Medical material delivery device

A medical material delivery device includes a shaft having a lumen that receives a therapeutic agent, and can include a guide having a channel for receiving a medical instrument adapted for positioning in conjunction with a bodily part. An expandable member positioned in conjunction with the guide is adapted for communication with the bodily part and is arranged to burst open when the expandable member is disrupted by a disrupting mechanism to deliver the therapeutic agent to the bodily part. Further embodiments include a medical instrument and an expandable member in conjunction with the medical instrument to burst or leak to deliver a therapeutic agent. The medical material delivery device can include a bodily fluid locator attached with the device, as well as can include a second expandable member to inflate and deflate to localize a bodily part, with a first expandable member bursting to deliver a therapeutic agent.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to surgical instruments, and particularly to a medical material delivery device.

2. Description of the Related Art

Medical material can be delivered to subjects in numerous ways, such as application on the surfaces of a subject's skin, oral ingestion, or administration to the subject through a needle or catheter, for example. These numerous methods can have advantages and disadvantages; therefore medical practice continues to seek new methods of material delivery to compliment the numerous other methods of material delivery.

In one particular area of medical practice, procedures involving the insertion of medical instruments into blood vessels or tissues or other bodily parts are common procedures in the medical field today. Even though they are common, closing of the openings caused by these procedures can be problematic. A current approach for sealing a puncture caused by a medical procedure as, for example, a procedure involving the puncturing of a blood vessel to perform an angiographic procedure, is to seal the puncture by using manual pressure. In this approach, manual pressure is applied directly to the skin above the access puncture for a time period until the natural clotting process of the body seals the puncture. A drawback of this approach is that it can be uncomfortable for the patient while the pressure is applied and it can be time consuming, including taking up the time of the medical staff assisting the patient.

Another approach to seal a puncture employs the use of absorbable intra-vessel anchors in conjunction with extra-vessel collagen sponges. Under this approach, the anchor and collagen sponge are held together by a self-tightening suture loop and slip knot, which, when tightened, sandwiches the puncture hole between the anchor and the collagen sponge. Although these devices can be effective in sealing punctures, in certain situations, for example punctures in the femoral artery, these devices may not work successfully. Other factors as can prohibit using these devices include the presence of peripheral vascular disease, a poor needle stick location by either having too high of a puncture or too low of a puncture, or relatively smaller blood vessel sizes which can interfere with anchor placement and prevent proper seating of the anchor against the blood vessel wall.

In an effort to overcome some of these problems, another device for sealing a puncture is a plug that is deposited outside the blood vessel at the puncture site with no component inside the blood vessel. This approach generally requires a consistent placement of the plug near the blood vessel wall. This consistent placement can be problematic, for example, when trying to seal a punctured artery pressure exerted on the plug as the blood pressure generated by the beating heart can cause the plug to move away from the puncture site in the arterial wall. This can result in a hematoma or other complications at the puncture site. Further, the plug may not seal the puncture site sufficiently enough to prevent leakage from the blood vessel.

Therefore, it is desirable for a device that can deliver a medical material for medical procedures to be able to do so in an easy, quick, less painful and secure manner.

Thus, a medical material delivery device addressing the aforementioned problems, that can include a method of delivery complimenting other methods of delivery, is desired.

SUMMARY OF THE INVENTION

Embodiments of a medical material delivery device are provided. An embodiment of the medical material delivery device includes a shaft having a proximal end and a distal end and also, a lumen that receives a therapeutic agent. A guide positioned at the distal end of the shaft is adapted for positioning in conjunction with a blood vessel or other bodily part. The guide further includes a channel that can receive a medical instrument. An expandable member is positioned in conjunction with the guide and communicates with the lumen of the shaft for expansion by the therapeutic agent. The expandable member is adapted for communication with the blood vessel or other bodily part and is arranged to at least one of burst, leak or become broken when the expandable member is disrupted by a disrupting mechanism to deliver the therapeutic agent to the blood vessel or other bodily part.

In embodiments of a medical material delivery device, the disrupting mechanism can include, for example, at least one of or one or more of one or more longitudinal breakage lines included in the expandable member, at least one generally circumferential breakage line included in the expandable member, a string attached to the expandable member, a needle positioned in communication with the expandable member and a chemical disrupting mechanism. Also, in embodiments of a medical material delivery device, the chemical disrupting mechanism can also include a solvent, such as a chemical solvent, to react with the expandable member, for example.

A further embodiment of the medical material delivery device includes an outer shaft, the outer shaft having a first lumen, the outer shaft adapted for positioning in conjunction with a bodily part. The medical material delivery device also includes a first expandable member, the first expandable member positioned to an exterior of the outer shaft for expansion by a therapeutic agent, the first expandable member adapted for communication with a bodily part, the first expandable member arranged to at least one of burst, leak or become broken when disrupted by a disrupting mechanism to deliver a therapeutic agent to an exterior area of the bodily part in communication with the first expandable member.

The medical material delivery device further includes a first delivery member, the first delivery member positioned in association with the outer shaft in communication with the first expandable member to deliver the therapeutic agent to the first expandable member. Also, the medical material delivery device includes an inner shaft, the inner shaft positioned within the first lumen of the outer shaft, the inner shaft having a second lumen adapted to receive a medical instrument, the inner shaft adapted for insertion within the bodily part.

Additionally, the medical material delivery device includes a second expandable member, the second expandable member positioned to an exterior of the inner shaft for expansion, the second expandable member adapted for communication with an interior of the bodily part, the second expandable member arranged to selectively inflate and deflate, and includes a second delivery member, the second delivery member positioned in association with the inner shaft in communication with the second expandable member to assist the second expandable member to one or more of inflate or deflate. For example, the second expandable member can be arranged to contact the inner vascular wall to prevent further withdrawal of the medical material delivery device and localize an arteriotomy.

