|Numéro de publication||US20050228309 A1|
|Type de publication||Demande|
|Numéro de demande||US 10/711,330|
|Date de publication||13 oct. 2005|
|Date de dépôt||10 sept. 2004|
|Date de priorité||31 déc. 2002|
|Autre référence de publication||CA2507950A1, CA2507950C, CA2797654A1, EP1578280A2, EP1578280A4, EP1578280B1, US6790185, WO2004060200A2, WO2004060200A3|
|Numéro de publication||10711330, 711330, US 2005/0228309 A1, US 2005/228309 A1, US 20050228309 A1, US 20050228309A1, US 2005228309 A1, US 2005228309A1, US-A1-20050228309, US-A1-2005228309, US2005/0228309A1, US2005/228309A1, US20050228309 A1, US20050228309A1, US2005228309 A1, US2005228309A1|
|Inventeurs||John Fisher, Frederick Ahari|
|Cessionnaire d'origine||Fisher John S, Frederick Ahari|
|Exporter la citation||BiBTeX, EndNote, RefMan|
|Citations de brevets (9), Référencé par (9), Classifications (11), Événements juridiques (1)|
|Liens externes: USPTO, Cession USPTO, Espacenet|
This application is a continuation of U.S. patent application Ser. No. 10/248,261 filed on Dec. 31, 2002, entitled “Sealant Plug Delivery Methods.”
1. Field of the Invention
This invention relates, generally, to methods for sealing biopsy tracts. More particularly, it relates to apparatus and methods that enable precise positioning of a bioabsorbable sealant plug in a predetermined optimal location.
2. Description of the Prior Art
Air leaks commonly occur at pulmonary tissue sites that have been dissected during surgical resection and manipulation or surgical resection or manipulation. Air leaks also occur after fine needle aspiration biopsy of the lung. Pneumothorax (air leakage) occurs in about thirty percent (30%) of lung biopsies. An opening in a lung is undesirable because air leaks therefrom and causes the lung to collapse. Openings in other organs, such as the heart, liver, kidney and the lime are also undesirable due to excess bleeding and other related problems.
Pending patent application Ser. No. 10/063,620, filed May 6, 2002 by the present inventors discloses a novel hydrogel polymeric base material formed into the shape of a plug to seal a biopsy tract to prevent pneumothorax in the lungs and bleeding in other internal organs. That pending patent application is incorporated by reference into this disclosure.
There remains a need, however, for apparatus and methods for accurately delivering the sealant plug under CT imaging and other imaging modalities and deploying it with a high degree of precision to achieve optimal efficacy.
The sealant plug must be placed beyond the pleura of the lung to prevent pneumothorax. Accurate placement is required for any depth and position of the biopsy or tissue tract. Such accurate placement must also be made for other internal organs such as the liver, kidney, the heart, i.e., the sealant plug must be positioned at or beyond the surface of such organs to prevent or eliminate bleeding.
There is also a need for a sealant plug having a faster rate of hydration than the plugs heretofore known. One of the most important parameters of a sealant plug is the expansion rate and its ability to seal a tract in a short period of time.
A sealant plug is needed that provides a faster expansion rate than the sealant plugs heretofore known so that it will seal a tract faster, thereby reducing pneumothorax in a lung and bleeding in other internal organs.
However, in view of the prior art considered as a whole at the time the present invention was made, it was not obvious to those of ordinary skill in the pertinent art how such apparatus and methods and improved sealant plugs could be provided.
The long-standing but heretofore unfulfilled need for a delivery system for accurately placing a bioabsorbable sealant plug in an optimal location in a biopsy tract is now met by a new, useful, and nonobvious invention. The novel method includes the steps of performing a biopsy procedure with a biopsy needle and a coaxial needle having a movably mounted marker thereon. When the biopsy procedure is finished, the biopsy needle is removed from a biopsy tract formed by the procedure. The coaxial needle is left in the biopsy tract in the same position it was in during the biopsy procedure.
A distance “a” is measured by an imaging means from a point of entry by the biopsy needle at a skin surface to the surface of the internal organ upon which the biopsy procedure was performed.
