Method for implanting a removable medical apparatus in a human body

• US 5,649,906 A
• Filed: 01/19/1995
• Issued: 07/22/1997
• Est. Priority Date: 07/17/1991
• Status: Expired due to Term

• Current Assignee: Celsa B Braun
• Original Assignee: Gilles Bovyn, Pierre Gory
• Inventors: Bovyn, Gilles, Gory, Pierre
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US08/374,835
• Time in Patent Office: 915 Days
• Field of Search: 604/49, 604/52, 604/53, 604/96, 604/104-106, 604/164-165, 604/171, 604/175, 604/280, 606/192, 606/194, 606/198, 606/200, 606/108
• US Class Current: 606/108
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0071 spherical

Abstract

A method for removably implanting in an implantable zone of a human body, preferably a vein, a divisible and flexible stem is disclosed. The stem includes a distal end and a proximal end, and may further includes a medical apparatus or implant fixed to one end of the stem. The method includes forming an access route to an implantation zone in a human body, followed by introducing a medical apparatus or implant into the body through the access route with the distal end of the stem first so as to implant the apparatus in the implantation zone, the stem having a length sufficient to extend along the route. The method further includes providing a locating member on a proximal end of the stem, the member being adapted to being disposed subcutaneously for locating the stem through the skin of the patients body. Thereafter, the locating member and the proximal end of the stem are disposed subcutaneously in the body in proximity to the access route. The step of disposing includes forming within the patients body in proximity to the access route, a small space for disposing therein the locating member fixed to the proximal end. After temporary implanting an implant, a removable strengthening cable can be inserted in the stem in order to displace the implant along the sheath during its positioning in an implantable zone such as a vein, in particular in the inferior vena cava of a patient. This implant can be easily removed after a certain period, when the risks of pulmonary embolism for example, is no longer feared. In the present invention, the medical apparatus may include at least one of a stent and a drug delivery means.

Claims

1. A method for medically operating within a patient'"'"'s body by means of an implantable apparatus comprising a divisible stem implantable within the body, the stem having a proximal and a distal end, the method comprising the steps of:

forming an access route to an implantation zone in the body;

introducing the apparatus into the body through the access route with the distal end of the stem first so as to implant the apparatus in the implantation zone, the stem having a length sufficient to extend along the route;

providing a locating member on the proximal end of the stem, the locating member being adapted to being disposed subcutaneously for locating the stem through the skin surface of the body;

disposing the locating member and the proximal end of the stem subcutaneously in the body in proximity to the access route;

the step of disposing includes forming, within the patient'"'"'s body in proximity to the access route, a small space for disposing therein the locating member fixed to the proximal end;

closing the small space in which is disposed the locating member fixed to the proximal end of the stem, whereby the locating member and the stem remain disposed in the body.

2. A method according to claim 1, wherein the stem is a catheter, and wherein the step of introducing the apparatus further comprises:

introducing through the access route, a guide wire, the guide wire extending to the implantation zone in which the apparatus is to be implanted;

introducing around the guide wire an elongated mandrel disposed within an elongated sheath;

withdrawing the guide wire and the mandrel from the patient'"'"'s body;

providing the catheter with an inner strengthening cable adapted to be removably disposed within the catheter;

introducing, into the sheath extending to the implantation zone, the distal end first and then the proximal end;

withdrawing the sheath from the patient'"'"'s body while leaving the apparatus in the implantation zone;

withdrawing the strengthening cable from the catheter; and

cutting the catheter at the proximal end, near the skin surface.

3. A method according to claim 1, wherein:

said implantation zone is a blood vessel; and

said step of forming an access route includes one of forming said access route percutaneously and forming said access route by denudation of said blood vessel.

4. A method for medically operating within a patient'"'"'s body by means of an implantable apparatus comprising a divisible extension stem implantable within the body, the stem having a proximal and a distal end, the method comprising the steps of:

forming an access route to an implantation zone through a skin surface of the body;

introducing the apparatus into the body through the access route with the distal end first so as to implant the apparatus in the implantation zone, the stem having a length sufficient to extend along the route;

wherein the length of the stem is such that the proximal end thereof extends out of the patient'"'"'s body when the apparatus is introduced into the body;

cutting the stem at the proximal end before providing the proximal end with a locating member, whereby a remaining length of the stem is adapted to the length of the access route;

providing the locating member on the proximal end of the stem, the locating member being adapted to being disposed subcutaneously for locating the stem through the skin surface of the body;

disposing the locating member and the proximal end of the stem subcutaneously in the body in a position in proximity to the access route; and

closing the access route, whereby the locating member, the stem, and the apparatus remain subcutaneously disposed in the body with the position of the locating member being discoverable by palpation.