Another embodiment of the medical material delivery device includes a medical instrument, the medical instrument including a lumen adapted for receiving a therapeutic agent, the medical instrument adapted for communication with a blood vessel or other bodily part, and also includes an expandable member, the expandable member positioned in conjunction with the medical instrument for expansion by the therapeutic agent when delivered in conjunction with the medical instrument, the expandable member adapted for communication with the blood vessel or other bodily part, the expandable member arranged to at least one of burst, leak or become broken when disrupted by a disrupting mechanism to deliver the therapeutic agent to an area of the blood vessel or other bodily part in communication with the expandable member. The medical instrument can include, for example, a trocar, a needle, a cannula, and a guide wire, a sheath, a scalpel or a catheter. Also, the medical material delivery device can include a bodily fluid locator, such as a vascular locator, to indicate communication of the medical material delivery device with the blood vessel or other bodily part by a presence of blood or other bodily fluid within the bodily fluid locator.

These and other features of the present invention, such as those including but not limited to medical applications, will become readily apparent upon further review of the following specification and drawings.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring toFIGS. 1A-2E, a medical material delivery device100is shown. The medical material delivery device100includes a shaft102that has a proximal end104that is situated towards a user and a distal end106that is at the other end of the shaft102away from the proximal end104and is situated towards a patient that is having or has had a medical procedure performed. The user, generally a health care practitioner, can control the medical material delivery device100by gripping directly the shaft102or, depending on the user's needs, the user can grasp a handle or similar structure that is secured to the proximal end104that can allow for the advancement and positioning of the medical material delivery device100.

The shaft102of the medical material delivery device100also includes a lumen108within the interior of the shaft102that traverses the length of the shaft. The lumen108is an open ended pathway with one open end of the lumen108at the proximal end104of the shaft102and the other open end of the lumen108is at the distal end106of the shaft102. This other open end of the lumen108that is located at the distal end106will insert and empty into an expandable member114. The expandable member114is positioned in conjunction with a guide110and expands by manual filling when the user places a therapeutic agent124, shown inFIGS. 7E-7F, into the open end of the lumen108located at the proximal end104of the shaft102.

The type of therapeutic agent that is placed within the lumen108of the shaft102that fills the expandable member114typically depends on the particular needs and the medical procedure performed on a bodily part. Examples of bodily parts to which embodiments of a medical material delivery device, as described herein, can include vascular and non-vascular bodily parts, such as blood vessels, trachea, bronchial tree, vascular tree, elementary tract, biliary tree, bones or other bodily compartments, spaces or cavities and, therefore, such bodily parts should not be construed in a limiting sense.

For example, if an angiographic procedure is performed, the medical procedure would typically involve the use of a medical instrument to puncture a blood vessel, such as an artery. Therefore, based on this procedure and a need to close the blood vessel, the user could select a therapeutic agent124, such as the patient's own clotted blood, thrombin, fibrin, a liquid embolic material, a lipid based sealing material, or any other common coagulation and embolization material. Other possible choices for a therapeutic agent124can include drugs that provide local or systemic therapeutic effects in the body, a phase changeable material, such as acrylic bone cement for procedures involving a vertebroplasty or kyphoplasty, collagen, coils, or any other common implantable medical material, such as to deposit a relatively small collagen plug, suture or coil adjacent to a puncture site.

The guide110of the medical material delivery device100is positioned at the distal end106of the shaft102and is adapted for positioning in conjunction with a blood vessel, as an example of a bodily part, as shown inFIGS. 7A-7F. The guide110can also be adapted for positioning in conjunction with other bodily parts, such as vertebrae, depending on the particular needs or medical procedure to be performed. As shown inFIGS. 1A-2E, the guide110is configured in a generally ring shape and includes a channel112that is configured to receive a medical instrument122as shown inFIGS. 7A and 7B.

The channel112allows for the guide110to be placed in conjunction with the medical instrument122, thereby allowing ease of use of the medical material delivery device100along with the medical instrument122during a medical procedure. The diameter of the channel112of the guide110can vary depending on the diameter of the medical instrument122that is being used in the medical procedure. For example, if the medical instrument122is a needle, then the diameter of the generally ring shape guide110will be less than if the medical instrument122was a scope. Other examples of a medical instrument122that can be used with medical material delivery device100include a trocar, a cannula, a guide wire, a scalpel, sheath, catheter or any other common medical instrument that is used for invasive medical procedures.

The expandable member114that is positioned in conjunction with the guide110is adapted for communication with a bodily part, such as a blood vessel, while the expandable member114is outside of the lumen108of the shaft102. The expandable member114can be made from a suitable material, such as an elastic medical grade material, a plastic material or a textile material, for example, that can be deflated, inflated/expanded and, when appropriate, disrupted, such as by being burst, that can allow for the expansion of the expandable member114, or can be made from other suitable material, such as depending upon the use or application, for example. By using an elastic material, as an example, the expandable member114can placed into at least three arrangements.

An unexpanded arrangement116ais shown inFIG. 1A, where the therapeutic agent124has yet to be placed within the expandable member114. The expandable member114can also be placed into an expanded arrangement116b, as shown inFIG. 1B, where the expandable member114is filled with the therapeutic agent124, or can be placed in other arrangements where the expandable member114is in one or more partially filled states, for example.

The third arrangement of the expandable member114is a burst open arrangement116c, as shown inFIG. 7E, where the expandable member114is disrupted by a disrupting mechanism118. The disrupting mechanism118causes the expandable member114to at least one of burst, leak or become broken, depending on the use or application, for example, to deliver the therapeutic agent124. Various embodiments of the disrupting mechanism118are provided inFIGS. 2A-2E. When the expandable member114is in the burst open arrangement116c, the therapeutic agent124contained within the expandable member114is delivered to the targeted bodily part, such as a blood vessel wall, that is in communication with the expandable member114.

Referring toFIGS. 2A-2E, various disrupting mechanisms118are shown while the expandable member114is in the expanded arrangement116b. As shown inFIG. 2A, the disrupting mechanism118can be one or more, desirably a plurality of, longitudinal breakage lines118aincluded in the expandable member114that cause the expandable member114to be placed into the burst open arrangement116c. The plurality of longitudinal breakage lines118aare lines that traverse the expandable member114and provide a weakened area on the expandable member114so that when the expandable member114reaches a certain or predetermined volume when filled with the therapeutic agent124, the plurality of longitudinal breakage lines118abreak and the expandable member114ruptures into the burst open arrangement116c. Alternatively, instead of being volume susceptible, these breakage lines can be designed to be pressure, chemical, electric, temperature or mechanical force susceptible and rupture into at least one of a burst, leak or broken arrangement, depending on the use or application, for example, to deliver the therapeutic agent upon exposure to these triggers.

