or the anchor itself, deforms and/or weakens, for example over several hours to several days due to, for example hydrolysis, so that with time the probe anchor becomes easier to remove and/or falls away from the anchor area. Additionally or alternatively, the probe, its connection to the probe anchor and/or the anchor itself, comprise a material that deforms due to increases in temperature and/or reverts to its original form when the original temperature returns. In an exemplary embodiment, an anchor probe comprises shape memory polymers that change shape in response to a temperature increase as identified by Steven Ashley in “Shape Shifters”,[0025]Scientific American, May 2001.
• An aspect of some embodiments of the invention relates to a two part soft tissue anchor, in which one part anchors directly to the soft tissue and a second part attaches to the first part. In an exemplary embodiment of the invention, the attachment method allows removing the second part from the anchored part. The anchoring may be of various kinds, for example adhesive or mechanical (e.g., at least one spike, a barb and/or a hook).[0026]
• Optionally, if the anchoring is at a wrong location (or if removal is desired for other reasons), the second part is removed and then, optionally, a new anchoring is made at a new location. The old anchoring may fall out by itself (e.g., using various mechanism as described herein) or it may be removed manually, for example at a more convenient time. Optionally a safety tether is attached to the anchoring section, to prevent undesired migration and/or to assist removal.[0027]
• An aspect of some embodiments of the present invention relates to providing a probe anchor that secures to an anchor area, for example in the birth canal or another tissue of the body, with an bioadhesive layer. In an exemplary embodiment the bioadhesive layer attaches to an area equal to or greater than 1 square centimeter so that forces from tissue movement, for example related to movement associated with the birth process, are spread over the attachment area to prevent premature detachment of the probe from the anchor area.[0028]
• In an exemplary embodiment the bioadhesive layer and/or the probe anchor biodegrade and/or weaken after a base period, for example three, six, eight, twelve, eighteen and/or twenty-four hours or a period that encompasses a typical birth process or a part thereof, for example 48 hours. Following the base period, the bioadhesive layer and/or probe anchor weaken so they remove with decreasing force, such as by the pulling of the probe by an operator, or possibly they fall out by themselves. Alternatively or additionally, the time is shorter, for example 10, 20, 30 or 60 minutes or a different time suitable for a procedure, such as monitoring a small number of contractions.[0029]
• In an exemplary embodiment, a probe anchor has a tissue bioadhesive surface that is adapted to adhere to the cervical and/or fetal tissue and a probe receiver surface adapted to receive one or more of a variety of probe attachments, for example that monitor the mother and/or fetus during childbirth. In an exemplary embodiment, the probe receiver surface is adapted to receive a probe with a bioadhesive layer. Additionally or alternatively, the probe receiver surface is adapted to receive a probe, for example, with a curved wire attachment end and/or a probe with two or more legs with sharp ends.[0030]
• In an exemplary embodiment, the probe anchor and/or its tissue bioadhesive surface deform, weaken and/or dissolve in response to an externally applied agent, for example a catalytic agent and/or electromagnetic waves, such as heat, ultrasound and/or electricity.[0031]
• Following the birth process, the electromagnetic waves and/or catalytic agent are applied so the probe, probe anchor and/or probe attachment can be easily removed from the birth canal.[0032]
• An aspect of some embodiments of the present invention relates to providing a probe with an expandable anchor to attach it to a tissue area. In an exemplary embodiment, fluid, for example contained in an internal reservoir, is released to effect expansion of the anchor once it is positioned in an anchor area. Additionally or alternatively, deflation of the expandable anchor is accomplished by releasing the fluid from within the anchor, for example, using an appropriate instrument that punctures the probe. Additionally or alternatively, the expandable anchor gradually deforms following a base period, so that it looses its securing aspects to the anchor area. Additionally or alternatively, the expandable anchor gradually dissolves following a base period and looses its fluid, deflates and removes from the anchor area and/or completely dissolves.[0033]
• An aspect of some embodiments of the present invention relates to providing a probe anchor deployer apparatus that aids in deployment and/or placement of the probe anchor in, for example tissue of the os cervix and/or the tissue of the birth canal and easily separates from said probe following deployment. In an exemplary embodiment, one or more probe anchors are contained in a sterile cartridge that fits into the deployer apparatus. Additionally or alternatively, one or more probe anchors fit into a deployment compartment on the deployer apparatus without a cartridge. Optionally, the deployer apparatus cartridge and/or anchor, are fully sterile during use in the birth canal. Additionally or alternatively, the parts of the deployer apparatus cartridge and/or anchor, for example, that come into contact with the tissue of the birth canal area, are sterile. In an exemplary embodiment, the deployer apparatus installs a probe anchor into a tissue of the birth canal in a single action, causing deployment of the probe anchor and/or separates from said anchor and/or does not require further manual inspection.[0034]
• In an exemplary embodiment of the invention, the deployer includes an anchoring activation mechanism that activates a corresponding anchoring mechanism of the probe. Alternatively or additionally, the deployer includes a release activator that can activate a release mechanism of the anchor, to assist in removal thereof from the cervix.[0035]
• There is thus provided in accordance with an exemplary embodiment of the invention, a probe anchor that attaches a probe to a tissue adjacent a birth canal, comprising:[0036]
• (a) a soft tissue anchor including a release mechanism;[0037]
• (b) a cable sufficiently pliable that it will not harm a fetus during passage through the birth canal coupled at one end thereof to said release mechanism; and[0038]
• (c) a control coupled to an opposite end of said cable and operative to remotely release said release mechanism using said cable without requiring manual stabilization directly to said anchor. Optionally, said release mechanism is mechanically operated. Alternatively or additionally, said release mechanism is electrically operated.[0039]
• In an exemplary embodiment of the invention, said release mechanism stores a releasing energy and whereby said control releases said energy. Alternatively or additionally, the anchor comprises an energy retainer that prevents activation of said releasing energy until its release by said control.[0040]
• In an exemplary embodiment of the invention, said probe anchor comprises two sections:[0041]
• (a) an anchor section that connects to said tissue and is adapted for the attachment of a probe section; and[0042]
• (b) a probe section that attaches to said anchor section.[0043]
• Optionally, said anchor section defines a volume suitable for receiving said probe section. Optionally, said probe section fits in said volume and is removably coupled to said volume. Alternatively or additionally, said volume comprises one or more resilient projections that restrain said probe section from exiting said volume. Optionally, said resilient projections release said probe section from said volume upon application of a probe-displacing force.[0044]
• In an exemplary embodiment of the invention, said anchor section weakens over time, facilitating its removal from said tissue. Optionally, said anchor section partially dissolves over time. Alternatively or additionally, said anchor section completely dissolves over time. Alternatively or additionally, said anchor section deforms over time. Optionally, said deformation occurs in response to a temperature change.[0045]
• In an exemplary embodiment of the invention, pulling said cable away from said anchor activates said mechanical release mechanism. Alternatively or additionally, rotating said cable around its axis in relation to said anchor activates said mechanical release mechanism.[0046]
• In an exemplary embodiment of the invention, said probe comprises a sensor that monitors said tissue. Optionally, said sensor comprises an ultrasound transducer ultrasonically coupled to said anchor section and ultrasonically coupled by said anchor section to said tissue.[0047]
• In an exemplary embodiment of the invention, said cable comprises a conducting wire. Optionally, said conducting wire carries signal data. Alternatively or additionally, said conducting wire is visually coded to indicate function or placement of said conducting wire. Alternatively or additionally, said conducting wire is connected to an antenna that transmits signal data. Optionally, said probe comprises an electromagnetic RF transmitter coupled to said antenna.[0048]
• In an exemplary embodiment of the invention, said anchor section is visually coded to indicate function or placement of said anchor section.[0049]
• In an exemplary embodiment of the invention, said anchor section is configured so it does not obstruct the birth canal during a birth process. Alternatively or additionally, said anchor section is configured so it does not obstruct manual examination of the birth canal.[0050]
• There is also provided in accordance with an exemplary embodiment of the invention, a probe anchor that attaches a probe to soft tissue adjacent a birth canal, comprising:[0051]
• (a) an anchor that has a closed position and an open position;[0052]
• (b) a tension element that urges said anchor toward said open position;[0053]
• (c) a closure control operative to maintain said anchor in said closed position.[0054]
• Optionally, said anchor comprises a wire passed through said tissue when said anchor is in the closed position. Alternatively or additionally, said anchor comprises one or more legs with sharp ends pressed into said tissue when said anchor is in the closed position. Alternatively or additionally, release of said closure control, allowing said anchor to return to the open position, is activated by an extension remote from said anchor.[0055]
• In an exemplary embodiment of the invention, the anchor comprises a tensioning element urging said anchor to be in said closed position.[0056]