A distance “b” is measured by the imaging means from the surface of the internal organ at the point of entry to a lesion within the internal organ.
Where a sealant plug of cylindrical configuration having a preferred length of about two and one-half centimeters (2.5 cm) is used, a distance “d” is calculated by adding two centimeters (2.0 cm) to distance “a.” If a plug having a length of 1.5 cm is used, distance “d” is calculated by adding 1.0 cm to distance “a.” If a plug having a length of 3.0 cm is used, distance “d” is calculated by adding 2.5 cm to distance “a.” The distance added to distance “a” must position the leading end of the plug at a depth in the biopsy tract such that about one-half centimeter (0.5 cm) of the trailing end of the plug protrudes out of the biopsy tract, beyond the surface of the lung or other internal organ, for a plug of any length. Thus, half a centimeter is subtracted from the length of the sealant plug, and that length is added to distance “a” to arrive at distance “d.”
After the biopsy procedure has been completed and the biopsy needle has been removed from the lumen of the coaxial needle and distance “d” has been calculated, the coaxial needle is advanced or retracted as needed so that its distal end is distance “d” from the surface of the patient's skin. Centimeter markings or graduations are imprinted, notched, or otherwise marked on the coaxial needle, beginning from its distal end.
More particularly, suppose a plug of length 2.0 cm is used and distance “d” is therefore calculated by adding 1.5 cm to distance “a” so that the trailing end of the plug will protrude from the biopsy tract by 0.5 cm when the plug is properly positioned. If distance “a” is 3.0 cm, then distance “d” is equal to 4.5 cm. If the distal end of the coaxial needle is less than 4.5 cm from the surface of the patient's skin at the conclusion of the biopsy procedure, the marker on the coaxial needle is moved to the 4.5 cm position and the coaxial needle is advanced until the marker abuts the patient's skin. If the coaxial needle is more than 4.5 cm beneath the patient's skin at the conclusion of the biopsy procedure, the marker is moved back if needed and the coaxial needle is withdrawn until the 4.5 cm marker thereon is flush with the patient's skin and the movable marker is then brought into contact with the patient's skin.
A supporting leg and a plunger are then connected to one another and their respective positions relative to one another are adjusted in accordance with a chart containing predetermined settings including a plunger-to-supporting leg ratio with respect to measurement of said distance “a.” Graduation markers on the plunger are provided to facilitate the interconnection. The plunger is then locked into position relative to the supporting leg, thereby forming a plunger/supporting leg assembly.
The sealant plug is then introduced into the coaxial needle at the trailing end thereof. The assembly is then brought into ensleeving relation with the coaxial needle. Specifically, the leading end of the supporting leg is positioned in abutting relation to the patient's skin. The leading end of the plunger enters into the trailing end of the lumen of the coaxial needle, pushing the sealant plug ahead of it in a trailing-to-leading direction. When the leading end of the supporting leg abuts the patient's skin, the sealant plug is still housed within the lumen of the coaxial needle, but it is positioned at the desired position. Specifically, the leading end of the sealant plug is flush with the leading end of the coaxial needle.
The coaxial needle is then removed from the biopsy tract while maintaining the supporting leg and the plunger in their respective positions, thereby deploying the sealant plug into the biopsy tract. The trailing 0.5 cm of the sealant plug protrudes from the biopsy tract, above the surface of the internal organ having the lesion that was the subject of the biopsy. The supporting leg and the plunger are then withdrawn, leaving the sealant plug in said internal organ at said preselected optimal position.
In a second embodiment, the method for delivering a sealant plug to an optimal position within an internal organ with a high degree of accuracy includes the steps of providing a supporting leg in the form of a pistol grip body that includes a pivotally-mounted trigger. A plunger is mounted to the supporting leg such that the plunger may be advanced or withdrawn when the trigger is pulled. A marker is slideably mounted on the plunger and graduation marks are provided along the extent of said plunger. Graduation marks are also are imprinted or otherwise provided along the extent of the supporting leg.