As shown inFIG. 2B, the disrupting mechanism118can also be a generally a least one circumferential breakage line118bincluded in the expandable member114. The generally circumferential breakage line118btraverses generally the circumference of the expandable member114and, similar to the plurality of breakage lines118a, provides for a weakened area on the expandable member114so that when the expandable member114reaches a certain or predetermined volume when filled with the therapeutic agent124, the expandable member114ruptures into the burst open arrangement116c. Alternatively, instead of being volume susceptible, these breakage lines can be designed to be pressure, chemical, electric, temperature or mechanical force susceptible and rupture into at least one of a burst, leak or broken arrangement, depending on the use or application, for example, to deliver the therapeutic agent upon exposure to these triggers.

As shown inFIG. 2C, the disrupting mechanism118can be a string disrupting mechanism118c, such as a string or a wire, for example. For this embodiment, the string119cis attached to the expandable member114at a breakage point120c. When the user pulls the string119c, the string119cwill pull apart the breakage point120c, causing the expandable member114to rupture into the burst open arrangement116c. This rupturing can be assisted by relatively high pressure escaping from the now opened breakage point120cinto the surrounding area outside the expandable member114.

As shown inFIG. 2D, another embodiment has the disrupting mechanism118as a needle disrupting mechanism118d. The needle disrupting mechanism118dincludes a needle119dand a needle guide120dthat allows for the tip of the needle119dto pierce the expandable member114at a piercing point121d. When the user directs the needle119dthrough the needle guide120dand pushes the tip of the needle119dinto the piercing point121d, the expandable member114ruptures into the burst open arrangement116c. The needle disrupting mechanism118dcan be connected to the shaft102of the medical material delivery device100by a bracket117, as shown inFIG. 2D.

Similar to the process of rupturing described above with the string disrupting mechanism118c, the expandable member rupture can be assisted by the relatively high pressure escaping quickly through the hole caused by the needle119dpiercing the expandable member114. As shown inFIG. 2E, the disrupting mechanism118can also be a chemical disrupting mechanism118ethat involves a chemical119e, such as a solvent or a chemical solvent, applied directly to the expandable member114. The chemical119ecan react with the expandable member114to erode the expandable member114until the expandable member114at least one of bursts, leaks or becomes broken, such as ruptures into the burst open arrangement116c. The solvent can be any common or suitable solvent that is safe for use internally with a human patient, for example. Also the disrupting mechanism can include the application of heat, an electric current, a mechanical force, radiofrequency energy, microwave energy, ultrasound, laser, coblation plasma field or other suitable disrupting triggers to the expandable member, for example.

Another embodiment of a medical material delivery device300is provided inFIGS. 3A and 3B. Similar to the medical material delivery device100, the medical material delivery device300includes a shaft302that has an open ended lumen308that traverses the length of the shaft302. One open end of the lumen308is at the proximal end304of the shaft302and the other open end is located at the distal end306of the shaft302. This open end of the lumen308located at the distal end306inserts into and empties into an expandable member314.

The expandable member314is positioned in conjunction with a guide310and expands when filled by a therapeutic agent that is delivered by the lumen308. Similar to therapeutic agent124of the medical material delivery device100, the therapeutic agent used with medical material delivery device300can be, for example, the patient's own clotted blood, thrombin, fibrin, a liquid embolic material, a lipid based sealing material, a common coagulation or embolization material, a phase changeable material such as acrylic bone cement, or any other common or suitable implantable medical material.

The guide310is positioned at the distal end306of the shaft302and is adapted for positioning in conjunction with a bodily part, such as a blood vessel. As shown inFIGS. 3A and 3B, the guide310is configured in a generally split ring shape and includes a slit311and a channel312that can accommodate a medical instrument, for example. The diameter of the generally split ring shape of the guide310can be adjusted because of the generally split ring shape, allowing for an increased diameter if needed. For example, if a user was initially using a needle as the medical instrument, and wanted to switch to a different medical instrument, such as a cannula, which typically has a larger diameter than a needle, the user would simply remove the needle from the channel312of the guide310and replace it with the cannula, and the guide310can adjust to a relatively the larger diameter of the cannula since the generally split ring shape of the guide310can be of a size to allow for an increase of diameter.

Therefore, a user likely would not have to replace the guide310during a procedure to accept another medical instrument. Further, the guide310can be made from a suitable material, such as a medical grade memory shape material, an example of such material being nitinol, that can allow for the generally split ring shape guide310to adapt around a medical instrument and to also allow for the generally split ring shape guide310to return to its original diameter once the medical instrument has been removed from the channel312.

The expandable member314is similar to expandable member114of the medical material delivery device100, and, similarly, is adapted to be in communication with a bodily part. The expandable member314and the expandable member114, as well as other expandable members described herein, can be made from various suitable materials, such as an elastic medical grade material, a plastic material or a textile material, for example, that can allow for the expandable member, such as the expandable member314and the expandable member114, to be deflated, inflated/expanded and, when appropriate, disrupted, such as by being burst. Further, expandable member314can be placed into at least three separate arrangements, such as an unexpanded arrangement316ashown inFIG. 3Aand an expanded arrangement316bas shown inFIG. 3B, or can be placed in other arrangements where the expandable member314is in one or more partially filled states, for example.

The expandable member314can have a slit315when the expandable member314is in the expanded arrangement316bbecause of the generally split ring shape of the guide310. The third arrangement is a burst open arrangement where the expandable member314is ruptured and the therapeutic agent, such as the therapeutic agent124, contained within the expandable member314is delivered to the bodily part that is in communication with the expandable member314, similar to the burst open arrangement116cofFIG. 7E.

Another embodiment of a medical material delivery device400is provided inFIGS. 4A and 4B. Medical material delivery device400includes a shaft402having a proximal end404and a distal end406. An open ended lumen408traverses the length of the shaft402and, similar to medical material delivery devices100and300, one open end is at the proximal end404of the shaft402and the other open end is located at the distal end406of the shaft402. This open end of the lumen408located at the distal end406inserts into and empties into an expandable member414.