5. A method according to claim 4, wherein:

the divisible stem is a catheter;

the implantation zone is in a blood vessel;

a vascular intervention means is fixed to the distal end of the stem; and

the step of introducing the apparatus into the body comprises the step of introducing the vascular intervention means into the blood vessel.

6. A method for medically operating within a patient'"'"'s body by means of an implantable apparatus comprising a medical intervention means adapted for medically operating within an implantation zone of the body and a divisible extension stem implantable within the body, the stem having a proximal and a distal end, and the medical intervention means being fixed to the distal end, the method comprising the steps of:

forming an access route to an implantation zone through a skin surface of the body;

introducing the apparatus into the body through the access route with the medical intervention means first so as to implant said intervention means in the implantation zone, the stem having a length sufficient to extend along the route, said step of introducing including;

introducing through the access route, a guide wire, the guide wire extending to the implantation zone in which the medical intervention means is to be implanted;

introducing around the guide wire an elongated mandrel disposed within an elongated sheath;

withdrawing the guide wire and the mandrel from the patient'"'"'s body;

providing the catheter with an inner strengthening cable adapted to be removably disposed within the catheter;

introducing, into the sheath extending to the implantation zone, the medical intervention means first and then the catheter;

withdrawing the sheath from the patient'"'"'s body while leaving the medical intervention means in the implantation zone;

withdrawing the strengthening cable from the catheter; and

cutting the catheter at the proximal end, near the skin surface;

providing a locating member on the proximal end of the stem, the locating member being adapted to being disposed subcutaneously for locating the stem through the skin surface of the body;

disposing the locating member and the proximal end of the stem subcutaneously in the body in proximity to the access route, the step of disposing including forming, within the patient'"'"'s body in proximity to the access route, a small space for disposing therein the locating member fixed to the proximal end; and

closing the access route, whereby the locating member, the stem, and the medical intervention means remain disposed in the body.

7. A method for medically operating within a patient'"'"'s body by means of an implantable apparatus comprising a medical intervention means adapted for medically operating within an implantation zone of the body and a divisible extension stem implantable within the body, the stem having a proximal and a distal end, and said medical interventions means being fixed to the distal end, the method comprising the steps of:

forming an access route to a blood vessel through a skin surface of the body, said step of forming an access route including one of forming said access route percutaneously and forming said access route by denudation of said blood vessel;

introducing the apparatus into the body through the access route with the medical intervention means first so as to implant said intervention means in the implantation zone, the stem having a length sufficient to extend along the route;

wherein the length of the stem is such that the proximal end thereof extends out of the patient'"'"'s body when the medical intervention means is introduced into the implantation zone, the method comprising the further step of cutting the stem at the proximal end before providing the proximal end with the locating member, whereby the length of the stem is adapted to the length of the access route;

providing a locating member on the proximal end of the stem, the locating member being adapted to being disposed subcutaneously for locating the stem through the skin surface of the body;

disposing the locating member and the proximal end of the stem subcutaneously in the body in proximity to the access route; and

closing the access route, whereby the locating member, the stem, and the medical intervention means remain subcutaneously disposed in the body.

8. A method for medically operating within a patient'"'"'s body by means of an implantable apparatus comprising a medical intervention means adapted for medically operating within an implantation zone of the body and a divisible extension stem implantable within the body, the stem having a proximal and a distal end, and said medical interventions means being fixed to the distal end, the method comprising the steps of:

forming an access route to an implantation zone through a skin surface of the body;

introducing the apparatus into the body through the access route with the medical intervention means first so as to implant said intervention means in the implantation zone, the stem having a length sufficient to extend along the route;

wherein the length of the stem is such that the proximal end thereof extends out of the patient'"'"'s body when the medical intervention means is introduced into the implantation zone, the method comprising the further step of cutting the stem at the proximal end before providing the proximal end with the locating member, whereby the length of the stem is adapted to the length of the access route;

providing a locating member on the proximal end of the stem, the locating member being adapted to being disposed subcutaneously for locating the stem through the skin surface of the body;

disposing the locating member and the proximal end of the stem subcutaneously in the body in proximity to the access route, said step of disposing including forming, within said patient'"'"'s body in proximity to said access route and close to said skin surface, a small space for disposing therein said locating member fixed to said proximal end, whereby said locating member is detectable by palpation though said skin surface; and

closing the access route, whereby the locating member, the stem, and the medical intervention means remain subcutaneously disposed in the body.