• In an exemplary embodiment of the invention, said anchor is adapted to change from a normal closed to a normally open configuration following attachment of said probe to soft tissue.[0057]
• In an exemplary embodiment of the invention, said tension element comprises a shape memory polymer. Optionally, said shape memory polymer is coupled to a delaying mechanism that delays said opening of said anchor. Optionally, said delaying mechanism comprises a material that biodegrades over a period of time during which period it prevents said a shape memory polymer from drawing said anchor into the open position. Alternatively or additionally, said delaying mechanism comprises a material that dissolves in response to an external causative factor.[0058]
• There is also provided in accordance with an exemplary embodiment of the invention, a probe that anchors in soft tissue adjacent a birth canal, comprising:[0059]
• a probe defining one or more lumens;[0060]
• a spike element set in each of said one or more lumens with a front end extending out of said lumen; and[0061]
• a deforming element that deforms in response to temperature increase above a base temperature, connecting said spike to said lumen;[0062]
• wherein deformation of said deforming element causes said front end of said spike to retract into said lumen. Optionally, said lumen includes a delay plug that prevents retraction of said spike element. Optionally, said delay plug comprises a material that weakens over a period of time. Alternatively or additionally, said delay prevents retraction of said one or more spike elements for a minimum of eight hours. Alternatively or additionally, said delay plug comprises a biodegradable material. Alternatively or additionally, said delay plug comprises a material that degrades in response to an external causative factor. Optionally, said external causative factor comprises a compound. Alternatively or additionally, said external causative factor comprises electromagnetic waves.[0063]
• There is also provided in accordance with an exemplary embodiment of the invention, an expanding probe anchor that attaches a probe to soft tissue adjacent a birth canal, comprising:[0064]
• a probe with an expandable anchor member adapted to be inserted into said soft tissue;[0065]
• a fluid reservoir containing a fluid, external to said canal and connected to said expandable anchor by a fluid conduit; and[0066]
• a valve between said reservoir and said anchor that maintains said fluid in said anchor following its flow into said anchor from said reservoir. Optionally, said fluid reservoir is flexible and compression of said reservoir causes said fluid to move through said conduit into said anchor member. Alternatively or additionally, movement of said fluid into said anchor member causes expansion of said anchor member. Alternatively or additionally, said anchor member weakens over time and maintains said fluid for a base period of time following which it releases said fluid. Optionally, said release occurs following a minimum of eight hours. Alternatively or additionally, said anchor member comprises a material that releases said fluid in response to an external causative factor. Alternatively or additionally, said anchor member comprises a material that releases said fluid in response to a natural biological material contained in said canal.[0067]
• There is also provided in accordance with an exemplary embodiment of the invention, a probe anchor deployment apparatus that attaches a probe anchor to soft tissue adjacent a birth canal, comprising:[0068]
• (a) an anchor deployment apparatus with a grasping end that grasps a probe;[0069]
• (b) a probe with an anchor mechanism suitable for attachment to said tissue;[0070]
• (c) a handle extension extending from said grasping end out of said birth canal; and[0071]
• (d) a deployment mechanism along said handle extension that deploys said anchor mechanism. Optionally, said apparatus is adapted to carry two or more probes. Alternatively or additionally, said apparatus is adapted to carry two or more probes in a magazine. Optionally, a second probe moves into said grasping end following deployment of a first probe.[0072]
• In an exemplary embodiment of the invention, said anchor includes a release mechanism and wherein said apparatus is adapted to activate said release mechanism.[0073]
• There is also provided in accordance with an exemplary embodiment of the invention, an adhesive probe anchor, comprising:[0074]
• an adhesive on said probe that adheres to a mucosal surface adjacent a birth canal with sufficient adherence to resist detachment due to forces generated by the birth process for a base period of time; and[0075]
• a sensor removably connected to said probe. Optionally, said base period comprises a minimum of eight hours. Optionally, said adhesive weakens in response to biological compounds naturally contained within said canal. Alternatively or additionally, said adhesive weakens in response to an external causative factor. Alternatively or additionally, said connection between said sensor and said probe is a mechanical connection. Alternatively or additionally, said connection between said sensor and said probe is a biodegradable connection that weakens over a base period of time during which it resists detachment due to forces generated by the birth process. Optionally, said wherein said base period comprises a minimum of eight hours. Alternatively or additionally, said weakening occurs in response to biological compounds naturally contained within said canal. Alternatively or additionally, said biodegradable connection weakens in response to an external causative factor.[0076]
• There is also provided in accordance with an exemplary embodiment of the invention, a method for securing an anchor, having a base and a curved wire having a point, to the cervix, comprising;[0077]
• (a) positioning said anchor at a tissue of the cervix such that said base contacts the cervix;[0078]
• (b) transfixing said cervix with said curved wire, point first, so that said point is covered by said base when said transfixing is completed. Optionally, said probe anchor comprises an ultrasound transducer ultrasonically coupled to said anchor and attaching comprises attaching said ultrasonically coupled transducer to said cervix.[0079]
• There is also provided in accordance with an exemplary embodiment of the invention, a method for adhering a probe with a sensor to soft tissue adjacent a birth canal and monitoring fetal passage, comprising:[0080]
• grasping a probe apparatus, including a sensor and an adherent surface that weakens over time;[0081]
• pressing said adherent surface onto said soft tissue;[0082]
• monitoring fetal passage through said canal with said sensor; and[0083]
• confirming the removal of said adherent surface from said soft tissue following its weakening below its adherence threshold. Optionally, said confirming occurs following a minimum of eight hours of adherence. Alternatively or additionally, said weakening occurs in response to biological compounds naturally contained within said canal. Alternatively or additionally, said weakening occurs in response to an external causative factor. Alternatively or additionally, the method comprises removing said sensor from said soft tissue prior to said surface falling off said soft tissue.[0084]
• There is also provided in accordance with an exemplary embodiment of the invention, a two part anchor, comprising:[0085]
• an anchor portion adapted to be anchored to soft tissue and including an attachment element; and[0086]
• a selectively attachable rider portion adapted to be attached to said attachment element. Optionally, the anchor comprises a sensor coupled to said rider portion. Alternatively or additionally, said anchor portion is adhesive to said soft tissue. Alternatively or additionally, said anchor portion mechanically attaches to said soft tissue.[0087]
BRIEF DESCRIPTION OF THE DRAWINGS
• Exemplary non-limiting embodiments of the invention will be described with reference to the following description of embodiments in conjunction with the figures. Identical structures, elements or parts which appear in more than one figure are preferably labeled with a same or similar number in all the figures in which they appear.[0088]
• FIG. 1 shows a cervical anchor ring attached to an anchor area, according to an embodiment of the present invention;[0089]
• FIG. 2 shows an alternative view of the cervical anchor ring of FIG. 1, according to an embodiment of the present invention;[0090]
• FIG. 3 shows a cervical anchor caliper attached to an anchor area, according to an embodiment of the present invention;[0091]
• FIG. 4 shows a coupling anchor area, according to an embodiment of the present invention;[0092]
• FIG. 5 shows a probe and bioadhesive probe attachment, according to an embodiment of the present invention;[0093]
• FIGS.[0094]6A-6D illustrate the operation of a cervical anchor hook in its attachment to an anchor area, according to an embodiment of the present invention;
• FIG. 7 shows a bioadhesive probe attachment, according to an embodiment of the present invention;[0095]
• FIG. 8A shows pin anchor mechanisms for use in the birth canal, according to an embodiment of the present invention;[0096]
• FIGS. 8B and 8C shows embodiments of a round pin anchor, according to an embodiment of the present invention;[0097]
• FIG. 9 shows a wireless signaler, according to an embodiment of the present invention;[0098]
• FIG. 10 shows an ultrasound sensor, according to an embodiment of the present invention;[0099]
• FIGS.[0100]11A-11C show a probe with a dissolvable expandable anchor tip, according to an embodiment of the present invention;
• FIGS. 12A and 12B show a probe with deforming anchors in tissue, according to an embodiment of the present invention;[0101]
• FIG. 13 shows a probe delivery apparatus, according to an embodiment of the present invention;[0102]
• FIGS.[0103]14A-14E show different probe anchor tip designs, according to an embodiment of the present invention; and
• FIGS.[0104]15A-15C show probes that differ in the location of a biodegradable section, according to an embodiment of the present invention.
DETAILED DESCRIPTION OF EMBODIMENTS
• FIG. 1 shows a[0105]cervical anchor ring100 with an exemplary attachment mechanism that attaches to ananchor area140, for example adjacent the birth canal, comprising tissue of the birth canal of the mother, her cervix and/or the fetus, according to an embodiment of the present invention.Anchor ring100 potentially fosters robust attachment of a probe wire extension of arod110 to cervical tissue. Further,anchor ring100 allows easy attachment using, for example, one hand at the anchor area and the other hand outside the birth canal and/or both hands outside the birth canal. Additionally or alternatively,anchor ring100 allows easy removal using, for example, both hands outside the birth canal and/or one hand at the anchor area and the other hand outside the birth canal. In an exemplary embodiment, these potential advantages, for example one hand attachment from inside or outside the birth canal are able to be configured on all embodiments of the present invention described below.