The expandable member414is positioned in conjunction with a guide410and expands when filled by a therapeutic agent, such as the therapeutic agent124, that is delivered by the lumen408. Similar to the therapeutic agent124of medical material delivery device100, the therapeutic agent used with medical material delivery device400can be the patient's own clotted blood, thrombin, fibrin, a liquid embolic material, a lipid based sealing material, a common coagulation or embolization material, a phase changeable material such as acrylic bone cement, or any other suitable or common implantable medical material, for example. As shown inFIGS. 4A and 4B, the guide410can be a flexible sheath that can be configured to wrap onto a medical instrument. The channel412of the guide410is formed once the guide410is wrapped onto the medical instrument.

Further, the shaft402can be integrally configured in the sheath forming the guide410so that the shaft402and the guide410can be integrally wrapped together onto the medical instrument. Or, depending on the particular needs or application, the shaft402can be separate from guide410and can be simply wrapped around the guide410while the guide410is wrapped onto the medical instrument, for example. When the guide410is wrapped onto the medical instrument, a plurality of slits411are formed from an edge of the sheath being adjacent to another edge of the sheath forming the guide410, for example.

The expandable member414is similar to expandable members114and314, including being in communication with a bodily part and being made from an elastic medical grade material, or other suitable material, that can allow for expansion. Expandable member414can also be placed into at least three separate arrangements, such as an unexpanded arrangement416ashown inFIG. 4Aand an expanded arrangement416bas shown inFIG. 4B, or can be placed in other arrangements where the expandable member414is in one or more partially filled states, for example.

The expandable member414can have a slit415when the expandable member414is in the expanded arrangement416b, the slit415typically being included in the expandable member414, particularly when the guide410is a sheath that wraps onto the medical instrument, for example. The third arrangement is a burst open arrangement, similar to the burst open arrangement116cofFIG. 7E, where the expandable member414is ruptured and the therapeutic agent, such as the therapeutic agent124, contained within the expandable member414is delivered to the bodily part that is in communication with the expandable member414.

Another embodiment of a medical material delivery device500is provided inFIGS. 5A-5F. Medical material delivery device500is similar to medical material delivery device100, but also includes a medical instrument522and a bodily fluid locator523, such as a vascular locator. Similar to medical material delivery devices100,300and400, medical material delivery device500has a shaft502having a proximal end504and a distal end506, and an open ended lumen508that traverses the length of the shaft502. One of the open ends of the lumen508is located at the proximal end504and the other open end is located at the distal end506, with this open end inserting into and emptying into an expandable member514.

The expandable member514is positioned in conjunction with a guide510and expands when filled by a therapeutic agent, such as therapeutic agent124, that is delivered by the lumen508. Similar to therapeutic agent124of medical material delivery device100, the therapeutic agent used with medical material delivery device500can be the patient's own clotted blood, thrombin, fibrin, a liquid embolic material, a lipid based sealing material, a common coagulation or embolization material, a phase changeable material such as acrylic bone cement, or any other suitable or common implantable medical material, for example.

The guide510is positioned at the distal end506of the shaft502and is adapted for positioning in conjunction with a bodily part, such as a blood vessel. As shown in FIGS.5A and5B, the guide510is configured in a generally ring shape and includes a channel512that accommodates the medical instrument522. The medical instrument522is adapted for insertion into a bodily part, such as a blood vessel, and can be attached directly to the shaft502or the guide510or the channel512of the guide510, depending on the particular need or application. Similar to medical material delivery devices100,300and400, the medical instrument522can be a number of different instruments, including a trocar as shown inFIGS. 5A and 5B, a cannula, a guide wire, a scalpel, or any other suitable or common medical instrument that is used for invasive medical procedures, for example.

In addition to the medical instrument522, the bodily fluid locator523, such as a vascular locator, is positioned in conjunction with the shaft502. The bodily fluid locator523can be a clear tube having a closed end located at the proximal end504of the shaft502and an open end located at the distal end506of the shaft502. The open end of the bodily fluid locator523is in communication with a bodily part, such as a blood vessel, and visually indicates to a user that the bodily part, such as a blood vessel, has been located and punctured by the presence of blood or other bodily fluid in the bodily fluid locator523, and the bodily fluid locator523can also indicate location of the bodily part by a tactile sensation or response, or both, for example.

When the bodily part, such as the blood vessel, is punctured, blood, or a corresponding bodily fluid, will flow out from the bodily part, such as the blood vessel, and into the open end of the bodily fluid locator523. As the blood, or other bodily fluid, flows into the bodily fluid locator523, it will be visible to the user through the clear tubing, notifying the user that the blood vessel or other bodily part has been found and punctured and that the medical material delivery device500is in communication with the blood vessel wall or other bodily part.

Referring toFIGS. 5C-5F, a method540of sealing a blood vessel546is shown. The first step540cof the method540is to position the medical material delivery device500in conjunction with a blood vessel546by passing the medical material delivery device500through the skin542and through the skin layer544. When the medical material delivery device500is passed through the skin542and the skin layer544, a skin puncture site554is formed. Further, as shown inFIGS. 5C-5E, the medical instrument522of the medical material delivery device500punctures the blood vessel546and enters the interior area550through a blood vessel puncture site552through an exterior surface548of the blood vessel546. The user can be notified that the medical instrument522has punctured the blood vessel546and that the medical material delivery device500is positioned in conjunction with the blood vessel by the visual indication of blood flowing through the bodily fluid locator523. During the first step540cof the method540, the expandable member514remains in an unexpanded arrangement516a.

A second step540dof the method540includes placing the expandable member514of the medical material delivery device500in an expanded arrangement516bfrom the unexpanded arrangement516aso that the expandable member514covers at least a portion of the blood vessel puncture site552and can also cover a portion of the exterior surface548of the blood vessel546, as shown inFIG. 5D. The user can continue to be notified that the expendable member514now in the expanded arrangement516bis positioned in conjunction with at least a portion of the blood vessel puncture site552by visual indication of the continued flow of blood through the bodily fluid locator523.

A third step540eof the method540involves removing the bodily fluid locator523from the medical material delivery device500since the user has already been notified in the previous steps540cand540dthat the medical material delivery device500is in communication with the blood vessel546. However, if the user so desires, the user can continue to have the bodily fluid locator523remain attached to the medical material delivery device500. A fourth step540fof the method540involves the expandable member514being placed from the expanded arrangement516binto the burst open arrangement516c. By placing the expandable member514into the burst open arrangement516c, a therapeutic agent, such as therapeutic agent124, can be delivered to the blood vessel puncture site552.

