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US5413571A Expired / Lapsed US ⏱️ 0.0 years remaining

Device for sealing hemostatic incisions

Assignee: SHERWOOD MEDICAL SA
•
Filing: 1992-07-16
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Granted: 1995-05-09
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Expires: 2012-07-16
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Abstract

Abstract A device for sealing incisions in the body of a patient wherein the device includes a bioabsorbable sealing member having an elongate shaft member and an elastomeric and flexible balloon member. The device may also include a preformed or injectable collagenous material associated therewith to hemostatically seal the incision in the body of the patient. The shaft member may include one or more lumens extending therethrough in flow communication with one or more balloon members thereon to provide a relatively simple device which effectively seals an incision in the body of a patient.

Inventors

  • 👤 Georges Katsaros
  • 👤 David G. Thomas
  • 👤 Richard D. Allison

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 13:43
CPC Classifications
A; A61; A61B; A61B17/00; A61B17/0057; A61B2017/00004

Claims Analysis

Total Claims: 56
Claim 1
Independent Claim 139 words
A method of sealing an incision or puncture in the body of a patient, the method comprising: providing a sealing means of a bioabsorbable material which includes a lumen therein and is absorbable within the body of the patient after a period of time sufficient for permitting effective closure of the incision; inserting the sealing means into the incision such that the distal end of the sealing means extends a short distance beyond the incision; causing the radial expansion of a portion of the sealing means; withdrawing the sealing means in the incision until the radially expanded portion of the sealing means contacts a predetermined portion of the incision to prevent the flow of fluids through the incision; and leaving the sealing means in a predetermined position in the incision to be absorbed within the body of the patient.
Claim 2
Independent Claim 139 words
A method of sealing an incision or puncture in the body of a patient, the method comprising: providing a sealing means of a bioabsorbable material which includes a lumen therein and is absorbable within the body of the patient after a period of time sufficient for permitting effective closure of the incision; inserting the sealing means into the incision such that the distal end of the sealing means extends a short distance beyond the incision; causing the radial expansion of a portion of the sealing means; withdrawing the sealing means in the incision until the radially expanded portion of the sealing means contacts a predetermined portion of the incision to prevent the flow of fluids through the incision; and leaving the sealing means in a predetermined position in the incision to be absorbed within the body of the patient.
Claim 3
Dependent Claim 34 words
The method as described in claim 1 further including the step of injecting a fluid into the lumen of the sealing means to cause the radial expansion of a portion of the sealing means.
Claim 4
Dependent Claim 38 words
The method as described in claim 1 wherein the distal portion of the sealing means includes a balloon member thereon and the method further includes the step of injecting a fluid therein to radially expand the balloon member.
Claim 5
Dependent Claim 47 words
The method as described in claim 1 wherein the sealing means includes a pair of balloon members thereon and the method further includes injecting fluids into the sealing means to radially expand the balloon members to retain the sealing means in the desired position in the incision.
Claim 6
Dependent Claim 28 words
The method as described in claim 1 wherein the method further includes inserting a hemostatic material into the incision about the sealing means to hemostatically seal the incision.
Claim 7
Dependent Claim 42 words
The method as described in claim 5 wherein the method further includes moving the hemostatic material which is a collagen material through the incision to a predetermined position in the incision wherein the collagen material is operatively associated with the sealing means.
Claim 8
Dependent Claim 46 words
The method as described in claim 5 wherein the sealing means includes an elongate shaft member and wherein the method further includes moving the hemostatic material along the shaft member to a predetermined position in the incision once the sealing means is positioned in the incision.
Claim 9
Dependent Claim 42 words
The method as described in claim 5 wherein the sealing means includes an elongate shaft member and wherein the method further includes injecting the hemostatic material through the shaft member to a predetermined position in the incision to hemostatically seal the incision.
Claim 10
Dependent Claim 41 words
The method as described in claim 1 wherein the sealing means is formed to include a plurality of balloon members thereon and wherein the method further included radially expanding a first balloon member adjacent to a distal portion of the incision.
Claim 11
Dependent Claim 51 words
The method as described in claim 9 wherein the method further includes radially expanding a second balloon member to retain the second balloon member in a predetermined position in the incision by engaging the tissue in the patient adjacent to the incision which is located proximally of the first balloon member.
Claim 12
Dependent Claim 33 words
The method as described in claim 10 wherein the method further includes inserting a hemostatic member about the sealing means to be positioned in the incision between the first and second balloon members.
Claim 13
Independent Claim 157 words