• In an exemplary embodiment,[0106]rod110 passes throughanchor area140 with asharp end104 to securecervical anchor ring100 to anchorarea140. In an exemplary embodiment, multiple anchor rings100 are packaged together in a single application kit that are appropriate for attachment at multiple sites, for example to the fetal scalp and/or one or more areas of tissue adjacent the birth canal, cervix and/or external to the mother. Optionally, the multiple electrodes apply separately to each area of tissue adjacent the birth canal and are removed separately from each area adjacent the birth canal and attach and/or remove in any order, at any time prior, during and/or following the birth process. Additionally or alternatively, the electrodes may be applied singly and/or in any combination to the birth canal tissue, for example so one or more probes are attached to the mother and not the fetus, for example prior to the breaking of the amniotic sac. Additionally or alternatively, multiple anchor rings100 are utilized in other monitoring procedures, for example EKG and/or EMG testing and, in fact, all the anchor devices shown as exemplary embodiments of the present invention, can be utilized with a variety of monitoring procedures.
• For[0107]rod110 to pass throughanchor area140,sharp end104 substantially removes from areceptacle106 by pullingrod110 in adirection134. Withsharp end104 retracted fromreceptacle106,anchor area140 is placed betweensharp end104 andreceptacle106 androd110 is moved in adirection132 to secure inanchor area140 for example by aspring120. In an exemplary embodiment,spring120 has afirst end130 that presses against ahousing stop128 and asecond end122 that presses against arod cam124. Withsharp end104 retracted fromreceptacle106,spring120 is compressed indirection134, creating pressure betweenrod cam124 andhousing stop128.
• As can be appreciated, some embodiments of the present invention provide an[0108]anchor ring100 that can be configured for placement with either left or right hand by a single operator as the same device is easily operated ambidextrously. Additionally or alternatively, in an exemplary embodiment of the present invention,anchor ring100, as is the case with other embodiments of the invention, can be placed in position by a single operator, for example an obstetrician, without additional assistance.
• When[0109]rod110 is released, it moves indirection132, extending further out of ahousing108 towardanchor area140 due to pressure ofspring120.Sharp end104 passes throughanchor area140 and presses intoreceptacle106 to attachcervical anchor ring100 to anchorarea140. Additionally or alternatively, manual pressure indirection132 is placed against an area of ashaft end150 so thatsharp end104 passes throughanchor area140 intoreceptacle106.
• To remove[0110]cervical anchor ring100 fromanchor area140housing108 is optionally stabilized with one hand, for example outside the birth canal, whilerod110 is pulled indirection134 using the other hand, for example outside the birth canal, to causesharp end104 to move out ofreceptacle106. Additionally or alternatively, one or both hands are placed in the birth canal during removal ofanchor ring100.
• In an alternative embodiment,[0111]receptacle106 is replaced with asharp outcrop142. Whenrod110 is released and moves indirection132,sharp end104 andsharp outcrop142 meet. This is useful in securingcervical anchor ring100 directly totissue anchor area140A assharp end104 more easily piercestissue anchor area140A whensharp outcrop142 focuses pressure ontissue140A at the tip ofsharp end104. In an exemplary embodiment, the ability forsharp end104 to move towardanchor area140 and/or away fromanchor area140A, is a feature that is shared with embodiments of the present invention described below and optionally provides an advantage by allowing safer and/or more secure attachment ofanchor ring100 and/or other probes described below.
• In an exemplary embodiment,[0112]spring120 is designed to exert force that retractssharp end104 fromreceptacle106. To install,anchor100 is placed overanchor area140 withspring120 pullingrod110 indirection134 so thatsharp end104 remains retracted fromreceptacle106. Pressure is placed onrod110, for example at anend150, against the action ofspring120 to causerod110 to extend indirection132, ofhousing108, throughanchor area140. The maintenance ofspring120 in the retracted position until pressed indirection134 potentially averts damage to tissue during insertion.
• In an exemplary embodiment,[0113]rod110 hasnotches152 that digitate withhousing stop128 to lockrod110 in position throughanchor area140. To removecervical anchor ring100 fromanchor area140,shaft end area150 is pushed in a direction154 to disengagerod110 fromhousing stop128.Rod110 is then pulled indirection134 and/orspring120 automatically moves indirection134, andsharp end104 disengages fromreceptacle106. In an exemplary embodiment during removal,sharp end104 is retracted byspring120 intohousing108, so possible harm to the fetus and/or mother is averted. In an exemplary embodiment,anchor ring100 can be removed from the tissue of the birth canal at any time during the birth process.
• Optionally,[0114]housing108 and/orrod110 as well as the materials comprising probe anchors in other embodiments of the present invention, comprise one or more of the following materials: polyurethane, mylar, elastomer, kevlar, nylon, or metal, based upon, for example, desired strength of material and/or resistance to reactivity with body fluids. The variation in materials in construction ofhousing108 and/orrod110, and other embodiments, for example, is based upon the resilience of tissue aroundanchor area140 and/or140A, the anticipated length of implantation, and/or the proximity ofhousing108 and/orrod110 to areas of increased pressure such as adjacent the birth canal. Optionally,housing108 and/orrod110 include, for example, a radiopaque area that allows it to been visible in a radiographic picture, as optionally provided in other embodiments of the present invention. Other materials may be used as well, for example as known in the art.
• In an exemplary embodiment,[0115]housing108, for example, has a diameter of between 3.0 millimeters and 10 millimeters dependent upon desired stiffness, diameter ofrod110 and materials from which it is made.Rod110, for example, has an outer diameter of between 1 millimeter and 3 millimeters, depending on the material strength, ductility and desired material stiffness. Other embodiments of the present invention, including their anchors and/or base to which the anchors are attached, may have similar diameters with similar size variation based upon similar application considerations.
• Typically, during the birth[0116]process tissue area140A expands. In an exemplary embodiment,tissue area140A occupies a chord along the radius ofrod110. Astissue area140A expands with the birth process, it occupies a larger chord along the radius ofrod110, without causing additional pressure ontissue area140A that might cause discomfort to the mother. The advantage of allowing tissue expansion along a larger cord of a curved anchor attachment such asrod110 applies to other similar embodiments of the present invention. Alternatively or additionally, curved anchor is elastic. Optionally, the anchor is placed to be parallel, orthogonal or at another angle to an expected maximal distortion direction.
• Additionally or alternatively,[0117]housing108 and/orrod110 comprise a material that degrades, so thatsharp end104, for example, weakens so that it is readily deformed to allowhousing108 to break free oftissue anchor area140A. Additionally or alternatively,housing108 and/orrod110 biodegrade over a period of time so that they fall offanchor area140A by themselves. In an exemplary embodiment,sharp end104 and/orrod110 is manufactured from shape memory polymers (SMP's) that deform, for example, due to the heat buildup, for example, from a body tissue. Optionally, insulation is provided, to slow down heating to a critical temperature. Deformation of sections ofanchor ring100, allows removal ofanchor ring100 from atissue140A, for example, with reduced force following a base period of attachment, as will be explained below.
• FIGS.[0118]15A-15C show a schematic diagram of aprobe1500, each with a biodegradable section in a different location, according to different embodiments of the present invention.Probe1500 comprises, for example, ananchor element1510 that inserts into an anchor area, for example a biological tissue within the birth canal, that is connected with anisthmus1512 to aprobe body1520.Probe1500 contains aninstrumentation section1540 that, for example, houses an ultrasound sensor that is connected to probebody1520 by alinkage1550 that, for example, comprisessharp end104 or other types of attachment means noted below in other embodiments, for example, allowing removal ofinstrumentation section1540 fromprobe body1520.
• In FIG. 15A, biodegradable sections include[0119]anchor element1510,isthmus1512 andprobe body1520.
• In FIG. 15B, biodegradable sections include[0120]anchor element1510,isthmus1512 and afront body wall1560adjacent isthmus1512.
• In FIG. 15C, biodegradable sections include[0121]anchor element1510 andisthmus1512.
• In the various[0122]biodegradable probe1500 embodiments, theanchor element1510 is implanted into an anchor area that causes the biodegredation of the various biodegradable sections. At the end of the birth process,instrumentation section1540, optionally including a wire extension to a monitor and/or an antenna that broadcasts information to a monitor, is removed by manipulatinglinkage1550, optionally with a mechanism located remote fromprobe1500, for example outside the birth canal. Following the removal ofinstrumentation section1540, biodegradation continues in each of the probe designs, resulting inprobe1500 falling away from the anchor area.
• In an exemplary embodiment,[0123]probe1500,instrumentation section1540,linkage1550 and/or a wire extension, for example, are manufactured from an SMP that deforms, for example, due to the heat buildup from a body tissue, so that it falls away and/or can easily be broken away fromtissue140A following a base period of attachment. In other embodiments, a melting material is used which slowly softens, melts or degrades due to body heat, pH, temperature and/or other birth canal ambient conditions.