Another embodiment of a medical material delivery device600is provided for inFIGS. 6A-6C. The medical material delivery device600has an outer shaft602that has a first lumen604that is configured to accept an inner shaft612. The outer shaft602and the inner shaft612each have an expandable member made from an elastic medical grade material that are positioned on the exterior of the respective shaft. Also, the outer shaft602and the inner shaft612can be arranged in a telescoping relation to each other, such as illustrated inFIGS. 6A-6C, for example.

The first expandable member608is positioned on the exterior of the outer shaft602and is filled for expansion by a therapeutic agent624that is delivered to the first expandable member608through a first delivery member606. The first delivery member606is positioned in association with the outer shaft602and can be located inside the lumen604of the outer shaft602or can be positioned on the exterior of the outer shaft602, depending on the particular needs or application, as long as the first delivery member606remains in communication with the first expandable member608so that the therapeutic agent624can be delivered into the first expandable member608.

When the therapeutic agent624is delivered through the first delivery member606and into the first expandable member608, the first expandable member608will expand in the same manner and arrangements as expandable members114,314,414and514of medical material delivery devices100,300,400and500respectively. Also, the expandable members114,314,414,514and614of medical material delivery devices100,300,400,500and600can be of various suitable shapes and sizes, as, for example, a sphere, sphere like, teardrop or ring like shape. The first expandable member608can be positioned into an unexpanded arrangement610aas shown inFIG. 6A, an expanded arrangement610bas shown inFIG. 6B, and a burst open arrangement610eas shown inFIG. 8F. When the first expandable member608is in the burst open arrangement610c, the therapeutic agent624can be delivered to a blood vessel puncture site812, shown inFIGS. 8F-8G, for example.

A second expandable member618as can also be of various suitable shapes and sizes, as, for example, a sphere, sphere like, teardrop like or ring like shape, is positioned on the exterior of the inner shaft612and is filled for expansion by a suitable fluid or material to expand the second expandable member618, as can include an aqueous solution, e.g. water, or a gas, e.g., air, for example, as shown inFIGS. 8B-8D, that is delivered to the second expandable member618through a second delivery member616.

The second delivery member616is positioned in association with the inner shaft612and can be located inside the lumen614of the inner shaft612or can be positioned on the exterior of the inner shaft612, depending on the particular needs or application, as long as the second delivery member616remains in communication with the second expandable member618so that a suitable material or fluid, such as a suitable liquid or gas, can be delivered into the second expandable member618.

Similar to the first expandable member608and expandable members114,314,414and514of medical material delivery devices100,300,400and500respectively, the second expandable member618expands when a suitable fluid or material to expand the second expandable member618, as can include an aqueous solution, e.g. water, or a gas, e.g., air, for example, fills the interior of the second expandable member618and can be arranged into at least three separate arrangements. The second expandable member618can be made of a suitable material, such as an elastic medical grade material, a plastic material or a textile material, for example, that can be deflated or inflated/expanded that can allow for the expansion of the expandable member618, or can be made from other suitable material, such as depending upon the use or application, for example.

The second expandable member618can be arranged into an unexpanded arrangement620aas shown inFIG. 6A, an expanded arrangement620bas shown inFIG. 6C, or can be placed in other arrangements, such as a deflated arrangement, where the second expandable member618is in one or more partially filled states, for example. When the second expandable member618is placed in the expanded arrangement620b, the second expandable member618can be placed into contact with the inner wall of a blood vessel, thereby preventing further withdrawal of the medical material delivery device600and also allowing for localization of the puncture site, for example a localization of an arteriotomy, as shown inFIGS. 8C-8D.

The second expandable member618can also be arranged into a deflated arrangement. When the second expandable member618is in the deflated arrangement, the inner shaft612can be removed from the lumen604of the outer shaft602, as shown inFIG. 8E. The first expandable members114,314,414,514and608and the second expandable member618of medical material delivery devices100,300,400,500and600, respectively, can be any of various suitable fillable objects, such as a balloon, a bag, a sac or other hollow fillable objects and can be of various sizes and shapes, and, therefore, should not be construed in a limiting sense.

The second lumen614of the inner shaft612is adapted to receive a medical instrument622, as shown inFIGS. 8A-8D. Further, the first lumen604of the outer shaft602is also adapted to receive the medical instrument622as shown inFIG. 8Eor additional medical instruments, depending on the particular needs or application. The medical instrument622can be a guide wire, as shown inFIGS. 8A-8E, or other instruments used in invasive medical procedures, such as a trocar, a cannula, or a scalpel, among others. The expandable members608and618can be expanded together at the same time, or the first expandable member608can be expanded first before the expansion of the second expandable member618, or the second expandable member618can be expanded before the expansion of the first expandable member608. The order of expansion of the expandable members608and618can depend on the particular needs or application, for example.

Similar to the expandable member114of the medical material delivery device100, the expandable members314,414,514, and608, of the medical material delivery devices300,400,500and600, can be disrupted so as to at least one of burst, leak or become broken, for example, to deliver the therapeutic agent by any of various embodiments of disrupting mechanisms, such as by the various disrupting mechanisms118a-118eprovided for and illustrated inFIGS. 2A-2E, as can depend on the particular needs or application. For example, the plurality of longitudinal breakage lines118a, the generally circumferential breakage line118b, the string disrupting mechanism118c, the needle disrupting mechanism118d, and the chemical disrupting mechanism118ecan all be used as a disrupting mechanism for the expandable members314,414,514, and608, of the medical material delivery devices300,400,500and600, and should not be construed in a limiting sense.

Regarding the materials that can be used for medical material delivery devices100,300,400,500and600, as stated previously, the expandable members114,314,414,514,608and618of the medical material delivery devices100,300,400,500and600can be made from an elastic medical grade material or other suitable material, depending on the particular needs or application, for example. The remaining components of the medical material delivery devices100,300,400,500and600can also be made from medical grade materials or other suitable materials, such as medical grade metals, plastics, or composites.

For example, the shafts102,302,402,502,602and612of the medical material delivery devices100,300,400,500and600can be made from stainless steel or other suitable material. Also, for example, various components of the medical material delivery devices100,300,400,500and600can be made from a medical grade memory shape material such as nitinol. The types of materials for the various components of the medical material delivery devices100,300,400,500and600can be selected depending on the particular needs and application, for example, and should not be construed in a limiting sense.