As in the first embodiment, distance “a” is determined and a distance “d” is calculated by adding to distance “a” a distance, in centimeters, that is 0.5 cm less than the length of the sealant plug in centimeters. A marker is used as in the first embodiment to denote the desired depth and the distal end of the coaxial needle is positioned at said depth.
With the trigger pulled to allow movement of the plunger, the plunger and the supporting leg are positioned relative to one another as determined by a setting provided by a chart as in the first embodiment, and locked together to form an assembly by releasing the trigger. The positioning is performed by aligning a graduation mark on the plunger with a graduation mark on the supporting leg in accordance with said chart.
A sealant plug is then introduced, using a suitable holding tool, into the lumen of the coaxial needle at the trailing end thereof and the plug is pushed in a trailing-to-leading direction with a leading end of the plunger until the leading end of the supporting leg abuts the patient's skin as in the first embodiment. The sealant plug is then positioned within the coaxial needle such that the leading end of the sealant plug is flush with the leading end of the coaxial needle. The coaxial needle is then withdrawn from the internal organ and from the patient's body while maintaining the position of the plunger. The plunger/supporting leg assembly is then removed and optimal positioning of the sealant plug is thereby obtained.
A third method for delivering a sealant plug to an optimal position within an internal organ with a high degree of accuracy includes the steps of providing a plunger in the form of a tube having a slot formed in its distal end so that the distal end is bifurcated into two arm members. An inside diameter of the tube is configured so that the inside diameter is smaller than an outside diameter of the sealant plug. The plunger is formed of a flexible and resilient material with memory so that the arms may be spread apart from one another. The arms are spread apart from one another and a trailing end of the sealant plug is positioned between the open arms. The tube is ensleeved in a sleeve member and the sleeve member is advanced in a trailing-to-leading direction, thereby causing the arms to close with respect to one another. Thus, the arms clamp down on the sealant plug. The sealant plug is positioned at a predetermined optimal position by following the steps of the first two embodiments and the sleeve member is retracted so that the arms spread apart from one another under their inherent bias, thereby releasing the sealant plug at the optimal position. The plunger and sleeve member are then withdrawn, leaving the sealant plug in the optimal position.
A fourth method for delivering a sealant plug to an optimal position within an internal organ with a high degree of accuracy includes the step of providing a cylindrical housing having screw threads formed on an external surface thereof and having a longitudinally-extending throughbore formed therein. A screw-threaded turning nut screw-threadedly engages the screw threads formed in the external surface of the cylindrical housing. The turning nut has a central hub that includes a leading end that extends into a trailing end of the bore formed in the cylindrical housing. A centrally apertured flat washer is positioned in leading relation to the leading end so that the flat washer is constrained to displace in a trailing-to-leading direction when the turning nut is advanced. A flexible and resilient gasket of frusto-conical configuration and having a central throughbore formed therein is positioned in leading relation to the flat washer so that the flexible and resilient gasket is also constrained to displace in a trailing-to-leading direction when the turning nut is advanced. A diameter-reducing taper is formed in the longitudinally-extending throughbore so that the throughbore has a reduced diameter leading end. The turning nut is advanced so that the leading end thereof bears against the flat washer and the flat washer bears against the trailing end of the flexible and resilient gasket, thereby driving the gasket into the reduced diameter leading end of the throughbore. The diameter-reducing taper serves to gradually compress the flexible and resilient gasket into the reduced diameter leading section as the turning nut is advanced. The trailing end of the sealant plug is positioned within the central aperture of the flat washer and the central throughbore of the flexible and resilient gasket so that the trailing end of the sealant plug is compressed as the flexible and resilient gasket is driven into the reduced diameter bore, thereby locking down on that part of the sealant plug disposed within the flat washer central aperture and central bore of said flexible and resilient gasket.
A fifth method for delivering a sealant plug to an optimal position within an internal organ with a high degree of accuracy includes the step of positioning a coaxial needle at a predetermined depth by employing an imaging means to determine a distance between a patient's skin surface and the surface of an internal organ just as in the earlier embodiments.