• In an exemplary embodiment,[0124]instrumentation section1550 comprises an ultrasound probe, for example, that contacts the tissue area withanchor1510. To facilitate proper coupling between the ultrasound probe and the tissue area, for example,isthmus1512 is designed so thatinstrument section1550 contacts the tissue over a large area. Additionally or alternatively, a coupling gel is provided between the tissue interface andinstrument section1540. In an exemplary embodiment of the invention, for example in a two part anchor as described below, the anchor attachment method is designed to be rigid enough so that ultrasonic waves easily travel from the surface of the birth canal tissue. Alternatively or additionally, the design provides a short distance between the sensor and the surface. Other sensors, for example oximetry sensors may also have special contact requirements, which are optionally provided by the anchoring and probe design, for example, optical oximetry sensors may require contact with the surface. In a two part probe such as described below, anchoring go section may include an aperture through which the sensor can reach and contact the tissue.
• FIG. 2 shows a[0125]cervical anchor ring100 attached to anchorarea140A, comprising ananchor projection212 that projects out of asurface220 of acoupling200, according to an embodiment of the present invention.Cervical anchor ring100 is, for example, assembled outside the birth canal by passingrod110 through apassage222 ofanchor area140A to securecervical anchor ring100 tocoupling200. Alternatively, it is assembled in the birth canal, for example, afteranchor area140A is attached. In this case,anchor area140A may include a guiding design (e.g., include a cone shaped depression) to assist in blind guiding ofring100.
• To install[0126]cervical ring100 assembled oncoupling200, an operator holds coupling200 with two fingers of one hand and eitherhousing108 and/orwire110 with the other hand. In an exemplary embodiment,housing108 and/orwire110 are of a length that allows manipulation ofcervical anchor ring100 with one hand outside the birth canal and/or cervix.
• Optionally,[0127]coupling200 comprises one of the materials used in the manufacture ofhousing108 and/orrod110 above. Additionally or alternatively, these materials and/or other materials specified in the invention description, can be used in the manufacture of the various other exemplary embodiments described below.
• Additionally or alternatively,[0128]coupling200 comprises, for example, biodegradable materials and dissolves, deforms and/or weakens following, for example, a base period of time. Additionally or alternatively,coupling200 comprises anadhesive layer210 that is, for example, a biodegradable adhesive that attaches to tissue.Adhesive layer210 biodegrades during attachment so that its adherence gradually weakens. After a base period of time, according to its composition that is formulated based upon its use,adhesive layer210 biodegrades to an adherence strength below a specific threshold level. Below this threshold level, for example, it falls off said tissue and/or removes from said with little force applied by the operator.
• When coupling[0129]200 is used in monitoring the progress of a birth and is attached to, for example, tissue in the human birth canal,adhesive layer210 and/orcoupling200 and/oranchor100, biodegrades below the threshold adherence level described above, over a period of 18 to 24 hours and/or a period allowing it to remain affixed through a long delivery period, for example maximally 48 hours. Additionally or alternatively,adhesive layer210 is designed to remain attached to tissue for a longer period of time, for example a few days. At the end of labor and/or when removal ofcoupling200 is desired, an external causative factor, for example hyaluronic acid or an alcohol derivative, is applied toadhesive layer210 to cause biodegradation within a short period of time, for example a few hours. An example of a biodegradable bone fastener whose degradation is increased by addition of an external causative factor, incorporated by reference herein is shown by Freedland in WO 01/49189.
• In an exemplary embodiment, should the birth occur in a shorter time so that[0130]coupling200 and/oradhesive layer210 remain intact and attached to anchorarea140A, an anchor attachment forexample rod110, is pulled indirection134, to retractsharp end104 fromreceptacle106, allowing easy removal ofcervical anchor ring100 fromcoupling200. Optionally,rod110 comprises a biodegradable material and, in an exemplary embodiment,rod110 weakens and is easily broken away fromcoupling200, as potentially would all embodiments of the present invention when removal is required following a short period of time.
• Additionally or alternatively,[0131]coupling200 and/oradhesive layer210 can be configured to remain above an adherence threshold for relatively short periods of time, for example, for as short a period as a half an hour. The potential advantage of such a short adherence period is the ability to rapidly monitor a short period of contractures to determine various tissue parameters. In an exemplary embodiment, coupling0.100 and/oradhesive layer210 for short observation periods, for example a half hour or less, can be designed without consideration of blocking fetal passages as they would be rapidly removed at an early stage of the birth process. Following this short monitoring period, probes with the design features notes in the other embodiments of the invention can be placed along the tissue adjacent the birth canal.
• A potential advantage of using[0132]coupling200 and/oradhesive layer210 in attaching a probe, forexample anchor ring100, to a tissue adjacent the birth canal is that should coupling200 be placed improperly,anchor ring100 can be disconnected from it and, optionally, attached to anothercoupling200 placed adjacent the birth canal. Additionally or alternatively, when a probe, forexample anchor ring100, requires multiple placement areas along a tissue of the birth canal,multiple couplings200 can be placed throughout the area andanchor ring100 can be moved from coupling200 tocoupling200 as needed.
• In an exemplary embodiment,[0133]housing108 and/orrod110 contains one or more piezoelectric areas, forexample area166 and/orarea170 that provide ultrasound signals to a biological tissue associated withanchor area140 and/or140A. In an exemplary embodiment, ahousing surface102 and/orreceptacle106 are spaced so that they make contact withanchor area140A to provide appropriate monitoring of the birth process. Additionally or alternatively,housing108 and/orrod110 contains apiezoelectric area170 or166 that receives ultrasound signals from the biological tissue. Examples of materials from whichpiezoelectric material170 and/or166 can be made include PZT-4, PZT-5 PZT-8 quartz and/or PVdF, all of which can be configured to ensure appropriate output and/or receiving capabilities. These transducer materials are commercially available, for example, from Stavely Sensor, Inc. of East Hartford, Conn. or from Boston Piezo-Optics Inc. of Bellingham, Mass. In an exemplary embodiment,housing108 and/orrod110 contains a conversion coupling that transforms ultrasound signals to radio-frequency (RF) signals. As noted herein, the coupling betweenmaterial170 andanchor area140 is designed to optionally allow appropriate transmission of monitoring signals and, for example, are appropriate to utilize in all embodiments that incorporate sensors of the present invention.
• Optionally,[0134]rod110 is elongated with a wire lead that attaches to a monitoring device and/or an antenna lead that sends signals to a monitoring device. Optionally,anchor ring100, and/or its leads, will not prematurely displace or block access to the birth canal due to its small size and robust connection.Anchor ring100, for example, does not block the birth canal due to its small size. A potential advantage of some embodiments of the present invention is the provision of robust connection ofanchor ring100 totissue140A potentially prevents premature disconnection and allows repeated manipulation of the leads out of the path of the birth canal, without risk that anchorring100 will displace and/or remove fromtissue140A. Additionally or alternatively, the small size and potentially robust connection ofanchor ring100 and/or other embodiments allows the mother to move freely during the birth process, for example, leaning on the bed and/or walking.
• FIG. 3 shows a[0135]cervical anchor caliper300 with amonitor wire330 attached to an area oftissue364, according to an embodiment of the present invention. Anchorareas342 and344 are, for example, tissue connection points forsharp ends322 and324 respectively adjacent the birth canal of the mother and/or on the fetal head. Additionally or alternatively,anchor areas342 and344 are part of atissue area364 of another body area, for example, skin and/or a mucosa. By attaching to two points alongtissue364,anchor caliper300 potentially provides robust, safe attachment to anchorareas342 and344. In an exemplary embodiment,sharp end322 and/or324 are easily manipulated during attachment with one hand pressingupper leg areas352 and/or354. The other hand, for example, is positioned onwire330, remote fromtissue364 and/or external to the birth canal, and aids in stabilizinganchor caliper300 during attachment.
• To secure[0136]cervical anchor caliper300 totissue364, aleg354, is pressed, so that it pivots on apivot314 andsharp end324 moves in adirection348 intotissue344. Additionally or alternatively, aleg352, is pressed so that it pivots onpivot312 and pushessharp end322 in adirection338 intotissue342. In this mannersharp end322 secures totissue342 andsharp end324 secures totissue344 so cervical anchor caliper is attached totissue364.
• In an exemplary embodiment,[0137]leg352 is fixed tocrosspiece318 and does not pivot onpivot312 and movement ofleg354 alone allows for tissue movement and/or expansion during the birth process. In an exemplary embodiment, fixedsharp end324 is pressed intoanchor tissue342 with one hand andsharp end324 is secured inanchor tissue344 by manipulatingwire330 with the other hand, for example external to the birth canal.
• In an exemplary embodiment,[0138]pivot314 and/or pivot312 allowlegs352 and/or354 to move in response to tissue expansion as occurs, for example, during the birth process. Allowing for tissue expansion prevents undue discomfort to the mother and/or loosening ofcaliper300, caused by expansion, thinning and/or movement oftissue364 during the birth process. In an exemplary embodiment, expansion means for other embodiments ofcaliper300 are included in other alternative embodiments of the present invention to allow comfort to the mother and/or fetus during the birth process.