Referring toFIGS. 7A-7F, an embodiment of a method700for sealing a puncture in a blood vessel of a patient using the medical material delivery device100is shown, the blood vessel being an example of a procedure involving a bodily part. A first step700aof the method700involves sealing a puncture in a blood vessel during angiography through a blood vessel706. A medical instrument122, such as a trocar, punctures the surface of the skin702and goes through the skin layer704continuing past the surface708of the blood vessel706and into the interior710of the blood vessel706.

A second step700bof the method700for sealing a puncture in a blood vessel involves the placement of the medical material delivery device100in conjunction with the medical instrument122. The medical material delivery device100is placed into position by a user manipulating the shaft102of the medical material delivery device100by either gripping by hand the shaft102or by gripping an attached structure such as a handle that is attached to the shaft102. The user can place the medical material delivery device100in such a position so that the guide110is in conjunction with the blood vessel706, as shown inFIGS. 7B-7C. The channel112of the guide110receives the medical instrument122that allows for the guide110to be placed in conjunction with the blood vessel706and for the expandable member114to be in communication with the blood vessel706and the surface708of the blood vessel706.

Once a user has completed the angiographic study, the medical instrument122is removed from the patient, as shown in a third step700cof the method700shown inFIG. 7C. The user can then expand the expandable member114as shown in a fourth step700dof the method700ofFIG. 7Dby placing a therapeutic agent124in the lumen108of the shaft102. As the therapeutic agent124travels through the lumen108of the shaft102, the expandable member114can continue to expand, such as into the expanded arrangement116bshown inFIG. 7D.

During a fifth step700eof the method700, the expandable member114will rupture into at least one of a burst, leak or broken arrangement, depending on the use or application, for example, to deliver the therapeutic agent, such as the burst open arrangement116c, as shown inFIG. 7E. The expandable member114can rupture by any suitable disrupting mechanism118, such as provided for and illustrated inFIGS. 2A-2E, such as the plurality of longitudinal breakage lines118a, the generally circumferential breakage line118b, the string disrupting mechanism118c, the needle disrupting mechanism118d, or the chemical disrupting mechanism118e, for example.

When the expandable member114has been ruptured, the therapeutic agent124that was formerly contained in the expandable member114is now released into the patient. As shown inFIG. 7E, the therapeutic agent124can be positioned in relation to the blood vessel puncture site712that was formed when the medical instrument122went through the surface708of the blood vessel706and into the interior710of the blood vessel706.

The therapeutic agent124, in the example illustrating the method700, can be any suitable agent that can promote blood clotting, such as the patient's own clotted blood, thrombin, fibrin, a liquid embolic material, a lipid based sealing material, or any other common clotting agent, for example. A sixth step700fof the method700can be to let the patient rest as the therapeutic agent124spreads and seals or substantially seals the blood vessel puncture site712and the skin puncture site714, such as shown inFIG. 7F.

Referring toFIGS. 8A-8G, an embodiment of a method800for sealing a puncture in a blood vessel806of a patient using the medical material delivery device600is shown, the blood vessel being an example of a procedure involving a bodily part. A first step800aof the method800as shown inFIG. 8Afor sealing a puncture in a blood vessel806involves the placement of the medical material delivery device600in conjunction with a medical instrument622. The medical instrument622, for example a guide wire as shown inFIGS. 8A-8E, has been placed inside the patient by a user.

The medical material delivery device600is placed in conjunction with the medical instrument622so that the first expandable member608associated with the outer shaft602and the second expandable member618associated with the inner shaft612are in communication with the blood vessel806. As shown inFIG. 8A, during a first step800aof the method800, the outer shaft602and the inner shaft612of the medical material delivery device600are placed through a surface802of the skin and skin layer804, through a surface808of the blood vessel806, and into an interior810of the blood vessel806.

During a second step800bof the method800shown inFIG. 8B, the user expands the second expandable member618associated with the inner shaft612into the expanded arrangement620bwhile the second expandable member618is positioned in the interior810of the blood vessel806and away from the surface808of the blood vessel806. The user expands the second expandable member618by placing a suitable material or fluid, such as a suitable liquid or gas, to expand the second expandable member618, as can include an aqueous solution, e.g. water, or a gas, e.g., air, for example, into the second delivery member616. The second expandable member618will then become inflated and be placed into the expanded arrangement620bas shown inFIGS. 8B-8D.

Further, during a third step800cin the method800, the user can position the expanded arrangement620bof the second expandable member618in communication with the interior810of the blood vessel806and the surface808of the blood vessel806. By placing the expanded arrangement620bof the second expandable member618in communication with both the interior810of the blood vessel806and the surface808of the blood vessel806, the second expandable member618can prevent further withdrawal of the medical material delivery device600and can also allow for localization of the puncture site, as shown inFIGS. 8B-8D.

When the expanded arrangement620bof the second expandable member618is positioned in communication with a side of the blood vessel puncture site812, the first expandable member608is then placed into the expanded arrangement610bduring a fourth step800dof the method800for sealing a puncture in a blood vessel as shown inFIG. 8D. The user expands the first expandable member608by placing a therapeutic agent624into the first delivery member606. The first delivery member606can carry and deposit the therapeutic agent624into the interior of the first expandable member608. The therapeutic agent624, in the example illustrating the method800, can be any suitable agent that would promote blood clotting, such as the patient's own clotted blood, thrombin, fibrin, a liquid embolic material, a lipid based sealing material, or any other common clotting agent, for example.

As shown inFIG. 8E, during a fifth step800eof the method800, the second expandable member618is deflated and is no longer in the expanded position620b. When the second expandable member618is in the deflated arrangement, the inner shaft612including the second expandable member618can be removed from the blood vessel806by the user, as shown inFIG. 8E. The user can remove the inner shaft612while the medical instrument622and the outer shaft602including the first expandable member608remain positioned in conjunction with the blood vessel806.