A positioning adaptor is provided and a supporting rod and a coaxial needle are interconnected to one another with the positioning adaptor to guide the supporting rod with respect to the coaxial needle. A supporting adaptor is provided for interconnecting the supporting rod and a plunger to one another. The supporting adapter is locked to the supporting rod. The relative positioning of the supporting rod and the plunger are adjusted based upon a chart as in the earlier embodiments, and the supporting rod and plunger are locked into position. A sealant plug is introduced into the lumen of the coaxial needle, at the trailing end thereof as in the other embodiments, and the plunger is advanced in a trailing-to-leading direction through said lumen, pushing the sealant plug in front of it until the leading end of the supporting rod abuts the patient's skin, thereby stopping the trailing-to-leading travel of the plunger as in the earlier embodiments. The supporting rod has a flat, atraumatic distal end that rests against the surface of the skin without imparting trauma thereto. As in the earlier embodiments, the leading end of the sealant plug is flush with the leading end of the coaxial needle when the leading end of the supporting rod abuts the patient's skin. The supporting rod and plunger are held in place while the coaxial needle is withdrawn from the biopsy tract. The plunger/supporting rod assembly is then withdrawn, leaving the sealant plug optimally positioned in the biopsy tract. i.e., with its trailing end protruding from the outer surface of the internal organ by a distance of about 0.5 cm.
Different dehydration techniques and different shapes and sizes have some effect on the expansion rate of a sealant plug. Another method of changing the expansion rate of the materials disclosed in the incorporated patent application is to induce stress in the polymer. A smaller in size stress induced sealant plug could be used in applications where more dwell time is needed during delivery and where a faster expansion rate is required after deployment. Stress may be introduced in three different forms:
A method of pre-stressing a dehydrated sealant plug so that it hydrates at a faster rate than a dehydrated sealant plug that has not been pre-stressed includes the steps of grasping a first end of the sealant plug with a first holder, grasping a second end of the sealant plug with a second holder, and separating the holders from one another to apply tension to the sealant plug.
The amount of stress is correlated with the expansion rate of the sealant plug. The stress can be induced gradually by pulling, pushing, compressing, rotating or otherwise momentarily deforming the sealant plug during the dehydration process. This is most efficiently achieved by special fixturing and machinery.
The stress may also be induced by the same techniques after the dehydration process is completed. Stress can be induced from one percent (1%) to ninety-nine percent (99%), but the working range is between twenty-five percent (25%) to seventy-five percent (75%). One of the methods is to stretch the dehydrated sealant plug by pulling it using special fixtures. Other methods include compression force and torque applied to the sealant plug. Expansion rates of two to five times faster than unstressed sealant plugs may be achieved by this method. Optimum results have been achieved by providing two (2) to three (3) times the expansion rate due to fifty percent (50%) induced stress.
A delivery system that can stretch a sealant plug before or during delivery may also induce expansion rate-enhancing stress.
An important object of this invention is to provide an apparatus for delivering and deploying a bioabsorbable sealant to a predetermined optimal location in a biopsy tract with a high degree of accuracy.
Another major object is to teach the art an ideal sealant plug deployment.
Another object is to achieve optimal efficacy by providing a sealant plug having a rate of hydration that is faster than the sealant plugs of the prior art while providing a smaller implant.
These and other important objects, advantages, and features of the invention will become clear as this description proceeds.
The invention accordingly comprises the features of construction, combination of elements, and arrangement of parts that will be exemplified in the description set forth hereinafter and the scope of the invention will be indicated in the claims.
For a fuller understanding of the nature and objects of the invention, reference should be made to the following detailed description, taken in connection with the accompanying drawings, in which:
Referring now to
Fine needle aspiration (FNA) biopsy needle 12 is slideably received in coaxial needle 14 in a well-known way. A syringe attached to FNA biopsy needle 12 is not shown to simplify the drawing. FNA biopsy needle 12 is used to collect a sample of cellular material from lesion 16 from lung 18 in this illustrative embodiment. The outer surface of lung 18, known as the pleura layer, is denoted 20.