A method of sealing an incision or puncture in the body of a patient, the method comprising: providing a sealing means having an elongate shaft means thereon and at least a first radially expandable balloon member operatively associated therewith and wherein the shaft means and balloon member are formed of a bioabsorbable material which is absorbable within the body of the patient after a period of time sufficient for permitting effective closure of the incision; inserting the sealing means into the incision such that the first balloon member is positioned distally beyond the incision; injecting a fluid into the balloon member to radially expand the balloon member; moving the sealing means proximally in the incision until the balloon member contacts a predetermined portion of the incision to seal the incision from the flow of fluids therethrough; and leaving the sealing means in a predetermined position in the incision to be absorbed within the body of the patient.
Claim 14
Independent Claim 157 words
A method of sealing an incision or puncture in the body of a patient, the method comprising: providing a sealing means having an elongate shaft means thereon and at least a first radially expandable balloon member operatively associated therewith and wherein the shaft means and balloon member are formed of a bioabsorbable material which is absorbable within the body of the patient after a period of time sufficient for permitting effective closure of the incision; inserting the sealing means into the incision such that the first balloon member is positioned distally beyond the incision; injecting a fluid into the balloon member to radially expand the balloon member; moving the sealing means proximally in the incision until the balloon member contacts a predetermined portion of the incision to seal the incision from the flow of fluids therethrough; and leaving the sealing means in a predetermined position in the incision to be absorbed within the body of the patient.
Claim 15
Dependent Claim 29 words
The method as described in claim 12 further including the step of positioning a hemostatic material about the shaft means of the sealing means to hemostatically seal the incision.
Claim 16
Dependent Claim 30 words
The method as described in claim 13 wherein the method includes positioning the hemostatic material about the shaft means prior to the insertion of the sealing means in the incision.
Claim 17
Dependent Claim 27 words
The method as described in claim 13 wherein the method includes inserting the hemostatic material into the incision after the sealing means is positioned in the incision.
Claim 18
Dependent Claim 18 words
The method as described in claim 13 wherein the method includes injecting the. hemostatic material into the incision.
Claim 19
Dependent Claim 24 words
The method as described in claim 12 wherein the sealing means includes a lumen extending substantially through the shaft means of the sealing means.
Claim 20
Dependent Claim 18 words
The method as described in claim 12 wherein the sealing means includes a plurality of balloon members thereon.
Claim 21
Dependent Claim 45 words
The method of claim 18 wherein a first balloon member is associated with a distal portion of the sealing means and the method further includes expanding the first balloon member so that the first balloon member is adjacent to a distal portion of the incision.
Claim 22
Dependent Claim 40 words
The method of claim 19 wherein a second balloon member is associated with the shaft member and is spaced proximally therealong and the method further including expanding the second balloon member in the incision proximally of the first balloon member.
Claim 23
Dependent Claim 25 words
The method as described in claim 20 wherein the method further includes positioning a hemostatic material about the shaft means to hemostatically seal the incision.
Claim 24
Dependent Claim 35 words
The method as described in claim 21 wherein the method further includes positioning the hemostatic material about the shaft means of the sealing means prior to the insertion of the sealing means in the incision.
Claim 25
Dependent Claim 33 words
The method as described in claim 21 wherein the method further includes injecting the hemostatic material through the shaft means to be positioned in the incision between the first and second balloon members.
Claim 26
Dependent Claim 40 words
The method as described in claim 12 wherein the shaft means includes a plurality of lumens therein and the method further includes injecting a fluid therethrough to allow the selective radial expansion at least first and second balloon members thereon.
Claim 27
Dependent Claim 31 words
The method as described in claim 12 wherein the method further includes the visualization of the fluid injected into the balloon member to thereby enable the visualization of the sealing means.
Claim 28
Independent Claim 153 words
A device for sealing an incision formed in the body of a patient wherein the incision extends from the skin of the patient into a blood vessel of the patient, the device comprising: a bioabsorbable sealing means having a lumen therein and wherein said sealing means includes an elongate shaft means and inflatable means operatively associated therewith, said shaft means and inflatable means being sized to seal the incision from the flow of body fluids therethrough wherein said shaft means is sized to extend proximally into the incision from a location generally adjacent to the blood vessel and said inflatable means is oriented along said shaft means and is sized to extend in the blood vessel generally adjacent to the incision and being constructed in such a manner so as to be absorbable within the body of the patient after a period of time sufficient for permitting the effective closure of the incision.
Claim 29
Independent Claim 153 words