During a sixth step800fof the method800shown inFIG. 8F, the user can place the first expandable member608into the burst open arrangement610c. When the first expandable member608is in the burst open arrangement610c, the therapeutic agent624that was contained within the first expandable member608is delivered to the surface808of the blood vessel806. A seventh step800gof the method800as shown inFIG. 8Ghas the user remove the outer shaft602from the patient. The patient can rest as the therapeutic agent624spreads and seals or substantially seals a side of the blood vessel puncture site812and the skin puncture site814.

As provided in the methods700and800, the medical material delivery device100and the medical delivery device600, for example, can be used to seal a puncture in a blood vessel. Medical material delivery device100, and the remaining medical material delivery devices300,400,500and600, which can be used to seal a puncture in a blood vessel, can also be used for other medical procedures that involve the delivery of various therapeutic agents, to a bodily part, such various therapeutic agents as can include water, a saline solution or contrast agents, for example.

For example, medical material delivery devices100,300,400,500and600can be used for occlusion of fistulas, sealing bodily leaks, isolation of body compartments, occlusion of patent ductus arteriosis, occlusion of atrial septal defects, occlusion of ventricular septal defects, performing vertebroplasty, performing kyphoplasty, embolization, delivery of a radiotherapy agent, delivery of a chemotherapeutic agent, delivery of other therapeutic agents, delivery of a diagnostic agent, hernia repair, and aneurysm embolization, among other procedures, as can involve bodily parts, and should not be construed in a limiting sense.

Referring toFIGS. 9A-9B, an embodiment of a medical material delivery device900is shown. The medical material delivery device900includes a shaft902having a lumen905with a catheter904positioned within the lumen905of the shaft902. The catheter904includes an expandable member908, similar to expandable members114,314,414,514,608, and618of the medical material delivery devices100,300,400,500and600, and the expandable member908can be of various shapes and sizes, such as a sphere, sphere like, teardrop like or ring like shape, for example.

The expandable member908can be made of similar suitable materials, such as an elastic medical grade material, a plastic material or a textile material, or can be made from other suitable material, for example, that can be deflated, inflated/expanded and, when appropriate, disrupted, such as by being burst, such as depending upon the use or application, for example. The expandable member908can be filled with a therapeutic agent, such as therapeutic agent124. The expandable member908can be filled with the therapeutic agent by a delivery member906that is in communication with the expandable member908. Further, the expandable member can be placed into various arrangements, such as an unexpanded arrangement910a, an expanded arrangement910b, and a burst open arrangement910c, for example.

The expandable member908can be placed into the at least one of a burst, leak or broken arrangement, depending on the use or application, for example, such as the burst open arrangement910c, by being disrupted by a disrupting mechanism in which the therapeutic agent positioned within the expandable member908can be deposited near an appropriate bodily part, such as a blood vessel puncture site, for example.

The expandable member908can be disrupted by any of various embodiments of disrupting mechanisms, such as by the various disrupting mechanisms118a-118eprovided for and illustrated inFIGS. 2A-2E, as can depend on the particular needs or application. For example, the plurality of longitudinal breakage lines118a, the generally circumferential breakage line118b, the string disrupting mechanism118c, the needle disrupting mechanism118d, and the chemical disrupting mechanism118ecan all be used as a disrupting mechanism.

Referring toFIGS. 10A, 10B, and 10C, a method of sealing a fistula1000is shown using medical material delivery device900. A first step1000aof the method1000, shown inFIG. 10A, includes the medical material delivery device900being placed in with an exterior surface1008of a blood vessel1006so that the medical material delivery device900is in communication with a fistula1010of the blood vessel1006.

During the first step1000aof the method1000the expandable member908of the medical material delivery device900remains in the unexpanded arrangement910aduring the first step1000a. A second step1000bof the method1000involves the placement of the expandable member908from the unexpanded arrangement910ainto the expanded arrangement910b, as shown inFIG. 10B. As mentioned previously, the expandable member908can be placed into the expanded arrangement910bby filling the expandable member908with a therapeutic agent124through the delivery member906of the catheter904.

A third step1000cof the method1000involves the expandable member908of the medical material delivery device900being placed from the expanded arrangement910binto the burst open arrangement910c, as shown inFIG. 10C. By placing the expandable member908into the burst open arrangement910c, the therapeutic agent contained within the expandable member908, such as the therapeutic agent124, can treat the fistula1010of the blood vessel1006.

Referring toFIGS. 11A, 11B, and 11C, a method of embolizing an aneurysm1100using the medical material delivery device900is shown. A first step1100aof the method1100is placing the medical material delivery device900in conjunction with an aneurysm1110of the blood vessel1106. As shown inFIG. 11A, the expandable member908of the medical material delivery device900remains in the unexpanded arrangement910aduring the first step1100a.

A second step1100bof the method1100involves the placement of the expandable member908from the unexpanded arrangement910ainto the expanded arrangement910b, as shown inFIG. 11B. A third step1100cof the method1100involves the expandable member908of the medical material delivery device900being placed from the expanded arrangement910binto the burst open arrangement910c, as shown inFIG. 11C. By placing the expandable member908into the burst open arrangement910c, the therapeutic agent contained within the expandable member908, such as the therapeutic agent124, can embolize the aneurysm1110of the blood vessel1106.

Referring toFIGS. 12A, 12B, and 12C, a method of repairing a hernia1200using the medical material delivery device900is shown. A first step1200aof the method1200is placing the medical material delivery device900in conjunction with a hernia1210of a tissue1206. As shown inFIG. 12A, the expandable member908of the medical material delivery device900remains in the unexpanded arrangement910aduring the first step1200a.

A second step1200bof the method1200involves the placement of the expandable member908from the unexpanded arrangement910ainto the expanded arrangement910b, as shown inFIG. 12B. A third step1200cof the method1200involves the expandable member908of the medical material delivery device900being placed from the expanded arrangement910binto the burst open arrangement910c, as shown inFIG. 12C. By placing the expandable member908into the burst open arrangement910c, the therapeutic agent contained within the expandable member908, such as the therapeutic agent124, can repair the hernia1210of the tissue1206.

Referring toFIGS. 13A, 13B, and 13C, a method of performing a vertebroplasty or a kyphoplasty1300using the medical material delivery device900is shown. A first step1300aof the method1300is placing the medical material delivery device900in conjunction with a vertebral body1310. As shown inFIG. 13A, the expandable member908of the medical material delivery device900remains in the unexpanded arrangement910aduring the first step1300a. A second step1300bof the method1300involves the placement of the expandable member908from the unexpanded arrangement910ainto the expanded arrangement910b, as shown inFIG. 13B.