• In an exemplary embodiment, a[0139]spring328 creates pressure to movesharp end324 in adirection350, towardanchor area344 so that release ofwire330, for example, allowssharp end324 to attach intoanchor area344. To releasecervical anchor caliper300 fromanchor areas342 and344,wire330 is manipulated, for example outside of the birth canal, causingsharp end322 to move indirection348, away fromanchor area342. Additionally or alternatively, the other hand is used to stabilizecaliper300, for example outside the birth canal, holding an extension ofleg352. In an exemplary embodiment,caliper300 disengages fromtissue areas342 and344 with a minimum discomfort to the mother. In an exemplary embodiment,spring328 incorporates a mechanism that causesspring328 to move in response to an electric current, for example provided fromwire330 that is configured as a conducting wire. This embodiment is applicable, for example, to all embodiment of anchors including spring mechanisms that cause movement of an anchor mechanism. In one exemplary embodiment of the invention, the electricity is used to heat a shape memory material that restraints the spring or forms a retraction element in itself.
• In an alternative embodiment,[0140]spring328 pullssharp end324 in adirection360, away fromanchor area344 so that manipulation ofwire330 causessharp end324 to attach intoanchor area344. In an exemplary embodiment, aftersharp end324 has been manipulated to secure inanchor area344, a holdingbar386 is pressed so that it encompasseslegs352 and354 abovecrosspiece318 maintaining the extended position ofsharp end324. To removecaliper300 fromtissue364,bar386 is removed from it maintenance position, allowingsharp end324 to retract indirection360 by the action ofspring328, thus ensuring rapid removal ofcaliper300 with both hands positioned outside the birth canal.
• In an exemplary embodiment, attachment and/or removal of[0141]anchor caliper300, and other exemplary embodiments of alternative anchor embodiments, are easily accomplished, for example, while the operator is wearing sterile gloves and, for example, while the birth canal and or sterile gloves are coated with a lubricant, for example septalon. In an exemplary embodiment,caliper anchor300 and/or one ormore wires330 are packaged in a sterile package that can be opened, for example, by a non-sterile assistant and/or passed to the operator, for example the obstetrician. Additionally or alternatively,caliper anchor300 and/or one ormore wires330 can be transported in a tray of sterilizing liquid from which they taken by the operator during the installation procedure. Additionally or alternatively, a probe wire, for example that is not sterile, is attached to the skin of the patient to provide grounding ofanchor probe300. Optionally following use,caliper anchor300 and/or one ormore wires330 are easily deposited in a standard disposal container in the operating theater.
• FIG. 4 shows coupling[0142]200 by which an anchor, forexample caliper anchor300, attaches totissue area364. In an exemplary embodiment,coupling200 has ananchor projection344′ and ananchor projection342′ and is attached totissue364 withadhesive layer210.Anchor projection342′ has apassage372 that is designed to receivesharp end322 ofcervical caliper300.Anchor projection344′ has apassage374 that is designed to receivesharp end324 ofcervical anchor caliper300.Cervical anchor caliper300 is secured tocoupling200 when sharp ends322 and324 are inpassages372 and374 ofanchor projections342′ and344′. In an exemplary embodiment,caliper300 is assembled withcoupling200 prior to insertion into the birth canal so that attachment ofbioadhesive210 can be accomplished so while holdingcoupling200 with, for example, two fingers. Additionally or alternatively, as with other anchor embodiments, a variety of areas ofcaliper300 may comprise biodegradable materials and/or SMP's so thatcaliper300 weakens, deforms and/or dissolves for easy removal.
• FIG. 5 shows an alternative embodiment of a[0143]probe apparatus500 that allows attachment of asensor522 totissue506 with a force-operable release mechanism, providing an advantage of easy removal ofprobe500. In an exemplary embodiment, probe500 comprising asensor522 within ahousing516 attached to an area oftissue506 with anadhesive attachment512, according to an embodiment of the present invention.Sensor522 is removed fromhousing516, for example, by pulling awire524, for example, external to the birth canal. Additionally or alternatively,sensor522 and/orwire524 are removed fromhousing516 by exerting force directly onsensor522, for example internal to the birth canal.
• In an exemplary embodiment,[0144]adhesive layer512 and/orhousing516 are biodegradable and degrade untilhousing516 falls away and/or completely dissolves, for example, sometime after completion of the birth process. Additionally or alternatively,adhesive layer512 and/orhousing516 partially degrade so thathousing516 and/or adhesive512 weaken below a specific threshold level and are removed with relatively little force, for example following the birth process.
• In an exemplary embodiment,[0145]sensor522 is held in asensor compartment530 ofhousing516 bybendable shoulders532 and534.Shoulders532 and534secure sensor522 insensor compartment530 against displacement forces that are typically generated in the birth canal.
• To remove[0146]sensor522 fromsensor compartment530,wire524 and/or probe550, for example, are pulled in adirection540 causingsensor522 to pressshoulder532 in adirection552 andpress shoulder534 in adirection554 untilshoulder532 and/or534 move sufficiently to allowsensor522 to pull out ofcompartment530.
• In an exemplary embodiment, removal of[0147]sensor522 fromcompartment530 is accomplished whileadhesive layer512 remains attached totissue506 without causing shearing separation withintissue506. In an exemplary embodiment, the force required to bendshoulder532 and/orshoulder534 is between 2 and 3 Newtons, though it could be 4 or more Newtons and/or 0.5 Newtons or less, dependent, for example, on the strength of the connection betweenbioadhesive layer512 andtissue506 and/or the magnitude and/or direction of forces expected during birth. In an exemplary embodiment, a greater force is required in order to separatehousing516 fromtissue506 and/or causing shearing separation withintissue506 so thathousing516 remains attached totissue506 following removal ofsensor522 fromcompartment530.
• [0148]Housing516 is shown adhered in a perpendicular position totissue506. Additionally or alternatively,housing516 can be designed to be adhered with the visible surface ofhousing516, as seen in FIG. 5, parallel to the surface oftissue506.
• Optionally,[0149]housing516 includes an aperture in its bottom, through which a sensor portion and/or protrusion ofsensor522 can directly contact the tissue. This type of design may also be used wherehousing516 is attached to the soft tissue using a mechanical means, such as a spike or using methods described herein for other embodiments.
• FIGS.[0150]6A-6D illustrate the operation of acervical anchor hook600 that attaches to ananchor area684 with ahandle634 that operates, for example, external to the birth canal in an exemplary embodiment, FIG. 6A shows a spring-loadedsemi-circular hook610 within atunnel614 in ahousing616 with asharp end690.Hook610 rotates around apivot hinge612 that is attached tohousing616.
• In an exemplary embodiment, a spring, not shown, causes[0151]cervical hook600 to press out oftunnel614. Anengagement pin618 in apin passage622 is pressed againsthook610 by aspring620, lockinghook610 insidehousing616, preventinghook610 from exitinghousing616.Pin618 prevents movement ofhook610, for example, either by the friction betweenpin618 tip and hook610 or through articulating with ahook notch688.
• In FIG. 6B,[0152]engagement pin618 has been retracted, allowinghook610 to travel in acurved trajectory686,exit housing616 and pierce through atissue area684.Pin618 presses forward to secure against anelbow682 to maintainhook610 attached totissue684. Optionally, the closing spring disengages fromhook610, oncehook610 is secured.
• FIG. 6C shows an[0153]activation mechanism602 ofcervical anchor hook600, comprising atube630 that houses acable628, attached at one end to pin618 and at the other end to handle634.Pin618 is retracted withinpin passage622.
• In an exemplary embodiment, hook[0154]610 normally remains intunnel614 by a spring action that presseshook610 in a direction666 (this force may be smaller, for example, than the force exerted by the not shown closing spring). In this fashion,housing616 can be manipulated into position ontissue684 withouthook610 causing irritation totissue684 or possibly catching on the fetus. Withhousing616 in position, manipulation oftube630, for example, causeshook610 to travel indirection686 to effect attachment totissue684. Oncehook610 is pressed throughtissue684, for example, pin618 automatically extends out ofhousing616 and presseselbow682 to maintainhook610 in the extended position.
• To remove[0155]cervical hook600 fromtissue684, for example, following completion of the birth process, pin618 is retracted intohousing616, forexample using cable628 andhook610 is pressed indirection666 by spring action. In an exemplary embodiment, handle634 is attached to grasparea632 by aseal652 that prevents inadvertent movement ofhandle634 in relation to632. Pulling onhandle634 while holdinggrasp area632 breaks seal652 andcable628 pullspin618 intohousing616. Ashook610 is spring-loaded to travel indirection686, it detaches fromtissue684.
• Additionally or alternatively,[0156]pin618 is pulled intohousing616 using, for example, a rotatable rod connected betweenhandle634 andpin618, allowing retraction ofhook610. In an exemplary embodiment the rod is rotated to pullpin618 intohousing616 and then detached frompin618 following use, for example by continuing rotation following retraction ofpin618 into housing. Following detachment of the rod frompin618, the rod is removed from the birth canal.
• With[0157]hook610 out oftissue684,tube630 and/orgrasp area632 are used to pullhousing616 from the birth canal, allowing removal ofcervical anchor hook600 from the birth canal with both operator's hands outside the birth canal.
• In an exemplary embodiment, in FIG. 6D, handle[0158]634 is attached tocable628 and pullinghandle634 in adirection650 in relation to agrasp area632 causescable628 to retractpin618 away fromhook610. Spring-loadedhook610 exitshousing616 and pierces throughtissue684 so thatcervical anchor hook600 is attached totissue684.Housing616 contains asensor area624 that monitors the subject throughtissue684.