A physician, employing CT scan or other suitable measurement techniques, introduces coaxial needle 14 through the patient's skin 22, between the ribs, and into the chest cavity. Such procedure punctures lungs 18. Coaxial needle 14 is then advanced further until its leading end is positioned near lesion 16. FNA biopsy needle 12 is introduced into the lumen of coaxial needle 14 and cellular material is obtained from lesion 16. FNA biopsy needle 12 is then withdrawn from the lumen of the coaxial needle and the cellular material is delivered to a lab for analysis. Biopsy needle 12 is not used again in the procedure because the biopsy procedure has been concluded and the only task left is to seal the biopsy tract with the novel sealant plug by delivering said novel sealant plug to a precise location within the biopsy tract. Specifically, the trailing end of the sealant plug should be positioned in a range of positions between two limits where the first limit is substantially flush with the surface of the internal organ and the second limit is a distance of about 0.5 centimeters above the surface of the internal organ.
Distances “a” and “b” are calculated using CT imaging software. The distances are measured normally, i.e., coaxial needle 14 is positioned in normal relation to skin 22 as indicated by directional arrow 26 in
Accordingly, for any lesion location and any needle point of entry, one-size sealant plug 30 fulfills all sealant requirements. In a preferred embodiment, the length of sealant plug 30 is two and one-half centimeters (2.5 cm).
Each plug 30 must be positioned within a biopsy tract with its proximal (trailing) end substantially flush with the pleura layer or extending outwardly from said pleura layer by a distance of about one-half centimeter (0.5 cm), or any point therebetween. This is an important feature of this invention. Where sealant plug 30 is used to seal a biopsy tract in an internal organ other a lung, the positioning is the same, i.e., the trailing end of sealant plug 30 is either flush with the surface of the internal organ or extends outwardly therefrom by a distance of 0.5 cm or less.
The novel delivery system to be disclosed hereinafter delivers the plug to its optimal position with a high level of accuracy under normal breathing conditions. The step-by-step procedure for delivery and deployment of plug 30 is as follows.
In step one (1), depicted in
In step two (2), a predetermined distance is added to distance “a” to produce a distance “d” and coaxial needle 14 is either advanced in the direction of directional arrow 32 or retracted in the direction of arrow 34 so that its distal end is distance “d” from the surface of the patient's skin. Holder 28 is positioned on a graduation mark on the coaxial needle that represents said distance “d” and holder 28 is placed into abutting relation to the patient's skin, thereby positioning the distal end of the coaxial needle at the desired depth as depicted in
The predetermined distance is 0.5 cm less than the length of the sealant plug, in centimeters. Thus, where a sealant plug is 2.5 cm in length and where distance “a” is 2.0 cm, holder 28 is slid along the length of coaxial needle 14 until said holder is positioned at the 4.0 cm graduation markers as depicted in
The next step, as best understood in connection with
Graduation markings in centimeters are provided along the extent of supporting leg 36 and plunger 38.
In the next step, plunger 38 is locked into position relative to supporting leg 36 by advancing locking screw 40 in a well-known way. When locked to one another, supporting leg 36 and plunger 38 form an assembly that moves as a single unit.
As indicated in
In the next step, depicted in
Plunger 38 and sealant plug 30 are advanced within said lumen of coaxial needle 14 until supporting leg 36 abuts the patient's skin and is stopped thereby.