A device for sealing an incision formed in the body of a patient wherein the incision extends from the skin of the patient into a blood vessel of the patient, the device comprising: a bioabsorbable sealing means having a lumen therein and wherein said sealing means includes an elongate shaft means and inflatable means operatively associated therewith, said shaft means and inflatable means being sized to seal the incision from the flow of body fluids therethrough wherein said shaft means is sized to extend proximally into the incision from a location generally adjacent to the blood vessel and said inflatable means is oriented along said shaft means and is sized to extend in the blood vessel generally adjacent to the incision and being constructed in such a manner so as to be absorbable within the body of the patient after a period of time sufficient for permitting the effective closure of the incision.
Claim 30
Dependent Claim 41 words
The device of claim 26 wherein said inflatable means includes a first radial diameter for insertion of said sealing means in the incision and a second radial diameter for operatively retaining said sealing means in a predetermined position in the incision.
Claim 31
Dependent Claim 29 words
The device of claim 26 wherein said shaft means is an elongate member having said lumen therein and wherein said lumen is in flow communication with said inflatable means.
Claim 32
Dependent Claim 34 words
The device of claim 26 wherein said shaft means includes a distal portion thereon and said inflatable means is operatively associated with said distal portion to operatively retain said sealing means in the incision.
Claim 33
Dependent Claim 46 words
The device of claim 26 wherein said inflatable means includes a first balloon member having a first radial diameter for insertion of said sealing means in the incision and a second radial diameter for operatively retaining said sealing means in a predetermined position in the incision.
Claim 34
Dependent Claim 29 words
The device of claim 26 wherein said shaft means includes distal and proximal portions and said inflatable means is operatively associated with said distal portion of said shaft means.
Claim 35
Independent Claim 174 words
A device for sealing an incision formed in the body of a patient, the device comprising: a bioabsorbable sealing means having a lumen therein and wherein said sealing means includes an elongate shaft means and inflatable means operatively associated therewith, said shaft means and inflatable means being sized to seal the incision from the flow of body fluids therethrough and being constructed in such a manner so as to be absorbable within the body of the patient after a period of time sufficient for permitting the effective closure of the incision; said inflatable means including a first balloon member having a first radial diameter for insertion of said sealing means in the incision and a second radial diameter for operatively retaining said sealing means in a predetermined position in the incision: and wherein said inflatable means further includes a second balloon means having a first radial diameter for insertion of said sealing means in the incision and a second radial diameter for operatively retaining said sealing means in a predetermined position in the incision.
Claim 36
Independent Claim 174 words
A device for sealing an incision formed in the body of a patient, the device comprising: a bioabsorbable sealing means having a lumen therein and wherein said sealing means includes an elongate shaft means and inflatable means operatively associated therewith, said shaft means and inflatable means being sized to seal the incision from the flow of body fluids therethrough and being constructed in such a manner so as to be absorbable within the body of the patient after a period of time sufficient for permitting the effective closure of the incision; said inflatable means including a first balloon member having a first radial diameter for insertion of said sealing means in the incision and a second radial diameter for operatively retaining said sealing means in a predetermined position in the incision: and wherein said inflatable means further includes a second balloon means having a first radial diameter for insertion of said sealing means in the incision and a second radial diameter for operatively retaining said sealing means in a predetermined position in the incision.
Claim 37
Dependent Claim 26 words
The device of claim 32 wherein said first balloon means and said second balloon means are operatively spaced apart from each other along said shaft means.
Claim 38
Dependent Claim 30 words
The device of claim 32 wherein said shaft means includes a plurality of lumens operatively extending therethrough in flow communication with said first balloon means and said second balloon means.
Claim 39
Independent Claim 103 words
A device for sealing an incision formed in the body of a patient, the device comprising: a bioabsorbable sealing means having a lumen therein and wherein said sealing means includes an elongate shaft means and inflatable means operatively associated therewith, said shaft means and inflatable means being sized to seal the incision from the flow of body fluids therethrough and being constructed in such a manner so as to be absorbable within the body of the patient after a period of time sufficient for permitting the effective closure of the incision; and wherein said sealing means includes a hemostatic means operatively associated therewith.
Claim 40
Independent Claim 103 words
A device for sealing an incision formed in the body of a patient, the device comprising: a bioabsorbable sealing means having a lumen therein and wherein said sealing means includes an elongate shaft means and inflatable means operatively associated therewith, said shaft means and inflatable means being sized to seal the incision from the flow of body fluids therethrough and being constructed in such a manner so as to be absorbable within the body of the patient after a period of time sufficient for permitting the effective closure of the incision; and wherein said sealing means includes a hemostatic means operatively associated therewith.