• In an exemplary embodiment,[0159]tube630 has a widening680 that ends in awasher678 attached to apivot control636. In an embodiment wherehook610 is normally held inhousing616, by stabilizinggrasp area632 with one hand androtating handle634 with the other hand in adirection674, movement ofhook610 out oftissue684 is effected. In an embodiment wherehook610 is normally extended fromhousing616, rotation ofhandle634 in adirection676, while holdinggrasp area632, causesbook610 to retract intohousing616.
• FIG. 7 shows an alternative embodiment of a[0160]probe apparatus700 that allows attachment of aprobe720 to tissue with a non-mechanical hookup.Probe700 has abioadhesive probe attachment700 with aprobe wire712 that attaches tocoupling200, according to an embodiment of the present invention. Optionally,probe attachment700 has abioadhesive layer710 that is biodegradable to attach to surface220 ofcoupling200.
• [0161]Probe attachment700 comprises, for example, silicone or other non-dissolving and/or biodegradable materials specified in relation to the composition ofcoupling200 whilebioadhesive layer710 may be similar in composition to that ofadhesive layer210.
• In birth monitoring, for example,[0162]adhesive layer710 biodegrades in the same fashion as doesadhesive layer210, over a period of time and/or through the addition of an agent or energy. For example, electromagnetic waves, such as heat, ultrasound or electricity, are applied in the vicinity of the flat section to cause dissolution ofbioadhesives710 and/or210,probe720,wire712 and/orcoupling200. In an exemplary embodiment, electromagnetic waves are applied through an independent applicator that is brought nearadhesive layer710. Additionally or alternatively,wire712 provides electric, heat or ultrasound energy that aids in ofbioadhesives710 and/or210,probe720,wire712 and/orcoupling200.
• FIGS. 8B and 8B shows some embodiments, of the many potentially different embodiments, of an anchor embodiment used in attaching a probe, for example, to a fetal scalp. In an exemplary embodiment, these embodiments, as other embodiments presented according to the present invention, can be used interchangeably for the fetal head and/or the birth canal. In addition, it should be noted that while some of the anchors described herein are especially useful for difficult to attach tissue, such as cervical tissue, which distorts, is mucal and/or experiences pressure and distortion during contraction and passage of the fetus and fetal scalp tissue which is wet and/or experiences large shearing forces during delivery, the anchors may be attached to other tissue, such as in the GI tract or in the mouth.[0163]
• In an exemplary embodiment, FIG. 8A shows a[0164]straight pin anchor800 with ahousing804 containing asensor808.Housing804 is attached to ashaft818 and has ahook802 that embeds in a target tissue, for example the fetal head. To securehook802 into the target tissue, one of the operator's hands is placed onhousing804 and a second hand, outside the birth canal, is used to guide placement, for example, by holding onto asheath828 that coversshaft818.Sensor808 sends signals to a monitor, for example, connected with awire830.
• FIG. 8B shows a[0165]round pin anchor810 with ahousing814 containingsensor808 with a with around pin812. In an exemplary embodiment,housing814 is placed against a target tissue area and rotated to embedround pin812 into the tissue.
• Additionally or alternatively,[0166]housing814 is attached toshaft818. By rotatingshaft818 in relation tosheath828,round pin812 rotates and, when held against a target tissue, embeds into the target tissue. Rotation ofshaft818 is accomplished, for example, by rotating agrasp area820 with one hand while stabilizingsheath828 with the other hand. In removingpin anchor800, both hands operate, for example, outside the birth canal, with one hand onsheath828 and/or ashaft stabilizer832 and the other hand is used to rotategrasp area820, causing roundpin812 to rotate out of the tissue area tissue.
• FIG. 8C shows an alternative embodiment of[0167]round pin anchor810 in whichsensor808 sends signals to a monitor throughwire830 andauxiliary wires806. In an exemplary embodiment,wire830 sends an ultrasound signal to provide positioning information andauxiliary wires806, for example, transmit additional data from anchor area, for example, providing monitoring of the fetal heartbeat. Additionally or alternatively,wires806 and/or830 are connected to probes that are attached to tissue and provide measurement of EMG, optical devices, for example, for glucose monitoring and/or other skin-attached probes.
• In an exemplary embodiment,[0168]wires806 and/or830 are color coded so that the operator is notified of the functions thatsensor808, for example, provides. Additionally or alternatively, the color coding allows proper attachment to an appropriate monitor. Additionally or alternatively,wires806 and/or830 and orround pin anchor810 are color coded and/or labeled in a manner that notifies the operator of the proper placement, for example on the fetal head and/or on the, os cervix. Additionally or alternatively,wires830 and/or806 and orround pin anchor810 are color-coded and/or labeled in a manner that notifies the operator of proper placement on the skin, for example, for EKG and/or EMG monitoring. Such visual coding, for example, is available on other embodiments of the present invention as well.
• Optionally,[0169]wires806 and/or830 are connected to one or more antennae that broadcast signals to a signal receptor that sends the signals to a monitor. In an exemplary embodiment, the different signals are broadcast in different formats so that they do not interfere with one another. For example, the positioning sensor provides ultrasound that operates in MHz, providing information on the relationship of the fetal crown to the birth canal. The ECG information is, for example, projected in the Hertz band. Additionally or alternatively, both sensors can operate in the MHz band and/or the Hz band, with significant separation of frequency to prevent interference. ECG information may be provided, for example, using one or more electrodes168 (shown in FIG. 1), which may alternatively or additionally used for other sensing purposes.
• FIG. 9 shows a[0170]wireless signaler900 that transmits, for example, RF signals. In an exemplary embodiment,signaler900 compriseshousing804 in which anincoming ultrasound energy912 is converted by anRF converter910, for example, toelectromagnetic RF energy914, possibly of same or similar frequency.RF energy914 is then detected by a nearby detector (not shown) and shown, for example, on a display. Further details of an exemplary embodiment are provided for example in the above referenced PCT application file don even date.
• In an exemplary embodiment,[0171]housing804 containsstraight hook802 and amoveable pin944. To anchorwireless signaler900 in tissue, for example,hook802 is pressed into the tissue.Moveable pin944 is retracted away fromhook802 usingshaft818 and pressed against the tissue.Shaft818 is then moved to causemoveable pin944 to move towardhook802 so that the tissue is secured betweenhook802 andmoveable pin944. Optionally,shaft818 is spring-loaded so that upon release it moves towardhook802 without further effort.
• In an exemplary embodiment, to remove[0172]housing804 from ananchor area840,sheath828 is stabilized with one hand. Grasparea820, attached toshaft818, is manipulated so thatmoveable pin944 moves away fromhook802 so thathousing804 removes from anchor area. As in other embodiments, both hands may be outside the cervix during removal.
• Additionally or alternatively,[0173]shaft818 is spring-loaded so that upon release, it moves away fromhook802. In an exemplary embodiment,grasp area820 movesshaft818 forward against the pressure of its spring, while stabilizingsheath828. A ratchet (for example similar tonotches152 in FIG. 1) is located betweenshaft818 andgrasp area820 and manipulated to keepmoveable pin944 in position towardhook802 during childbirth. Following childbirth, the ratchet mechanism betweenshaft818 andgrasp area820 is released so thatmoveable pin944 retracts away fromhook802 andhousing804 is easily removed from the target tissue.
• FIG. 10 shows[0174]ultrasound sensor1000, for example that sends and receives ultrasound signals. In an exemplary embodiment,sensor1000 can be used, for example, inhousing804. A smallpiezoelectric transducer1048 has twoactive faces1046 that are soldered, for example, to acoaxial cable830A. Additionally or alternatively, atwisted pair wire830A may be used.
• FIGS.[0175]11A-11C show aprobe1100 in atissue1184 with an expandinganchor tip1102 that is adapted for use in soft tissue, for example adjacent the birth canal and that, for example, deflates and/or biodegrades following use. In FIG. 11A,anchor tip1102 is shown in the pre-expanded state following being pressed intotissue1184. In an exemplary embodiment,anchor tip1102 exhibits rigidity sufficient to be pressed intosoft tissue1184 by movingprobe1100 towardtissue1184. Additionally or alternatively, an anchor delivery system provides a rigid deployer guide that, for example, surroundsanchor tip1102 to aid in pressing it intotissue1184.
• FIG. 11B shows[0176]anchor tip1102 expanded causingside points1104 and1106 to press laterally intotissue1184. Expansion foranchor tip1102, for example, is through the introduction of a fluid, for example, sterile saline and/or inert gas. Additionally or alternatively,anchor tip1102 can anchor intissue1184 with a variety of alternative shapes, for example a sphere orsingle side point1104. Removal ofanchor tip1102, for example, is accomplished by deflatingtip1102.
• In an exemplary[0177]embodiment anchor tip1102 is attached to atube1120 that extends outside the cervix and expansion and/or shrinkage is accomplished, for example, by pressing an expansion gasket to press a fluid intoanchor tip1102. Astop1124, for example ontube1120 and/or the expansion gasket, maintains the fluid under pressure during the expansion period. Shrinkage and/or deflation, is accomplished by releasingstop1124 so the fluid exitsanchor tip1102.
• FIG. 11C shows a dissolvable embodiment of[0178]expandable anchor tip1102 in which astop1124A is contained onprobe1100 andtube1120 has been removed paststop1124, leavingtube1120 withinprobe1100. Additionally or alternatively,tube1120 and/orgasket1124 are external to probe1100, for example, as part of an antenna housing. Following a base period of time, expandanchor tip1102 begins to deform so that side points1104 and1106 loose their shape andprobe1100 can be removed fromtissue1184. Additionally or alternatively, the walls ofanchor tip1102 become thinner after a base period of time sotip1102 deforms to gradually release the fluid it contains.
• Additionally or alternatively,[0179]expandable anchor1102 has an internal expansion mechanism, that expandsside points1104 and/or1106 automatically in response to an activation stimulus. An activation stimulus, for example, comprises increased pressure during insertion that cause an internal fluid reservoir to break and fillanchor1102 with pressurized fluid. Additionally or alternatively, an activation stimulus comprises application of electromagnetic waves or a catalytic agent that causes a fluid reservoir to break.