Plunger 38 and sealant plug 30 travel together as a unit as aforesaid, so plunger 38 stops traveling in said trailing-to-leading direction when supporting leg 36 abuts the patient's tissue. At that time, sealant plug 30 is positioned at the distal end of the plunger but is still housed within coaxial needle 14 as depicted in
Coaxial needle 14 is then removed from the biopsy tract (i.e., it is withdrawn from the body of the patient). Supporting leg 36 and plunger 38 are maintained in their
In the final step, supporting leg 36 and plunger 38 are withdrawn, leaving sealant plug 30 in lung 46 at the desired position as depicted in
Graduation markers 52 are imprinted, notched, or otherwise affixed to supporting leg 36 as depicted. Holder 28 is mounted upon plunger 38. The chart referred to in the disclosure of the first embodiment is consulted and plunger 38 and supporting leg 36 are positioned relative to one another in accordance with the CT scan measurement-based chart of
For example, suppose a particular CT scan measurement is made and the distance from the surface of the patient's skin to the internal organ (distance “a”) is determined to be 3.0 cm. That measurement is looked up in the chart of
Just as in the first embodiment, sealant plug 30 is introduced into the lumen of coaxial needle 14 at the trailing end thereof with a suitable holding tool, and the leading end of plunger 38 is used to push sealant plug 30 toward the distal end of coaxial needle 14. When the leading end of supporting leg 36 abuts the patient's skin, the leading end of sealant plug 30 is flush with said distal end of coaxial needle 14 as depicted in
Plunger 38 does not fully occupy the lumen of coaxial needle 14 because the outer diameter of the plunger is less than the diameter of the lumen. Accordingly, a saline solution or other suitable substance, which may take the form of a liquid fluid, a powder, or other substance, may be introduced into the coaxial needle lumen, from the trailing end thereof, so that it flows around plunger 38 and reaches sealant plug 30. Such substance is selected to begin or accelerate hydration of sealant plug 30. Thus, expansion of sealant plug 30 does not rely entirely on the presence of bodily fluid in the patient. Moreover, the trailing end of sealant plug is most affected by said substance, as is desired because it is the trailing end that extends beyond the surface of the internal organ within which the biopsy procedure was performed. Such prehydration may be desireable when sealing a lung biopsy tract.
Contrast agents may be added as well to the saline solution or other expansion stimulant to improve visibility of the sealant plug installation under CT scan.
Those skilled in the art of machine design, having seen the first two embodiments of this invention, will now be aware of numerous other ways to accomplish the precise positioning of sealant plug 30 as disclosed herein. All obvious variation of the disclosed embodiments are within the scope of this invention.
In a third embodiment, plunger 38 a (
When the distal end of plunger 38 a is opened as at 56 by spreading said ends apart, the trailing or proximal end of bioabsorbable sealant plug 30 is then positioned between said open ends as indicated by assembly arrow 58 in
As depicted in
When sleeve 60 is retracted as depicted in
A fourth embodiment is disclosed in
Longitudinally-extending throughbore 72 is formed in housing 70 and extends therethrough from the trailing to the leading end thereof. The trailing end of bore 72 accommodates leading end 66 of turning nut 64. Flat washer 74 is positioned in leading relation to leading end 66 and said flat washer is therefore constrained to displace in a trailing-to-leading direction, indicated by said directional arrow 68, when turning nut 64 is advanced.
Silicon gasket 76 of frusto-conical configuration is positioned in leading relation to flat washer 74 and is also constrained to advance in the direction indicated by arrow 68 when turning nut 64 is advanced.
Throughbore 72 has a diameter-reducing taper 72 a formed therein and a reduced diameter leading end 72 b. As turning nut 64 is advanced, leading end 66 thereof bears against flat washer 74 and said flat washer 64 bears against the trailing end of silicon gasket 76, driving it into reduced diameter leading section 72 b of throughbore 72. Diameter-reducing taper 72 a serves to gradually compress silicon gasket 76 into said leading section 72 b as said turning nut 64 is advanced.
Flat washer 74 and silicon gasket 76 are centrally apertured and receive the trailing end of plug 30 therewithin. Accordingly, said trailing end of plug 30 is compressed as silicon gasket 76 is driven into reduced diameter bore 72 b, thereby locking down on that part of plug 30 disposed within the central aperture or bore of silicon gasket 76.
After plug 30 has been stretched in the manner indicated in
A fifth embodiment is denoted 80 as a whole in
The distance between skin 22 and lung 20 is determined by CT scanner or other suitable means. Based upon that measured distance, the relative positioning of supporting rod 36 a and plunger 38 are adjusted and locked accordingly as in the earlier-described embodiments. Plunger 38 and supporting rod 36 a are then inserted through coaxial needle 14 and positioning adapter 82.