A third step1300cof the method1300involves the expandable member908of the medical material delivery device900being placed from the expanded arrangement910binto the burst open arrangement910c, as shown inFIG. 13C. By placing the expandable member908into the burst open arrangement910c, the therapeutic agent contained within the expandable member908, such as the therapeutic agent124, can repair the vertebral body1310. The therapeutic agent124can be a number of therapeutic agents commonly used in vertebroplasty or kyphoplasty procedures, such as bone cement.

Referring toFIGS. 14A, 14B, and 14C, a method of treating a patent ductus arteriosus1400using the medical material delivery device900is shown. A first step1400aof the method1400is placing the medical material delivery device900in conjunction with a patent ductus arteriosus1410by placing the medical material delivery device in an aorta1406to be in communication with a pulmonary artery1408through the patent ductus arteriosus1410. As shown inFIG. 14A, the expandable member908of the medical material delivery device900remains in the unexpanded arrangement910aduring the first step1400a.

A second step1400bof the method1400involves the placement of the expandable member908from the unexpanded arrangement910ainto the expanded arrangement910b, as shown inFIG. 14B. A third step1400cof the method1400involves the expandable member908of the medical material delivery device900being placed from the expanded arrangement910binto the burst open arrangement910c, as shown inFIG. 14C. By placing the expandable member908into the burst open arrangement910c, the therapeutic agent contained within the expandable member908, such as the therapeutic agent124, can repair the patent ductus arteriosus1410.

Referring toFIGS. 15A and 15B, an embodiment of a medical material delivery device1500is shown. The medical material delivery device1500includes a catheter1502having a lumen1504. The catheter1502includes an expandable member1506, similar to expandable members114,314,414,514,608, and618of the medical material delivery devices100,300,400,500and600, respectively and can be made of similar suitable materials, as described, for example.

The expandable member1506can be placed into various arrangements, such as an unexpanded arrangement1508a, as shown inFIG. 15A, or an expanded arrangement1508b, as shown inFIG. 15Band be of various suitable shapes and sizes, such as a sphere, sphere like, teardrop like or ring like shape, for example. The expandable member1506can be made of similar suitable materials, such as an elastic medical grade material, a plastic material or a textile material, for example, that can be deflated, inflated/expanded and, when appropriate, disrupted, such as by being burst, that can allow for the expansion of the expandable member1506, or can be made from other suitable material, such as depending upon the use or application, for example.

The expandable member1506can be placed into the unexpanded arrangement1508aand expanded arrangement1508bby having a therapeutic agent, such as therapeutic agent124, placed within the expandable member1506. The therapeutic agent, such as therapeutic agent124, can be placed within the expandable member1506through the lumen1504of the catheter1502. Further, the expandable member1506can be placed into at least one of a burst, leak or broken arrangement, depending on the use or application, for example, by being disrupted by a disrupting mechanism in which the therapeutic agent positioned within the expandable member can be deposited near an appropriate bodily part, such as a blood vessel puncture site, for example.

The expandable member1506can be disrupted by any of various embodiments of disrupting mechanisms, such as by the various disrupting mechanisms118a-118eprovided for and illustrated inFIGS. 2A-2E, as can depend on the particular needs or application. For example, the plurality of longitudinal breakage lines118a, the generally circumferential breakage line118b, the string disrupting mechanism118c, the needle disrupting mechanism118d, and the chemical disrupting mechanism118ecan all be used as a disrupting mechanism, for example, and should not be construed in a limiting sense.

The medical material delivery device1500further includes a bodily fluid locator1510, as shown inFIGS. 15A and 15B. The bodily fluid locator1510is similar to the bodily fluid locator523of the medical material delivery device500, and can allow for the user to be notified that the medical material delivery device1500is placed in a relative position with respect to a blood vessel or other bodily part. For example, if the medical material delivery device1500is placed near a blood vessel puncture site, bodily fluid such as blood can flow into the bodily fluid locator and can notify the user that the medical material delivery device1500is at an appropriate location relative to the blood vessel. The catheter1502and the bodily fluid locator1510can be placed in conjunction with one another and secured together through various mechanisms, such as a bracket1512, as shown inFIGS. 15A and 15B.

Referring toFIGS. 16A and 16B, a medical material delivery device1600is shown. The medical material delivery device1600includes a catheter1602having a lumen1604. Positioned in conjunction with the catheter1602is an expandable member1606, as shown inFIGS. 16A and 16B. The expandable member1606is similar to expandable members114,314,414,514,608,618, and1506and can be of various suitable shapes and sizes, such as a sphere, sphere like, teardrop like or ring like shape, for example.

Also the expandable member1606can be made of similar suitable materials, such as an elastic medical grade material, a plastic material or a textile material, for example, that can be deflated, inflated/expanded and, when appropriate, disrupted, such as by being burst, that can allow for the expansion of the expandable member1606, or can be made from other suitable material, such as depending upon the use or application, for example. The expandable member1606can be placed into various arrangements, such as an unexpanded arrangement1608a, as shown inFIG. 16A, and an expanded arrangement1608b, as shown inFIG. 16B.

The expandable member1606can be placed into the unexpanded arrangement1608aand the expanded arrangement1608bby having a therapeutic agent, such as therapeutic agent124, placed within the expandable member1606. The therapeutic agent, such as therapeutic agent124, can be placed within the expandable member1606through the lumen1604of the catheter1602. Further, the expandable member1606can be placed into at least one of a burst, leak or broken arrangement, depending on the use or application, for example, by being disrupted by a disrupting mechanism in which the therapeutic agent positioned within the expandable member can be deposited near an appropriate bodily part, such as a blood vessel puncture site, for example.

The expandable member1606can be disrupted by any of various embodiments of disrupting mechanisms, such as by the various disrupting mechanisms118a-118eprovided for and illustrated inFIGS. 2A-2E, as can depend on the particular needs or application. For example, the plurality of longitudinal breakage lines118a, the generally circumferential breakage line118b, the string disrupting mechanism118c, the needle disrupting mechanism118d, and the chemical disrupting mechanism118ecan all be used as a disrupting mechanism, for example, and should not be construed in a limiting sense.