• FIGS. 12A and 12B show an alternative embodiment of a[0180]probe1200 that uses SMP technology in attaching to and removing from tissue. In an exemplary embodiment, FIGS. 12A and12B show probe1200 made of, for example, shape memory polymers (SMP's) as identified in “Shape Shifters” inScientific American, May 2001, noted above. An SMP is capable of changing shape in response to a temperature increase. With the addition of heat, for example from the body, an SMP deforms into a temporary configuration. Upon removal of the temperature increase an SMP will revert to its former shape. An SMP can be formulated to deform at a wide variety of temperatures. For example SMP's made of polyurethane recover their shape as the temperature drops to between 30 and 70 degrees Celsius. The temperature at which the change occurs, for example, is dependent upon the formulation of the polyurethane-based SMP. SMP's, for example, are biocompatible and capable of 400 percent shape recovery.
• In an exemplary embodiment, springs[0181]1220 and1222 are made of an SMP and anchored toanchors1250 and/or1252 at one end and toanchors1230 and1232 at the other end.
• After a base period of time, for example encompassing the delivery period, SMP springs[0182]1220 and1222, reach a deforming temperature and deform into a shape, as shown in FIG. 12B that causes retraction ofanchors1240 and/or1242 intoprobe1200 so that it can be removed from atissue1210.
• In an exemplary embodiment, a[0183]biodegradable polymer wedge1260 that biodegrades as a result of, for example hydrolysis in the wet tissue environment, is located adjacent to anchor1240 and abiodegradable polymer wedge1262 is located adjacent toanchor1242.Polymer wedges1260 and1262, for example, dissolve over a base period of time, for example 12-24 hours and/or a period that encompasses, for example, a typical birth process. Thus, even as SMP springs1220 and1222 change, for example, within several hours and exert force to pullanchors1240 and1242 withinprobe1200, they are prevented from retracting due to the interposition ofwedges1260 and1262. Following dissolution ofwedges1260 and1262, SMP springs1220 and1222 pull anchors1240 and1242 intoprobe1200.
• FIG. 13 shows a[0184]probe deployer apparatus1300 that can be utilized in a sterile field, according to an embodiment of the present invention.Probe deployer1300 has a well1340 or other receptacle in whichprobe1200 is held.Probe1200 is shown with acoiled wire extension1360 andanchor tips1230 and1232 in the retracted position.Probe deployer1300 has ahandle1326 and alever1310 that ends in atrigger1320.Lever1310 pivots on apivot1328 so that astrigger1320 is pressed in adirection1312,lever1310 moves in adirection1346. Aslever1310 moves indirection1346, aprong1322 moves againstanchor tips1230 and1232 to cause them to exitprobe1200 and anchor intissue1210.
• Additionally or alternatively,[0185]lever1310 moves indirection1346, pressingprobe1200 out of well1340 so thatprobe1200 easily separates fromdeployer apparatus1300 following implantation into the tissue, for example, adjacent the birth canal. In an exemplary embodiment,deployer apparatus1300 installsprobe anchor1200 intotissue1210, for example of the birth canal, in a single action and/or does not require further manual inspection. Additionally or alternatively,deployer apparatus1300 is disposable following a single use. Additionally or alternatively,deployer apparatus1300 can be used multiple times and sterilized between uses.
• In an exemplary embodiment, the entire[0186]probe deployer apparatus1300 is sterile and handled by an operator with sterile gloved hands. Additionally or alternatively, handle1326 is not sterile, being handled by an operator wearing non-sterile gloves while, for example, the area ofdeployer1300 neartissue1210 is sterile. Additionally or alternatively, the parts of the deployer apparatus cartridge and/or anchor that come into contact with the tissue of the birth canal area are sterile. In an exemplary embodiment, one or more probe anchors1200 are contained in a sterile cartridge that fits into thedeployer apparatus1300 and advance forward to deploy in tissue, for example, with a spring mechanism so that oneprobe1200 is always ready to be deployed until there are no further probe anchors1200.
• In an exemplary embodiment, the deployer apparatus may be adapted for use with other anchors, for example as described herein, optionally, including a release mechanism suitable for the particular anchoring method used, for example, a pin retraction for the embodiment of FIG. 6. Alternatively or additionally, the deployer apparatus includes a control for attaching to the anchor release mechanism, for assistance in removal of the device, for example, a pulley to pull on the cable (in FIG. 6).[0187]
• In an exemplary embodiment of the invention, the anchors are provided on a conveyer line, so that when one is deployed, the next comes into position. Alternatively or additionally, a spring is used to advance the anchors. Mechanisms similar to those used in surgical clip deployers may be used as well known in the rat.[0188]
• Optionally,[0189]deployer apparatus1300 is equipped with afirst positioning prong1320 and/or a second positioning prong that aid in centeringprobe1200 automatically on an external surface of the cervical os. Additionally or alternatively,positioning prongs1320 and/or1322 are radiopaque to aid in proper placement ofprobe1200 on an external surface of the cervical os so that the operator can readily assess the position ofprobe1200 using a radiographic imager suitable for imaging during deployment.
• In an exemplary embodiment,[0190]probe1200 remains intissue1210 for a base period of time, following which it deforms, dissolves and/or is modified in shape so that it can be easily removed fromtissue1210, for example, by pulling onwire extension1360.
• FIGS.[0191]14A-14E show several embodiments of different probe anchor tip designs, according to an embodiment of the present invention that optionally are deliverable withprobe delivery apparatus1300, according to an embodiment of the present invention. In an exemplary embodiment,delivery apparatus1300 delivers a wide variety of probe anchors including those shown in FIGS. 14a-14E, the various embodiments demonstrated as exemplary embodiments of the present invention. Additionally or alternatively, as can be readily appreciated,delivery apparatus1300 can be modified in various ways in order to deliver any number of probes with designs other than those specifically shown.
• FIG. 14A shows[0192]anchor tip1102 attached to aprobe base1410 that is cylindrical, for example allowing it to interface with well1340. In an exemplary embodiment,anchor tip1102 is in the deflated position as shown in FIG. 11A and it is delivered totissue1184 withdelivery apparatus1300. In an exemplary embodiment,prong1322 presses againstcylinder1410 and causes the release of a pressurized fluid to expandanchor tip1102. Additionally or alternatively, following the birth process, or, when used in alternative tissue following use,probe delivery apparatus1300 is used to pierceprobe1410 and release the pressure so thattip1102 deflates.
• FIG. 14B shows a modification of[0193]round pin812 that demonstrates more circular revolutions thanround pin812 pictured in FIG. 8B. In an exemplary embodiment,prong1322 rotates as it moves indirection1346. Aprobe1400B, for example, is delivered to an anchor area andcircular tip810 rotates into the anchor area asprong1322 presses on it indirection1346, securingprobe1400B to the tissue. In an exemplary embodiment, following use ofprobe1400B,delivery apparatus1300 is attached to probe1410 and, by causingprong1322 to move indirection1348, it reverses its rotation to causeround pin812 to rotate opposite to its rotation during implantation, causing removal ofprobe1400B.
• FIG. 14C shows a[0194]probe1400C withtip1102 coupled with a pancake-shapedprobe1420.Pancake probe1420 may have use where a low profile is important, for example in taking measurement within the pleural sac around the heart.
• FIG. 14D shows[0195]probe1400D with flexible tips1130 that spread away from each other prior to deployment and contract toward each other to secure to a tissue. In an exemplary embodiment,prong1322 presses into apassage1338 ofprobe1400D and presses against scissor ends1436, causing the spreading of flexible tips1130 away from each other. Release ofprong1322, for example, allowtips1430 to contract toward each other and attach to an anchor area. In an exemplary embodiment, removal ofprobe1400D is effected by pressingprong1322 into scissor ends1436, causing them to expand away from each other so thatprobe1400D can be removed from the anchor area.
• FIG. 14E shows[0196]probe1400E with a pincer arm1440 that has aslope edge1452.Prong1322, for example, is pressed into apassage1450 until its tip pressesslope edge1452, causing pincer arm1440 to spread from astationary arm1442 as it pivots on aspring pivot1454. Removal ofprong1322 fromslope edge1452, for example, allows pincer arm1440 to move towardstationary arm1442 and secure into an anchor area.
• Removal of[0197]probe1400E is effected by pressingprong1322 intoslope edge1452, causing pincer arm1440 to spread fromstationary arm1442 so thatprobe1400D can be removed from the anchor area.
• The present invention has been described using non-limiting detailed descriptions of embodiments thereof that are provided by way of example and are not intended to limit the scope of the invention. It should be understood that features and/or steps described with respect to one embodiment may be used with other embodiments and that not all embodiments of the invention have all of the features and/or steps shown in a particular figure or described with respect to one of the embodiments. Variations of embodiments described will occur to persons of the art.[0198]
• Furthermore, the terms “comprise,” “include,” “have” and their conjugates, shall mean, when used in the claims, “including but not necessarily limited to.”[0199]
• It is noted that some of the above described embodiments may describe the best mode contemplated by the inventors and therefore may include structure, acts or details of structures and acts that may not be essential to the invention and which are described as examples. Structure and acts described herein are replaceable by equivalents, which perform the same function, even if the structure or acts are different, as known in the art. Therefore, the scope of the invention is limited only by the elements and limitations as used in the claims.[0200]