Supporting rod 36 a has a flat, atraumatic distal end 37 that rests against skin 22. Plunger 38 is positioned in trailing relation to sealant plug 30 when supporting rod 36 a comes to rest against skin 22, and the leading end of sealant plug 30 is flush with the distal end of coaxial needle 14 as in the earlier embodiments.
Supporting rod 36 a is held in place while coaxial needle 14 is withdrawn from the biopsy tract. Supporting rod 36 a and plunger 38 are then removed, leaving sealant plug 30 optimally positioned in the biopsy tract with its trailing end extending from the internal organ by a distance between 0.0 to 0.5 cm.
In all of the embodiments disclosed herein, the sealant plug is understood to expand both radially and longitudinally upon coming into contact with blood or other bodily fluids or upon contact with a saline solution or other expansion-enhancing substance. However, in some applications a longitudinal expansion may be undesireable. For example, foreshortening in arterial stents such as a Wall® stent causes misplacement of the stent at the right target location. Longitudinal expansion of a sealant plug can cause the plug to move away from the target. By inducing a certain amount of stress, a dehydrated sealant plug could be increased in length prior to hydration so that subsequent hydration of the plug causes radial expansion only. This is achieved by balancing the residual stress induced in the plug to achieve a very small longitudinal expansion. With increasingly refined techniques, the expansion approaches a zero percent (0%) length expansion.
The ability to cause a rapid rate of hydration due to different levels of residual stress induced in a dehydrated plug can be harnessed to control drug release rates when different drugs are diluted with polymers. The polymers may be soluble or insoluble, biodegradable or nonbiodegradable, and natural or synthetic. Polymers may be therapeutic themseleves or they may be used to deliver therapeutic agents. Polymers may be provided to minimize inflammation or to promote inflammation as may be desired for a particular procedure. They may be chosen to suppress secondary bleeding and late fibrotic scarring. Polymers may also be selected to promote angiogenic and fibrogenic responses, and so on.
Different hydrogel-base polymers may also be used for such applications as well, including hydrogels, thermoplastics, homopolymers, copolymers or blends, natural or synthetic. A hydrogel is an aqueous phase having an interlaced polymeric component, prepferably ninety percent (90%) water by weight. A hydrogel may also be defined as a colloid in which the dispserse phase (colloid) has combned with the continuous phase (water) to produce a viscuous, jelly-like product. Poly(oxyalkene) polymers and copolymers such as poly(ethylene oxide)-poly(propylene oxide) copolymers, and copolymers and blends of these polymers with polymers such as poly(alpha-hydroxy acids), including but not limited to lactic, glycolic and hydroxybutyric acids, polycaprolactones, and polyvalerolactones, can be synthesized or commercially obtained.
Polymers may be themselves bioactive or contain embedded or grafted bioactive molecules, peptides, lipids, drugs, or other moities. Such polymers may suppress, maintain or stimulate a biological response.
By controlling the rate of expansion, the rate of drug delivery is also controlled. Faster hydration rates, for example, provide faster dilution of drugs.
It will thus be seen that the objects set forth above, and those made apparent from the foregoing description, are efficiently attained. Since certain changes may be made in the above construction without departing from the scope of the invention, it is intended that all matters contained in the foregoing description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.
It is also to be understood that the following claims are intended to cover all of the generic and specific features of the invention herein described, and all statements of the scope of the invention that, as a matter of language, might be said to fall therebetween.
Now that the invention has been described,
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|Classification aux États-Unis||600/562, 604/131|
|Classification internationale||A61B10/02, A61B10/00, A61B19/00, A61B17/00|
|Classification coopérative||A61B2017/00004, A61B10/0233, A61B2019/462, A61B17/00491|
|12 juin 2007||AS||Assignment|
Owner name: MEDICAL DEVICE TECHNOLOGIES, INC., FLORIDA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:BIOPSY SCIENCES, LLC;REEL/FRAME:019416/0555
Effective date: 20070122