Claim 41
Dependent Claim 16 words
The device of claim 35 wherein said hemostatic means is operatively oriented about said shaft means.
Claim 42
Dependent Claim 15 words
The device of claim 35 wherein said hemostatic means is formed of a collagenous material.
Claim 43
Independent Claim 171 words
A device for sealing an incision formed in the body of a patient wherein the incision extends from the skin of the patient into a blood vessel of the patient, the device comprising: a bioabsorbable sealing means wherein said sealing means includes an elongate shaft means and a manually expandable member thereon, said shaft means including at least one lumen associated therewith in flow communication with said expandable member, said shaft means and said expandable member being sized to seal the incision from the flow of body fluids through the incision wherein said shaft means is sized to extend between the skin of the patient and a location generally adjacent to the blood vessel of the patient and said inflatable means is oriented along said shaft means and is sized to be received in the blood vessel generally adjacent to the incision and being constructed in such a manner so as to be absorbable within the body after a period of time sufficient for permitting the effective closure of the incision.
Claim 44
Independent Claim 171 words
A device for sealing an incision formed in the body of a patient wherein the incision extends from the skin of the patient into a blood vessel of the patient, the device comprising: a bioabsorbable sealing means wherein said sealing means includes an elongate shaft means and a manually expandable member thereon, said shaft means including at least one lumen associated therewith in flow communication with said expandable member, said shaft means and said expandable member being sized to seal the incision from the flow of body fluids through the incision wherein said shaft means is sized to extend between the skin of the patient and a location generally adjacent to the blood vessel of the patient and said inflatable means is oriented along said shaft means and is sized to be received in the blood vessel generally adjacent to the incision and being constructed in such a manner so as to be absorbable within the body after a period of time sufficient for permitting the effective closure of the incision.
Claim 45
Dependent Claim 54 words
The device of claim 38 wherein said shaft member is sized to receive a fluid containing member operatively associated therewith such that fluid from said fluid containing member may be received in said expandable member to cause the radial diameter of said expandable member to increase in response to the receipt of fluid therein.
Claim 46
Dependent Claim 20 words
The device of claim 38 wherein said expandable member is a flexible member formed to manually receive a fluid therein.
Claim 47
Dependent Claim 13 words
The device of claim 40 wherein said fluid includes a radiopaque material therein.
Claim 48
Dependent Claim 16 words
The device of claim 38 wherein said expandable member is formed of an elastomeric bioabsorbable material.
Claim 49
Dependent Claim 16 words
The device of claim 38 wherein said shaft means is formed of a semi-rigid bioabsorbable material.
Claim 50
Dependent Claim 18 words
The device of claim 38 wherein said expandable member includes a pair of radially expandable balloon members thereon.
Claim 51
Dependent Claim 16 words
The device of claim 44 further including a hemostatic material operatively positioned about said shaft means.
Claim 52
Dependent Claim 25 words
The device of claim 45 wherein said hemostatic material is operatively positioned between said balloon members which are operatively space apart along said shaft means.
Claim 53
Independent Claim 118 words
A device for sealing an incision formed in the body of a patient, the device comprising: a bioabsorbable sealing means wherein said sealing means includes an elongate shaft means and a manually expandable member thereon, said shaft means including at least one lumen associated therewith in flow communication with said expandable member, said shaft means and said expandable member being sized to seal the incision from the flow of body fluids through the incision and being constructed in such a manner as to be absorbable within the body after a period of time sufficient for permitting the effective closure of the incision; and further including a hemostatic material operatively surrounding at least a portion of said shaft means.
Claim 54
Independent Claim 118 words
A device for sealing an incision formed in the body of a patient, the device comprising: a bioabsorbable sealing means wherein said sealing means includes an elongate shaft means and a manually expandable member thereon, said shaft means including at least one lumen associated therewith in flow communication with said expandable member, said shaft means and said expandable member being sized to seal the incision from the flow of body fluids through the incision and being constructed in such a manner as to be absorbable within the body after a period of time sufficient for permitting the effective closure of the incision; and further including a hemostatic material operatively surrounding at least a portion of said shaft means.
Claim 55
Dependent Claim 14 words
The device of claim 47 wherein said hemostatic material is an injectable collagenous material.
Claim 56
Dependent Claim 25 words
The device of claim 47 wherein said hemostatic material is a preformed collagenous material which operatively surrounds at least a portion of said shaft means.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1998-05-08 1998-11-07 1999-05-09 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2002-05-08 2002-11-07 2003-05-09 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2006-05-08 2006-11-07 2007-05-09 $7700.00 Window Closed / Lapsed

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