Claims (77)

1. A probe anchor that attaches a probe to a tissue adjacent a birth canal, comprising:

(a) a soft tissue anchor including a release mechanism;

(b) a cable sufficiently pliable that it will not harm a fetus during passage trough the birth canal coupled at one end thereof to said release mechanism; and

(c) a control coupled to an opposite end of said cable and operative to remotely release said release mechanism using said cable without requiring manual stabilization directly to said anchor.

2. A probe anchor according toclaim 1 wherein said release mechanism is mechanically operated.

3. A probe anchor according toclaim 1 wherein said release mechanism is electrically operated.

4. A probe anchor according toclaim 2 wherein said release mechanism stores a releasing energy and whereby said control releases said energy.

5. A probe anchor according toclaim 4 comprising an energy retainer that prevents activation of said releasing energy until its release by said control.

6. A probe anchor according toclaim 1 wherein said probe anchor comprises two sections:

(a) an anchor section that connects to said tissue and is adapted for the attachment of a probe section; and

(b) a probe section that attaches to said anchor section.

7. A probe anchor according toclaim 6 wherein said anchor section defines a volume suitable for receiving said probe section.

8. A probe anchor according toclaim 7 wherein said probe section fits in said volume and is removably coupled to said volume.

9. A probe anchor according toclaim 7 wherein said volume comprises one or more resilient projections that restrain said probe section from exiting said volume.

10. A probe anchor according toclaim 9 wherein said resilient projections release said probe section from said volume upon application of a probe-displacing force.

11. A probe anchor according toclaim 1 wherein said anchor section weakens over time, facilitating its removal from said tissue.

12. A probe anchor according toclaim 11 wherein said anchor section partially dissolves over time.

13. A probe anchor according toclaim 11 wherein said anchor section completely dissolves over time.

14. A probe anchor according toclaim 11 wherein said anchor section deforms over time.

15. A probe anchor according toclaim 14 wherein said deformation occurs in response to a temperature change.

16. A probe anchor according toclaim 2 wherein pulling said cable away from said anchor activates said mechanical release mechanism.

17. A probe anchor according toclaim 2 wherein rotating said cable around its axis in relation to said anchor activates said mechanical release mechanism.

18. A probe anchor according toclaim 1 wherein said probe comprises a sensor that monitors said tissue.

19. A probe anchor according toclaim 18 wherein said sensor comprises an ultrasound transducer ultrasonically coupled to said anchor section and ultrasonically coupled by said anchor section to said tissue.

20. A probe anchor according toclaim 1 wherein said cable comprises a conducting wire.

21. A probe anchor according toclaim 20 wherein said conducting wire carries signal data.

22. A probe anchor according toclaim 20 wherein said conducting wire is visually coded to indicate function or placement of said conducting wire.

23. A probe anchor according toclaim 20 wherein said conducting wire is connected to an antenna that transmits signal data.

24. A probe anchor according toclaim 23 wherein said probe comprises an electromagnetic RF transmitter coupled to said antenna.

25. A probe anchor according toclaim 1 wherein said anchor section is visually coded to indicate function or placement of said anchor section.

26. A probe anchor according toclaim 1 wherein said anchor section is configured so it does not obstruct the birth canal during a birth process.

27. A probe anchor according toclaim 1 wherein said anchor section is configured so it does not obstruct manual examination of the birth canal.

28. A probe anchor that attaches a probe to soft tissue adjacent a birth canal, comprising:

(a) an anchor that has a closed position and an open position;

(b) a tension element that urges said anchor toward said open position;

(c) a closure control operative to maintain said anchor in said closed position.

29. A probe according toclaim 28 wherein said anchor comprises a wire passed through said tissue when said anchor is in the closed position.

30. A probe according toclaim 28 wherein said anchor comprises one or more legs with sharp ends pressed into said tissue when said anchor is in the closed position.

31. A probe according toclaim 28 wherein release of said closure control, allowing said anchor to return to the open position, is activated by an extension remote from said anchor.

32. A probe according toclaim 28 comprising a tensioning element urging said anchor to be in said closed position.

33. A probe according toclaim 28, wherein said anchor is adapted to change from a normal closed to a normally open configuration following attachment of said probe to soft tissue.

34. A probe anchor according toclaim 28 wherein said tension element comprises a shape memory polymer.

35. A probe anchor according toclaim 34 wherein said shape memory polymer is coupled to a delaying mechanism that delays said opening of said anchor.

36. A probe anchor according toclaim 35 wherein said delaying mechanism comprises a material that biodegrades over a period of time during which period it prevents said a shape memory polymer from drawing said anchor into the open position.

37. A probe anchor according toclaim 35 wherein said delaying mechanism comprises a material that dissolves in response to an external causative factor.

38. A probe that anchors in soft tissue adjacent a birth canal, comprising:

a probe defining one or more lumens;

a spike element set in each of said one or more lumens with a front end extending out of said lumen; and

a deforming element that deforms in response to temperature increase above a base temperature, connecting said spike to said lumen;

wherein deformation of said deforming element causes said front end of said spike to retract into said lumen.

39. A probe according toclaim 38 wherein said lumen includes a delay plug that prevents retraction of said spike element.

40. A probe according toclaim 39 wherein said delay plug comprises a material that weakens over a period of time.

41. A probe according toclaim 39 wherein said delay plug prevents retraction of said one or more spike elements for a minimum of eight hours.

42. A probe according toclaim 39 wherein said delay plug comprises a biodegradable material.

43. A probe according toclaim 39 wherein said delay plug comprises a material that degrades in response to an external causative factor.

44. A probe according toclaim 43 wherein said external causative factor comprises a compound.

45. A probe according toclaim 43 wherein said external causative factor comprises electromagnetic waves.

46. An expanding probe anchor that attaches a probe to soft tissue adjacent a birth canal, comprising:

a probe with an expandable anchor member adapted to be inserted into said soft tissue;

a fluid reservoir containing a fluid, external to said canal and connected to said expandable anchor by a fluid conduit; and

a valve between said reservoir and said anchor that maintains said fluid in said anchor following its flow into said anchor from said reservoir.

47. A probe according toclaim 46 wherein said fluid reservoir is flexible and compression of said reservoir causes said fluid to move through said conduit into said anchor member.

48. A probe according toclaim 47 wherein movement of said fluid into said anchor member causes expansion of said anchor member.

49. A probe according toclaim 46 wherein said anchor member weakens over time and maintains said fluid for a base period of time following which it releases said fluid.

50. A probe according toclaim 49 wherein said release occurs following a minimum of eight hours.

51. A probe according toclaim 49 wherein said anchor member comprises a material that releases said fluid in response to an external causative factor.

52. A probe according toclaim 49 wherein said anchor member comprises a material that releases said fluid in response to a natural biological material contained in said canal.

53. A probe anchor deployment apparatus that attaches a probe anchor to soft tissue adjacent a birth canal, comprising:

(a) an anchor deployment apparatus with a grasping end that grasps a probe;

(b) a probe with an anchor mechanism suitable for attachment to said tissue;

(c) a handle extension extending from said grasping end out of said birth canal; and

(d) a deployment mechanism along said handle extension that deploys said anchor mechanism.

54. Apparatus according toclaim 53 wherein said apparatus is adapted to carry two or more probes.

55. Apparatus according toclaim 53 wherein said apparatus is adapted to carry two or more probes in a magazine.

56. Apparatus according toclaim 54 wherein a second probe moves into said grasping end following deployment of a first probe.

57. Apparatus according toclaim 53 wherein said anchor includes a release mechanism and wherein said apparatus is adapted to activate said release mechanism.

58. An adhesive probe anchor, comprising:

an adhesive on said probe that adheres to a mucosal surface adjacent a birth canal with sufficient adherence to resist detachment due to forces generated by the birth process for a base period of time; and

a sensor removably connected to said probe.

59. A probe according toclaim 58 wherein said base period comprises a minimum of eight hours.

60. A probe according toclaim 59 wherein said adhesive weakens in response to biological compounds naturally contained within said canal.

61. A probe according toclaim 59 wherein said adhesive weakens in response to an external causative factor.

62. A sensor according toclaim 58 wherein said connection between said sensor and said probe is a mechanical connection.

63. A sensor according toclaim 58 wherein said connection between said sensor and said probe is a biodegradable connection that weakens over a base period of time during which it resists detachment due to forces generated by the birth process.

64. A probe according toclaim 63 wherein said wherein said base period comprises a minimum of eight hours.

65. A probe according toclaim 63 wherein said weakening occurs in response to biological compounds naturally contained within said canal.

66. A probe according toclaim 63 wherein said biodegradable connection weakens in response to an external causative factor.

67. A method for securing an anchor, having a base and a curved wire having a point, to the cervix, comprising;

(a) positioning said anchor at a tissue of the cervix such that said base contacts the cervix;

(b) transfixing said cervix with said curved wire, point first, so that said point is covered by said base when said transfixing is completed.

68. A method according toclaim 67 wherein said probe anchor comprises an ultrasound transducer ultrasonically coupled to said anchor and attaching comprises attaching said ultrasonically coupled transducer to said cervix.

69. A method for adhering a probe with a sensor to soft tissue adjacent a birth canal and monitoring fetal passage, comprising:

grasping a probe apparatus, including a sensor and an adherent surface that weakens over time;

pressing said adherent surface onto said soft tissue;

monitoring fetal passage through said canal with said sensor; and

confirming the removal of said adherent surface from said soft tissue following its weakening below its adherence threshold.

70. A method according toclaim 69 wherein said confirming occurs following a minimum of eight hours of adherence.

71. A method according toclaim 69 wherein said weakening occurs in response to biological compounds naturally contained within said canal.

72. A method according toclaim 69 wherein said weakening occurs in response to an external causative factor.

73. A method according toclaim 69 wherein comprising removing said sensor from said soft tissue prior to said surface falling off said soft tissue.

74. A two part anchor, comprising:

an anchor portion adapted to be anchored to soft tissue and including an attachment element; and

a selectively attachable rider portion adapted to be attached to said attachment element.

75. An anchor according toclaim 74, comprising a sensor coupled to said rider portion.

76. An anchor according toclaim 74, wherein said anchor portion is adhesive to said soft tissue.

77. An anchor according toclaim 74, wherein said anchor portion mechanically attaches to said soft tissue.

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